**PRESIDENTIAL ADVISORY COUNCIL**

**ON HIV/AIDS**

**34th MEETING**

**MONDAY, OCTOBER 15**

**AND TUESDAY, OCTOBER 16, 2007**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**HUBERT HUMPHREY BUILDING**

**200 INDEPENDENCE AVENUE, SW**

**WASHINGTON, D.C.**

*Transcript by:*

*Federal News Service*

*Washington, D.C.*

**INDEX**

**Monday, October 15, 2007**

> **PAGE**

**Welcome 1**

***Marty McGeein, MBA, BSN, RNC, RN***, Executive Director, PACHA

**National HIV Testing Mobilization Campaign Announcement 2**

**Panel Discussion: Insurance Reimbursement Policies for HIV Testing
20**

***Andrew Baskin. M.D.,*** National Medical Director for Medical Policy

and Program Support, Aetna

***Robert Thomas, M.D.***, Medical Director for Clinical Affairs,

CareFirst Blue Cross and Blue Shield

***Joseph Razes***, Technical Director, Divisions of Advocacy and
Special Initiatives,

Centers for Medicare and Medicaid Services

**Crystal Methamphetamine Epidemic 48**

***Nora D. Volkow, M.D.,*** Director, National Institute on Drug Abuse,

National Institutes of Health

**Update on CDC Testing Initiative 66**

***Bernard M. Branson, M.D.,*** Associate Director for Laboratory
Diagnostics,

Divisions of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention, Centers for Disease Control and
Prevention

**AIDS Epidemic in the Caribbean 83**

***Lisa Fitzpatrick, M.D., M.P.H.,*** Director, Caribbean Regional
Office,

Barbados, Global AIDS Program, Centers for Disease Control and
Prevention

**Tuesday, October 16, 2007**

**Welcome 99**

***Raymond V. Gilmartin,*** PACHA Co-Chair

**Appreciation for Service 99**

***Edward C. Green, Ph.D.***

**Update on HIV Travel Issue 109**

***Igor V. Timofeyev,*** Director of Immigration Policy and Special
Advisor

for Refugee and Asylum Affairs, Policy Directorate,

Department of Homeland Security

**Report on the National Conclave on HIV/AIDS Policy for Black Clergy
119**

***Debra Fraser Howze,*** President and CEO, National Black Leadership
Commission

On AIDS

**Listening Session 128**

***Anna Mitchell,*** Associate Director, Domestic Policy Council, The
White House

**PEPFAR Reauthorization 138**

***The Honorable Mark R. Dybul,*** Ambassador, U.S. Global AIDS
Coordinator

**Motions and Voting 160**

**Public Comment Period 174**

**ADJOURN**

**PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS**

**MEMBERSHIP**

Troy Benavidez

AstraZeneca Pharmaceuticals

Wilmington, DE

Robert Bollinger, Jr., M.D., M.P.H.

Johns Hopkins School of Medicine

Baltimore, MD

Cheryll Bowers-Stephens, M.D., M.B.A.

The Schopenhauer Group, LLC

New Orleans, LA

Freda Bush, M.D., FACOG

East Lakeland OB-GYN Associates

Jackson, MS

Shenequa Flucas

Beaumont, TX

Raymond V. Gilmartin

Harvard Business School

Boston, MA

Robert Kabel, J.D.

Baker & Daniels, LLP

Washington, DC

Reverent Herbert Lusk II

Philadelphia, PA

David J. Malebranche, M.D., M.P.H.

Emory University

Atlanta, GA

John C. Martin, Ph.D.

Gilead Sciences, Inc.

Foster City, CA

Marilyn A. Maxwell, M.D.

St. Louis University

St. Louis, MO

Jose A. Montero, M.D., FACP

Tampa General Hospital

Tampa, FL

Beny J. Primm, M.D.

The Addiction Research and Treatment

Corporation

Brooklyn, NY

Robert R. Redfield, M.D.

University of Maryland

Baltimore, MD

Carl Schmid II, M.B.A.

Washington, DC

Barbara Wise

WiseChoices, Inc.

Littleton, CO

Ram Yogev, M.D.

Children\'s Memorial Hospital

Chicago, IL

**SPEAKERS LIST**

Andrew Baskin, M.D.

Aetna, Inc.

Blue Bell, PA

Christopher Bates, M.P.A.

Office of HIV/AIDS Policy

U.S. Department of Health

and Human Services

Washington, D.C.

Bernard M. Branson, M.D.

Division of HIV/AIDS Prevention

U.S. Department of Health

and Human Services

Washington, D.C.

Mark R. Dybul, M.D.

U.S. Global AIDS Coordinator

U.S. Department of State

Washington, D.C.

Lisa K. Fitzpatrick, M.D., M.P.H.

Global AIDs Program

U.S. Department of Health

and Human Services

Atlanta, GA

Debra Fraser-Howze

National Black Leadership Commission

on AIDS, Inc.

New York, NY

Anna Mitchell

Domestic Policy Council

The White House

Washington, D.C.

Joseph A. Razes

Centers for Medicare & Medicaid

Services

U.S. Department of Health

and Human Services

Washington, D.C.

Igor V. Timofeyev, J.D.

Policy Directorate

U.S. Department of Homeland Security

Washington, D.C.

Nora D. Volkow, M.D.

National Institute on Drug Abuse, NIH

U.S. Department of Health

and Human Services

Bethesda, MD

MARTY McGEEIN: Thank you. I would ask that the PACHA members to please
take their places. Oh, look at how casually Dr. Yogev is strolling up
there.

Okay. As you can probably tell, I'm not Dr. Maxwell, just in case there
was any confusion here. Her plane -- she got bumped off a flight last
night and she should be in the air now coming from Colorado Springs, and
so I said, "No problem. I will open up," and then eventually we will
turn this over to Carl Schmid to handle the panel, one of the panelists
currently here.

So, good morning, and welcome to the 34^th^ meeting of the President's
Advisory Council on HIV/AIDS. I am delighted some of -- most of you
could join us. We've had some members with -- that developed conflicts
at the last minute and they will be either be joining us later or they
will be here tomorrow. And we will lose one member tomorrow.

Before we actually begin the business of the day, I want to tell you
that there are some new security rules for the Department of Health and
Human Services. You may have noticed it as you came in. You got a little
tighter scrutiny than you had in the past, which was tight enough, but
the badge that you have on your -- on your PACHA badge -- this goes for
both the members and for the members of the audience -- allows you only
access to the restrooms, and in this case, to cafeteria. Ordinarily, it
would only be the restrooms and the elevator. So you will be asked to
show identification. There's security in the hall. You'll be asked to
show identification if you do seem to wander off anyplace other than the
cafeteria, and I think they're not checking the bathrooms, thank
goodness. But I just wanted to let you know. It is part of an ongoing
and long-term effort to increase security across the board.

Our meeting today is, as it usually is, divided between domestic, day
one and international, day two. We have a very interesting discussion
today. It ranges from how insurance companies pay for health insurance
or HIV testing, all the way to what's happening in the Caribbean, which
is at the special request of Dr. Primm.

I'm going to ask that we go around and introduce ourselves, less for me
because I actually know you guys, but more importantly, for our
recorder. Again, I am Marty McGeein. I'm the executive director of PACHA
and I am the principal deputy assistant secretary at HHS. Dr. Redfield?

DR. ROBERT REDFIELD: Bob Redfield, I'm from the Institute of Human
Virology, University of Maryland.

DR. EDWARD GREEN: I'm Ted Green, Edward Green, Harvard School of Public
Health.

MR. BOB KABLE: Bob Kable from Washington, DC.

DR. RAM YOGEV: Ram Yogev, Children's Memorial Hospital, Chicago.

BARBARA WISE: Barb Wise, speaker for Wise Choices.

DR. BENY PRIMM: I'm Beny Primm from New York City, of the Addiction
Research and Treatment Corporation.

DR. JOSE MONTERO: I'm Jose Montero from the University of South Florida,
College of Medicine.

DR. DAVID MALEBRANCHE: David Malebranche, Division of General Medicine
at Emory University in Atlanta.

SHENEQUA FLUCAS: Shenequa Flucas, outreach educator for Triangle AIDS
Network.

DR. FRIEDA BUSH: Frieda Bush, private practice, OB/GYN in Jackson
Mississippi and clinical faculty, University of Mississippi.

JOHN MARTIN: John Martin, Gilead Sciences.

CARL SCHMID: Carl Schmid, the AIDS Institute, Washington, DC.

MS. McGEEIN: And Carl is chair of our domestic subcommittee and Dr.
Redfield is chair of our international subcommittee. If you look at your
agenda, it appears as though we are loosely scheduled this morning, and
then from there on, we just put your little noses to the grindstone and
grind away. But we -- since we are actually running a little ahead of
time, I'm going to check to make sure that Christopher is good to go?
Christopher, good to go. Okay.

This is actually an interesting day. It is a special memorial -- a
special day that Christopher will talk about, as will Miguel Gomez, but
today, we are rolling out the National HIV Testing Mobilization
Campaign. The legitimate question could be why are we doing this at
PACHA, in particular? There are a couple of very relevant points. PACHA
asked that we start looking at how we increase testing and the Office of
Public Health and Science answered.

For those of you who don't know, Christopher Bates is the acting
director of the Office of HIV/AIDS -- HIV/AIDS policy -- say that fast
three times -- here at the department and he is located within the
Office of Public Health and Science.

In December 2005, PACHA produced a series of recommendations for a new
America HIV strategy, several of which are directly relevant to this
campaign. You asked that HIV testing be a routine part of primary care
in the United States. You stated that because HIV testing is the gateway
to HIV treatment and care, testing should be encouraged wherever
possible. And you further stated, with very strong emphasis, that the
federal government needs a comprehensive, invigorated campaign,
communication campaign, of our domestic HIV/AIDS policy. The National
HIV Testing Mobilization Campaign that we are launching here today
represent OPHS's, Office of Public Health and Science, part of the
administration's efforts to address your recommendations.

And with that, I will turn it over to Christopher. There you are.

CHRISTOPHER BATES: Good morning. Oh, God, you'll have to do better than
that. Good morning. Yes, let's get some energy going.

I'm really happy to be here to re -- can you hear me, okay, good -- to
reintroduce, I think, to you the mobilization campaign. I spoke to you
about it a year ago as an idea that we had in the Office of HIV/AIDS
Policy. Well, now it's a reality and what you see on the screen there
are the several fliers that we have adapted for this mobilization
campaign, and we're really proud of them. And as you can see, they
reflect the subpopulations, as well as the general populations' impact,
by this epidemic.

The reason this campaign is important is not simply because of the sense
of urgency that you all expressed, but because the CDC has indicated
that nearly a quarter of the 1.3 million Americans who are living with
HIV do not know their status. They're HIV positive, don't know their
status, and should be brought into care and treatment. So this campaign
helps facilitate that. It gives us an opportunity to not only bring
those folks into care and treatment opportunities, but it gives us an
opportunity to further educate the general public and highly impact the
population about the importance of HIV testing and the impact that this
disease has in our country.

I'm trying to stick to the script, so that I could also keep to the
time.

We are basing the root of this campaign on staying healthy, and what
we're saying to Americans is that if you are between the ages of 13 and
65, which is identified in the CDC's new HIV testing guidelines, is that
you should be tested for HIV. And with the new emphasis placed on the
routinization of HIV, we think that this campaign is going to be a very
strong element to help further that along in our clinical settings.

I think, without going into further babble about that campaign, because
most of you know about it and I think it's very self-explanatory, I'd
really like to field your questions. And, Marty, if you want to
participate in this with me, you can, but I'll take the heat at this
point.

MS. McGEEIN: Ah, good. (Laughter.) Questions from the table?

DR. PRIMM: Let me not allow you to get away without some questions,
Christopher. I'm concerned about the CDC's monies and testing.
Apparently, there was \$45 million that were funded, were given for the
heightened awareness of -- to fight HIV among African-American campaign,
and only \$35 billion now have been allocated to jurisdictions that
support that effort. I'd like some answers about that.

In terms of the original proposal that was issued by the CDC called for
about 1.5 million African-Americans to learn their HIV status, and now
I'm hearing that there's only about one third of that group, or about
one million people, that you are targeting. That to me seems to be quite
shocking, particularly with the problems in the African-American
community as they are. Can you do some explanation about that?

MR. BATES: Sure. First of all, let me -- just for a bit of background --
all the states received from the CDC HIV testing money, and the states
also conduct, as a part of that effort, an assessment of which are the
impacted populations. So states really do heed to where they should
place an emphasis in terms of their HIV testing activities. And most of
the highly impacted states with large portions of racial and ethnic
minority folks are, in fact, targeting their efforts towards this -- or
these populations.

In addition, we are referencing the \$45 million that Dr. Gerberding was
able to get from the Congress, does, in fact, support additional efforts
on top of what's presently being done by the states to, in fact, address
HIV as it relates to African-Americans. There will also be a piece of
that that will relate to Latinos as well.

So the two most impacted populations will have their HIV prevention
activities strengthened and more targeted that has been done in the
past. They really are focusing on about, I think, 16 -- and we have a
colleague here from the CDC in the back, Eva Margolies, who might be
able to add to that, but I believe there are 16 cities and states that
are being highly targeted, and that right now is making an assessment
about where they might want to do additional work, particularly in rural
communities. So I think that over the next couple of months, you'll see
those remaining dollars probably released.

DR. PRIMM: But what about the extra -- the \$10 million that's left
over, what -- would you have somebody answer that question for us
sometime today because that's quite a considerable sum of money.

MR. BATES: Eva may know.

EVA MARGOLIES: Thank you. Hi, I'm Eva Margolies. I'm the policy director
for the National Center for HIV, STD, and TB Prevention at CDC. Just to
clarify slightly, the \$45 million was not -- Dr. Gerberding found that
within CDC's budget. Congress did not give that to us, and we did put
out \$35 million that went to 23 states in local health departments, and
the criteria was based on their percentage of AIDS cases, and that's how
we determined who was eligible. Beny, I don't know if we're going to be
able to get it to you by today, but the remaining money was used to
support testing efforts and going towards some activities, such as
social marketing campaigns to get people in to be tested. Some of it's
being used internally for contracts, but it's all around testing. I can
get that for the council, but I probably won't be able to get it today.
I can send a message back. I just don't have that information with me.

And regarding the number of tests, that was an estimate of what we
thought the money could buy, and we really won't know how many tests
have been conducted until after the health departments report back to us
about the number of tests that were performed. All the money was to be
used in high-risk areas, highly focused with the intent of identifying
as many HIV positive people who are unaware of their status as possible.
So I hope that helps.

DR. PRIMM: Somewhat. I just participated in a meeting in New York last
Monday and Tuesday, where over 100 African-American ministers and a
number of physicians from the National Medical Association attended that
meeting at Time Warner, sponsored by the Black Leadership Commission on
AIDS. And I was quite, quite excited about the responses of these
African-American ministers from all parts of the country relative to
testing and to the acceptance of heightened awareness to be given to
their respective congregations repeatedly on Sundays and other times
when the church is out. And that was quite, quite impressive.

And I'm wondering, are we going to be targeting those institutions in
the church to provide for them ways to be able to better test for people
who want to volunteer to step forward to get tested in the
African-American community? And I think that would be one of the focuses
of the CDC and of any other effort, and to support that effort. You were
there, Chris, as you know, and you witnessed the receptivity of that
audience, which is quite different than what we have seen in the past.
So would you comment on that, please?

MR. BATES: Two things. One is, we have continued to do outreach to
African-American churches, as well as other community faith leaders
around the country. With the heightened response that the CDC is doing
with this campaign, we have every, every intention of partnering with
most of those denominations that were represented there and many of the
ministers there, and the media activity around public forums and
community town hall meetings, where we hope to both, not only advocate
for HIV and AIDS, but also work with local health departments and some
of the community based organizations that will be providing HIV testing
opportunities either on site, at the time that these events take place,
or offsite. And we'll make sure that they have the information so people
will know where to go and they'll know how to access testing
opportunities.

DR. PRIMM: Kevin was there, but he had to leave and I'm wondering
whether this message is being carried back to Dr. Gerberding and people
at the CDC, so they can move on this pretty fast and furious. I would
like for this committee to make recommendations to the president that
that happens.

MR. BATES: Okay. If you recall, one of the documents in the binder was,
in fact, a form that all of the participating ministers were asked to
complete, which would identify a representative in their denomination or
from their church that we could start an ongoing dialogue with, hoping
to provide them technical assistance and support as they move forward,
trying to create these opportunities for testing at the multiple
churches that were represented there at that event.

MS. McGEEIN: Two things and I know I've got two questions here. First of
all, there will be a speaker tomorrow morning to give us a recap of what
happened at the meeting. And so this -- we are not leaving this topic
for very long, but could you tell me exactly what the campaign is going
to do?

MR. BATES: Okay. The campaign at this -- this campaign is situated much
different than a lot of the other efforts that we've done. In the past,
the department has gone out and tried to create events and at those
events, give us opportunities to market our information. Instead, what
we're going to do is go through a series of exercises to identify events
that are taking place across the country by organizations, groups, and
institutions, such as conferences, conventions, and forums. We'll invite
ourselves in. We'll have three opportunities of engagement with them.

One is just to pass out information and to have people available to
field questions about HIV testing and where to go get tested. Two, we'll
be prepared to offer workshops on HIV testing and AIDS 101. And three,
we hope, in some instances, to be able to invite federal officials in to
be speakers at plenary sessions and major gatherings where they will
have large audiences, and we can actually engage with people around the
HIV testing message in a different way.

MS. McGEEIN: Do you have a target?

MR. BATES: We hope to touch about three to four million people over the
next year.

MS. McGEEIN: Is this on the campaign?

MS. : Yes.

MS. McGEEIN: Because Dr. Redfield is about to explode. Yes.

MR. SCHMID: I guess that was really my question too. What exactly is the
campaign, but I guess to take it further, is the White House or the
secretary going to issue a press release today on this? Is there going
to be a press conference? Are there going to be PSAs on TV? Are these
going -- these documents, they look great. Are they going to be in
doctors' offices around the country? I guess, just to take it a little
further.

MR. BATES: Okay, great questions. One is that we do have 10 people out
in the regions who will be moving our materials in a whole host of
venues and some of that will be to put in the hands of public health
departments. Also, we will have all of this information on the -- on our
webpage and it will be downloadable, and we'll encourage people to do
that, to download this information and to make it available that way.

In addition, we will, in fact, have PSAs, both radio and TV, and a part
of what we did in New York on last Monday was we had six ministers, both
male and female, who sat with us and we were able to create a TV video
PSA. And then we had a couple also radio spots done by some of the
ministers participating in that meeting. We hope to have that material
available probably by the end of November. And we've got a commitment
from BET, I should say, on that same day to air it and Creflo Dollar,
who also has a TV evangelist program is also going to air our TV PSA. We
will be working with a marketing group to do work for radio with our
radio spot.

MS. McGEEIN: Mr. Redfield?

DR. REDFIELD: I wanted to follow up on Lenny's point. I think, as you
look at how to try to reach this 25 to whatever -- 50 percent of
Americans that don't know they're infected, and particularly, with the
epidemic concentrating in the African-American community, I think more
aggressively taking advantage of the structural realities of the church
is fundamentally critical.

And -- I've sort of -- as an old-timer who's been involved in this since
the beginning, almost over a quarter of century now, I don't recall of
any targeted initiative that the Department of Health and Human Services
has had that tried to totally embrace the faith community, the mosque
community, the temple community, to become a point of diagnosis. And I
think there may be opportunities to expand that.

And we have some small pilots that we've done in Baltimore, but they're
very hard to get funded to go into the church community. We, like Lenny,
have found that the pastors now are ready. They probably weren't ready
before, so I'm not being critical of the fact we hadn't done it before
because you can't do something if the people aren't ready to invite you
in. But I think they are ready now in many communities.

And so one may want to look much more -- re-look at this of how to have
an initiative to get diagnosis established, not in emergency rooms only,
not in hospitals only, not in clinics only, but the idea of doing it in
the structural institution of church, temples, mosques, where people can
feel a little safer. And if the church community could get into
facilitating diagnosis and then providing that sense of that safety with
education support, I think you could probably get a large majority of
those individuals who don't know they're infected to have that knowledge
much more rapidly than just the program that's targeting medical
establishments. So what I'm suggesting is some internal debate to really
re-look at, could we do something even more aggressive about trying to
engage the church community as a point of diagnosis?

MR. BATES: Okay. If your recall, in the president's FY'07 budget, he, in
fact, asked for \$25 million to be targeted to African-American faith
communities. In this instance, those monies were never realized. But in
spite of that, the CDC continues, and so does our office continue,
through the minority AIDS initiative, to move forward a dialogue with
faith communities, both African-American and Latino, around
opportunities for, not only doing HIV testing, but also educating these
communities about the epidemic in ways in which to protect themselves
from the transmission of HIV.

So I appreciate this, and hopefully the PACHA will continue to support
us in our efforts to try to bring more emphasis on these organized
communities and to use the faith community as a strong vehicle for these
messages.

DR. REDFIELD: Just a quick follow-up, but, Chris, what do you think
right now are the major barriers to diagnosis that we're not addressing
as optimally as we could?

MR. BATES: I -- two things that I've seen that worked really well
recently, and that's when leadership in communities actually take the
test in public settings. That has been very, very effective. Jesse
Jackson has been doing a lot of that recently. Some of the other pastors
who were at this meeting that we just had have been doing that. That's
been effective.

It's also been effective when faith leaders and other community leaders
actually talk about HIV, actually engage a dialogue around the epidemic
and the importance of testing and the importance of people, are really
getting to a place of taking charge of their health and being in the
control of their lives. I don't think that that has been done at the
same levels that health departments have gone out and tried to move
their messages through community health workers. I think it's a
different dynamic.

And now that we have this movement of leadership around the country,
both in African-American organizations national, and also Latino
organizations national, we're starting to see a change. But the whole
issue of stigma associated with HIV testing is real and every day we're
trying to address that.

MS. McGEEIN: Frieda?

DR. BUSH: Yes, Chris, good morning

MR. BATES: Yes, good morning.

DR. BUSH: I wanted to follow up on the question about what's being done
in private practice. Being a private practitioner, getting awareness of
literature, and even knowing that is downloadable, is something that the
person in the everyday nine to five -- well, not nine to five, but
everyday trying to make a living, may not really be aware of it. We
don't necessarily watch BET and PSAs, anything.

And I'm thinking getting the information out to the everyday private
practitioner, and perhaps utilizing the organized medicine. I know you
referenced AMA a minute ago, but there are other organized medicine
areas where African-Americans in particular may also participate, the
AMA, the ACOG, the Southern Medical and community health centers.
There's a large network of those that are not health departments.

MR. BATES: Okay. Please be sure to understand that the CDC has met with
all of the national medical groups, all of the HMOs and the like, and
have had extensive conversation about the importance of even downloading
their material that's presently available on the webpage. I think this
is going to be a slow and probably difficult process to get everybody on
board, but local health departments, state health departments are
definitely moving the conversation about the importance of integrating
into the clinical settings, conversations about HIV prevention,
opportunities for HIV testing.

Specifically, we see a lot of movement around testing of pregnant women.
And so I think this is going to be an evolving process that's going to
happen over a period of time. This has been in play for about two years
now, and I think we've moved a long way ahead. I think there's a lot of
work to be done, but it's not all going to rest on the shoulders of the
federal government. We really have to get our state and our local health
departments on board and having them move this conversation along with
us.

MS. McGEEIN: Next question, but let me just -- to follow up on Frieda's
question, are we going to frontload any of the private practitioners,
any of the medical associations with this data, with these information
sheets?

MR. BATES: We hope to work with CDC to not only move our sheets, but
also to move their data sheets as well. And we have not come up with a
strategy for doing that at this point, but we are in constant
conversations with the CDC. Dr. George Roberts has just been moved to a
marketing office, and he's going to be heading up an effort there to do
more marketing of not only their materials, but other materials that we
find effective in conveying our messages.

MS. McGEEIN: Okay, thank you. Dr. Martin.

MR. MARTIN: I guess I -- Chris, thanks. I'd like to ask you a couple of
things just to help in my mind for clarification, and I've enjoyed your
presentations in the past, I think both here and to the CDC panel, and
this is part of a continuum of what you're doing. And I guess what
you're announcing today is the new materials, is that correct?

MR. BATES: Exactly, yes.

MR. MARTIN: And is there going to be a press release for that or
something from --

MR. BATES: We've really -- we've been out piloting this for about six
months now. And so it's sort of already out in the community, but these
documents have finally gone through a clearance. They've been vetted by
everyone who needs to see it and they are together, and we have the
materials, and we access them with HIVtest.org and other people can use
them.

We're hoping that you can go through our AIDS.gov and then it will lead
you to this. We probably are about two weeks away before our webpage is
up, but once our webpage is up, this will be available to the public.
And not only can governments at the local and state level, but
individual organizations can brand our materials and put their
information on it, both name of organization, address, phone numbers,
things of that sort. So we're really going to put this in the public
domain and make it available to any and everyone who wants it.

MR. MARTIN: I think that's just helpful for all of us to know because we
can, through our organizations --

MR. BATES: Well, remember, when I came to you the first time, I said
that we had hoped to use some of you to help us convey our messages.
That's still on the table.

MR. MARTIN: So when it's up, send an email to all of us to make sure
we're -- there is an editorial that came out in the *New York Times*, an
op-ed from a local doctor in the city -- I think many of you have seen
it. It was sent around to all of us, about the -- that most emergency
rooms aren't doing this. They're emergency rooms only because they have
outside funding and that -- there's just not the money available to
broadly do testing.

MR. : You brought up community medical center, that that seems to be the
biggest barrier of all and as part -- will this campaign help to get at
that, or is that something completely different?

MR. BATES: Well, this campaign is not out to have the conversation about
money. (Laughter.) That's going to take place in another venue.

MS. McGEEIN: You'll think about that tomorrow, but that is an excellent
question to ask our panelists when we bring them because it is how the
private side are reimbursing for this testing and how the public side is
reimbursing. So it is -- it is a very legitimate question.

MR. BATES: But can I give one example of just something I think is
phenomenal? Howard University Hospital has completely integrated HIV
testing across the entire span of the hospital. So there is no entry
point in the hospital where you'd come in for services where you would
not be introduced to the idea of an HIV test. And that's being done here
in D.C. and we think that other communities will follow Howard's lead.

MS. McGEEIN: Dr. Malebranche.

DR. MALEBRANCHE: Chris, thanks for coming. I was at the meeting too with
the black clergy last week, and that was pretty amazing, so I'm looking
forward to the conversation tomorrow. My question had more to do about
the practical side of implementing the HIV testing initiative. And maybe
it's a question for both you, Chris, and for Marty, with regards to
what's the status of all the states that have actually passed the laws
that have allowed this to happen without the informed consent, because
right now in Georgia, I'm still telling my residents -- I'm training my
residents by myself to say, "Look, when you're screening for
mammography, colonoscopy," I keep reminding them to do the HIV testing,
too.

So I'm sending them back individually, but they still have to go back
with a special informed consent form. And so as part of this whole
initiative, what is being done continually about making sure that those
legal barriers are removed, so that these medical facilities can
actually incorporate this with -- in a quicker fashion?

MR. BATES: I'm not -- I don't have the specifics around what CDC is
doing so --

DR. MALEBRANCHE: And there was an article that we got about -- that was
put in our packet about the states. There are a lot of states that I
don't think have still passed the law. So what does that mean as far as
us, and what can we do as a committee or a council to help expedite
that?

MS. McGEEIN: Chris, it's all on you. You take this one; I don't want it,
and I feel like this is a preview of attractions to come. At 2:00 PM,
Dr. Branson from CDC will be with us to talk about testing initiatives,
and once again, as I told Dr. Martin, that's an excellent question for
him. But remember that there are some infrastructure issues that we --
the states are independent -- that we can't deal with, and especially
states that only meet every other year, their legislatures only meet
every other year, but that's an excellent question for Dr. Branson. And
Eva is on her Blackberry right now, tell him, "Heads up, this question's
coming."

Dr. Primm, how could I--

DR. PRIMM: Thank you, thank you. I don't mean to monopolize this thing.
I was wondering who Bob was talking about when he was talking about
supporting Lenny, and I looked around the room -- (laughter) -- but he
was talking about Beny, really, and -- (laughter) -- so anyway, I want
to thank you, Bob, for that. But I'm concerned about something else too.
In the American Medical Association news, there is an article about
routine testing making slow inroads. And one of the things that's
reported here is that the National Alliance of State and Territorial
AIDS Directors found the lack of funding was by far the most important
reasons for physicians and other health care professionals to resist
making testing more common.

And when we spoke about Gerberding funding the \$45 million within CDC,
it kind of shocks me that \$35 million supposedly had been spent and
\$10 million is still there. What's happening with that money? Is -- are
there going to be more monies appropriated for testing so they can help
physicians and these ministers and other people who want to get
involved? That's really important to know if -- she just found this
money.

What about our own president's emergency plan for AIDS relief? Why don't
we have one of those kinds of things here for domestic focus so that we
can get these people tested and get them into treatment, and so forth?
We need a pep (ph) for our country. And so I think that just finding
some money within CDC, that's nice, but there ought to be more monies
appropriated directly for this problem because if this problem was in
another community, like it is in the community from which I come, it
would be a national, a national emergency and crisis for us to do
something about it.

MS. McGEEIN: Really, that comment has no answer, so we would -- yes, Dr.
Yogev?

DR. YOGEV: Beny, with all due respect, there is a community that's
already suffering, although there is the money and Congress was blocking
it. It's pregnant women, and mother to child transmission --
(unintelligible) -- you're right, but it's your population, but I'm sure
you're aware that in Ryan White was specific sanction for \$30 million
to be given to encourage doing testing on women, and it was blocked in
the Congress and it's going to be discussed in the Senate. We support,
unfortunately for quite many AIDS advocates. So I'm with you. We need to
do a national something, but the fact that between ourselves, we're
still fighting on this one --

MS. McGEEIN: Frieda? Dr. Bush, I am sorry.

DR. BUSH: That's okay. I just want to say I'm very appreciative of this
campaign and the quality of the brochures, the attentiveness you've
given to different faces and ages because it affects us all. So I just
want to applaud the effort, although you've heard our questions about
the mechanism of instituting it, but the effort and the brochures, I'd
be proud to have these in my office.

MS. McGEEIN: We'll see if we can get you some. (Laughter.) I would love
to. We have a little bit of time left, and if we have exhausted the
questions from the table -- well, we have one more from Dr. Redfield.

DR. REDFIELD: It's really a comment or a reaction. The -- it really
does, I think -- it's unsettling to all of us, and I know you guys have
worked very hard to try to deal with this, the 20 -- now what, 22, 23
years since we had the ability to diagnose this disease. We still
haven't been able to interrupt what I call unwitting transmission. A
significant number of Americans still don't even know if they're
infected or not. So they're not even able to make an informed decision.

I think the data has shown, although some questioned it early in the
epidemic, that knowledge of infection does have an impact, and I think
there's been a number of studies that the government supported to show
that. One of the things to consider that I think --just throw out to
take back is, rather than have a national AIDS testing day, maybe we
should have a national -- maybe it should be -- 2008 should be the year
of diagnosis, not focusing on a day, but let's say -- let's escalate
this to say, "We need to get this disease at least diagnosed. It's
treatable. It's preventable. We want to get it diagnosed and we're going
to have a testing year."

It's not just a day thing. It's not just one day a year. It's going --
we're going to embrace for the entire year to try to accomplish that,
and really go after this unwitting transmission. If this was multi-drug
resistant tuberculosis, we would diagnose it, okay? If this was -- well,
we don't have it now, but just to give the analogy. For example, if this
was smallpox, we'd diagnose it. The fact is, this is an illness that has
all the consequences of those -- and even more so. It's totally
treatable and preventable, but the key to that is diagnosis.

So I think -- again, I also applaud the efforts you've done over the
years and continue to do, but I think maybe we need to escalate it a
little now, and maybe just say, "This is it. The year 2008, we're going
to get -- the United States is going to eliminate ignorant transmission
because we're going to let people have the benefit of knowledge because
it's treatable and preventive," and really look at what the internal
resourcing requirements are that actually try to facilitate the ability
of the states and the cities, and the nation.

And I already argued about maybe an expanded initiative in
nontraditional medical facilities that may be more comfortable for some
people to get diagnosed, like the church, like the temple, like the
mosques, because I think it could be no greater testimony to -- from the
AIDS prevention point of view to this administration. Let's get rid of
unwitting transmission. Let's look at 2008 as a -- as the year of
diagnosis.

MS. McGEEIN: Interesting concept. We have a few minutes. We have a
speaker after Christopher, but I wanted to -- are there three quick
questions from the audience?

Q: I just want to remind everybody that as you're talking about --

MS. McGEEIN: Wait to get to the speaker or to the --

Q: I just -- I'm Frances Ashe-Goins, deputy director for the Office on
Women's Health. I just wanted to remind everybody, even though you
didn't say it, that nurses are a key player in the healthcare
institutions, and as you're working with all the medical institutions,
be sure to work with the nursing organizations also. They are key.

MR. BATES: Duly noted.

DR. PRIMM: Marty, I don't want you think greed has seized me. It has
not, but I really would like some comments on my suggestion that there'd
be a domestic pep for -- particularly focused on this issue. And I just
feel strongly, so strongly, about it and I see a groundswell, both in
the Congress and among the theological population in my community, to do
something about this.

And I think this administration could gain a great deal if they began to
focus on it as Bob Redfield just talked about, and as I've been talking
about it. And we've been together here for some 25 years ourselves, both
of us. And I just don't feel that we should just pass it off by -- you
didn't insult me by saying, "There's no comment," but we have a few
minutes left here for Chris from 9:00 to 10:30 and maybe we could
comment on that.

MS. McGEEIN: I am not at liberty to comment on the feasibility or lack
of feasibility. This is something you've brought to me before at the
domestic subcommittee. I understand the passion behind it. I do not -- I
would have to investigate the enormous amount of lift that would have to
be done. I am not -- not no commenting -- I am not blowing it off. I am
simply saying that I don't -- I'm not at liberty to comment on it, but I
think Dr. Bush had a comment.

DR. BUSH: My comment had to do with the idea of stamping out ignorance.
So the year of -- I just think that's a -- a year of diagnosis would be
great and who doesn't want to stamp out ignorance? So I'd even propose
that as a title for the campaign. I also would like to say, when I made
the comment about the pictures looking like us, all different across the
ages, I recognize that some of the pictures, you can say, are more
mature people, but it would be neat to have somebody with gray hair --
(laughter) -- perhaps Bob or -- (laughter) -- or Beny. (Laughter.)

MR. BATES: Okay, could I comment a little bit towards Beny's question?
Dr. Primm, I think we're struggling in the department to work within the
boundaries of the resources that we have to address this epidemic. I
think that the CDC was quite brave in stepping up to the plate and
saying, "Let's do a campaign focusing on African-Americans," in a much
different way than they've done this before.

I think going across all of the CDC and looking at all of the resources
they have, and how they're using those resource, and realigning those
resources so that they can more effectively account for what the dollar
is buying, if you will, in terms of the services related to prevention
and particularly to HIV testing. I think, given a year with the
evaluation piece that they have aligned with this campaign, I think
we're going to see some changes.

But I think we're also going to be challenged by the fact that this is
still not an easy thing to do. We have, as a major barrier, questions
around the comfort level of people talking about sexual behaviors,
sexual activity, substance abuse. All these things come into play and we
have not always, at the local and state level, been able to force those
venues for people to comfortably do this. A lot of this was done in the
late '80s and I think we backed away from it and we went to TV and we
went to radio and we went to print media.

But this campaign, and this epidemic, really requires a lot of highly
sensitive conversations, people in very intimate settings to talk about
things that are very difficult to do through the mediums that we most
refer to. So I think that CDC is seriously looking at this, and they are
repositioning their prevention interventions to address the epidemic,
particularly as it relates to African-Americans and Latinos and in a
highly different way. And I would just like to acknowledge that on their
behalf.

MR. MARTIN: Chris, we all agree with you on that and what you've done,
we've been quite impressed with. But there's a sentiment here of maybe
-- it's difficult. The resources aren't there. Maybe there is a
sentiment that we, as PACHA, can help. And just hearing Bob and Beny
talking, it would strike me that we should try to craft a simple -- and
you can't comment yet because you don't know what's going to happen --
(laughter) -- but to help the process happen --

MS. McGEEIN: I like my job.

MR. MARTIN: -- we might as well reach across maybe our two subcommittees
and craft a resolution at this meeting that we can -- that we keep
simple, that has that 2008 theme, and sort of gets back in a way to what
we've talked about a lot and have passed resolutions on as a national
plan, which we don't have; but maybe just viewing -- rather than say,
"We want a big national plan," maybe the resolution should be simple
enough to focus on this subset of the national plan, Beny, that you and
Bob could work on maybe for this meeting.

DR. PRIMM: Thank you, John.

MS. McGEEIN: If there are no further questions or comments from the
table --

Q: I'm Jim Friedman. I'm the new executive director of the American
Academy of HIV Medicine. I want to talk a little bit about how we are --
we represent about 1,500 HIV/AIDS providers and we really are ready to
get involved in this in a much more strong way. I have not been involved
in the AIDS community over much of my career, but more recently,
obviously, as the executive director, I have.

MS. McGEEIN: Excuse me, Jim. Is this a question about the mobilization
campaign?

Q: It really is. I think there is an opportunity here to involve
organizations like ours in getting that word out and utilizing our
membership as a way to reach out to a variety of different groups. And I
would encourage CDC and Chris and others to reach out to organizations
such as ours, more proactively on this testing campaign.

MS. McGEEIN: Okay, thank you very much. Okay, one more question? Hearing
none. Thank you very much, Christopher, for coming in and sharing your
time with us. And the next person coming to the podium will be Miguel
Gomez.

MIGUEL GOMEZ: Good morning, everyone. I think many of you know I work in
the same -- for Christopher in the Office of HIV/AIDS Policy and one of
my responsibilities in that office is coordinating our HIV/AIDS
awareness days. And today is National Latino AIDS Awareness Day. And we
have with us the person who is the president of the National Latino
Commission on AIDS, which worked with the Hispanic Federation, faith
leaders, civic leaders, all around the country to build a network, to
create one of the most effective AIDS awareness days throughout the
United States.

And what we're going to do is pretty simple this morning and we're very
grateful to be able to take a few minutes of your time, is I'm going to
ask Dennis to talk about what is happening with National Latino AIDS
Awareness Day across the United States very briefly, and then I have a
handout for you to share what we're doing here at the Department of
Health and Human Services to promote awareness in the Latino community
across the United States.

And Dennis again, is the president of the Latino Commission on AIDS. He
has been there since 1986. Shortly after law school at Stamford, he
became a -- he worked in the legal field, slowly moving from California
to New York to become a legal advocate. And we're really proud to have
him here. And, Dennis, thank you, and here's the microphone.

DENNIS DELEON: Thank you very much, Miguel. We've enjoyed nothing but
support from Miguel and from the CDC and from the Office of Minority
Health. We've been doing this now for five years and we've been doing it
really because the awareness of testing was just about -- was low to
below low in the Latino community. And the major purpose of the day
really is testing, and I'm going to -- you have the packets that we
distribute and prepare that go to all the 1,500 participants around the
country. And today, there are 240 events taking place in 15 -- in 40
states. So it's a pretty widespread effort. Every jurisdiction fashions
its own activities if they -- and a lot of them rely upon the website.

And what I want to do is spend a couple of minutes just describing to
you how we use the web, and how the web can be a key partner in these
mass mobilizations because the technology is there. You just have to
learn how to use it and both the providers and also the community, and
we've been very successful because this year most of our involvement
came through the web.

In addition to the web, though, we also have a national advisory
committee which meets on a biweekly basis, starting in March, and we
have groups that have come together in different areas of the country.
Different community based organizations are oftentimes at war with each
other over funding because they're forced into such few funds. What
National Latino AIDS Awareness Day, NLAAD, has done is to bring these
groups together around a common objective. So we now have, for example,
in Northern Virginia and Maryland, we have a combined effort with the
D.C. Department of Health where they're working together and that's --
that to me is a great deal of success. Los Angeles, we have groups that
don't talk to each other working together to promote testing on this day
and this period of time.

Now, the basic homepage is -- it introduces you to the day and if I
could leave the mike for a minute -- the basic -- here outlines testing.
It outlines the sample poster, which you can obtain and the way to go
from this page to a Spanish language page is to click the top corner of
the page which says "Espanol" and -- next slide, you go to a Spanish
version of the home page. And there, you see a person can register to
become a participant. And additionally, below the red box, you have
actual news about National Latino AIDS Awareness Day.

And below that box, you have multimedia resources. And below that box,
you have actually multimedia, and then you have testimony, testimonials,
people who have lived with the disease, the role of -- how testing
played a vital role in their becoming healthy. And those testimonials
become very important because when media calls and they want comments on
the day, or they want to connect to our local group, testimonials like
these things are very, very important to have.

The next slide is the planning. If you look over the top -- the bars
across the top, we have planning. And this is just one of the planning
pages, but it tells people how to organize a local coalition around HIV
testing for National Latino AIDS Awareness Day. And we walk them through
it in Spanish and in English.

This then leads to the next slide, which is a multimedia -- which is,
I'm sorry, the resources, of which we have them all listed there, and
there really are quite a few resources, most of which are available in
Spanish. We wish there were more and people have a wide -- they can just
download it and they can fashion it to their own jurisdiction. Our name,
the Latino Commission on AIDS name doesn't appear on anything.
Basically, they can make it their own literature.

The next slide shows multimedia. We have a variety of PSAs that they can
download, and I'll show you how in a second. The PSAs were made by Cable
Positive, by NBC, Universal, Telemundo, and these PSAs can be either
forwarded to a friend, tell a friend or they can be downloaded to the
purple bar up on top there. And then we have over on the far -- your far
right, photographs of actual events that took place in the previous
year.

Next slide -- the purpose of showing pictures of actual NLAAD events is
that people have a sense of what can be done because no one -- sometimes
people call us and they don't know what to do. And through photographs
and through technical assistance, we can suggest ideas within their
resources in different cities. Los Angeles spent \$200,000 on a bus
campaign to coincide with this. Miami did a massive campaign throughout
the state, about 25 myths related to HIV. So local health departments
are buying into this also and encouraging testing, addressing the things
that prevent people from getting tested.

Next slide, please. Next slide, please. They key thing -- anyway, go
back, yes. The key thing is the red box, the event search. If you click
search, you're going to -- next slide -- you're going to get all the
events, and this year, we have all the events listed. And you can just
click on an event and you actually find out what's happening in
Pittsburgh at this one event in -- I'm sorry -- Pittsburgh, California
and Martinez, California. And so -- and the group locally, they can
basically choose to create a user account. So -- next slide, real quick
-- "Join NLAAD." There you can register and basically, you can modify
your event. Next slide. You can register -- next slide -- and here you
can select and describe your event. You can pick a poster. And then you
can conform that poster to your event. And then you can describe the
event, and then you can go back to this page and modify this event. Next
slide. Next slide. This is also part of organizing events. The key thing
here is the -- I'm getting somewhere out of whack everything.

MR. GOMEZ: Well, actually, Dennis, I think I can help because one of the
things I want to make sure is that people have a chance to ask you some
questions.

MR. DELEON: Okay, let me just -- can I have more with that? This is an
example of one city. This is Contra Costa County in California. This is
all the events happening in Contra Costa, California, and they're
listed, and you can -- the person who has a password can edit, can
delete, and can preview the events in that area, and can edit those
events. Next slide. And lastly, this is an example of the District of
Columbia. They have a variety of events and this is -- basically, these
events can be registered on the site through these means. Next slide.
Events that are registered, these are more examples of events that can
be registered.

Next slide. Lastly, NLAAD is a -- this website is a vital resource in
the effort to mobilize a community because if the local jurisdictions
don't have control over what's being said about their event, if they
can't modify things at the last minute about a different location for
something, then the media cannot connect to it. They cannot connect to
it.

For example, we have 33 faith communities in New York City. We're doing
testing today at 33 locations of Spanish-speaking faith communities, and
we're -- and those are all listed on our -- on this website. Some things
may change and the media may want to cover one of those things, and this
is how the media connects to what's happening in the field.

A really well articulated web presence is truly important. We were
helped a great deal by the CDC. We were helped a great deal by OMH and
by Miguel's office to develop a really vibrant tool, which I think is
going to be very important for the campaign that Chris is trying to do
because the web part of the campaign is really essential in terms of
maintaining a timely resource for that kind of activity.

MR. GOMEZ: Great, and stay just for a second, Dennis, because mine is
really short and I really -- why I said I wanted to help you, Dennis, is
because I've been coordinating HIV/AIDS awareness days for several years
now. And one of the things that I realized is what Dennis pointed out,
if you do not use your webpage effectively and do an assessment that
people can actually use it and do usability assessment, you're not
helping the community.

And that's why I stated the Latino Commission on AIDS, along with
others, has one of the most successful days. But I'm very proud here at
HHS, I'm going to have a handout for you all, and for those in the
audience, it's on the table. It's very simply from Dr. Fauci at NIH to
Dr. Graham at OMH; they are all involved in media activities. At the CDC
today, we have finished doing a radio media tour. There's a new MMWR and
throughout the country, we've been offering technical assistance to help
organizations augment their use of Web 2.0 tools. So if you want more
information, you go to AIDS.gov. I want to thank you, and if you have
any questions, just let us know. Any questions?

MS. McGEEIN: Thanks to both of you. We've got just a few minutes. Okay.
Dr. Green.

DR. GREEN: Yes, just a quick question. Hearing about Latino programs in
HIV/AIDS, I found myself wondering about just in our hemisphere, we have
daily speakers of Portuguese, French, and Dutch and various Creoles. I
just wonder what's available in languages other than English and
Spanish.

MR. DELEON: We don't have Portuguese. We don't have -- we do have
English and Spanish. That's kind of the profile in the United States.
This is not meant to be an international campaign.

DR. GREEN: Well, there's quite a few Brazilians and Haitians and native
speakers of other languages in the United States. That's --

MR. DELEON: Well, everybody does what they're competent at, and we're
not competent at reaching the Haitian community and the Brazilian
community.

DR. PRIMM: I have a comment, Dennis, and first of all, let me
congratulate the Latino Commission on AIDS and all that you all do
because it's really tremendous. And I -- to piggyback on Bob Redfield's
support and his suggestion that instead of this being a one day
situation in the country, that that ought to be 365 days a year, with
what's happening in your community and my community. We need this focus
instead of having it just one day, it should be every day. And I think
these rifle shots are great, but we need a sustained thrust at this
problem unless we are not going to be successful. And I congratulate you
on what you've done so far, but hopefully, you and I can work together
to try to help expand it.

MR. DELEON: I hope so and I hope that there's wisdom in the White House
about -- it's not just -- it's a problem also among Latinos. Latinos are
also affected and attention is paid to the need for testing Latinos.

DR. PRIMM: As you know, I've been a proponent in this committee for
doing something in Puerto Rico and the Caribbean, and you and I have
talked about that. I think that, in itself, because of what's happening
in Puerto Rico and New York and the relationship is enough to make us
refocus on these two areas in a different kind of way.

MS. McGEEIN: Okay, thank you, Mr. DeLeon for joining us today. I
appreciate it. We are about to take a break. I understand that the
coffee is hot and the food is hot. I think it's -- although now Nancy's
shaking her head, no. (Laughter.) Please tell me the food is --

MS. : (Off mike.)

MS. McGEEIN: Okay. So let's take probably a 20-minute break and be back.
We'll have our panel.

(Break.)

MS. MCGEEIN: Close, but no cigar yet. Tic-tac?

Okay. Our next presentations is a panel discussion on insurance
reimbursement policies for HIV testing, and I am going to hand this over
-- the moderating duties over to Carl Schmid, who is the chair of the
domestic subcommittee.

MR. SCHMID: Good morning. We've already touched on this important issue
already this morning, and as everyone knows, the CDC last September
issued recommendations that -- that asked people to be tested between
the ages of 13 and 64, routine opt-out testing in healthcare settings.
And it's a goal that we're all working towards and we've already
discussed this morning some of those barriers to implementing that.

And this afternoon, Dr. Branson's going to give implementation update,
but one of the biggest barriers that we've identified is the whole
reimbursement issue and who's going to pay for all these tests every
time someone goes to a medical -- a doctor's office, an emergency room
to get tested in that routine way. We -- we've heard that there is some
money for -- in the public healthcare settings that CDC is supplying.
There's also some private money that's out there as well to ensure that
people get tested. But if we're really going to have routine testing,
opt-out testing in healthcare settings, this reimbursement issue is
going to have to be tackled.

And so I'm very pleased that we have three gentlemen who are
representing some of the -- the largest reimbursers in the country, and
that is the CMS that handles Medicaid and Medicare, and then we have two
representatives of very large private insurance companies. So I'm going
to quickly go through their bios and then we'll have each of them
present their remarks and then we'll open it up for questions and
answers.

But first, from CMS is Joe Razes. He is senior technical advisor for the
Centers for Medicare and Medicaid Services. He's responsible for leading
the team that is implementing the health-related portions of the Ticket
to Work and Work Incentives Improvement Act legislation. He is also one
of CMS's point people on HIV/AIDS issues.

Secondly, we have Dr. Andrew Baskin. He has been employed with Aetna
since 1998, where his current position is national medical director for
medical policy and program support. Some of his current activities
include oversight and support for development in the implementation of
medical policy, including regarding medical necessity of new technology
in specialized services, reimbursement, and coding policies, as well as
disease management, wellness programs and medical plan and benefit
designs.

And then we have Dr. Robert Thomas with CareFirst BlueCross and
BlueShield. Dr. Thomas' responsibilities include the overseeing medical
management, utilization management and case management appeals process,
quality in credentialing for the Maryland as well as the national
capital area plans. In addition, he is an advocate for the network
positions within the structure of CareFirst.

So first of all, I'd like to thank all of you for being here today and
we look forward to your presentations. And we'll begin with you, Joe.

JOSEPH RAZES: Okay. Thanks very much, Carl. Thank you very much, Carl.
Okay, as Carl mentioned, I'm one of the point people at the Center for
Medicare and Medicaid Services, the folks that bring you the Medicare
and Medicaid programs. I want to -- I will talk just briefly about the
Medicare and Medicaid and then the issue of routine testing for this,
from the federal perspective. Should be a lively discussion here.
(Laughter.)

Okay. Medicare, most you folks in the room are aware of our programs.
Medicare is the program that provides medical services primarily for
individuals over 65. Also, it provides Medicare for individuals who have
end-stage renal disease and also individuals who are disabled. There's a
two-year waiting period, but if they're disabled according to the social
security definitions. So basically, that's the group under Medicare that
is covered.

Now, with respect to the payment for testing, it is paid for by
Medicare, but it again has to be ordered by the treating physician. In
general, Medicare, because of the age characteristic of the populations,
there has not been a large incidence of HIV/AIDS-related findings, but
that's increasing somewhat, but it's a relatively small proportion in
relation to the entire Medicare program.

So moving on to Medicaid, again, Medicaid is a state federal program
which provides healthcare for low-income or no income individuals. There
are a number of required services that states must provide. Lab services
is one of those five services. Under those laboratory services, states
have the option and do provide for -- the screening for HIV, but again,
it's not on a routine basis. It's based on the potential risk and an
order by a physician. So it is not part of a general panel tests for the
most part -- or I'm not sure -- I'm not aware of any state that has it
as a general panel test.

Reimbursement for -- for this service is usually tied to Medicare
reimbursement. Most states follow reimbursement for physician, hospital,
laboratory services, but they often will reimburse at a percent of the
Medicare. They can -- by law, they cannot pay more than what Medicare
pays for -- that choosing not an issue. States are -- because they can't
print their own money, they're looking to try to save money. So they
usually pay a percentage of the Medicare reimbursement rates and they
can go as low as 80 percent of the Medicare rate, which some would
argue, is not generous to begin with. So -- let's -- but again, as I
say, this is a state federal partnership. The federal government does
not require states or mandate states provide HIV testing as on a routine
basis.

So we get into this issue of routine testing and I want to call your
attention to a fact sheet -- am I working? Am I too -- am I too --?
There -- a victim of technology here. I want to call your attention to a
study that's on the table out front there. It's -- it's an (APE ?) --
it's Study of Majority of States Bar HIV Tests, and it provides a good
-- yes, okay, folks, have seen -- it provides a good overview of this
particular issue, but again, on the Medicaid side, there is no
requirement for this. There have been discussions. I know the Center for
Disease Control has tried to -- has been promoting this particular
issue. We get in -- at CMS, a number of folks on the coverage side, on
the policy side, on the reimbursement side were well aware of this
initiative, but again, part of the problem comes down to -- we've got
states that require -- that have laws that require informed consent.
We've got -- some states have laws with respect to counseling,
post-testing counseling. We've got issues with patients who are
embarrassed by this. They don't want others to know about it. They're in
denial. They are concerned about the potential job loss if this gets out
or even with their relationships.

So best to sum this up, again, it's a state federal relationship. We do
-- we -- Medicaid requires the states to cover laboratory services, but
the states, in essence, have a broad latitude in terms of determining
what they will cover: the circumstances, the frequency of those
services. So that's a general background for the discussions here today,
at least from my perspective, but we'll get into it later, I guess.

MR. SCHMID: Thanks Joe. Dr. Baskin?

ANDREW BASKIN: Thank you. I was asked to make a few remarks and I was
kind of given an open slate there. I was just saying that you're
representing the private commercial insurance industry and perhaps talk
about the reimbursement and -- for this type of testing. But as I was
thinking about that, I'll be honest with you, I had a couple of
thoughts, and one of them really just came yesterday afternoon when I
was driving with my two daughters, 19 and 17 years old. Spontaneously,
their conversation was discussing about Gardasil and HPV and getting a
vaccine, and how their friends were going to get a vaccine. It's a
conversation that, when I was in practice, of course, eight or nine
years ago, was almost unheard of. This is an open conversation. They had
no qualms about discussing it between them and no problems about
discussing it with their father. I don't see that same conversation
happening with HIV. And yet HIV has been an issue for a lot -- well, not
a lot longer, but certainly a much more serious issue for a lot longer
and involving a lot more people than HPV in terms of mortality. So that
was very telling to me.

By the same token, the pharmaceutical industry has been marketing
wizards. Let's face it. It's easy to talk about the HPV and erectile
dysfunction, another one sexual disease that doctors are afraid to ask
their patients about when they're in the office, but it's common
conversation at the dinner table. Once again, HIV has not been that. And
the reason I say this is because that -- that kind of image or that
marketing issue goes beyond just the patient community. To be honest
with you, it goes to the physician community and it goes to the
insurance community and basically all -- everybody that's part of
healthcare. I would say that even within the insurance community, we're
perhaps guilty of not feeling comfortable about this particular problem.

That being said, I also went online last night to the site that was
around this organization here and was very surprised to know that today
was National Latino AIDS Awareness Day. I had no clue and I'm in the
healthcare industry for the last 25 years. I also didn't know that there
were monthly days for the last six months, for other AIDS
awareness-related issues. So once again, that's not something that's --
that's common knowledge even within my own industry necessarily. So that
message isn't getting everywhere.

As far as reimbursement issues, as far as coverage for this type of
testing, when the CDC made its recommendations, I guess in September of
2006, it was soon thereafter, at least in my company, and I presume most
companies easily adopted that as a covered benefit. No problem. It's a
preventive testing and it is covered the same way that any other
preventive test, as simple as a lipid panel, or a gonorrhea culture, or
any such test.

Interesting enough, it's also at least in our company it's been
categorized as what we call a preventive test -- for those of you who
are more familiar with insurance, there are certainly insurance policies
that segregate out preventive testing versus general medical testing,
and that there may be actually better benefits for people with
preventive testing. And this has been listed as a preventive test for
our company. It's interesting that most companies, I think, that I hear
about when I get out talking to my colleagues elsewhere, do follow the
United States Preventive Services Task Force recommendations for all
testing. This is one of the few times, to be honest with you, that we
went beyond that as soon as the CDC made the recommendation. We did not
wait for that general adoption to be made by the United States
Preventive Services Task Force, and felt that this was important enough
that we would just go ahead and open the policy, immediately consider
this a preventive test and therefore fully covered.

As far as I know, in my company and once again with my colleagues, I
don't know of any particular payment policies that would put any barrier
to anyone getting this test in whatever venue that they -- that they get
it as long as it's performed in a medical setting. Admittedly, home
testing which could potentially be purchased over the counter is not
something that's usually insurance-covered, but certainly the usual
blood test and the newer oral swab and the finger-stick test are covered
equally so.

One of the -- one of the things I do want to mention before I pass it on
to Robert is that when this CDC recommendation came out last year, I am
on the committee that does develop our clinical policies, our medical
policies which determine what's covered and what's not and under what
circumstances. It was interesting that it was a little bit confusing in
that the recommendation is kind of nebulous, kind of a generic
recommendation. It's not -- it's not like the -- pardon me -- the
American Gastroenterological Association came out and said that you
should have a colonoscopy every ten years, a very objective number,
something that people can latch on to.

It's very confusing to say that the general recommendation for everyone
13 to 64 years old to get this testing done in a medical setting. The
first question that came off: well, how often? You know, every
encounter? When you come in for a cold, or when you come in for your
annual physical? I mean, it's not tied to anything. Pap test is tied to
an annual examination that a woman gets. Vaccinations are tied to -- to
get in to school at certain ages, or at certain pediatric checkups which
are very much timed. This is a very general recommendation, and frankly,
while we -- while we easily adopted it, it's very hard to get the
message out there to anybody to do it because it is -- it's not a very
concrete recommendation, not very objective. And frankly, what we hear
back from the -- (unintelligible) -- community is they're little unsure
as to -- as to whether this really meant everybody, every time or
something less than that. And that confusion, I think, does make it a
little more difficult to get this message across.

Thank you.

ROBERT THOMAS: I'm Robert Thomas of the CareFirst BlueCross -- oh,
sorry. There it is. Hi, I'm Robert Thomas, CareFirst BlueCross and
BlueShield Association. We have absolutely no barrier to HIV preventive
testing. It's -- it again -- Andrew Baskin stole my thunder, but we
consider it just like any other test, just hyperlipidemia and diabetes
-- even level A1C, any type of test. We don't -- we follow the CDC
guidelines in a parallel fashion. We reprinted them on our website. It's
super transparent, really easy to use, the website, and we've also gone
into conjunction with the -- (unintelligible) -- clinic here to just
purchase an outreach van and goes to just all parts of the city, and I
think outlying counties to just recommend and encourage the oral HIV
testings. So -- not just for CareFirst BlueCross and BlueShield members,
but for all people. And every time I see that van, I get -- I'm kind of
proud because there's so much negativity about the medical insurance
industry, but that is something that CareFirst has gone into.

Let me see what else to say. And -- our post-testing, we also just
recommend HIV -experienced physicians have just a printed list for just
members who test positive and then later just progress with the disease,
et cetera.

But that's all I have to say. We have -- we want no barrier for HIV
preventive testing. Thank you.

MR. SCHMID: Well, that was easy, and thank you for the good news.
(Laughter.) I have, I guess, two questions, then we'll open up as well.
I guess for the private insurers, that's excellent news, what if the
state covers -- requires prevention and counseling, and that's probably
an additional code, would you cover that as well?

MR. THOMAS: You're talking on ENM codes, a certain type of coding,
complexity of care. When a patient goes to a physician, there are ways
to code of the encounter, of somebody coming in for a Pap test or a
routine of a blood pressure check, there is a certain code for that.
Paying for other physicians -- it's not just about paying for gastric
bypass surgeries and these expensive surgical procedures, but we want to
also encourage physicians that -- spend time with your patients and then
have complex care patients, such as HIV positive patients, or this HIV
encounter to just code appropriately, and we reimburse those codes, so
you know, something about coding and then paying for the physician's
mental time. I forgot to turn my microphone off. (Laughter.)

MR. BASKIN: I might add -- yes, it's the same thing. There are -- there
are ways to bill for preventive services counseling whether it'd be a
separate -- a separate service in and of itself along with the testing,
or whether it'd be included in some other examination that you're doing
and those are fully reimbursable. There isn't a barrier to that.

MR. SCHMID: Okay, Joe. (Laughs.) How can -- how can we get Medicaid to
cover routine testing? Is it a directive? Is it a congressional law?
What are the avenues to make that happen?

MR. RAZES: Good question, Carl. (Laughter.) Well, obviously a law is one
way to do it if you could get -- get that passed. I do believe that
there may be some resistance on the part of the states on that. So it's
-- while that may be an easy way to go, I think the approach that CDC is
taking in terms of coming up with an initiative and trying to push the
benefits of it, is certainly another way to go. Some education on the
part of the states is something to do -- is a good approach as well,
probably better from the ground up rather than the top down, but I think
it's not just a reimbursement issue, and that's why I think that CDC,
the work that they've done is good and this needs to be promoted,
adopted, incorporated at the local level because of the ramifications
that I mentioned a little bit earlier about -- and Dr. Baskin was even
talking about, his daughter is talking about.

You know, one thing -- but when it comes to AIDS, it's sort of like a
double disability or double negative in terms of the thing that we're
dealing with, the disease we're dealing with here. And again, people
don't want to know, they don't -- they are concerned about their jobs,
their relationships, and I think for the states, it's a money thing.
States are always trying to find ways to reduce cost. If you're taking
about reimbursing for the actual (penile ?) test, then you're also
talking about the ENM codes because you're going to have to have
post-counseling to boot.

I want to bring up -- again, with respect to the loaded nature of this,
why I would suggest that we do try to push it from -- from the ground
up, or at least give the states and the public an opportunity to
incorporate this. A few years back, my wife had some testing and there
was a positive for a sexually transmitted disease. Okay, all right, that
was not good. That came on a Friday and then Joe's got to explain his
behavior -- (laughter) -- the lab -- the doctor's office is closed at
5:00. We get home. We looked at this at 6:00. It wasn't the greatest of
weekends, but we've had a good relationship and that was good. Monday,
you know, right in there calling, and when we explained it, they checked
into it: oh, it was a mistake.

Okay, well, it's good -- people aren't allowed to carry guns because I
would have liked to have shot somebody -- (laughter) -- but I mean, this
is -- this is -- I mean, can you imagine if somebody would get this that
wasn't having the greatest relationship, or there were lot of tensions
there, maybe somebody was unemployed and there were lots of other
factors? To get this kind of information, or maybe it came to me
directly and I left it out, or somebody else, the significant other
found this and saw -- it's just one of these types of issues, AIDS is
one of these issues. It's not strictly a reimbursement issue.

So I guess to answer your question, I would endorse what CDC is doing,
try to get some involvement from the ground up to do this. And it looks
like there is some success here, but again, when you're dealing with a
social issue like this, nothing is going to happen quickly.

MR. SCHMID: Okay. So is the administration in support then of having
this covered by Medicaid? It sounds like you're putting the opposition
to the state. So does that mean that the administration is supportive of
it?

MR. RAZES: Well, the administration's supporting CDC's efforts
presumably. I am not -- I'm not sure what CMS's -- well, CMC's position
is -- we're leaving up to the states is basically. It's a state federal
partnership. We're leaving it so punting, I guess, in some respects. But
again, we do respect the states rights in terms of what they cover and
the conditions under which they cover it.

DR. GREEN: Yes, if I may -- I'll pose a general question. I work in
Global AIDS Africa, Asia -- (unintelligible) -- so I don't know the U.S.
data very well. One of the arguments for promoting testing, in addition
to getting people the treatment, who need treatment, is to hopefully
testing and counseling impact people's sexual behavior. There's a
widespread belief in Global AIDS that testing leads to positive changes
in sexual behavior, whether people test positive or negative. I'm not
sure the evidence supports that, but there's a widespread belief. So my
question is -- and I don't know if you gentlemen know -- but what do we
know empirically about any impact on behavior from testing?

DR. MALEBRANCHE: I can actually answer that. There's plenty of
literature in the United States that actually speaks to that. Yeah, it's
not just a global thing, but in the United States, with several
different groups, regardless of income or sexual behavior, so on and so
forth, it's found that HIV testing encourages -- if someone finds out
they're positive, they're more likely to engage in safer sex. So we've
been doing that for a while here in the States.

MR. SCHMID: Dr. Redfield?

DR. REDFIELD: I wanted to try to -- maybe one of the two of you or maybe
yourself, Andrew, first, I want to get down to the specifics because I
still feel that this cost reimbursement is an obstacle to the
implementation particularly. And when I look at the cost, there is the
cost of pretest counseling, for example, in the state of Maryland where
we practice, about 4,500 patients in our population with HIV infection,
there's a cost of the actual test and there is a cost of posttest
counseling. There is a professional cost and being regulated in
facilities like we are, there's a facility fee cost. So I -- it'd be
useful to me -- you might not be able to answer it here, but I'd really
like to see how Aetna and how Blue Cross, Blue Shield in particular, and
if it's also the case for the federal government's Medicaid program in
particular. How it -- Medicare and Medicaid, how it compensates for
those real costs because my -- in terms of reimbursement -- because my
view right now is that the current reimbursement, the actual money that
get reimbursed for doing pretest counseling and posttest counseling, the
professional cost, the facility fees doesn't pay for the cost, the
actual cost of doing it.

So again, I may be misunderstanding this because I can -- in our own --
in our own marketplace and it does seem to be an enormous disincentive
for some of the major hospitals from more widely introducing this. So
I'm a great educator. So if you can give me the actual data that it
actually does, there's a way to bill for this and it actually -- you
don't lose money, I'd like to educate the hospital systems in Baltimore
that they actually are faults in their claim, that they lose money by
providing the service. So I'd like to get a sense, you know, how do you
bill to get the pretest counseling, which may be five to ten minutes of
professional time, posttest counseling, five to ten minutes of
professional time, the test, the facility fee. How do you bill for that?
Because what I usually see is the test gets reimbursed, but I don't see
-- I haven't seen how everyone else is getting the professional time,
facility fee reimbursed because -- and so if I'm mistaken, I'd like to
learn so I can teach people differently so.

MR. BASKIN: A very complex question and the reason it's complex is
because these -- the tests can be obtained in so many different
settings. So it would be a very different answer whether the test is
obtained in the doctor's office, whether the test is obtained by the
doctor seeing it and sending it to the laboratory, whether the test is
obtained in an outpatient department of a hospital or an outpatient
laboratory of a hospital, whether it'd be obtained as inpatient, so --

DR. REDFIELD: Maybe for me, if you could just focus down on whether it's
done in an outpatient clinic affiliated with a hospital.

MR. BASKIN: And there are permutations and combinations there.
Certainly, there are people that are sent to an outpatient department of
a hospital, obviously, not the preferable way, by the way. We'd rather
people be hooked up through their medical home, which is theoretically a
physician's office, which would be the best way to go, and in fact,
that's an easy reimbursement answer because there are specific codes to
bill for that and that's reimbursed and it's pretty fluid there.

In a hospital outpatient setting, it's a little tricky. Certainly, the
test itself, the technical blood test and the result of it is easy. It's
a simple code known to the insurance company. The insurance company pays
the bill, that's --

DR. REDFIELD: And the lab gets the money, there's no question of that --

MR. BASKIN: The lab or the hospital gets the money. Now, the problem is
that in a hospital setting, a lot of it has to do with the type of
contract the insurer may have with the hospital, which can take many,
many different forms. Some contracts are more all inclusive and some
contracts are very piecemeal. In other words, you bill for every bit of
a service rather than a global reimbursement.

And the other problem is who at the hospital would be doing the
counseling. In other words, are you talking about a physician, a certain
-- if a physician at a facility did pretest counseling or posttest
counseling, the physician can submit that bill, either on their own or
as an employee of the hospital, depending on their situation. So that
would be probably analogous to being done in your office, to be honest
with you.

Now, the question becomes if a non-physician did the pretest counseling,
in most -- in many situations or many states, a non-physician, not under
the tax, the physician can't even bill for the service. So if a bill
doesn't come in, it can't get paid, and there's no direct, in many
instances contracting with a non-physician at a facility. So I would say
that in those instances, those people usually employed by a hospital and
in fact, that the reimbursement for the test would be including the
services of their employee, which would be the non-physician, whether
it'd be a nurse or some other type counselor.

And then the next argument would be, well, what's the relationship with
the hospital in terms of how much they're getting paid, does it
reimburse them enough for that service or not. Frankly, in my nine years
with the insurance industry, it's never been -- I've never had that
complaint -- that the hospital was complaining about being
under-reimbursed for and HIV test.

DR. REDFIELD: I'm just going to come back as a user. It's not going to
be solved probably. But maybe I can learn more about the codes. I think
you pointed it out that the laboratory always gets reimbursed for the
cost of the tests, and they've negotiated whether it's, with any three
of your groups, what the discounted price is going to be in the test.
And I guarantee you it covers costs. Otherwise the laboratory wouldn't
be doing the business, okay? And it even gives the pathologist a little
chunk of change for signing his name at the bottom of it.

But the reality is there's really no mechanism, particularly for those
services like that where someone would come in and again, we run a
number of clinics in a variety of different settings in Baltimore. They
would come in and want to have an HIV test as part of their evaluation,
say, they've a partner or someone who's HIV-infected or something. That
again, to get the reimbursement for the facility fee or the nursing time
or the physician is something that's not operationally occurring. I
mean, whether those mechanisms -- it's just not occurring, and as a
consequence -- I've got a lot of pride for (Harvard ?) for what they've
done, okay? But most hospitals had not taken to integrate the CDC's
recommendations in its current form, even if we're restricted by pre-
and posttest counseling consent signing, I want to argue, because of the
financial realities of it.

At this stage in the game, no one's paying for that 20-minute of that
nurse's time, or that ten minutes of that doctor's time, and as a
consequence, no one's trying to encourage a broader implementation of
this policy. And again, it's not just the uninsured population that this
isn't happening for because I think it's not happening -- sure, if you
go in for a general physical exam and in the context of that, the doctor
charges whatever he charges for a general physical exam in the context
he does the HIV. That's -- that's going to be covered, and I can
understand how that's rolled into the benefit. But if we're doing a
targeted effort to try to get an enormous number of people to come
forward and get diagnosed in the context, and now we're adding a
significant engagement, most clinical interactions in many of these
practices are not more than ten,15 minutes. That's a clinical
interaction. And now you're adding another ten to 15 minutes of a
clinical interaction of some healthcare professional. I think this is
what the disconnect has been.

We said we want to do something, but we haven't figured out ahead of
time that it has enough value that we want to pay for it, either through
our insurance mechanisms or through our federal and public support. So
I'm still going to take the point of view, and I'd be glad to have
information that you can give us some time in the weeks ahead that this
is still a major obstacle, that reimbursement isn't a solved issue in
terms of the operationalization of HIV testing in the community. It may
-- you may think it is, but I don't see it. I don't see it from the side
that we're functioning.

MR. THOMAS: I've never experienced -- you know, this is the first time
this has come to my knowledge. Hospital contracting in Maryland is
complex, multilayered, aggressive, and hospital outpatient testing --
the optimum of scenario is for a patient to go to their primary care
physician, and as I said physician and not provider. And so this testing
occurring in hospital outpatient facilities and hospitals' problems
getting this reimbursed, I have -- I've been working with Blue Cross and
Blue Shield for about ten years, and this is -- I've never been made
aware of this, and I've never experienced this. And if you -- if you
have some type of scenario, some type of hospital situation, e-mail me
-- at doctor -- [www.robert.thomas.com](http://www.robert.thomas.com/),
carefirst.com. But I had never seen this before. I'm kind of confused. I
don't know if this is about -- for nurse counseling that's not being
paid for, or some other situation --

DR. REDFIELD: I think it'd be useful for me --

MR. THOMAS: Totally confused me --

DR. REDFIELD: -- yeah, I think get the billing codes to see, because
again, it's maybe unique to the hospital-based practices that we deal
with, but -- and again, it has -- maybe you deal with contracts, say,
the hospitals that I work with have with Blue Cross, Blue Shield or
Aetna and others, that these are not reimbursable events, but the
reality is, I haven't seen evidence in our situation that these are
compensated events for the professional time required, whether it's
nursing time -- in general, it is nursing time. And it sort of just
rolled in to the cost of doing business.

And I think it's had -- it has a disincentive that if institutions,
again -- if we could align our public health interest with the ability
of the institutions to see that it's also not in their negative interest
from a financial perspective, this would happen very easily. If you try
to roll out policies, and that institutions see -- have a negative
financial consequence on them, they don't move out as fast. I mean,
we've seen the same thing in our PEPBAR programs. Those hospitals that
have expanded PEPBAR care to say 100, 200, 500 people and found that it
causes their hospital to lose money, don't want to expand. Those
hospitals that learn how to take the advantage of the PEPBAR program to
provide great care for people and strengthen their system, want to do
more. And I think there still is this issue with these isolated testing
events that we're trying to expand in all these clinical settings. Like
you said, let's add it on to all these clinical settings. But how do we
get it on and get reimbursed beyond the cost of the test? And I've seen
the cost of the test reimbursed, but I haven't seen beyond the cost of
the test reimbursed.

MR. SCHMID: Dr. Yogev?

DR. YOGEV: I just want to follow on Dr. Redfield's point. What
unfortunately unique about this test is the counseling. See, when I sit
in my office and I do CBC and a lipid and everything, I don't tell
patient why I have to do it. This is a standard of care. I do talk to
them when an abnormal result arrive. Over here, by law, I have to spend
time in a different state, it's shorter or longer, before I even do the
test. In some state, we still have to go and sign in on a consent form
which takes the time. That's the time which we're talking about and
because of that we shy away from it because it's not a law. So it's --
this disease is a political entity more than a disease, and you're
treating it as a disease and you pay for the test and thank you very
much. And that's the issue that needs to be resolved.

But let me ask a couple of questions, because I think you're taking
advantage of the -- what's going on, and I hope I'm wrong. But let me
tell you that when I go to clean my teeth one day before the six months
that you imposed on, I have to pay for it because you say it's six
months and it was only 179 days. The word that CDC put it out
unfortunately is really to initiate the process because that's so many
we don't do, but never told us how often can be done. And at least in
Illinois, I chat with four of the companies and none of them is saying
how often I can repeat the test, and that's an issue because people who
are sexually active can get it in the next act, and we need to put it
into some kind of cycle.

So I would appreciate your respond to that. And last, because it's
almost the same branch, unfortunately the CDC said 13 to 64. I'm 65. I'm
still sexually active. (Laughter.) You're not going to reimburse me for
the test because you're going to do just 13 to 64.

MR. : (Off mike, laughter.)

DR. YOGEV: Oh, thank you. I always like -- (laughter) -- the point is --
the point is really, I'm a pediatrician. I want to look from the other
side. We have, unfortunately, girls less than 13 years and obviously,
boys who are becoming pregnant. And I was wondering if you would expand
on sexually active period of life, or you're going to follow strictly
all that CDC recommended because you like to do that, and then
unfortunately we take a big part of the population that we need to
check.

DR. BASKIN: I'll respond to that and if Robert wants to add something, I
suspect it's going to be the same answer, and that is that you can order
this test, perform this test as frequently as you feel it's medically
necessary. There's no barrier in my company to the frequency that you
order the test. And secondly, while the CDC made a recommendation, which
we have adopted, from age 13 to 64, there's no barrier if you're
ordering this test on anyone from birth until -- until death. There is
no age limits in our system that would stop this test from being paid
for when you order it. So -- not -- a non-issue from my point of view.

MR. THOMAS: Also a non-issue, and we'll reimburse your physician time
appropriately for the counseling each and every time you'd order that
test, there is no set of a barrier or limitation on the amount of time
you can order that test.

DR. YOGEV: I hope there is a hardcopy of this meeting, so I can take it
to my state and show it to the people over there.

MR. : (Off mike.)

DR. YOGEV: Yes -- (laughter) -- because it's -- I can tell you that we
refused on a 12-year-old. That's why I was raising the issue, but it's
good to know. And you don't represent --

MR. : (Off mike.)

DR. YOGEV: That's why I say you don't represent --

MR. THOMAS: That's tacky, and that's --

DR. YOGEV: Thank you.

MR. THOMAS: Guidelines are guidelines, not set in stone, but if a
physician would send this -- you know, would -- that's a very appealable
kind of issue, but that is a tacky gesture not to appeal if there was a
12-year-old girl who was sexually active. You order the HIV test and
it's denied -- it's denied obviously from a computer set point maybe,
but just -- that would be a very appealable decision and we would not --
I just find that not appropriate.

DR. PRIMM: I have -- I'm sorry -- David.

DR. BUSH: I have a -- I guess a couple of questions which I think you've
touched on with that last answer, but part of mine is that Blue Cross,
Blue Shield is not universal, that there is different Blue Cross --
Blues, as they say, geographically. And my question is do you all have a
universal policy because my experience has been locally in Mississippi
that they have, like, a Healthy U that is annually that is designated
and they will reimburse based on what's designated as part of the
Healthy U, and if you order something else outside of that, whether it's
based on risk, or just the patient wants it, or you have read the CDC
guidelines and think all people should get it, that it's not reimbursed
and the patients say, well, I'll have to pay for this out of pocket,
therefore, I'll come back and get it. So my question is you sound really
great, but is that universal across all Blues, and what can we do
especially, like I said, when there is a risk or something that we
identify?

MR. THOMAS: I'm not a Blue Cross and Blue Shield associate. I'm -- I
would work for CareFirst -- CareFirst/Blue Cross, Blue Shield. I think
there're multiple Blue Cross and Blue Shields in the United States. It's
a franchise, not like Mickey D's, but nevertheless we have national
guidelines, [www.bcbs.com](http://www.bcbs.com/), and as far as I'm
aware, those guidelines -- we do recommend preventive testing. What
happens in Mississippi -- I'm just quite surprised at that. I don't know
-- that's confusing for me, I mean, because our national guidelines --
we follow the CDC's obvious recommendation. So if you could -- you could
-- you could send me some information on that, but I didn't know in
Mississippi, they're not -- not covering HIV testing for sexually active
adults.

DR. BUSH: It's not listed on the -- you know, like, with the lipid panel
and the things like that, so -- the other question that I had to do with
the actual cost of the test being reimbursed versus what is it that you
have identified as your reimbursement, and the -- whether you had any
idea -- so that's one thing, the actual cost of the test being totally,
completely reimbursed in the private doctor's office, what we would
charge for it. And the other had to do with the sense that you would
have for other insurances besides the Blues and Aetnas, as you're
sitting here, other private.

MR. THOMAS: What's the question again? And I think Andrew would love to
answer it. (Laughter.)

DR. BUSH: Oh, okay. Well, the actual cost in the private doctor's
office, similar to what Dr. Redfield was saying, versus what you have
determined you will reimburse. And then the second question was if you
had a sense of other private insurance carriers beside the Blues and the
Aetnas that are sitting here before us?

MR. BASKIN: So -- so you're looking for the actual dollars paid to the
doctor's office? I mean, are you looking for a dollar amount? I guess --
I'm unclear, to me.

DR. REDFIELD: I think it's sort of similar to my question, but I didn't
know if you'd answer it here or you'd have to send this stuff, but it's
-- you all must have determined what the actual cost is, the real true
cost, what the cost to do totally, and you also determined what you've
agreed to reimburse.

MR. BASKIN: Well, the reimbursement, as we stated, is broken up into
pieces. In other words, you bill for the test itself, which is just
technologically, the -- you know, you take the blood and run it through
whatever machine or whatever testing procedure as you go through to do
the test, unless it's one of the point of service tests, then presumably
it gets sent to a laboratory, in which case, then the laboratory may
bill us, or you may bill us as a pass-through billing, but that amount
varies from contract to contract. But oftentimes, it's based on --
similar to what better care rates are. It just depends on the contracts.
You're talking about a test, however, that may cost -- that may be
reimbursed anywhere from \$7 to \$10 or -- so it's not an expensive test
in and of itself.

The counseling services are billed by the physician as a separate item
or a separate line item, and that's once again a negotiated rate. So
what do you get for an average visit through your insurance company may
be, depending on the level of the visit, a minor visit, you may get
\$30; a major visit, you may get -- a medium visit, you may get \$50 or
\$60. This particular code, counseling services code, if it's separately
billed, has its own value relative to that.

And I -- once again, I can't give you an exact number because that
number varies from place to place around the country, but it varies the
same way that your normal office visit reimbursements vary. So it's in
line in most companies with the relative value units that are placed on
those particular services truthfully by CMS, and then many companies
follow that relative value. So how's that value relative to another
office service that you would provide. Does that answer the question?
I'm not certain that I did.

DR. BUSH: I'm not certain that you did either, and one of the things
I'll have to do -- you mentioned \$6 or some inexpensive number. That's
not my recollection of the number, but I will verify that on break.

MR. BASKIN: And I don't have the exact number either. I do know that the
-- that once again, I can speak for myself in nine years, and I am
involved in reimbursements and, in fact, in earlier part of my career, I
was part of setting fees in the Mid-Atlantic region for our company. I
-- (inaudible) -- the national job for the company. And frankly, I've
never had anyone complaining we underpaid for the actual test itself.
Now, if that's happening, that -- you know, I think I would have heard
it since that was part of my job, but it's never been an issue. If it is
with a particular provider, by all means, that provider should contact
the company.

MR. SCHMID: Also I have a question about other insurance companies?

DR. BUSH: Yes, I was just concerned about -- in our office, we probably
have ten or different -- ten, 12 different insurance providers that come
through our office and I'm thinking, like, United and others, if you had
a sense for how they were reimbursing as well.

MR. THOMAS: I can answer that. I don't see there will be -- I don't
think it's in a company's interest to -- not to work with -- of
physicians appropriately concerning HIV. I don't think there is just
money being made in the industry from just under contracting with
physicians and labs, et cetera, about HIV. I've never experienced the
kind of a -- appeal or a complaint from a physician concerning this
issue. Again, drawing the blood is a piece of this. Sending the -- our
sending the blood to the laboratory, or the saliva -- just counseling
for this testing -- a physician counseling for this testing pre-imposed.
I -- it's reimbursed appropriately.

So it may -- and it varies by contract, by contract hospital, physician,
ambulatory center, but I'm just not experienced, or I have never
experienced any particular animosity concerning this issue, or that
we're underpaying for this. I experience a lot of complaints about we're
underpaying for other things, but not HIV testing. Unless you have a
more specific question, I don't know what else to say. I didn't mean to
be so aggressive. (Laughter.)

MR. SCHMID: Okay, Beny do you have a question? And I want to get -- I
can't see people over here, so --

DR. PRIMM: I have a question for both Drs. Baskin and Dr. Thomas. I --
just to give you a scenario, I have a patient, for example, a
14-year-old African-American girl who has had reports from our office
and has had receptive anal coitus and, of course, vaginal coitus and
oral sex. And I want to, instead of giving her the rapid oral test, I'd
like very much to -- I suspect that she may be infected because she's
been moving around the neighborhood. I'd like to do an RNA test. Would
you pay for it?

MR. BASKIN: The simple answer is yes.

DR. PRIMM: Thank you.

MR. THOMAS: Same here.

DR. PRIMM: Thank you. I think this is a real important area of concern
that we have because people, they may come to the doctor and in most
instances, they don't just wake up one morning and say, I'm going to go
get an HIV test. They come because they think that something happened
that they may need to know about, okay? And those instances, I think one
should consider testing for the virus itself and the reason for that is
because they are most contagious at that time, right, that they have
just been infected. And to find out then and to begin treatment as early
as possible, if that's the doctor's choice, it will also help to protect
the community from a public health -- (unintelligible).

MR. MARTIN: Yes, Beny, you should add that the normal test would not
show they're infected yet because at the early stage. That's why he's
bringing that up.

MR. THOMAS: I don't think that would be -- that testing would be denied
or under-reimbursed, but I don't think that's part of the CDC guideline,
by the way, but that's your -- as an individual physician and your --
your clinical experience, I think it's appropriate, so -- and I don't
think there would be a reimbursement problem with that. There is nothing
within our claim check reimbursement -- our computer system that would
kick that out, especially if you -- (unintelligible) -- unless the
physician, or the billing company would miscode it, I think, or
something like that, but -- anyway -- and for the audience, the RNA test
is the HIV titer, I think, you're recommending that would show the
amount of HIV (ever present ?) before the -- other more traditional
tests would turn positive.

DR. PRIMM: I think that would be an excellent recommendation for certain
communities.

MR. SCHMID: David, you had a question? Oh, Shenequa? Okay.

MS. FLUCAS: Thank you for your comments. I wondered once the persons
find out that they are HIV positive, will you continue to cover that
person?

MR. BASKIN: Absolutely. It's not -- not even an issue. I mean, it's
ethically not an issue and, in fact, I think it's not legal, but it
wouldn't even -- not even a consideration that the results of those
tests don't commingle with insurance-type information in the company at
all, any way, shape, or form.

MR. SCHMID: David?

MR. THOMAS: I agree, but just to (reaffirm ?) the question, if a person
is -- are you saying if a person is, let's say, covered by Aetna and
then their HIV test is positive, do you mean could they be terminated
from their coverage, or do you mean if someone who's HIV positive, can
they obtain health insurance in America 2007?

MS. FLUCAS: Because most insurance companies, before -- like if a person
goes --

MR. THOMAS: -- underwriting.

MS. FLUCAS: -- uninsured, you know that they're positive, then they
would not be able to receive coverage, or the person who's already
receiving the coverage to continue to receive that coverage.

MR. THOMAS: Absolutely.

DR. MALEBRANCHE: Okay. My question, I think it's great to hear about the
private insurers and that's great. I love that. But I'm going to bring
to it back here because we've kind of let this issue -- kind of go to
the side. And my concern is particularly because we keep hearing -- in
my community -- I work in Atlanta, Georgia, and I work at Grady
Hospital, where practically all of our patients are uninsured. And we
all know that HIV is more of a social issue, and particularly in the
United States, when you drop HIV in a condition that is underserved with
the other kind of social determinants and structural determinants, lack
of income, lack of finances, lack of insurance, this is a problem. And
this is where the HIV epidemic has taken hold.

So it's great that for private folks they can go and then get it
covered, but it's really, really bothering me that in the -- in the
areas and with the populations that need to have this test covered that
are more disproportionately affected by the numbers in the United
States, that we're basically throwing our hands up and saying stuff
like, well, it's up to the states. Now, there's got to be something we
can do. The question I have is we have to able to hold the states
accountable and it's not saying that there has to be some federal
mandate that runs everything, but the states have to be held up to some
kind of standard. And if there can't be one kind of standard, if you're
just saying, well, it's up to the states and if there's a ignorant or
uninformed politician in one state that's disproportionately affected by
HIV among black and Latino communities, then while you throw your hands
up, they won't be able to get the coverage for the test. And so that's
going to be a problem.

If that's the case, what can we focus on, say, the test or the states
that are more disproportionately affected, and maybe say, look, you guys
need to step up and take maybe the top ten states and really start to
push this and push them to make this legal because as it stands now,
it's really becoming a barrier. And it's great with the private
insurance, but I can guarantee you that from the numbers in the United
States, the numbers of people that are becoming HIV positive are not the
ones who are all holding private insurance.

MR. RAZES: Well, I agree with what you're saying. Of course, from the
federal perspective, we've got the Medicaid program. You're referring
to, I believe, also a population that probably doesn't have insurance,
or -- and that's -- that's a bigger social issue.

The issue about maybe targeting the states that are top ten states or
what have you -- maybe, I don't know, CDC or somebody that -- CDC's in
the driver's seat with respect to the initiative, but I think that to
get awareness on the states -- and I don't want to just say, well, it's
just -- it's a state's right. I think there are a lot of things that
could be done. The benefits of identifying folks -- I mean, states are
looking at it maybe from the dollar and cents; people are looking at it
from a more practical standpoint, life-threatening impact on life.
What's it going to cost a state if the person just has the virus versus
if they get full-blown sick? I mean, it's going to double, triple,
quadruple their cost.

So you could look at it from the standpoint of -- it's like that old
commercial "you can pay me now, you can pay me later" type of thing too.
So I think there are benefits. I think there are ways of identify -- the
states that have large populations like that, trying to educate them, to
get them to move in the direction to cover these individuals. I don't
have any answer for the larger issue of folks who aren't covered by
Medicaid. And one thing I want to mention --

DR. MALEBRANCHE: Oh, no, no, let me -- let me just say the most -- the
people that are uninsured that come to us do apply for Medicaid and then
they end up getting Medicaid. So that's part of the issue as well. And
so it's not -- I'm not just talking about the people that don't have
anything, but, like, the folks who come to us and come to Grady
Hospital, they do go through social services and eventually get Medicaid
and that ends up being that coverage. So that is a problem if this is
going to come up, and I don't want to get in conversations where we're
putting a cost on somebody's life before they even test for the --
that's a little bit funny to be talking about at the table.

And you have a group of professionals here that will report to the
Department of Health and Human Services, eventually to the president of
the United States, what can we do to help move this, because this is not
the private insurance seems to be on board. The barrier seems to be with
Medicaid and Medicare, which is the insurance coverage for most of the
people, particularly black and Latino who are living with this disease
and who are at risk for this disease. So what do we need to do there?

MR. RAZES: Well, again, I do believe that the educational aspects of it
to again promote the interest at the local level up, and I -- I
certainly don't want to make this as a financial responsibility, looking
at it just in terms of dollars and cents, but states are looking, I
mean, they've only got a limited amount of money. Dr. Redfield was
talking about reimbursement rates. State of Maryland is in the red. A
number of states are, and they're not going to be expanding services if
they don't have the money to cover it. And the point I was trying to
make with the identification of individuals at an early stage, it is --
it is cheaper and more effective to provide those services when as early
in the process as possible. So that's the point. It makes -- it makes
good sense from a medical standpoint and from a fiduciary standpoint as
well.

MR. SCHMID: A couple of other people have some questions. I have another
one. Could you talk about the discussions that CMS has had with CDC
regarding this issue?

MR. RAZES: Carl, I'm not sure. I'm not in at the upper levels at this
point in terms of what those conversations have been. I mean, you know,
my level, yes, lots of --but I cannot at the higher up.

MR. SCHMID: John?

MR. MARTIN: Yes, I have some questions for you on the same topic. First,
just for Bob, what percent of your patients that you're talking about,
trying to get reimbursement, have private insurance, from your clinics?

DR. REDFIELD: In the non-federal associated clinics probably 35 percent
--

MR. MARTIN: And then --

DR. REDFIELD: 30 percent.

MR. MARTIN: And then beyond that it goes much smaller? Yes.

So one of the issues I think is just sort of uniformity. We hear a lot
of discussions of uncertainty, and until reimbursement is handled in a
uniform way I think it's pretty difficult to make it work because of the
complexity of the patients, complexity of the hospitals. And the -- and
Medicaid here would be a huge step forward and for -- Beny made a
comment earlier. I don't know if you were here there (sic) but it's his
theme, if this was in any other population we wouldn't be waiting around
for states. We wouldn't do this bottom up thing. So I think most of us
are kind of -- we've lost our patience for a bottom up approach any
more. We'd like to know how it can be done otherwise. Carl, you mention
a congressional mandate. But my question is has CMS mandated testing for
any other disease? Does CMS have that authority? The sort of a mechanism
that a flip could be -- a switch could be flipped tomorrow and that this
problem would be solved?

MR. RAZES: I'm not familiar with it. I mean most of the types of tests
are -- that are say preventative or what have you, are optional, so to
speak, but not mandatory. And like on the Medicare side it's --
obviously it's got to be a law and it would have to be so on the
Medicaid side as well.

MS. MCGEEIN: I don't want to take him off the hook, but changes to
Medicare and Medicaid have to be congressionally mandated.

MR. RAZES: I see.

MS. MCGEEIN: We don't have that authority.

MR. THOMAS: Yes. I thought --

(Cross talk.)

MR. BASKIN: The Department is --

(Cross talk.)

MR. BASKIN: -- flipped a switch with the --

MR. THOMAS: Nonexistent I think.

MR. BASKIN: Yes.

MS. : You guys are much more flexible than we are.

DR. REDFIELD: Okay. No I wanted to just go back and get a sense from the
three of you then. CDC announced their new recommendations. I think they
were formally announced in September of last year. Give me a sense of
what impact that's had on the change of HIV testing that you've all had
to reimburse or the situations in which you've had to reimburse. In
other words, if it's all just doctor's office that has -- has there been
any changes either in the amount of testing that you're doing in any of
the three different reimbursement groups you have, or the situation in
which the reimbursement is coming. Because CDC clearly recommended to
take this beyond the doctor's office. And I'm just interested to see,
how has it penetrated CareFirst, Aetna, Medicaid, Medicare in terms of
-- (inaudible) -- changes and reimbursement requests for HIV testing?

MR. THOMAS: I don't have exact numbers at all for that question but --
and there's also been no appeals for any disgruntled hospitals or
facilities or ambulatory care centers or nurse practitioners -- problems
with payments. So we'd like to hammer out this issue.

DR. REDFIELD: Yes. My approach is to the flip-side here. I'm not worried
about the reimbursement. You've made the case that you all do that.

MR. THOMAS: I mean not (a testing ?)

DR. REDFIELD: I'm just trying to see as an indicator how effective the
policy has been implemented. Maybe you would have numbers. It would be
useful for this committee to see what the penetrant was, say, 2005-2006,
and what the penetrant was 2006-2007. Does it get a sense -- is this
policy being translated?

MR. BASKIN: Frankly, I'm not aware that those numbers have even been put
together. Not that they couldn't easily be from my company, but I don't
believe it's been on the radar screen to do so. Interestingly enough,
when you're talking about quality measures like that a lot of what we do
is driven by (HETIS ?) measures, and it was actually something I was
hoping to bring up. That one of the things that drives insurance
companies to promote certain practices -- and it's one thing to say that
we cover this and we'll pay for it, but frankly, I don't know that we do
a lot of active promotion of it. Not that we do a lot of active
promotion of things like this in general. But certainly we do promote
mammography rates and PAP screenings and certain depression measures
that come out of (HETIS ?). And in fact one avenue to potentially get
this recommendation more broadly taken off is to potentially create a
(HETIS ?) measure of to work with NCQA to do such a thing because that
would -- it would make everybody stop and simply start to measure, and
in measuring then have to show that there's an improvement down the
line. But frankly, it hasn't been -- it hasn't been the direction we've
gone.

MR. RAZES: From a CMS perspective, I was touching base with folks on
both sides of the shop, and Medicare it's basically negligible in terms
of any sorts of increase. And on the Medicaid side, at least based on
the preliminary data that we've gotten, there hasn't been either. But
Medicaid is a bit lower in terms of getting our data.

DR. PRIMM: My question, Mr. Razes, is concerning testing in prisons.
Would Medicaid pay for testing of people that are in the prison or jail
system? And as they get out, when they are not felons, ex-felons and not
necessarily eligible for Medicaid or Medicare, would you pay for tests
for those individuals who have a pretty high percentage of HIV
infection?

MR. RAZES: Medicaid will not pay for testing for individuals who are
incarcerated. If they were eligible prior to incarceration or when they
get out Medicaid would pay for it, but not while they're in prison.
There are programs at the state level to get people on to Medicaid as
soon as they are released from prison, but again, no services while
they're in prison.

DR. PRIMM: That process is rather slow in my experience of ex-felons.
When they come out of prison, there's great deal of a problem that --
it's not necessarily so for people who have mental health problems,
because their medication, for example, is paid for and generally they
are given medication when they leave prison and they right away can get
it at the pharmacy. But not HIV-infected people, which is dangerous for
us, out here in the community.

MR. RAZES: Yes.

DR. PRIMM: And there ought to be some recognition of that and maybe some
changes suggested by you as you go back to talk about that issue,
because it's a serious issue in the African-American community.

MR. RAZES: I agree with you, sir. Some states have programs, limited in
scope sometimes, pre-released types of programs so that they link people
up with the services so that they've got them when they walk out the
door with respect to employment, with respect to medical assistance.
It's not done -- it's not common place, per se. It's not a general
practice, but there are bright spots. But that is definitely an issue.
And yes, I can take that back.

DR. PRIMM: I appreciate that. Thank you, sir.

MR. SCHMID: Any other questions from the membership?

DR. BUSH: I'm not sure this is much a question as a comment. And first
of all I'd like to say I appreciate you coming and -- the private
practitioners in particular -- and enlightening us on what you are
doing, because at our previous meeting we are getting information that
reimbursement was a barrier. And so for you to say the private
practitioners are on beard is very enlightening. And for us here in
PACHA, we now know, although as I've said I'll be checking some things
out myself, but the mechanism that you mentioned (HETIS ?) promoting
mammograms, how could you all help us in -- or how could that be done to
get them to say just like mammograms the CDC has recommended X. And so
that it would be disseminated to more than just the 12 of us in this
room, but to other people where it will be utilized in private practice.
So I guess I want to say again thank you for that information. Now how
can we get it utilized on the private side?

MR. THOMAS: I think the answer to that is just national -- NCQA that's
-- for it to be incorporated into the way that insurance companies are
evaluated as to quality care measures.

MR. SCHMID: Dr. Baskin, I'm glad you brought up the whole promotion and
education of HIV testing. And that's another -- the recommendations that
came out from the CDC said that every person who gets tested will be
given information about HIV and what a test is, what is HIV, how it's
spread, et cetera. But I don't know if CDC is still implementing these
recommendations in the different healthcare settings, but I would like
to see what those documents are. And wondering if -- you don't want
every doctor's office to have different ones. Maybe there'll be standard
ones, but it may be good for something that the insurance companies may
want to put together and provide in the healthcare settings. And that's
a way that you could promote the testing.

MR. BASKIN: Well, as companies, I would venture to say that we all have
web content available to our membership as well as to our providers
regarding HIV in testing and the like -- and the information that you're
talking about. I agree, however, that we all have our own information.
Now, if we were to read it of course, I doubt there'd be any actual
difference in the information other than presented in a different way
and with different paragraph --

MR. THOMAS: Different font size. (Laughter.)

MR. BASKIN: Right. And things like that. Certainly, if we all had the
exact same information, that would all well and good. We've actually
been able to do that on a few things where we've had some cooperation
amongst insurance companies. It's a really --

MR. THOMAS: Diabetes for example.

MR. BASKIN: Yes. Diabetes. Exactly. We have some joint guidelines and
there are certain states where we've had to get together and do joint
guidelines. But in reality there are hundreds of insurers around the
country, and despite what people think, we don't meet, we don't
conspire, we don't --

MR. THOMAS: Kidnap small children. (Laughter.)

MR. BASKIN: There's really no reasons for us legitimately to get
together other than on quality issues, and that's handled in different
forms, to be honest with you. It's handled though things like NCQA or
AHRQ or any of these other kind of national agencies of which most of us
are members.

MR. THOMAS: Thank you. Dr. Redfield.

DR. REDFIELD: I just have one last question. I do want to --

MS. : The microphone.

DR. REDFIELD: I wanted to thank you for your comments. And I do think as
David says the discrepancy is probably more between the public sector
reimbursement than the private sector. The private sector -- you all
seem to continue to sort of lead the way in providing not only access to
care for people that are HIV infected which you've done and continue to
do, but I'm interested, because we've got this policy -- this new policy
to try to promote new diagnosis that there's an alignment of interests,
the public health interest to eliminate ignorant transmission, and I
think just from a health company point of view that getting people
diagnosed early and get them in care and preventing transmission to more
people within -- because they're likely, if they're in the context of
different businesses, to have other members that they probably could
transmit to.

So there's an alignment of interest here. Are there things that could be
changed from your perspective from the outside, from the government's
perspective, or others that have not -- that could help increase your
ability to be part of promoting this new policy? I mean, you mentioned
one that I wrote down, clearly that the getting into this measurement
issue would be a positive one. There are other ones we forgot to ask
about that would allow your industry to be more part of moving this
policy forward, not -- in partnership with the government.

MR. THOMAS: Your question confuses me.

DR. REDFIELD: Well, I'm asking again. We're trying to get more young --
more Americans diagnosed. That's a goal. And it's -- again, for someone
who's been involved for 25 years, it does sadden me that 22 years after
the AIDS -- or 21 years after the AIDS test was deployed we still have a
significant number of Americans not diagnosed. So we need everybody's
help on this, including the -- the health insurance industry as a
component of that. It's not the whole thing; it's component of that.

You all have done as much -- a lot of things that you feel to help make
sure doctors can order this test and there's no interference, and that's
-- I think you've convinced -- I mean clearly that's what's on the table
and that's reality. I think some of us may not know how to code for
everything, but we'll go back and learn some of those issues in terms of
the dis-linkages. But the public sector, certainly there's a hole. And
in the uninsured there's a hole. And Ryan White recently modified it so
that at lest now using Ryan White funds you can try to diagnose somebody
with HIV infection, which historically we couldn't use --

MR. THOMAS: Which are being decreased, I think.

DR. REDFIELD: Yes.

MR. THOMAS: Are they not? Ryan White funds? No?

DR. REDFIELD: Oh, I don't think they're being decreased. No.

MR. THOMAS: Decreased, right?

MS. : No.

DR. REDFIELD: No.

MR. THOMAS: No? Oh, I'm sorry.

DR. REDFIELD: Different states, depending on how they've moved, may have
different modulations. So the State of Maryland may have some
modulations in a negative side because maybe not of being as
aggressively engaging U.S. -- federal guidance that came down probably
five years ago. But what I'm trying to get at, the question was, just
like you in my question told me about this -- if we've got this
measurement that might help. Are there other things that could better
engage the insurance industry to be a more effective member of this team
of trying to make it so by the year 2010 all Americans with HIV
infection know that they have HIV infection? That's all I'm asking. That
you might have some other idea that we need to consider.

MR. BASKIN: Frankly, I agree with you, it's in our best interest as well
as everyone's best interest, to have this diagnosis made as early as
possible and this testing be widespread. We're all aware of the barriers
that insurance companies have of trying to get messages out directly --
direct to consumer. Kind of average marketing from insurance companies
is one that's taken with a little bit of hesitation by the public. It's
a little more difficult for us to initiate, but it is possible for us to
partner -- partner with clinics, partner with hospitals. I'm certain
that CareFirst and I know that Aetna, through its foundation, does
actually put monies out to support these types of efforts and --

DR. REDFIELD: Yes, like the Whitman-Walker band thing.

MR. BASKIN: Yes. There's charitable funds through both of our companies,
I'm sure, and any large insurance company. And I know ours specifically
being -- are being utilized to address ethnic and racial disparities in
healthcare and this would certainly fit the bill. So there are those
opportunities. But what I'm basically trying to say is opportunities for
us to kind of help, but partner with somebody who may be considered more
acceptable to the community, to the membership.

DR. REDFIELD: Is there a way that the government side can help you all
be more effective in doing -- that's what I -- we've asked you a lot of
what you can do. My last question really is more about are there things
that could be changed from the government side to make you a more
effective partner? That's where I was trying to get at.

MR. BASKIN: Well, there's perceived barriers that probably aren't truly
there. There's all kinds of -- and I mean we're all aware of these
things. They've all been kind of touched on at some point in time. But
all this perceived barrier about being uninsurable -- if you already
have insurance, you're going to somehow lose your insurance. That's just
-- I certainly -- we've mentioned that if you're uninsured and try and
get an individual underwritten policy, that may bean issue for you. But
certainly for an insured person --

MR. THOMAS: Well, it would be non-existent. You know that.

MR. BASKIN: Certainly for an insured person, those things aren't issues.
There are still people that feel if they get a test that somehow or
another the insurance company utilizes that information or passes it on
somewhere or somehow shares it. I mean these things are illegal and
quite frankly, unethical. And to the extent that the government has
passed these types of regulations, whether it be in the states or
federal regulations, it's not being believed, which makes it actually
harder for us to do what we try and do to promote good care.

I mean, if we would attempt it promote this, to be honest with you, we'd
be accused of something as opposed to welcomed as a partner in some way.
So to the extent that the government can reassure the public -- and I
really look at this as a public safety issue, to be honest with you --
it's just not been out there. I mean here's the -- I started out with my
comments by talking about the fact that that's something we don't talk
about. Well, it's something we don't trust either.

And after 20-some years of this, we've gotten nowhere as far as I'm
concerned. And maybe perhaps I'm talking more personally than for the
company. But it is a barrier for us as a company to have that kind of
atmosphere out there and that image that just makes it hard. But we are
willing partners. But I agree with you, it's hard to find the venue and
the right partnerships to make this happen.

MR. SCHMID: One last question.

MR. THOMAS: I agree completely. And I think your question touches almost
a political one in the sense that when so millions of Americans have no
health insurance, commingling with the lucky few that do, and fear of
losing your job, but this really -- I think this question is just rather
political. And I think the most that we can do is ask for a change at
the government level. It pains me to hear Dr. Primm talk about just
prison inmates. That's a growth industry in our country, it seems. So I
just -- again that's just I think -- I'm speaking personally, but I
think that the answer is at the voting booth. So thank you.

MR. SCHMID: One last question, John.

MR. MARTIN: Thank you. So this is a very helpful discussion, but there
seems to be a little bit of discrepancy. So this op ed that Carl sent
out to us, it's from a physician here in Washington, D.C. -- it's not
there, we got it by e-mail some time ago. It's from a physician here in
Washington, D.C., who's talking about screening within the ER. So one of
the things we talked a lot about is if we could screen patients who come
to the ER, that may be their only source of medical care, we could
perhaps pick up a lot of HIV. I believe it was in South Carolina where
the study was done where they demonstrated that statistically.

So what he wrote is health insurers general pay for an emergency room
basis based on final diagnosis. An HMO will pay a fixed amount for a
sprained ankle. If this patient receives an easy-to-perform but
unrelated HIV screen, the hospital is unable to recover the cost of
that. And so that's what he's writing is the barrier there, to be unable
to do testing in the ER.

MR. THOMAS: Jim, I'm confused again. (Unintelligible) -- the emergency
room where most of the uninsured get their care, Jim, they're not
reimbursing for HIV tests? Is that -- which is more related to Medicaid
--

MR. MARTIN: But that means uninsured --

MR. THOMAS: -- or private insurers?

MR. MARTIN: Well, that's the question here. I don't know. It says health
insurers --

MR. THOMAS: Yes, I don't --

MR. MARTIN: -- generally, but he may be referring to public payments.
But the question I have would be private payers reimburse it?

MR. THOMAS: As far as I'm aware, that would be reimbursed.

MR. MARTIN: So it's not just --

MR. THOMAS: An ER visit is coded and --

MR. MARTIN: Yes.

MR. THOMAS: -- et cetera, et cetera. But I don't know -- to be honest, I
don't know just what the numbers are, but I could find out since we have
a division called medical infomatics. It sounds very scary, and it's
overseen by an M.D. here at the --

MR. MARTIN: We all like data.

MR. THOMAS: But I would wonder how ERs are responding to that when
someone comes in for a sprained ankle and your 14-year-old teen and
you're with your mother and you order an HIV test. I bet I bet that's
not done a lot. So -- anyway, that's my response.

MR. MARTIN: Yes. Well, right here at this place where they do have
funding from other sources, 60 percent of the ER patients accept an HIV
test, 75 percent told us they thought the ER was a good place and 80
percent would recommend it to a friend. But I think this is a unique
situation where they have the funding, that they can apply it uniformly
though all types of patients, and don't have the divergence of public
and private payers.

MR. BASKIN: Well, let me just respond to the -- it was a comment there
about you pay a certain rate for an ankle sprain and then they do an HIV
test and they're not reimbursed. There's a lot of semantics going on
there, a lot of interesting interpretation of the way the hospitals get
reimbursed. And in fact, contracts with hospitals take many, many forms.
One such form is a global payment for emergency room that would be based
on certain levels of severity or it could be one set average payment
that -- all comers, meaning that if you have a heart attack and you go
to the emergency room, you may get reimbursed the emergency room the
same amount as a sprained ankle and it's kind of an average type of
thing. So there's a lot of different ways to do it.

But in doing so, if there is a global payment strategy, then a contract
which has been agreed upon readily by both parties and theoretically a
rate was negotiated that both parties would accept, one to pay and one
to accept, whatever is done during that time is essentially reimbursed
as part of that global payment. If a hospital is now adding new services
that weren't there when they last negotiated, the next negotiation
includes that. So it's rather naive to think that because a hospital
performs an extra blood test that it didn't actually get reimbursed, and
in reality it is being reimbursed as their global payment.

If a hospital is reimbursed on a more fee-for-service basis which is a
different type of contract, which is literally we pay for each component
of what you've done, then once again I'm not aware of anything, at least
in my company -- I'm once again going to say I'm presuming CareFirst as
well -- would stop that additional payment to go out for that test. So
I'm a little -- I just am a little concerned about whether that really
is accurate or not.

MR. MARTIN: So just maybe for some of the other people here then who
work in this type of setting -- I don't -- so fair to say global
contract then there may be -- ERs and hospitals may in incentivized not
to provide the HIV test. If they work it into the next round, would they
be more incentivized to do it or would they still -- is this going to be
a barrier to testing going forwards? I guess that's my question.

DR. REDFIELD: Yes. And I think this finally I think got me were I tried
to start. Because I think clearly in the individual person you've both
helped me understand everything is reimbursable if you know how to do
it. But it is these global contracts. And so it's really not the
insurance industry; it's the disincentive. And this is why it would be
really great if you do have the data. I know I'd love to see testing
penetrants, and see over time how it's changing because it's just --
it's determination of how effective the policy is penetrating. That -- I
suspect none of these individuals put this in the contract negotiations,
and so the disincentive is really back at the hospital level.

That comes back to our first question where I find there our hospital is
less reluctant to do it because, quote, "they're not getting compensated
for it." Well, they are compensated. They getting global -- they're
going to have global contracts with everybody. They just decided they
didn't put this in their original formula and this is a new cost --
because I'm trying to still figure out what is it that we can do
effectively to help CDC's recommendations get implemented. That's all
we're trying to figure out. And it seems to me one of the realities, it
comes down to the finances, but the finances may be buried in these
global contracts, and again, how to incentivize that this gets included.
And you mentioned one of the ways maybe to do it is to make it one of
these measures because then people are at least measuring it. I think
that clarifies for me where the reimbursement issue is. It's probably
really on these global contracts when they are technically being
reimbursed for it. It's their decision how to allocate the dollars that
they're given.

MR. BASKIN: Well, just in defense of the hospitals just for a moment I
would find it difficult to believe that the hospital and the emergency
room setting is not doing the test because they're under a global
payment and therefore trying to trim their costs as much as possible.
I'm honestly going to give them the benefit of the doubt on that one.

And frankly it's not that things couldn't be contracted another way, but
understand the complexities of when you're contracting with a hospital,
you're contracting for thousands upon thousands upon thousands of
services, and they are not negotiated line item by line item. And
actually the hospital prefers to have a global payment in most
instances, and in fact it's a joint agreement as to whether to do that.
It's not an overbearing -- it's not like the insurance company comes out
and says, "You've got to do it this way." It's what works for both
entities.

So to the extent that hospital says, "Geez, I want to open up an HIV
testing clinic," I can't believe there's any insurance company in this
country that wouldn't be willing to talk to them and say, "Well, how can
we make that so that it's not a disincentive for you to do that?" But
those conversations, they're welcome. They are entirely welcome.

MR. MARTIN: I think we -- yes, we're coming from, we know the testing is
not being done near to the extent that you would envision it to be done.
And so what are the barriers that are doing that, that are causing that
problem? This has given some guidance I think, of where to go with --
(inaudible).

MR. SCHMID: Right. Well, I want to thank all of our panelists. I think
they've done an excellent job of presenting more information. And as we
said, this is one of the barriers, one of the major barriers to
implementing CDC's policies. And I think we heard some positive news
from the private insurance company today. And I think we'd like to
further investigate some of the information. And I think we heard that
we have a long ways to go in the public financing arena for
reimbursement, and that's where most of people with HIV are, as we
discussed.

And maybe in the future, and maybe this could be in the domestic
subcommittee, our future meeting, but if it does rest with Congress,
maybe we need to hear from some congressional staffers or members of
Congress. If it does have to do with the states, maybe we could bring in
some state Medicaid directors. But I think this is an issue that the
committee is going to continue to look into.

But I want to thank all of you for being here today. It's been very
helpful. Thank you. (Applause.)

MS. MCGEEIN: This concludes our programming for this morning. We'll
break for lunch now and come back into session at 1:00 p.m. I will once
again advise the members of the audience that we have limited -- they
have limited accessibility. They can make it to the cafeteria and back.
They can make it t the restrooms and back. But security will prevent you
from going off the floor for the moment. Thanks.

(Break.)

MARILYN MAXWELL: Good afternoon.

MR. : Good afternoon.

MS. MAXWELL: It's great to be with you. Welcome to the afternoon session
of our first day at a PACHA meeting. At this time, we'd like to welcome
our next speaker, Dr. Nora Volkow. Dr. Volkow is the director of the
National Institute of Drug Abuse at NIH. NIDA supports most of the
world's research on the health aspects of drug abuse and addiction. As a
research psychiatrist, she pioneered the use of brain imaging to
investigate the toxic effects of drugs and their addictive properties.
Dr. Volkow spent most of her professional career at the Department of
Energy's Brookhaven National Laboratory where she has held several
leadership positions including director of nuclear medicine, chairman of
the medical department and associate director for life sciences. Dr.
Volkow is going to speak to us today on crystal methamphetamine
epidemic.

Thank you and welcome.

NORA VOLKOW: Thanks very much. (Off mike.) It's a pleasure and
opportunity to speak to you about the importance of methamphetamine
addiction and the HIV/AIDS epidemic but in general more about drugs than
the HIV epidemic. Of course methamphetamine puts sense of urgency.

One of the things that we've been all of us very unfortunately
disillusioned with was the negative trial for the Merck vaccine for
HIV/AIDS because we were all looking forward to the possibility of
generating a vaccine which would be incredibly capable of course in
preventing drug use. The failure of this vaccine sets us back and the
concept -- it highlights how difficult it is going to get a vaccine for
HIV. In speaking with immunologists, it's not straightforward, and we
may never have a vaccine in the next 10, 15 years. So we need to look at
other strategies that we can do to actually prevent the HIV/AIDS and
that's prevention, prevention, prevention, and this is where my
presentation comes around.

Drugs, from the beginning of the HIV epidemic have played an
extraordinarily important role in its dissemination. It's been estimated
that at least 30 percent of the cases of HIV from the inception of the
epidemic until now have been accounted by drug use, except that that
accounting has been specifically focused on injection drug use. By using
contaminated material, drug users are at a very high risk of infecting
themselves, and this is recognized. It's a national and international
problem.

Then there's another aspect which has been much less investigated which
is the use of drugs themselves produce during intoxication a change in
the mental state of the individuals that can favor behaviors that
increase their likelihood of getting infected with HIV. On top of that,
there is some evidence that certain drugs may produce physiological
changes in our bodies that facilitate that infectivity with HIV when
having a sexual transmission with someone that -- sexual interaction
with someone that is infected. And finally, we've come to recognize that
the combination of HIV and drugs is actually quite deleterious and it
can accelerate the progression of the disease.

This is just some epidemiological data to show how really the whole
trajectory of the HIV epidemic is changing, and particularly all of the
vectors associated with the disease. In around 1997, we see a dramatic
decline, this is the number of cases, of eight cases and death, so these
reflect -- (unintelligible) -- numbers of death cases here, and this is
since the inception, and that's 1985 to 2004. You can see the dramatic
decline in the number of deaths and this is very much in part associated
with the antiretroviral therapy which has been very effective in
decreasing the number of people of getting AIDS. At the same time, I
think equivalent, as important as the antiretroviral therapy is that the
number of cases has gone down of new infections, and this has to do with
effective prevention interventions which is something that as bad as the
HIV/AIDS epidemic is and devastating, we have to recognize we can
prevent it. We know the vector and we should be able to prevent it. So
there's been advances both in terms of the treatment as well as the
prevention.

Initially, the HIV epidemics were subscribed very much to men having sex
with men, and that still continues to be the number one mechanism for
infectivity of HIV/AIDS. The number two case was injection drug use, and
you see it here, and interestingly in the United States at least we have
been very successful in decreasing the number of people that inject
drugs who became infected, and that has to do a lot with the
introduction of treatments for these individuals, which for the most
part reflect individuals that are injecting heroin and to a lesser
extent, individuals that may be injecting cocaine or methamphetamine.

Unfortunately, there is another area where we are not seeing decreases,
but we are actually seeing increases despite the success in prevention
in other areas, and that is individuals getting HIV out of heterosexual
contacts. And what's unique about this group is two things about them.
First of all, 50 percent of the new cases of HIV now are related to
individuals that are 25 years or younger, many of whom come out of
having heterosexual sex, and the other one has to do with the fact that
many of these heterosexual contacts are done under the influences of
drugs, whether it is alcohol, marijuana, cocaine or methamphetamine,
that facilitate behaviors that otherwise a person wouldn't engage on,
whereupon again, highlighting the importance of the involvement of drugs
on the HIV epidemic, not just on the injection drug use, but actually on
the utilization of drugs that can favor risky sexual behaviors.

And the importance of this vector, not just use of drugs based by
themselves increasing the risk of getting HIV as highlighted by this
study that was just published by -- (unintelligible) -- in 2007 on a
large cohort of individuals in New York City. These were actually two
cohorts of subjects, one of 2001, 21 subjects that were attending
treatment in a New York Clinic, and the other one represented 450
subjects that were not involved in treatment, were just recruited by
advertisement. And what the investigators were doing was actually
addressing the prevalence rate on these individuals that were drug users
and were dividing them into those that were current injectors versus
non-injectors, both in the group that actually was receiving treatment
for drug addiction as well as in the group that was not receiving
treatment for drug addiction.

And what you can see clearly is that it does not make any difference in
terms of prevalence of HIV where you are injecting drug use or you are
not. The prevalence rates on both groups of subjects are extremely high.
Thirteen percent for injection drug users, 12 percent for people that
are taking drugs but not injecting them in this cohort. In the other
cohort that is not actually even receiving any type of treatment for
drug addiction, current injectors is 15 percent and individuals that are
not injecting or taking drugs is 17 percent. It's close to one in every
five subjects has HIV positive. And that gets you an indication about
how extraordinarily important drugs are in the HIV/AIDS epidemic.

Now, why could that be so? And I basically stated to you there are two
mechanisms by which drugs, just intoxicating yourself with drugs, can
increase the likelihood of getting HIV/AIDS. One of them is that drugs
decrease normally what we call the (brakes ?) of our brain, that is, the
areas of the brain in the prefrontal cortex that allows us to control
our emotions and our desires. When you get intoxicated, the functions of
those areas goes down. Interestingly, the areas of the brain involved
with limbic functions responsible for sexual desire go up, and this just
illustrates those effects; this is the effects of intravenous
methylphenidate, it's a stimulant drug, less potent, much less potent
than methamphetamine but having similar pharmacological actions. And
what you are just actually doing in this study is recording the sexual
desire when individuals are give a placebo versus injection of the
stimulant drugs, whether they are non-drug users controlled subjects or
they are regular cocaine abusers.

Regardless of whether you regularly abuse drugs or not, just being
intoxicated with the stimulant drugs, such -- and as I say, this is less
potent than methamphetamine -- just by itself with no sexual
stimulation, just giving the drug will increase sexual desire in the
subjects. Now, when you put these together with the concept of people
take drugs not just in a laboratory condition but actually in the case
of methamphetamine explicitly when they are going to be going to social
environments with the possibility of sexual contacts, there you can see
that the interaction of just the increase in sexual arousal becomes --
could be very, very problematic.

What do we know about the neurobiology? Well, what I'm showing you here
are brain images of activation when an individual is sexually aroused.
And the way that these studies are done, you use functional magnetic
resonance imaging and you expose subjects to in this case a sexual
video. The subjects report feeling sexually aroused and the degree of
sexual arousal is correlated with activation of these areas that are
circled here which are the limbic areas of the brain that include the
famous amygdale, the temporal (pole ?) and the hypothalamus. Those are
all areas of the brain implicated in instinctual functions and what we
call the limbic brain, here illustrated more or less here in green.

When the subjects are brought back to the laboratory and the
investigators say, I don't want you to get sexually aroused, you can do
that, you can control your desires. We all know that. And that we do
that by cognitive influence. The cognitive influence in our brain is the
frontal cortex. And what you see here is the subjects are shown exactly
the same sexual video, but the investigators have told them before they
showed them the sexual video that they don't want them to get sexually
aroused. Yes, and the subjects are able to not feel sexual arousal even
though they are seeing the video, and you can see also their brain does
not activate in the limbic areas of the brain. Interestingly, it
activates into the prefrontal cortex, this areas of the brain here,
where you are actually -- this area here sends connections, anatomical
connections to the limbic brain that actually can inhibit its function.
And to the extent that you can activate these frontal cortical areas of
the brain, you can inhibit the function of the limbic brain and you can
regulate your actions.

Well, that very interesting balance between the primitive parts of our
brain that deal with instinctual behaviors and the cognitive parts of
our brain that allow us to exert cognitive control such that we can
exert free will and regulate our actions, and we can say no, even though
we may want to say it but it's socially inappropriate or it would be
risky, that is the prefrontal cortex. That's the proper balance. And
that balance is totally and completely disturbed when you get
intoxicated with drugs. And these are actually images of the brain,
summarizing the effect of in this case alcohol intoxication in a group
of subjects, 20 normal controls which were given a moderate dose of
alcohol. And what you see are different slices of the brain, and in blue
are the areas that get deactivated when a person gets intoxicated with
alcohol, and in red are the areas of the brain that get activated when
the person is intoxicated with alcohol.

And what is striking is how basically, is these two areas that are
balancing get opposite effects. The prefrontal cortex, exactly the area,
exactly the same area that was able to get activated to inhibit that
gets deactivated in the persons that are intoxicated with alcohol. This
is the -- (unintelligible) -- of prefrontal cortex all in blue. And the
areas of the brain, the famous limbic frame area, this is the amygdale,
the area that got activated when the subjects were sexually aroused,
this is the temporal (pole ?) which was also activated when they get
sexually aroused, the nucleus accumbens that I didn't show it there, but
also the hypothalamus, all of these areas get activated by alcohol. So
you have exactly the opposite pattern of effects that you would want
when you want a person to make a decision whether they indeed want to
engage in a sexual relationship or whether this could be detrimental for
their health and they shouldn't do it.

So that's what we know about it. So yes, indeed, the use of drugs goes
way beyond intravenous drug use, but it actually has to do exactly with
the effects of the drug in changing our mental state and how the brain
functions. But it's also clear that the combination of -- for those that
already have HIV and taking drugs can be very deleterious, and there are
many, many studies showing that. I just want to show you one that
illustrates the deleterious effects on the brain of human subjects for a
particular marker, a protein that is very important in our brain, to
actually enable us to initiate movement or motoric operations, for
cognition, for motivation.

This is called the dopamine transporter which marks the famous dopamine
cells. When you damage these dopamine cells, when you kill approximately
80 or 85, that's when you start to develop what we call Parkinson's
disease. And it's a very unfortunate disease for those suffering for it
because by destroying these cells which are responsible for initiating
action, these patients literally cannot initiate movement and they are
trapped in their own bodies. The way that you treat these patients with
Parkinson's disease is giving them medications that can boost dopamine
in their brain, and by activating dopamine systems, they can move again.
The dopamine, however, as I say, is not just involved with initiation of
movement; it's involved with initiation of a wide variety of behaviors
and that's why it's so fundamental for motivation.

So these images here represent the concentration for a protein that
serves as a marker for dopamine cells. This is a normal person, and the
colors represent the concentration of this marker. This is a patient
with HIV, and you can see the decrease in the coloring red here which is
the areas which have the highest concentration of this marker is going
down. So this is quantified, 17 subjects and 15 with HIV. These
basically have no evidence of neurological symptoms. They just show a
decline in these markers of the dopamine cells. And these are patients
that also are HIV but are also abusing substances, in this case
specifically cocaine. And you can clearly see that the combination is
much more deleterious. You see it in the images, you see it in the
quantification.

Again, putting forward the concept that unfortunately what happens with
HIV is that the virus targets cells in the brain. It can (leave ?) in a
latent phase affecting cells in the brain and otherwise the person can
be perfectly normal. And indeed, this has become one of the most
challenging things to do when you are treating someone with HIV because
the medications don't go into the brain. This is one of the last
repositories of the presence of the virus in the human body. Incredibly
important for pharmacological therapeutics if we could actually target
medications that could get rid of the virus in the brain. But combining
it with drugs actually just accelerates the deterioration of the effects
of the virus in the brain.

Now, let's come back to methamphetamine, because that's what I was asked
to (call in ?). I basically illustrated how drugs, all of them, whether
it's legally like alcohol or illegal, are deleterious to the brain. But
methamphetamine stands even I would say one step above those deleterious
actions for a wide variety of reasons. Methamphetamine being a
stimulant, of the stimulants that one that's the most potent of all of
them, one of the things I showed you with another stimulant that was
much milder, that it increases sexual desire. Well, methamphetamine does
that even in a more effective way, and this is recognized in men having
sex with men to the point that they basically describe that when they
want to have sexual interactions, particularly when they are interested
on engaging in these risky behaviors, they may actually take
methamphetamine to facilitate this behavior. So exactly what you don't
want them to do and they want to do, and whatever cognitive abilities
that they may have or concerns about it, if they want to basically get
rid of those concerns, get rid of those inhibitions, they'll take
methamphetamine, and it works, unfortunately.

The use of methamphetamine being such a potent stimulant also produces
more significant disruption into brain function than other drugs. And
among other things, is that people that get addicted to methamphetamine,
which happens faster than with other drugs of abuse -- in fact, for
example, the studies that have looked -- how long does it take you to
become addicted to cocaine, which is very addictive, which is
approximately three years, studies that have looked at methamphetamine
report that you can become addicted in less than one year. So here you
have one of the consequences these people becoming addicted to drugs are
much less likely to take their antiretroviral therapy as indicated,
which among other things could have deleterious consequences because it
can promote the emergence of resistant strains.

In animal models, methamphetamine increases the replication rates of
viral particles, so we believe that this may also be facilitated by --
use of these drugs may also facilitate the replication of the virus in
humans, but again, this is at the animal level. It's very difficult to
demonstrate that in the human brain. We don't have the --
(unintelligible) -- to look at it.

And again, one of the other things that happens when you chronically
take methamphetamine, the ability of your brain to properly exert
cognitive operations gets disrupted, and then, that in turn even when
you're not intoxicated, can lead you to poor judgment and to engage in
behaviors that otherwise you shouldn't.

So speaking about methamphetamine, you asked the question and we've seen
it in the news, how bad of a problem do we have with methamphetamine
vis-a-vis the number of people that are affected, and very important,
how is the trajectory of that methamphetamine epidemic? And here we are
really in a very interesting situation because on one side, indicators
of prevalent rates of methamphetamine appear to show that the
methamphetamine abuse in our country is stable and it certainly has not
increased between 2002 or 2006 -- or 2001 and 2006. And there are two
major surveys. There actually three major surveys and all of them agree
on this.

One of them is funded by the National Institute on Drug Abuse, which is
the one that I'm showing you here, which is called "Monitoring the
Future." It's a particularly important survey because it targets high
school students and it is during the adolescence years where you see the
highest risk for drug experimentation and initiation. So this surveys
gives a very good pattern of the extent to which a drug will be
problematic in our country. The other survey, which is the one that is
done called the "Household Survey," surveys people that are 12 years or
older, but the results are very similar to the ones that we are
reporting here on "Monitoring the Future." And the final survey is the
one that is done by the CDC that also surveys individuals of all ages.
And again, three surveys have not seen a pattern of escalation.

Now, let's look at the prevalence rates. If you look at the age range of
high school kids, 12 to 17, it is a little bit less than 1 percent,
which is more or less somewhat equivalent, slightly lower than you see a
prevalence rate for this age group on cocaine, which is 1.2 percent. The
rate goes up in 18 to 25 years of age where we currently have a rate
that -- it's a little bit less than 2 percent, and this increase from 12
to 17 to 18-25 corresponds to what you see with any pattern of growth.
And indeed, the highest prevalence rates across any life span occur
exactly on this age range. The highest rate of experimentation occurs
here, so they experiment and then they go later on to repeated drug use
at this age. And so approximately 2 percent of 18 to 25. say 1.8 to 2
percent. are using it. Twenty-six or older, you see the decrease, and
again, that reflects very much the patterns for other drugs of abuse.

So overall, we see prevalence rate that is not negligible. I would say
that having a prevalence rate on average across all ages of
approximately 1 percent is not negligible, one in 100 persons, because
it is a devastating disease in terms of the addictiveness and the
toxicity. And it is nonetheless not as high as you see with cocaine and
a little bit lower than you see with heroin. But on the other hand, what
we're seeing, and that's the issue of the paradox, and I think that even
though the numbers are as they are, to me are higher than they should
be, you want them lower, we're seeing other indicators that are telling
us that even though the numbers here look for us like stable, stable,
stable, stable, indicators of seeking treatment, methamphetamine
treatment admissions, because individuals in detoxification program or
even more worrisome vis-a-vis the magnitude of the problem, numbers of
admissions into emergency room because of problems associated with
methamphetamine, all of these have gone up.

So here you have this paradox on the one -- the indicator is telling you
that it's stable, but look at the significant increases in terms of the
number of admissions for treatment related to methamphetamine as well as
admissions for emergency rooms related to methamphetamine, as well as
epidemiological surveys indicating that the number of methamphetamine
abusers in states that in past did not have such a serious problem is
dramatically increasing; in other words, methamphetamine which was at
one point limited in the west states of the United States and some of
the central states is now becoming much more disseminated throughout the
whole United States and unfortunately, throughout the world. We have
some countries in East Asia where the number one drug of abuse
equivalent to marijuana is methamphetamine.

So here we have a problem in our hands, we have countries like Mexico
where methamphetamine -- people didn't even know methamphetamine existed
five, six years ago have some states like Colima where methamphetamine
is being produced evidently that is the number one drug problem
currently in five years, an escalation on the problem of
methamphetamine.

So in light of these studies, to me I would say that we do not have the
epidemic problem of methamphetamine under control, because if we had it
we wouldn't see these escalations, certainly in the United State, not to
say I'm not touching the international because I think that
international we are actually seeing a very rapid growth of the problem
of methamphetamine throughout the world.

Now, in the United States, this increase in the number of people seeking
admissions or in the number of emergency rooms, may basically very well
reflect the fact that we've seen also a shift in the pattern by which
people take methamphetamine. Normally, when you take -- initially people
took methamphetamine by the route of orally, and that was known for
many, many years, but when you take the drug orally, it is much less
addictive than when you take it by smoking or injection. Why? Because
the drug reaches much higher concentrations and its effects are much
more addictive, and I can answer if you have questions on that. And we
are seeing a shift in the pattern of route of administration from less
addictive to more addictive forms of administration for methamphetamine.

So what do we concern about methamphetamine, and for those of you that
are looking into your displaced hard copies there, there's a slide here.
For many years, we have shown from all the drugs of abuse the one that
produces greater toxicity is methamphetamine. Of all of the drugs of
abuse, the one considered most addictive is methamphetamine. And it is
directly associated with behaviors that increase the risk of infection
of HIV and Hepatitis C, which actually creates a big burden on morbidity
and mortality. And the other thing that makes it unique, it's very easy
to manufacture and you can actually do it in your kitchen sink, and
there are recipes in the web so you can actually get going, and that
makes it incredibly difficult to control because it is not that you
necessarily have to buy it from your drug dealer, you can manufacture
it. And while in the United States this is something that has been more
or less under control because they have controlled the supply of
precursors, that is not the case for most countries in the world.

This is just to illustrate the toxicity effect of methamphetamine.
Methamphetamine, like all of the drugs of abuse, increases dopamine
except it does it by huge, huge amounts, and when you produce large
amounts of dopamine from the dopamine cells, this is damaging to the
dopamine cells and can kill them. And indeed, here you have a normal
control, again the marker that I had shown you for dopamine cells. This
is methamphetamine abuser. And the type of damage I showed you before,
HIV plus cocaine, the type of damage that you see by methamphetamine
alone is even greater than you see by the combination of HIV and
cocaine. So methamphetamine is particularly disruptive to dopamine
cells. And this loss of this marker is associated with disruption in
motor activity as well as memory, so it has cognitive and motoric
consequences; so in other words, it damages your brain leaving the
person at the disadvantage to actually go back into a productive
lifestyle.

This is just another marker of brain activity, a normal control and a
methamphetamine abuser showing how -- this is a control and
methamphetamine abusers in the brain. You can actually look at that and
mark directly which areas of the brain, using that technology, have less
activity. And interestingly, you can tell them during early
detoxification or late detoxification. This is nine months with no drug
use at all, and you can see these areas of the brain here. If you were a
neuroscientist, you will jump and I said, "Oh, my God." This is an area
that you don't want to be dysfunctional, this area here. This is the
area of the brain that gives excitement, that makes you interested on
things. If I damage this area of the brain in an animal, the animal will
basically lose interest on the basic behaviors, behaviors even of
survival. So if I can damage these, one, the animal will not be
motivated by eat, will not be motivated by social interactions, will not
be motivated by sex.

So what you're doing by chronic use of methamphetamine is really
destroying the area of the brain that is key in motivating a wide
variety of behaviors, and that's a long lasting effect of
methamphetamine, a key component. Anything that we do in terms of
treatment or rehabilitation has to consider ways to try to integrate the
function of these areas of the brain. The person that has this
disruption, of course, wants to still get some level of excitement in
their life. They will get it if they take drugs because they are such
potent reinforcers, but they also would go at extreme behaviors in order
to get some level of gratification.

Now, that's where we can come in in many other ways to sort of say,
prevention, prevention, prevention, prevent drug use, prevent HIV. If
you treat drug abuse, you can prevent HIV. And this is an old study,
it's 1993, it's 14 years of age, but again, it just illustrates how
dramatic the treatment of drug addiction can be in the prevention of
HIV. This is the rate of seroconversion in individuals that -- for HIV
in an 18-month period, in individuals that were heroin abusers,
intravenous drug users, that had no treatment versus those that had
either a partial treatment or a continuous treatment. In 18 months,
there was a 20 percent seroconversion of HIV in individuals that were
injecting drugs that did not receive treatment. Look at the dramatic
reduction. It's basically less than 2 percent in those that receive
continuous treatment. So this is exactly where we can make a dent on the
HIV epidemics, prevent the HIV epidemics, and it requires a multi-prong
approach, but a key element in that multi-prong approach is prevent drug
use, treat drug use.

So what do we have for methamphetamine treatment? I wish I could stand
up here and tell you we have a wide variety of methamphetamine
treatments just like we have for heroin. We've been pretty successful on
heroin treatments. We've been also successful in nicotine treatments.
Methamphetamine we have much less so. Most of the interventions that we
have -- in fact, the only interventions that we currently have for the
treatment of methamphetamine are behavioral interventions of which there
is one called the Matrix Model that uses a multi-prong approach that
involves brute therapy as well as cognitive and motivational treatment
for the methamphetamine abuser has shown the greatest likelihood of
success. And the next slide actually shows some of the results of the
efficacy of the Matrix Models. This is -- the numbers of days of
methamphetamine use at baseline approximately was close to 12 days in a
month. After treatment, this has basically been reduced by less than
half. So the Matrix Model works, it's not a panacea. It does not work
for all subjects. But it can definitely benefit many individuals.

In the meantime, of course we are aiming at developing medications,
testing medications. Our budget is limited because it's very expensive
to get new medications into the clinic. It's approximately half a
billion to a billion dollars, which all of our budget. So what we're
trying to do is partner with pharmaceuticals that may be interested, but
there are not many interested, but we're trying to make them interested,
or using medications that have been developed for other purposes like
for example, bupropion is a medication that has been developed as an
antidepressant which also has been shown to be beneficial for the
treatment of nicotine addiction. And what was shown is a benefit, this
is the number of days or equivalent days of people that are clean when
they are in blue which is on bupropion. So it shows some benefit
bupropion in preliminary studies for methamphetamine abusers, but again,
it is not going to be the panacea. We're actually aiming at multiple
strategies for the treatment of methamphetamine addiction, and I can go
into it if you ask questions.

So clearly what we know, and it's actually what makes common sense, but
is clearly documented by scientific research, is that we need to develop
strategies for preventing HIV/AIDS in all of its modalities. And we can
take another approach which was funded by NIDA which indicates that a
way that you can make a major impact in the prevention of HIV is by
screening interventions. And you will say, well, why would screening
improve the HIV epidemics or prevent HIV? Well, 25 percent of those
people that have HIV don't know it, and yet they account for more than
50 percent of the infections. So what does that tell you? That if a
person does not know that they are HIV, that they are less likely to be
cautious in terms of risky behaviors. That's one of the things that it
tells you. Ergo, if you are able to document their infectivity, you can
do an intervention to teach them strategies such that they are less
likely to transmit HIV to others. But also incredibly important, you can
offer them treatment that number one, will increase their survival, but
number two, will decrease their infectivity; thereupon the extraordinary
importance of making screening a more universal process.

In fact, these are studies that clearly document the benefits for the
person that is infected himself or herself, while at the same noting
that it's not just that you're going to be increasing the life
expectancy of the subjects. And the costs are actually equivalent to the
cost of screening for other things like colon cancer or breast cancer.
But you're going to decrease the HIV epidemic because you're going to
recognize this individual, you're going to be able to treat them, and by
treating, you will decrease their infectivity.

The other thing that is very exciting about screening is that now it is
possible to do HIV rapid testing where you can get the result in less
than 20 minutes, which is very important because a significant number of
people that went to get tested, actually one-fourth of them who test HIV
that are positive fail to return to receive their results, so they never
know what the outcome is. This can now be avoided because you get the
results right there, is very inexpensive and it's not complicated, so
you can train individuals in non-medical settings to be able to perform
this test making it much more widely available for people to be able to
be screened.

The way that I view it, so having said all of this again, go back to my
basic ABC -- ABC to me in HIV is prevention, prevention, prevention. You
ask me, DEF, it's prevention, prevention, prevention. I think that the
fact that we have medications that can help individuals has been
incredibly useful, but the bottom line is HIV is still the number one
cause of morbidity and mortality worldwide in individuals that are 18 to
45 years of age, and that is not decreasing. So how do you do it? Well,
we have the examples of what we've done in the United States last
century. If you are asking me, and many people agree on this one or
also, what was the most effective intervention that we used last
century? Curiously, it was the prevention interventions, smoking
cessation.

Smoking cessation which was a big success. It was not perfect. We still
have 15 percent of all adults in this country smoking. It basically
brought it down from 45 percent. As a result of that, there was a
dramatic decrease in morbidity and mortality associated not just on
cancer but from cardiovascular diseases. And again, if you just look in
terms of numbers of people that have been saved out of the smoking
prevention intervention, as well as the cost in healthcare that has been
saved, it is a gigantic impact of this intervention.

So if we have been able to do it with cigarette smoking, my perspective
is we should be able to do it with HIV/AIDS. And we have to face the
notion that we should be able to do that prevention whether we get that
illusive HIV vaccine or not, we have an urgent need to do prevention
interventions, that can put a stop into the HIV/AIDS epidemic. And with
that, I thank you for your attention, and now I will be happy to answer
any questions that you may have.

MS. MAXWELL: Thank you for that most informative presentation.
Questions?

MS. VOLKOW: There are questions in the back it seems like.

MS. MCGEEIN: I have one. On page 9 of your slide, most effective
preventions.

MS. VOLKOW: Yes.

MS. MCGEEIN: Is this with one -- this is the slide I'm looking at. Is
this with one episode of exposure or is this because of --

MS. VOLKOW: No.

MS. MCGEEIN: -- multiple episodes?

MS. VOLKOW: Multiple episodes.

MS. MCGEEIN: Okay. Thank you.

MS. MAXWELL: Yes. Carl.

MR. SCHMID: Thank you for your presentation. You have a budget I think
you said of over half a billion dollars, right, for HIV?

MS. VOLKOW: No, no, no. Our budget is a little bit less than \$1
billion, of which \$300 million go for HIV and drugs.

MR. SCHMID: Okay. Thank you.

MS. VOLKOW: Three hundred million.

MR. SCHMID: And you said there's only one behavioral intervention right
now for crystal meth.

MS. VOLKOW: No. There are many behavioral interventions. I said that the
one that's most promising is the Matrix Model.

MR. SCHMID: Okay.

MS. VOLKOW: There's motivational interventions, incentive interventions,
group interventions. There's a wide variety. But the most effective is
that one that we call the Matrix Model.

MR. SCHMID: Okay. And how do you interact with -- NIDA does the
research, SAMHSA does a lot of the treatment programs and CDC does a lot
of the actual -- implement the prevention programs. So I'm just
wondering how you interact with both of those agencies?

MS. VOLKOW: Well, historically, we had a long history of interacting
with SAMHSA and we have very different ways that we interact. One of the
things is we do (braided ?) funding whereupon we actually take their
funds and our funds, bring them together and fund investigators that are
both from the academic as well community treatment programs. That's one
of the ways, so we give grants that actually maximize the likelihood of
having individuals from both communities.

The other thing that we do is we have a clinical trial network whose
function is actually to take a research product and bring it --
determine its efficacy and effectiveness in a community treatment
program. Those that are actually found to be effective, then they are
taken to a group that is basically formed, half of the group is people
from NIDA and half from SAMHSA, to transform that product into something
that will be disseminated across all of SAMHSA into community treatment
programs. So we transform it and maintain its sustainability.

And the third one is we constantly have educational seminars to bring
the information that we have out of research into the SAMHSA activities.
And that, for example, includes bringing the directors for the different
states into our annual meeting which is "Blending the Sciences" to bring
them up to date with evidence-based findings that they can then
implement. So we have a wide, wide variety of activities with SAMHSA.

With CDC, it's newer and we've actually started with them on projects.
Specifically now we've very interested in changing the culture such that
we know that screening is very valuable. And CDC took that information
to say, screening should be universal at least once in your lifetime,
and if you're at high risk, it should be done periodically. The concept
is that you can ask a person and they say, "I don't want to be tested,"
so one of the next projects in that clinical trial network that then
will go into SAMHSA organization is exactly how do we approach the
treatment community programs such that they can start to evaluate
screening and what are the outcomes. And CDC is working with those on
that, so that will be a common partnership.

And we've generated a series of meetings, again, to try to get
information. We're very, very interested in trying to find out how to
approach different cultures and communities because what may be valuable
in an Hispanic community, may not necessarily be appropriate for a
Native American or an African American, so we've involved the CDC. So
now our HIV screening program we're directly working with them.

MS. MAXWELL: Beny?

MR. BENY PRIMM: Dr. Volkow, I just want to congratulate you on a most
beautiful presentation, and to also ask you a question about the
physiology of amphetamines and methamphetamines on the erectile function
of males.

MS. VOLKOW: Yes. And you know, it's interesting. One of the things --
and again, I do not -- a lot of the work that has related to enhance
sexual desire that occurs with methamphetamine has been more of an
anthological type methodology, so the anthologists go out there in the
community and interact and live with these individuals. And one of the
things that they've complained is that methamphetamine in fact may
interfere with sexual performance. So as a result of that, what is
described out of these studies is that it is not uncommon for
individuals to mix Viagra with methamphetamine, and so they have the
enhanced sexual desire and they can overcome the adverse affect that
methamphetamine may have by being a vasoconstricting agent. So this in
turn poses further risk because as Viagra can produce cardiovascular
pathology, and the combination of methamphetamine which also can produce
arrhythmias with another drug, from that perspective cardiac risk is
heightened by it.

DR. PRIMM: It's been said that male sexual behavior, particularly men
who have sex with men, often changes under the influence of
methamphetamine where men are more apt to have receptive anal sex
because of the inability to have an adequate erection to have an
insertive form of sex.

MS. VOLKOW: And there's also the issue they too also try to compensate
with the use of Viagra, but I did not know specifically about the issue
of the changes in sexual behavior themselves on a given individual. But
yes, it is -- and the thing that is interesting -- many things are
interesting -- but that effect of methamphetamine appears to be
secondary to its ability to increase dopamine so dramatically. So you
can see the same effect if you give drugs that can increase dopamine,
and that enhancement of sexual desire, except that methamphetamine does
it more intensely and for a very long period of time. The duration of
methamphetamine goes for hours.

MS. MAXWELL: Ed.

DR. GREEN: Yes. Thanks for a very interesting talk, and I wish I had
hours to just ask you lots of questions, so let me restrict it to a
couple of questions but start by asking for a clarification. It seems
like in your third slide, you're showing evidence that whether the drug
use is injecting or non-injecting it's a roughly equal risk factor.

MS. VOLKOW: Yes.

MR. : Is that right?

DR. GREEN: So that would suggest that it's not needles per se, but
rather the disinhibiting effect, the clouding of judgment effect is
actually is more sexual transmission than we might have thought, if you
eliminate needles but you still have drugs. But even with that third
slide, I would that the type of drug is important. Is this only talking
about stimulants like cocaine and meth?

MS. VOLKOW: These results to my knowledge has only been shown so
unequivocally with a large sample for cocaine. This is cocaine.

DR. GREEN: For cocaine. This is cocaine only.

MS. VOLKOW: This is cocaine only. I would expect that similar number
would come about with methamphetamine because it's a stimulant drug.

DR. GREEN: But not opiates.

MS. VOLKOW: But I do not know about heroin, I would not know how it
would work with heroin.

DR. GREEN: Anyway, that's a very interesting and important finding. If
you could make some comment about what you see as the effect of this
needle exchange programs unless that's a sort of taboo subject. And the
last question is, it's my understanding that if we're only looking at
injecting drug use that HIV prevalence has decreased in the last decade
in this country, and if so, why?

MS. VOLKOW: Yes. The injection drug use -- and that's one of the things
that we have to consider, this pertains to New York City and the United
States, where the campaign really of educating people about the dangers
of using contaminated needles has been going on for many, many years,
where you have easy access to needles whether they are given for free or
you go into a drug store, they are very, very cheap. I do not know that
that will be -- I would actually be surprised if you get the same
situation in a place where you cannot get needles and where a high rate
of those needles is contaminated. So I think that these numbers pertain
to the particulars of that city.

We know -- multiple studies have been done vis-a-vis the impact of
interventions for syringes in drug abuse and addiction, and you probably
are aware of the results. There was one study in Canada interestingly
that has shown that the exchange of syringes in fact increase the rate
of HIV, and that's the only study that has shown negatives. And that
study was done at a period in time when the rate of cocaine abuse was
increasing. So that's the only study where the exchange of syringes have
been shown to have a negative effect. What we --

DR. GREEN: Can I ask you about -- the Institute of Medicine, med
analysis funded by the Gates Foundation, that the results were available
a year or two ago. I'm trying to remember what -- I thought the bottom
line was as far as needle exchanges, while it may have various benefits,
it was not shown to impact HIV incidents.

MS. VOLKOW: What it shows though in that study is that by itself, it
requires to be -- (unintelligible) -- in the context of a treatment
intervention. So the combination of a needle exchange problem with
treatment for the person that's addicted is an effective way for
preventing HIV. So what they are saying is you should not just think the
obvious things in a vacuum. You actually need to intervene with
treatment. The other aspect about the case of heroin injection is that
we have very effective treatments, and that's why I say I wish we had
the same for methamphetamine or cocaine where we don't.

MR. : (Off mike)

MS. VOLKOW: Buprenorphine and methadone work, and they are pretty
dramatic. And indeed, one of the things that were very interested and
sort of I think that part of the aspects are interested on worldwide, is
I love to, and this is what's sort of crystallizing, I'm trying to
engage in our international research to generate the heroin vaccine.
Because if we could generate the heroin vaccine, which actually in
animal models has been developed as effective both for morphine and
heroine, a person that would want to inject a drug will not be able to
get any high, and that would be a very effective intervention for
helping individuals that are addicted to heroin worldwide.

DR. GREEN: Would that be a one-time treatment or is this like naltrexone
where it has to be continuous?

MS. VOLKOW: Well, with naltrexone we're working also -- we're working in
long -- treatments that can last very long. That's why I say
internationally. Because if you are in rural China, is going to be
incredibly difficult for a Chinese person to go on a daily basis to get
their methadone. It's also going to be unrealistic. And so if you can
get, for example a naltrexone -- and the problem with naltrexone in the
treatment of heroin abuse is it works, but people just stop taking it.
So we're aiming now at the naltrexone that's a Depot naltrexone that
lasts at least six weeks. So you go and you may not like it, but you
cannot stop taking it. And that way, you can manage populations that may
not have easy access to a medical community. With naltrexone, we're
seeing effectiveness, the Depot naltrexone, for six weeks. With a
vaccine you can aim -- based on what we have, there's some experimental
data showing positive effects of two nicotine vaccines with positive
signals. We are also working with a cocaine vaccine that has a signal
that's approximately eight to 12 weeks, so the idea is to be able to
cover a longer period of time.

DR. GREEN: In all cases, it works by blocking the pleasure centers?

MS. VOLKOW: No. It blocks by destroying the drug, just like with any
vaccine. You generate antibodies for heroin or you generate antibodies
for cocaine or you generate antibodies for nicotine.

DR. GREEN: So the immune system destroys the drug?

MS. VOLKOW: The problem and the challenge is just like with the HIV
vaccine of course, it's not so formidable of a problem, not everybody
mounts the antibodies, so you need to get an antigen to which you couple
your drug that is strong and powerful enough to generate sufficient
antibodies that last long enough. So we've been successful, for example
-- we funded now for many years a company that has developed monoclonal
antibodies against methamphetamine, and it works, so you can put -- but
in terms of its effectiveness, it's been useful. You have someone that
gets into the emergency room intoxicated with methamphetamine which can
lead to cardiovascular toxicity. You can actually give the antibodies
and reverse the effects of methamphetamine. But those monoclonal
antibodies have a relatively short duration, one week or two. But it's
that type of thinking and trying to get something that's longer lasting
that we could actually eventually utilize.

MS. MAXWELL: What's the most common mode of methamphetamine use: oral,
smoking or IV?

MS. VOLKOW: It depends. Actually, when it is abused by people that are
addicted, smoking. For people that -- a lot of people take
methamphetamine for sexual reasons. They take it orally. We've known for
at least four years that truckers, people that drive trucks for many,
many hours without having to sleep, abuse methamphetamines also, because
it's a stimulant, it keeps you awake. They take it orally.

MS. MAXWELL: Beny.

DR. PRIMM: Dr. Volkow, I'm very concerned as an anesthesiologist
relative to giving a vaccine that would block the effects of heroin and
morphine. What would we use in cases of severe and acute pain and so
forth that would be as effective as these analogues?

MS. VOLKOW: Well, you are an anesthesiologist, so you know much better
than I that the wide variety of opioids that are available. And what's
interesting, which is not a case for naltrexone, if you have naltrexone,
that will block all of the opiate receptors, so whether you're working
with Demerol or you're working with fentanyl, or you're working with
hydrocodone, whatever, you're going to block them with naltrexone, not
with a vaccine. The vaccine is only going to target heroin and morphine.
The problem is, and that's why I say it may not work very well in the
United States, is that in the United States you have a wide availability
of prescription opiates, so a person that's addicted to heroine gets the
vaccine, they'll go out and take OxyContin, they will go out -- in
China, in a rural community, that person will not be able to get
OxyContin. So it's not a problem that -- but on the other hand, that
Depot naltrexone could be an issue on someone that requires a surgery.
That's absolutely correct.

MS. MAXWELL: Ram.

DR. YOGEV: What you are showing me is something which really bothers me
for a long time is in the Ryan White which is the biggest one which
we're here for treatment, the one who would suffer the most in the cut
and very limited is the mental health. (Unintelligible) -- epidemic
which is growing. What are your agency and other agencies doing to make
those treatment available to this population?

MS. VOLKOW: To individuals with mental illness. Yes, and you're touching
obviously perhaps of the populations those that are most vulnerable, and
indeed, in the United States as well as worldwide, but I know the
statistics in the United States, the individuals that are at greater
risk of taking substances are those with mental illness, whether it is a
psychosis like schizophrenia or depression or something of a learning
disability.

One of the things that has been unfortunately very much eroded in the
clinical treatment in the United States is that psychiatric treatment
has been divorced from the treatment of drug addiction. Fortunately for
other countries, that's not necessarily the case. In some European
countries, the treatment is very well integrated. Not in the United
States. And indeed except for a few providers like -- (unintelligible)
-- most -- even in academic centers -- do not integrate it, like they
don't integrate in any way the HIV treatment with the drug abuse
treatment. And as a result of that, you have a person that's taking
drugs, tests positive, it's sent to a completely different place and
it's lost in the process.

So I wish I could have better responses to use. We are identifying as an
area that needs to be addressed, and so we are providing information
from services research to document the value of integrating the
treatment of both, which will again, require that we change the
educational system at the specialty level such that psychiatrists are
trained to treat both the addiction as well as the other psychiatric
diseases, which is not right now what happens in the United States. I
don't know where you come from but --

DR. YOGEV: You see, the issue is that I think that as a committee, we
need to discuss how to do exactly what you just said, the integration. I
can tell you in Chicago we are trying to shy away from these patients
because they're becoming expensive and there's no place where to -- to
direct them to, and in the Ryan White the minimal is there. So it's not
sufficient for the epidemic which you are showing which might affect
HIV. So I think as a committee, we need to look into -- all the things
which you are showing us, that there are of some success. Even a 60
percent reduction is great. But to do that, we need to find the funding
and recommend for it.

MS. VOLKOW: Yes, I know. And I would appreciate -- we're working with of
course the American Psychiatric Association as well as the American
Medical Association to try to facilitate the integration of treatment,
and that implies integration of the treatment of drug abuse in
psychiatry but also the involvement of the medical community and the
recognition, evaluation and treatment of drug addiction which it
basically has washed its hands of. As a pediatrician or as a general
practitioner, most physicians do not evaluate -- (unintelligible) --
they are not get reimbursed for that. So anything on those lines -- to
me it's very clear cut -- change in policy that would have a dramatic
effect in the outcomes.

MS. MAXWELL: Our last question will be from Beny.

DR. PRIMM: Okay. Dr. Volkow, I'd like to go on record as saying to this
audience that the Addiction Research and Treatment Cooperation where I
founded that organization and still executive director, we have
integrated (four ?) comorbid diagnoses, certainly mental health and of
course substance abuse treatment of all kinds and it's flourishing and
doing quite well. There's a new building in the (Hollam ?) community
that's really named after me that the whole sixth floor is designated
just for the treatment of mental health problems associated with
addictive behavior. Thank you.

MS. VOLKOW: Well, I'm glad to hear that and I congratulate you for that.

MS. MAXWELL: Thank you, Dr. Volkow.

MS. VOLKOW: Thanks to you all. Bye, bye. (Applause.)

MS. MAXWELL: At this time we welcome Dr. Bernard Branson who is the
associate director for Laboratory Diagnostics in the division of
HIV/AIDS prevention in the National Center for HIV/AIDS, viral
hepatitis, STD and TB prevention at the CDC where he also conducts
research into HIV prevention strategies. Dr. Branson has been the chief
architect for the CDC's activities surrounding new technologies for HIV
testing including rapid HIV test. And Dr. Branson has been involved in
providing HIV care, counseling and testing for more than 20 years.
Welcome Dr. Branson.

BERNARD BRANSON: Thank you. I'm going to speak somewhat about the
adoption of CDC's recommendations but I did want to start out to at
least correct on misstatement that was made earlier this morning when
Dr. Primm asked about doing RNA testing on a patient of his, that in
fact, a part of CDC's new recommendations to include the process of
doing RNA testing when acute HIV infection is a possibility so that is
part of the new recommendations and I think it follows in very well with
the question that you were asking in our seeking to diagnose people
early.

DR. PRIMM: Thank you very much, Bernie.

MR. BRANSON: I'm going to start out with presenting some examples from
the field on the adoption of HIV testing and CDC's recommendations. We
anticipate that we will have more representative national data probably
not before the middle of 2008 with respect to actual numbers of people
tested given the nature of the data collection systems. The first
example was actually a published one which started in San Francisco
Public Health, and as you'll notice from several of these examples, a
number of jurisdictions initiated the process of implementing CDC's
recommendations when we distributed the first draft of the
recommendations in May of 2006.

In San Francisco, the required separate signed informed consent in their
health -- (unintelligible) -- and in their clinics, and it required that
if a specimen was submitted to the laboratory without a special consent
as part of the requisition that the specimen be rejected. They changed
that requirement in May of 2006 and then they compared their rates of
HIV testing and the new diagnosis before and after the change, and what
you see here with the blue line is the time period when they changed the
requirement, and so testing which had been on a slight increase took a
relatively abrupt increase after the change in the informed consent
requirement, and they went from a diagnosis of 20.6 HIV positive tests
per month in their health (system ?) to about a 50 percent increase to
30.6 HIV positive tests per month just as a result of that change. This
was the first of the (ecologic ?) data at least that supported some of
the parts of CDC's recommendations that were intended to try to make
testing more realistic and easier to conduct in healthcare settings.

The state of New Jersey is another example where the Health Department
has begun to assist rapid HIV testing in their emergency departments.
They started a pilot project in March of 2004 actually, but now they are
up to supporting HIV testing in 23 emergency departments. The Health
Department provides HIV counselors and test kits and they offer
counseling to the patients in the EDs while the rapid HIV test is
running. As of August, 2007, they've tested nearly 16,000 people.
Because they are using rapid test, 15,700 and 98.3 percent received
their test results. They identified 384 HIV positive people that 2.4
percent overall rate compares with a 1.7 percent rate in their publicly
funded testing out of emergency departments. Of those, 280 or 73 percent
were new positives, and so some individuals are coming back through the
emergency rooms who are not in care who do get tested again, get
identified again and get anther opportunity to refer them back into
care.

The next project that I have some data on is from the New York Health,
New York City Health and Hospital Corporation. This is the largest
municipal hospital system in the United States. They established a goal
to increase their testing which had been at the baseline of about 55,000
tests per year in their entire system from 2003 to 2005, and also to
increase the number of patients who learned the HIV status earlier. This
is all conducted in New York State, and in New York they still have a
two-part state mandated consent form which must be signed for all HIV
testing. But the evidence basically in their first year of
implementation, fiscal year 2006, they went from 58,000 to about 92,000
tests. More recently, as of June 2007, they arrived to 132,000, nearly
133,000 tests in their whole system, but importantly, and the number of
HIV positive persons they identified in their systems more than doubled
from approximately 700 per year up to about 1,500 per year in '06 and
1,600 new HIV positive diagnosis in fiscal year 2007. And these are all
unpublished data from these different sources.

Another example comes from the JPS, the John Peter Smith Health Network
which is a large public house for the system in Fort Worth, Texas. They
also initiated primary point of care HIV screening in their emergency
department. They started using the rapid test here back in 2004 for the
people in the sexual assault network and then again started a more
expanded HIV testing program here when CDC's draft recommendations came
out in May of 2006, and I show this to indicate that their data runs
from October to September according to their fiscal year and most of
this expansion has been in their emergency department.

So you see basically the overall increases in the testing that they have
done there from 648 HIV positive individuals in fiscal year 2005 up to
981 in '06 to 910 in the first nine months of fiscal year '07 on track
to achieve the approximate diagnosis of 1,200 individuals. Interestingly
here at this institution, they also kept track of the most diagnoses of
the people who were diagnosed HIV positive, and the number one diagnosis
was chest pain, the number two diagnosis was seizures and the number
three diagnosis was abdominal pain. So at the current time, doing an HIV
test is part of the standing orders for all patients who come to this
emergency department with the complaint of chest pain and the basis of
the experience they've had up until now. Obviously, those diagnoses
represent the kinds of patients who are coming to their emergency
department facility, and so that a lot of people are being diagnosed
when they have conditions that are unrelated and that otherwise would be
suggestive of HIV disease.

CDC did conduct several demonstration projects in emergency departments,
and I want to go through a description of three of them that were
published in June in MMWR. In two programs in Los Angeles and New York,
the emergency department's screening programs were counselor based for
the counselors offered and performed the rapid HIV test and also
provided pre and post-test counseling. In the third program in Oakland,
the test was offered by the triage nurse, the testing was done by the
emergency department staff, usually the nurses who also disclosed the
test results after performing the test.

So in these three emergency departments, they also saw a large number of
patients during this time period, was all the same one year time period
between about 50,000 and 70,000 patients. They were able in the two
counselor-based programs to offer testing to 1,700 patients and 1,500
patients compared to 31,000 patients who were offered testing in a
program that was staff based. The people who accepted the proportion as
very high in the counselor-based programs but considerably lower in the
program. However, the absolute number of people who accepted testing was
still considerably higher in the staff-based screening model. People who
were actually tested, almost everyone who accepted in the
counselor-based model was tested because of other -- (unintelligible) --
in the emergency department, only 6,000 of the 16,000 people were able
to be tested in the staff-based model, but the bottom line is that they
identified approximately of the same percentage, around 1 percent of HIV
positive people, but that was only 13 people in the Los Angeles ED, 19
in the New York and 65 in Oakland emergency department. And so this we
felt is again some evidence that the models that make testing more
routine and rely on routine staff in order to conduct the testing have a
significant impact on identifying more HIV infected persons.

In Oakland as in several of the other programs, we are encouraging the
programs to conduct patient satisfaction surveys in order to make sure
that people agree with the process of HIV screening, and so of the HIV
positive persons, 57 of the 65 completed the survey, all of them said
they were satisfied with the process and 96 percent of them felt that
the result disclosure was private. Of the HIV negative patients again,
99 percent were satisfied with the process. A slightly lower percentage,
only 91 percent felt the disclosure was private. In this institution as
in many others, the patient was often separated only by curtains and
they would very often deliver the HIV negative test results to persons
when they were just in the cubicle, only taking the persons with
positive results off to a private setting when it was necessary in order
to do that, to disclose an HIV positive test result.

So we were interested to find that the patients' (possession ?) of
privacy was maintained despite their testing and disclosure of negative
results in a variety of busy clinical areas in these emergency
departments. I think earlier and in fact someone quite from Jeremy
Brown's program here at George Washington University Hospital Emergency
Department. They set out an opt-out screening program in their emergency
department after CDC's recommendations came out in September, and in
their first three months, between September and December of 2006, 7,000
persons were offered HIV screening, again, 56 percent accepted, and
we're seeing this in most programs between 52 and 60 percent of people
offered screening routinely accepted.

Again, 41 or 1 percent of those persons were HIV positive. They also
offered a patient satisfaction survey, and this was given both to people
who accepted the HIV test and to people who decline the test, and of
those people who were administered the test overall, 84 percent said
they would recommend HIV testing to a friend if they went to the
emergency department, and similarly we're looking at about 74 percent of
people said they agreed or strongly agreed that the emergency department
is a good place to perform HIV testing and only about 11 percent -- I'm
sorry, about 14 percent of people disagreed that the emergency
department was a good place in order to conduct HIV testing. We are
encouraging most of our programs now to conduct this kind of assessment
with patients in order to make sure that they feel positively toward
this expanded testing similar to the way most providers seem to do it.

I want to spend just a moment talking about policy support for expanded
HIV testing. In the first of these which we consider are important was
from the American College of Emergency Physicians. This is the national
emergency medicine specialty society that has more than 25,000 members,
practitioners of emergency medicine with 53 chapters representing each
state in the districts of Columbia and Puerto Rico. Their policies cover
many different areas and are distributed to all of the American College
Emergency Physicians members to address key issues and illustrate
important concern. They issued their policy with respect to HIV testing
and screening in April of 2007, which states as follows: first, the
early diagnosis and treatment for HIV can prolong life, reduce
transmission, has been demonstrated to be a cost effective public health
intervention. They felt that HIV testing in the evaluation for acute
care conditions should be available in an expeditious and efficient
fashion similar to the testing and results of other conditions.

But HIV screening which is for asymptomatic persons, when deemed
appropriate by the emergency physician must meet the following
conditions: first, it has to be a practical and feasible for emergency
department settings and it cannot interfere with the primary acute care
mission of emergency departments. They recommended the offer based on
the local prevalence and the medical needs of the community integrated
with the resources of the entire healthcare system, and that it must
adequately address patient confidentiality, state -- (unintelligible) --
requirements for informed consent, provider training and the need for
counseling and (legalist ?) care.

They did reemphasize that it has to meet local and state requirements,
and I think there's already been some discussion of that here today, and
it must be contingent upon adequate funding to meet the (added ?)
operational and personnel costs for sustainability. So while this is a
supportive statement of expanded screening in emergency departments, it
highlighted I think the important problems of making sure that there
were compliant with state and local requirements, and also dependant on
the sources of reimbursement in order to cover the costs for testing for
the many patients who are uninsured.

This is our -- (unintelligible) -- so far of the places that have
enacted legislative changes since 2006. I noticed there was a handout of
the AP story saying nobody had done anything since last year, and that
is actually not the case from the evidence that we've done this review,
so that states that have explicitly removed written informed consent
requirements that include Iowa, Illinois, Indiana, Louisiana, Maine, New
Hampshire and New Mexico, the legislation has passed both the assembly
and the Senate in California and has gone to the governor's desk
awaiting signature, and there is legislation under discussion at the
current time when it has been proposed in both New York and in
Massachusetts.

The states that have specifically passed legislation enabling opt-out
prenatal testing include Georgia, Iowa, Illinois, Louisiana, Nevada,
Rhode Island and Tennessee, and again, it's passed both House and the
Senate in New Jersey and it is waiting the governmental action. So that
this I think represents for us a surprising number of places that have
taken action since we issued our recommendations just in September in
2006 to get legislatures, especially in large states to move as quickly.
Yes, sir.

DR. MALEBRANCHE: I wanted to ask what worked in getting that moved so
quickly? Like what happened?

MR. BRANSON: What I can say is that we provide technical assistance on
request, so we don't have all details of what happened in those areas,
but I think the thing that was most instrumental in the places that
moved forward was some very strong support from the medical society, so
that for example the California Medical Association was a co-sponsor of
the bill together with the AIDS Healthcare Foundation there in order to
do that. I think similarly in Illinois, the Medical Association got
together and they partnered and sort of struck some negotiation with the
community based organizations, but clearly I think that provider
organizations moving forward made a considerable difference.

There is a continuum of state laws that is being maintained by the
National Clinicians Consultation Center. This is a HRSA funded program
at the University of California San Francisco and so this website
ucsf.edu/hivcenter, you can click on your specific state, it will take
you to a summary of what requirements and either statute or regulations
are, and then they have behind that the specific statute or regulation,
and in many places it is not a statutory barrier as has been pointed out
but there are some regulations and a large number of jurisdictions for
example I just received information from Missouri where they have
specific regulations for non-clinical settings, in other words for HIV
testing programs that have one set of requirements that are different
from the recommendations for their clinical settings and they sent our a
clarifying letter to all of the providers in their state to let them
know that they believe their regulations are completely consistent with
CDC's recommendations for opt-out HIV testing.

CDC has been attempting to provide assistance to priority jurisdictions,
and one of the ways of doing that in order to get these recommendations
implemented has been to conduct a series of strategic planning workshops
and these are very much sort of grass roots levels where we recruit
teams and individuals from hospitals usually including nursing,
laboratory, emergency department and very often risk management in order
that the plan for HIV screening in the institution. The format of these
are to provide basic information about screening, and then one of the
most effective parts if actually bring in people who are already
conducting successful screenings programs in this kinds of environments
in order to do our lessons from the field, question/answer session, then
each of these teams does a strength/weaknesses opportunities and threats
analysis, participate in some practical nuts and bolts workshops about
how to do the screening and then for the institution they develop an
individual strategic plan.

We are following up with each institution at six months and 12 months in
order to gage what their progress has been in implementation, but in the
series of the workshops we've completed in Los Angeles, Miami, Chicago
and Boston, Los Angeles and Miami were the first two in Jackson Memorial
and UCSF and UCLA are all conducting HIV screening now in their
facilities, and we're seeing similar movement in the other places. There
are additional workshops right now scheduled in Washington D.C., New
York City and San Antonio and eight more are planned for the
jurisdictions that are funded under CDC's new initiative.

CDC has established cooperative agreements with certain healthcare
professional organizations including the American Academy of HIV
Medicine, the arm of the American Hospital Association known as the
Health Research Education Trust, the National Medical Association and
Society for General Internal Medicine, these are designed to promote the
extension of HIV screening and also the developments of some
standardized materials that can be used in each of these kinds of
practice venues in order to provide the recommended information for
patients.

This is one example of the thing that is up and running from the Health
Research and Education Trust which is specific for emergency
departments, it's an entire website called edhivtestguide.org, and then
basically it has the list of all the kinds of resources that are
available here, and many of these related to information for patients,
delivering tests results, documenting results. They are all in
downloadable forms either in Microsoft Word format or in PDF format so
that institutions can use these relatively standardized forms to provide
their own specific information on that, and we see our other
implementation guidance specific for individual venues following a very
similar pattern to this, so that we'll be able to have resources that
can be shared across these different venues but still have some specific
resources tailored for individual circumstances and assuring both
cultural competence and understanding for low-literacy patients.

CDC did implement for 2007 the president's HIV testing initiative making
\$35 million available for testing in priority jurisdictions, and I'll
show you a list of those in just a moment. In addition, we executed an
interagency agreement with HRSA to provide \$1.75 million for provider
training which will be done by the established network of AIDS Education
and Training Centers. Until now, most of the scope of the AIDS Education
and Training Centers has been train providers to deliver increasingly
sophisticated HIV care. This initiative is designed toward working with
other providers in order to get them to start thinking about HIV
screening and implementing the HIV screening.

There was another \$750,000 for national organizations to deliver
provider support, and \$1 million to evaluate more broadly the adoption
of the recommendations, and then \$4.1 million for social marketing
campaigns including one called "One Test, Tow Lives" devoted to prenatal
testing. "Prevention is Care" is a social marketing campaign for
delivering HIV prevention services for HIV infected persons who are in
healthcare settings, and then a third one for marketing routine testing
to healthcare providers in a variety of venues.

This is a list of the 23 funded jurisdictions. They received money in
2007 in order to implement HIV testing. These jurisdictions actually
represent between 82 and 85 percent of the locations where the black
AIDS cases were reported in the United States in 2005, and so we
particularly tried to target this initiative in order to have it
integrate with our heightened national response to the African-American
epidemic in the United States, and the national organizations that were
supported include the University of Washington to develop a web-based
continuing medical education program, the professional, the American
College of Obstetrics and Gynecology to develop tool kits for
professionals, the National Black Alcoholism and Addictions Council to
work with substance abuse providers, the Public Health Foundation to
develop implementation guidance for STD clinics, the health research and
education trust, again for implementation guidance, and the AETC
National Clinicians Consultation Center.

One thing we felt was important is that if people were identifying more
HIV infected people, that providers who may not have expertise in HIV
needed somewhere to refer them and someplace to call for advice. And the
National Clinicians Consultation Center maintains a telephone hotline
where people can call for clinical information as well as providing
referral information. Similarly, the AIDS Education and Training Center,
National Research Center maintains the national repository of education
materials, both informational materials for patients and educational
materials for providers, and then the National Evaluation Center is
working with individual programs, in particular in helping to evaluate
patient responses and reactions to the expanded HIV screening.

So for us at CDC, our priorities and our next steps include number one,
securing additional endorsement by professional associations. One of the
issues in terms of making this standard a care is that CDC makes a
recommendation, but it is very important that professional associations
endorse these in order to basically making it much more binding. This is
very effective with the prenatal screening recommendation. When the
American College of Obstetrics and Gynecology came out with their expert
opinion thesis, said everybody should be doing this. They have already
come out with an endorsement saying that all women who are being seen in
obstetricians' offices should be screened for HIV consistent with CDC
recommendations. We feel this endorsement fits in with working on the
issue of third-party reimbursement and we're continuing to work with
different groups on addressing third-party reimbursement.

Similarly, we've been responding to requests to continue to help develop
practical material for providers and information materials they can use
with their patients and obviously to continue to conduct evaluation of
this program in order to see exactly what the uptake is of CDC
recommendations and see if we can identify both examples of best
practices and continue monitoring for any potential adverse effects and
some people have raised concern about a large change in the nature of
screening with changes in both the counseling and the informed consent
procedures.

I would like to acknowledge a large number of people who provided what
was mostly unpublished data on all this implementation right now,
because this is still very early in the course of getting information
together so that from the New York hospitals, from Forth Worth, New
Jersey Department of Health, (Alameda ?) County, and GW University
Hospital and in particular, NASTAD, the National Association of State
and Territorial AIDS Directors who has been maintaining pretty much a
registry of the changes in legislation as the individual states reported
into them, they have been sharing that information with us.

Thanks very much. (Applause.)

MS. MAXWELL: Thank you Dr. Branson.

Questions? Beny?

DR. PRIMM: Bernie, I'm concerned about maybe I'm confused, and it's not
uncommon for me to be confused that there were \$45 million appropriates
I thought for to fight HIV among African-Americans campaign. Is that
true, or was it 35 million that you put forth?

MR. BRANSON: Thirty-five million dollars went after the states, and the
other money went out to support those efforts including what I listed
there having to do with provider training in those area, making
materials available to clinicians, consultation center so that the
additional money, the difference between the 35 and the 45 was to
provide the necessary resources for them to be able to actually
implement the -- (unintelligible).

DR. PRIMM: Well, it was reported this morning that this money was found
in CDC by Dr. -- (unintelligible) -- and I'm wondering is that going to
be a continuous program like this or this is just a one-shot deal, some
states did not for example, like Mississippi and Alabama, did not get
any money where there's great problems, or how will these states
continue to get their money? Will it be a competitive for grants again
or what?

MR. BRANSON: Obviously, we are dependant on appropriations, and so we
are hopeful that there will be continuation of this money. We don't have
a guarantee that there will be a continuation. So when this money was
announced, it was announced as one-time money with the possible
expectation of continuation depending on continued appropriation and
perhaps Eva Margolis (ph) can address this?

EVA MARGOLIS: Thank you very much. Just to clarify, the money was --
(off mike). Thank you. (Laughter.) The money was put into our fiscal
year 2008 base, so the money will not be one-time dollars. It was put
out as one-time -- we put it out before the FY08 budget was submitted
and it was for a three-year cooperative agreement.

DR. PRIMM: I'm also wondering why the numbers were reduced from 1.5
million to one million in terms of the people to be tested. I asked that
question -- (off mike).

MR. BRANSON: We put out a request or an expectation that 1.5 million
people would be tested. We then received proposals from the different
states which came up to just about I think 1.2 million people that they
were proposing testing. We feel that we would like to begin leveraging
this process in order to achieve a higher number than that, but until we
get started, I think it's going to be very difficult for us to tell -- I
think what was in their proposals was their best guess of what they
could accomplish.

DR. PRIMM: Last question. Would that be an RFP to -- ministers met in
New York this past Monday and Tuesday, over 100 of them met with the
National Medical Association and ministers and members of Congress, five
members of Congress attended that meeting. Will there be, and this bunch
of money that you have adequate amounts to now maybe fund efforts on
their part to do some testing within churches in all of the United
States which I think is just tremendous.

MR. BRANSON: The bulk of the money that we put out at this point in time
was to go towards expanding testing in medical settings, but up to 10
percent of those funds could be used to retesting for programs in
non-clinical settings, and so we see that as a part of the subsequent
announcements that we do like our usually CBO announcement plus a
continuation of this would be potentially usable for activities like
you're speaking of in non-clinical settings like churches.

DR. PRIMM: We just need to get that information out there so people can
know about it and begin to focus in on those dollar if that's possible.

MR. BRANSON: Great.

MS. MAXWELL: Ram.

DR. YOGEV: First, a question about the rapid testing. For more than 10
years, we know that if you do two rapid testing with different
methodology it's as accurate as doing the western blot, yet the CDC has
continuously recommended to do a test and verify it with a much more
expensive test which takes longer to do. Is there any move of trying to
resolve it really right there and then by recommending those tests in --
(unintelligible) -- and Columbia and -- (unintelligible) -- even in
Texas in the late '90. The two tests are working as good. Is there any
progress in that direction?

MR. BRANSON: We have several cooperative agreements now evaluating the
use of those tests, and also in December of this year will be the HIV
Diagnostics Conference. There are proposed algorithms for both point of
care confirmation and new algorithms for laboratory confirmation that
will be discussed at that meeting in December. However, there's also the
recent publication that came out from some workers in Uganda using that
multiple rapid test together which showed that its specificity and
confirmation was only about 92 percent. And so before we make a specific
or explicit recommendation across the country, we need to look at the
exact combinations of tests we have here to make sure they are as
accurate as the western blot.

DR. YOGEV: The other question is in the CDC budget to about \$30 million
incentive to state will fulfill the criteria of the CDC of opt-out, and
one of the reasoning -- and the last (money ?) went to the Appropriation
Committee that there is no state to fulfill those criteria, therefore
there was specifically prevented CDC to use those funds. As of Thursday,
I know of one state that Illinois fulfills those criteria and the two
questions: one, is that money frozen or is moved to something else, and
two, done this changes now that I hear from you that California and I
know that Illinois is doing is would it be something to reconsider?

MR. BRANSON: Just a couple of points, but I think Eve perhaps can
perhaps address those specifics on the budget.

MS. MARGOLIS: Okay. Yes. The money actually was not in CDC's budget for
FY2007. We were actually prohibited in congressional language from
spending that money. In FY08 we don't have a budget yet, so it's yet to
be seen whether or not we're going to get funding for that. If we don't
get funding for that, we're going to have to cut the state HIV
prevention dollars because there's no other -- that's where the funding
will come from if we don't get new dollars. Regarding your question
about the eligibility, the way that language was written, just having a
law or regulation isn't sufficient enough to qualify for the money.

I don't have the exact phrase in my head, but you have to actually show
intent to implement the policies, the policies in place so that it's not
just a state giving lip service and passing the law. They actually have
to take steps to implement it. So we've been asked that question many
times about how many states are eligible and it's really hard to say. We
know who definitely may not be eligible. Well, actually we don't even
definitely know that because the absence of a law or REG, a state could
go ahead as long as they had a policy in place. So really the only way
we're going to know who's eligible is put out an RFA and find out who it
is, and we're not going to do that if there's not -- depending we're
going to wait and see what the congressional language says on that
section of the law.

DR. YOGEV: Just a quick clarification. If certainly in the CDC budget
and then they say don't use it, that money is completely taken away or
those 30 million are transferred to something else?

MS. MARGOLIS: The 30 million was actually never in CDC's budget. The way
this section is written in Ryan White it says it comes out of CDC's
prevention budget, but it was actually never in our budget.

MS. MAXWELL: Bob.

DR. REDFIELD: Thanks for all you do. Two questions: one came up a little
bit today when we talked to the third-party pairs, we had Blue Cross
Blue Shield here, we had Aetna here. Were you in the audience at the
time?

MR. BRANSON: Yes.

DR. REDFIELD: So you heard the comment about sort of the vagueness of
recommendations. I know in the Defense Department when we started
routine diagnosis in the context of sort of an annual education thing,
the first time we did it, for the first couple of years we did it
annually, and then we recommended it every two years. Is there any
thought to try to get a little more prescriptive with CDC's
recommendations particularly at this stage in terms of trying to move
this forward?

MR. BRANSON: First of all, one big part of our intention with the
recommendations in terms of the nature was to eliminate the requirement
for medical necessity protesting, because a big -- (unintelligible) --
that we heard from most providers as well as from a lot of the people in
the ED workshops is that if you have to demonstrate medical necessity,
in other words that a person is eligible for HIV test, they either have
to be sick, or there's not only a procedure code for the testing, but it
has to be associated with the diagnosis code, and only applicable
diagnosis code was lifestyle associated problems which is not something
most people want reported to their insurance company. So by having a
broad recommendation, we felt that if it was screening across the board,
it would allow for people to begin to do reimbursement without requiring
medical necessity, and to date, the claims that have been denied have
been denied because they have not had the requirements of medical
necessity, and so some people are contesting them.

With respect to the second question about the frequency to repeat
screening, our recommendation was based on the cost effectiveness
analyses which said, to the threshold that we recommended, the 0.1
percent demonstrated prevalence or yield of screening, that was
effective across -- (unintelligible) -- but one-time screening in the
country, and without getting some information on where the yield of
screening would be, we thought that we didn't have the factual or the
data basis in order to proceed with the recommendation for a periodicity
for screening. It was a topic on which we convened the consultation. I
think it would be probably similar to the military which should be an
evolving recommendation.

DR. REDFIELD: Just a quick follow up. Can I do a quick follow-up? It
sort of puts in perspective because again, I think the leadership to
CDC's put out on this and your own personal involvement is obviously
enormously appreciated and it's something that needs to be done. Earlier
on, I sort of suggested I'd love to see the year 2008 to be the sort of
the year of diagnosis rather the day of diagnosis, because we are since
we rolled the HIV test in '85, we're almost 22, 23 years into it and
still somewhere between a quarter and some people even say more, some of
those ER data might even suspect might even be higher than 25 percent of
Americans don't know they're infected. Just sort of as a reaction in
terms of what we need to do here.

Mara (sp) reminded there's 300 million people in the United States. I
assume again, I'm not a -- (unintelligible) -- heartbeat, but let's just
say two-thirds of them reach that recommendation of 13 to 65. If we got
a test for \$5, we're still talking about \$1 billion a year just to run
a testing program. If we assume about a third of people are uninsured,
now we're talking about \$300 million a year program. If we really
believe this is important, and I happen to be one of those who really
believe it's important, that's a treatable preventable epidemic, it
seems that we need to now take the policy recommendations and get it
resourced through the public sector and the private sector, to try to
move so that again, all Americans have the opportunity to know if
they're infected or not.

It really is going to be somewhere between from a public side it's going
to be, in view, somewhere between \$500 million and \$1.5 billion to
make sure that the poor and the uninsured get the same benefit of our
public health recommendations as the rich. It's more of a comment that
maybe you want to react to it, because I know you're working the best
you can within the resources, but now it's to translate that war into a
broader public policy.

MR. BRANSON: Obviously, we would like to have resources to see this
implemented. We are working and sort of coming up with something because
I want to be careful when we stir about calculations like the 300
million U.S. population, about 45 to 48 percent of people say they've
already been tested in the U.S. and there's about 16 to 21 million
people who are tested each year already in the United States so we're
doing a lot of testing that's already out there. What were talking about
is going incrementally, and while I would like to see -- the Bronx is
about to announce an initiative to be the first burrow that knows its
status.

Oakland is doing the same thing in terms of being the first city, so
people are moving forward. The other side of it is that the people in
these emergency departments where they're having 100,000, 120,000 visits
a year are terrified that they would be expected to test everybody in
the first year, and so the other side of that is to allow them to
recognize that we're looking forward toward incremental implementation
so that we're not going to attempt to overwhelm any of these service
providers by trying to have them do all of this within 2008, so although
that would be sort of a desirable slogan, I think we'd like to see move
a little -- (unintelligible).

MS. MAXWELL: Carl?

MR. SCHMID: You've been very busy for the last two years since these
recommendations have been put out, and I guess my question is the
implementation because it is already been implemented but you haven's
put out all the implementation guidelines yet for the different
healthcare settings, and I guess as a community (we ?) representative,
we want to make sure that confidentiality is maintained, that
information is presented on HIV/AIDS, that it is truly opt-out as you
recommend, that there is linkage to care and that debating non-state
laws there's informed consent and prevention counseling. So I guess I'm
a little concerned that it's being implemented but the guidelines aren't
out there yet. So I guess what is your timeline with the implementation
of the guidelines and developing all these materials?

MR. BRANSON: I want to be careful about two things. One is that CDC
doesn't pretend to know how this should be done in every healthcare
setting out there. In developing the emergency department guidelines
there are a large number of site visits, we did a bunch of demonstration
projects with them so that we learn from those experiences, and each one
of the other implementation guidance is being developed similarly, so
for example, the Prevention Training Centers, they work with SCD clinics
as doing it for STD. The Society for General Internal Medicine is
instrumental as being the author behind the part four primary care
settings.

And so I don't want to create the image that CDC is now going to tell
everybody how they should do their job because we think that we're
learning this from the people who are doing it, and so each one of these
workgroups who is developing the drafts of the implementation guidance
has got very active representation from the people. They've also
received the fundamental principles that I think maybe the community
groups have gotten together, fundamental principles that should be
present in part of each of this counseling and testing programs, so that
we have several drafts of this implementation guidance. They're being
reviewed by an editor. We plan to get commentary from them in other
places, but just sort of a (slide shift ?) that CDC is not going to
issue implementation guidance in all these places we're coordinating its
development with the people who are actively doing these programs.

MS. MAXWELL: Freda.

DR. BUSH: Thank you. Actually Carl asked a portion of the question that
I was going to ask, but I'll follow that up with the example on page two
of what's going on with the emergency department in New Jersey, it
specifically said that counseling was offered while rapid HIV testing is
done. So I was wondering exactly how was it implemented, if you can
recall? Was it seen as a barrier while they were waiting, and what type
of counseling was done at that particular time? Was there literature
given, especially to those who were HIV negative? You mentioned they
were treated a little different from the positives, so that would
enlighten us.

MR. BRANSON: In Oakland there were -- I'm sorry, so the New Jersey
example when counseling was provided at the same time, that started
before CDC's recommendations came out, and so the program was set out to
deliver the classic or traditional prevention counseling and testing
where separate counselors would go and approach people in those
emergency departments but give them the same kind of services, is not
quite what CDC is recommending at the current time. So they would
receive prevention counseling and testing.

Many of the emergency departments were at first reluctant to have people
there because they essentially thought that they were going to get in
the way, and so as they became accustomed to having people there and
realize that there were a lot of their patients spending an awful of
time waiting anyway in the emergency department and there was plenty of
time to offer this additional service, they were welcomed a lot more and
it became a lot more acceptable to the people who were providers in
those circumstances. Our only concern is the same that I showed with the
example from Los Angeles and New York is that the counselor-based models
are able to reach such a tiny fraction of the people who need to be
tested in those environments, and the idea is how best to balance those
two means which is to try to identify the people who need to be
diagnosed with HIV and provide counseling when it could be beneficial
and that's a balance everyone is trying to work out.

MS. MAXWELL: Beny?

DR. PRIMM: Bernie, I wanted a little bit more clearance of the use of
the RNA testing that you talked about as a preamble to your speech to
get some clarity when it could be used and how did you suggest it would
be used?

MR. BRANSON: Our recommendation currently is carefully worded and it
says that when acute HIV infection is a possibility that you should do
an RNA test in conjunction with an antibody test in order to diagnose
acute HIV. The Public Health Service treatment recommendations say that
for a person who has had a high risk exposure and who has symptoms of a
viral syndrome, they should be tested with an RNA test together with an
antibody test.

Right now, what we're trying -- Eric Rosenberg for example in
Massachusetts General is looking for acute HIV infection specimens, and
he went to its hospitals laboratory and looked at everybody whom a --
(unintelligible) -- test had been done basically and tested those, and 1
percent were positive for HIV RNA. They had undiagnosed acute RNA, so
that a lot of people with viral syndromes are going through these
environments and not being tested. On the other hand, because of the
cost and the complexity of the RNA test, we don't necessarily recommend
that everybody who has a viral syndrome be tested.

And so right now, I think our recommendation be similar to that of the
U.S. Public Health Service that a person who has had a risk exposure
similar to the woman that you described earlier this morning in the
example that you gave and some symptoms consisting with the viral
syndrome would get an RNA test.

DR. PRIMM: Would that be good for prisons too, and then who would pay
for it? Those are the --

MR. BRANSON: Well, in prisons of course, usually is the correctional
system health system that's responsible for the cost, and these other
environments, that's exactly what we're looking at, it's one of the
reasons we're not recommending this to be done on everyone. It's simply
because it is so expensive. One other correction is that there is one
qualitative RNA test that's approved by FDA for diagnosis. I know that
mentioned today had to do with the -- (unintelligible) -- or the viral
load test but there is a qualitative diagnostic test that's approved for
HIV diagnosis for acute infection or for confirmation.

DR. PRIMM: Okay. What is that test?

MR. BRANSON: It's APTIMA made by Gen-Probe, qualitative RNA test.

DR. PRIMM: Thank you, Bernie.

MS. MAXWELL: Raymond?

MR. GILMARTIN: We touched on this a little bit earlier in the discussion
I think but what would you say are the most significant obstacles or
barriers that have to be overcome with this whole program?

MR. BRANSON: Well, we hear back from providers in terms of the most
significant obstacles and this is what they report doing these workshops
that we've been attending and it's been very instructive, and they say
that the most significant obstacles for them had been in the states that
have regulatory or legislative barriers, those barriers which impose too
much of a requirement on them to be able to process the people who are
coming through, and then the cost related issues. Several people have
looked at the patients coming through and they looked at the issue of if
they can recover reimbursement from some of the third-party patients,
how much of the uninsured can they cover.

We had to specify that CDC's money could be used to support testing for
uninsured patients, but we do want the -- (unintelligible) -- get used
to the idea of spreading this out among the others. We've been working
directly with the state, Medicaid medical directors in order to get
reimbursement from the Medicaid program, so New York for example has
already announced their specific reimbursement strategies and levels for
screening in those kinds of places, but I think those are the two
biggest barriers that have been identified for us.

MS. MAXWELL: John?

MR. MARTIN: I think my comments are -- (off mike) -- other people --
(unintelligible) -- caught in the middle here. First off, thank you very
much for your presentation. It really shed a lot of light on the issues
we've been discussing all day, and it's clear that you're making a lot
of progress on a lot of various -- but the concern of course is the
scale of the problem, and you talked about getting leverage, Bob talked
about the cost, and you made the point about being incremental, and it's
clear that the total dollar amount together when screened would not go
on forever, and so spreading it out to some degrees is important.
However, I think we're also concerned about how the epidemic into
communities has kind of gotten away from us and it should not be too
incremental, in other words.

And so my question is just sort of if you can give us some insight of
how it's happening at the federal level to coordinate all these
activities because it's obviously exceptionally complicated, hard for us
to understand even though we talk about it all day, so what's going to
happen between now and the end of the year and over 2008 to address
Bob's point of making 2008 the testing year that will do the best we
possibly can?

MR. BRANSON: I think that we're taking actions at as many levels as we
can. We have continued to meet with HRSA, with SAMHSA and we work with
the other areas for which they are responsible. CDC has been attempting
to take some of the lead in working this through, but I think that it's
important to sort of recognize that primarily, we saw our
recommendations as being recommendations for providers and we did not
intend to set up an entirely yet new structure of counseling and testing
that would be publicly funded. We basically recommend the flu shot every
year, but we don't pay for it for everybody in the country, and I think
that what we would like to do it try to make sure we get the other
sectors involved and not view this all as being a strictly federal
responsibility.

MR. MARTIN: Yes. That's really clear. That's the leverage part and you
mentioned the -- (unintelligible) -- third-party payers. We're here to
talk about 35 versus 45 million when the numbers' magnitude versus the
magnitude above that. But the program has had some sort of the
responsibility to create the environment where that's implemented and
who's trying to make that happen.

MR. BRANSON: We count mostly on our partners in order to work with
Congress in order to try to get that money for us since we can't seek it
directly.

MS. MAXWELL: David.

DR. MALEBRANCHE: I had a question that was slide 15 on -- it's the last
slide on page five. I know you can't bring it up, but it basically was a
slide that looked at the three different ED demonstration products and
compared projects between Los Angeles, New York and Oakland. And I
noticed that the number of patients, they were all in the high in tens
of thousands. It was 47,000 for Los Angeles, 72,000 for New York and
65,000 for Oakland. But then the number that was actually offered
testing was so disproportionately higher in Oakland and I didn't know if
you would shed some light on why that was or kind of what happened was
the targeted screening based on risk profiles and the other one and then
they just screened all comers in Oakland or how did that work, because
that number just seemed -- it's outrageously different.

MR. BRANSON: I'm sorry if I didn't make the point clear enough because
that was exactly the point I was trying to make sure that sort of hit
home. The difference was that when you had counselor-based model and it
was only the counselor who was offering testing, there was only so many
people they could do that to, whereas in the other models were staff
models and everyone who came through triage was asked, do you want an
HIV test and everyone who was in the emergency department would either
follow up or would perform the testing and it quite clear that the staff
based model was much more productive both in offering the testing and in
performing the testing.

MS. MAXWELL: Dr. Branson, you had mentioned that about at least 48
percent of people in the U.S. have been tested?

MR. BRANSON: They say they've been tested.

MS. MAXWELL: Does that include blood donors too?

MR. BRANSON: No.

MS. MAXWELL: Okay.

MR. BRANSON: No. This is for the National Health Energy survey where
they have an annual question: have you ever been tested for HIV and then
they also ask have you been tested in the last year, and that number has
been suddenly increasing, that people would say they're ever been tested
and that does not include blood donors.

DR. PRIMM: Bernie, probably just a comment. One of the most successful
testing programs going on is that in Oakland with Marsha Martin and of
course Rendell -- (unintelligible) -- and Barbara Lee. Very, very
interested in which whole thing, and as a consequence of that, they have
now been organizing and I'm sure those numbers are going to be even be
more astronomical than what you have and it's because of a concentration
of important people being involved in the issue, getting tested
themselves, stepping up and so forth. That works and that's what's
happening, and Marsha's out there now and she's making it work even
better, so I think that to show that slide of then before she got out
there, you can now imagine what's going to happen after.

MR. BRANSON: We're looking at it as a model, but clearly, the local
community leadership, there's also been involvement from the corporate
sector there with Lee Meistrauss (ph) and others who have gotten
involved and really supporting these kinds of activities, and we see
this very much as a model for what other communities could do.

MS. MAXWELL: Any other questions?

MS. MCGEEIN: Just that we promised Dr. Branson he'd be off because he
has a plane to catch.

MS. MAXWELL: Okay.

MS. MARGOLIS: Can I just add one other comment because a lot has been
dais about CDC finding money and I don't want to leave the committee
with the impression that we just have \$45 million laying around to move
all around, but the way the budget we got in FY07 was a continuing
resolution from Congress and there were some projects that were ending,
and there was a new one that was starting up and there was an
overlapping budget period and there were some cost saving there, and
decisions were made within the agency on where was the best place to put
that money and we wanted to put it to presidential initiatives that had
not received congressional funding and so that is how the \$45 million
came about. So I just wanted to let the council know that, since it
sounded like we just kind of found money lying around.

MS. MAXWELL: Thank you. And Dr. Branson, thank you for that great
presentation and safe travels to you. (Applause.) At this point, we are
going to take a 10-minute break before our last presentation.

(Break.)

Number range CHAPTERDR. MAXWELL: Okay, we'll go ahead and get started
for our final session. And we have Dr. Lisa Fitzpatrick, and I'm sure
they saved the best for last. That's what they always say. Dr. Lisa
Fitzpatrick is a director of the Caribbean regional office of the Global
AIDS Program. She is responsible for all global AIDS program activities
in the 21 Caribbean country in HIV prevention, care, treatment,
surveillance and infrastructure development, provision of medical and
epidemiologic advice and consultation as a national and
internationally-recognized expert in HIV/AIDS. Dr. Fitzpatrick. Thank
you.

DR. LISA FITZPATRICK: Thank you. Good afternoon. I realize I'm what's
standing between you and the door, so I will talk to you for about 25 or
30 minutes and then give you an opportunity to ask questions. Excuse me.

I have one correction to the bio. The job she described is actually my
former job. As of two weeks ago I have moved on from that position. And
I'm actually on vacation. (Laughter.) But when I heard --

DR. MAXWELL: We appreciate your dedication.

DR. FITZPATRICK: -- about the opportunity to come and talk to you about
this, I gladly accepted, because I think it's a very important topic
that few people know well. And I actually think I'm the person at Health
and Human Services who knows the most about what's going on in the
Caribbean right now so --

DR. MAXWELL: What is your current job?

DR. FITZPATRICK: I don't have a job. (Laughter.) I'm resting. So a much
needed break. You'll probably agree after I finish my presentation.

So I was asked to give a talk on the HIV/AIDS epidemic in the Caribbean.
There's a lot to say but because there is, I decided to cover everything
in a very general way and let you ask more specific questions because I
wasn't exactly sure what it is you wanted to know about HIV in the
Caribbean.

Can we move this?

So just a brief overview. I'll talk just a few minutes about regional
context to set the stage for you. I will then give you a brief overview
about HIV/AIDS in the Caribbean and talk about some challenges and
opportunities, and then open it up for questions.

Oh, what did I do? Yeah -- no, it's fine now.

So to orient you, there's a map on the table. I don't know if you have
the map. You have the map. In case you need to refer to the map
throughout the presentation. There's some confusion about the different
countries in the Caribbean, what's considered Caribbean and what's not,
so it's always helpful I think to show a map. You'll hear me refer to
the OECS. That stands for Organization of the Eastern Caribbean States,
and it's really the six little islands off to your right. So the
Organization of the Eastern Caribbean States are those six islands, and
they've decided to form a federation. So they use a single currency.
They're also trying to develop political and regional strategies for
those six countries, so just so that you understand OECS.

The regional office for CDC was based in Trinidad and Tobago. We have a
few people there still. But now the regional HID-AIDS offices for USAID
and CDC are both located in the United States Embassy in Barbados. And
then we have two -- (inaudible) -- programs, bilateral programs in
Guyana and (Haiti ?), denoted by the yellow circles. And most of the
Caribbean --

DR. PRIMM: From Anguilla all the way down to Trinidad -- (inaudible) --
in front of me?

DR. FITZPATRICK: No. Anguilla is part of the British territories --

DR. PRIMM: Oh.

DR. FITZPATRICK: -- so it's --

DR. PRIMM: What are the -- (inaudible)?

DR. FITZPATRICK: It's Antigua, Balanika, St. Lucia, Grenada, St.
Vincent, St. Kitts.

And when people work -- generally when organizations work in the six
OECS countries they often will also extend their support to Trinidad and
Tobago, Surinam, which is actually down in South America but considered
Caribbean because they're English-speaking, and then also Barbados.
Barbados is not considered OECS, but a lot of times there's program
communization that includes Barbados.

Most of the Caribbean is English-speaking. There are a few
French-speaking countries. We don't work in most of the French-speaking
countries. And as you'll hear, most of the countries we work in are
English-speaking because of our collaboration partners. I mentioned the
two bilateral programs. Guyana, also in South America, but considered
Caribbean because they're English-speaking. And then Haiti next door to
Dominican Republic, also English-speaking. A few French speakers in
Haiti, but by and large most of our work is with English-speaking
collaborators.

So if you have any more questions about geography, just bring me back to
the map.

I just want to talk to you a little bit about context. And the reason
I'm showing you pictures from Carnival is because I think Carnival is so
deeply embedded in the psyche of Caribbeans that it really spills over
into lots of the -- of the activities, of the -- (unintelligible) -- of
the countries. So there's a Carnival in almost every Caribbean country.
And it also will help you understand a little bit about why it's
difficult to implement some of the prevention programs in the Caribbean.
I would encourage you to participate in Carnival any time. It's a very
eye-opening experience, by the way -- very educational.

A little bit about the region. There's striking diversity within the
region. Ethnic and culturally diverse. I talked a little about there are
Spanish-speaking, there's French-speaking, there's English-speaking, and
then there are couple places that speak Dutch in the Caribbean. So it's
very diverse. So there's no one size fits all for anything in the
Caribbean.

Economic disparities. You may hear some of the countries in the
Caribbean are very rich. I think the mostly commonly-thought-of country
is Bahamas, when they think about the wealth that there is in Bahamas.
But I'm here to tell you there is extreme poverty in the Bahamas and
throughout the Caribbean.

Political calaloo. Calaloo is a dish in the Caribbean that's made with
-- actually, I can't tell you everything that's in it, but it has greens
and spices. And it's a mixture of lots of different things, and it's a
dish that you can find throughout the Caribbean. So we refer to lots of
things as "calaloo" as a figure of speech. The point I'm making here is
that every country considers itself autonomous. So it's different when
you're trying to apply regional strategies throughout the Caribbean
because everyone wants to say, "Well, we're different," when in actual
fact in many ways they're very similar. So there's absence of regional
consensus.

Economies of scale. We think the Caribbean -- if they would band
together, they could accomplish lots. But again, because there's this
tug-of-war between being autonomous and working together, so it's a bit
of a struggle.

Limited human resources. I think that goes along with some of the
economic disparities, and it limits our ability to implement programs
because we don't have the human expertise in the region or enough bodies
to do the work.

And then there's an -- (unintelligible) -- for slower pace. So we may
want program implementation to happen faster, but it's difficult if your
partners are leading the way and they're okay with something that might
take a month here may take a year in the region.

They say a picture is worth a thousand words, so I just put this picture
in to show you that there is disparity. The building on the top is a
building in Trinidad and Tobago. The next street over, I took the
picture on a street in Trinidad and Tobago, and on that street you'll
find homeless people, you'll find poor people, you'll find dilapidated
housing. On the top right, that's the building where the Ministry of
Health is housed in St. Kitts, and you can see the level of disrepair in
that building. But if you go a few miles from the building you'll see an
elaborate resort.

So what's the story with HIV/AIDS in the Caribbean? I'm going to talk to
you just briefly about the players, who are our partners. The
epidemiology, and I have "as we know it," because there are so many data
gaps in the Caribbean.

So I don't know how much you know about the Caribbean, but you probably
have heard that the Caribbean has the second highest rate of HIV in the
world. And I'm not sure that's true. And the reason I'm not sure is
because we don't have a lot of data, consistent data, in the region. But
even so, there's a low overall prevalence. However, I think if we were
to look for concentrated epidemics we could find it. So Surinam is a
great example. Surinam has a public health department with an
outstanding epidemiologist. So she has conducted studies in men who have
sex with men and commercial sex workers over the last five years.

And to her surprise, she found that the MSM -- this study was done in
2004, the initial study. Or sorry, in 2003. And she found that the MSM
population had a -- (unintelligible) -- prevalence rate of 18 percent;
CFW's (sp), 24 percent. So she repeated the study a couple of years
later, and the CFW rate was 22 percent but the MSM rate was about the
same. She took the information to the minister of health to say, "Look,
we have a problem," and he said, "Well, it's a good thing it hasn't
gotten any higher." So that gives you some idea about the disconnect
between the political will and the leadership and what needs to happen
in the region. And I think if you were to look for concentrated
epidemics you probably could find them because general prevalence
information really isn't telling us very much.

There's pervasive stigma and discrimination throughout the Caribbean.
It's very tangible. People lose jobs, people lose homes. It's
frightening actually. There's HIV/AIDS resentment throughout the region,
and this is because, as you'll see, the region is fairly wealthy when it
comes to HIV/AIDS resources in dollar amounts; however, it's not the
primary health priority at the moment. Similar to us, it's chronic
diseases.

And then I've already mentioned data and technical gaps, which I'll talk
a little bit more about. I wanted to give you a snapshot of the funding
scenario in the region. Most of the money in the region is from external
donors. I have a question mark by (PAHO ?) because to my knowledge we
don't have a funding estimate from PAHO that outlines how much money
they have in the entire region. The USG or U.S. government money,
although it's 130 million, 80 percent of that money or more is allocated
to two bilateral programs in Guyana and Haiti, and the rest is spread
between the donor groups that I have at the bottom, CDC, HIRTA (sp),
USAID, Department of Labor, Department of (inaudible) HRSA and Peace
Corps.

So I just wan to say a couple of words about the two major players when
it comes to HIV in the Caribbean. The Caribbean Epidemiology Center --
has anybody heard of CARREC (sp)? Okay. CARREC is considered to be the
CDC in the Caribbean. So they're the agency that's tapped with
epidemiology surveillance, laboratory support, throughout the region.
And they are parented by PAHO. So it creates a bit of a difficult
dynamic sometimes because PAHO really makes decisions on behalf of
CARREC, but CARREC is on the ground in the Caribbean executing and
implementing programs.

Now, to get back to English-speaking. Most of our collaborations in the
Caribbean are with English-speaking countries because CARREC is the
major player when it comes to HIV and AIDS in the Caribbean. However,
they're getting some backlash from some of the non-English-speaking
countries and they're having discussions now about how to be more
inclusive. But countries have to pay into the CARREC system in order to
receive services, or that's the way it should work. HIV funding
comprises 60 percent of the CARREC budget, which is a problem that's
becoming increasingly visible because of chronic diseases being the
highest priority at the moment.

The second part I want to tell you about is the -- (unintelligible) --
Caribbean and HIV/AIDS partnership. This is an organ of Caribbean
community, which is -- we call it CARRICOM (sp), but it's equivalent to
our U.S. Congress. So the Caribbean community has prioritized HIV/AIDS
as an important issue, so they PANCAP, the Pan-Caribbean AIDS
Partnership. And it's a collaboration between all -- among all the
stakeholders in the Caribbean. So whether you're an external donor,
whether you're a researcher, whether you're a public health department,
locally, externally, if you're interested in working in the Caribbean
they ask you to buy -- not buy into -- but to commit to this
partnership. And really, it's about collaboration and harmonization of
efforts, which I think is critical when you have so many donors and so
many players in the region and so many countries that insist on acting
autonomously. So they have a regional framework, but I have to say
they're -- they're still working the kinks out in the regional framework
because although they have priority areas, each area was not assigned to
a specific agency or group, so it's difficult to know who's doing what.
So they're working on harmonization. But the idea of PANCAP has been
highlighted as a You and AIDS best practice, and I think it's a good
idea. I think all over the world there's a need for better harmonization
and collaboration when it comes to program implementation. Excuse me.

So just a few words about the epidemic. And I don't have a lot of
statistics and data for you from the region. And the reason is because
the Caribbean is not a region that traditionally systematically and
consistently monitors, analyzes and uses data. But hopefully that's
changing over the next several years. But the leading cause of death
between those ages 15 to 44, and I think it sounds a lot like here in
the U.S., is HIV. The new infections, all these statistics were compiled
by You and AIDS in 2005. Every two years or every three years You and
AIDS compiles the statistics around the world and disseminates epidemic
profiles. You can find all those information on the You and AIDS website
if you're interested. But I think the important point about the data
triangulation exercise that You and AIDS does is that the data they use
are only as good as the data that they're getting from the countries.
And so sometimes the countries don't have the most accurate information.
Which means that we're not sure how relevant or how valid these
estimates are.

I have a question mark by "women." Fifty percent of the new infect -- 51
percent of the new infections were thought to be in women. The question
mark is not to say that that's not true. The question mark is, when you
hear that the rates of HIV are increasing among women in the Caribbean,
it's because I think the strongest programs and the strongest
infrastructure in the Caribbean is in PMTCT. So because you have a
captive audience with mothers who are already coming into the system
it's easy to test them, rather than going out and finding people who may
have other risk factors.

This is just to give you a snapshot of some of the high-burdened
countries. So the ones in blue, Bahamas, Belize, Guyana, Haiti, Trinidad
and Tobago, are though to have the highest rates of HIV. I have Cuba in
pink. I also gave a one-pager on Cuba. I don't know if you have it.
Okay. I gave you the one-pager on Cuba because as you can see here Cuba
always reports the lowest rates. And we don't have a program in Cuba for
obvious reasons. But we do have what we call an ambassadors prevention
program. There are eight U.S. embassies -- or nine U.S. embassies in the
Caribbean. And Cuba has a U.S. embassy, so they come to the ambassadors
prevention program meeting every year. And what was explained to us last
year is that the data coming out of Cuba are suspect, and the reason
they are is because there's -- I'm trying to figure out the best way to
say this. Cuba does not want the rest of the world to know what's really
happening in Cuba. So the data that are coming out are the data that
were allowed to be released. So we really have no idea if this is
correct. But you'll see in the You and AIDS fact sheet Cuba continues to
do well. Cuba has always had a low prevalence, but I would just take
that with a grain of salt.

For those of you who wanted to see some data, it's always nice to have a
little bit of data. So in 2005, there was a behavioral surveillance
survey conducted in the OECS. And these are the groups that they
surveyed. And as you can see, they're pretty young people, in-school
youth, youth on the block. And I wanted to show you some of the
findings. These were the striking findings I thought. HIV general and
prevention knowledge was poor among in-school youth and taxi drivers.
And so these are questions like, "Can you get HIV from a toilet seat?
Can you get HIV" -- what -- "How can you get HIV?" basically. It was
those types of questions. "How do you prevent HIV?" So you can see 27
percent were unable to identify misconceptions about HIV in the
in-school year. There's a high degree of HIV-related stigma. This I
think is appalling. And I think if we would survey more widely
throughout the world you may find similar degrees of stigma. But 1 to 8
percent were accepting of people with HIV. Early sexual debut, up to 30
percent were sexually active before age 15. And then of concern to the
CDC program, poor HIV testing uptake, because that is one of our areas
of focus.

So I'm going to talk a little bit about data gaps. As I mentioned,
regional consensus is pretty absent in the Caribbean, so we don't have
regional strategies that have been implemented, although it would be
nice. Because it's early to learn, I think, from one program to another
about their successes and failures. Epidemiology and surveillance, data
collection, care and treatment, general prevention, PMTCT. I think the
region would benefit from regional strategies on all of these things.
And we've been working with CARE (sp) to develop those but it's not so
easy to implement, particularly when countries want to use the
information to their own satisfaction.

I think I'm not going to cover the rest of that.

HIV testing. This is a high priority for the USG team in the Caribbean.
But we don't have a regional strategy for scaling up HIV testing. One of
the problems -- and I would say this is -- bullet number 2 is the
biggest problem we're seeing right now, is that the region endorses a
laboratory-based strategy. I was not here for Bernie's presentation but
I'm sure he must have talked to you about all the new modalities in
rapid testing and why it's important to expand testing. Well, we've been
shouting those same messages in the Caribbean, and it's not going over
quite so well because the region endorses a laboratory -based HIV
testing strategy. So we have three countries, Guyana, Surinam and
Trinidad, who actually have implemented a rapid testing algorithm in
several of their clinics and it's going really well. So one of the
things we hope to do is model some of these programs in other countries
to see what the acceptability, what the feasibility is like.

There are many people trained in the region in traditional VCT (sp), the
traditional model where you bring the person in, you counsel them
extensively, test them, have them come back for their results. But
unfortunately in the Caribbean sometimes it can take up to four weeks to
get your results.

I'm not going to say much about laboratory capacity other than to say
this is a big gap in the region because we need technical support to
build laboratory capacity. There are no accredited labs in the
Caribbean, including at the Caribbean Epidemiology Center which is the
public health institution that should provide laboratory support.

A laundry list of things we still need to know more about. But I have at
the top of the list migration impact. And I have it at the top of the
list because this is I think a critical area for the U.S. to study. What
is the impact of people moving so fluidly across our borders? People
coming from the U.S. to Puerto Rico to the wider region, people leaving
the region, easily coming to the U.S. New York City I think and
Brooklyn, there's a large population of people from Trinidad and Tobago,
and they move freely between Trinidad and New York. Some problem with
Guyana moving to other places throughout the region. So it's an area
that we don't know a lot about.

We also have anecdotal information about the Bahamas epidemic being
affected Haitian migration. But we don't have data to substantiate that.
It would be nice to look to see what are the demographics of the new
cases in Bahamas? So we actually have talked between the regional
programs, and the Haiti program, the -- (unintelligible) -- program in
Haiti about Haiti about conducting a collaborative study, but then we
were told that it's difficult to do such a study because we can't use
Haiti money in Bahama because of the parameters around --
(unintelligible). So this is one of the challenges we've run into, and
it would be very nice to be able to devise ways for the regional
programs in the rest of the region to benefit from the --
(unintelligible) -- dollars in the region.

And then the rest of the areas we need to know about, risk factors and
transmission routes. We don't have a lot of information. I suspect this
MSM activity, the behavior here, I think it's higher than 12 percent.
But again, I think it's concentrated epidemics but because of the stigma
and discrimination in the region it's very difficult to obtain this
information. We had a failed study two years ago because people were not
interested in being tested.

(Unintelligible) -- coverage. Spotty, but many countries offer free HIV
therapy. There's a variety of combinations that are used, and we can't
say from one country to the next, okay, this is the standard regimen,
this is the standard regimen, or these are the three regimens that they
use in this country. But these are all data gaps that we need to get a
handle on.

And then finally, I'll mention prevention efforts. You'll see most
at-risk populations somewhere later in the presentation. This is a high
area of focus for USAID in the region. Again, it's related to knowing
where the risk is. It's thought that there's very little IDU
transmission in the Caribbean, except for Puerto Rico. I have no idea
where that comes from because I haven't seen any data and I haven't seen
anyone looking for it. It may be true.

This is Morochas (ph) Bay, by the way, 30 minutes from my old house. I
was never there. (Laughter.)

So why aren't we seeing more data and impact from the region? So it took
me almost two years to figure this out. But we have a very fractured
regional response. Just lack of coordination. So while we have over
\$300 million in the region, it's not coordinated. So I'm afraid there
is extensive duplication of efforts. And I mentioned to you PANCAP (?)
in the very beginning. That's why PANCAP is critical to the success of
the HIV/AIDS -- t stopping HIV/AIDS transmission in the region. Because
I think they are in a powerful position to coordinate the efforts, to
know who's in the region, who's doing what.

I've already talked about lack of systematic data collection, monitoring
and use.

And then poor human resource capacity. The brain drain in the Caribbean
is similar to what I saw when I worked in Africa. It was very shocking.
And most people actually come here, particularly nurses. And Trinidad
and Tobago has recently engineered a contract with Cuba for healthcare
providers, and so now lots of Cubans have moved to Trinidad and Tobago
to provide healthcare. So another issue to put into the migration pot.
What will be the effect of moving Cubans throughout the rest of the
region to -- how does that impact the epidemic.

So, this, by the way, is a retreat that I took my staff. We had a
team-building exercise. It was fabulous. Here's where --
(unintelligible).

This is a quote I like to use often because I think it applies to so
many things. And while it seems that there are lots of challenges in the
Caribbean, where there's a challenge there's always an opportunity.

So we've had to refocus and think about what our goals are and how we
can actually address some of the root causes. And so now because USAID,
CDC and HRSA are the biggest players in the region on the U.S.
government side, we've thought about our goals. And we would like to
develop a regional public health leadership, because I think there's
sluggish program implementation because people aren't trained in public
health, they're not trained in data collection, and a lot of times
they're not trained in the specifics of clinical monitoring and so on.
And I think that all gets back to public health leadership and program
management.

And we've like the availability and access to strategic information.
Strategic information I hope you've heard is this new term that we're
using to refer to surveillance, epidemiology data, monitoring,
evaluation and information. Any information that you need to improve or
to drive your program.

And this is a big area also for CDC for obvious reasons. USAID is taking
the lead on expanding our prevention program. The CDC is providing
support to improve the PMTCT (sp) response in the region.

I'm going to skip that.

I put this slide in here because I thought you might like to see a
little tactical use here. You can see a sign by the secretary. This was
a strategy we used to try and help move the testing agenda forward. And
it was actually Bill Steiger's (sp) idea. I met with him to tell him
about the challenges we were having. Of course, we can't improve
surveillance activities without knowing how many people are infected,
and we can't know that until we get people tested, and that's why CDC
wants to improve testing, but everything is so slow. And he said, "Well,
since you talk to the prime minister all the time, why don't we send a
letter endorsing rapid testing." And I thought it was a brilliant idea.
So they followed through and they sent it down and I waited and waited,
and nothing happened. But it's okay, we tried. And these are the kinds
of strategies that we have to use all the time. As a matter of fact, we
have a phrase called the triple C. It stands for conspiring to convene a
coincidence. Makes you very tired though. Your brain never shuts off.

So I'm going to wrap up, but I wanted to just give you a snapshot of
what the U.S. government is doing in the Caribbean and where. Because
there's also a lot of confusion about who's working where, what we're
doing. And as you can see, I mentioned earlier that our efforts in the
region are fragmented. And the USG is really not much better. We're
trying, but it's difficult when, again, country solidarity, politics in
the region are coming into play. People who have been there for years,
external partners and internal partners, have been there. It's not easy
to come in and reorganize the entire scenario.

So as you can see, each U.S. government agency really works in a
different place, but most of the action is in the OECA. Why is that? I'm
not sure. I think it's because they're smaller countries, there's less
infrastructure in those places. It's seen as a place that needs a lot of
support, which is true. But I also think that because they're now a
federation, theoretically you should be able to intervene at the
federation level and have everything circled down to the countries, but
guess what, that doesn't happen either. But I would say we are making
some headway on the testing front in the OECS, particularly because they
have a global fund and we've been providing some technical expertise.

You probably also noticed the absence of Puerto Rico and U.S. Virgin
Islands. It's because as far as we know, our mandate in the region is
not to focus on Puerto Rico and U.S.V.I. because they are U.S. and we
were told that because they're U.S. they will be handled with a
different pot of money rather then PETFAR money.

So I think I have one more slide, and it's issues for you to consider.
U.S. is part Caribbean. So do we need a broader collaboration? And I
think we do. I've already talked about the migration border issues, how
is it contributing to the race of HIV in the region. Do we need to
strengthen our technical, financial and infrastructural support? In the
region, money talks. I think that's true around the world, but
particularly in the region. He who has the biggest purse carries a lot
of voice. Is stronger USD public health leadership role warranted? I
definitely think this is true also. I's certainly worth considering,
because HIV is not the highest priority anymore. It may be on par with
chronic diseases, but it's falling.

Will support for U.S. -- for regional prevention -- (unintelligible) --
yield benefits to the U.S.? This gets back to the migration issue. If
you conduct strong prevention in the Caribbean, does that lead to -- are
we going to see better prevention or reduced transmission in the U.S.?
Feeds right back into migration border issues.

And then given the data gaps and migration challenges, is the current
USD funding scheme appropriate? And by that I mean, as I told you, most
of our money in the region is in Guyana and Haiti. But what about the
rest of the region? There was a delegation, a high-level delegation that
came up to talk to Washington on Capitol Hill -- I'm sorry -- the White
House a few months ago about this very issue. And they come to us all
the time asking us, but we -- our hands are really tied, so we have to
stick to the program and talk about what we can offer with the amount of
support that we have.

So with that I'll close. I think I talked longer than 30 minutes, but
let me know if you have any questions.

DR. MAXWELL: Thank you, Dr. Fitzpatrick. I have a question. You
mentioned that in the Caribbean about 18 to 27 percent of the population
is ever tested with only 10 to 17 percent that know the results of the
test. How can that be? Why does that happen?

DR. FITZPATRICK: It's because of failure to return for test results.
Because even in the study -- this was a controlled situation. They
conducted rapid testing but they didn't give results back. That was part
of the study protocol. So they relied on people to come back for their
test results. But even though that was the study, I think that's pretty
indicative of what happens in most of these programs where you have to
wait two to four weeks to get your results. People are lost to follow
up. I think it even happens here at home. Maybe not to that degree but
--

DR. MAXWELL: Ted?

DR.GREEN: Yeah. I'd like to make a comment and ask a question or two.
First of all, you said that -- just a correction, I lived Surinam and I
speak the national language and it's not English. The official language
is Dutch, and the lingua franca is a Creole -- (unintelligible). That's
the one I speak.

I think you're right in suggesting that these are mostly concentrated
epidemics. I think that was what your slide and what you were
suggesting. And to look at Surinam, the example you gave, pretty high
rates of -- among MSM and commercial sex workers, and yet 1 percent
national prevalence. The Dominican Republic was estimated by You and
AIDS to be 2-1/2 percent. Then USA did a population-based survey and
found it was slightly less than 1 percent.

One question is, are you aware of any countries that have had
population-based -- (unintelligible) -- surveys other than the DR? And
secondly, I raised this question earlier about whether for Caribbean
immigrant groups in the U.S., if we have AIDS prevention materials in
French, Dutch, any of the Creoles, like Haitian Creole? So those are two
questions.

DR. FITZPATRICK: The second question, not to my knowledge.

DR. GREEN: Well, there must be materials in Haiti. Why couldn't we, you
know, bring them here and use them in Miami and Boston? I live in
Boston. A lot of Haitians there.

DR. FITZPATRICK: Oh, I'm sure that could happen, right, Eva? Yeah, sure.
That's no problem I wouldn't think. I don't know the extent of the
materials that are available in those countries. But if we have them and
if they're U.S. government property there's no problem with that.

DR. GREEN: Are you aware of any countries -- yeah.

DR. FITZPATRICK: Yeah.

MR. : Population-based surveys --

DR. FITZPATRICK: The population-based survey. Jamaica did a
population-based survey some years ago, but I haven't seen any recent
data. And when they did that survey, I can't recall the number, but it
was in their range, 1-1/2 to 2 percent, so it's still low. But I don't
know of any other countries that have done a population-based survey.
They're very expensive, as I'm sure you know, so.

Any more questions? Well, see, as I said, I'm standing between them and
the door.

DR. MAXWELL: Any other questions for Dr. Fitzpatrick?

DR. PRIMM: Lisa, I know you. Thank you so very much for coming, and
thank you for all of your collaboration with me that you've done when
you were there in -- (unintelligible). I really appreciate that.

I'd like you to say something about Puerto Rico, if you would. And I
know there is lots of exchange. People go to Puerto Rico to get treated
from the other islands in many instances, and go to Florida. What about
that trafficking back and forth for treatment?

DR. FITZPATRICK: Again, Dr. Primm, I'm sorry, I can't say anything about
Puerto Rico because we -- the extent of our relationship with Puerto
Rico is having Puerto Rico provide some support, and it's minimal
support, to the rest of the region for anti-retral viral drug
resistance, which is something we actually have tried to back away from,
because I think as you saw there are much more important things I think
the Caribbean should focus on. But having said that, that is the only --
that's the only technical area that we've worked with Puerto Rico. And
pretty much, again, it's because our understanding was with PETFAR
dollars, they were not to be used collaborating with U.S. territories,
in the U.S. None of our activities are in Puerto Rico, so I really --
I'm sorry, I don't have -- if that's what you wanted to hear about, I
probably could have looked that up, but I can't say much about Puerto
Rico.

DR. PRIMM: You also tried to do testing on certain islands with
cooperation from -- (unintelligible) -- technologies. What happened to
that project?

DR. FITZPATRICK: Yeah. We were designing a study in four countries to
look at the acceptability and feasibility of oral rapid testing. And in
two of those -- the countries were Haiti, Guyana, Surinam and Trinidad
and Tobago. And in two of the countries we received permission from the
minister of health -- the ministry of health to conduct the study. The
other two, we're still waiting for permission to do the study. The study
is also still in clearance at CDC, but that should be coming through any
time. So I think it's just a matter of time. Probably another month or
two. But again, it depends on what's happening at those ministries of
health. They all seem very willing to be in the study. The collaborators
on the ground at the clinic sites. But it's the ministries of health who
have to approve.

DR. PRIMM: And who is your replacement, so that we would be able to know
that individual for contact with correct?

DR. FITZPATRICK: My replacement is Dr. Shirley Lecher. She is not on
board just yet. She is an HIV vaccine researcher from Walter Reed.
Walter Reed? I think so. So that's L-e-c-h-e-r. But again, you could
probably funnel those kinds of questions through Eva and she could give
you the information. I'm not sure how long it will take Dr. Lecher to be
on board.

Eva could probably also address your question about Puerto Rico.

EVA MARGOLIS: Well, I'm not sure I can really answer your question. I --
(off mike).

DR. MAXWELL: Is your mike on?

MS. MARGOLIS: (Off mike, laughter.)

(Inaudible) -- leave it on?

I just wanted to confirm that Puerto Rico does get the domestic HIV
prevention dollars, and we have a project officer for Puerto Rico. It
has been an area that we have struggled with over the years. And some of
you may be aware. I mean they've been in the newspaper recently. HRSA
has had issues. There's all kinds of problems with the healthcare
service delivery program in Puerto Rico. The FBI has been involved.
Several years ago they had difficulties getting their prevention funds
out and they asked us to compute their CBO dollars for then, which we
have. So money is going to community-based organization for prevention.
I can't say much more about what's going on there because I don't have
the specific details. But I know we did provide for PACHA information on
the number of cases in Puerto Rico, but as far as being able to comment
on contributing factors back and forth across the border, I really
can't. I'm sorry.

DR. FITZPATRICK: I think that underscores though the need to improve the
collaboration between the U.S. territories and the rest of the
Caribbean. Because we really have not tried to foster or develop
relationships, because really those are the parameters of our funding,
and it's something that we have no control over so --

DR. MAXWELL: David.

DR. DAVID MALEBRANCHE: Lisa, what do you think would be the best
solution, I mean given PETFAR and their focus just on Guyana and Haiti?
Because it sounds like you're almost suggesting there should be some
kind of separate program. Do you think that would be better, or do you
think in the preauthorization of PETFAR and kind of revamping that, that
more Caribbean nations should be included? What do you think would be
the best --

DR. FITZPATRICK: Yeah.

DR. MALEBRANCHE: -- the best approach.

DR. FITZPATRICK: Thanks for asking that, David. I think it's important
to assess what's really going on in the Caribbean and looking at where
the data gaps are, and I'm not suggesting at all that we should take
funding away from Guyana and Haiti. I'm suggesting that there is a
broader need for support throughout the rest of the Caribbean. I show
that there are at least five or six other countries that have a high
burden, but because of the way PETFAR funds are allocated, it's based on
GDP, it's based on the amount of resources in a country, and so some of
the countries may appear to have more access to wealth, but when you get
to the infrastructural problems and you look at what's happening in the
health sector, there's a lot of poverty, there's a lot of need, there
are a lot of gaps. So that would be my suggestion, that if PETFAR is
re-authorized, there's a need to critically look at what's happening in
the region and what the needs are and if the current funding strategy
makes sense.

DR. PRIMM: Do you think, Dr. Fitzpatrick -- first, you've let the
federal government now, so you would be able to answer --

DR. FITZPATRICK: Not yet.

DR. PRIMM: Well, you're on vacation. You're on -- whatever. (Laughter.)
Could you comment on how well you think the funds that are provided to
PETFAR in Haiti and Guyana are helping the cause? Are they being
adequately disbursed and spent toward prevention and care of that
patient population who --

DR. FITZPATRICK: Mm-hmm.

DR. PRIMM: -- may be suffering from this disease? Can you comment on
that?

DR. FITZPATRICK: I can comment a little bit on that. I think the PETFAR
dollars have been a tremendous benefit to both those countries. The
numbers of people who are now on care is far -- far exceeds what they
would have been able to do without PETFAR dollars. I think the money is
allocated according to the parameters that are set forth in the PETFAR
legislation. And you probably know that a certain percentage of funds
for the bilateral programs have to be spent on treatment, a certain
percent has to be spent on prevention, and so on and so on.

And so if your question is what do I think about that, I think that also
deserves a second look, because some countries -- again, it's not a one
size fits all. There are some countries the governments are already
paying for medication, so it doesn't help to have PETFAR money to pay
for medications when you could pay to develop infrastructure or you
could pay to expand prevention programs or expand testing or build
laboratory capacity. So I think it deserves a look at what each place
needs rather than saying these are the parameters. And I know it's
easier for reporting. We've had these conversations. It's easier to say
to Congress, "Okay, 80 percent of the money was spent on medications and
now we have 2 million people on drugs because of that." But
realistically and practically, it doesn't always work that way. And I
think it's important to consider the context on the ground when making
those decisions.

DR. MAXWELL: Any other questions? Dr. Fitzpatrick, we want to thank you
for going above and beyond the call of duty and coming in on you
vacation to give us this great presentation, and we wish you the best.
Thank you.

DR. FITZPATRICK: It was my pleasure. Thank you. (Applause.)

DR. MAXWELL: This concludes our meeting. We will reconvene after --
we'll reconvene tomorrow at 8:30. And Marty has some comments.

MS. MCGEEIN: Like you thought you could get out of here without them. I
will draw your attention to the agenda for tomorrow morning. At 10:15,
that particular session is billed as a listening session, and the
purpose is for you to share with our guest your thoughts on the
epidemic, on what you do for a living, and how those two intersect.
Okay. All-righty.

DR. MAXWELL: Could you give us just a little more insight so --

MS. MCGEEIN: Unlike our usual, there won't be a presentation. There
won't be a presentation followed by questions. It will be what's called
in Washington a listening session. It is -- I believe Mrs. Clinton calls
these a conversation. It is designed to be a conversation with the PACHA
members as opposed to a prepared speech followed by Q&A.

DR. PRIMM: I prepared in draft form a resolution that I'd like to be
considered, and I added to my draft anything that anybody suggested as I
circulated it to each member of PACHA. And she's just finished it. I
would like each one of them to take it if they would, and have a look at
it, and then mark it up even more if that were the case.

MS. MCGEEIN: Okay. Apparently they're sending around -- I will simply
remind you that these have to be cleared through the domestic -- or the
international subcommittee and then brought back to the full committee
--

DR. PRIMM: Sure.

MS. MCGEEIN: -- tomorrow afternoon.

DR. PRIMM: Sure.

MS. MCGEEIN: So --

DR. MAXWELL: So we will address yours in the --

MR. : We will address it --

DR. MAXWELL: -- domestic.

MR. : -- in the domestic.

DR. PRIMM: Thank you. Marty?

MS. MCGEEIN: Yes.

DR. PRIMM: That's why I gave it to everyone present here, so that they
would see it, and international and domestic, so that I could get some
concurrence if I could from everybody. That's why I did that.

MS. MCGEEIN: Okay. Thank you.

DR. PRIMM: Thank you.

DR. MAXWELL: Okay. Everyone have a good evening and we'll see you
tomorrow.

MS. : We have a bus.

DR. MAXWELL: A bus apparently at 4:20 downstairs, but usually they're
down there a little bit early.

(Cross talk.)

DR. MAXWELL: Yeah, you actually could walk.

(End of day one.)

MR. GILMARTIN: Well, good morning everyone and welcome.

So, I'm pleased to be sharing this role with Marilyn and I find out that
a significant part of the role is telling the bus driver to leave --
(laughter) -- executive decision. Exactly. Well, with such a
distinguished group it's a pleasure to have the opportunity to do even
that and speaking of a distinguished group, we'd like to being by
recognizing one of our colleagues who -- for his very important service
and we have some, and also is part of this, as I recall from that last
time, is that we're calling upon you to make some comments based on your
experience and some you'd like to -- suggestions you'd like to pass
along to the rest of us, so I look forward to that.

So, Ted, if you would come forward, we have -- (inaudible).

MS. MCGEEIN: Absolutely, for the wonderful four years that you have
shared with us, and the not quite year that you've shared with me, we
would like to thank you for your service, the Presidential Advisory
Council on HIV/AIDS. Here is a note from Secretary Leavitt, your
certificate of appreciation from Secretary Leavitt, a little remembrance
from Secretary Leavitt -- (laughter) -- a remembrance from President
Bush -- (applause).

We need to shake hands.

(Pause, off-side conversation.)

DR. GREEN: Oh well, I was afraid I was going to be late this morning,
the traffic was backed up and because I'm on my way to Africa later
today, I was given the great honor of having a parking space for today
underneath the building, but the traffic was terrible and then it took a
while getting in.

I just jotted down the outline of, you know, thinking back over my PACHA
experience. I was asked to serve in 2003 and what was going on then is I
was devoting my every waking moment to trying to tell the world about a
model of prevention that's different, that was and still is different
from what we do in most of the world. What we do in most of the world
for sexually transmitted HIV is promote condoms and various ways --
treat the treatable STDs, voluntary counseling and testing, and that's
just for the sexually transmitted part.

I was, I actually started to work in AIDS before the USG became involved
in AIDS outside the United States, which started in, I think, mid or
late 1986 with the AIDS Comm and AIDS Tech projects. I was working in
condom social marketing for family planning and the first thought anyone
had is, oh, well, we need to quadruple our efforts to get condoms out
there and have people use them consistently. I mention that because some
people have accused me of being anti-condom, but, you know, for three
years I was working in condom promotion for family planning. We began to
do it for AIDS prevention and I got to use existing funds to do quick
studies of sexual behavior, I was working in Nigeria, Liberia, and the
Dominican Republic.

Flash ahead to 1993, I went to Uganda for the first time and lo and
behold, the incidence and prevalence were coming down in Uganda and
condom social marketing was just getting off the ground. It had hardly
done anything outside the capital city, and yet incidence and prevalence
-- we now know that incidence started to come down in the late '80s and
they only really began their prevention program in 1986, so I thought,
well, this is the story of the century. Here's the first success story,
at least the first success story in Africa, in fact it was the first
anywhere, and the most dramatic to this day, and I knew it wasn't coming
down because of condoms and that's what everybody thought and hoped and
expected. The company that I worked for, as a condom social marketer,
was the same company that had the contract with USAID to promote condom
social marketing in Uganda.

Anyway, I, as an anthropologist, I just, you know, quickly went around
and spoke to nurses and doctors of STD clinics, various officials,
traditional healers, traditional birth attendants, I just quickly talked
to everybody and said, what's going on? And what I heard was -- and I
saw the evidence for it -- the government had developed its own
prevention program. It didn't wait for Western experts like me from
Europe and America to come and tell them what to do; they quickly
mobilized themselves and promoted monogamy; fidelity, if you're in a
polygamous marriage, fidelity within that -- not having multiple
partners, that was the main message. And the church was very much
involved, which is unusual in AIDS prevention at that time. It's still
not that common, even with PEPFAR and things you may have heard; it's
still not that common.

So I thought, wow, the world's really going to be happy and -- I found
out a couple years later that the cost of the program at that time, that
was so effective, was 23 cents per person per year. So, I thought, wow,
I've got a great story and the world's going to be so happy, but the
world wasn't happy because we had a lot invested in the way we were
promoting AIDS prevention and there was a lot of politics and there was
a lot of ideology and right from the get-go, people thought that I was a
partisan in the culture wars in the United States: condoms versus
abstinence.

And I was saying, you know, this is not about abstinence or certainly
not about abstinence only, it's mostly, it should mostly be about
whether we really try to actively discourage people having multiple sex
partners or not and delay of the age of first sex is an important
factor, but it's not as important because it only affects a relatively
small segment of any population, you know, at the age at which teenagers
begin to come -- become sexually active. And to this day -- (chuckles)
-- you'll hear, abstinence only doesn't work, as if that is the
discussion, and it shouldn't be.

Well, I came back to Uganda a few times -- well, actually -- no more
biography. PACHA -- so, in 2003, I was getting my message out. I was
asked to testify in Congress twice and then twice after that, but 2003
twice that year; brief White House staff, I was in public debates, I had
op-eds in four newspapers including the New York Times and the
Washington Post. I was controversial and making a lot of enemies among
my colleagues, who suspected that I had somehow become a religious
conservative. And when I joined PACHA, we had a diverse group, then as
now, and there was liberals and conservative, and I'm a liberal, but
conservatives liked my message and the liberals were suspicious.

But unlike some other boards I've served on, the people at PACHA for the
most part -- in fact I can't really think of any exceptions of
close-minded people -- people in PACHA were willing to look objectively
at the evidence and find common ground and some people that maybe
thought I was a little bit crazy at first, I think we -- they've come to
respect me; I've come to respect them -- and I promised Marty I wouldn't
make any invidious comparisons with other advisory agencies, but this
has been a good one.

Some of the highlights -- Secretary Tommy Thompson invited a few of us
on the international committee to come to -- to come on a trip to
Africa, four countries including Uganda. And all of the leading people
in AIDS, the head of U.N. AIDS, PEPFAR, which just started, and the
number two at PEPFAR was Mark Dybul, who is number one, I think he's
coming today, Richard Feachem, Tony Fauci, Peter Piot of U.N. AIDS, all
the leading people in AIDS were on that trip, either for all of it or
some of it.

So I had a chance to meet those I haven't met. A couple of -- there were
a couple of senators, and we had the CEO of Pfizer -- Hank McKinnell on
PACHA, and we had the CEO of Merck on that trip. It was a great
opportunity to meet powerful and important people in the world of AIDS.
I wish I had time to tell you about -- I'll just tell you very briefly.
We come to Uganda and Uganda was chosen of -- among the four countries
because of its great success in AIDS prevention. And we had four days
there. By the third day, there was no mention of any kind of prevention
that was not a medical device. In other words, the whole thing has sort
of become medicalized and commoditized if that is a word.

You know, they were talking about trials for vaccines and future of
vaginal microbicides, and nobody was talking about the ABC program. And
this is just to show that Uganda sort of drifted away from their
original indigenous African response to AIDS, and because of the foreign
donors -- I know this is sort of heresy -- but the foreign donors wanted
to fund what they wanted to fund, and what they're used to funding --
promoting fidelity, monogamy, partner reduction, and abstinence or delay
of sexual debut was not something that then or now, with the exception
of PEPFAR, foreign donors were comfortable funding, for reasons we don't
have time to go into.

I'm writing a new book called "AIDS and Ideology," and I explore this.
So a couple of us on the trip complained, and all of a sudden the Uganda
government was happy to talk about their ABC program. They were used to
Europeans and Americans not really wanting to hear about this.

Well, the next highlight was when Hank McKinnell, two and half years
ago, whenever it was, one day in a meeting of the full council said, you
know, what would be interesting is to -- apart from any considerations
of political feasibility, economic and financial considerations, what
would it take to bring HIV incidents to zero. The new infections next
year and globally, what would it take to have no new infections.

And I seconded that idea, and pretty soon -- and almost immediately
we're talking about bringing in this person, that person. I said, let's
do something different. There is enough experience around this table.
Let's draw upon what we know. And let's not bring in people because you
can bring in people that, you know, you have reason to believe will
promote this, and reason to promote that.

Let's just draw upon our wisdom and experience, and come up with -- and
we ended up writing this monograph, this 99-page -- I think it was --
monograph, achieving an AIDS-free generation, and that illustrated what
I was talking about the ability of PACHA to be objective about the
evidence, and some people ended up supporting things they didn't really
support at the beginning of this exercise. So it was a successful
exercise in people from -- with diverse experience to diverse political
views focusing on the evidence, and I was proud of that.

Then maybe the next highlight for me was and is the white paper on
PEPFAR-2 or PEPFARther, as we're calling it, which we're -- well, we
have a draft. We have a draft that has actually been over -- gone over
several times by the international committee. And there again, there
were some pretty sharp disagreements at the beginning of this exercise
with new -- there were new people in PACHA, and I was thinking, oh, we
did. We finally achieved consensus. We had this book and some of the
people who saw things the way I see them left, and just new people --
oh, we have to go through this all again. But once again, I don't know
if we're just lucky in PACHA or somehow -- but whatever reason, we were
able to go through a similar process, but even in more depth. And we had
the Institute of Medicine evaluation of PEPFAR as, you know, looking
over our shoulder because that'd already been done and released.

And maybe I'm not supposed to make any kind of invidious comparisons,
but I -- (laughter) -- but I will; I'll stick my neck out. I think our
white paper is much more evidence-based, and I believe it's -- you know,
it's gone to the full committee now, is that right?

MS. : After today's -- (inaudible) -- meeting is over.

DR. GREEN: About to, yeah.

So again, we had people with divergent views. Let me mention why we have
divergent views. I think, apart from politics, we have two basic types
of epidemics: generalized and concentrated. And in most of the world is
concentrated, which means the three universal high-risk groups for HIV
infection -- gay men, injecting drug users, and commercial sex workers
-- that's where you find most of the infections, and it varies among
those groups. Like in Africa, there aren't many injecting drug users,
but there is commercial sex. And it doesn't make much sense to promote
monogamy, fidelity, or abstinence to a commercial sex worker.

But in like manner -- everyone recognizes that, but in like manner, to
go into an African village and talk to a primary school, and some
students could be up to 15 years old or so, and most of them haven't
started to have sexual intercourse, if the only thing you have in your
toolkit are condoms, you know, treating their STDs and clean syringes,
which I know is not U.S. government policy, but other donors, that's not
really appropriate for people who are not currently at risk.

And I think if all of our experience is in Thailand or some country with
a concentrated epidemic, you can't quite wrap your mind around the
importance and effectiveness of promoting not having multiple sexual
partners. And Uganda was only the first country to prove that when
governments and NGOs and FBOs promote monogamy, fidelity, not having
multiple partners, and abstinence appropriate to your target audience,
their age and whether they're currently at-risk or not, that it works,
that if you promote it, you get higher levels of those things, and that
has a big impact.

And where we are right now, we have about seven countries in sub-Saharan
Africa where we have documented HIV prevalence decline in every country,
without exception, about five years before we see this change of
prevalence -- and what's happening is a change in incidence, the rate of
new infection -- we see a significant decline in the proportion of men
and women who report more than one sex partner. So that's not a
randomized controlled trial, but that is the next probably most
persuasive type of evidence, a consistent associational pattern.

I think I probably don't need to go on any longer, probably used up my
time, but I want to -- let's see, I think we've mentioned advice. I
wasn't thinking about giving any advice, except to keep in mind that
there's all this common ground, no matter how -- a lot of passions run
high when talking about HIV/AIDS for a number of reasons that I think we
all know. Passions run very high, and when there is disagreements about
AIDS, it can get quite personal and heated.

My experience at PACHA has proven that people from diverse backgrounds
and political viewpoints can come together objectively, looking at
evidence, and the way to do this is to be friendly, respectful,
open-minded. For example, like my friend Ram here, who united different
views but, you know, I think we both learned from each other.

And then also to keep the mind that what is needed for AIDS prevention
differs, whether we're talking about generalized or concentrated
epidemics. One reason is that in generalized epidemics, where HIV is in
the general population and not in definable high-risk groups, it has
never been possible, whether for family planning or for AIDS prevention
or STD prevention, it's never been possible to achieve high levels of
consistent condom use in any general population. It has been possible in
high-risk groups. That's not to say we shouldn't promote condoms to
everyone, but we have 25 years of AIDS experience and 50 years of
family-planning experience telling us that you're going to need
something else in addition, not instead of, but in addition to condoms
for general populations.

So with that, I'd like to thank everyone, all my colleagues in PACHA for
being good colleagues, and the various leaders and directors and
administrators for treating me very well. And I'm sorry to be leaving,
and I've had a great experience here. Thank you.

(Applause.)

MR. GILMARTIN: Well thank you very much, Ted, for those remarks.
Whitey's (sp) informed me that our speaker, our 9:00 speaker, has not
yet arrived.

MS. : Five minutes.

MR. GILMARTIN: Five minutes. So if we think it's appropriate, maybe we
just can have a conversation with Ted as well in terms of what his
experiences had been, and some reactions. On that trip: It wasn't the
CEO of Merck who -- which I was, but it was our head of Europe-Middle
East and Africa, Per Wold-Olsen, who is I think, you know, the
government of Romania practically credits him personally with helping
provide access to HIV/AIDS drugs to deal with a problem that they were
having, so he was very committed. But he met John Martin on that trip,
so that was a very fateful trip in which they established a relationship
that led to a working relationship between John's company and Merck in
terms of being able to put together combinations. So it sounds like it
was a very important event.

The other thing I would just add to your comments is that, you know,
based on my comments that at my first meeting at how Merck has been
involved with Botswana. So the president of Botswana was here in
Washington and meeting with the press in a roundtable setting. And he
was asked -- and of course the program in Botswana includes prevention,
which is condom distribution and education of, you know, in schools
about talking to kids about how to prevent HIV transmission.

And so to your point, he was asked what I would consider to be a leading
question about abstinence; more or less, to have him answer, yeah,
that's a ridiculous approach. But he actually came back, he said, no,
it's very important, and it's very much part of our program. At the same
time, it wasn't a question of either/or; it was both. And I think that
gets lost, unfortunately too much, as you were saying before, in the
whole discussion. So it's great to hear how effectively this group has
been able to come together and hear different viewpoints, and perhaps
develop some different perspectives as a result of listening to one
another.

Yes, Ram. So why don't we just pitch in, rather than formally call in on
everyone.

DR. YOGEV: I'm sitting on this committee now almost three-and-a-half
years. Most of the members who left before you, I was really sorry on a
personal level. I think the committee's going to do is the intellectual
capability that you brought in, and never yielded without asking why.
And that's a great, great asset that we're going to miss. So thank you
for what you did. I wish you'd stay another six months so I can leave
first.

(Laughter.)

DR. GREEN: To comment from Ray's remarks, I have an opportunity to make
a presentation in Botswana at the end of November to high levels of the
government and to parliament about some of the newer findings. You know,
it's not just having multiple partners; it's having multiple and
concurrent partners.

And in southern Africa, in and around South Africa, a lot of marriages
are interrupted by the men migrating to South Africa to work in the
mines, to work in the cities; I mean, it's the only really
industrialized country in Africa, and it's a big magnet for labor of
especially men. And they leave their wives in the village for months or
years at a time. And in addition to having casual sex with a non-regular
partner, not infrequently -- it's not most, but a significant minority
of men and even of women establish an ongoing relationship, the man with
somebody where he's working, and the wife eventually with a man in the
village who helps pay the school fees to the children.

And it turns out that since HIV is actually difficult to transmit
through normal, heterosexual intercourse, it's these ongoing concurrent
relationships that are very risky, and it raises greatly your chances of
encountering somebody in the high-viral load period soon after
infection, when the viral load is higher than it ever will be again. And
so some of the people that were resisting the ABC approach -- and that's
been so politicized we probably need to dump it and come up with -- in
fact, I did come up with something.

You've all heard E equals MC squared; I've been saying E-squared equals
MC-squared. E-squared is epidemic squared, a hyper-epidemic, is due to
multiple concurrent partners, that's one MC, and lack of male
circumcision, the other MC. So that's a little mnemonic aid to --
(laughter) -- this is why these are the two main reasons that HIV rates
are so high in and around South Africa: lack of male circumcision and
having multiple concurrent partners.

Anyway, I hope this really comes off, and I have the chance to speak to
the folks in Botswana. And I lived for four years in Swaziland, which is
the only country that has higher infection rates than Botswana, and they
have similar issues of absent husbands.

DR. PRIMM: Ted, speaking of male circumcision, what is your take on that
for the problem in the African-American community in the United States?

DR. GREEN: Well, Beny, I think you've asked me this before, and I'm
afraid of sticking my neck out in an area that I'm not really grounded
in the evidence. My understanding is that circumcision is -- and by the
way, the reason we say male circumcision -- like what other kind is
there -- in some Muslim areas there's what they call female
circumcision. And that's another matter, and it's also called female
genital mutilation. Beny, when I say circumcision of course I mean men.
My understanding is that it's less common among African Americans than
among white Americans, and the free-randomized controlled trials that
we've had, that have now turned everybody around and saying, yes, this
is something we need to promote, I personally would only be comfortable
promoting it in Africa because that's where all the trials were.

But you've heard what people have come here from NIH and so on, CDC,
saying no, no, there's evidence that it's important for gay men; it's
important for everyone. So theoretically, increased circumcision of
black men theoretically ought to reduce chances of HIV infection.

I'm sure you've all heard that the major reservation about this is that
it might promote a false sense of security, and men might take more
risks in their sexual behavior than they would if they weren't
circumcised. But that's true about using condoms; it's true about a lot
of things. If you reduce the risk are you going to, as they say,
compensate for that reduced risk by increasing your risky behavior,
which actually happened in the United States among gay men after
anti-retrovirals became available. We saw levels of risky behavior
actually increase.

So my only answer is that it theoretically should help. I know it's a
very sensitive issue, but it's not mixed up in religious beliefs. In
Africa, and in the Muslim world, circumcision can be part of your
religious belief. But I don't know of any religion that says don't
circumcise.

Anyway, that's my short answer -- my long answer.

DR. BUSH: Ted, I would like to thank you also for I guess the zeal or
compassion of which you were so energetic in getting the truth of what
was going on in what you observed in Uganda, even at the risk of, you
know, like you said when people began to question your motivation. So I
appreciate you for persisting.

And I wanted to venture out a little bit and ask you, I guess, when you
mentioned E-squared equals MC-squared. Beny asked about the male
circumcision component, so I'm going to ask about the multiple
concurrency, and if you had any comments about its impact in the
African-American community.

DR. GREEN: Oh, in the African-American community. Yeah, you were asking
me -- we started to talk about this yesterday, and then we got
interrupted; the meeting started or something.

Well, having multiple concurrent partners is a high-risk factor whether
you're African, African-American, or Polish. Whoever you are, it's a
definite risk factor for the several reasons, but mainly because it's
difficult to transmit HIV if you have ongoing relationships. And also,
people in ongoing relationships don't use condoms; I mean, a few of them
do, but it's rare. And there've been studies that show that for people
that are married, or living together, or just having an ongoing sexual
relationship, no matter what you do, no matter how much you beg, plead,
and give them free condoms, you're not going to achieve significant
levels of consistent condom use. So that's another reason that multiple
concurrent partners are having that as a risk factor; you're not going
to see a lot of condom use.

Now, we don't have a clue -- (chuckles) -- really, how to discourage
these. I think what happened in Uganda -- and I'm going to Uganda this
evening, again, with an express purpose of trying to explore the
concurrency factor. We know the prevalence went down, we know that the
proportion of men and women reporting more than one partner went down
significantly, but we don't know about concurrency versus the other kind
of casual sex with a non-regular partner.

What I think I'm going to find -- and this is only speculation at this
point -- is that there was a lot of decline in casual sex; you know, one
pickup sex worker or something like that. I don't know in the situation
I described, sort of a stereotype of a man having sort of a second wife,
but he's not married to her, and maybe even his wife, who's neglected
and not living in the same location, having an ongoing male sexual
partner -- I'm not sure how many of those ongoing relationships were
ceased; I suspect not many.

But I think what did happen is that young people entering young
adulthood, where they might have the mobility and the flexibility and
the finances to have a second sexual partner, that maybe they didn't
enter into those relationships. So it was sort of preventive rather
than, you know, people saying, oh, concurrency is a real risk factor so,
you know, either leaving the wife or leaving the girlfriend. So we're
going to explore that, and then set up some, you know, surveys to try to
measure more accurately what's going on.

Oh, by the way, there is a -- in Botswana, I'm pretty sure it's
Botswana, Population Services International, with money from CDC, is
going to do a randomized-control trial to try to isolate the multiple
partners, whether concurrent or irregular, to try to isolate that factor
and measure how determining is that versus condoms and other things. So
that's something I've been wishing we could have for a long time.

MR. GILMARTIN: In Botswana, they cite that as one of the major issues
that they have because, you know, the way it was described to me was
people have concurrent relationships at three different locations, which
would be the cattle posts, the home village, and place of work.

DR. GREEN: So that's E-cubed equals MC-squared.

(Laughter.)

MR. GILMARTIN: So I mean, and they are monogamous relationships in each
one of these locations, as described.

DR. GREEN: But they're multiple, concurrent monogamous relationships.

MR. GILMARTIN: (Inaudible) -- concurrent partners, which they saw as a
major contributor as to why HIV infection spread.

DR. GREEN: Yeah. Is Merck -- do you have a hand in this study?

MR. GILMARTIN: I don't know for sure, but I don't think so. But I can't
say that for sure. It's been about a year-and-a-half or two before I was
--

DR. GREEN: Yeah and this is just recently come up, this funding, this
opportunity.

MR. GILMARTIN: But they're very -- you know, one of the things that's
impressive about the country, as you've seen in other places, that is
the commitment throughout the country to really battle this because they
are fighting for their survival and those infections.

DR. GREEN: Yeah. And by the way, Botswana -- Africa in general
challenges what we think we know about AIDS. I've also gotten in trouble
with my colleagues by pointing out that maybe it shouldn't be this way,
but we see an association in Africa between greater wealth, greater
education, and higher infection rates. And the general thinking is, oh,
it's poverty driving HIV infection rates, and I mean, that's sort of
intuitive. If the woman has no money, she needs to get into a
relationship with a sugar daddy or turn to commercial sex. This is what
is widely believed, and there were people in PACHA who were saying, you
know, we shouldn't be doing A, B or C; we should be raising economic
levels through financial, you know -- something that would raise income
levels.

Well, yes, and that would help a lot of other diseases; it would improve
reproductive health, it would improve tuberculosis. But in Africa, so
many things are different than outside of Africa. We see this
association -- and Botswana and South Africa have the most money going
to AIDS programs of anywhere in Africa. They have the highest levels of
income and education. Women are more powerful than compared to -- I was
in West Africa, in Muslim West Africa in January, Senegal and the
Gambia. Women have far less power there, and we all think that, you
know, more female -- women's empowerment would lower rates.

I'm all for ending poverty, increasing women's rights, and I've worked
in women in development; I've worked in that field. But it's just very
tricky, the relationships between the things that we are promoting, and
we should promote them, but we need to look at the relationship between
that and HIV more carefully in Africa because it keeps confounding the
outside experts.

MR. GILMARTIN: Well, thank you very much, Ted, and thanks for everyone
else's comments as well. Clearly by the comments we're all going to miss
you, and best wishes on your trip this evening, and if you have an
opportunity, pass on my regards to some of the government officials
there as well. Thank you.

So turning next to our first speaker on the agenda, welcome, sir.

IGOR V. TIMOFEYEV: Thank you.

MS. : A victim of Washington traffic. (Laughter.)

MR. GILMARTIN: Yes, which -- yes.

So Igor Timofeyev, who is director of immigration policy and special
advisor for refugee and asylum affairs at the department of homeland
security. He has served as an associate legal officer to the president
of the international criminal tribunal for the former Yugoslavia; he has
also clerked for Justice Anthony M. Kennedy of the U.S. Supreme Court.
So Igor, please.

IGOR TIMOFEYEV: Thank you very much.

(Off mike.)

Okay. All right, I think I'm wired.

To Chairmen Maxwell and Gilmartin, members of the Presidential Advisory
Council for HIV/AIDS, thank you very much for inviting me to be with you
today. And I'm honored to speak to you about an important initiative of
both President Bush and the Department of Homeland Security to
facilitate travel of HIV-positive individuals into the United States.

I'm particularly pleased to see members of your domestic subcommittee,
such as Carl Smith (sp), who invited me to speak to them about a month
ago on this very issue. And I must ask for their indulgence as some of
what I have to say will sound familiar.

As all of you know, on December 1^st^ -- (audio interference) --

So as all of you know, on December 1^st^, 2006, on last World AIDS Day,
President Bush has announced an initiative that forms an integral part
of this administration's effort, dedicated to ending discrimination
against people living with HIV and AIDS. The president directed the
sector of Homeland Security to initiate a rulemaking that would propose
a categorical waiver for HIV-positive individuals who seek to travel to
the United States on visas of short-term duration. This rule seeks to
create an easier and faster process for these people to come to the
United States on short-term visas. What the rule would do is it would
offer authorizations of short-term, non-immigrant visas and also
temporary admission for foreign individuals who are currently
inadmissible solely due to their HIV status.

As such, the rule would provide for a more streamlined process than the
one that currently exists to authorize these individuals to enter the
United States as visitors, for either business or pleasure, for up to a
period of 30 days. In a nutshell, HIV-positive people who wish to travel
to the United States for short visits would no longer be required to
seek admission under the more complex, individualized, and case-by-case
process that exists under the current policy.

The rule seeks to accomplish this change in a way that, for the
imposition of requirements derived from the current practice, would
minimize potential costs to the United States government and the risk to
public health. This proposed rule is currently being developed by the
Department of Homeland Security in close collaboration with our
counterparts at the Department of Health and Human Services, and also
the Department of State. In the latter, we are working together with
both the office of the global AIDS coordinator and the Bureau of
Consular Affairs.

As with any regulation, the rule would have to be approved for
publication by the Office of Management and Budget, and we're in close
communication with them as well as with the domestic policy and homeland
security counsels at the White House. This had been, and continues to
be, a very collegial process, and the draft rule has already benefited
significantly from the comments we have received from our colleagues in
the inter-agency.

While the proposed rule is not out yet, I anticipate that we will see it
officially published very soon, and by very soon I mean within days and
not weeks. So it really will be coming, I expect, in the Federal
Register quite shortly.

At this point, once the rule is out we will be looking forward to
receiving public comments on the rule, and I hope that the listening
session we will have later today will also be a fruitful precursor to
that process. I expect that once we have received and reviewed the
comments from the public, we will be in a position to issue a final rule
-- and I take a breath before I say this, but not too deep a breath, I
think by the World AIDS Day, and if that proves impossible then by the
year's end.

So we really -- we have a cooperation with OMB. We have managed to put
this rule on a fairly fast-tracked, accelerated process, but hopefully
still one that will enable the public to react as it should to this
initiative.

So why is this rule necessary? What does it seek to accomplish and how
does it build upon our experience in adjudicating waivers from
HIV-positive individuals who seek to come to the United States? To
answer this question, we need to look at the current statutory
framework, at its history, and at the current practice concerning
issuance of visas to HIV-positive individuals seeking to visit the
United States.

Let me turn to the statutory framework first, since its inception in
1952, the Immigration Nationality Act provided that foreign nationals
who have any, and I quote, "dangerous, contagious disease," close quote,
are ineligible to receive a visa and therefore excluded from admission
to the U.S. The statute did not specify which diseases would fall into
this category, but left that determination to regulatory action.

In 1987, by statutorily mandated regulation, HIV was added to the list
of dangerous, contagious diseases that indeed makes an individual
inadmissible to the United States. Accordingly, foreign nationals who
were infected with HIV have been rendered ineligible to receive a visa.

In the early 1990s, the Department of Health and Human Services, which
is charged by statute with determining what constitutes a communicable
disease of public health significance, considered a regulatory amendment
that would have removed HIV from the list of those diseases. In
response, in 1993, Congress amended the immigration law to expressly
specify that, open quote, "infection with the etiologic agent for
Acquired Immune Deficiency Syndrome," close quote, shall constitute a
communicable disease of public health significance.

This statutory change introduced an explicit prohibition against
HIV-positive individuals who seek to travel to the United States. And
this prohibition was made immune from a regulatory amendment. To date,
infection with HIV is the only medical ground of inadmissibility that is
written into the immigration statute, as opposed to being left to
regulatory discretion.

While this prohibition is therefore both harsh and unambiguous, it is
not inflexible. The immigration law gives the secretary of Homeland
Security discretionary authority, subject to certain restrictions and
conditions, to approve the issuance of a visa and temporary admission
into the United States of a foreign national who is otherwise
inadmissible. This authority extends to instances where the
inadmissibility is based on health-related grounds, which includes the
HIV infection.

How does the process work? People who wish to come to the United States
on a temporary basis, such as for business purpose or for pleasure, must
file an application at the U.S. consulate abroad. As a part of that
application, the individual must answer whether he has any communicable
diseases of public health significance, which includes HIV. During the
subsequent interview, a consulate officer will ask the applicant
questions concerning his application to determine whether to recommend
that applicant for a health-related waiver of inadmissibility.

This recommendation is made on the basis of the guidelines that have
been developed by the Department of Homeland Security, and its
predecessor agencies in consultation with other relevant government
agencies, such as the HHS. Normally, the recommendation would go through
a level of supervisor review right at the consulate. This is a part of
the waiver process that is administered by the Department of State in
the course of its normal -- the charge of its normal duties of issuing
visas, reviewing and issuing visas.

After this process is complete, if the consul officer recommends a
waiver, that recommendation is forwarded to a special office within the
Customs and Border Protection, a component agency of the Department of
Homeland Security, that is charged amongst other things with the
determination of which individuals must be admitted into -- or may be
admitted into the United States. That office, which is called the
Admissibility Review Office, would review the recommendation to
determine whether it conforms with the guidelines for waiver issuance.
If it does, the office will make the decision to issue a waiver and that
decision will be communicated through the relevant consulate abroad to
the applicant.

What are the guidelines that the State Department's consul officers and
now admissibility review officers follow while considering these waiver
requests? Currently, this review is done on a case-by-case basis and it
employs a balancing test which involves several factors. In general,
when considering whether any waiver of statutory inadmissibility,
whether for health-related reasons or for others, should be issued, we
consider -- and we must consider -- three factors: the risk of harm to
society if the applicant is admitted, the nature of the basis for
inadmissibility, and the nature of the reason for travel into the United
States. Again, these are general criteria that would be applicable to
any kind of immigration waiver.

Guided by these factors, we have developed a series of more narrowly
targeted criteria to guide the exercise of discretion with respect to
waivers for foreign nationals who are HIV positive. These criteria were
first developed in a series of guidances and instructions in the last
1980s, so that was not only well before my time at the Department of
Homeland Security, it was well before the creation of the Department of
Homeland Security itself. And these criteria were issued by the former
Immigration and Naturalization Service, which had authority with
immigration matters and by the Department of Justice of which the former
INS was a part.

As is almost always the case with immigration, there are not -- these
criteria are not straightforward and simple. There are actually three
different sets of criteria: one that applies to any request for an
HIV-related waiver, and two that address more specific situations, and I
will describe those shortly.

The criteria that would apply to any request for a waiver of HIV-related
ground would require that the consular officer or CVP officer consider
three factors: first, whether the danger to the public health
represented by the applicant is minimal; second, whether the possibility
of a spread of infection is also minimal. And third, whether the
applicant's admission will result in any previously unauthorized cost
for a government agency in the Untied States, be it local, state, or
federal. To approve a waiver, our officers must find that the formative
factors -- the danger to the public health and the potential spread of
the infection -- are not more than minimal and that there will be no
cost to government agencies to which the agency had not consented
before.

Then the second set of criteria applies to situations when an individual
wants to travel to the United States for a visit of short-term duration,
one that would not exceed thirty days. In addition, the individual must
present a reason for travel that would qualify as a public benefit for
the United States and one that would outweigh any risk to public health
that his travel may pose. Such public health -- public benefit could
include, for example, attendance at an academic or health-related event,
conducting business with the United States, visiting close family
members, or traveling through the United States in transit to engage in
similar activities in a third country. Such transit also may not be
greater than five days.

The supplemental set of criteria was developed in order to provide for
more streamlined decision making in this specific category of cases
where there is a discernible public benefit reason for an individual's
travel to the U.S. And it reflected also common sense experience that an
HIV-positive individual who wants to come into the United States for a
short period to visit his relatives, to teach in a university, would not
normally present a danger to public health.

In addition, we have developed a third set of policies, one that
addresses instances where an individual wants to travel to the United
States to attend a scientific, professional, or academic conference.
That is, in itself, of a public interest. Such a conference event must
first be designated by the secretary of Health and Human Services. And
in these situations, an individual who has HIV will not have to go
through an individualized waiver review process because his attendance
of such a designated event is already deemed to be a sufficient public
benefit to justify a waiver. The period of admission authorized under
this event-specific set of policies is shorter than under the more
generalized criteria I described and must not exceed 10 days.

Over the years, we have granted waivers under this set of procedures for
an individual to attend events such as the Salt Lake City Olympic Games,
the U.N. General Assembly special session on HIV/AIDS in 2001, various
universal fellowship or metropolitan community churches events, and the
2006 Gay Games in Chicago.

I should also add that our criteria require HIV-positive applicants for
admission to establish that they're aware of the HIV-positive condition,
that they have received and are following adequate medical counseling,
that they are current under medical care and are traveling to the United
States with a supply of drugs as is medically appropriate and one that
is adequate to cover the length of the anticipated state. The applicant
must also demonstrate that he has adequate medical insurance or other
financial means available to him to cover anticipated medical expenses
during his stay in the U.S.

Now, what is the experience that we have gained during some 20 years,
almost 20 years of reviewing and adjudicating the HIV-related waivers? I
think this experience has shown to us that both DHS, and before DHS's
existence, the Department of Justice, have consistently approved
recommendations from consul officers for non-immigrant visas to aliens
who are HIV-positive where the following set of factors has been
present: first, where the applicant sought to travel to the United
States for 30 days or less, for a purpose consistent with a business
visit or a tourist visit classification, or was in transit to go through
the United States to a third country; second, the applicant has received
medical counseling; third, the applicant was in compliance with
medically advised behavior and medically prescribed treatment protocols;
and finally, the applicant was able to demonstrate availability of an
adequate supply of medication, if any were prescribed, and therefore was
not likely to require assistance resulting in any cost to any level of
government agency in the United States.

Also, with the help from our colleagues at the Department of Health and
Human Services, we have gained great understanding and expertise
regarding the threat to the public that is posed by HIV-positive
individuals. In particular, we believe that the current policy we have
adopted has provided adequate protection to the public health of the
United States and that individuals who have HIV, who aware of their
medical conditions, receive appropriate medical counseling, are in
compliance with medically prescribed treatment and medically advised
behavior, have presented little risk to the public health in this
country.

So based on this experience and as added knowledge, the administration
began thinking about how to further simplify and streamline the waiver
process. In particular, we looked at the event-specific waivers that we
issued -- the third category of waivers I described -- and we wanted to
see whether we could approve -- whether we could develop a set of
further streamlined process that would involve -- that would be based on
that sort of set of policies or group waivers. And we face the challenge
of trying to see how we can simplify a waiver process that involves at
least two government departments -- Department of Homeland Security,
Department of State -- and also on many occasions such as with
event-specific waivers, also Department of Health and Human Services.

So in short, we wanted to develop a set of policies where a consular
officer would be able to analyze a visa application, look at the
appropriate factors to consider, and if satisfied that these criteria
are met, will be able to issue a visa outright without a further review
by our admissibility review officers. So in that sense, the process
would emulate, would be based on this third set of event-specific
policies that I have described where there is the visa -- a consul
officer is able to issue a visa outright without the further
individualized review by our CVP officers.

The obvious benefits of this policy is that applicants who wish to visit
the United States for short periods of time would be able to get the
applications approved more quickly without this additional step of
review. What we did is we look at the legal possibility of doing so and
even though, so far, all the waivers that we have -- we have effected in
this area have been done on a case by case basis; there is nothing in
the immigration statute that would stop the secretary of Homeland
Security by also issuing a waiver through the rulemaking process.

So based on that legal conclusion, we have decided that this is a rule
that we can put forward and develop. And again, as I mentioned before,
and as I know on last December 1^st^, President Bush announced this
initiative and directed the secretary of State to request from the
secretary of Homeland Security the initiation of that process, which
Secretary of State Rice has done on June the 6^th^, requesting that the
Department Homeland Security grant the limited waiver of inadmissibility
under the Immigration Nationality Act to person who are currently
inadmissible to the United States solely due to their HIV-positive
condition.

More specifically, Secretary Rice recommended the waiver for persons who
seek short-term, technically called B-1 and B-2 visas; these are the
visas for business and for pleasure, which includes tourism. And she
specified that his waiver would apply to people who did not have active,
contagious, symptomatic infections associated with HIV or AIDS.

So my department, the Department of Homeland Security, shares the
president's and Secretary Rice's firm commitment to enable, on this
categorical basis, the admission into the United States of HIV-positive
individuals who do not have such active contagious symptoms, and to
enable those -- that admission in instances when these individuals want
to travel for short visit to the United States and do it for a
permanent, streamlined process that employs standardized criteria as
opposed to the current case by case individualized process.

Because the rule is not yet out, I am somewhat constrained in terms of
speaking of what will be in the rule, but I think the rule will
capitalize on the policies that we have currently developed, on the
knowledge that we have gained through administration of those policies.
It would take into account a lot of advice that we received from the
Bureau of Consular Affairs, that will bear a greater burden -- or at
least a greater workload in terms of reviewing and determining those
applications, and also from the Department of Health and Human Services,
which has done a lot to inform us with the latest medical opinion.

And certainly we are looking forward to comments -- once the rule is
out, for comment from the public and from, you know, really individuals
and organizations such as yours which have a great deal of expertise, a
great deal of knowledge and can really inform us on how best to
formulate and to shape this rule.

I, perhaps, if there are specific questions about the rule, I may be
able to address it throughout the question and answer, but again, until
the rule is out, which I expect will be very shortly, I will be -- I
will have to be somewhat limited in what I can say. So, thank you very
much. If there are questions, I'll be happy to take them.

MR. SCHMID: Thank you for coming back and visiting us, and thank you for
the good news that we will see the proposed rule very soon. We're very
pleased to hear that.

I guess, you know, when you spoke to the domestic subcommittee, many of
us said, you know, this is a law that needs to be changed. So I wanted
to put that on the table, but I know you are preceding based on current
law, but I would like to put that out there that I think we should look
at changing the current law.

But given that we have to live with the current law, I do have two
questions. One is, I believe now when people are given a waiver,
case-by-case, it is stamped on their passport through a numeric code
that they have HIV. Is that going to continue under this? Is that, first
of all, correct, and will that continue under the waiver? And the second
thing is -- and this is just because I'm not so knowledgeable on all
these issues -- does everyone who enter the United States have to obtain
a visa? And this is, I know, you know, pertaining to people who have to
get a temporary visa. So my question is, if they don't have to, you
know, how are you going to deal with those people?

MR. TIMOFEYEV: With the people who don't have to get the visa? Sure.

Well, I can't comment on the law, so that's -- (laughter) -- the law is
out there, and in part that's why I sort of wanted to stress that this
is the one specific instance where the statute very unambiguously
constrains us, constrains HHS. So we tried to see what we could do
within the law. And just in that sense, I would say that this
categorical waiver we propose is, while there is a precedent and there
is certainly the legal authority for that, it is a somewhat new
departure. I mean, this is the first time in which, when the secretary
of Homeland Security has proposed doing a categorical, fairly sizeable,
categorical waiver. So in that sense, I think we should appreciate that
it is quite a noble element that we're introducing here.

In terms of what is currently being stamped in the passport, I believe
that the only notation that is done is that there is a waiver granted on
a specific section of the INA, which I think is section 98212-D3A. So
really there is a notation on the passport, but it's not a notation that
says this is the HIV waiver. It just specifies the ground, the statutory
authority under which the waiver is granted. And that statutory
authority is not HIV specific; it's a waiver that can be granted for
medical, for health-related inadmissibilities. So in that sense, that's
how it's currently marked.

Under the rule, what we anticipate is we will develop probably similar
process when there is a notation in the passport. The reason for a
notation is very obvious: We want to communicate to our customs and
border patrol officer who will do the actual admission that this is a
waiver that is issued for 30 days; it's issued pursuant to particular
regulatory authorization from the sector of homeland security. There is
a transparent process by which the officer would be able to identify it,
but it's not one where that would identify HIV or AIDS. If concern is
about sort of stigmatizing, that is something that we certainly want to
avoid.

We actually looking at the possibility -- and I speak on somewhat
tentative terms -- of seeing if we can maybe do away with the notation
altogether, and communicate that information from the consulate, the
consul offices, who issue the visa through the electronic database.
There is something called the consular database, through which our CDP
officers have access and into which the information can be entered. I
say tentative because there are technical issues involved that sort of
depend on interoperability of two government databases, and how that
information can be communicated. But really, our hope is that we
eventually can move to this, and maybe even at the time the rule's
implemented, to a system where that information will be communicated
electronically. So then, if indeed it seems easier, we will do away with
the notation in the passport, and just communicate electronically.

I mean, speaking in general, the State Department slowly has been moving
towards a more electronic system which engenders a lot of opposition,
not just there but also elsewhere from people who are used more to a
kind of old-fashioned system of flipping through a passport and seeing
what the information is there. But we're slowly beginning to rely on the
fact that there is more information, and more specific information, we
can communicate more effectively through the electronic means.

And in terms of the people who don't require visas, that is true. If you
come from what is called a visa-waiver country -- most of Western
Europe, United Kingdom, France, others, also I believe Australia and a
few other Asian countries -- I think only about six countries that not
within Western Europe -- and also Canada. Canada is not a visa-waiver
country, but they also don't require visa. Normally, you don't require a
visa if you come from that country to the U.S. for a short visit; the
problem is that once you have a ground of inadmissibility under the
immigration law such as the HIV infection, then you're not admissible to
the U.S. and you have to get a waiver from that inadmissibility.

And that is why even people who apply, say, from the United Kingdom and
who have HIV do have to go to the U.S. consulate there, fill out a visa
application, specify that they have this condition which by law makes
them inadmissible, and get the waiver. So in fact, the consulate where
we process the greatest majority of those waivers is indeed our
consulate in London. And through the outreach that the consulate has
conducted where there is groups -- for instance, there is groups in
London, United Kingdom, it really informed the public that if you do
have that condition, even though you're within the visa-waiver country,
you do have to go and actually get a waiver from that inadmissibility.

DR. MALEBRANCHE: Thanks for coming back, Igor, to bring up this topic.

I wanted to ask because I heard about the part of the waiver wouldn't be
included for people who showed evidence of some kind of communicable
disease or opportunistic infection. Was that part of it that I heard?
Like, the waiver wouldn't be offered to those folks that seemed like
they were suffering from something. Did I mishear that?

MR. TIMOFEYEV: Yeah, the way that we're designing this -- and this was
present from the beginning; this was, as I mentioned, was present in
Secretary Rice's request for it -- is that the waiver not encompass
people who have the active contagions and sort of symptoms of the
disease. So if what your question is, you know, what kind of symptom
will disqualify someone --

DR. MALEBRANCHE: Yeah, well, my question is about like, the only
opportunistic -- and it's not even an opportunistic infection per se,
would be something like active tuberculosis, that would create an
immediate threat, Things like microbacteria, thrush, you know, any kind
of other Cryptococcus, is not going to present an immediate threat to
somebody else if they're suffering from that unless their immune system
is compromised as well. So again, it kind of gets back to Carl's point
about the law kind of being a little bit interesting, and maybe a
misunderstanding of what is exactly communicable unless somebody's
having direct sexual contact with somebody.

So I'm kind of wondering where we're going with this, with regards to
all that because the waiver is good, I congratulate you guys on moving
forward with that, but the law seems to me to be inherently flawed,
unless someone else can add something more to that, another communicable
disease that would present a threat on a plane or immediately to other
people, what that would be.

MR. TIMOFEYEV: I mean, I think there were two parts to your question,
and I'll defer to this group on the more medical, you know, medical
understanding. But it is right that the law quite strictly specifies HIV
infections, in that sense to the extent that HIV infection is different
in terms of, you know, its communicable nature and the public health
danger that it presents. I mean, again, I defer to you, but we're
constrained by the law in that we have to address that.

And I think when the law speaks about the communicability, it's not
speaking just in terms of travel on the plane or travel on the train
across the border; it also speaks about the communicable nature while
the individual is in the United States. So that may be different from
tuberculosis.

DR. MALEBRANCHE: But you could make that argument with an assumption
about Hepatitis B, Hepatitis C, anything that's sexually transmittable.
So that's -- you understand where I'm getting at with this?

MR. TIMOFEYEV: I think so. What I guess my response is, you know, there
is --

MS. MCGEEIN: It's the law. If we want to change the law, that's a
different issue. But it's --

DR. MALEBRANCHE: Yeah, that's probably what I'm getting at, is that what
can we do to change that law because it's an archaic law.

MS. MCGEEIN: I don't think we necessarily disagree with you, but it is
the law.

MR. TIMOFEYEV: As I said before, you probably remember, as I said when I
spoke to the domestic subcommittee, as a member of the executive branch
it is my duty to execute the law. So I kind of defer to others on the
question of whether or not it should be changed and how.

But I just want to address, briefly, maybe what is also part of your
question. To the extent that someone who has HIV comes to a consulate,
and then the question is well, does he exhibit active symptoms. And some
things -- again, this is something where we would have to develop based
on the medical opinion, you know, sort of guidelines and instructions,
education for the consul officers, again, capitalizing on really what is
being done now.

But if someone has a rash, or he has a cold, and these are really not
symptoms that actually indicative of a high, you know, communicability,
I don't think that that individual will be precluded from receiving the
waiver. So it really will have to be -- there will have to be a
discretionary process that the consul officers determine to see whether
or not such an individual can get in.

MR. GILMARTIN: Well, thank you very much.

MR. TIMOFEYEV: Thank you.

(Applause.)

MS. MCGEEIN: I just want to make a point that Igor made at the beginning
of his presentation. I'm going to make it again more strongly. When this
MPRM (?) comes out, that he is working 24 hours a day, and has been for
months, on, it is going to come out with a very defined but relatively
short comment period. So I will send an email out to all of the loyal
PACHA fellows that indeed, it is in the federal register and the comment
period is X, whatever it turns out to be because you know, there really
is a desire to meet the needs of the community.

MR. GILMARTIN: (Off mike) -- brings many years of public service, both
inside and outside of government, to the public health arena. And from
June of 1995 until July 31^st^, 2001, she served as a member of this
advisory council on HIV/AIDS as an appointee of the 42^nd^ president of
the United States, President Clinton. So in 2003, she was appointed by
Mayor Bloomberg to serve on the New York City Commission on HIV/AIDS;
and now in 2007, she was nominated by Governor Eliot Spitzer to serve as
a member of the New York State Public Health Council.

So welcome, Ms. Fraser-Howze. Welcome, it's a pleasure to have you with
us.

DEBRA FRASER-HOWZE: Thank you very much. Good morning, everyone.

I am very pleased to be here. I want to thank, first, Dr. Beny Primm,
who's the vice-chair of my board at the National Black Leadership
Commission on AIDS, for giving me an opportunity to speak to you, and
I'm going to say hi; and thank you, David, who also participated in the
national conclave.

There was something that is not in my bio, and I don't know why, and I
have to go back and ask my office why: While I did serve on the
commission under President Clinton, I was also asked to be reappointed,
and served on this commission under President Bush for the first year,
and probably because at that time we did have subcommittees, and I was
chair of the subcommittee that focused on communities of color. So there
was a need to do some transitional work, specifically because of the
staggering numbers in our communities. So I'm glad -- this is déjà vu.
I'm home; I'm very, very happy to be with you today.

You know a little bit about us, when we were founded. We're 20 years
old. That makes us the oldest and largest black AIDS organization
working on policy and community development in the country. Our focus is
a model that would include, starting first with the clergy -- and it's a
20-year-old model so it's nothing new, starting with the clergy and then
putting around them a number of people in the community that make things
work, that will give them the information they need to move forward. And
that includes elected officials, social policy experts, medical business
and media leaders.

These groups are now called affiliates, and we have them in nine cities
across the country, and we're working on eight additional cities. They
do undertake public policy on the local level. Their focus is to develop
new resources for communities of color. And they also look at very
specific policies, when policies seem to be out of whack.

And I'm going to give you one short example of Ronald Johnson, who I see
is here, who's been a founding member of my board, he's in the audience.
Years ago in 1988, we discovered that there was a law in New York City,
who has a division of AIDS, that said that when a person is sick with
AIDS, they will send out a homecare attendant. The homecare attendant is
there to care for the individual who is ill.

We had homecare attendants actually going out, caring for the individual
who was ill, but the disease had changed. The individual who was ill was
no longer a gay, white male individual; it was now a black woman or a
Latino woman with three and four children. So these home attendants,
following their rules, would go out and attend to the person who was
sick, which was the mother. They were not allowed to fix breakfast,
dinner, or lunch for the children, care for the children in any way, but
to focus on the individual who was sick. That was the law; that the
regulation for that particular program.

And in understanding that the policy had not changed, and nobody
maliciously didn't change it; the epidemic changed. This epidemic is
evolving and expanding on a daily basis. The decision was then for the
ministers to go in, look at that policy, and go back to government and
do all they could to change that policy. We've been doing policy like
that around all kinds of issues including needle exchange, which is
probably the worst issue to deal with in the African-American community
because they were absolutely against needle exchange. We've been dealing
with issues like that for the entire 20 years of this epidemic.

I'm giving you some of that history because I want you to understand
that this national conclave on HIV/AIDS policy for black clergy did not
come out of air; it comes from a 20-year foundation of the clergy doing
just this type of work. And in order to begin with this, we had to ask
ourselves two questions, or base this on two premises. And one was, what
would you do if you had no fear? Around 20 years in the epidemic, clergy
have been around this epidemic for 20 years. You've been doing some
things well, some things not so well. BLCA is a policy organization, so
we're not doing program, and you know, we're not doing very specific
programmatic pieces; we do mostly policy and developing new resources,
and bringing people together to do that on local levels, and then on a
national level. But what would you do if you had no fear? You the
clergy, you the people that we go to, to both save our souls and save
everything else -- so, you know, the leaders and the leading institution
in the African-American community.

The other thing was that we started with the premise that we are not
bankrupt. We've seen these affiliates work all over the country. We've
seen new resources; we've seen the clergy, you know, join with local
elected officials, join with local health departments particularly, and
work with the health departments and the elected officials to do major
programs like testing, get policies out, resources in the community so
that they could go out and promote that everybody in the community
should be tested. So we knew that this worked.

I'm going to attempt to go through this with you because I have to
confess to you that my grandson did this PowerPoint for me last night
because I'm technically challenged. (Laughter.) So I explained to him
that Uncle Beny got me speaking at this President's Advisory Council on
AIDS, I need some help; and Michael got up and went with it. So I'm not
even sure I know how to turn on the --

MR. : (Off mike.)

MS. FRASER-HOWZE: Okay. Turn the page. Oh, okay. Thank you so much.

So when we brought the clergy together -- there's something that you
should know because this will not be on the slides unless he did it and
didn't tell me. We asked the clergy for a very specific statement: How
would you open this up? Let me take you back a little bit before that.

Dr. Calvin O. Butts III -- Reverend Doctor Calvin O. Butts III, is
chairman of our board of directors. He reached out to Bishop T.D. Jakes.
I don't think that people really know that in our community, there are
different factions of ministry; that all black clergy are not the same,
absolutely not. We have a very conservative wing of black clergy groups,
we have a more liberal wing; we have what we call activist preachers,
the progressive preachers; we have an unbelievable mosaic of black
clergy in our community. And to make the mistake to think that they're
all the same is deadly. You can walk in there and speak about one issue
and get absolutely cut off, and they'll never invite you back again. So
you have to be very, very careful. It pays to ask somebody who knows
who's who in the room.

So you should know that the pairing of these clergy, the traditional
activist clergy and the mega-church clergy leader, was different. So
they had some things that had to be worked through just to sit down
together, theological perspective. But when they did the heavens opened
up and it showed us, again, that we are not a bankrupt community.

When they agreed to work together and call in ministers from all over
the country, we started with an invitation of 50; we ended up with 168
ministers and medical leaders, with the likes of Creflo Dollar and, you
know, you've got T.D. Jakes, you've got Creflo Dollar, you've got Fred
Price's children, you've got Eddie Long; you have a number of ministers
that you probably know about because if you look at The Word Network, or
glance through it every now and then, they're all over The Word Network.

We're talking about ministers that, you know -- and other end the Calvin
Buttses of the world that have the traditional church, the mainstays,
the Adam Powell churches, that write the Martin Luther King kind of
history in our community; that have, you know, standing-room-only
attendees in their church on Saturdays, and do other work in the
community as activist clergy. And then you're talking about the
mega-churches, somebody like a T.D. Jakes, who has 16,500 parishioners
coming into him every Sunday morning, and that's just one of the
churches that was there.

We're talking about a good 3.5 million African-Americans that we're
talking to by just talking to them in the room, and we're not even
including their television ministries. So we have to really understand
the power that these folks bring to -- 168 people brought to the table.
In addition to that, we were joined by the National Medical Association.
The National Medical Association, in August of this year, declared that
HIV/AIDS was a state of public health emergency in African-American
communities. They released this statement at their convention, and they
released a policy document that looked at very specific areas of
concern, and solutions to those areas of concern.

They officially, in August, turned that document over to the National
Black Leadership Commission on AIDS, who was at that time putting
together this conclave of black clergy, and asked that BLCA take this to
the black clergy, and have the black clergy ratify what 30,000
African-American physicians said needed to happen on HIV/AIDS. We were
then later joined by the National Conference of Black Mayors, the
National Caucus of Black State Legislators -- we were then joined by a
number of individuals, but the two core groups in this were the clergy
and the medical providers.

What would you do if you had no fear? In the spirit of our historic role
of advancing prophetic social justice ministry -- this is the clergy --
black clergy is stepping forward to play a stronger leadership role in
advocating for theologically sound HIV/AIDS public policy. Working with
the National Black Leadership Commission on AIDS, we have determined to
live up to the biblical mandate that calls us to be the light of the
world.

With faithfulness to this calling, we must compassionately embrace those
who are infected with and affected by HIV/AIDS. Through life-affirming
ministry, we are committed to caring for the physical, mental and
spiritual needs of all people in our communities who lives are being
devastated by this insidious disease. Just as African-American clergy
fervently came together 50 years ago to fight for civil rights, we are
banning together today to bring an end to HIV/AIDS and its potential to
obliterate our community; to combat this plague which is claiming five
to 7,000 lives per day worldwide and is destroying black families and
killing black men and women at a disproportionate rate of genocidal
magnitude. Then, they go on to their very specific recommendations.

What you should know before I go over some of those recommendations is
this: They came together to ratify the policies of the National Medical
Association, so this is not something that -- they as clergy know that
they're not medical providers. They left there with a new law; they
created and wrote a new law. They invited every political person that
they felt they needed, from Representative Charlie Rangel and
Representative Townes on the health committee, and James Clyburg, to
talk to them about educating other elected officials about what needed
to be done.

And then this sharing of information -- okay, do I do down? Okay.

One of the things that they agreed that they would definitely -- I'm
sorry, did I mess something up? My grandson told me, don't touch
anything -- (laughter) -- just ask somebody to push the buttons,
Grandma. Okay, yes. Okay, thank you. He told me somebody would help me
-- (laughter) -- he said, you're going to the President's Advisory
Council, for god's sakes, somebody will help you. So good, this is good.
(Laughter.)

They promised to aggressively seek that every person in their sphere of
influence, and I think that I discussed with you what their numbers
looked like, got tested for HIV. And that is a critical piece of what we
need to do to end this epidemic in our community. They're going to
promote HIV awareness and they're going to make sure their congregations
are equipped to address the issues factually.

It's not just, you know, we want to talk to you, and everybody should
sit around and sort of hold hands, and sort of worship on getting this
thing corrected. We want you to know how many African-Americans are
infected, how the disease is transmitted, how you protect yourself from
this disease. And, yes, that's going to involve some tricky
conversations in the black church; they're going to have to talk about
condoms in the church, they're going to have to talk about a lot of
things. They're ready to do that, and they've been doing it for a while.
They're ready to move on.

They're also ready not to let other religious leaders in other
communities make a decision about what they know is affecting their
community more than any other community. And they're joining, along with
their partners, which are the 30,000 black medical doctors in the
country, make them more affirmed that they are taking the right stance.
This is something that this administration has focused on, and they're
right there with it, the ABC model. But of course, they've added D:
Don't engage in risky behavior.

Of course, there was a lot of discussion at the meeting about this. A
lot of discussion to sort of move folks, not just with the ABCD model,
we have D but we actually went to E, F, G -- (chuckles) -- and had both
long periods of discussion. But they were very clear that it would be
the ABC model, they agreed with it. There're nothing wrong with telling
people to abstain, you know, especially young people. They don't see
anything wrong with it, and I don't see anything wrong with it. And in a
sexually transmitted disease, it is absolutely ridiculous to think that
this is not something that you do. In our community we embrace that,
particularly for our young people. In fact, I'm a black woman over 50;
I'm in one of the highest new-rising rates of new infections in the
country and I could tell you that I have abstained, whether I want to or
not. (Laughter.)

So that whole discussion about sexual activity is revved a little more
than it actually is going on in the community. They found that also,
that in our community, we're not more sexually active than any other
community; in fact, we're probably a little more conservative. So those
are the things that they did agree to. Next slide.

They are calling on the president and congress to declare this a public
health emergency. Now, this is not the first time this was asked for.
This was asked for in 1998, I believe it was, when I was on this
presidential council, and we went to then-President Clinton and asked
him to declare HIV/AIDS a state of public health emergency. He would not
do it; he declared that HIV/AIDS was a severe and ongoing crisis
requiring emergency federal intervention, which allowed a group of folks
to work with some legislators and have the minority HIV/AIDS initiative
created that gave some relief to communities.

Right now, we're talking about testing all of these people of color in
the community, and we haven't fixed anything. So they're getting tested
and going into a system that's broken, and it's going to be a lot of
them in the system that's broken. And the concern is now, we need to
stop for a minute, understand the emergency proportions that we're in:
one in every 50 black males and one in every 160 black women estimated
to be HIV positive; that's a catastrophe in the United States of
America. So we need to stop right now, look at this as a public health
emergency, and then begin to actually respond to it for the emergency
that it is.

A national AIDS plan, I'm sure that you heard about that, the fact that
we don't have one for this country. And hopefully it's this body that
moves us closer to having a national AIDS plan. But we certainly need
one, and we need one that is succinct. We talked about what the
components of an AIDS plan would be, and that is how they got into the
actual writing of a piece of legislation. They said, you know, it is not
unusual, you know, we had Floyd Flake there who was a former Congressman
Floyd Flake, Reverend Floyd Flake, head of Allen A.M.E. Church, and we
had passed the buck there who is the head of Abyssinian Development
Corporation, the home church of Adam Clayton Powell, who probably wrote
more laws -- who did write more laws, before and since -- you know, than
any other congressman that was focused on the uplifting, particularly of
people in communities of color.

So they looked at what that meant. Now, these ministers are ministers of
great means. They have not little flocks but huge ones, and made some
decisions based on their knowledge, and as you can see, with the act,
including measurable goals, timetables, specific objectives for their
national AIDS plan, these are not a group of ministers who are
unknowledgeable about the system. Next slide.

They want to look at the historical treatment of African Americans --
that is going to be one of the pieces of the act, and -- look at how
that plays into making priorities in how we move forward. And let me
just say this to you, that one of the biggest problems that I have seen
in the 20 years that I have been doing this work, in responding to
African-American communities, is our absolute mistrust of the public
health system, for good reason, good historical reason. Again, we're not
bankrupted as a community, and we're also not ignorant as a community.

Part of our tradition in our community is an oral tradition, brought on
because we had no other choice. But that oral tradition is so strong and
those discussions and the stories, and those realities of those stories
based on fact, like the Tuskegee experiment, have not gone away. And we
as public health officials, should not sort of roll our eyes in the air
every time we hear it because it has a true and real impact on saving
the lives of these African Americans who are in need.

They also talked about endorsing some very specific legislation that is
already out there like Maxine Waters's bill that talks about prisons and
testing and discharge. It is something so basic, you know. I don't need
to go into it with you about what is going on in the prisons and the
guys are being discharged and they're coming home and having sex with
their wives, their girlfriends, and infecting them because they are
having sex in prison -- next slide -- and there is not any real follow
up. Next slide.

So they did call -- they are calling on -- and I'm not here to ask you
this specifically, but we're asking you to look at this and understand
their feeling of their need to call on -- you should also understand
that this is a very bipartisan group, full of both Democrats and
Republicans. These clergy are not in one camp. Next slide.

They believed that -- I think that we are repeating -- I think that we
are going over the same slides once again. But you can -- if you can
keep going and let me see if they are -- go ahead -- all right -- yeah,
okay. I think that -- I think that Michael did a very good job.
(Laughter.) Thank you, Michael. Thank you for Grandma. I give him an
applause. Thank you very much.

MR. GILMARTIN: Thank you also.

(Applause.)

We have time for question or two. Does anyone have a comment?

REVEREND HERBERT LUSK II: Yeah, I -- I want to get her attention.

MS. FRASER HOWZE: Sure.

REV. LUSK: Yeah, I just want to commend you on what you're doing. I'm
very excited about what is taking place. I'm part of that mosaic that
you talked about. I'm Reverend Dr. Lusk.

MS. FRASER HOWZE: Hi, Reverend Lusk.

REV. LUSK: All right, one of the things that I noticed as I looked at
some of the information -- and Dr. Butts is someone who I'm very
familiar with. T.D. Jakes is someone I'm very familiar with. The TD
evangelists, the social entrepreneur faith-based leader -- Dr. Butts is.
I just think -- and you may already have done this, but what I did not
see is I did not see leaders of major denominations. I didn't see Blake
(?), Church of God and Christ. I didn't see Bill Shaw, who was my
president.

MS. FRASER HOWZE: Bill Shaw was absolutely there from the beginning of
the meeting to the end of the meeting, as was the president of the
Progressive Baptist, as was -- I mean, we have -- we ensured that we
invited Thurston. We invited the leaders of all of the major
denominations and they were all there except Blake who had a scheduling
conflict. But he is absolutely on board.

REV. LUSK: Well, let me just embellish for this council.

MS. FRASER HOWZE: Yes.

REV. LUSK: These individuals, these leaders of denominations are very
powerful men. And even more powerful than the people that you'll see on
TV. You're talking about -- you're talking about Dr. Shaw who has --

MS. FRASER HOWZE: -- 8.5 million.

REV. LUSK: About 9 million. We say nine. We are bragging 9 million. We
probably have about 7 million -- (laughter) -- about 9 million
individuals that they can talk to on a given Sunday morning is the
message is accurately shared. The second thing would be Blake, somewhere
around 6 million.

So what you're doing is just fantastic. I just wanted to commend you on
it. We just also encourage you to continue to -- and even as you present
this, to mention these guys and to get these guys out in the front. They
need to be in the front of this.

MS. FRASER HOWZE: Yes.

REV. LUSK: Bill Shaw needs to be on the front of this, and Blake needs
to be on the front of this, and Thurston needs to be on the front of
this. So keep doing your work. God bless you.

MS. FRASER HOWZE: Thank you. Thank you, Reverend. God bless.

DR. GREEN: Yeah, I also want to greatly commend you for the work you're
doing. I work at the Harvard School of Public Health, and I have been
very involved in African AIDS and some Caribbean AIDS, and one of the
things I have come to do is help mobilize and show the impact of
faith-based organizations in Africa on the terrible epidemics there.

A couple of questions: What can somebody like I do to help from the
outside -- what can the -- what could PACHA do? And lastly, I wonder if
you're linked up with the -- I'm not sure of the exact name, but the
National Association of Black Pastors' Wives.

MS. FRASER HOWZE: Yes, Vivian Berryhill.

DR. GREEN: Yes, Vivian Berryhill. She is a friend of mine. We went on a
trip to Africa --

MS. FRASER HOWZE: She was on the planning committee of the whole event.

DR. GREEN: Great, great. That answers that. But then -- so what can
PACHA do and what can a non-black pastor like myself do?

MS. FRASER HOWZE: Yes, we are actually right now pulling together an
advisory council to this endeavor. I found that we needed an advisory
council. Many of my Republican friends came to me. Some white Mormon
from Utah -- (chuckles) -- came to me and said how do I get involved in
giving some support to this and helping -- helping with this. And we
came up with the idea of having an advisory council that will work with
us, that will work with the ministers to move this. Some of the other
mega preachers as well have asked as well how to get involved.

How can PACHA be involved? The best of all worlds would be that PACHA
would endorse the conclave. I'm not asking for PACHA to endorse a
specific piece of legislation because I used to be a member of PACHA. I
know you can't do that. But to endorse the concept of the conclave, the
fact that these ministers are on their own coming together, representing
millions and millions of African Americans, and endorse the concept of
the moving forward. That would be something that we would very much
appreciate that we can say that the president's advisory council -- and
we would help to work on the wording of that, but that would be very
helpful to us.

MR. GILMARTIN: So I think that is a good summary statement to conclude
this session. I know that many of you would like to be engaged in the
conversation.

MS. FRASER HOWZE: I will be here.

MR. GILMARTIN: But we have lots -- thank you, everybody, for helping
arrange this and orchestrate this, and thank you, Mrs. Fraser Howze for
your presentation and for joining us for that.

(Applause.)

(Break.)

MS. MCGEEIN: PACHA members, if you'll please take your seats.

MR. GILMARTIN: I expect a few members are getting their last-minute
chance at the coffee -- (laughter) -- and will be with us in a second.
So we'll just give them a minute or two.

So the next item on our agenda is a listening session. And being new to
the group, but having heard at the first meeting that I attended that
one of the things that we wanted to have the opportunity to do was
express viewpoints sort of in a more discussion or more free-flowing
framework, rather than the kind of structures of listening to a series
of presentations. So it's in that spirit that we have arranged for Anna
Mitchell to join us as part of the listening session. And Anna is an
associate director of the Domestic Policy Council, where she works on
healthcare policy and has a particular focus on domestic and
international HIV/AIDS issues.

And the Domestic Policy Council coordinates the domestic policy-making
process in the White House. And it also offers policy advice to the
president. It also works to ensure that domestic policy initiatives are
coordinated and are consistent throughout the federal agencies. I'm sure
not an easy job necessarily to do.

So Anna's role with us today basically is to listen to us. And it's an
opportunity for us to express viewpoints, opinions -- and so, we're not
in a Q&A-type mode; it's more to gather and take information back. And I
think, given her position, we can be very effective in drawing together
our viewpoints and so on in passing them along. And of course that
provides us an opportunity downstream to have a continuing contact point
as well, as is needed. So with that, I'll just open the floor. And I'd
like to run this in a discussion mode and not be too formal about
calling on people and lining people up for responses. But just to
initiate a conversation --

ANNA MITCHELL: Actually, Raymond, I just wanted to --

MR. GILMARTIN: Sure.

MS. MITCHELL: Thank you for that warm introduction and express my
gratitude for all of you that are here today and serve the
administration and serve the American people working on these issues.
It's good to see some friendly faces, both here at the table and also
out kind of in the audience. When Marty asked if I would come do a
listening session, I jumped at the opportunity because we haven't had a
chance to do this yet. And I'm very much eager to hear what you want to
make sure we're aware of, what we're doing well, what we're not doing
well, what we could do better, and really use this as a starting point
moving forward.

MR. GILMARTIN: Okay, excellent, good. So, begin.

DR. YOGEV: There are so many issues I don't know where to start.
(Laughter.) It goes without saying that the president should be really
congratulated on what PEPFAR is all about. It's an unbelievable change.
And I have to admit in public I was not in favor of this president until
he did that. And now, I think that's his legacy. My issue is while we're
doing so well internationally, somehow we forgot the domestic agenda.
And it goes in different levels.

I'm involved in research through the NIH and it's almost disheartening
to see how much of the funding of the NIH, which was not increases, you
know. And it's a problem by itself. It's diverted in this specific area
to the international. And domestically, it become to the point that we
are going to lose the ability to do an appropriate research. And
especially, I'm a pediatrician, so especially in pediatrics, for some
bizarre reason, there is a notion that pediatric AIDS in the United
States is over.

While it's true that a number of new cases is really cutting down nicely
and the recent CDC recommendation report will change it even more, we
still have to deal with somewhere between 15 and 20,000 kids who are
growing, and all they expertise of what to do with patients who have
multiple exposure to those drug and resistant and new issues with
discovering they're getting more and more diseases that we didn't expect
they will have because it become a chronic disease. And funding to that
is cut below the minimum.

So I would appreciate if somebody will look into the whole issue of how
we spend the money for research on those issues, domestically and
internationally. And the same one -- I'm sure that some of my colleagues
will join me in much better English in the forum -- is what we are doing
with the clinical level? We are always limited on funding and every
other day there is a cut because there's less in the Ryan White; there's
less in something else.

So our patients are getting to the point -- our ability to several
points, get to the point that we are studying -- (inaudible) -- less and
less. And I'll give you one small example. Because we're doing so well
-- and none of us -- 10 years ago, if you had told me that I have a kid
who's going to be adolescent and go to university, I would laugh in your
face. Well, now the average age, age of infected kid in the system that
follows them, is around 16 years.

When they reach to 18, in my state, for example, Illinois, and I don't
know if it's in other states. Medicaid is stopped unless you have a
handicap. So now, we spend all of our good time and hours and effort to
avoid them, avoid the patient to get AIDS because they have nothing. At
then, at the age of 18, we cannot do almost anything with them. So we're
getting a growing population of adolescent who are a little bit
handicapped because unfortunately, this disease is affecting their
ability to such an extent that they are not as well-prepared to go into
the world. They have no work, cannot get insurance because they already
preexisting condition, even if they go there. And yet, there is no
governmental agency to help us to take care of them.

MR. GILMARTIN: Okay, thank you. Ted?

MR. GREEN: Yeah, I'd like to sort of the idea that Ram expressed. It's
something we've been discussing in PACHA over quite a period of time,
which is the special risks of African Americans, Hispanics, and we
should add, Native Americans, and this began to coalesce yesterday into
something specific when Dr. Primm started to draft language for
proposing something like a domestic PEPFAR with the word emergency in
it: legislation, funding, policy to address on an emergency basis the
spread of HIV in minority communities. So it's sort of a domestic PEPFAR
and maybe Dr. Primm would like to say more about that.

DR. PRIMM: I certainly would. I think that's what is necessary in this
country to show that we are as serious about this disease entity and
territories as we are in the rest of the world. I think when we look at
places where money is being spent, in North Korea and everywhere else,
that we are under great criticisms in the African-American community
about, well, what's happening here? What's happening here in the United
States?

There is an example of what could happen. The prison system, for
example, in California, has been sort of demanded to be taken over by
federal jurisdiction because it was so bad. I think this ought to happen
in Puerto Rico where things are so terribly in times of people getting
diagnosed, getting tested, getting treatment to people and not being
able to spend their moneys adequately to take care of the people. The
federal government ought to step in and do something about that problem,
with people dying like they are. Same thing in the African-American
community.

I think a domestic PEPFAR would be the ideal thing to do. I think we
need, as recommended by the clergy that just met, I think you might have
been in the room while Debbie was talking. We need a plan. We don't have
a plan. And if we don't get that plan, this administration is under I
think great scrutiny and criticism because of the lack of a plan. And
so, I feel very strongly that the message should be taken back to the
Domestic Policy Council and certainly to the president that that is a
great feeling out here and great sensitivity about this issue.

MR. GILMARTIN: Barbara?

MS. WISE: I speak to young people. I've been speaking to them about the
last four years. And I've met several -- I'm HIV positive -- and I've
met several young people who are HIV positive and have kept in contact
with many. And as I'm watching them grow and I'm so excited how healthy
they've been and how people have worked so hard to help them be that
way. But it is -- I'm watching them hit the college age, 18, and
starting to hit college. And what do they do? You know, how do they get
health insurance? And they're already trying to navigate how do they
discuss this as they go into college to their roommates in the dorms.

And you know, I mean there's a lot of issues already and I just want to
give them support. And if we've already worked so hard to help them stay
healthy, can we figure out a way just to help continue that for them and
navigate this piece? I think that would really be something that we
could do. Thanks.

MR. GILMARTIN: Thank you, Barbara. Reverend Lusk?

REV. LUSK: I don't want to take the discussion away from the young
people because it's very important. What you've said is extremely
important. But I want to just piggyback on what Beny had to say and also
what Ed had to say regarding the African-American community with the
numbers the way they are. I mean, I don't know at this point in the
administration what can happen, but I think it would be important to our
country and also important to the legacy of our president.

The group that met in New York -- significantly to start somewhere would
be just meeting with the group. I mean, just his presence, you've got
the bully pulpit. And we use it every Sunday morning, we reverend
doctors do, to get things across and to bring attention on things that
are important. And some type of visit, some type of gathering, some type
of rally of some sort would be a beginning.

MR. SCHMID: I'd like to echo and support everyone's call for a national
AIDS strategy and a heightened awareness and response to the domestic
epidemic. But in addition, the president and the administration can do
something now. You know, it would be nice if we -- if he would announce
a strategy, but absent that, you know, we do have the power of the
budget. And he could propose annually, and he still has to deal with
this year's labor HHS bill and I know you're working on next year's as
well.

So I would just make a pitch for the CDC. You know, we have, they're the
center that's dealing with prevention activities. And their budget has
not gotten that much of an increase, though they did get an increase
this past year, the HIV component. But it's just, you know, we need more
money for those problems because the need is so there, is so great.
Especially, you know, when we hear that the incidence rate may be higher
than what we currently have.

And then the same -- you know, we've been talking in the last couple of
days about testing, increased testing, which is something that we have
to do since there's so many people undiagnosed. But then, once they find
out that they're positive, we need to make sure that there's care and
treatment for them. And, yes, some of them will have private insurance.
Others will have Medicaid, Medicare. But then, you know, many will fall
to the Ryan White CARE Act. So just a pitch that we need increases there
as well, with people living longer, you know, they're going to need the
care and treatment. And I congratulate the administration for proposing
some increases and let's hope that they come to fruition this year and
for next year as well.

MR. GILMARTIN: Thank you.

MS. FLUCAS: Good morning to you. I would like to see more of the help
with Ms. Barbara. We see a lot of issues going on with our young people.
If we don't help talk about the language, about the condom use, and
about the body parts -- because I looked at a textbook that my 13 year
old has and not a lot of information about HIV and AIDS are put into the
textbooks. You see limited information about it. But if we're going to
try to talk to them about abstaining from sex, we have to first get them
comfortable with their bodies.

Because by the time we get to 18, we don't want to talk about sex -- oh,
shh, behind us. But I think that is a very important issue that we have
to first get them introduced to the language to talk about sex and HIV
and AIDS in order to stop the spread. Because becoming infected at 19,
there were issues that went along from my teenage years that would have
probably changed some of the behaviors if I would have got the
information at an early age.

MR. MARTIN: Excuse me, thank you for joining us today. It's great that
we have the opportunity to talk to you. And I think throughout the
government, the federal government, there are a lot of really good
things going on with what the CDC and the NIH have done for a lot of
years. The concern though is that -- we all feel it and it relates to
what Beny's talking about, that need for more leadership.

And with the administration having about a year to go, we all have the
concern that there may not be the urgency. But in fact -- and it's kind
of a mystery to me. It would seem to me that within this year, there's
an opportunity to set a stronger path. We have an epidemic and some
minority communities, especially the African Americans, that's gotten
out of control. And it's clear that that's happened and that with the
power of the federal government, we'd like to see a much stronger
response to that.

And maybe on your Domestic Policy Council having, bringing in some more
people that have a lot of experience addressing these types of issues to
help rally the various parts of the government to more effectively deal
with these programs, whether it's to start to build a national plan or
to better leverage that the CDC is doing to make testing more universal
and part of routine medical care.

But what we'd like to really see, all of us, is a considerable effort in
bringing out the leadership of this and the coordination of those
activities. Thank you.

DR. MALEBRANCHE: Thank you, Anna, for coming. I'm going to be stepping
out on a limb here, and I don't think this has been mentioned already.
But we need a national plan. (Laughter, chuckles.)

MS. MITCHELL: I've got that one down.

DR. MALEBRANCHE: Did you get that one? Okay, good. I just wanted to say
that, you know, to kind of -- (chuckles) -- to kind of echo that. I
can't beat that drum enough and I think -- you know, PEPFAR is just an
amazing template and it's just strange that we have done such wonderful
things internationally and we still have kind of sub-pockets

And just listening to Ted talking today about issues of sexual
concurrency and those kind of issues, those issues are documented as
being part of what's driving the epidemic among African Americans today
in the United States. And there's some literature supporting that. So I
think some of the dynamics internationally do translate into what's
going on over here.

In addition, while we're focusing on a national plan, I think -- you
know, a lot of our discussion for the past few PACHA meetings have been
on HIV testing, HIV testing, HIV testing, HIV testing. And I want to
remind the president and everybody that's in the White House that's
dealing with these issues, that we've had adequate testing for syphilis
and gonorrhea for years. And we've had, we've been able to eradicate or
treat, completely knock out syphilis or gonorrhea in an individual who
comes up positive for it. But yet, epidemics still keep coming up.

And in my experience, I'm a clinician who deals with HIV and internal
medicine. I also do a lot of speaking with churches, teenagers, college
students. The one thing that I've noticed is a generational divide. And
I do notice that there's a lot of misinformation. I think when we look
at pockets -- and Reverend Lusk mentioned this -- about focusing on the
youth. And I think the youth, it doesn't always hit home with them.

So while we've been beating this drum about education, another
generation has come up. And because they don't see people around them
being impacted with HIV or living and getting sick or dying from HIV, we
need to keep up a sustained educational plan as well that traverses all
economic strata as well as racial and ethnic groups in the United
States. That has to be part of the plan because if we just keep testing,
it is kind of similar to just telling me to just not have sex because
they don't the education on why or how. With this stuff, they just kind
of are told certain things.

The same things need to be done with seniors. And so, we're looking at
sub-pockets of the epidemic. No one wants to talk about the senior
community. At Grady Hospital in Atlanta, Georgia, we diagnose someone
with HIV who's over 60 at least once every month that I hear of. And so
something is missing in the translation. And it's not necessarily just
that these people aren't getting tested, but I think, while we're
focused on testing and treatment, those are great things, but the other
component has to be sustained education and prevention if we ought to
follow a national plan. So I just want to kind of put that out there as
well.

ROBERT KABEL: I would like to just accentuate what some of what David
said ad John that actually as -- and Carl's discussion of the
appropriations process as the president, the White House, develops the
last budget to be delivered to Congress sometime in January, you might
really -- and falling back on the information that we've had -- that
there's insufficient funding for testing. That a lot of hospitals and
other places are ready for testing, but there just isn't sufficient
funding for it.

And the other aspect of AIDS in America is that the educational funding
has really subsided and it's taken a back seat to treatment, which is
important. But the president could make a great statement in his budget
and then build the campaign around it in his final year, for testing and
education around domestic HIV and AIDS.

MS. WISE: Yeah, I think also that education piece is very important. And
I've been really looking at that closely in terms what education is
being offered to counselors who counsel people for testing or when they
get their test results. And I think we do need to develop a deeper base.
We have a lot of protocols and steps set for, you know, people who are
doing risk reduction. There's been a lot of research, a lot of resources
invested in those approaches. And I think we could also invest a little
bit and look at some resources and actual protocols and steps on more
than just saying no.

You know, if people want to do A or B, what are some other skills that
we can really develop for a person who is choosing those options. And to
start educating young people because there's 53 percent of the young
people that are waiting to have sex. And so, how do we keep those young
people safe and get them education before they get this.

REV. LUSK: I would just like to just add. I guess I'm pretty much saying
the same thing everyone is saying. Other than, this is not only the
right thing to do in terms of putting emphasis on what's going on in the
minority community, but it's also a tremendous opportunity.

And I've been fortunate enough and blessed enough to have had some
personal involvement with our president. You know, he's visited my
church two, three times. I've met with him, had private conversation
with him. And you know, I don't think what I know about the man -- I
know he cares. I mean, I'm not under any illusion about that. He's a
caring person.

And I personally would like for other people in my community to know him
the way I know him. And I think that this issue presents an opportunity
for him, not only to do the right thing, but also to add to whatever
legacy that will remain for him.

MR. GILMARTIN: Just, you know, most of my experiences have been in
African and sort of the international arena. But one of the things that
one does not hear much about in the U.S., and it may be because I had as
much involvement. But the idea of public-private partnerships in
addressing AIDS in other parts of the world has been a very important
element. And that's included from school (?) companies; that's included
faith-based organizations, non-governmental organization.

And the theme that we always were using was the fact that no one in an
institution on its own can deal with this issue, that it really does
require a partnership. And just listening to the presentations this
morning, such as in the suggestions that you made, Reverend Lusk, is
whether or not there is a new opportunity here for partnerships that
perhaps was not available before.

And so, picking up on some of those themes may be, you know, a way
forward here and address these issues in a way that's different than
we've done it before. Because there's a lot of emphasis on what the
government should do. And that's an important role, and the funding is
an important role, but, how to engage communities along with the
government as well. And I think we've seen a good presentation,
demonstration of that this morning. So there may be a big opportunity
here that wasn't available before.

DR. PRIMM: Yes, let me, a good example of what you're just talking about
is what happened at that clergy conclave. Pharma was there; Abbott was
there, Pfizer was there and great, great, support. I mean, and I've been
asked by other people, why weren't we notified? They would have been
there. So the twinning and the tripling and the quadrupling, and all
that kind of thing, is happening out there.

But what we're talking about also here is that if the president said
that, if the president talked to -- had a talked to the people like Herb
is talking about, it makes a great deal of difference from that bully
pulpit. His presence or his recognition, for example, of Mutombo, for
his good work, what he did in Africa, was an incredible kind of thing
for the African-American community. It would be for an announcement of a
plan now to focus on that issue, an announcement of certainly -- you
could call it PEPFAR if you wanted to, whatever you want to call it, but
we've got to do something about this issue in these communities that are
suffering in our country that are not seem to have the attention.

And I know he cares. And I know you care at the White House. And you
know, this is a two-way street, too. I mean, we've been talking to you
and everybody's said something. I want to hear something from you --
(laughter) -- quite frankly, if you could, if you would.

MR. GILMARTIN: Well in fairness to Anna, she's here to listen and so on.
Looks like you're raring to go --

MS. MITCHELL: Well, you guys have given me many important and insightful
points to take back. I appreciate your passion, your work on this
issues, and you're absolutely right; the president cares deeply about
HIV issues and AIDS issues both at home and abroad. And I think he has a
consistent record on that. And it's great to work for somebody who cares
as much as he does because that trickles down from the top. And I have
to commend my colleagues over here HHS because they are also busy at
work on these issues.

And I know a question I often get when I meet with groups is, you know,
what's going on with offices, a national AIDS policy. Why is there no
director? No one is paying attention to these issues. And that couldn't
be further from the truth in the sense that you have dedicated
individuals working on these issues every day on behalf of the
administration, on behalf of Americans in both our domestic efforts, but
also our international efforts.

And while we continue to search for a director to head up that office,
in the meantime those responsibilities are carried out within the
Domestic Policy Council, myself and other colleagues I have there as
well as colleagues over here at HHS. So I know we're very busy. And I
think you've heard from speakers over the past day and had some
discussions about what some of the issues are. I know Igor talked about
the (waiver?) rule we're working and hope to get that published soon for
comment.

And I know that Ambassador Dybul is, I think, next on your docket. And
he's going to talk about PEPFAR reauthorization. But you guys raised
excellent point about our efforts here, domestically and -- Carl's right
that the timing is pretty much on point here as we start to think about
what we're going to tee up in the next budget request that we send to
the Hill. So I just want to reassure everyone, that's one of the reasons
I wanted to come to you, is to show that there is a person over at EEOB
working on these issues. There are quite a few people over there that
spend a lot of time thinking about this and reaching out. And like I
said before, I hope that this can be the beginning of a conversation.
And we can look at some of the ideas that you've put worth and how we
can put them into practice or, you know, use them as a starting point.

MR. GILMARTIN: Okay, very good. Thank you very much. (Applause.)

DR. GREEN: Ambassador Dybul is not here. I want to pick up on a comment
--

And I've been eager to go; I want to clarify that. I bet she's eager to
get engaged in the conversation. (Laughter.)

MS. MITCHELL: And one thing that I would add, too, is that the feedback
and perspectives and expertise and personal perspectives that each of
you lend to this issue are so critical. And when we talk about kind of a
comprehensive effort, there are a lot of different pieces that go to
that. There's a role for the government; there's a role for the private
sector; there's a role for NGOs and faith-based. And all of these pieces
working together is really how you tackle as big as and as complicated
sometimes as HIV/AIDS.

DR. GREEN: I would like to pick up on a comment that Barbara made, which
is that 53 percent -- I think the figure is 53 percent of high school
American teens have not become sexually active yet. It wasn't that way
20 years ago; it was something like 45 percent. It has crept up. And I
mention this because two of the rallying cries for people working in
AIDS for a long time has been, we're all at risk and teenagers are going
to be sexually active; we've got to face it and make sure that they have
condoms.

And I want to state for the record, especially since this is my last
meeting, that if we go by the best survey evidence from Africa, that a
majority of African teenagers who are unmarried are not yet sexually
active. Actually, the measure we -- well, the measure we have is, have
you had sex, sexual intercourse in the past year. In every country in
Africa, a majority of African teenagers have not been sexually active in
the past year. And it's -- like America, like the United States, it's
moved up because of fear of AIDS probably. It ranges from a simple
majority in countries like South Africa to 85, 90 percent or higher in
some very conservative countries in Africa. So I mention this because
our approach has mostly been risk reduction. This administration has
added risk elimination and I second what Barbara was suggesting, which
is that in addition to just the abstinence or the abstinence message, we
need to find programs that help empower teenage -- especially girls to
resist peer pressure and boyfriend pressures to become sexually active
when they don't want to be.

We have actually some good programs developed by UNICEF, developed by
African NGOs of life skills and empowering and focusing on future goals
and ambitions. So I just wanted to say for one last time that we need to
look at both types of target audiences: those at risk -- and anybody
having sexual intercourse with more than one partner is at risk --- and
those not currently at risk. We need to find ways to help them remain
not at risk.

MR. GILMARTIN: Okay. We have a little more time if anyone has another
thought. I think we've hit the major themes and -- (applause).

MS. MITCHELL: Thank you very much.

DR. MAXWELL: I just wanted to make a comment. Ted, and something that
you said, certainly we know without a doubt that concurrent partners is
a major risk. I certainly don't want us to lose focus of, even if it's
your first time, if you're with an infected person, that still puts you
at risk. Many people may practice what we call serial monogamy, which is
not protective, too. So, you know, I don't want us to lose sight of that
--

DR. GREEN: I totally agree. There's two types of risky, multi-partner
sex. And having, changing partners often, even if it's monogamy, it's
serial monogamy and that could be risky, too.

DR. MAXWELL: It's so amazing how young people think they're doing such a
good thing and that they're following all of the rules. And they'll tell
you, I'm just with one person. But just with one person for two weeks?
For six months? For nine months? I mean, they just think they're doing
the greatest thing that they're monogamous.

MR. GILMARTIN: So we are pleased now to have our next speaker with us on
our agenda, Mark Dybul, the ambassador, as you know. Particularly this
group knows, serves as the United States Global AIDS Coordinator, leads
the implementation of President Bush's emergency plan for AIDS relief.

From March to August of 2006, just to give you a bit more background, he
served as acting U.S. Global AIDS Coordinator. And prior to that, he
held the position of deputy U.S. Global AIDS Coordinator and assistant
U.S. Global AIDS Coordinator. So moving up, you've been moving up in the
world. (Laughter.)

But before that, he served on the planning taskforce for the emergency
plan. So you were an architect and then you had a chance to become
engaged and implement it as well, and was a lead for HHS for President
Bush's International Prevention of Mother and Child HIV Initiative. So
Mr. Ambassador, thank you for joining us.

AMBASSADOR MARK R. DYBUL: Thanks, Ray. (Off mike) -- and that
partnership. We have really moved past. And this is part of the
president's overall development agenda. We have moved past donors and
recipients to true partnership, which the only way that we're going to
succeed. And it's actually the only rational approach. There has been
almost this notion and still does exist, I'm afraid, of, oh, we're over
there to help these poor people.

That is not what the president's development agenda is about. That is
not what the American people are about. It really is a partnership of
supporting people on the ground. And that's also the only way it's going
to work, in terms of transformation. It's really a change in how we've
approached the world and I think a fundamental piece of why PEPFAR has
succeeded.

You're all aware of the dollar amounts and how significantly they've
increased. President Bush called for a \$15 billion commitment; we'll
actually exceed that depending on how the '08 budget comes out,
somewhere between \$18 and \$19 billion over five years. That's the
largest international health commitment in history dedicated to a single
disease. It is currently the largest global health program in the world.
So it gives you a sense of the scale and the rapid scale-up.

I do think it's important for us to note, also, that we've increased at
a pace that others aren't following. Right now, we're providing about as
much as the rest of the world combined. And I think we need to recognize
that, going forward, we cannot succeed in this global epidemic unless
more people respond. Also, importantly, this slide shows that we have a
bilateral and multi-lateral component. The Global Fund is a key part of
how we operate. And in fact, we provide about 30 percent of the
resources for the Global Fund. Some people say we should give more or
less. I think the important thing about this slide is that it shows our
percent, relative to bilateral, is not remarkably different than most of
the rest of the world. The reason we look so different is because we
have so much money that is going towards the bilateral program.

There's a misconception about PEPFAR which I don't think most people in
this room have and that is that it's only 15 countries. It's not. It's
120 countries. And you can see in blue where PEPFAR is active. But we
have 15 focus countries shown in red, 12 in sub-Saharan Africa, Guyana,
Haiti, and Vietnam. And I think it's important to note, still these 15
countries have half of the disease in the world. So we are in an area
where we have half of the resources in the world and we're also focused
on where half of the disease is located.

One of the most important things about PEPFAR and the president's vision
for this and for all of development is that it's not just about money.
For too long in development, all we talked about was money and what
money we were contributing to disease. The president said, we're going
to commit a lot of money, but we're going to get results. And those
results were, as you know, the two-seven-and-ten goals, to support
treatment for two million, to support prevention for seven million, and
to support care and treatment for 10 million, including orphans and
vulnerable children.

I did want to point out that -- well, I'll talk about that in a second
actually. I think what I'd like to begin with is prevention. You know,
there have been some pendulum swings lately about, oh, we should just be
doing prevention or we need to move more from treatment. We need to be
very careful about prevention swings. The president got it right and the
Congress got it right. You need to combine prevention, treatment, and
care. You can't have an effective prevention program if you don't have
care and treatment. And you can't have an effective treatment program
and reduce the need for treatment if you don't have effective
prevention.

So the president got it right and Congress got it right when they did
this approach. We're going to go through some results very rapidly so
you can see them. But I want to begin by saying, the reason that we have
so many results is because of the pace at which we've moved money. Over
the first three years of PEPFAR, we are 94 percent obligated and 67
percent outlayed, or what would typically be called expended. I
challenge any governmental or non-governmental, particularly start-up,
to get anywhere in that ballpark. People are generally happy with 30
percent obligation and three percent expenditure in the first three
years of an initiative. So that's why we've seen such rapid pace,
because the money is moving so quickly.

In terms of prevention, prevention has always been the bedrock of the
PEPFAR program. We cannot keep pace and treat ourselves out of this
disease; prevention is key. There are still as many new infections in
the world as there were 10 years ago, just as there are just as many new
infections in the United States as there were 10 years ago. But we have
had great success. And that success is based in a very comprehensive
approach. This pie chart shows how our resources are distributed: about
46 percent, 47 percent go for treatment; about 29 percent go for
prevention, if you include counseling and testing -- and it's a nicely
distributed set of resources. Counseling and testing is about 7.8
percent, PMTCT around 7 percent. Sexual transmission is about 12
percent, of which 7 percent is for A and B and the 5.2 percent for C.

I think everyone should be aware that the United States, since PEPFAR
has begun, the United States government has provided 1.67 billion
condoms. As Peter Piot has said, that's more than all other countries
combined. The important thing is, it's done in the context of a rational
approach, which includes A and B now, which it didn't used to, because
in generalized epidemics, which is where we're working, you need A, B,
and C. And the day -- I came to this as a treatment specialist, not a
prevention specialist.

But as you look at the data, they are just overwhelming. Every place
that's been looked at: Kenya, Zambia, South Africa, Ethiopia, Botswana,
Namibia, Uganda, importantly. Everywhere where we've seen stabilizations
and declines, it's been based fundamentally in A and B, also C, but if
you look at the data, it's actually a little bit more for the A and B
components. So we need to stick with what works.

And we need to do that in reauthorization. In terms of sexual
transmission, well, we went over the data. In addition to the condoms,
we've supplied A, B, C prevention messages to around 61 million people.
Now, we need to step it up a bit and we can talk in the question and
answer about some of the innovative stuff we're going to be doing around
prevention as we move forward.

I just wanted to show you some of the data. Most of you are familiar
with this in terms of the impact of A and B -- A, B, and C. These data
are from Kenya, where they saw 30 percent reduction in HIV over a
five-year period, 30 percent reduction. You can see that the bulk of
that change, in terms of behavior change, was, A, people who reduced or
delayed their sexual debut. Multiple partnerships went down
dramatically, a 50 percent reduction, particularly among men. And at the
same time, we saw some increase in condom use, although not a lot. The
reason for that isn't that condoms don't work; the reason for that is
that for too long, all we did was condoms. So we kind of already hit our
peak. What we're trying to do now is have a more balanced approach. And
that's having a significant impact on the prevalence rates.

If you look in Zimbabwe, an article published in Science magazine, we
saw the exact same thing. And to be honest, this is not the result the
authors thought they would have. And they'll tell you outright. But now
that they've seen that, they are some of the biggest promoters of A, B,
and C. It's from London, actually, where these data were done and
published. And it was clear that reduction in partners and delay in
sexual debut are the greatest, some of the most important indicators. I
was just with Allan Rosenfield up in New York; I think most people know
where Allan comes down on a lot of issues. He told me, they just did a
meta-analysis and it's clear to them that delay of sexual debut is one
of the most important things in terms of reductions in prevalence where
we've seen successes. So I think people are starting to understand the
need for all of these approaches. But we need to stick with them as we
move forward.

There are some areas we need to step up, such as prevention for
positives. This is something we're doing in the United States. We have
to be careful about how we say this because there's no intention and we
cannot stigmatize. But only an HIV positive person is capable of
transmitting the virus to someone who's negative. And so, we've got to
get people into care and treatment who are HIV positive to teach them
effective approaches to avoid HIV/AIDS. And we're really stepping up our
activities there. I think it's important to note, however, that where
we're seeing a lot of HIV transmission, in terms of positive people, are
in discordant couples, couples where one is positive and one is
negative. And that's a very different population. While we have had
great success in increasing condom use among casual partnerships in
Africa and here, we do not have much success among regular partnerships
because it's viewed as a lack of trust. That's true in the United States
and it's true in Africa. I may even have some data on that depending on
where we go.

We're also dealing with cross-generational sex, a very important problem
in virtually every country in sub-Saharan Africa, where older men are
preying on younger girls. And you can see how many more young girls are
infected compared to boys. And that's largely, we believe, largely
because of trans-generational sex. Now, importantly, one of the things
we've trying to do, and I think this is something that we need to
understand as we're talking about this and one of the reasons people are
harping on prevention these days is, you know, we can show treatment
results pretty rapidly because you can show numbers. And you can do it
almost on a monthly basis. What we're talking about in prevention is
changing human behavior. And it's very difficult to change a
25-year-old's behavior; it's much easier to get to people while they're
young.

And so, a lot of our prevention activities are generational, cultural
change. And you can't see those changes in a year, but you can predict
that they'll be successful based on the existing data. And part of that
generational change is going to be how boys and girls interact and how
men and women interact. And one of the things about ABC programs is
we're getting in early and teaching boys to respect girls, and teaching
boys and girls to respect themselves so that they'll delay their sexual
activity.

And that, actually -- we're starting to see tremendous changes on an
anecdotal basis; it's going to take awhile to -- in how boys treat
girls. And we also have a lot of programs targeting this approach,
targeting changing how boys and girls interact, which will reduce sexual
activity. We've got right now, in our last year, about 830 interventions
which somehow relate to gender issues, at a total of \$442 million. We
can skip that one for now.

This is about multiple concurrent partnerships. There are two types of
partnerships we deal with, as I mentioned. One is casual partnerships --
and we're seeing remarkable reductions in frequency of casual
partnerships, particularly among young men. However, there is another
problem in sub-Saharan Africa and that is a cultural issue about
multiple concurrent partnerships, where it's normal for a man to have
multiple partners, not necessarily wives, but multiple partners,
particularly when they live in different areas. And I'm not going to get
into this. But it just shows these networks of interaction between
regular partnerships. And that's one of the things that's going to be
most difficult to change because it's a much deeper part of the culture
than casual partnerships, but something we're going to need to tackle
because, as I mentioned, discordant couples, where one is positive and
one is negative, is becoming one of the most pronounced issues.

I also want to mention, because this is misunderstood, in many cases, in
several countries, there are more women positive than men in multiple
concurrent partnerships or in discordant partnerships. It's not always
the man who's positive and the woman who is negative. This is a very
important slide to us because after 20 years of social marketing, you
see absolutely no change in condom use in regular partnerships. And
again, that's similar here than it would be in Africa.

I think, I just saw something in Ghana, which really brought this home
to me. I visited a great program where we support women in prostitution.
They are almost all using condoms now; they have 90 percent condom use.
But then they showed me some data showing they have 90 percent condom
use, but they say, I have a 20 percent prevalence rate. And that didn't
make sense to me. If 90 percent of them are using condoms all the time,
why are 20 percent infected. And what they told me is, the women in
prostitution will use condoms when they're with their clients, but they
will not use them when they are with their regular partners. And that's
the scope of the problem we're up against.

So we have a lot of programs now trying to identify discordant couple
and then try to get them to use condoms in those regular partnerships
and also be faithful; we don't want them going around spreading it to
others. But it's going to be really hard. And the best success we've had
so far is in Rwanda, going from 13 percent to 15 percent use. But that's
not enough. So we've got to think intelligently. And we're actually
thinking about male circumcision and some other approaches with these
folks.

PMTCT is a very important issue to us and a very important part of where
we are. President Bush had a mother and child initiative before he had
the broader picture, and it's something we're very focused on because
it's something we can avoid. So far, we have reached six million women
through PMTCT programs and have probably averted around 100,000
infections. I think it's important to look at these data that show the
scope of coverage in the focus countries.

There are still countries that have a long way to go. But I think it's
important that five of the fifteen focus countries have actually already
achieved the objective of the mother and child initiative, which is 50
percent coverage of PMTCT over a five-year period. So we're already
there is five countries, but we need to go a lot further. Botswana is a
great success story. They had, as you can see, very little coverage,
well, relatively good coverage, but it almost doubled over the course of
the last three years. And they did it because they changed their
policies. They went to opt-out testing and they went to use of rapid
tests. And because of that, and simply because of that, they were able
to double their access. South Africa will never get over 50 percent if
they don't change their policies. And so, going forward, we need to work
with policy change; it's not a matter of just programs; it's policy
change.

I wanted to show this because safe blood is a part of what we do, too.
We've gone from 37 percent clean units to 53 percent clean units in the
focus countries, which I think is a great advance. Some countries
actually now have fully clean blood supplies because of PEPFAR.

I want to shift to treatment a bit and I'm not going to spend a lot of
time there because most people here about the treatment successes. You
know that, through March of last year, we were supporting 1.1 million
people in treatment in sub-Saharan and one million in sub-Saharan
Africa. When President Bush announced PEPFAR, 50,000 people in all of
the sub-Saharan Africa were receiving treatment. That's the type of
scope and scale we are seeing. And again, this isn't because of
Americans; this is because of people in the country doing the work.

Here is the trajectory. This is a trajectory we're seeing across all of
the countries, but also in each country. And importantly, it's not just
about numbers and treatment; it's about life years saved. So far we have
supported the saving of 3.5 million life years. Now, why is that
important? Because people are staying alive to take care of their kids
so they don't become orphans, they are staying alive to contribute to
the economy, they are staying alive to become peacekeepers. It's not
just about getting people into treatment; it's about transforming the
society because of the treatment and, importantly, creating hope. And I
think that is probably the greatest thing about PEPFAR, is it's created
a hope that cannot be overcome.

Here is the numbers that I think are most start: a 1200-fold increase in
treatment over three years -- rather extraordinary. And this just shows
graphically how that is accomplished. Three years ago -- basically dark
green is good; light is bad. Three years ago this was the percent
coverage in the focus countries. This is where we were last year. And so
rapid movement to national coverage.

I think an important part of why we have succeeded is the rapid use of
generic products through the FDA process. So far the FDA process has
approved 51 generic products for use in the focus countries, first time
in history that we're doing this as a government, rather extraordinary.
The first approval for the three-in-one combination for pediatrics,
which will be essential as we scale up our pediatric programs, is
through this FDA process. Importantly, for those of you on domestic
issues, there are three generics now available in the United States
because of this process. Hugely successful program, and it's one of the
reasons we've been able to scale up our products. But at the same time,
we are ensuring that we wouldn't give a product to an African family we
wouldn't give to our own family.

In terms of care, I am afraid most people are forgetting about care and
we cannot. The orphan situation in Africa is one of the most tragic. Our
goal, again, is to support care for 10 million people including 2
million -- including orphans and vulnerable children. We have scaled up
in care similar to treatment -- 4.5 million. This is actually -- it's
about a six-month lag from the treatment results. So we're certainly
much higher. And we have actually supported care for 2 million orphans
and vulnerable children.

An important part of what is going on in PEPFAR is more than those
numbers; it's what's happening beneath those numbers. And it's mainly
about building the capacity of local organizations. Eighty-three of our
partners -- 83 percent of our partners are local institutions, are local
organizations. That is critical because we're talking about transforming
societies, and we can't do that from U.S.-based organizations; we have
to build the capacity and build the local environment. We have supported
25,000 care and deliver sites in the first three years. That is
expansion of the sites. And I think it's essential to understand that
much of what we're doing is building systems.

There is a lot of criticism saying we don't build systems because we
focus on prevention care and treatment numbers, but it's just not true.
There is an evaluation of our treatment sites. As you can see, the U.S.
government was providing 92 percent of all of the capacity-building work
that was going on in those treatment sites -- 92 percent.

And as you can see, we're actually doing more in the public sector than
in the private sector. We may not directly fund the private sector
because of governmental flows of money, but we support private
institutions to support the capacity building of local institutions.

One of the hot topics these days is are we drawing from the other health
systems so that we can do HIV/AIDS activities. And the data right now
are a resounding no. A lot of people are talking in terms of opinion but
all of the data right now point to the fact that what we're doing is
building health systems, not just for HIV/AIDS.

A study was conducted in Rwanda to ask the question: With a massive
infusion of AIDS resources, what happened to the rest of the health
system? So they looked at 22 non-HIV/AIDS indicators, health indicators
to see what happened to them. Seventeen of them went up in a
statistically significant way. All right, 17 of them went up and nine in
a statistically significant way. Family planning went up in a
statistically significant way. Anti-natal care went up in a
statistically significant way. Use of laboratories went up in a
statistically significant way.

If you look at hospitalizations, this is actually an old number. There
was a 30-percent reduction in hospitalizations for general health. As
many of you know, 50 percent of hospitalizations in many countries are
for HIV/AIDS patients. If you care and treat them, you don't have to put
them in the hospital anymore. We saw the same thing in this country. If
you reduce hospitalizations by 30 percent, you just enhanced the
capacity of the health system by 30 percent because nurses and doctors
and physical space and laboratory space is now freed up for other types
of health care. So we are absolutely expanding health systems.

And if you look at a couple of pictures, it tells you why. On the left,
you see what a laboratory used to look like, on the right a renovated
lab. You couldn't do anything in the lab on the left, but on the right,
you can now do a lot of things. And while you might have an AIDS clinic
twice a week, you now have a laboratory for your health clinics the rest
of the week. And so they are -- we're seeing an increase in use of
laboratories for non-HIV/AIDS indicators.

A waiting room on the left, renovated on the right. Now, who wants to
sit in the waiting room on the left? No one. So people don't come to
clinic and don't feel comfortable coming to clinic. Now they have a
welcoming environment. This is a clinic we didn't renovate; we built
completely. We just opened it in Tanzania, Secretary Leavitt did.
Beautiful clinic that is building capacity in Tanzania. What I like
about it is there is a nurse in there and we are also paying the nurse's
salary.

Bill Gates reflected this when he wrote an op-ed recently in Newsweek
basically talking about the important work of PEPFAR in building
capacity and supporting what is going on in the communities. We're also
building supply chains and services that just didn't exist before. If
you build a supply chain for AIDS drugs, you can send TB drugs out, and
that is precisely what we're doing, 120 different products and
commodities. We are building warehouses. We're creating a capacity that
never existed before.

Now, as we look forward to where we are going to go, we also need to
think about how we do things, and we need to think about our indicators
because our indicators drive -- a lot gets derived from our indicators,
and we're taking a new look at our indicators. We have to have output
indicators, which is how many people in treatment, how many infections
did you divert, how many people in care.

But we're looking at a new approach to indicators that move from
assessment and planning to impacts. So ultimately, as in this country,
we want to know if treatment reduced morbidity and mortality. We want to
know if treatment increased the economy because people were able to work
and productivity went up. In behavior change, we want to know if boys
are treating girls differently, not just the number of infections
averted. We want to know if people are reducing their partners and
changing their behaviors. And so we're going to have a new generation of
indicators that will be available in January. Not surprisingly
prevention is the most difficult for this, but we have every technical
working group working with stakeholders to develop a next generation of
indicators.

So that is where we have been. I think where we're going is the next
phase of PEPFAR. And as you all know, President Bush called for a
doubling of the original commitment to \$30 billion. So already going
from what was the largest international health initiative in history to
doubling of that. Importantly, he called for new goals. We should never
commit dollars without goals, and the goals are to support treatment for
2.5 million people, so going from two to two and a half to support
prevention of 12 million infections, so going from seven to 12 and
supporting care for 12 million, including 5 million orphans and
vulnerable children. We have a very specific orphan goal this time.

You can see there is a bit of a shift towards prevention. We're almost
doubling the prevention goals, versus a 20 or 25 percent increase in
care and treatment. That makes sense. We needed grasp massively expand
care and treatment so that you could do more in prevention. People won't
get tested if there is not treatment. We know that from this country.
You can't identify HIV-positive people if you don't do testing, and no
one is going to get tested if they don't do treatment, which means you
can't do effective prevention.

If in discordant couples, if there is no treatment available, a woman
has absolutely no chance of getting a man tested. So it all fits
together in a very progressive 10-year look, and the president, again,
is leading the world in a rather extraordinary way. If we get that \$30
billion, the American commitment to global AIDS for a 10-year period
will be around \$50 billion.

We are also looking at things in a different way to some degree. We are
certainly going to continue our services. We are not going to back away
from supporting prevention, care, and treatment in the countries where
we have done the work. But going forward, we're not -- with new money,
we're not talking about focus countries as much anymore.

What the president said is we're going to develop partnership compacts,
which means we're going to go work with countries that want to tackle
their own epidemic. And what that functionally means is if we can save
two lives with one tax dollar or one life with one tax dollar, we think
we ought to go where we can save two lives with on tax dollar. And that
means the countries will do things to fight their own epidemic,
including resource commitment. Now, in Mozambique, they are not going to
be able to commit a lot; in South Africa they will; in India they should
be able to as well.

So we need to talk with the countries about their resource commitment to
match our resource commitment. And not -- not match, but contribute. And
not necessarily just for AIDS; we also want them to be increasing their
health system, so we need to work with them in the countries.

But we also need them to have a policies and practices that will save
more lives, such as workforce policies that allow task shifting so that
we can get to more people with prevention, care, and treatment services,
such as rights for orphans so that they are protected legally, such as
gender equality, rules, regulations, and approaches, so that men aren't
misusing women, such as having opt-out testing because we can save many
more lives through PMTCT if we put a dollar where we have opt-out
testing than where we don't.

But it's going to be different in every country. This isn't an MCC-type
partnership compact; it's more working together in partnership,
expanding our partnership with the countries as we move.

I want to end with this group by just saying what the American people
have done through President Bush's leadership and strong bipartisan
support is nothing short of a miracle. It is without a doubt one of the
most significant humanitarian efforts in history. It is building hope
where there was none. It is transforming individuals, communities,
nations; in the case of Africa, this transforming a subcontinent. For
those of you who have been there in six-month intervals, the change is
extraordinary. There is a sense of we can tackle our problems.

And we are part of a broader development approach. President Bush has
doubled resources for development, quadrupled them for Africa. It
includes the Millennium Challenge Corporation, the president's malaria
initiative, the women's justice and empowerment initiative, the African
education initiative, debt relief, doubling of trade, because ultimately
-- with Africa because ultimately that is the engine that will fuel
development.

So we are part of a much bigger picture that is transforming people's
lives. Importantly, people in those countries are also getting a new
window into the hearts of Americans. President Kikwete from Tanzania and
President Mogae of Botswana were just in Washington last month talking
about what the American people are doing in partnership with their
countries, in glowing ways and ways you couldn't possibly have
envisioned three years ago. And we see this at every level, from
presidents, to ministers, to tribal leaders, to individuals in their
communities. They have a different sense of what the American people are
all about.

Importantly, as President Bush has said, it's also good for the American
people. It's very good for the American people and our character, and
represents who we are, and Africans and Asians, and the people in the
Caribbean are starting to see that; they are starting to see what we
stand for and that we stand with them. And that is transforming a lot
more than just development.

This work has just begun. This engagement in this noble and humanitarian
effort has just begun. It is noble, and it is ennobling for us as
Americans, and we look forward to working with you and everyone. And as
President Bush has said, we're going to get a bipartisan bill to
reauthorize this so we continue in this noble and ennobling work. So
thanks very much, and I'm happy to take any questions you have.

(Applause.)

MR. GILMARTIN: (Off mike) -- great. Thanks very much, and a great record
of accomplishment. Congratulations to your leadership as well. So
questions for the ambassador? Yes, Ed.

DR. GREEN: Yes, thanks for a great presentation. This is my last meeting
at PACHA after four years, and I had the chance to address the council
this morning and talked a lot about prevention and Africa and
generalized epidemics, so it's great to have you reinforce what I was
saying.

I would like to call attention to two things you said and then -- and
ask a question. You said -- you pointed out that this is the greatest
concentration of resources on a single disease ever, and you also
pointed out that we're seeing stabilization and probably has declined in
some countries in Africa. Of the 14 original PEPFAR countries, according
to the data I have seen, we actually are seeing prevalence going down in
seven of them, half of the countries.

Most of the people don't know this in the general public and even in the
AIDS profession. And in the IOM evaluation of PEPFAR, that wasn't
stated; it wasn't mentioned.

My question is, wouldn't you -- I mean if prevalence were not going down
anywhere and after \$15 billion I could see how you wouldn't want to
mention it, and I also recognize it's difficult to show that these
programs rather than somebody else's programs are the reason, but why
wouldn't we want to mention that we're seeing prevalence going down in
half of the focus countries?

AMB. DYBUL: Well, we do, quite a bit. It's just a matter of whether or
not anyone wants to hear it. And, you know, there was an op-ed recently
in The Washington Post recently saying we need to stand up and say
prevention has failed and that's where people's heads are at, and it's
just not true, and we need to change the message -- we say it all the
time.

Now, we have to be careful in some of the evaluations because sometimes
the drop, we don't know is a real drop; it's at least a stabilization
because our ability to collect data has improved dramatically. One of
the big problems is we're stuck with prevalence, which is really a look
backwards, not a look forward. And as we put more and more people on
treatment, prevalence could actually go up. So, we desperately need an
incidence marker; we're almost there. We have a validated incidence
marker which is being calibrated right now. And I think once we have an
incidence mark, we'll be in a much better position to advocate.

But part of the -- it's not that we don't say this; it's that people
don't want to hear it. And -- but I think it's a huge success story,
it's a huge success story. Now, the prevalence needs to keep going down,
you know, a 30 percent reduction in Kenya still has us at 10 percent
prevalent, so we still need to keep going down. But I think we need to
talk about the fact, and we are talking more and more about the fact, of
the great success that we're seeing in prevention, at the same time
saying we need to do even more.

DR. GREEN: And maybe we should mention for the record that we have kind
of a proxy for incidence in looking at prevalence in the youngest
cohort, 15 to 19, because that's the group that would be least affected
by mortality. And so, when we see that going down, we have a sense that
we're really having some impact.

AMB. DYBUL: And we do have mathematical models, so where we see the
reduction in prevalence in Kenya, we actually have incidence that looks
exactly the same when you do the mathematical models. It'll be much
better when we can actually show it through incidence markers and we're
going to have them soon. And we've actually been storing samples over
the last couple years, we were allowed to, so we can go back and look at
that in an effective way.

But it is an issue and I think there's been a lot of progress, you know,
in a recent floor debate, every member regardless of which side of the
aisle they were on, talked about the importance of abstinence and
fidelity. Could you imagine that three years ago? Inconceivable. And
that's where we are. We have Chairman Lantos talking in the
reauthorization saying, it's going to be important to have an abstinence
and fidelity component. And people are talking about prevention, but I
think we need to talk about successes and not just throw our hands up in
failure. We're kind of repeating what we did in treatment; oh,
treatments is impossible, we can't possibly do it. There was a sense of
despair. Now, everyone's talking about how great treatment is; we need
to do that in prevention.

But we also need to be better at prevention, we need combination
prevention. We need to hit kids everywhere they are, we're talking about
combination prevention now. We've got lots of great programs, but
they're not all in the same place. So, you'll have a great faith-based
program in one place or a great school-based program in one place, or a
great program that works with sex workers or women in prostitution in
another place, but they're not all in the same place. So, we actually
have activities to do that so that you get people everywhere they turn,
not just one or the other places.

We also need to get in the 21 century; we're still doing stuff we were
doing, you know, and methods we were using 20 years ago, so we need to
advance ourselves a little bit too. And we've got some great projects
that are happening that we hope to announce soon to deal with it. But I
couldn't agree with you more.

MS. : Please identify yourself.

DR. YOGEV: Ram Yogev from Chicago. There's no question that it's a
miracle. Just because you mentioned the program, one thing which came to
my attention just because of one of your people, your technical
assistant mentioned, it's only 6 percent of pregnant women that are
prone to getting ARV to find out that mother-to-child transmission
program are beautiful and separated and you're right you increase them,
but separated from the care. And one -- you know, from the experience of
the United States, we reduce it if you deal (?) with mother-to-child
transmission, the best you can get is 50 percent. If you put in care,
you're going to get to 80, 90 plus percent. Are there any constant
effort to make sure that mother-to-child transmission will also give
care to the women as part of the whole gestalt?

AMB. DYBUL: It's a great question, Ram, and you're absolutely right. We
need to move from short course therapy to full course therapy and we
actually think we're missing a lot of PMTCT work that's going on because
what's happening in most countries is the pregnant women are getting
referred to testing -- to treatment sites and we're losing them in terms
of our data collection in the PMTCT sites. And I've seen clinics where
this happening.

We actually have tried to collect data on pregnant women receiving
anti-retroviral therapy; the problem is the data systems are capable of
doing that right now, but we're building them so we can. There are
concentrated efforts, very strong effort, to get us to that point.
Botswana is going to be there very soon, and you know, in three years
they got from 50 percent to 90 percent. Their national transmission rate
is 4 percent, it's approximately what the United States has. And they're
working on this, Nigeria is working on this, we're working with every
focus country to have practices and policies in the ministry that allow
this type of approach. Some people are doing innovative stuff that's
even beyond what many people in this country would do, which is to give
women regardless of CD4 cell count anti-retroviral therapy for 18 months
through the breastfeeding period.

So, there are a lot of efforts. I think we're missing effective
programs, but we're not doing enough. The other thing is, we're just --
we've got to get policy change towards opt-out testing or we're not
going to get anyone into these programs. And we have to have rapid tests
used rationally, not the way many people have used them. But you're
absolutely right.

DR. PRIMM: Mark, I wanted to ask you a question, I don't know whether
you would go this far or not, but I'm going to ask the question. What is
your opinion about expanding PEPFAR and making it also a domestic focus
because particularly in certain communities and expanding it, certainly,
in the Caribbean, which is you know, our really our sandbox, America's
sandbox is the Caribbean. And we had a report yesterday about what's
going on in the Caribbean and it seems as if certainly the two countries
that are there that you're focused on may have shown some improvement
but there are other countries there that need the help very badly.

I personally spoke to the president about this in a private meeting and
he had indicated to me at that time that he would think about expanding
it in the Caribbean. I, now, am talking about expanding it to include a
domestic PEPFAR for the African American community and Puerto Rico. It's
just incredible to me what's going on there, that it's just as bad as
sub-Saharan Africa.

AMB. DYBUL: It's going to be easier for me to address the Caribbean
question. I couldn't agree with you more on the Caribbean action and
that's why we're not talking about focus countries for the next phase;
we're talking about where we can have greatest impact on a dollar for
dollar basis. And I personally think that the Caribbean is a place where
we can see action in a holistic way across the Caribbean. You know,
Guyana and Haiti when we started to have the highest prevalence rate in
the Caribbean, we need -- we have a pretty robust program in the DR
because Haiti and DR are on the same island and it's not good to have
one and the other and we're actually doing more and more across the
island. I was just in Haiti and saw some of that. But I think we can do
more in the Caribbean region, if the Caribbean region wants to step up
their fight as well.

You know, the Caribbean has done rather well, although there's still a
lot more that can be done. They're one of the regions with
stabilizations or declines in infections. We're seeing the same types of
behavior change in the Caribbean region at some countries. We've seen
come countries expand their care and treatment close to what would be
considered universal access, although that's a terrible phrase. But more
can certainly be done and we think it can be done in a more regional
way.

We actually have a regional program now, particularly for training, and
because of the mobility, we think it's an area that's ripe. So, we'd
like to work with the Caribbean region in the next phase and actually
this year we might do more of this. In 2008, we're looking at doing more
of this across the region.

In terms of the United States, I'm going to leave that to the Department
of Health. Even though I work for the Department of Health and Human
Services, I'm in detail to the Department of State, and in the
Department of State we only deal with the global problem of HIV/AIDS, so
I'll leave that to Martin, those who work on the domestic side to think
about that. Certainly from a legislative standpoint, that would not be,
it couldn't be PEPFAR in terms of what needs to be done for the domestic
issues, we'd leave that to the committees that deal with -- Health and
Human Services and other committees that deal with that, and to the
department.

DR. PRIMM: I understand that you can't, but what I'm thinking is, the
epidemiology that we are saying in the African American community
parallels that that we see elsewhere. And wouldn't this call for
something of that nature and that hasn't been effective as you have
talked about it in miraculous terms today. I mean, that's the kind of
thing we need in our community too and that's why I asked you the
question, not that you would say, hey, it would work, but a PEPFAR would
work I think or something like that.

AMB. DYBUL: The only thing I would add, you know, the president in his
State of the Union address two years ago talked about this issue in the
State of the Union. I mean, I think you all around this table know what
-- I mean, I have friends that have worked for 20 years who'd say they
would beg for a single line in the State of the Union for 20 years and
he talked about this issue in the State of Union. He talked about the
need to increase our efforts in the African American community,
particularly to get some testing so people can be provided with
services. He talked about some of our vulnerable populations, such as
prisons, so there's definitely some focus on this, I'm just not engaged
in that.

MR. GILMARTIN: If I could make a comment and I'll ask -- having had a
chance to see in Botswana, as you know, first hand the kind of progress
that's been made. The other thing that came through your talk on
partnerships was the fact that, I think that the success is the result
of a new models on how to approach HIV/AIDS that could have application
here as well as they could have in other parts of the world. So, I know
it's not necessarily within your scope, but it would be great to --
maybe you want to take this Mike -- how do we capture the elements or
principals of success that are embedded in those outcomes so that we can
transfer that information?

And some of the things that you've found have been sort of goes right
against the dogma that people have had all along. Even on testing, for
example, on opt-out, which you talked about, you know President Mogae
was criticized in the international community, by civil rights groups
saying he's violating human rights. Yet, when given the opportunity,
people took advantage of it and it had a dramatic impact of the fact
that people knew their status, so.

There are a lot controversial areas here that the model might be able to
cut through and demonstrate here if you go this direction, here's the
benefit and the result of that. So, I'm just making a statement.

AMB. DYBUL: But I think it's actually an important one and Ray of course
is being modest because a lot of the success in Botswana is because when
he was MERC he got it all going and there are great lessons. And we are
actually starting. Kevin Fenton from HHS who oversees, from CDC, who
oversees the domestic AIDS program, we've actually begun talking about
how we share lessons learned back and forth because we have lessons to
learn from them here, there's some lesson that can be learned across as
well, and some of them are opt-out testing, some of them are adherent.
The Africans actually do a much better job at adherence than we've done.

There's a lot of good opportunities -- and that's what we're trying to
get through from this partnership; it's not just us going to help these
poor people, it's actually -- I mean you always, some of you have been
over there, some of the most intelligent, creative people you will ever
-- I mean, you meet a hero a day when you're out there. And that's the
kind of thing we need to be learning from.

MR. SCHMID: This actually ties in with what you were just talking about
in measuring outcomes and later today we're going to be considering a
recommendation for PEPFAR reauthorization, it's going to -- we're
talking one of the elements discusses the need for monitoring evaluation
research. And I'm just wondering, in your opinion, how much should we be
spending on that? It's definitely -- you mentioned it in your
presentation, it's definitely an important component, but how much
should we be?

AMB. DYBUL: How much is a tough question. I can tell you what we should
not have is a set amount. So, I've heard people propose 10 percent
should be spent on monitoring eval; well, that's more than we spend on
orphan care. Do we really think that we should be doing more in terms of
that than in orphan care? I don't think -- I mean, we know how to do
this stuff. It's true we need to refine and improve and we need what
we're calling public health evaluations. And we were about, I think, 5
percent, 4 percent, or 3 and half percent of our resources for
monitoring an evaluation.

We could recognize it wasn't working that well, and so we've actually
changed it to public health evaluation to look at broader issues and
there's some things we're collecting that no one else can; I mean with 2
million people in treatment and 10 million people in care and these
massive prevention programs, we're the only ones who can really look at
some of the outcomes and markers and other things. But in terms of the
scientific questions, that belongs to NIH. I don't have the staff and do
not want the staff to try to create such a program. We should not be
doing that. This is one of the dangers going forward with PEPFAR,
because of its success, people are trying to get us to do everything and
that's actually a bad model. It will destroy our focus and it will make
it much harder for us to get the good work done.

And we happen to know how to do good prevention, care, and treatment,
but we need to do monitoring and evaluation and these public health
evaluations to do anymore. So, I would strongly encourage you to not put
in a percent or an amount, but to encourage the work to be done, to make
sure that we're doing it. And that's what we're trying to do with these
new approaches with public health evaluation. We're bringing in NIH and
CDC to help us. We actually have our new director of that in my office
is someone who's a CDC economist, a fantastic person who can help us
evaluate the costs and the other pieces of care and treatment. His
deputy's going to be a part time detail from NIH and then we have an
interagency group to work on this, so there's no question we need to do
better at it and we're putting the systems in place, but the notion of a
directive around this, I think, would be extremely hazardous and it's
not our core competency and we ought not be doing it beyond what I think
we're trying to; that belongs to other parts of the U.S. government.

MR. SCHMID: Just to clarify, the -- what NIH does in this area, is that
part of the PEPFAR budget, or is it outside the PEPFAR budget?

AMB. DYBUL: Both, when OMB submits as is mostly -- our budget is one of
the most complicated things you'll ever see. There are actually about
eight different spigots of money that go in to make up the total dollar
amount you see for PEPFAR. We actually unfortunately lots one of the
spigots last year because the malaria money used to be part f our
overall amount. But it's -- the amount that comes from the global AIDS
program, which is from the HHS budget which is about \$140 million and
includes child survival and health at around \$350 million. It includes
some of NIH's money for global vaccine and microbicide and other work.

It includes the global find, it includes a bunch of these small State
Department spigots, FSA, CESF, and that includes the biggest peach,
which is the global HIV/AIDS account. So, some of the money is
technically there but we have completely stayed out of it and we need to
stay out of it. Tony Fauci and NIH ought to be managing that money, not
us. And so, we leave that to them to manage. And that's the way I think
it should be.

And then with the 3.5 percent I told you is just within the programmatic
budget to do the programmatic evaluations that need to be done, and
that's about, last time I saw the numbers, 3 and a half percent, which I
think is about right. That's a lot of money when you're looking at
budgets the size we're seeing. We just need to use it better.

The other thing we were seeing is, you know, a lot of our partners were
doing evaluations; we never knew about it, that's why we have this new
international implementers meeting. And what we saw was everyone was
collecting data on the same -- the exact same question and we didn't
know about it. And they were collecting in a way that you couldn't
aggregate it because it was collecting data from data, that's insane.
You know, we're duplicating effort, first of all, and therefore not
looking at questions we could be looking at, and then you have all these
data pieces that you can't put together to answer one coherent question.
And that was the point of this new public health evaluation approach, to
bring all the pieces together and maybe in a year we'd come back and
say, look, we actually need to spend more on it. But that doesn't
require an earmark; what it requires is us to rationally look at the
program and figure out the best way to do it.

DR. MALEBRANCHE: David Malbranche from Atlanta, Georgia. I appreciate
the comments, especially about the complexity of sexual behavior between
partners and the condom use, it mirrors -- I do some behavioral research
here in the States and what people say about how they choose to not use
partners -- condoms with their single or their serious partners, but
then with casual partners are more likely to use condoms so it reflects
that tremendously.

I had two questions, there was one slide that you actually had up that
you went over briefly that I think had CD4 counts and outcomes and I
want to know if you could tell us about that. And the second question
was, I was wondering if you could speak a little bit more about some of
the programs that you've seen in the countries that work on the issues
of masculine socialization or masculine empowerment for young men? I
mean, you read a lot and you see in the literature a lot about
indicators of what it means to be a man, and sometimes in this country
as well as other countries, you know, sometimes getting an STD is
considered a right of passage for being a man.

Can you talk about some of those things because sometimes we talk about
how women are getting infected and we just look at men as vectors of
transmission, and I'm interested a lot of time in my behavioral work
about how the men are contracting it and what can we do with that, so I
wanted to know if you could speak a little bit on what you've seen there
too?

AMB. DYBUL: Yeah, no, I think that's an incredibly important issue, how
we do that. I can tell you about a couple of those programs, can you
tell me again what precisely you wanted on the first part?

DR. MALEBRANCHE: Just as far as like outcomes, as far as CD4 count, what
you guys have been seeing up to this point.

AMB. DYBUL: So, that, the reason I passed over that is those are not
actually the good data I want and I know are out there and we're trying
to collect right now. That was just on the increase in CD4 cell counts
in the first 12 months of treatment so we know people are taking their
drugs and the CD4. The important data that I know are out there because
I'm talking to our partners and we're actually accumulating now -- I
just asked Bill Pop to do it -- is, what is the CD4 cell count at
entering? What is the CD4 cell count at diagnosis?

To me, that's the most important piece because you know, when Ray
started his program in Botswana, they were saying 30 percent of people
die in the first three months because everyone is coming in on deaths
door. But now, what they've seen is that's not happening anymore. People
are coming in earlier and earlier and we all know, you need to get --
that's why the care piece and why everyone in the world is forgetting
about care is so important. You need to get people in care programs when
their CD4 cell count is 600 so you can monitor them until it gets down
to 250, 200, whatever the country's guideline is to treat them optimally
or we're not doing effective treatment.

We also need people in the care program so we can teach them to practice
safe sex so that they're not transmitting the virus. So, that CD4 cell
count at entry, I just talked with Bill, he's got it and others have it
and that's what I want to collect, so I don't -- that one's not
surprising. CD4 cell counts go up when you start treatment.

In terms of what we're doing with -- I think this is one of the most
important areas and when we actually had a gender consultation on how we
could do a better job at dealing with the deep cultural issues of gender
as it relates to our program. I mean, we can't change the -- PEPFAR
can't change the cultures of these worlds, but we can deal with some of
them. One of the key elements that came out from groups working on
gender is get to the men because the men are actually the ones preying
on the women and there's a limit to how much negotiating a woman can do
in the circumstance, a real limit, whether it's A, B, or C.

So, like some of the better programs I've seen are the Men as Partners
Program in South Africa. It's an extraordinary program that teaches
young men, particularly those that don't have access to school and other
things, that it's not macho to abuse women, that it's actually right to
respect women. And that's cool, that's macho. And it's been an
incredibly successful program, you know, there are data now on how men
and boys have changed their view towards women.

There's a program with the Maasai warriors in Kenya, similar to the STD,
you used to prove you were a man as a Maasai warrior, basically you'd
all get together at age 14 or 15, I can't remember, and one of the
mechanisms by which you prove you deserve to be a warrior is by raping
as many women as you could effectively. And we intervened in a program
and now that's radically changed to teach them, no, you prove that
you're worthy of being a warrior by respecting a woman and that's
radically changed some of the behavior there. These are some of the
important programs I've seen that try to deal with it.

But I think ultimately -- these are kind of doing catch-ups; these are
trying to get to 25-year-olds and 20-year-olds that are currently -- we
have a great one in Nigeria doing the same thing and college kids
started it themselves to teach boys that you should be waiting for
sexual activity. You know, the reason they did it, they did a study and
when they asked all the incoming freshmen, 80 percent of the boys said
that they've always had -- or that their friends have already had sex,
but only 20 percent of them actually had, so it's a sense of, you know,
yeah -- (chuckles).

So, they actually started a program to identify them, to teach them, you
know it's okay, it's actually cool to continue to not have sex. So,
that's -- these are the types of programs but once of the most important
things we're doing, I think for the long term, because this is a
generational thing, this is not -- it's hard to change behaviors of
25-year-olds, 30-year-olds, God knows for me a 50-year, 40-year-old,
it's not so easy. But if you can get to kids when they're young and
teach them to respect themselves and respect others and respect women,
that's these life skills programs that we're putting into -- Botswana's
doing a national scale-up of life skills programs. We've been working
with them for three years and we're going to support that, we're already
supporting it. We're doing this in multiple countries.

That's how we're, for generations, going to change this and that impacts
on boys' and girls' behavior towards each other. So, we're not only
going to impact their sexual behavior, we're going to impact gender
equality, and you know, I was in a high school in Botswana where we
started to do this early, as one of the pilot projects, and if you go
into most high school in Africa and you have the boys and girls together
and you ask questions, only the boys are going to answer, because that's
the way the system works. In this high school, the boys could barely get
a word in edgewise and the girls were talking about how they wanted to
doctors and nurses and be teaches and be an engineer. That is -- that's
how we're going to change this stuff.

The problem is, I think what we're doing is, you know kids are in school
only for so long. Kids are in their faith community for so long and then
they leave or there's a point at which they don't listen to their elders
anymore, so we've got to get them at every place and there are a lot of
kids who have access neither to, in the slums and other things, to
school or to faith-based organization, so we need programs that reach
them as well. We need them all in the same geographic area or we'll make
progress that will not succeed.

And that's what we're working on, this combination prevention to mere
combination treatment where we're doing all of the things in the same
place. But, you know, that's why I think Ted's point is right. There's
so much success out there, but we're not going to see it; we're not
going to see it on six-month intervals, the way we can see treatment.
And we need to avoid these pendulum swings of oh, just go back and do
this, or -- and without treatment we're not going to have effective
prevention.

REV. LUSK: Yes, my name's Herbert Lusk from Philadelphia, Pennsylvania,
congratulations on all the good news that we've heard. My organization,
Stand for Africa, is in five countries in Africa now and I just want to
reiterate the hope that we see when we go there. I'm going there now
somewhere between two and three times a year in the last five years.
I'll be meeting with the Tanzanian president in December.

Two questions; the first one is your new partners initiative, you're
going to continue that? Very good, and for good reasons; obviously
there's some good things happening and you've got to bring new groups in
and we're constantly pushing new groups in, I want to repeat that again,
new groups in, include my group. But then, the other question is how do
you deal with the comment made by a president of a country like South
Africa, for instance, the president mentioned that the drugs themselves,
the medicines themselves, are contributing to the AIDS problem. How do
you guys approach that? How do you deal with that?

AMB. DYBUL: It's a very good question. And it's always good to see you,
Pastor Lusk, I mean you got in early and have been involved in Africa
for a long time and it's been so important for the work and we are going
to continue the new partners initiative. You know, it's taken a lot of
heat, but we think it's essential because there are a lot of partners
out there that are doing good work that need to be brought into the
government. And we can't succeed and scale up without them.

One of the things that's been, we've noticed, as a lot of the new
partners don't have the skill set yet for responding to U.S. government
grants and for the reporting for the U.S. government grant, which is a
complicated thing. And that's led to a cycle of people who know how to
do that keep getting all the money.

So, we're actually going to put out two new approaches for -- to provide
technical support to help build the capacity of partners so that they
can compete on a level playing ground because right now they can't. And
we're going to do that now because we recognize that we're just not
doing enough to support partners' ability to play out -- we're not
trying to make them win a grant; we're trying to have them on a level
playing field so that they can effectively compete if they have a good
program and show their program's effective. So, we have some work to
improve it and we're working on that.

You know, South Africa this year is going to commit probably \$800
million of their own dollars to HIV/AIDS; we're going to commit around
\$600 million. They have by far the largest anti-retroviral, national
antiretroviral program in the world, hundreds of thousands of people now
getting treated. And a lot of that is through public sector programs
that we're also supporting. But political leadership's important and it
-- we could probably be further along in a lot of countries if there
were the type of political leadership that President Mogae, President
Kikwete, and others have shown.

So, what we need to do is work with political leaders and do work with
political leaders to get those political statements. And the president
of South Africa has actually been very good in terms of budgetary
support and has changed dramatically in public statements around these
issues. But we think we need to do more.

The other important thing is, political leadership is not just
presidents and governments. There's a limit to how much people listen to
public health officials and presidents and -- you've got to get to the
leadership at every level, which is the local leaders, the church
leaders, the people everyone listens -- the traditional healers, the
people listen to at the local community. All health is local and we've
really got to build that -- and we're spending an awful lot of time and
resources to build that leadership locally as well, so if we have
problems at a higher level, there is that local support there that will
keep going. But it's a very good question and that's why -- one of the
reasons we're in the State Department.

MR. GILMARTIN: (Off mike) -- one last because I think you wanted to ask
a question, too? I'll defer to you.

DR. BUSH: My question had to do with how much of the disease, I guess,
is attributable to one of the slides that you had talking about
trans-generational sex. And I know at one time there was the myth that a
virgin would help cure an older man. So, I just saw you kind of run past
that and I was curious, especially when David brought up the question
about behavior in men and the gender issue.

AMB. DYBUL: The fact of the matter is we don't know for sure, and it's
different by country and different by region of country. But what we do
know is that younger girls in a lot of countries are five times as
infected as the young boys, and there are two reasons for that: one is
trans-generational sex of the older men preying on the younger girls.
The other is, and there's actually been a study on this which is
fascinating, the young -- the young boys tend to travel in packs that
are highly sexually active and they are the ones who are transmitting a
lot of the virus in some areas, particularly in college age kids, high
school and college kids, whereas most of the boys aren't. So, it's a mix
of these things, we believe, but we're not sure.

Fortunately a lot of the old myths are dying away as people become
educated. It's one of the reasons care and treatment are so important
because as you medicalize a disease, as we saw in this country, a lot of
the old knowledge and the old stigmatization goes away. The churches
have become very involved; you know, there were some churches that
taught that it was a curse from God or something else. What is amazing
is their brethren and sisters in the cloth have actually gone after them
and said, you've got to stop saying this stuff and changed the way they
behave. And they get together to do that. The Coptic bishop in Kenya,
who actually is for all of South Africa, Southern Africa, actually goes
to talk personally with pastors and others who have said this, to say,
look I have diabetes, do you think I'm cursed from God? I'm a bishop.

So, as we medicalize the disease, as people understand the treatment and
care and also the prevention components, a lot of that's going away. And
there's been great success. A church that taught polygamy in Zimbabwe
now teaches monogamy because of HIV/AIDS. So, a lot of these barriers,
both cultural and others, are starting fall away because of the success
and the expansion of prevention, care, and treatment programs. So, it's
still there, to some degree, there's still people who believe, you know,
the CIA introduced HIV, you know -- but the percents and the not -- it's
really dramatically down. And I think a lot of that is because of the
hope that's been created.

You know, when people see the opportunity, when people see that they can
control their lives and -- a lot of these older myths just start to fall
away. So, lots more work to do but good success.

MR. MARTIN: Mine was just a comment that I could have made after you
left, too, but it has -- (laughter) -- it has to do with the leadership
thing, the point you brought up, that the president, that you have done
a fantastic job and it's created this miracle. And the money could have
easily been wasted and it's been very effectively spent and it's
accomplished a lot. So, in a way I'm just thinking about the resolution
that Beny has put together about domestic issues. The passion you talk
about, the knowledge and the leadership on this international stuff has
been so essential for the success. And we can contrast that with when we
-- you talked, so the various prevention programs. It's fantastic and
it's music to all of our ears.

Another example would be the, we've got to get these countries to do
opt-out testing whereas here in the United States, we hear we're waiting
for the states, you know, it has to be their initiative and so it's a --
in my mind, it's a very dramatic difference of the leadership and style
and I know there are aspects of it, that there are reasons for of
course. But I think, just any way we think about this resolution, that
to really recognize what this leadership has meant to the international
effort. It has indeed been a miracle that you've accomplished. Thank
you.

MR. GILMARTIN: Thank you, Mark. Terrific, great to see you. Thank you
all, thank you very much.

So, we're going to break for lunch at this point and we have lunch on
the fourth floor. I'll wait for Marty to come back to give us the
details here.

And so -- well this is -- hold on everybody. Oh, he's just saying
goodbye. So, this is a working lunch that we have and will take place on
the fourth floor and --

MS. : Can you turn that off?

MS. : Yes --

MR. : You're going to describe the details.

MS. MCGEEIN: This is, as you know, we recess for lunch now. We'll
reconvene at 2:00. The domestic subcommittee will be meeting in room
four -- or conference room 443E. The international will be in 422F.
There are people at the top of the elevator and at the bottom of the
elevator. And if you get lost, just call for Nancy, she'll head out and
find you.

(Break.)

MR. GILMARTIN: All right. I will call us to order. And the sequence
we're going to follow is first, the international committee to present a
document that we have been working on for quite a period of time and
continue to work on actually over the last two hours or so and made some
final changes. So we're putting that up on the screen so you can see the
recent changes that we've made and then open for comment. Then, we'll
move from the international to the domestic committee after that. So
Bob, would you lead us off on the international committee to report?

DR. REDFIELD: Thank you very much, Ray. As I think everybody in the
group now has had an opportunity to look at the white paper that we've
prepared related to the PEPFAR reauthorization. I know I talked to Carl
yesterday; there are some additional recommended edits that you've made
that you're -- we can either comment on them or some of them are, I
think, factual updating of numbers that we talked about, which I thought
was very helpful, very useful, so that we have -- because when Bob
Archer (sp) and I started this document, it was about nine months ago, I
think, or a year ago. So we're going to update some of those numbers.

And I don't know if we want to go through Marty specifically or whether
the committee will allow us to take the updated numbers from Mark's
presentation from a couple of weeks ago and just edit them in, okay,
because they're not contextual; they're just updating the numbers. So
I'd like to have the discussion really on the content issues that people
think if there's omissions that they feel that or if there's still an
emphasis issue. And prior to doing that, I'd like to just go through
some of the changes that our own committee, again, has recommended to
the document, largely from an emphasis perspective and so everyone here
could just be familiar with the changes that we're recommending to be
included in the document, too. So, okay.

MS. : A little technical difficulty over here.

DR. REDFIELD: I think I can do them without people seeing. If we want to
go to the document, the major and -- the major changes that we had
recommended under the executive summary -- it's really going to be
executive summary recommendations. We look at recommendation number four
and there was a lot of discussion -- I know Carl brought this up
yesterday to me from the domestic subcommittee perspective --

MR. SCHMID: Those are my views; it wasn't from the domestic committee.

DR. REDFIELD: So Carl brought up, from his review, that the question of
whether or not there was the issue of operational research, research
should be included in our perspectives of this document. And I had tried
to raise the point of view over the last year and a half that PEPFAR is
a highly successful program, but it does need to be guided. And the
mechanisms that we have to guide it are to evaluate it and in a sense,
to try to determine what are the parameters that would help it be guided
more clearly. And the term we use for that is operational research so we
felt that it's important to highlight -- and again, I don't mean to be
negative and I wouldn't say this if the previous ambassador didn't use
this in his own speeches that it was a ready, fire, aim approach and
again, you know, in a sense justified because of the urgent need to get
people on therapy. We think at this stage it needs to be a
ready-fire-aim approach, and so, bringing in some -- strengthening the
evaluation and operational research. If you read the document carefully,
you'd see that there was sometimes a little confusion, I think, in the
way it read, whether it went from operational research to more
developmental or what we could call more just developmental research.

And so, we have recommended some changes in item four so that the
document that you have currently, we would just eliminate the last
sentence suggesting that some of this money be used for developmental
research so that there's no confusion. The purpose of the research
allocation in this document is to optimize standard practice and to
monitor and evaluate. And I think that's the contextual change. I don't
know, Ray, if you wanted to make a comment because you sort of used an
analogy that you had in industry to try to do the distinction.

MR. SCHMID: Yes, just to that point is that, you know, that in my former
world and even in terms of the material I'm teaching now to (pressly
minute?) about the BMBAs is making the distinction between what goes on
in operation and what goes in a research organization. So in the
document, we tried to make that clear that was PEPFAR is an implement or
an operational entity and as an operational entity, needs to do the
research on how to optimize its operations. And so, there is aim and
fire as opposed to -- and particularly, as Bob has pointed out, once we
start scaling up from thousands of people to millions of people, being
off a little bit on your findings on thousands of people is not as
serious as when you scale up to millions.

So therefore, this research is very important. But also, not to confuse
the mission or the focus of the organization as an operation, we're
advocating that they stay focused on the operational research to
optimize. And that although other new research, original research and
developmental research, needs to be done, it should be in another entity
and not part of the PEPFAR initiative.

So that's a distinction that we made in four. And we did that by
dropping the, in effect, the last sentence of four. We had substantial
discussion over that and there are different points of view on that, but
sort of as a majority came out on that point.

DR. REDFIELD: Yeah, it wasn't a unanimous perspective, but I think it
was definitely a consensus perspective. And so, that was the major
change in the recommendations. There was some wording changed to item
three.

DR. YOGEV: Before you leave four, a major change on the 10 percent.

MS. : (Off mike.)

MR. GILMARTIN: Yeah, if you could.

DR. YOGEV: Please because we did address that.

DR. REDFIELD: All right, point number three was -- in the executive
summary was changed completely. I can't see where we are.

DR. YOGEV: Can you go to point four?

MR. : We're on four.

DR. REDFIELD: All right, number four reads, the office of the global
aids coordinator, OGAC, should be encouraged to invest substantial
annual funding to support research. And the final sentence that's now
highlighted was deleted.

MR. GILMARTIN (?): And we wanted to also use the word, I think,
operational research, right?

MS. : So in the first line, allocation to support operational research?

MR. : Yeah.

MS. : Okay.

MS. : So the 10-percent advance?

MR. : No, that's gone.

MS. : It's going.

MR. : We're working with two different documents here, sorry.

> MR. : What happened?

MS. : There was some translation problem.

MR. : Okay.

MR. : But we had a document --

MR. : Put the word operational --

MR. : So the first sentence essentially reads, the office of the global
aids coordinator, OGAC, should be encouraged to invest substantial
annual funding.

MS. : To support operational research.

MR. : And that's substantial annual funding as well.

MR. : And then, we get rid of that.

MR. GILMARTIN: I guess the thinking on that is that we didn't feel that
we should be that prescriptive.

MR. : And then, item three there was wording changes. And if you want to
read it?

MR. ANDERSON (?): PEPFAR should continue to promote rational,
evidence-based, targeted prevention depending on age, circumstances, and
risk profile. Therefore, abstinence and delay of sexual debut, mutual
fidelity between partners, reduction in number of casual and concurrent
partners, correct and consistent use of condoms, open parens, known as
the ABC model, closed parens, should remain the priorities for PEPFAR
prevention programs in areas or regions with generalized epidemics and
as a strategy for general populations everywhere. And the last sentence
now reads, in addition to primary emphasis, other available
interventions must be considered as back-up strategies. And the absolute
last sentence was removed.

MR. : Yeah, it was the last sentence. It was restructured. Do you want
to -- I guess for people to see it, I don't know if you're going to type
it in there or --

MR. ANDERSON: PEPFAR should continue to promote rational,
evidence-based, targeted prevention depending on age, comma, targeted
prevention, targeted prevention, depending on age, comma, circumstances,
comma, and risk profile, period. Therefore, abstinence and delay of
sexual debut semicolon --

DR. YOGEV: Just take the ABC out -- (inaudible).

MR. : Yeah, you don't need to retype the whole thing.

DR. YOGEV: Just take the ABC out -- (inaudible).

MR. ANDERSON: It begins, therefore abstinence and delay of sexual debut,
mutual fidelity, right, and then everything -- after the word condoms
and then parenthetically known as the ABC model -- (pause) -- should
remain the priorities for PEPFAR prevention programs in areas or regions
with generalized epidemics and as a strategy for general populations
everywhere.

MR. : Then we took out the last sentence --

MR. ANDERSON (?): Now, number three ends with the sentence, in addition
to primary emphasis, comma, other available interventions must be
considered as backup strategies, period.

DR. REDFIELD: Must is a pretty tough word.

DR. GREEN: I was thinking should because --

MS. : We'd like to stay away from the must word.

MR. : I'd prefer to say the word should there.

DR. REDFIELD: So is there any discussion, concern, since again everyone
had the chance to read the document, but since we changed the context of
how we're summarizing the recommendations, it's important to give people
an opportunity to see if they're comfortable with the way we've framed
that. Okay? And I think those are the major recommendation changes. Bob,
is there another one -- there was a minor wordsmith I think on number
10.

MR. ANDERSON: Number 10 now reads, to ensure the sustained availability
of new drugs and formulations for pediatric patients -- oh, I'm sorry.
In the executive summary, page two.

DR. REDFIELD: There it is.

MR. ANDERSON: To ensure the sustained availability of new drugs and
formulations for pediatric patients, pregnant women, and adults living
with HIV infection, OGAP should develop long-term strategies that fully
engage the creativity, development, and market capacity of the
pharmaceutical industry.

MR. GILMARTIN (?): You know, from a technical detail, pregnant women is
kind of redundant. There are other women besides pregnant women.

DR. REDFIELD: So those are the major changes and some minor edits within
the session that discusses the research component, just to reflect, you
know, taking out the area of investigator-initiated to reflect the
consistency with the recommendation and also to be non-prescriptive in
terms of the amount of money that was invested in the operational
research.

So if the committee would concur, we would just make those editorial
changes that we have. But in the interest of time, I didn't go through
them. They just reflect those major changes that we made in
recommendation number four. And is there any other --

DR. YOGEV: We suggested and we agreed that you're going to add the --
(inaudible).

DR. REDFIELD: Yeah, I was going to bring that up. Any other comment
other than anybody have? The second area that we wanted to and the
question can be discussed whether it becomes an independent
recommendation of if it becomes one of the discussion areas. If you look
at the document, if you take a second to look at it, how it's formatted.
When we get to the challenge -- page seven we sort of get to the
challenges. And we talk about the challenge to optimize best practice,
the challenge for the use of modern evaluation, the need to build human
capacity, the need to increase availability of therapeutics for children
and infants -- childrens of all ages, the need to look at expanding
support within the Western Hemisphere and the Caribbean. The need to
expand end-of-life and palliative care services because the reality is,
as you saw, even though we're making progress, we still probably have
one out of five people in need of therapy not receiving therapy
although, again, I'm very optimistic that this program, by the end of
the next cycle, can get close to getting a majority of people on therapy
that need therapy by today's standards. Although, it's likely that the
standards of therapy will change over the next five years so that it
may, in fact, be that all people with HIV infections. So we'll always be
playing a little catch-up there.

But in those contexts -- and then we talked about the need for
administrative procedures and the need for sustainability. It seems like
one of the areas that we didn't comment on that there was some
discussion in our committee and again, was whether there's a need to
have a separate paragraph at least, even if it's not a recommendation
that's discussed, to emphasize the need of the program to continue and
development and improve ways to empower women in these countries --
dealing to empower women in the context of not only their own treatment
and prevention and care for HIV infection. So I don't know how people
feel.

It wasn't addressed as an independent item. We had some discussion at
this international subcommittee at lunch about it. There was, I think, a
general consensus that the document would be strengthened by adding a
recognition that we need to continue to develop, that that plan needs to
continue to decide to develop programs that facilitate and empower
women, particularly as related to HIV care, treatment, and prevention.
So just open that up. Carl mentioned that also to me as one of the
things he felt was a deficiency, the document, that it didn't mention it
anyways. So I just throw that out to have some discussion for --

Carl, you brought it up. Maybe, you'd like to --

MR. SCHMID: Yeah, well I appreciate you guys' discussing it, but I do
feel that the document was absent. It didn't talk about that at all. And
I think that's a very important issue, particularly in sub-Saharan
Africa and Mark -- Ambassador Dybul talked about it as well today. And I
just think, as a recommendation as PEPFAR gets reauthorized, to
recognize what they're already doing, but to continue to do that, to
empower women. And we could come up with some other language as well.
But I would be interested in seeing what other members of the committee
--

MR. GILMARTIN: I think our sense was that was something that we had left
out; we should add something along those lines.

MR. : I would agree. It would be under the challenges section as well.
Were you planning on putting it or --

DR. REDFIELD: That's what I was thinking, to put it there like we did,
to have a separate paragraph that this is a challenge, and important
challenge. We need to continue to -- we need to recognize this is a key
issue and we need to continue to focus on this. And again, depending on
how people fell, we could take a sentence out of that and put it as a
recommendation or we could at least have it in the text of the body. I
was thinking more of having it in the text that we recognize it and, you
know, just have it as one of the elements. Because not every single
thing that we listed in here did we put. We tried to keep the
recommendations down to 15, you know, just because we wanted people to
sort of read the key recommendations.

But again, I'm open if the committee feels differently. If it's in the
context of the document, you know, what I'd like to ask is that we can
develop that paragraph to recognize that. And really, almost along the
line of almost what Carl just said, but putting it into language, that
this is an important thing to recognize and that the PEPFAR program
needs to continue to look at how empower women in these areas,
particularly of HIV prevention as well as getting access to care and
treatment for HIV infection, and that we see that as an important
component, that continues to need to be expanded. I mean, that's more or
less what it would say. And put it in under the needs, under the
challenges areas.

MR. : Yeah, I think that's the appropriate -- for me, that seems to be
the appropriate amount of emphasis that needs to be on it.

MR. GILMARTIN (?): I have an actual on this as an approval. So, would
you like to move this?

DR. REDFIELD: Yeah, I would like to request that with those editorial
changes that we stated we'd make in terms of updating the numbers,
adding the paragraph on the empowerment of women, and modifying the text
to correspond to the recommendation changes that we made on number four
that we'd be able to do that internally and request that the document be
approved by the full committee to be forwarded to the secretary for the
administration's use.

MR. GILMARTIN (?): So we have that motion on the floor. Do we have a
second?

MR. : Second.

MR. GILMARTIN (?): Any further discussion? All in favor say aye.

(Chorus of ayes.)

Opposed? Carried. Thank you very much. Thank you, Bob. Thank you
committee, full committee for your comments. Okay, now we're ready to
move next to the domestic subcommittee.

MR. SCHMID: Thank you and thank you, Bob, for incorporating a lot of
those suggestions into the final document. The domestic committee is
presenting three resolutions for the four committees' consideration, and
if we could get those. But the first one is having to do with addressing
the crisis in Puerto Rico. The subcommittee has been, has expressed an
ongoing concern with the situation in Puerto Rico. We've heard comments
from the public, the full consul, but also at our last domestic
committee meeting, we did have a representative of the governor's office
and also a member of the community as well.

So should I go and read it since this is all new to? It's on the screen
I know the -- well I guess the members of the full consul have seen the
earlier draft and you can see how we did make some changes. But we go
through and address some of the issues and I do not know how much money
has been returned by the commonwealth in those years. That is a question
mark and I hope we could incorporate that number, if HHS could get that
number.

MS. MCGEEIN: I'm sure that it is gettable.

MR. SCHMID: Okay, if we can't then I suggest that we say it has returned
millions of dollars if we cannot get the exact number that they have
returned.

MS. MCGEEIN: (Off mike.)

MR. SCHMID: So I'll give a moment for everyone to look at that.

DR. REDFIELD: One of the comments in item four, you might say, since we
don't have the numbers, that they received the amount they received and
you could either say returned or you could say had to return, you know,
millions of Ryan White funding over the last five years. So like you
said, just either returned or was unspent and returned, or something
like that -- time to emphasize, you know that -- but I agree. I would
probably take the number out if you're not positive of the number?

MR. SCHMID: Yeah, the inspector general number for San Juan is a quote
from the inspector general's report. It's just the commonwealth is the
number I don't know.

MS. MCGEEIN: The five-year period ending in '03. We're now in '07. I
will accept the 6.5, but I think in talking about the crisis --
(inaudible) -- the numbers are not --

DR. REDFIELD: If it is that out of date, you know, over five years, you
might want to just say, whereas they received money and have had to
return, you know, a significant portion of these Ryan White dollars
unspent or something like that because I have to admit, if I see that
there was a problem five years ago, I don't understand why I'm -- I'm
trying to think of who is going to read this and say, wait a minute, you
know.

MR. SCHMID: Okay, so we could change that to reflect that both the
commonwealth and the city of San Juan have received X amount of money,
but they have returned unspent funds in the tune of millions of dollars
-- there are millions been like that. Hopefully with the full committee
will give us the latitude, too.

Any other comments from? Okay, hearing none then.

MR. GILMARTIN: Yeah, I guess I will.

MR. SCHMID: Thank you.

MR. GILMARTIN: Is that, and you can put that forward in a motion that
this resolution --

MR. SCHMID: Okay, I move that the full consul adopt the motion as
amended.

MR. : All right, a second to that.

MR. : I'll second.

MR. SCHMID: All in favor say aye.

(Chorus of ayes.) Any objection? (Pause.) Okay, motion carried. Thank
you.

MR. GILMARTIN: Thanks, Carl.

MR. SCHMID: Okay. Our second resolution has to do with the information
that is given to patients when they are tested. And we wanted to make
sure that they be given information about -- when they are given
information about HIV/AIDS that they be given information -- I'll just
read it -- "On the behavior practices of primary risk avoidance and risk
reduction we developed and be given to the person who is waiting for an
HIV test during the window of opportunity. And I would call on Freda if
she wants to add anything on this? If the -- we've all seen it on the
domestic side so I guess I would -- looking for comments from people
from the international committee.

Any questions?

MR. GILMARTIN: All right, so would you like to move that one as well?

MR. SCHMID: Yes, I'd like to move that the full council adopt the
resolution as presented.

MR. GILMARTIN: And a second, please?

MS. : Seconded.

MR. GILMARTIN: All in favor say aye.

(Chorus of ayes.)

MR. GILMARTIN: Opposed? All right, thank you.

MR. SCHMID: And the final resolution has to do with when people are
presented with HIV counseling that if -- when they do choose abstinence
that they be given ample information about abstinence and that they have
-- including trained counselors and skills developed and materials
presented to them. Any -- does Barb -- you want to talk about this one
at all?

MR. GILMARTIN: Okay.

MR. SCHMID: Any questions?

MR. GILMARTIN: Any questions?

RAM YOGEV: I have one. It's not clear to me, the way it's written, how
the person choses abstinence. Did he receive all options or the
discussion was only abstinence and then you give him whatever you say? I
think by that we are beating what we are trying all the time to say, is
we need to educate the whole and then if they choose this one. So, I
would like to see where is -- the principle key is to educate for ABC,
whatever, if a person choose abstinence, which I am very much in favor.

And then to -- I mean, it suggests that abstinence is the only thing
which you are going to do, which I think beats the effort.

MR. SCHMID: I think that's an excellent suggestion.

DR. BUSH: So, like -- oh, number three whereas a person presented with
the options chooses abstinence as a personal goal, be it resolved?

DR. YOGEV: Yeah, just to put what other options -- I like the idea that
we don't give up education and we need to encourage this, but education
should include abstinence and obviously according to the age --
abstinence, be faithful, what other options, condom, whatever, and then
if he chose abstinence. See, this is too generalized, so for example, I
will never tell you to teach a kid at age of 10 to use a condom; I think
it's wrong. You should talk to him about abstinence, if at all, after
you've taught the education. If he grows and is sexually active, you
know at the age of 15, what is that number, 50 percent I think are
sexually active in high school, you need to give them everything. If you
are sexually active, don't jump from one to the other; be faithful and
then if you decide to use, the way we chose, here's a condom; that's
what you do with it.

If he then chose to be abstinence, I have no problem with what you say,
but I want to see that going in direction of age-oriented, intellectual
-- or not, maybe it's sort of wrong word, but you know -- level of
understanding what we're teaching and if abstinence, we give them what
to do with it.

MR. SCHMID: So, Ram, do you have any suggested language. I could see
something changing that third whereas to something like, whereas when a
person dot, dot, dot, when --

DR. YOGEV: The second one -- whereas the goal setting is focus on the
age of who you're counseling which will include abstinence, be faithful,
condom. What was the deal? I like the D this morning; it was great.

DR. PRIMM: Don't do risk behavior.

DR. YOGEV: What? Don't do risk behavior, thank you.

DR. PRIMM: Risky behavior.

DR. YOGEV: Yeah, risky behavior. And then, whereas the person is choose
abstinence, that's the person's choice, which I respect, go ahead and do
whatever you say.

MS. WISE: When I wrote it, I was thinking in the first one we addressed
age and development level. In the first whereas.

MR. SCHMID: And I think that goes well with what he says.

MS. WISE: And then the HIV client-centered, then you would have -- you'd
have the client and then, so then it's all up to the client and then if
they choose abstinence.

DR. YOGEV: You see, whereas personal goals settinG in the focus client
center counseling, which will include all, everything, then it would --

MS. WISE: What if they are little?

DR. YOGEV: That's according to the culture and to the client age,
culture, whatever, language, sex, whatever. And add over their -- or you
have the age.

MS. WISE: Which can, maybe can include, instead of will? Can include?

DR. BUSH: So, this adding an -- after include -- ABC, just or ABCD, just
let's you know that they have all of the choices in front of them and
they choose abstinence, then we need to support them and help them
succeed that.

MR. SCHMID: That is the thrust, I believe, of the resolution.

DR. BUSH: That is the thrust.

DR. YOGEV: But it's not here, when you put can, can include, that tells
me --

DR. BUSH: It will include.

DR. YOGEV: It should include.

DR. REDFIELD: I think again, as you get back to can, if it's an
8-year-old person you're evaluating, I think that you're going to --
this is the whole issue of being sensitive to culture. There are some
cultures that are, you know, they're sensitive to age, and I think
that's what Barbara's trying to do is trying to make this that it's not
whether or not everyone has to learn X, Y, and Z. But when somebody does
say, listen, I'm into this A thing, okay, she's trying to say that, you
know --

DR. YOGEV: I hear you, you have an excellent point. Maybe an
appropriate, just appropriate portion of the ABC according to client,
culture, you see --

MS. WISE: Appropriate to the clients?

DR. YOGEV: But, before they're just appropriate sectional to ABC or they
really, you see what I'm saying?

MS. WISE: Up top at the first whereas?

DR. YOGEV: Yeah, on the first one, by that you're saying what Dr.
Redfield so appropriately pointed out, that there is -- I cannot ask a
Catholic priest to teach condom, it is to be fair not to --

MS. WISE: Right, so, I agree. I see what you're saying. So, whereas one
of the -- provides --

DR. YOGEV: We're saying you need to consider everything, choose it
according to what you do, and if you chose abstinence, then go -- then
it's fine with me.

MS. WISE: So, it's provide services that are appropriate?

DR. YOGEV: Provide services --

MS. WISE: -- A, B, and C that are appropriate to the client's culture,
language, sex?

MR. SCHMID: I think I just got lost.

DR. YOGEV: Guidelines is to provide ABC services --

MR. SCHMID: ABC services, right.

DR. YOGEV: -- that are appropriate level of -- and by that you put what
-- Dr. Redfield is absolutely correct, you can then take it out in full.
And then if you choose, and then I'm not sure if you need --

MS. WISE: And then we can take out the other --

DR. YOGEV: Number two.

MS. WISE: -- number two, the ending part of number two.

DR. YOGEV: Right, exactly. You can combine number two and three
together, you say well, whereas personal goals set in focus client
center if the person choose.

MR. SCHMID: Yeah, I would also like to see the -- in the final that ABC
be spelled out. Okay, I think this is an excellent change. Thank you for
that.

Any other -- Jose?

DR. JOSE MONTERO: I got one question. ABC, if you're talking about
someone's risk grouping IV drug use, you're not going to attack
something -- ABC's not enough. It's risk -- well, that's risky behavior,
I mean because you're not going to capture that.

DR. YOGEV: So, so -- that's a point which --

MS. WISE: But we're talking --

DR. YOGEV: The situation was put in so nicely. You put abstinence, be
faithful, condom and whatever was the D, don't do -- so services
according to culture, then a person chose of which -- you see because
the first thing which will happen is those who are so sensitive to
abstinence only will right away jump when I say, you are only abstinence
only and we say, no, we say everything. But if the guy chose abstinence,
educate him how to do it right.

DR. REDFIELD: The recommendation's not trying to be exclusive of
individuals that use IV drugs, okay, it's just trying to be a
recommendation relating to when you relate abstinence, be faithfulness,
and condoms, that, for those individuals in their own personal choice,
choose abstinence, the following. And I think it's worth emphasis, I
think it's worth emphasis because historically, we've had maybe
over-emphasis on the condoms and so now it's important to have sort of a
balanced emphasis. Allow people the ability to figure out which one of
these prevention strategies is the most appropriate for them and then
begin to try to reinforce those strategies so that they can be effective
for those individuals.

MR. SCHMID: Any other comments on the proposed resolution?

So, I would like to move that the full council adopt the resolution as
amended.

MR. GILMARTIN: All right. A second?

MS. WISE: Second.

MS. : (Off mike) -- be faithful.

MR. : Be faithful -- (off mike).

MR. SCHMID (?): It's not condom services either. (Laughter.) Yeah, we'll
work on this.

MR. GILMARTIN: We'll work on this. All right, so we have a second for
this?

MS. : Second.

MR. GILMARTIN: Would you like to second this, Barbara?

MS. WISE: Yes, I'd like to second this please.

MR. GILMARTIN: Any further discussion? All in favor say aye.

(Chorus of ayes.)

MR. GILMARTIN: Opposed? Motion carried.

MR. SCHMID: Well, thank you. And we did have another resolution that we
began to address that we unfortunately did not have time to complete and
that was the one authored by Dr. Prim calling for a domestic PEPFAR and
a year of testing. We are disappointed that we didn't get to address
that but the subcommittee has agreed to continue to work on that and we
will discuss it in our domestic subcommittee meeting and present it at
the next full meeting next March. So, thank you very much.

MR. GILMARTIN: Good, thank you very much to both subcommittee chairs for
an excellent outcome.

The -- we now move into the public comment phase of our meeting and I'll
turn over the chair to Dr. Maxwell.

DR. MARILYN MAXWELL: Okay, for this final section of our meeting I have
a list of those that have signed up for public comments. Public comments
will be held to three minutes and you'll be given signs at one minute
and 30 seconds.

Our first public comment will be from Greg Smiley.

GREG SMILEY: Here we go, okay. My name is Greg Smiley. I'm the director
of public policy for the American Academy of HIV Medicine. We represent
MDs, DOs, nurse practitioners, and physician assistants specializing in
HIV medicine. And I just wanted to make a quick public comment about the
need for better reimbursement for HIV screening, that you referred to
yesterday's panel and I've got some great positive responses from Aetna
and CareFirst. I think that we've still seen from our CDC workgroups
that we've conjoined of clinicians from different disciplines around the
country from OB/GYNs, family physicians and so forth, that there isn't
enough adequate reimbursement for screening and so we're not seeing as
much uptake of the CDC recommendations because of that.

NASTAD, which is the National Alliance of State and Territorial Aids
Directors, just had convened a meeting in January of emergency
departments, and they reported that, again, the biggest barrier to
emergency departments taking up HIV screening was the need for better
reimbursement for that. So, we did hear some positive news yesterday
from Aetna and CareFirst, but some other conversations that we had had
with other private insurers and HMO organizations had really not come on
board yet for the need for screening. I'm citing, like, the U.S.
Preventative Services Task Force and their recommendations to not
necessarily recommend HIV screening is a reason to not also reimburse
for it.

So, we had come up with some potential solutions that the council and
other organizations should look at, making available the need for
reimbursement of the screening and we decided that like, CMS could issue
a dear state Medicaid director letter to all the state Medicaids and
say, these were the guidelines, say, and this might be a good option for
you to take up reimbursement. Relevant medical societies, such as ours,
could convene a meeting of the state Medicaid medical directors, a lot
of the state Medicaid programs have specific medical directors that give
them advice, and so we could bring them together and then, you know,
discuss the need for screening.

The Health Resources and Services Administration could and should change
their policy to require that community health centers offer HIV
screening as a part of their communicable diseases screening requirement
and work to ensure that such centers have adequate resources to cover
screening services and test kits and so forth. AMA has also been
discussing a CPT code for screening and we wholly encourage them to
adopt that.

And then finally, private insurers, such as -- well, other private
insurers besides Aetna and CareFirst should follow their lead and
reimburse for HIV screening and the AMA and the Association of Health
Insurance Plans should consider convening a meeting of major insurers to
discuss the needs for that. So, hopefully, you can maybe take that up in
your next meeting as well. Thank you very much.

DR. MAXWELL: Thank you, Carl?

MR. SCHMID: Yeah, I just wanted to make a comment that we -- I should
have said this when we were closing -- that one of the issues that we're
going to continue to look at in the domestic committee is this
reimbursement issue. Do we have written comments, by the way, of their
now? That would be great, thanks.

DR. MAXWELL: Okay, our next comment will be from Suzanne Miller.

SUZANNE MILLER: Hi. Good afternoon, my name is Suzanne Miller, public
policy associate for the AIDS Institute. Today I would like to comment
on the urgent need for a national HIV/AIDS strategy in the United
States. After more than 25 years of this disease, the United States is
still without a comprehensive outcomes-oriented and evidence-based
national plan to effectively and proactively respond to the HIV/AIDS
epidemic.

An effective, comprehensive national HIV/AIDS strategy should do several
things. Among them, one, set ambitious visible and credible prevention
and treatment targets and require annual reporting of progress made;
two, identify clear priorities, responsibility, and accountability for
action and encourage interagency coordination; three, prioritize the
needs of groups most impacted by and at greatest risk for HIV; four, the
need to address structural and social factors that increase
vulnerability to infection, such as poverty, housing, and incarceration;
five, scale up federal funding for HIV prevention, treatment, and
research programs; and six, incorporate many sectors of society into the
development of a national plan, including government, business,
community, non-governmental organizations, faith, research, and people
with HIV/AIDS.

We are at a critical juncture in this epidemic; while after 25 years we
have made some gains as a nation in the areas of prevention, care and
treatment, and research efforts, this epidemic is unfortunately far from
over. The rate of new infections has plateaued at more than 40,000 per
year for the past 15 years, and we are hearing that CDC will soon
release a much higher estimate of new infections. Additionally, an
estimated half of all people who know they're HIV-positive do no have
access to anti-retroviral medications.

African Americans, Latinos, and gay men continue to bear the brunt of
this disease while federal funding for HIV prevention, care and
treatment programs, and research efforts continually fail to keep pace
with actual funding needs. Furthermore, we cannot pull back on our
commitment to finding a vaccine and ultimately a cure. While the U.S.
has positioned itself as a global leader in biomedical research and the
fight against HIV/AIDS abroad, we have failed to adequately respond to
the epidemic here at home. We can no longer demand a national HIV/AIDS
strategy of other nations we provide support to while ignoring the need
for one at home.

I also wanted to say that more than 180 organizations across the country
have signed on to a movement demanding a national AIDS strategy and you
can go and visit their website at www.nationalaidsstrategy.org and sign
on as an individual. And we also ask that PACHA make the development of
a national AIDS strategy a priority by passing a resolution. Thank you.

DR. MAXWELL: Thank you, Ms. Miller. Next we have James Sykes.

JAMES SYKES: Good afternoon, my name is James Sykes, the global advocacy
coordinator for the AIDS institute and today we would like to provide
public comment on the reauthorization of the president's emergency plan
for AIDS relief and biomedical HIV/AIDS research. Four years ago the
president began a bold initiative to provide care and treatment to 10
million people infected and affected by HIV/AIDS. As we approach
reauthorization of this landmark legislation, the AIDS Institutes
respectfully offers public comment in two key reauthorization areas for
your consideration and hopefully inclusion of them in your advisement to
the president.

First, at the threshold of PEPFAR reauthorization, we know that
approximately 24 million more people have become infected with HIV since
the program began despite its successes. It is obvious that we cannot
treat our way out of this pandemic. There's a need for an enhanced
emphasis on comprehensive, evidence-based HIV prevention. We know the
epidemic is rapidly increasing in ASIA and other regions of the world,
often driven by intravenous drug use. Comprehensive HIV prevention must
include needle exchange and referral to HIV testing, counseling, and
substance abuse treatment.

The AIDS Institute also asks that you advise the president to consider
removal of the abstinence-only earmark in the light of the Institute of
Medicine's findings of the ineffectiveness of such programs. At the same
time, the HIV prevention program must include expansion of comprehensive
and evidence-based ABC approaches to minimizing the sexual transmission
of HIV and other sexually transmitted diseases.

Secondly, reauthorization needs to be carefully planned with an emphasis
on sustainability. The AIDS Institute supports a reauthorization of at
least 4.5 -- \$5.4 billion per year as a floor, not a ceiling, as
recommended by the global advocacy community. The goals of the program
-- of the program expansion in sustaining current programming are both
important to continued success of PEPFAR.

A final comment regards ensuring continued biomedical research to find
improved life-sustaining anti-HIV drugs with increased accessibility
worldwide as well as here at home. The AIDS Institute asks this body to
convene a meeting about the important topic; the need for new drugs is
well known as we see clear evidence of biological resistance and the
lack of new classes of anti-HIV drugs being developed. The AIDS
Institute encourages such a meeting to include scientists, clinicians,
the National Institutes of Health Officials, World Health Organization
representatives, non-governmental organization representatives, people
living with HIV/AIDS, and the private sector, including the
pharmaceutical and biotechnology industries.

Two goals of such a meeting is to bring increased public awareness to
the need for continued research and to generate a consensus about ways
in which key stakeholders may move forward in the pursuit of improved
HIV therapies. Thank you very much.

DR. MAXWELL: Thank you. Next we'll have Mr. Ronald Johnson.

RONALD JOHNSON: Thank you and good afternoon. My name is Ronald Johnson.
I'm the deputy executive director at AIDS action council here in
Washington, D.C. We are encouraged by the expressions of support for a
national AIDS plan that have been made at this meeting, including the
support for the concept of a domestic PEPFAR. Core elements of a
national AIDS strategy must be addressing the HIV/AIDS epidemic in
communities of color.

Human -- geographic and population and human disparities that cut across
and go beyond communities of color must also be addressed. You've heard
the sound recommendations this morning that emerge from the national
conclave of black clergy. Yesterday was Latino HIV/AIDS Awareness Day
and I bring to your attention the call for action for a Latino AIDS
agenda and the upcoming summit meeting in January to adopt a Latino AIDS
agenda. It's important to realize that plans that target highly impacted
communities are completely compatible with an overall national AIDS
strategy.

Indeed, the advantage of calling for a national AIDS strategy is that it
can encompass the various specific plans that are needed to end this
epidemic. A national AIDS strategy must enhance, not obscure, our
ability to address specific population and geographic disparities and
disproportional impacts, particularly in communities of color that
continue to mar and characterize this epidemic. That is a way to be
truly effective in ending this epidemic, and that needs to be the focus
of a national AIDS strategy. Thank you.

DR. MAXWELL: Thank you very much. Our final comment will be from Marsha
Martin.

MARSHA MARTIN: And I've got to do a show and tell.

I'm Marsha Martin, director of Get Screened Oakland and I bring you
greetings from a former colleague of yours, Mayor Ronald V. Dellums, who
some of you might recall was also on PACHA at one time.

I want to share with you a little bit about an initiative that's
underway in Oakland. Indeed, Get Screened Oakland, it is building upon
the successes that we had an opportunity to experience in Washington,
D.C., and is part of what I would describe as a growing movement of
municipalities undertaking this effort to expand screening for HIV and
expand the opportunities for people to know their status, getting care
of they're positive, and understand HIV transmission and work to prevent
transmission if they're negative and stay healthy that way.

A couple of things I want to point out to you and I think it would be
valuable for PACHA to consider having a discussion on municipal
responses to HIV. And the idea of a municipal response is, of course,
where you bring an entire community together using executive leadership,
community leadership, you know, all the sectors to come up with a plan
and then work collaboratively to mobilize and execute that plan.

That is 25 years into the epidemic, a new conceptualization; it's
happening around the globe. We have mayors and provincial leaders and
district leaders engaged in HIV, but the United States, it's really been
20 years since we've had the kind of executive leadership. And as we
look to routinize HIV screening, steps to making that success is to be
able to bring everybody into a room and to work with people
collaboratively to make that happen.

And, yes, it's important to find about who's going to pay for it, the
insurance companies, et cetera et cetera, but if you don't have an
entire community engaged in this conversation, it doesn't work. So, an
important part of the next step, as you look at routinizing HIV
screening, is to have this discussion of community-wide efforts. If John
Martins were here, I would also then tell you about the public-private
sector part of this. Get Screened Oakland is fully a public-private
sector operation; 75 percent of the funds that work Get Screened Oakland
came from the private sector.

California is a county government-based public health system; our city
does not have its own health department. The mayor, showing his
leadership, has committed local budget dollars to make this work and to
match the private dollars; so, public-private partnership, bringing it
together to make an initiative like this work. Gilead is supporting us
in the Bronx, Gilead is supporting Oakland, Gilead is supporting
Baltimore, Gilead is supporting Los Angeles; there are communities
around the country that are engaged in this municipal, get everybody
together in a room to talk about expanding HIV screening.

And I would encourage PACHA, as they begin to look at the issue of a
domestic response to HIV to not forget the cities. And we remember that
PACHA came to Washington, D.C., and met and heard from local leadership
around what's going on. We would like to extend you the same invitation
to come to Oakland. Mayor Dellums would be thrilled to host his
colleagues in the Presidential Advisory Council and would like to invite
you to really take a look at a community in the shadow of San Francisco
and what they are doing to try to respond to an epidemic 25 years later.
And the materials I passed out to you, you will see the new social
marketing campaign just kicked off in October where the mayor is
standing up inviting people to get screened for HIV, where the mayor is
fully behind this initiative.

Understanding what you all have talked about is the role of leadership,
executive leadership, in engaging a community. We had it here in D.C.;
it will happen again here in D.C. now that Dr. Hader is in place. We
have it in Oakland. We encourage you to come join us and we'd love to
host you, thank you very much.

DR. MAXWELL: Thank you. We thank everyone for all of the public
comments. This concludes our 34^th^ full council meeting of the
Presidential Advisory Council on HIV/AIDS and the full committee will
convene again in March. Safe travels home everyone.

(END)