PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS

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THIRTIETH MEETING

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MONDAY,

JUNE 19, 2006

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The above-entitled matter convened at 9:00 a.m. in Room 800 of the
Hubert Humphrey Building, 200 Independence Avenue, S.W., Washington,
D.C., Louis Sullivan, M.D., Co-Chair, presiding.

COUNCIL MEMBERS PRESENT:

LOUIS SULLIVAN, M.D., Co-Chair

TROY BENAVIDEZ, Member

ROBERT BOLLINGER, M.D., M.P.H., Member

JACQUELINE S. CLEMENTS, B.S., Member

EDWARD GREEN, Ph.D., Member

ALAN HOLMER, B.A., J.D., Member

JANE HU, Ph.D., Member

FRANKLYN JUDSON, M.D., M.P.H., Member

HERBERT H. LUSK, M.Div., Member

SANDRA McDONALD, Member

JOE McILHANEY, M.D., Member

ROBERT REDFIELD, M.D., Member

DAVID REZNIK, D.D.S., Member

M. MONICA SWEENEY, M.D., M.P.H., Member

RAM YOGEV, M.D., Member

PACHA Staff Present:

JOSEPH GROGAN, Esq., Executive Director

DANA CEASAR, Program Assistant

PRESENTERS:

MARK DYBUL, Acting U.S. Global AIDS Coordinator,

Office of the U.S. Global AIDS

MIGUEL GOMEZ, Director, The Leadership Campaign on

AIDS, Office of HIV/AIDS Policy

ANDREW KAPLAN, M.D., Professor of Medicine and

Microbiology & Immunology UNC School of Medicine

PETER A. LEONE, M.D., Medical Director, HIV/STD

Prevention & Care Branch, Associate Professor of

Infectious Diseases, UNC-Chapel Hill School of

Medicine

JOHN C. MARTIN, Gilead Sciences

MARTY McGEEIN, Deputy Assistant Secretary for

Disability, Aging and Long Term Care Policy,

Office of the Assistant Secretary of Planning

and Evaluation

JAMES D. SHELTON, M.D., Acting Deputy Director, Office

of Population, United States Agency for

International Development (USAID)

DAVID ALAIN WOHL, M.D., Clinical Associate Professor

of Medicine, AIDS Clinical Research and

Treatment Unit, UNC-Chapel Hill

C-O-N-T-E-N-T-S

[PAGE]{.underline}

WELCOME - REMARKS

Dr. Louis Sullivan 5

WELCOME

Joseph Grogan 7

PREVENTION

Dr. Monica Sweeney 9

HIV TESTING DAY

Miguel Gomez 9

TREATMENT AND CARE

David Reznik 30

RYAN WHITE REAUTHORIZATION

Mary McGeein 32

HIV, SEXUAL NETWORKS AND COLLEGE CAMPUSES

Peter Leone 70

HIV AND INCARCERATION

Andrew Kaplan and David Wohl 135

INTERNATIONAL

Robert Redfield 202

U.S. RESPONSE TO GLOBAL HIV/AIDS

Mark Dybul 203

DIRECTION AND LDEVEL OF THE GLOBAL EPIDEMIC

James Shelton 263

THE FUTURE OF HIV TREATMENT

John Martin 315

ADJOURN

P-R-O-C-E-E-D-I-N-G-S

(2:09 p.m.)

DR. SULLIVAN: Good morning, everyone. Welcome to the 30th meeting of the
Presidential Advisory Council on HIV/AIDS.

And let me thank all of you for coming. As noted on the covers of your
books, this is the 25th year that we have been aware of HIV and AIDS,
and over that 25 years a lot of things have happened.

Among them, when I came to Washington in 1989, we as a nation were
almost having an AIDS panic. There were demonstrations on the campus of
NIH by advocates saying that we were not spending sufficient dollars or
giving enough attention to this. There were discussions on the Congress.

And that year in October of 1989 I was pleased to approved reimbursement
of AZT as a treatment, the first treatment shown to be effective against
this virus.

Which you contrast that to today where we have more than two dozen
medications. We also have another contrast: people with the diagnosis of
HIV often look forward to perhaps 12 to 18 months survival; now today
they\'re looking at 12 to 18 years with their families raising children,
earning wages.

So we\'ve made a lot of progress. One of the predictions at that time
was that within four years we would have a vaccine against this virus.
Of course that is something that has proved to be very elusive.

We\'ve made a lot of progress in our understanding and treatment of this
disease, but what\'s clear to all of us is, we don\'t yet have a cure.
This continues to be a major epidemic around the world.

In the United States where we have been more fortunate in our efforts,
we still see an increase in the number of people who are carrying the
virus. A few years ago it was 800,000. Now the data are a million to 1.1
million.

So all of us are challenged to support our scientists our legislative
leaders, and others, as we work to try to find better ways to control
this virus.

I think today\'s meeting and tomorrow\'s gives us an opportunity to not
only review where we\'ve been but also see some of the challenges that
still confront us, and where we need to go, areas not only in terms of
research, but funding, policies, et cetera.

So I\'m looking forward to the discussions today and tomorrow, and
again, thank all of you for your contribution to these efforts.

With that I will turn to our executive director Joe Grogan for his
comments.

MR. GROGAN: Thank you, Dr. Sullivan.

Just a few quick points. I guess first and foremost this is a sad day
for me, personally, and for PACHA, because we\'re losing some members
who I\'ve grown very close to, I know we all have, including Dr.
Sullivan and Anita Smith as co-chairs. Tomorrow will be their last day
serving as co-chairs.

I got a nice note from Anita. She\'s actually in Africa, and she
couldn\'t make it back. She had meetings all last week, and meetings
starting tomorrow or the day after, I think, so it would have been a
little bit crushing for her to make it all the way back and turn right
around.

But she wanted to express her regrets in not making it today, and also,
the gratitude she\'s felt from all of you in serving on PACHA for over
four years.

Secretary Leavitt, also, he wanted to be here today, and he called Dr.
Sullivan. He had something on the schedule for about nine months that he
couldn\'t get out of, but he did want to express his gratitude to Dr.
Sullivan and to Anita, and to all of you here, and especially those who
will be leaving.

And I know Monica who chaired the prevention subcommittee will be
leaving as well.

So I want to thank you now. We\'ll have a little bit more tomorrow, but
I wanted to just thank you now before we get started.

And then I guess our first speaker is going to be Miguel Gomez to talk
about testing day.

DR. SULLIVAN: I might say, if Dr. Sweeney is our prevention chair, as a
comment, as we lead into the discussion.

PREVENTION

DR. SWEENEY: Thank you.

I\'m very happy to have Miguel Gomez here again, because he does come
and speak to us often, and leading up to next Tuesday I think it\'s
really very appropriate that he\'s here, and we\'re happy that you\'re
here to address us again about HIV testing.

Thank you.

HIV TESTING DAY

MR. GOMEZ: Good morning. Thank you.

And Joe, as you are saying all these goodbyes, I know these individuals
are going to continue to be warriors in the fight against HIV/AIDS.

So what\'s important is that many times I actually, because of my role
and responsibility for coordinating on behalf of the department, HIV
observance day, I just want to give a quite update on what\'s happening
with observance days as a whole; talk about national HIV testing days;
and really just pose a question for PACHA itself.

And actually the only reason I\'m using a PowerPoint presentation today
is to show you, look, there are now eight HIV observance days now, our
newest is Native American HIV/AIDS Awareness Day, which is actually
going to commence next year on March 21st.

In March we had National Women and Girls AIDS Awareness Day which went
out of the gate with gangbusters with over, in its first year, 160
events across the United States.

What\'s important to know again is, why are we so invested in these
awareness days? Sometimes this is a statement of the obvious, but it\'s
important to reinforce that it\'s important for the department and I
know for national groups and local groups to use their resources and use
the day to really get our messages out by supporting observance days, or
raising that awareness.

But one thing that is also just core and important to the department it
really does allow us to promote our policies, resources and programs.

And look at all those observance days, and I keep getting calls for
more. Those working with our elderly want an awareness day. Those just
on June 8th in the Caribbean there was Caribbean AIDS Awareness Day
which was not recognized nationally but was first time held in the
Carribean so we are looking and meeting with those groups to see what is
happening with that event, and will continue into the future.

One of the things that has been so important to us in the department is,
we will continue to provide technical assistance, but one thing we have
found is that building new partnerships with our faith communities, and
community-based organizations who haven\'t been involved in HIV
messaging but are willing to do events around observance days.

And we will continue to work with the lead organization around national
HIV testing day, which is the national association of people with AIDS.

And this year we did something different which is, we linked June 5th,
the 25th observance, and national HIV testing day, to try to do a
one-two punch.

And one thing here in the department which some of you have heard that
we do before, which is really important to repeat, is, we try and role
model that we should make HIV testing routine.

So if you saw when you were coming up in the elevators today there were
signs, we offer HIV testing for our employees around observance days.

It\'s real important to destigmify, and also make it seem in our health
unit just like we offer flu shots, we offer an HIV test.

What\'s real important is that we also have web page for our HHS
employees and the public which is actually housed at the office of
minority health.

And this web page which is on the screen is the home page, which if you
click on one of the icons, you can learn about events that are happening
on those observance days throughout the country.

What\'s interesting, which is the most popular piece, is, this is the
one for national HIV testing day. It\'s a little bit hard to see,
perhaps, but you see that there is a poster. What we place on the web
page that\'s real important is a poster that any community group can
manipulate and use so that they have something that is colorful but can
list their local event. They can turn that into letterhead, or they can
print it out as posters, and list their local organization.

What\'s interesting on this web page, the most downloaded product
throughout the entire country is a basic one-page fact sheet still on
the basic facts on HIV/AIDS. The poster is the second most downloaded
thing from our web page. And the third most visited is the listing of
all the community events around the country.

Again, national HIV testing day is what\'s in front of us. Again, it is
that opportunity as we already know for folks to learn their status. But
it\'s also important for us, we have to take a step back in our local
communities to respond to the terrible myths that still respond in our
communities. I\'m sure most of you saw the Kaiser study that came out
about a month and a half ago showing that perhaps up to 37 percent of
Americans think that you can get HIV from kissing; 16 to 20 percent
think that you might be able to get it from a toilet seat still today.
So we really need to remember that these observance days not only for
testing day to get information that we want people to know their status,
but we still need to get some of the basic facts out on HIV/AIDS.

The lead organization, many of you already may know, is the National
Association of People with AIDS, and they have a contract with the
Centers for Disease Control.

What\'s real important about working with the National Association of
People with AIDS is the fact that their messaging often will focus on
having it come from a person living with HIV/AIDS. And all the focus
groups, there\'s been about 27 in the last two years around the country,
has taught us again, our testing messages, real important to come from
people living with HIV/AIDS.

And throughout the local community, the National Association of People
with AIDS, it is highly trusted, and they also have a new executive
director with the organization, just as a sidebar.

One of the things that is a step back, and one of the things, what we
are doing with all grants, or many grants that we provide any agency
when it comes to observance days is to really look to make sure that
we\'ve having evaluation components. And we can say for last year\'s
national HIV testing day that not only did we have 165 events throughout
the country but that we actually saw an increase of folks going to HIV
test dot org. And I\'m sure all of you know what hivtest.org is. It\'s
actually a federal web page, but folks, what they do is, they simply go
to this web page, put their zip code in, and they can be linked
immediately to a place to get an HIV test in the community in which they
live.

It\'s very easy to use, and it also contains a list of all community
events for National HIV Testing Day.

What we found, which is very interesting, is when folks wanted to learn
about where to get a test, they did not want it to be hivtest.gov.

For this year\'s national HIV testing day there are some leading
entertainers who are going to be involved. You may not necessarily in
this room know who they are, but a group of younger folks will know,
especially some of the stars, the first gentleman, he\'s a rapper and
has his own show. Judy is an absolutely outrageous comedian. Christina
folks know, talk show host in the Latino community. Dennis folks know
from the show 24. Selma Hayek is a big star within the Latino community.

But again this just shows you that in partnership that we\'re making
sure that we\'re getting out the press kits, radio and TV interviews are
being set up both with local, state and national folks; community papers
are happening. And what\'s really interesting to us is that we this year
decided to actually send out less of the kits to help communities do
work because we weren\'t sure if they were actually being used, and
there\'s been almost 4,000 of those kits already requested this year,
and double the number of phone calls to the national association of
people with AIDS to get information on national HIV testing day.

And already that we know of there are about 135 planned local events.

I already sort of told you quickly about hivtest.org, which is very
important, both the White House and HHS promotes individuals going to
this website so they can get information on their HIV testing.

It\'s also important to know that we link with other national
organizations to link to their databases to make sure this is accurate
and up to date.

One thing before going to closing what I\'d like to really share is that
national HIV testing day is the second most visible day. It gets, in the
33 largest media markets, it\'s the second largest number of hits after
World AIDS Day.

And however in the last two years we\'ve seen a 40 percent decrease in
the number of news coverage for national HIV testing day, and that\'s a
concern of ours. And so we\'re of course pushing for more activity.

But one of the things that we found sort of startling is that the First
Lady actually spoke on testing issues on June 2nd, which we thought
would be very powerful. It got almost no news coverage.

She also called for something called International HIV Testing Day, and
we don\'t know when that day is going to occur; it hasn\'t been
determined yet. But when you have powerful tools like the First Lady
speaking out, supporting national HIV testing day, supporting testing,
we really as a community and as PACHA ask you, how do we step back and
look at how do we promote these awareness days, because they do work on
the local level; they do work within specific community; but there is a
lot of work we need to do.

And I\'ve really actually even posed that to the organizations that are
sitting behind you. Because again we\'ve pumped a lot of money into
observance days. But at the same time what are we doing at the national
level? One of the things I liked Joe Grogan on World AIDS Day and other
observance days, we\'ll send you an email asking you to send it out to
your colleagues asking them to acknowledge the observance day.

But is there something that we should be doing in advance? Is there
something our offices should be helping you do? Because again, we see
the lower press coverage, more local events, but the overall goals of
getting more people to know their status, we still are challenged to
make our efforts more effective.

I want to thank you again, and if you have any questions, I\'ll take
them.

DR. SWEENEY: Are there any questions?

We have the opportunity now to get all our answers to national
observance days.

DR. SULLIVAN: May I? Thank you very much for that presentation.

I really have two questions. One is, what is the process by which an
organization gets designated for an AIDS day?

And because you mentioned that there\'ll be the Native American day, and
so suggested that there is some process that really occurs.

And my second question is also with the comment that there are eight
AIDS awareness days throughout the year.

And I guess my question here is whether or not having that number may
really be confusing, and whether that may be a factor contributing to
the disappointing press coverage if we have frequent days.

So I guess my question pertaining to that is, have you thought of the
idea of -

MR. GOMEZ: Less is more?

DR. SULLIVAN: So I\'m sure that you\'ve had some discussions, but I
wonder what the rationale is for having all these days spread out as
opposed to having fewer perhaps with a larger effort.

MR. GOMEZ: Sure.

Your first question about how a day gets designated, it\'s a mixed bag,
sir. For example Caribbean AIDS Awareness Day, there was a congressional
resolution from a member from California who named June 8th Caribbean
AIDS Awareness Day.

Usually what happens is, community organizations in partnership with
national organizations, come together at some meeting and declare that
they would like X day to be an observance day for the community they
reach and serve.

Here at HHS our standard operating procedure is we recognize that call
to action, we wait one year to see if actually the events do get pulled
off; and if there is a network of nationally recognized and local
organizations who will plan events, HHS to date will recognize that
awareness day.

Again, we do have to step back, and I actually love your feedback, are
there too many? Given my history what I have found is that at the local
level the community organizations are not challenged by this, and the
best example is, because I was very concerned when we added yet another
one in March called National Women and Girls HIV/AIDS Awareness Day, but
was astounded in the first year, again, there were over 160 events
immediately around the community.

It increased testing from our evaluation within those communities; it
brought new people to the table, so we were very optimistic.

But it\'s a question I can\'t answer, do we have too many at this time?

DR. SWEENEY: Yes, David.

DR. REZNIK: Hi Miguel, thank you for your presentation.

My question is, when it comes to HIV testing day, is there buy in in
activity from the medical associations, the American AMA, the Hispanic
medical association and the national medical associations? Because the
CDC guidelines are calling for routine testing, and it would be
interesting to see if the medical associations are sending out fact
sheets via email communication, or are they involved in these events, et
cetera.

MR. GOMEZ: Sure. The Hispanic Medical Association and the National
Medical Association have been requested and have committed to actually
placing information on their web pages and doing newsletter articles.
The other medical association to my knowledge have been approached, but
I can\'t document if there has been any action.

DR. SWEENEY: Dr. Redfield. Oh, I\'m sorry, yes.

DR. BOLLINGER: Thank you, that was a great presentation.

I have a quick question. Reflected in my question might be a suggestion
about marketing this issue a bit.

What percentage of the HHS employees have been tested and are aware of
their HIV status? And how much has this national testing day contributed
to that awareness within your own organization? Could you use that as a
marketing tool?

MR. GOMEZ: We do, actually. One thing that is really important for the
last several years, both on World AIDS Day and national HIV testing day,
we have about 67,000 employees. What we do is, we send most every
observance day, those observance days, an email to our 67,000 employees
letting them know that it is X observance day and that we encourage them
to know their status, and we also highlight the fact that at least in
the DC area we offer our employees HIV testing and then we direct them -
we encourage them to learn more about HIV testing, and to go to
hivtest.org.

And that model has helped us work with four different faith
denominations and about five corporate entities. What we do is, we
challenge them to do the same things for their employees.

And so we\'re very excited that actually this World AIDS Day all the
Catholic parishes in the United States will actually get a message to
the individual parish encouraging them to have an HIV testing message
very much like we do here at HHS. And there\'s about five national
organizations that will be sending out emails to their employees and
networks saying, we\'re basically challenging them, we can do it here at
HHS, you can do it for your entity.

DR. BOLLINGER: But how effective is it? You talked about how important
evaluations are?

MR. GOMEZ: Oh, I\'m sorry. Actually, what we have found with our
evaluations of the individuals who do get tested that we - actually, I
can\'t quite - I remember I was pleased with the results. I can\'t
remember the exact data. People were pleased it was offered at the
workplace, and I don\'t want to guess what the other information is; to
be honest I just don\'t quite remember.

What was real important to us because we also do it in partnership with
our local health department here in D.C. is that their testers felt
satisfied that they were willing to keep coming back, and with their
limited resources I found that pleasing, but I can\'t answer your
question at this time.

DR. REDFIELD: Thank you, Miguel.

I wanted to follow up too on this sort of evaluation, because obviously
the purpose of these days, and I think Dr. Sullivan\'s point of view
probably deserves some reflection, you can dilute this out, but the
purpose is that ultimately we become much more routine, not that day,
but 365 days a year, in trying to get early diagnosis of HIV to be the
prototype so that at least ignorant transmission of HIV can be
confronted.

And my own view is, our nation hasn\'t optimized that historically, and
we\'re 25 years into the epidemic, and we\'re still trying to see if we
can actively totally engage the health community.

But what I would suggest is that people look at ways to be really very
aggressive in getting evidence-based data to evaluate whether our
policies are doing that.

For example one simple way which again in Bob\'s and my state, which is
a little discouraging in Maryland, if you look at the mead CDC four-cell
count at the time of initial diagnosis, it\'s under 300. And that
suggests to me that whatever we\'re doing isn\'t kind of getting there.

So it would be interesting to know across states what is the mean CD-4
cell count at the time of initial diagnosis, and then the following year
is it getting better? Are we actually proactively engaging?

There may be ways from a policy point of view to - I\'m not a punitive
kind of person. I\'m more the incentive kind of person. So incentivize
states to bring that up, that those states that show that they are doing
well, maybe they get greater support. There is a tendency to support
those individuals who do worse. I think that doesn\'t necessarily create
the right environment.

So it\'d be very useful for someone to really get a handle on it. If the
issue is early diagnosis, one of the ways is mean CD-4 cell count at the
time of diagnosis.

There\'s another way that would be interesting to me to get a handle on,
how many of us know that I wasn\'t infected two years ago but I\'m
infected now, in other words, as opposed to what we see too frequently
in our clinics, we found out someone is infected and we ask, well, when
is the last time you\'ve been evaluated, and they say, well, I never had
an HIV test before.

So people who are at risk for HIV infection, if they are proactively
engaged, if the medical community is engaged, they should be able to
say, well, I know I wasn\'t infected two years ago, because I was HIV
negative two years ago.

So I think there has to be a much more objective criteria for this
evaluation of the effectiveness of our policies in gaining early
diagnosis as a standard.

MR. GOMEZ: I agree with you.

I mean it\'s great to know that last year we saw a bump of 35 percent in
the number of people being tested, and X number of communities; but more
data would be helpful.

DR. SWEENEY: I\'ve just been told that we\'re just about out of time.
But I\'m just going to ask about the poster.

People over 50 are increased incidence in people over 50, and of course
with the health disparity, African-Americans. And yet on the poster as I
can see it here, there isn\'t anyone that is representative of an older
person.

And it\'s disproportionate in the number of - I\'m looking on the
observance day website - in the number of people who are representative
of where the epidemic is now, which is primarily over 50 percent black.

I just wanted you to comment on that.

MR. GOMEZ: Sure. Actually I believe we do have a mature individual who
is in the bottom corner. I can actually show you a copy.

And I do take note about needing to make sure that we are representative
of the disproportionate impact on the African-American community.

DR. SWEENEY: Thank you.

DR. SULLIVAN: Madame Chair, let me ask one final question if I might.

On the poster describing HHS efforts, you say you provide free anonymous
testing to federal government employees.

I guess that raises a question: Does that mean that someone who is not a
federal employee who comes to one of these observances may -

MR. GOMEZ: No, that was just for our building here, sir; that was an
example.

DR. SULLIVAN: I see.

MR. GOMEZ: And again in closing I want to thank you, but also actually
to step back, because one of the things that we have found that has
been - still we\'re very excited about what\'s happening locally, and I
want to reinforce that.

But also what we haven\'t seen as much of our national players, like
bodies like PACHA, actually speaking out at events or participating, and
we really want to encourage that, and we\'re real excited that about 15
mayors around the country will be involved in HIV testing day events,
and the next time I see you I think we\'ll be talking about perhaps
World AIDS Day, and I wanted you all to know that departments in the
United States World AIDS Day event will take place in Memphis this
December 1st bringing faith, civil and public health leaders together.

Thank you very much.

(Applause)

DR. SULLIVAN: Thank you, Miguel, for that update.

We\'ll now move to our Treatment and Care Committee under the leadership
of Dr. Reznik.

So David.

TREATMENT AND CARE

DR. REZNIK: Thank you, Dr. Sullivan.

We\'re going to have quite a challenging year in treatment and care
because of the new prevention initiatives, the testing days that you\'ve
heard about, getting people identified earlier into care.

We\'re going to have to look at how we provide that care. And one of the
key aspects of that is Ryan White which we\'re still waiting for
reauthorization on.

There will be other issues that we\'ll face as well. But to start off
our presentation today, I have to read this lady\'s title: deputy
assistant secretary for disability, aging, and long-term care policy in
the office of the assistant secretary of planning and evaluation.

So in this job Ms. McGeein, who is a nurse, has responsibilities related
to active aging, innovative ways to finance long-term care, improving
the quality of life for disabled persons, HIV/AIDS, medical malpractice,
regulatory reform initiatives, and patient safety.

And when you look at all those different things that Ms. McGeein has had
to deal with, there has been an extraordinary amount of time spent on
getting the Ryan-White Care Act reauthorized.

I believe that our voices were heard over the last two years, as we\'ve
discussed this with Marty. And I\'m very grateful for what is basically
a thankless job. Because people don\'t realize the amount of time and
effort and meetings with community and legislative folks that go into
something as complicated as the care act is. I don\'t know if people
realize how complicated this piece of legislation is, and how small
changes can have large impacts.

So it\'s with a great deal of thanks and respect that I introduce Ms.
Marty McGeein.

(Applause)

RYAN-WHITE REAUTHORIZATION

MS. McGEEIN: Thank you, David. As always, I am delighted to be here. And
I think I\'m a decent multitasker. It\'s how things get done. But this
doesn\'t explain why I haven\'t returned any of your phone calls in the
last few months.

I see lots of new faces at the table. Some of you have no idea who I am.
Others know that I come here routinely and tell you either good or bad
news.

The news today is mixed. We\'re going to talk about the reauthorization,
and it is a work in process.

I\'m going to divide my presentation into three pieces: principles,
process and product. And of the three, although the product is what most
interests you, the process is the one that we really should be focusing
on today.

As you know the president is intensely interested in this issue, and he
laid down some principles that the Ryan-White reauthorzation was to
follow: life-saving care to those most in need; establish a core set of
medical services; establish a severity of need index; do away with some
of this jockeying around the formulas; routine voluntary testing in
public facilities; redistribute the unobligated balance; and unless you
are a cost accountant, the unobligated balances things goes right over
your head. Let me just explain the bottom line, money the grantees do
not use that we the department are unable to recoup and put into better
or more product uses goes back to the Treasury.

Out top, bottom, side was, no intent to destabilize the system.
Absolutely the guiding principle: do not destabilize the system.

The process that we\'re involved with, Secretary Leavitt announced the
administration principles last summer. And I think some part of PACHA
was there.

As soon as the announcement we started a series of educational briefings
for Hill staff. These briefings included HRSA, they included CDC, they
included ASPE, my shop; they included ASL which is our legislative shop.
They included anyone who needed to bring in to instruct a very large
group of legislative assistants who were going to be active in this
issue.

That series of briefings went on for six months. The congressional
leadership of the two authorizing committees, Senate Health and House
Energy and Commerce, committed to a bipartisan and bicameral approach to
writing this legislation.

The goal was to have one bill that everyone had agreed to prior to the
bill going to any of the committees for markup or vote, so that we have
one bill, that once it was settled, it could be passed and signed into
law.

This group became known as the Four Corners Plus One. The Four Corners
were the Republican-Democrat Senate-House leadership; the Energy and
Commerce Democratic and Republican leadership and HHS.

So it was Four Corners Plus One which some of the people in the back
seats have heard about, oh the Four Corners are meeting.

This bipartisan bicameral group has met over the past five or six months
a lot. There have been some days when there have been meetings everyday,
and some meetings that last three or four hours.

And now I understand why people hate meetings so very much, as if I
needed it really impressed on me.

But we\'ve gotten a lot of work done. In May the Senate Health Committee
passed the Ryan-White HIV Treatment Modernization Act of 2006 with one
dissenting vote.

There are basic elements of the bill - and this is where I need to warn
you, warn the PACHA people, the people in the back - we are not through.
The bill changes - as data becomes apparent, the bill changes; as
someone makes a case that we have made, a tactical flaw, an error, or a
policy flaw.

We are open and listening to suggestions. And I see Bill McCall back
there.

What I\'m telling you is, there are some basic tenets. There are some
things that will not change. But I am not going to tell you in deep deep
detail what\'s in the bill, because of what I find is a moving target.

The basic elements in the bill: the title structure remains the same, so
there\'ll be a Title I, Title II, Title III, Title IV.

Elements of the current act that are working effectively will remain.

Funds that were distributed by formula today will be distributed by
formula under the new act.

The HIV reporting requirement which was in the 2000 reauth will
absolutely remain in this and the department will enforce it.

All grantees will be held to a 10 percent cap on admin cost. All
grantees who treat beneficiaries - because not everyone treats or has
their hands on clients - will be held to the 75-25 percent division. And
when the president talked about core medical services, he believed that
any penny not spent on these life-saving services was perhaps not best
used.

So our negotiated position was that 75 percent of the finances that you
received to treat a beneficiary must be spent on the core medical
services.

The 25 percent, remaining 25 percent, may be used for support services
as long as they achieve a medical outcome.

All formulas where appropriate will be based on living AIDS cases.
There\'s a big change for some areas. All grantees will submit an audit,
submit to, and submit the audit every other year.

All grantees must demonstrate in their application how the proposal fits
within their state plan.

And HRSA is going to be fairly stringent on this requirement.

In Title I at the moment it\'s proposed to create three tiers. As you
know Title I is the EMAs. Eligibility would be based on living AIDS
cases over the past five years. And EMA would cease to be if it fails to
meet the eligibility criteria for three consecutive years.

The division of the funding in Title I would change from 50-50, which is
sort of in my language 50 percent base, 50 percent for supplement, to a
66 two-thirds 33 one-third change. The 33-1/2 would be the supplemental.

There would be a three-year phaseout of the hold harmless provisions.

In Title II, the base and ADAP remain. There are two new supplementals,
one in Title II base, and another in ADAP.

The three percent set aside in ADAP is increased to five percent.

Each state that receives ADAP funds, which is everybody, must create a
drug list that reflects the public health service HIV/AIDS treatment
guideline, to provide for consistency across the nation.

In Title III stays very much the same. All grantees providing services
must adhere to the 75-25 split. Rural health clinics and certain Indian
health centers are eligible for Title III funding. This is a major
change.

And the Indian health service is excluded from payer of last resort
provisions.

In Title IV - David is going to do the hi-fi this time - much stays the
same. There will be an increased focus on family-centered care. All
grantees must submit audits to the state agency, which is the same as
the other titles.

And GAO will be asked to conduct an evaluation of Title IV funding for
program effectiveness - actually the language is better than that - but
it\'s something that has never been done.

Title V, coordination of HIV programs must include the minority AIDS
initiative. We have inserted public health emergency language.

Katrina taught this department, the government, and the United States, a
lot of lessons. But what it taught the department vis-a-vis Ryan-White
was that we were unprepared to do anything for the grantee that needed
help during this emergency.

Once our emergency authority expired, we were helpless. So we were
trying to do some fix, but it\'s not going to be in this act for
Louisiana. But it did, it all of a sudden made people realize, my
goodness, we really need to be prepared for this in the future.

In Title V, GAO will submit a report to Congress every two years on
barriers to program integration. What we are trying to achieve, although
it doesn\'t sound like it from all these pieces, is, there is one
profile for treating a patient within a state, so your Title Is, your
Title IIs, if you\'ve got Title III money, if you\'ve got Title IV
money, that they are working together to improve the health of the
particular client who is receiving services.

Spends money - this is a basic change. The spends will be used to
develop a standardized electronic planning commission data system to
improve grantee reporting of client level data to the secretary.

We struggled with this. This secretary and the president and I think all
of us in the room understand that health IT, health information
technology, is really where the world both needs to go for quality, but
it also is the better way to maintain records. It ameliorates medication
errors, overtreatment, undertreatment. There are things that health IT
can do that a paper record can\'t do.

And there are some major institutions, the VA for one, Hopkins for
another, that have already instituted health IT and are understanding
its value.

We struggled with how to introduce it into Ryan-White understanding full
well that every penny of a grantee\'s money is so precious, it is so
necessary for care. So we feel that SPINS was an appropriate place to
take that up.

And that pretty much concludes what we are planning to do.

Joe had asked that I allow some time for questions, so have at it.

Oh, good, I\'m done.

DR. REZNIK: Ram?

DR. YOGEV: You mentioned that at least two of the titles are going
according to living AIDS cases.

MS. McGEEIN: Correct.

DR. YOGEV: This is markedly in contrast to what we are trying to do. We
stop the AIDS. I have now my own state, Illinois, children who have AIDS
by definition, because they don\'t have active AIDS, they reach 18, they
don\'t have where to go.

Why are we not going through the HIV? It\'s also contradictory to me to
go and identify HIV patient, because the HIV is not a major burden of my
system, and yet I\'m giving only by AIDS or reduced by number, whether
they died or because of treatment.

So the premise to go by AIDS doesn\'t make sense to me.

MS. McGEEIN: Thank you. Actually I\'m glad you brought that up. The
statement will be HIV/AIDS, so your clients will be picked up.

DR. YOGEV: So we are going to go by HIV.

MS. McGEEIN: Yes.

DR. YOGEV: And that\'s why we\'ll go to annual reporting and so forth?
Thank you.

MS. McGEEIN: Soon as you started I realized, but I didn\'t say it. You
guys are doing a good job. You\'re keeping clients from progressing to
AIDS.

DR. REZNIK: Dr. Redfield.

DR. REDFIELD: I just would be interested if you could give me some sense
of the debate or the thought process that decided to keep all the titles
separate.

As a recipient I think I have about 40 separate Ryan-White grants which
I try to patch together to provide care for 3-4,000 people, and some
times I get funding for all the pieces that I need, and sometimes I
don\'t get funding for all the pieces I need. And we don\'t have Title
III money unfortunately, which I have seen to be a more effective way of
integrating comprehensive care and treatment.

So I\'d just be interested from your perspective about how that debate
goes of trying to integrate this rather than having all these separate
titles and separate perspectives and separate requirements.

If the purpose is now to try to see that this is integrated care from a
medical point of view, which I\'m an advocate of, the 75-25 split, so
the support of care supports primary care.

So I\'d just like your view on that, or how those discussions happened
in this six months of interaction that you had.

MS. McGEEIN: Well, it was endless. There were both political reasons and
policy reasons.

The political reasons were obvious. The Title I to EMAs said, we can\'t
do this. Please don\'t do it.

The groups that advocate for the Title I grantees said basically the
same thing, that they could not rely - they did not believe that they
could rely upon the state to adequately address the needs within what is
now their EMA, and they felt that they made better use of the money by
coming straight to them.

That has some validity. If California had to consistently go to the
governor to find out, or to the state AIDS director, this is what we
need in San Francisco, there probably would be a loss of efficiency.

And one of my goals, and people who have been talking to me for a period
of time know that I want this act to be efficient, we feared a lost of
efficiency.

From the policy side, as a policy person, I don\'t disagree with you. I
believe that one fund however we allocated it out to states and
territories, have the potential for being more efficient.

But that would be the equivalent of a demonstration project that I am
not willing to undertake with a \$2.2 billion program that people\'s
lives are dependent upon.

So I hear you, I understand you. We\'re not that far apart, but it
presents lots of problems.

DR. REDFIELD: But again I guess the door would be open then for
considering in the future what you said, for some areas to try something
like that as a demonstration project to see if and how that could be
accomplished.

MS. McGEEIN: If somebody wants to step forward with a proposal we would
love to look at it. What state are you from?

DR. REDFIELD: Maryland. Do you have HIV name reporting yet?

(Off-mike remark)

DR. REZNIK: I have a question, Marty? And I don\'t know how to ask this
without asking a specific, so it might take me a second.

I guess the best way to ask the question is, will we have
reauthorization before the recess? I\'m not talking about the July 4th
recess; I\'m talking about before people go home for elections. It\'s
been two years, two state of the unions, incredible effort on your part,
and of the Four Corners, and we seem to be held up again.

So your take: will we get reauthorization this year?

MS. McGEEIN: Oh, gosh, are you going to hold me to this.

All of us are desperately wanting reauthorization. We believe that the
changes that are being proposed sets the - lays the predicate for a
different type of Ryan-White system.

The hold up on the House side - and I actually admire the person who
held it up a little bit - he - the belief was the data, the modeling
data that we had presented, didn\'t exactly capture all of the changes
and so basically to use my kid\'s language it got kicked to the curb.

We ASPE are about to start a new modeling - a new modeling run to see if
we can get data sufficient. That is the only thing that\'s holding it up
on the House side. As you know it was scheduled to be marked up last
week. A good look at the data said, time out, we\'re going to do
something different.

It is scheduled - I was actually going to look before I came - it is
scheduled in the House this week or possibly next week. There is on all
sides, the Four Corners Plus One, the advocacy groups, the people at
this table, the grantees, they want this over; the president wants this
over. But we also want an effective bill. We also want something that is
actually going to work. So we are willing to spend the time.

But I understand the election year pressures, and the need to get out of
here. The House is supposed to go out the 5th of August, and it\'s going
to stay out until the 5th of September. That means either a really
really busy July or a really really busy September.

But I\'m not giving you a yes or no answer, because in my heart of
hearts I so want this to be enacted.

DR. REDFIELD: Well, on your data run that\'s coming out of your
department, will you have that prepared?

MS. McGEEIN: We don\'t even have the data yet. So once we get - these
are not hard runs. These are not complicated multivariant runs. We\'re
waiting for one set of data. As soon as we get that data we\'ll start
loading codes and it\'s good to go. And computers are nanoseconds.

But because we are making changes, the data that we are looking for has
to be changed along with it. So we are asking agencies and operatives to
do things that they do not routinely do. I understand the reluctance; I
also understand the difficulty.

MR. HOLMER: Are there outstanding funding issues?

MS. McGEEIN: Not really. Do you have one in mind?

MR. HOLMER: No.

MS. McGEEIN: I\'m just trying to think. No.

DR. REZNIK: I think there\'s been some community push-back on the level
of increase that some of the titles within the Care Act are getting, and
some are actually being flat funded. I think that might be.

MS. McGEEIN: Is that your - okay. As you know the president is putting
in \$95 million into the Care Act, that currently is targeted to go,
\$70 million of it, is targeted to go part of it into the base Title II
and the remaining into ADAP. It\'s very specific months to clear the
waiting list. The \$25 million would go into Title III, it\'s scheduled
to go into Title III.

But as I\'ve said before to this group, my famous Lyndon Johnson quote,
the president proposes, the Congress disposes, the appropriators are
meeting as we speak, and we will see if we get the increase.

Easy group.

DR. REZNIK: Dr. Yogev.

DR. YOGEV: My understanding now is that some of the title will be open
to cities with 500 HIV/AIDS cases; is that correct?

MS. McGEEIN: That is not - that much - in the current act there is
something called the emerging communities. I think it\'s a city within
the metropolitan statistical area, and they have 500 up to 999 cases
that is not all - this is basically the same thing. The proposal is to
move that grouping, that type, into Title I. It may get moved back into
Title II. That is one of those - it flips on alternate days.

DR. YOGEV: If you do it it will increase the number of cities that are
going to pick up on the same amount of funding. Obviously it will affect
the biggest -

MS. McGEEIN: If it\'s a five year count. So they would have to
demonstrate that that had that number of cases for five years.

DR. YOGEV: Yes, but still, 500 is a much smaller number, which is
appropriate; I have no problem with that.

The point is there will be many more competing on the same amount of
money. Is that taken any way into consideration.

MS. McGEEIN: We\'re the authorizers. The Four Corners are the
authorizers; they\'re not the appropriators. Whether the appropriators
make the choice to put more money into Title I or Title II, we can
suggest but we cannot make them do it.

DR. YOGEV: I\'m a little bit worried about the efficiency, because with
all the documentation audit now you are requesting which are
appropriate, it\'s going to increase that administrative part, which are
not going to be paid by the same funds that are not going to be
disbursed to a much bigger number of cities.

MS. McGEEIN: I\'m going to have to ask you to remember that all of these
cities are located within states. The states will get money, and if
there is a city, or a grantee within a city that seems to be bearing an
unequal burden, then it\'s there obligation to let the city know that.
That\'s number one.

Number two, the Title III grants are designed to look at sort of
overall. If you\'ve got a city that has had a serious decline in their
financial resources from Ryan-White because of this new category, they
can certainly apply for one of the supplementals.

So there are two or three branches, avenues, revenue streams, that are
in the act that a city as you describe certainly could look at and go,
hm, I think that might work.

DR. REZNIK: I\'m back, and then Dr. Redfield, Marty.

There\'s two questions I have. One concerns ADAP, because you just
mentioned that part of what the president wanted was funding to address
the waiting lists.

And I\'ve read the legislation. Actually, I\'ve never read legislation
so many times that my eyes started crossing. Is there a mechanism in
this bill that would allow - we have that president\'s AIDS initiative
last year that was \$20 million, and there wasn\'t a mechanism through
the Care Act to actually get the money where it needed to go.

Will there be a mechanism in the reauthorized bill that will allow that
to happen.

MS. McGEEIN: These are all really good questions, thank you.

Yes, the second set aside in ADAP is called - Dr. Sullivan and any other
medical person - a potential space. For this time, for this cycle, it is
anticipated that \$40 million of the president\'s money will go into
that second set aside, the second supplemental. There\'s a set aside,
and then there\'s a supplemental. And the criterion for the supplemental
is specifically that there is an AIDS waiting list that needs to be
cleared, or that as Michelle very graciously identified, you have found
new cases through testing initiatives and cannot provide care for them;
that that\'s where \$40 million of that money is to go.

DR. REZNIK: So it could be states in the south. It could be New York; it
could be California, depending on their case minding.

MS. McGEEIN: Correct. But since one of your criteria would be a waiting
list, one can presume it will be states in the south.

DR. REZNIK: And then my follow up was, you just sort of mentioned that
tier three is sort of bouncing back between Title I and II depending on
the conversation.

Is there any similar conversation that you\'re willing to scare - she
scares me sometime - willing to share on core services? Is that
discussion - are the core services sort of set now? Is that set by the
Four Corners Plus One and over with?

MS. McGEEIN: That\'s done.

DR. REZNIK: That\'s done.

DR. REDFIELD: I just wanted to take an opportunity to learn a little
more on the waiting list, and you didn\'t mention the south as
disproportionately probably in that category in terms of patients that
have waiting lists for medication.

In the state of Maryland we\'ve been able to avoid waiting lists. How
much does the state contribute to this process? How much is federal
versus state? I mean are we again rewarding people that don\'t
contribute? Or is it the fact that southern states, like say North
Carolina, has a waiting list because they are not getting adequate
federal funding, or is it they\'re not using some of their own state
funding?

I\'d like to understand this a little better, because I\'m perplexed by
it.

MS. McGEEIN: All the above and next. First of all under the current
formula where we are counting AIDS cases, and it\'s a 120-month count,
so basically it\'s a 10-year count, in those cities and states where the
epidemic is fairly new, or that are doing a phenomenal job of keeping
people from progressing to AIDS, they do not get picked up in the
formula either for Title I or for Title II.

So in the south where for some period of time the epidemic was either
hidden or it had just migrated to there, they are getting very little
through the current formula.

So part of it is, certainly in Alabama, Georgia, Louisiana, North
Carolina, South Carolina, part of that is, there is aa federal -
they\'re getting less federal funds than the northern tier who have had
the older epidemic. That\'s number one.

How much the state puts in, I don\'t have that data; I don\'t even know
if that data exists. I\'m looking at Joe. David is telling me yes, it
does.

But it\'s a blend. The thing that we can fix is the federal formula. The
formula issue does affect those states that have a younger epidemic or
are doing a really good job keeping people from moving to AIDS.

There are some states who have their own financial problems who are
unable to put much money in. We have some states with less than perfect
Medicaid programs.

The fine line that we tried very carefully to walk is, we did not want
to create any perverse incentives to those states that have readily good
Medicaid programs who are willingly treating HIV patients or the AIDS
patients that take the burden off Ryan-White.

So it is a mix, it is a stew of reasons, that we could thread our way
through, but the only thing we\'ve got our hands on is the federal
funding.

DR. REZNIK: Dr. Sullivan, and then one more from over here.

DR. SULLIVAN: Marty, thank you for keeping us informed about the latest
study process.

I guess my question is related to I think some of the feeling I sensed
with members of the council, and that is, there aren\'t many legislative
days before Congress adjourns, and this really has been a long slow and
tedious process.

I guess my question is, would it be helpful for this council to urge the
Congress to really complete this bill before it adjourns before the
year; then coupled with that is another question to be sure if I\'m on
cycle, if they don\'t complete the bill this year, do they start all
over again? Or is this carried over?

Because it\'s taken a long time to get here, and what I hear you saying
is, we\'re very close, but somehow I get the sense - and this may be my
own misinterpretation - but I get the sense that this could run out of
gas, and we might end up without this.

So my question is, how can this council be helpful in trying to be sure
we get this really across the goal line so we\'ll really have this bill
and this funding.

MS. McGEEIN: This is when I speak very directly and I make everybody in
the room nervous, so of OGC is here, you might want to step out.

I don\'t know what PACHA\'s charter is. I don\'t know if it is within
your purview to send a message to Congress urging them to get this
across the goal line. I don\'t know that; I would bow to your more
considered opinion. I can\'t tell you that.

We are acutely aware of how few legislative days are left. You were
secretary here, sir, you know how much we live by the legislation
calendar.

There is among the Four Corners Plus One, we want to get this done for
all sorts of reasons.

There are people, there are groups, single people, groups of people,
that do not want us to get it done. And there\'s a movement to try to
stop it.

So we are working mightily to get it done. We believe that we have the
power to get it done. But you do need to know that there are people who
do better under the current act than they will under the new act. So
there are people who would just as soon see this fail.

If this fails, if this effort fails, regardless of what happens in the
November elections, we will not see a bipartisan bicameral group start
over again in January.

The president is still president. We will put our proposal forward; the
Democrats will put theirs forward; the Republicans will put theirs
forward; and then we\'ll duke it out.

But the reason I spent some time on process is, this is a very unusual
process, and the goal was to make sure that everyone was heard - I spent
a year or more, Joe was at many of the meetings, more than a year -
listening, thinking through, analyzing, collating information, from your
group, from the CHAC, from the advocacy groups, from individuals, we
read everything. We analyzed everything. We came to the table prepared
we thought with positions such that they represented not everybody\'s
personal opinion but the collation of those.

I want this to happen. I want this to occur. I want a new Ryan-White act
as predicate laid down. It is important for the clients who receive the
services.

DR. REZNIK: Marty, first, the amount of effort as I mentioned earlier -

MS. McGEEIN: How many questions are you allowed?

DR. REZNIK: I\'m chair of this section.

MS. McGEEIN: Fine.

DR. REZNIK: Until they boot me here. It\'s been an incredible effort by
all members that have been involved in this.

I have one question that\'s sort of a little bit different. It ties in
the testing initiative that really emanates from HHS through HRSA, it\'s
the bureau of primary care. Is the bureau of primary care actually
working towards routine testing in the community health centers which is
a concern?

And two, since I think that eventually has to happen, my final concern,
I guess my final statement, because as I said I\'ve seen the latest, my
latest version of the bill, I\'m sure not what you\'ve seen, I am
concerned about the percentage increases that are in the titles.

I know that it\'s not an authorized decision on appropriations, but I do
know that when the appropriators look at a bill, and it suggests that
3.7 percent for titles one through four, maybe - or three - and then
that four in part are flat funded, I think that we\'re going to - if
we\'re successful we are identifying more people; we will identify them
earlier in the disease.

But as someone who works in a very large program in Atlanta, we are
slammed. I mean honestly slammed. We are already a core service model in
that community. We have been for several years.

And if we see another huge influx of patients with a percent increase
that is much less than the cost of providing medical care, I\'m afraid -
and then Dr. Saag will talk to this tomorrow - and we\'re not seeing a
great swarm of new young providers coming to deal with this, I\'m afraid
that our own infrastructure, our own ability to care for this patient
population could dwindle with that number.

So I guess it\'s a two-pronged question. One, is the bureau doing what
it needs to do to get people tested?

And the 3.7 percent, I mean if that is what it\'s going to take to get
something passed then I\'m going to support it, but I think there is an
issue there, and I think there is an issue for ADAP. I think there are
issues for the care providers in one, two and three and other parts of
the act. I think that\'s important.

And I guess I ought to finally say before I let you speak is that we
will come up with a motion, whether or not it\'s within our
jurisdiction; Joe can determine that. But we will say something very
strongly, because I\'ve been acutely aware of the effort and the
dedication and the compassion that\'s gone in from all parties involved
in this process, and it needs to be completed.

MS. McGEEIN: Thank you.

On the Bureau of Primary Health Care and community health centers, they
are as committed to testing as probably anybody in the department, and
they are - and NIA is an interagency transfer of money - they operate
for this purpose with IAE from CDC. So they are receiving funds outside
of their appropriated base on a transfer level to make sure that testing
is occurring in the community health centers and other centers where
they are active.

But the big difference, and you probably picked up on it, but the big
difference in the law is that we are now seeing the rural health
centers, before were excluded from any service or any treatment money,
are now an eligible grantee, so that expands that base where we keep
hearing a lot of the problem is, but there are not the providers per se
to take care of it. So by including the rural health centers, and by
including the Indian health service both as a grantee, but also
excluding from the payer of last resort provision, we hope, we believe,
we\'re expanding that network of providers more broadly.

On the 3.7 percent increase there is this wonderful language called
notwithstanding. The appropriators tend to do what the appropriators
want to do. As I say they\'re doing it right now in Congress.

As I remember over the last three years or so that this issue has been
on my desk, I do believe that ADAP has consistently received additional
funds while the other titles have not.

David, I agree that there should be more money in this act. I also know
that there are multiple demands. Talk to Dr. Sullivan sometime in an
offhand moment. There are multiple demands on the federal budget right
now; this might be the best we\'re going to do. And it is an increase.
Everyone keeps saying it\'s level funding. Only in Washington is a 3.7
percent increase level funding.

So I hear you. I understand you. This is probably the best that we\'re
going to be able to do. Plus we\'re getting \$95 million extra.

DR. REZNIK: Jackie, and you\'ll be the last question.

MS. CLEMENTS: Okay, thank you.

Dr. Redfield, I guess in defense of North Carolina, I have to say we put
an enormous amount of money into our ADAP program. We are in the
southern states that are seeing a huge emergence of this infection, new
infections.

So you ran through, Ms. McGeein, a whole list of things that are part of
this legislation.

Can you tell me - and it really sort of blows my mind sometimes - but do
you see that this new act is going to help the southern states? And the
president did say, and we said, that we want the money to follow the
disease, and it is in the south, so we\'re in need of help in that area.
A lot of southern states are.

And so do you see that that is going to happen?

MS. McGEEIN: If we did nothing else other than shift the formula to
HIV/AIDS, if we did nothing else and walked away, your state would do
better, because you\'re a named space reporting state.

So if that alone, that changes the dynamic. It changes the way the funds
will be distributed; that should make a significant change.

Is it going to be enough to make up whatever shortfall exists in your
states? I can\'t tell you. But I do know that just that alone will make
a difference.

The federal government theoretically cannot legislation for states. But
the thing that we heard consistently over the year of information
gathering was that the epidemic is in the Southeast. The new burgeoning
epidemic disease zone.

So without creating a Ryan-White program for the Southeast, which you
probably would like, what we needed to do was to make the program that
we\'ve got more rational. And counting AIDS cases doesn\'t cut it.

So the biggest piece that you\'re going to get is going to be the HIV
counts. DR. REZNIK: Thank you, Marty, for a wonderful presentation, for
putting up with all our questions.

And again, please thank those Four Corner people plus yourself for the
tremendous effort that\'s gone into updating and modernizing.

Thank you.

MS. McGEEIN: A pleasure. As always, it\'s fun.

(Applause)

DR. REZNIK: Dr. Sullivan.

DR. SULLIVAN: Well, thank you very much.

We\'ll take a break until 10:25, and we will make up the 15 minutes we
are behind by having 45 minutes for lunch. So we\'ll try to keep the
rest of the schedule going. So 10:25, thank you.

(Whereupon 10:15 a.m. the proceeding in the above-entitled matter went
off the record to return on the record at 10:31 a.m.)

DR. SULLIVAN: Our next part of our deliberations will be under the
leadership of the prevention committee, who is chaired by Dr. Sweeney.
So Monica we\'ll have you take the chair.

PREVENTION

DR. SWEENEY: Thank you.

At this time I am going to introduce Dr. Leone, who is going to talk
about HIV sexual networks in college campuses.

I will just read what is written in our agenda and hope that you will
read his impressive bio.

Dr. Peter Leone, medical director, HIV/STD prevention and care branch,
associate professor of infectious diseases at UNC Chapel Hill School of
Medicine.

And it\'s really a pleasure to have Dr. Leone here. I have read some of
his things, and know that this is going to be very informative for us as
we go forward.

Dr. Leone, welcome.

HIV, SEXUAL NETWORKS AND COLLEGES CAMPUSES

DR. LEONE: Thank you. I appreciate the opportunity to present. And I
want to thank Joseph in particular who arranged for me to come here.

And we\'ll hopefully get into some lively discussion. I wish I could
tell you I had great answers for what I consider to be an ongoing
epidemic on our college campuses. I don\'t.

But I think one of the things that I\'m concerned about is that there
was a lot of attention brought to this matter maybe two years ago when
Lisa Hightow and I first reported on what we saw as a burgeoning college
outbreak among black college students in North Carolina.

Unfortunately, that epidemic seems to continue, and we have data that
actually runs through 2004. So what I want to do is give you a brief
overview on how that came to sort of our understanding of the outbreak;
what it means I think in terms of how this thing ties together. And I\'m
sure we\'ll get into some discussions about whether or not this is
unique to college campuses in North Carolina; whether or not it\'s a
broader issue that needs to be addressed; and whether or nor these cases
are somehow different than the underlying issues that black MSM face in
the south.

So with that I\'m going to go ahead and get started and actually present
a real case, a 21-year-old African-American male college student who
presented at student health at UNC, the urgent care clinic there; had
five days of sweats, heartburn, sore throat and fatigue, and on
examination was febrile but had a yeast infection in his mouth, had what
we call pharyngitis, and some tender cervical adenopathies, the swollen
lymph nodes in his neck. And again if you look at his labs pretty
nonspecific findings, low white blood cell count, mild elevation of his
liver enzymes, all which would suggest that he had some diffuse
inflammation, viral illness.

He had an HIV antibody test done, which is a standard way of doing
testing, and was negative, but he actually saw one of the infectious
disease physicians at UNC who thought about acute HIV, and this is
indeed what he had.

And the HIV viral load had over 6 million copies per mil, was p24
antigen positive as well, which is one of the proteins that we see
expressed on HIV, and was HIV-DNA positive.

So what this college student had was acute HIV, the very earliest stage
of HIV, and who Mike Cohen who is going to be here tomorrow - it\'s like
UNC day I think between today and tomorrow, so I\'ll have to give Mike a
little bit of grief, the fact that his staff actually made it here
before he did. He\'s coming in from England tonight.

But the importance of this was that we had just set up a program in
North Carolina at around the time that we started seeing college cases,
picking up this very early stage of acute HIV. And I think this is
important when we look back at how this epidemic took off, what drove I
think the early stage of this epidemic was the fact that we had a lot of
new cases with very high viral loads. Six million copies per mil means
that you\'re looking at very high potential for transmission. Short
phase of high infectivity during acute HIV only about eight weeks to 12
weeks, but important in terms of the fact that a lot of these kids are
missed, given a diagnosis of a nonspecific viral illness.

Now to put things in a broader context before I come back to what we see
among college students in North Carolina, this slide is looking at modes
of transmission in North Carolina in terms of risk factors. And what you
can see in this slide is that starting around 2001 - 2002 we started
seeing an increase in the number of MSM that were being diagnosed with
HIV, which has continued actually through 2005.

This parallels what you\'re going to see in terms of the takeoff of
college cases in North Carolina.

In November of 2002 North Carolina established acute HIV tracing and
screening program call STAT Program. It\'s a program designed really to
look at doing screening on folks who are HIV antibody negative, and
rolling those tests over to pooled assays which we can do HIV/RNA
screening. It\'s robotic pooling. It allows us to pick up this very
early phase like the case that I just talked about among the college
students in North Carolina.

First three months of the program we had five acute HIV cases. Two of
them were among college students; same town; they weren\'t connected
through direct sexual partners.

Now that may not seem like a lot, but for us that seems pretty unusual
that we would have two cases in the same town, and really raised a lot
of questions about, is this a bigger issue? What was the sexual
transmission network like? And so we would be looking further.

To be honest we made a few phone calls to a couple of clinics in the
area, and we found out that some of the clinicians in these HIV clinics
reported seeing college students newly referred to them, so that
actually started us looking back and doing a retrospective review of all
the states\' surveillance records, and men between the ages of 18 and
30, starting January 2000; now we have data through April 30th, 2005,
and in the summer we\'re going to be doing another sweep to complete
2005 and the first part of 2006.

We reviewed all 100 North Carolina counties. Now the reason we were able
to review records in North Carolina is that North Carolina has had HIV
reporting for years, name reporting of cases, all newly diagnosed cases
of HIV in North Carolina are interviewed. That information is entered
into the CDC STD MIS system. It\'s an information system that is kept
confidentially at the state.

When we saw this we were able to go back, review those records, and
actually abstract data that would allow us to look at this age group and
look for risk factors.

So we looked at all the counseling and testing site data, and reviewed
all of the DIS interview records that were available for newly diagnosed
young men between the ages of 18 and 30.

In doing that with Lisa Hightow we actually found about 1,400 cases of
new HIV diagnosis in men in that age group during that time period,
about a five-year time period.

About 1,200 of these cases were available for reviewing; that\'s about
85 of the cases. And it turned out that 13 percent of these were among
college students.

Now let me be very clear about what I mean by college students here.
That means when they were diagnosed they were enrolled in a school. So
we asked them when they were being interviewed, what\'s typically asked
is, where do you live? Where do you meet partners? Our DIS routinely do
that as a part of interviewing and review.

And in this case what they heard was that they were enrolled in a
school. So this college student listing is a pretty narrow definition.
They had to be enrolled in a college at the time they were diagnosed.

Does that mean they got infected in school? Not necessarily, but given
the age of these folks it\'s hard to believe that they got infected at
15 or 16, and what we are seeing when we start looking at this a little
bit more is that I do believe that many of these students got infected
while they were in school.

Now the bulk are still non-college students; 87 percent or so are not in
school. But it\'s the trend that is concerning here.

If you look at 2000, and look at the number of cases on the left hand
part of the slide, and the Y-axis here is by year, you can see an
increase in the number of college students, which is the light blue
column in terms of number of cases. The number of newly diagnosed cases
has also gone up during that time period.

Now it looks like there was a drop in 2005 but part of the reason for
that is, this is only the first quarter, and even though we have
reporting of cases that is mandated within seven days, there is always a
lag in terms of getting reports into the state where we can review. So
we\'re actually not going to have 2005 data until the end of the summer.
So I\'d be happy to come back at some point and tell you whether or not
our programs that we\'ve instituted in North Carolina have made a
difference in the last year or so. If anything the cases may have gone
up because we\'re doing more work on campuses.

So let\'s just look at the college cases, and what you see here are
about five cases in 2000. By 2004 we\'re up to nearly 50 cases.

Now that may be because we\'re seeing a slight increase in MSM, but if
you look at the percentage of total cases of young men between the ages
of 18 and 30, and how many of these were in college students, you can
see that it\'s not just a matter of increase in sheer number of total
new cases diagnosed. We went from around five percent in 2000 to around
15 percent in 2004.

So what we think is an alarming increase, and one that from an epicurve
standpoint would suggest that the numbers have gone up.

Now this doesn\'t explain why. It just says that we\'re seeing and
increase, and an increase in the number of cases in college students.

Now 14 or 15 percent may not seem like a lot, but just stop and think
about that number for a second. That means that about one in seven newly
diagnosed cases are in college students. That\'s pretty alarming.

In addition what it means is that we\'re probably underestimating the
number of cases that we\'re seeing here because again, the way we
collect this information is what\'s reported to us. It doesn\'t mean
that there aren\'t other folks that are infected.

And when we break this down a little bit more and look at the number of
college cases based on classified them as rather AIDS cases, whether
they were chronically infected or recently infected, and by recent
infection we mean that they either were acute HIV where they did not
have antibodies but were RNA positive, the first eight to 12 weeks of
HIV infection, or they had a documented negative test within six months
of being diagnosed with HIV.

And remember I said that early phase of HIV is very infectious. Lots of
virus in the blood and in general secretions, and again, may be a
driving force for transmission.

Now this is a retrospective look. So we don\'t believe, at least
starting in 2003 when we looked backwards that we biased the
information.

There were no new interventions on college campuses to increase
screening. And yet you can see here that when this thing took off, what
we can see is that about 30 plus percent, almost a third of these cases,
were recently infected college students.

Again, probably an underestimation of the total number that are recently
infected. Now we think that\'s important, because that\'s a driving
force we believe in terms of transmission, and I would like to think
that that\'s a contributing factor for why this thing took off when it
did in 2001-2002.

Now if we look at the cases, 85 percent of these are among
African-American males. So the bulk of these are young black men. In
\`79 about 60 percent report only having male sex partners, but about a
third report having both male and female sex partners, and about four or
five percent only female partners.

So almost 40 percent of these men report having female partners. Now
unfortunately Oprah got hold of this information, and invited an
individual who has written a book on the \"down low,\" focused on this
information. He actually posted this article on his website, or at least
the initial reports. And I think what\'s happened is we\'ve had a lot of
diversionary talk around men who are on the quote unquote \"down low,\"
men who identify as being heterosexual but have male partners on the
side.

And really what we\'re seeing here is more bisexuality, not men who are
not identifying as having sex with men; and I think that information has
further stigmatized MSM of color, further marginalized the group that
we\'re trying to reach, and has really sort of I think removed attention
from what is an ongoing issue here which is about how do we address an
issue of transmission that is affecting the broader aspects of the
community, both men and potentially women.

And we\'ll come back to this MSM-W, men who have sex with men and women
issue here in a second.

Now if we look at the college students, and we do a comparison of the
college cases, meaning the young men who are in college, and compare
those to the newly diagnosed men who are not in college, we find that
the college students were about three times more likely to be
African-American; about three times more likely to be diagnosed with a
recent infection; three times more likely to have both male and female
sex partners; and note where they meet their partners - the Internet
about sixfold greater than the non-college students, and on college
campuses.

Not surprising they would meet students to have sex with on college
campuses - about 16, 17 fold greater risk. There are 30,000
African-American male students who attend colleges in North Carolinian
any given year. If we assume that five percent of those are MSM, men who
have sex with men, that only leaves about 1,500 MSM black male college
students. So if these students are more likely to meet other students to
have sex with, and our data would suggest that they are much more likely
if they\'re college students, it\'s a pretty small sexual network pool.

If you have HIV that enters into that network, then you\'re going to see
much more transmission occur, especially during these early stages.

So what we have here, I think, are small networks and isolated groups of
individuals who connect up with acute HIV driving the epidemic.

The question has been, well, how do we make that connection, given that
we have all these scattered cases, we\'re looking at the whole state.

What ties them together? Well, the two - three things are going to be
the bars, the Internet and the college campuses.

The college students were less likely to meet someone who was diagnosed
with AIDS. They were less likely to know or have a partner with known
HIV or AIDS, which would suggest that we\'re going to have to do a lot
more testing and education on campus.

We published an article with the CDC, the MMWR article where they did
interviews, college cases, and they also looked for quote unquote
controls, meaning non-HIV infected MSM who are college students, and
those who were young men who were not.

We found no differences in behavior, but a common thread in all this was
that none of them thought that they were at risk of acquiring HIV. In
fact about 70 to 80 percent of the young men who were diagnosed with
HIV, when they came in for the test that led to their diagnosis thought
that they were unlikely or very unlikely to contract HIV; yet 40 percent
of those men engaged in unprotected receptive anal intercourse with a
partner that they did not know their HIV status.

Are they dumb? No. They know how HIV is transmitted. But as human beings
they underestimate their risk.

Lots of reasons for that. They don\'t consider themselves quote unquote
gay. When they hear messages that are talking about HIV, they view it as
something that\'s out there in other communities, not theirs.

Number two, there is no discussion in North Carolina leading up to this
around ways that MSM can protect themselves. What they hear in their
schools is about abstinence, and abstinence until marriage.

I\'m all for abstinence, but these men don\'t perceive risk, and when
they engage in sex, whether it\'s anal intercourse or oral sex, they
don\'t understand that they\'re putting themselves at risk for acquiring
HIV, even though it seems obvious, because they don\'t believe their
partners are at risk, because they are young healthy men.

When asked why they didn\'t think they were at risk, what we\'re hearing
is, well, they didn\'t look like someone who would have HIV. They were
in school; they were healthy; they were good looking; they drove nice
cars; they dressed well. Has nothing to do with HIV, yet that\'s what
they\'re holding onto.

They\'re afraid, frequently when we talk to them, about getting HIV
tested, because they\'re worried about being further marginalized or
stigmatized on their own campuses.

So what\'s happened because of a lot of the homophobia that still exists
within communities, these guys meet folks, have anonymous sex, and
because there is no discussion about ways that they can protect
themselves, no open discussions about the risk for them, they put
themselves at risk.

Now you\'ve got a lot of maps. I\'m going to run through these pretty
quickly, because I really do want us to have time to talk.

We wanted to understand what the extent of this was, and this is a map
that looks at the number of cases by colleges, and where they connect.

And what you can see here is that we can connect many of the schools
into a network, the yellow dots the size of the yellow dots represent
the number of cases. And you can see, our metropolitan areas tend to
have the higher number of cases, and these cases connect across the
state.

But note here, we\'ve got cases that connect into Alabama, Louisiana,
South Carolina. We know for a fact we have cases that connect up into
D.C. and Virginia.

Yet there is very little reporting about what is going on amongst
college students in other parts of the south. I don\'t believe based on
our data that this is unique to North Carolina, nor is it unique to our
college students. It\'s a much broader issue in the south that is going
to have to be addressed; otherwise we\'re going to have a generation of
young men who are going to be dying in the next five to 10 years, or
coming in sick, because they don\'t perceive themselves at risk or
infected with HIV.

To understand this a little bit better, we did a network analysis, and
this is done for other diseases. But we wanted to actually look at HIV
in a slightly different way, and that is to treat the individuals and
the schools as well as the clubs as individual sites, and see if we
could connect things up to explain this.

Now this is a network diagram of the college cases who are connected by
partners. And what you can see here is there\'s been a lot of scattered
partnerships.

Individuals here that don\'t seem to connect, and these closed loop
networks, mean that these are all sexual partners, but nothing that ties
all these cases together.

So the question here is, how do we explain this big epidemic if we\'ve
got these small little clusters? Well, the way to do that is to not - is
to realize that we\'re maybe not getting all the information on
partners. And indeed a lot of these partners are anonymous sex partners,
so there is no name, no contact, no information.

But we do know the schools, and we were able to get information from
these students about where they meet their partners in terms of what
other schools. So we treat the schools like partners here to draw
networks.

So the circles represent the different schools. You can see the greens
are out of state schools, but note here we have University of North
Carolina system, community and technical college, and private schools
such as Wake Forest, Duke University.

These connect up, so this is one school. The triangles represent
students. The solid line means that this student with HIV attends this
school; the dotted line means that this student meets partners at this
school.

And you can see that we can connect much of the individual cases if we
start looking at the schools as a place of connection, not just
individuals.

If we did what we call an egocentric network where we look at the
schools as the component first, and then look at where we branch off,
you can see that the S here represents schools, the Cs represent college
cases, and you can see a rather large network in red that connects many
of these cases together. All the reds are all one network.

So the explanation for why this took off I think again is that they\'re
meeting students at other college campuses, which is why we desperately
need more activities on our college campuses to say HIV is real, it\'s
not just real out in the community; it\'s not just real in developing
countries. It\'s real and it\'s being transmitted on the college
campuses which you attend.

Now I said that we\'ve looked at multiple factors that connect. We only
have several MSM bars for minorities in the state, and they tend to be
in the major metropolitan areas, and again, these are major connecting
points.

Here we look at one of them. It\'s a bar. And we look at the cases. And
you can see how many of the college cases connect to one bar.

It acts as sort of an accelerant, a way to bring these students into one
place where they can meet across geographic areas. Jackie knows that
students drive to Greensboro from Charlotte to Raleigh. There is a big
night in Raleigh, North Carolina where students actually come down from
Washington, D.C., to see a DJ, which brings students in from across
North Carolina and other states.

Charlotte is a hub that brings people in from South Carolina, Atlanta,
we\'ve got a mixing of populations here, students meeting other
students.

And then there is the Internet. This is one website where the students
that we interviewed said they met partners. And you can see how the
Internet also ties this together.

Now why is this important? It\'s important, because when you look at
acute and recent cases, you can see how they tie up very well with this
network. So the red dots here represent acute cases of HIV, and you can
see we\'ve got websites in here and bars and colleges that connect up
with all of these students.

So these students are connected through many different ways, and when we
start looking at only named partners, it falls apart.

So if we are going to do interventions, we need to actually plan on
doing more over the Internet, which allows a safe haven for folks to
meet individuals, especially in rural North Carolina. We need to do
things in bars. The CDC based on the early reports funded an initiative
called a popular opinion leader model for young black men in our bars in
North Carolina. We got funding for one year. It\'s over; no continuation
funding.

And we actually had a very good campaign that started to do education
outreach to young men in the bars where they did not design their own
outreach information, their own distribution. And the whole goal, to be
blunt, was to reduce the amount of unprotected receptive anal
intercourse.

The data over the course of a year suggested that we had statistically
significant reduction in risk behavior with students reaching students;
yet that funding has stopped.

In some ways you can\'t keep going back after the populations we\'re
trying to reach, tell them we\'re going to start initiatives, do it for
awhile, and then pull the plug on the end of it and expect that they\'re
going to be able to do this either on their own, and that it says that
we have good faith to continue the activities.

So one of the things I\'d like to see happen is a reinvestment in some
of the initiatives that have started, not just in North Carolina, but
other parts of the country, to reach minority students.

Now again looking at these cases, you can see how complex all of this
is, and I just throw these up here, mostly so you have an idea of the
complexity of the components.

Now let\'s go back and look at the MSM-W. Remember I said that I thought
that I thought that talking about the \"down low\" has been somewhat
distracting dealing with the overlying issues around transmission.

Taking a quote out of the New York Times that did an article now three
years ago on the \"down low,\" it says in a letter written to them on
their article, I think a lot of these young men only have wives or
girlfriends to cover up their homosexuality. In the meantime they are
denying who they are.

And my question is: Are they? And I don\'t think that they are. And the
reason for that is based on these three things.

We get them confused when we have discussions, and unfortunately when
we\'re doing outreach I think it also gets confusing. Sexual orientation
refers to whom you are attracted; that could be men, women or both.

Sexual identity is how you describe yourselves to others, and it\'s
contextual.

Sexual behavior, though, is with whom you are having sex. Our outreach
activities need to be based on sexual behavior.

So I\'m going to use a very brief example because people say, well, how
can this possibly be? Either you\'re gay or you\'re not, you\'re
straight or you\'re not.

My question is, how many times do you have sex with a man to be gay? Is
it once? Twice? Three times? In our country we tend to think of things
in very divisive attitudes. We do that with race and skin color; we do
that with sexuality.

I\'m going to use my ethnicity as a stepping off point. I\'m an
Italian-American. My grandparents were from Italy. They moved to - or
took a boat - to New York. My parents were born and raised in New York.
So was I. We moved when I was a kid to Ohio. And about 21 years ago I
moved to North Carolina.

When I lived in New York as a kid, people asked me what I was, I said
Italian.

When I went to Italy to visit my relatives, they looked at me like I was
crazy if I said I was Italian. I was American. In New York I was an
Italian-American. In Ohio I was a Yankee, and when I moved to North
Carolina, there was another expletive in front of that.

The point is, I\'m all of those things, but it really depends on where I
am and who\'s asking the question. Yet around sexual identity and
behavior, we like to lock people into blocks.

So let\'s go back to this issue of MSM-Ws. I mentioned that about a
third of the college students reported having sex with men and women in
the previous 12 months to their being diagnosed.

The overwhelming majority of those were African-American. In fact the
college MSM-Ws were more likely than the non-college to frequent bars or
clubs, to meet sex partners, and one-third of the college students who
identified themselves this way reported the names of only male partners.

So we have a problem reaching a lot of the women. I think that that\'s
something again we need to redouble our efforts here to do more outreach
and encourage testing among young women who are at risk.

Now looking at the gender of the sex partners, you can see the
comparison here of the 18 to 30 year old men, the first 103 cases.
Thirty-six percent of the black college students reported both male and
female sex partners, compared to seven percent, or only one out of 14 of
the white students.

And in a multivariable analysis when we compared this, we found that
MSM-W were twice as more likely to look at all those 18 to 30 year old
men to be college students.

And note this last bullet. In terms of reporting 10 or more sex partners
in the past year, about three times more likely.

So the MSM-W is an important bridging group we believe, not in terms of
the heterosexual community, but there may be some difference here about
really connected across networks.

So barring an article, some data from an article we published with Lisa
Hightow, looking at these networks, you can see looking again at the
college networks, we have six separate networks, seventeen schools, 58
students. If we add any MSM-Ws here, we have one giant network, 95
students, 26 schools.

So the MSM-W we believe is a critical group to do outreach if they
don\'t identify necessarily as being gay or heterosexual. So we have to
come up with the right target message, the right way of really doing
outreach.

So prevention for bisexual men. Some bisexual men may be in transition
to homosexual identity; I don\'t think we really know. Other bisexual
men will never identify as being gay, and may not even identify
themselves as being bisexual. Again, more research around this is really
needed.

And all of this again comes back to being more creative and dealing with
the Internet. So again if we look at the percent of students meeting
folks over the Internet, we can see that this has really taken off to
now more than 60 percent of the new cases report meeting their partners
over the Internet. And by doing that you don\'t have to identify
yourself, you don\'t have to identify your sexual identity, necessarily.
You can meet people, but the problem is you know nothing about them. So
even if you ask about sero status, it\'s only helpful if you are
positive and your partner is positive.

If you are negative and the person says they\'re negative, you\'re still
taking a chance. So I think again we\'re going to have to be very clear
on our messages. And I\'ll skip over these for the sake of time.

Then we can see how complicated these networks are.

Now it\'s not just black college students. In the last year we\'ve seen
a change now where we\'re seeing crystal meth in the mix, and again the
Internet that plays into this.

So this is a rather complicated sexual network looking at primarily
white college students. You can see the reds are the acute, and not how
this one acute case in the center connects up over the Internet to many
other cases, and crystal meth is in the mix.

So I think if we\'re going to do activities on college campuses, we need
to address issues around a growing at-risk population.

So what do we learn about this outbreak? We recognize it because we\'ve
had real time surveillance methods that have been linked to partner
counseling referral methods, and traditional outbreak investigation,
which is what we did.

We did a network approach which allowed us to find things that we
didn\'t seem to see connected before, and what we demonstrated is that
this was an ongoing network transmission for African-American MSM and
MSM-W attending school.

And more importantly, bars and the Internet really do I think act as
accellerants for transmission. So if we\'re going to begin doing
interventions, and if we\'re going to try to intervene, we have to
address not only the college campuses, but really be more creative in
our efforts in bars, and in particular over the Internet.

And finally college students represent an at-risk population for an
ongoing HIV prevention interventions. Now again, you may say well, this
is a small percentage of all the transmission that we\'re seeing, but
it\'s an important percentage, because it is a rising middle class
population in the south. Future leaders for African-Americans in the
rural south in particular. They are going to be dying with HIV if we
don\'t intervene now; we are going to see further transmission if we
don\'t intervene now.

So we really need to step it up in a way that doesn\'t further
marginalize a group that we so desperately need to reach.

I\'m hoping again we\'ll have a chance to talk. I think it\'s 11:00
o\'clock, and I assume we have a few minutes for questions.

So I\'m going to stop talking about PowerPoint slides, and maybe move
from behind the mike.

DR. SWEENEY: Thank you very much for that, and we are going to take a
few questions. And I know there are a lot of questions, but we\'ll give
Jackie privilege this time being a North Carolinian.

MS. CLEMENTS: Oh, thank you, thank you. So very southern of you.

Peter, I want to thank you for your presentation. I\'ve seen you do a
part of this before.

And I think I want to say something that sort of reinforces something
you said earlier. We\'ve been talking a lot about routine testing, and I
think it\'s important to have routine testing to reduce the barrier for
an opportunity for a person to get tested.

However with the routine testing comes the removal of the educational or
counseling piece, and one fo the things that you mentioned, and that I
have talked about, though a lot of folks know the basics of how you
become infected with HIV, what they don\'t do, like you said, is
internalize that and use it to protect themselves from infection.

So when we\'re talking about getting rid of counseling, we\'re talking
about getting rid of providing that educational piece, routine testing
will reduce the barrier; just that. It will reduce the barrier. However,
most of the folks that we test are probably going to be negative, and
when they hear that they won\'t get the education, and so they\'re going
to go back out and do what they\'ve been doing because they keep coming
back getting that negative result, so they don\'t get that information
to say what you\'re doing is putting you at risk for infection.

And that is my big concern for - I work down the street from HBCU. I
test a lot of those college students that come through there. And that
is an issue they don\'t understand how the risk factors are actually -
what they\'re doing, what their behaviors are.

DR. LEONE: You know I actually agree with the CDC initiative to try to
expand testing and make it routine from the sense that, one, we\'ve got
about a third, 25 percent of known HIV infected individuals who don\'t
know that they\'re infected.

However if you look at minority communities, especially black MSM, it\'s
much higher. Some of their data would suggest that it might be 50 - 60
percent of these men don\'t know that they\'re infected. So expanding
testing is critical, and yet I don\'t think you can do it to make it
routine and have all the counseling pieces in place.

But I do worry about cutting out counseling altogether, and addressing
the needs that are there for high risk individuals.

Now on the heterosexual, married, and we\'re in a mutually monogamous
relationship. Do I need HIV counseling? I don\'t.

So I think we have to recognize that there may be different needs in
different situations, and we\'re going to have to figure out ways of
delivering that.

My big concern is that, and I\'ve seen it, a negative test doesn\'t mean
that it\'s okay to have unprotected sex. Yet this group, I think, will
take their negative test as a get out of jail free card. And I\'ve seen
it happen.

We had a case of five transmissions that happened because a case of
acute HIV was missed, a college student thought he was HIV negative, and
had unprotected sex, and we saw transmission down the road.

So the problem we get into is, I think we\'re going to have to also
counsel folks that a negative test on your partner doesn\'t mean that
you don\'t use condoms, that you don\'t engage in risk reduction if
you\'re going to engage in sex.

And somehow that has to get out, and I think we still need to provide
counseling around that, but it may be in a different setting outside of
the medical setting. I think you can\'t necessarily do all of this at
once.

DR. SWEENEY: I\'m going to follow David Reznik\'s model - remember he
asked about 10 questions because he was chair; I\'m only going to ask
one.

Based on the 21-year-old actual case that you presented, I\'m wondering
whether you think when you\'re testing for HIV that the HIV/RNA antigen
test should be the standard instead of using antibody tests?

DR. LEONE: Well, you ask the million dollar question. I think my boss,
Mike Cohen, will hopefully address it, because we exchanged slides, so I
promised him I wouldn\'t talk too much about it.

I think we\'re going to need to change our strategy. The antibody test
works really well. The problem is, you miss this window.

Now should RNA or antigen testing be done everywhere. The problem with
RNA is that it\'s expensive and there\'s a time delay. But the
technology is certainly there to do really sensitive p24 antigen
testing.

And so I think what we\'re looking at is probably coming up with a
combined assay that would do a rapid antibody and antigen test, and then
you can roll those folks over. That\'s where we need to drive, I think,
development.

What would be even better yet, and I was just in New York at NYU talking
about this last Monday, what we need is a point of care test that can be
rapid for p24 antiget. And it can be cheap now.

There is a company that actually is marketing, not in U.S. yet, an
antibody p24 combo assay that would be relatively cheap compared to the
RNA assays.

So what we\'re doing in North Carolina is to step over, I think, until
we get to something like that.

It doesn\'t have to be everywhere, but I think in high risk settings
like STD clinics we do need something else besides the antibodies.

DR. SWEENEY: Thank you.

I think Dr. Bollinger, and then Ted.

DR. BOLLINGER: I just had a very quick follow up question. Thanks again
for a great talk.

As you move toward more routine availability of some rapid testing that
you\'re describing, particularly for acute infection, it gets back to a
question that was raised a few minutes ago about the need for
counseling.

One of your premises is that the acutely infected people are
significantly driving the new subsequent infections in these networks,
and so without - if you have that kind of rapid test available, and you
are not linking counseling to them, you\'ve got a particular challenge.

So I think it\'s important as we have more and more technology for more
rapid testing, particularly for identifying acutely highly infectious
people, the counseling is critically important to link to that testing.

DR. LEONE: We need more I think understanding about what\'s the
appropriate counseling message. And the nice thing about this, and
actually Andy\'s wife, Carol Golin, and I have been talking about this,
is with acute HIV a small change in behavior for a short period of time
can actually have dramatic downstream benefits in terms of reducing
transmission.

So if you can get people to just change their behavior for 8 to 12 weeks
you can maybe have a significant impact in transmission networks.

DR. SWEENEY: Dr. Green.

DR. GREEN: Thanks for an interesting talk.

It sounds like a very basic problem was that these men didn\'t feel at
risk for HIV infection. So I was thinking about the first two countries
in Africa, the first two AIDS success stories, Senegal and Uganda. Both
countries were successful in making men and women feel personally at
risk for HIV infection. In fact of all the countries in Africa by about
2,000, women in Senegal felt more at risk than women from any other
country in Africa, and yet Senegal has the lowest HIV prevalence of any
continental sub-Saharan African country.

Anyway the formula seemed to be fear arousal, even though we don\'t like
that term, and then self efficacy, showing people clearly what to do to
not become infected.

So it sounds like with the population you\'re dealing with of MSM/W
because they were college students and drove the right cars, men didn\'t
feel at risk, so here in these countries in Africa men and women were
made to feel at risk, and then people were told clearly what to do.

In the case of Uganda in particular, the main message was, stick to one
partner; it wasn\'t abstinence. It was partner reduction. Or be faithful
to one partner.

So you mentioned you had a program in bars. I\`m wondering if you use
either education to make men feel at risk, when they don\'t - when you
know that that is a basic problem. And then if the prevention message
was, stick to one partner for something, you mentioned distribution and
protected sex, so that sounds like condoms.

I wonder what your prevention message was.

DR. LEONE: Well, the prevention message was something that they
developed about HIV is here, they knew about the data, they needed to
take steps to protect themselves, so it was a self efficacy model that
was used. And I think it really had tremendous impact, because the
messenger was one of their peers.

I think the challenge here, especially for young black men, is, they
don\'t relate frequently to what they view as gay white male message,
and frequently because of the homophobia that exists in many of the
communities, they don\'t want to be identified that way, and I think
what happens is, while they\'re trying to explore this, many of our
young men come from rural counties, rural towns. They come to a college
campus. They\'re not sure what they\'re interested in, or who they are
attracted to. So they experiment, or they do activities that put them at
risk.

The hard part has been delivering that message in a way that\'s viewed
as being safe, because a lot of them don\'t want to hear it in a large
group setting. So I think you are right, we need to deliver a broader
message to men, because we don\'t know if a person is straight, gay or
bi, and the truth is, in some of our minority communities in particular,
if you are sexually active you are at risk, period. That\'s really all
that really matters. Which is why I think we want to focus on behavior.

How we deliver that in a way that doesn\'t just create fear is the real
challenge, and I don\'t know, we need more I think behavioral research
to figure out what is the best message or how do we deliver it.

DR. SWEENEY: Dr. McIlhaney.

DR. McILHANEY: I think that what you presented, your studies were
brilliant, just really, really good.

I\'m going to ask a couple of questions, three questions. And I\'m not
challenging your comments, but just to know what you have to say about
this.

First, you said 18 to 31 -

DR. LEONE: 18 to 30.

DR. McILHANEY: Do you have a distribution. Were most of these real young
college kids?

DR. LEONE: Yeah, so most of them were under 25. I think the median age
was somewhere around 23, thereabouts.

DR. McILHANEY: So they were mostly pretty young people?

DR. LEONE: Yep.

DR. McILHANEY: Second, if your behavior change message primarily is the
usage of condoms, our group, our science group, looked at the
effectiveness of condoms with alternative sexual behavior, oral sex,
anal sex, particularly. And as I remember, there wasn\'t one good study
about the effectiveness of condoms with anal sexual behavior.

Are you familiar with one that -

DR. LEONE: No, I think part of the problem is to be honest getting
funding to do those kinds of studies and how you do them. And I think -
so it\'s hard to do them.

But also what I want to be very clear about, I believe in telling a lot
of these students that they should wait. No one is advocating that they
should go out and engage in high risk activity. Nor do I want anyone to
get the opinion or the feeling that by talking about condoms we\'re
saying it\'s okay to engage in these behaviors.

But the truth is for many of these students they have no other venues to
talk about their sexuality, or to explore it. So the least we can do is
make sure they can protect themselves with condoms. Yet there is not
much information out there, both pro or con, about anal transmission.

DR. McILHANEY: Don\'t get me wrong, I think every one of these kids
should use condoms if they are - I think they should be set down in
front of somebody eye to eye and told you must use your condoms.

But my question is, when we say protective, if we don\'t have studies
that show what the level of protection is, we need to be straightforward
with what we know.

DR. LEONE: We have good studies looking at transmission of HIV in
condoms. What I\'m not aware is condom use specifically for anal
intercourse.

DR. McILHANEY: That\'s what I\'m talking about.

DR. LEONE: So I think we can look at discordant couples. We can look at
population based levels. And there at least the suggestion would be that
condoms really are very effective.

DR. McILHANEY: And intuition wise I would say that they are probably
somewhat effective with anal intercourse. But we know they break a lot.

Anyway, I just had that question. I think we need to be careful about
what we know and what we do tell people.

The other is that you made a comment that you certain thing abstinence
and faithfulness important, and that\'s a message all these kids have
heard.

Do you have data on that, that these kids, the primary message they\'ve
heard has been about abstinence?

DR. LEONE: Well, I do, because North Carolina is an abstinence only
state, and it\'s been that way for awhile. We have four school
districts - I think it\'s down to three now - that have a comprehensive
curriculum.

So virtually all these students, when they were coming through school,
because that started in the mid-1990s, heard abstinence only.

And the abstinence curriculum I reviewed in North Carolina - I was
booted off of reviewing the subsequent thing - does not talk about
anything other than vaginal intercourse and abstaining, period.

So the dilemma, and I\'ll be really blunt about this, if you are told to
abstain until you are married, and you only hear about vaginal
intercourse and you can\'t get married, then you are sort of told if you
are someone who is attracted to men, your options are never to have sex.

DR. McILHANEY: Sure, I understand that.

DR. LEONE: So that\'s the dilemma for a lot of these kids coming up to
be really blunt about it, and I think that that is unconscionably bad
public health.

DR. McILHANEY: The real question is, what do these kids, by the time
they get in college, even understand or retain what they\'ve heard.

DR. LEONE: They have an hour or two hours of HIV education in high
school, and that\'s it. And Jackie can tell you, and I\'ve looked at the
curriculums. It\'s really pretty basic.

So we really need to - I think the problem is that it\'s the highest
risk folks that we\'re really missing what we need to deliver. The
messages that are out there for lower risk heterosexuals probably may be
sufficient; may be not, because they get other STDs, that\'s a whole
other story.

But around HIV we\'re going to need to do more to target, I think, MSM,
especially young MSM.

DR. McILHANEY: Okay, thank you.

DR. SWEENEY: You\'re on, Sandra.

MS. McDONALD: It is always a pleasure to hear you present. I really
appreciate your hard work, particularly looking at college students.

Have you had any contact or any information on any other college
campuses that might be experiencing young males or females who are
positive? Do you have any information about any other college setting?

DR. LEONE: Outside of North Carolina?

MS. McDONALD: Yes.

DR. LEONE: Well, I know there was some work down in Atlanta that was
being done, and that as far as I know involved a series of meetings and
one town hall meeting that was conducted there. And then that, so far as
I know, didn\'t continue after that.

I\'ve talked to Dot Brown who is at an HBCU outside of Baltimore who has
done some work up at her school. That\'s been about it.

So there\'s been a real lack, even though we\'ve met with the college
health association around doing more, we need more funding to do more on
the campuses, and particularly, the HBCUs.

MS. McDONALD: Unfortunately, stigma is a great barrier.

DR. LEONE: We talked about that, and my big concern is how do you do
outreach on HBCU campuses who are very dependent on not so much research
grants but on students attending the schools to survive, without their
being labeled as being the HIV school.

So when I\'ve gone out to talk, I\'ve actually had students, or schools,
asking, well, how many cases came from this school or that, which I
never do.

And the concern is that whoever steps up to the plate first is going to
be labeled as a school that has lots of HIV and people aren\'t going to
want to send their kids there.

So we really need a grassroots I think across-the-board effort to
address this and embrace it that has to happen at a much higher level in
the system.

DR. SWEENEY: Joe Grogan, and then Rev. Lusk.

MR. GROGAN: Thanks, just quickly I have two questions.

One is, have you been speaking on college campuses at all? Is there any
interest among college presidents in having this message brought to
students?

And then the second question is, you mentioned a couple of times about
the students getting missed, and getting diagnosed with maybe
indeterminate viral infections. I\'m wondering is that because maybe
nurses and doctors don\'t perceive the students are at risk, and
they\'re not doing these tests? Maybe you could comment on that.

DR. LEONE: So the first question, yes, Lisa Hightow, Justin Smith and I
are working on college campuses. We have a grant though the Department
of Health and Human Services, project style, to do outreach on campuses
in the area and Raleigh.

It\'s been very successful at Central. North Carolina Central has
stepped up to the plate big time to be involved. But even they have sort
of a little bit of resistance of doing even more activities.

North Carolina A&T has also been really open to activities on campus.
But the problem is, a lot of the college university presidents don\'t
want to be identified with HIV, and that\'s true in the majority of
universities, too. I can\'t get the chancellor at UNC to ever address
this in a broad way.

So I don\'t think it\'s unique to HBCUs. We\'ve only had a couple of
schools.

Benny Primm came to speak in North Carolina. We had a meeting, great
attended meeting at North Carolina A&T, and then the plan is, over the
next year, we\'re going to have a little college tour of HIV testing
days with this project style on each one of the state campuses in North
Carolina, so we aren\'t just targeting HBCUs but the HBCUs in North
Carolina, some of them have stepped up to the plate.

Now getting back to the second question, the problem has always been
around acute HIV, as it\'s a relatively rare event, and clinicians
don\'t think about it, and if they do they order the wrong test. So we
really need to do more awareness around the signs and symptoms and get
clinicians to start thinking about it in terms of their differential
diagnosis.

The second thing is, we know who\'s at risk, so I think there should be
an awareness campaign for MSM around the signs and symptoms of acute HIV
so that they go in and get care.

Looking at the five cases that I didn\'t talk about of the acute HIV
that we had last summer among college students, all of them went to be
seen. None of them were diagnosed the first time they went in for HIV.

It\'s a real problem, and I think we have to do more education around
that.

DR. SWEENEY: Reverend Lusk.

REV. LUSK: Great presentation; thank you so much.

I was just wondering, could you give me just a little more information,
detail, on what you felt the confusing or the conflicting message was on
the Oprah show regarding the \"down low\" message, and how it conflicts.
And also these numbers are really kind of frightening, particularly just
hearing you say that many college presidents are not even open to
discussing the situation.

Some type of rejection if it\'s not dealt with, if there is no
intervention, how bad could it be in your estimation?

Those are the two questions I have.

DR. LEONE: Pretty bad. I don\'t think we know the extent of it. And the
problem is I see continued transmission that is happening on the
campuses. And again because these networks are small, I really think
that we are sitting on the precipice of the significant problem on our
campuses.

We\'re now up to 153 cases, and I anticipate by the end of the year when
we do our sweep for the last year we\'ll be probably close to 180 to 200
cases, somewhere in that ballpark, since the beginning of this. So that
is significant.

I think that I worry about it actually moving more into the middle
class, because this is an ever-revolving population. Students are in for
a couple of years and then leave, and they go back to their hometowns or
communities, many of them undiagnosed. So we don\'t know how many
students we\'ve missed.

The confusion I think with the Oprah show was the fact that black men in
this country have been marginalized, pushed to the side, stripped I
think of a lot of dignity that\'s been there. To have a show which
focused on sort of raising the suspicion that black men are again
transmitting a disease, not only to other black men but to women, in my
estimation, can further marginalize the group that we are trying to
reach.

And the truth is that, in looking at the college students, virtually
none of them were quote unquote on the down low. The majority of them
identified as being bisexual. They weren\'t open about necessarily
talking about wanting to fit into one slot or the other with a
definition. But they didn\'t have this sort of I\'m heterosexual and I
actually have sex with men on the side mindset.

So although I think it\'s probably real, my concern is that it\'s
sensationalism; it doesn\'t really get down to dealing with the core
issues here about behavior and understanding how to deliver message.

And I think as long as we talk about trying to identify who it is who
can give me quote unquote HIV we never get down to the basic issue,
which is, you have to be responsible for yourself, and if you are
someone who is dealing with your own sexuality, you need to find out
what your own status is and protect yourself as well.

And that\'s what I worry about. Actually Oprah asked me to come down to
the show, and I said no, because I didn\'t like where the show was going
to go. Initially it was going to be talking about college students, and
then the next thing it was going to be about the book. So I stayed at
home. One of our college students actually went and was interviewed. And
J.L. King has made a lot of money off this.

DR. SWEENEY: We have time, and the two hands were David Reznik and Dr.
Redfield.

David, you get to ask one question.

DR. REZNIK: The abuse I take.

My question is, any training going on for the clinicians at these
colleges to recognize acute HIV syndrome, and if you knew how many of
them present with candidiasis, just out of curiosity.

DR. LEONE: Yeah, it\'s a small number that present with candidiasis.
I\'ve looked at the presenting symptoms, and it\'s small. It\' somewhere
less than 10 percent. I think it\'s actually down around three to five
percent. So we\'ve seen it, but it\'s relatively rare.

We\'ve done some education. We haven\'t done enough. We\'ve met with the
colleges. We\'ve talked about this. We talk about acute HIV. We\'re
actually trying to do a series of interventions across the state now to
sort of take it on the road, but again, I think we need a lot more help.
There\'s only a handful of us going out there doing this, so we\'ve met
with some of the student healths early on with this thing, and they\'ve
been on board.

I still get pages and phone calls from in particular some of the student
healths in the area, but I still think we\'re missing it. Because the
students unfortunately don\'t necessarily go to student health. When we
went to North Carolina A&T what I was impressed, things haven\'t changed
much from when I was a college student. Students are afraid that they
get diseases from going to student health, rather than student health
helping.

So we had a big meeting at A&T and I swear they went on for 15 minutes
how people were coming back with urinary tract infections from going to
student health and being seen. And so like whoa, let\'s get back to the
issue here.

Unfortunately, they go back to their primary care providers quite often
in North Carolina because they have insurance, or because they don\'t
want to talk about their sexuality, and they get missed.

So I think we\'ve worked on student campuses, we\'ve worked with the
coalition of college student health, but we need to do more.

DR. REZNIK: Just to follow up there is a very good AIDS education and
training center, Southeast AIDS education and training center, which is
based out of Emery, that has a presence in North Carolina. And maybe
they should focus on training the clinicians to recognize acute HIV.

DR. LEONE: Well, I\'ve met with Robin Swift who is at Duke, and we\'ve
talked about this. We actually have posters now that we\'re distributing
and little cards, so we\'re going to be sending those out.

The problem is, we tried to set up some meetings, and we didn\'t get any
hits from the clinicians on wanting to give talks. We had three of us
that had agreed to give talks through that training center in North
Carolina.

So again, I think we\'re going to have to push the agenda on this,
because I think many clinicians just don\'t think it\'s important.

DR. SWEENEY: Before Dr. Redfield, are condoms easily available in North
Carolina without waiting to ask the clerk or go behind the - you know,
they\'re put behind the desk so you have to ask - behind the counter so
you have to ask for them? And are there free condoms available on
campuses?

DR. LEONE: There are free condoms, and Jackie can comment on -

MS. CLEMENTS: There - well, on campus, I\'m not sure how available they
are.

DR. LEONE: I\'ll tell you a story which is still a little disturbing. Go
ahead, Jackie.

MS. CLEMENTS: But they can go to any health department, they can come to
where I work and get free condoms. But they are not just sitting out,
and you do have to ask for them.

And also with response to David\'s question, students don\'t like to go
to student health to get tested. They don\'t like to be tested at
student health because of their concern that the information may get
out. Students work in student health, and so they don\'t usually go
there for testing.

DR. LEONE: So condoms are available through all our publicly funded
clinics for free, but you usually have to come up and ask for them,
which is a barrier.

In terms of college campuses, it really varies. Some of the schools that
are more religious based, we\'ve worked with, are now at least beginning
to approach having condoms, but many of them didn\'t like the idea of
having condoms.

But even on our status campuses, UNC in particular, they have free
condoms that are available, but the students aren\'t actually allowed to
physically hand them to someone. They have to be in a bowl or a bag or
out, and the reason is that one of the former chancellors didn\'t like
the idea that they were handing out condoms and said that you can\'t do
that.

So there is no written rule about it, but a sort of unspoken rule on
campus. So my suspicion is that if that is true at UNC which is viewed
as one of the more liberal campuses in North Carolina, you can think
about the barriers that exist on some of the other campuses.

DR. SWEENEY: And Dr. Redfield, you\'ll have the last.

DR. REDFIELD: I\'ll shift gears for a second.

Peter, again, I think people know, again, really to congratulate you and
your team over the - I think it\'s been almost three or four years now
I\'ve been following the idea of trying to diagnose HIV infection using
viral detection methods by pooled, and you\'ve obviously demonstrated it
and its effectiveness.

I\'d be interested from your perspective, because I again, having been
in this now for 25 years, I know when we got the antibody test, the
public health service fairly rapidly applied that, for its prevention
consequences.

I think you can make a very compelling argument that sero-negative HIV
infection, particularly among young people that are sexually active and
STD clinics in particular, a lot of the epidemic is driven by that
population; a lot of work has shown that. So what\'s it going to take to
try to take these evidence based data that your state has provided and
you have done to try to more effectively integrate that into a public
health approach?

DR. LEONE: I think it\'s going to take more data than just North
Carolina. And we talked about this. I\'ve been out to Colorado and
Denver. Frank knows. Literally we\'ve been going from state to state to
try to push this.

Now I\'ll give my little beef here. I shouldn\'t in North Carolina be
the person going out there having to push the agenda countrywide. I
don\'t mind doing it; it\'s fun; I like working with my colleagues.

But there really should be a more bigger buy in at the federal level
around this. Instead what we got is a demonstration project which is
great, but it\'s been saddled with too many questions, and it\'s going
to take another five or 10 years before this gets rolled out.

And I don\'t think you need more data. At some point you respond to what
you know in HIV, because by the time you wait for more data you\'re five
or 10 years down the road.

So we can do this; we can do it cheaply. We know where we need to target
this. And I think STD clinics is a great place to start. We should be
doing it, but we need more help and support.

Upstate New York is doing this, but they\'re doing it on their on.
Colorado and Denver is going to be doing this, but they\'re doing it on
their own.

This is the story across the country. DR. REDFIELD: I\'d just like to
echo that point of view. It\'s sort of frustrating to see commonsense
and public health and then to have evidence based data show this with
the perseverance that your group has done to take it through the
different steps to make this practical, and then demonstrate its
practicality.

And I think this is an area where the public health service in
particular, on the federal level, needs to be much more aggressive in
trying to see this implemented.

DR. SWEENEY: I \`d like to thank you again. You wanted discussion. You
knew you could count on us for a very lively discussion, and I hate to
cut it short.

I hope you\'ll be here -

DR. LEONE: I\'ll be here.

DR. SWEENEY: \-- you\'ll be here so that we can get you at lunchtime,
because there are other people who have questions.

Thank you again very much.

DR. LEONE: Well, thank you for the privilege of being here. Thank you
very much.

(Applause)

DR. YOGEV: Can we discuss a new committee that PACHA recommend to revive
p24 antigen? p24 antigen was killed. The two companies that did it and
are still doing it, because it doesn\'t detect less than 10,000 as
effectively. But acute infection, what\'s unique about it is, if you
notice, six million. That\'s exactly what happened in the pediatric, and
we cannot get p24 antigen.

P24 antigen is so cheap if you do it enough, and maybe PACHA should push
to encourage companies to produce it and people to use it, and here you
have one of the indications, it would be very important to push it
forward. It would be cheaper than the ELISA. It was cheaper than the
ELISA.

(Off-mike voice)

DR. SWEENEY: Joe is taking notes on things we need to follow up on, and
that will be on the list of things that we need to address, and thank
you.

At this time we are going to move the program to our next speaker, Dr.
Andrew Kaplan, professor of medicine and microbiology at UNC School of
Medicine. And he\'s one of the founders of the UNC Prison Work Group,
and he will be speaking to us, I have on my paper, HIV and
Incarceration, but on the slide, we have Collateral Damage
Incarceration: HIV in Vulnerable Communities.

But he\'s before us to speak on incarceration and HIV.

Thank you very much.

HIV AND INCARCERATION

DR. KAPLAN: Yes, thank you very much.

I think before I begin it\'s at least worth acknowledging that following
Dr. Redfield\'s comments about North Carolina, there have been three
consecutive speakers from North Carolina. So I\'d like to express my
condolences.

In any event we\'re going to talk today about the impact of
incarceration on the treatment of people living with HIV, as well as the
spread of the epidemic through vulnerable communities.

I feel that this title is a particular apt one, because we have come to
understand, and we hope to convince you, that incarceration is an
important barrier to the effective treatment of HIV infected people, and
it also plays an important role in encouraging the spread of the
epidemic through vulnerable communities.

So I\'m going to talk a little about the setting of incarceration and
the overall impact of incarceration; the spread of HIV within prison;
medical treatment in prison; HIV testing in prison; and then the special
case of county jails.

Following my talk Dr. David Wall is going to talk with you about the
transition from incarceration to freedom for HIV-infected patients.

Before I begin, though, I need to acknowledge our collaborators. As we
heard we\'re members of the UNC prison working group. And here are the
people that are part of that group and have done a lot of work that I\'m
going to speak with you about.

And we\'ve heard a lot today about funding, and I also need to
acknowledge the people that have provided the money for the work that
I\'m going to tell you about. Pretty much all the data that I\'m going
to show you has been funded by grants from the National Institutes of
Health, specifically the National Institutes of Mental Health and the
National Institutes of Drug Abuse, and at NMH it\'s Chris Gordon, Andrew
Forsyth, David Stott and Dianne Rausch; and NIDA it\'s Elizabeth
Lambert.

And these people in addition to providing the funding have provided a
lot of the intellectual support as well as the guidance, and we\'re
thankful to them.

So it really is no exaggeration to say that minorities in general, and
African-Americans in particular, reside at the intersection of two
powerful overlapping and ultimately reinforcing epidemics. Those
epidemics are the epidemic of HIV infection, and the epidemic of
incarceration.

Black Americans are as you know black Americans are at risk of acquiring
HIV at rates that are severalfold higher than white Americans. Sixty
percent of the prison population are racial or ethnic minorities. As you
can see about 12.6 percent of all black men between those two ages are
in prison or jail.

And then finally the prevalence among inmates is about eight to tenfold
higher than in the general population.

As I said I\'m going to talk about the setting and impact of
incarceration, and I\'d like to think about it in different levels
starting with society.

First of all incarceration reflects a tremendous diversion of resources
from other things we could be doing with them. For example North
Carolina, the budget of the department of corrections is about a billion
dollars a year, which is just about the same as the budget for the
division of social services and the same as the budget for the division
of mental health and substance abuse.

There is one example you can use. About three million children have a
parent in prison. That\'s about five percent of the children in the
country have at least one or both parents in prison, and as you might
imagine children with parents in prison are at risk for a number of bad
outcomes, including about a fivefold risk of becoming incarcerated
themselves.

And then finally I think it\'s worth noting the sort of what I think is
the morally corrosive effect of having all these prisons, keeping all
these people under incarceration, and spending all this money on this
one thing.

It\'s interesting, those of you who are familiar with the work of the
early abolitionists, they talk a lot about the moral depredations of
slavery, particularly the obviously the effect on slaves. But they also
spend a lot of time talking about the morally corrosive effect of
slavery on the slaveholders, and I think that\'s something that affects
all of us, and that we need to consider when we talk about this debate.

In terms of the national level at any one time about two million people
are incarcerated in the United States, and this is a 300 percent
increase in the last 25 years.

As far as the state prison systems are concerned, about 600,000 people
are released every year, and we\'ll hear more about the impact of that
from Dr. Wall later, but it\'s important to note that not only do you
have two million people in prison, but there is a tremendous churning of
people going in and out of prison which causes disruption of social
networks as well as lost economic opportunity.

The county jails, ten million people pass through that system every
year. One out of every five of the HIV infected people in the U.S. will
pass through the correctional system every year, making the point that
there is a tremendous overlap between HIV and incarceration.

And then finally it\'s been estimated that if current trends continue,
about one out of 20 of us can expect to spend a night in jail sometime
during their lifetime.

I\'d just like to do sort of a little prison 101 just to kind of get you
up to speed in terms of the system of incarceration. There are -
virtually all of the people that are incarcerated in the United States
are kept at one of three levels of incarceration. There is the federal
penitentiary system. These tend to be older inmates. They\'re in for
longer periods of time. And the medical system in the federal
penitentiaries tend to be in house systems in which all the doctors are
employed by the federal government and they have prison hospitals et
cetera.

At the next level, and what I\'m going to talk mostly about, is the
state prison system. Each state has an integrated system of state
facilities. Usually quite a few; in North Carolina it\'s about 87. These
are different levels, maximum, medium and minimum level security.

The inmates are a little younger. They\'re usually in their early 30s.
The average length of sentence is three to five years. In terms of
medical care there is usually a hybrid of prison docs that are employed
by the state, as well as usually some contract people.

And in fact that\'s what we do; we provide the HIV care for the North
Carolina Department of Corrections.

Finally, there is a different entity, and these are the county jails.
And these are very different from the other two. Usually these are run
as independent entities by each country, generally run by the county
sheriff. They have a very high turnover. The average length of
incarceration is on the order of 48 hours. Police bring people to the
county jail straight off the street, so there are a reasonable
percentage of people who are either drunk or high or actively psychotic.

Because they are each run by the individual counties, although there
is - there are rules in terms of how they need to be managed, and how
the medical care needs to be delivered, as you might imagine, this is
the level of incarceration at which there is the most amount of
variability, and I\'ll talk a little about that at the end of my talk.

The impact of incarceration at the community level, in the United States
there is about one white man for every white woman. In terms of the
African-American community, there are about nine black men for every 10
black women, so the ratio is somewhat skewed.

That\'s in part due to the fact that the African-American men die at
greater rates than white men, but it\'s also due to the fact that so
many African-American men are in prison. AS you can see about one-third
of black men between the ages of 20 and 29 are under correctional
supervision, either in prison or on parole.

And then finally as far as the community is concerned, you know prisons
are dangerous places. There are a lot of people who are there for drug
crimes. And I think when you have so many people go in and out of
prisons, what eventual you\'ll see, certainly you\'re at risk of seeing,
is a normalization of incarceration itself, as well as a change in the
normative community values in terms of what\'s okay in terms of sex,
violence and drug use, what\'s acceptable.

Here\'s a study that was conducted by a colleague of ours, a member of
our group named Dr. Ada Adimora. She looked at about 250 black men and
women with and without HIV infection in North Carolina.

So comparing the HIV-infected men with negative men, she found that the
infected men were sixfold more likely to have had a sex partner who had
been incarcerated; the HIV-positive women were fourfold more likely to
have an incarcerated partner; about 81 percent of the HIV-infected women
reported that at least one of their last three sexual partners had been
incarcerated; so four out of every five women knew that one of their
last three sexual partners were incarcerated.

And then finally, about a quarter of the HIV-infected women, and about
two-thirds of the HIV-infected men, had themselves been incarcerated
during the past 10 years.

And obviously their individual impacts of incarceration affects,
obviously affects your employment prospects, benefit eligibility. For
example in North Carolina if you\'ve been convicted of a drug crime
you\'re ineligible for food stamps for six months following you release
from prison.

Once again, you\'ll hear more from the next speaker about all the
challenges associated with reintegrating into society, so now we\'re
saying that in addition to those we\'re not going to help you find food
for six months if you\'re convicted of a drug crime.

They\'re disruptive of social and family networks. Prison itself can be
a brutalizing experience, as we\'ll hear in a minute. And then finally
I\'ll talk a little bit about HIV transmission itself within prison.

So before we begin to talk about the inmates themselves, it\'s probably
important to think about who is getting incarcerated. What\'s the
population that\'s getting incarcerated?

And due to limitations of time, I\'ll just focus on one thing, which is
the experience of violence for the people who are incarcerated, and talk
specifically about women.

There are a number of studies that have been conducted, but in general,
they report that between 10 and 90 percent of women have been the
subject of violence.

In a study that was conducted by another member of our group, Kathy
Fogel who is a professor at the UNC School of Nursing, she - we\'re
conducting a randomized control trial of an intervention to limit HIV
risk behaviors of HIV-negative female inmates upon release.

And one of the things we did is, we collected data about their
experiences with violence, and the results are shown here. What you see
is 81 percent of them report that they have ever experienced violence or
abuse. About half of them have said that they have ever been forced to
have sex. About half of them also said that they were hit, kicked,
slapped, physically hurt in the last year. Three quarters say that they
were physically or emotionally abused. Ironically only 10 percent say
they are afraid of a partner or someone else. And about two-thirds said
that they ever felt unsafe.

To look at those numbers a little more, of the women who said they were
physically hurt, hit, slapped or kicked in the last year, they reported
that this happened an average of 32 times in the last year, so about
once a week or so these women were physically abused.

As far as who is conducting it, once again to give you a sense of what
their lives are like, almost all of this violence is intimate partner
violence; it\'s almost all people they know, either a partner or an ex,
in terms of who\'s hitting them, who\'s abusing them, and who is making
them feel unsafe.

Now to move to HIV transmission within prison, it clearly occurs,
although there is not a lot of data saying how much.

Here is an example of a syphilis epidemic in the Alabama Department of
Corrections that was evaluated by the CDC, and you can see the number of
cases increasing.

Just in case you thought that there wasn\'t sex going on in prison, here
is another example of the social networks that Peter so eloquently
described.

Here is someone that is infected with syphilis, and these lines indicate
sexual contact between this person and this person. This guy had sex
with nine people, and this person had contact with six people in prison.
So this is something that occurs, and certainly presents a risk for HIV
infection.

Now a more thorough study was recently reported by the CDC and the MMWR
in April. And what they did is, they looked at HIV transmission in the
Georgia state prison system. So in 1998 Georgia implemented a policy in
which everyone entering prison was tested for HIV. And then people were
tested again later on a voluntary basis. So inmates were tested at the
beginning, all of them, and some of them, for whatever reason, decided
to get tested, or if there was a medical indication that they should get
tested, they were tested.

And what they found during a seven-year period is, 88 male inmates were
negative when they came in but turned positive sometime during their
incarceration, which indicates they were infected while in prison.

Remember this is a lower estimate of the number of people, because
although they tested everyone when they came in, they didn\'t test
everybody again, so we\'re certainly missing some people.

The Georgia Department of Corrections has about 45,000 inmates. The
median age is 34 years, and about two-thirds are blacks. This is a
reasonable approximation of all the state prison systems in the
Southeastern United States.

About two percent were known to be HIV infected, and among those the
overwhelming majority were African-American.

To look for a minute at the people who were infected in prison, 54
inmates reported have male-male sex while in prison. About
three-quarters of those reported no male-male sex during the six months
before incarceration, and this gets to another idea of sexual identity
and sexual behavior. These are people who at least six months before
prison had no male-male sexual contact, but while in prison had that, so
there is some suggestion that there might be more male-male risk
behavior when you\'re incarcerated for a long period of time with just
other men.

Among these, about three-quarters reported consensual sex, and 89
reported sex only with other inmates.

Of the 43 inmates who reported consensual sex, 30 percent reported using
condoms or other improvised barrier methods - things like rubber gloves
or Saran wrap.

Of the 14 inmates who had sex in return for something else, about 3
reported using improvised barrier methods but not condoms, and no
barrier methods were used during rape.

I think it\'s important to step back and consider this for a moment,
what this means. So these are people that were convicted of a crime,
that we\'ve put in prison. They\'re incarcerated; they\'re under our
supervision. We can\'t protect them from getting raped. We can\'t
protect these men under our supervision from getting raped.

In addition, in almost every jurisdiction in the United States, it\'s
not permitted to have condoms in prison. So these are guys who are using
Saran wrap. They understand they\'re at risk. They try to protect
themselves; but we deny them the means to protect themselves.

Here are the people that are most at risk in that study in terms of a
multiple variable analysis. If you had male sex in prison, if you
received a tattoo in prison, or if you are African-American, you are
more likely to be infected.

Perhaps more troubling is this information that if you body mass index
is under 25 at entry you\'re at greater risk of infection.

The body mass index, or the BMI, is an overall measure of your size. It
takes into account your weight and your height. So in other words, just
to give you a frame of reference, my BMI is about 23.

So smaller people, smaller men, were at greater risk of infection. And
whether that\'s because they were more likely to have sex, or were less
able to defend themselves against sex, is not clear; but it\'s certainly
troubling.

It\'s interesting, medical treatment in prison, there is a fair amount
of data, although there is a lot of variability, you\'ve all heard the
horror stories, there is a fair amount of data that medical treatment in
prison is actually better than comparable people get on the outside or
the same people get on the outside.

And here\'s a review of studies of pregnancy. These are women who gave
birth in prison. And what you can see from that top panel there is that
women who give birth in prison are shown up here, and these are compared
to themselves to the same women who gave birth out of prison, or
compared with these controls. And what you can see here is the risk of
having a low birth weight infant.

Women who give birth in prison are about half as likely to have a low
birth weight infant as women who give birth - when the same women give
birth on the outside. And I think that is a measure of what it means to
take people out of a chaotic environment and provide them social service
and free medical care.

And it\'s also telling that as horrible an environment as prison is,
it\'s better for these people medically than when they\'re out of
prison.

Here\'s some data that was published by one of our colleagues, Becky
Stevenson White, and what you see here in the gold bars are the viral
loads of people who stayed in prison, and the red bars, you see the
viral loads of people who were released and then reincarcerated. So the
gold bars are much lower indicating that the viral loads are better
controlled than after people are released.

I only have one slide for HIV testing in prison, because almost nothing
is known about HIV testing in prison. Nineteen states have mandatory
testing; 31 states that incarcerate about 70 percent of the state prison
population, prison testing is voluntary.

We have recently submitted a proposal to do HIV testing anonymously in
all of the inmates entering the North Carolina Department of
Corrections, to look at what encourages testing, and to look at the
risks associated with getting diagnosed in prison in terms of abuse or
violence.

There is a fair amount of data to suggest that the people who decline
voluntary testing when they get to prison are the people most at risk of
in fact being HIV infected.

And then finally to end with the special circumstances in talking about
jails, remember I told you that jail is a fairly chaotic environment
with high turnover. This is a study that was done by one of our
students, someone named David Rosen. And he surveyed all the county
jails in North Carolina. He found that only a quarter tested more than
one person for HIV per month. In three-quarters of the jails the health
screening form was administered in a common area, typically to a group
of inmates.

So essentially what you\'re saying is that in the last 12 hours all the
inmates that are incarcerated get into a room like this, and a prison
guard will ask, who wants to be tested for HIV, raise your hand?
Obviously it\'s not an optimal setting.

Corrections officers then administer the screening form in virtually all
the jails and dispense medication in four out of five of the jails. And
as you might imagine these are not people that are trained as
pharmacists; they are not people trained to do health screening. And
it\'s an inherently coercive environment. So this is obviously not the
best way to get sensitive health information from a newly incarcerated
person.

And in terms of confidentiality, all the medical staff and all the
offices agreed with the statement that if an inmate is taking
medications in jail, other inmates will know about it.

So I\'ll stop there and let my colleague, David Wohl, take it from here.

DR. WOHL: I want to thank the board for the invitation to present to
this group, and I\'ll just jump in so we don\'t lose any time.

As Andy mentioned we are providing HIV care in North Carolina to the
state of North Carolina Department of Corrections, and also are doing
the work that we\'ve talked about here.

So I\'m going to just capitalize on the background that Andy gave you
and try to make several points.

One is that incarceration fuels the HIV epidemic through the modes that
Dr. Kaplan has gone over, and I\'m going to capitalize again on some of
the themes, indicating that we felt HIV is fostered by incarceration, by
the disruption of the existing relationships, personal relationships
that people have before they\'re in prison and after they get out. And
that there may be prompting of risk behaviors in and out of prison.
I\'ll go over some of those data.

As Dr. Kaplan mentioned, HIV care in most prisons and some jails is
good, but I think the benefits that are accrued during incarceration are
usually lost after release as we saw with the increasing viral loads of
people after they get out of prison.

And I think in the absence of a reduction in the absolute number of
people we incarcerate, who are at risk for HIV infection, the transition
from prison or even jail to the community is probably the best
opportunity we have to reduce the contribution of imprisonment to the
spread of the virus.

Some points that are worth thinking about again and emphasizing is that,
again, one out of every five persons living with HIV infection passes
through a correctional facility, so there are opportunities that we can
leverage in order to impact the effect of incarceration on HIV, and
also, HIV on communities that people return to.

And I think it\'s also important to recognize that the vast majority of
persons who are incarcerated do not stay in prison for a very, very long
period of time, especially HIV infected persons. For men the mean
duration is about two years, and for women, it\'s probably half of that.
Women get incarcerated for other types of offenses, and usually petty
crimes that carry shorter sentences. So people are cycling in and out of
prisons and into the community at an astounding rate.

So we\'ve gone over some of the disadvantages, and I\'ll point these out
again, of incarceration as far as HIV is concerned, and incarcerating
large numbers of persons, especially persons of color, can have
deleterious effects, socially disruptive, just as we\'ve talked about, a
removing a significant number of men from a community can contribute to
some of the behaviors that we\'re trying to avoid as far as HIV
transmission, and that gender imbalance that Dr. Kaplan mentioned.

In prison HIV transmission does occur, and the Georgia data are very
insightful there. But again in the context of how many people are
infected in Georgia in the Department of Corrections, it seems that just
a small percentage of those who are incarcerated with HIV in that system
acquired their infection in prison, and a great majority came into
prison with their HIV.

I\'ll show you data that indicate that there are probably increase risk
behaviors by people after they\'re released from prison, and that there
may be increased risk behavior by the partner who remains in the
community.

So there are all sorts of effects that are going on both within prison
and outside of prison.

There are advantages of course to incarceration, and this has been
pointed out as well. It\'s a point of opportunity for HIV testing. Many
states do a better job of that than others. Transmission risk reduction
interventions can also be applied. You have a captive audience, and
effective evidence-based interventions can be applied and can be
effective.

In prison HIV treatment improves the health and potential productivity
of the individual inmate, but possibly even has benefits after the
person gets out, and reduces infectiousness, as you\'ll hear more about
I\'m sure in the next day or two. HIV therapy can reduce the amount of
virus that is in the blood plasma, and by extension, in different
compartments within the general tract, and reduce infectiousness, so
there could be a public health benefit that should be realized as well.

And effective discharge planning if done correctly can link people to
community resources that they may not have accessed prior to their
incarceration.

So who are the people who are getting out of prison? Well, our research
and others indicate and paint a picture of a very complicated setting,
where most people have no home to go to. The majority of people in our
system don\'t have a stable setting in which they will return. Our work
also demonstrates that more than 50 percent of the people require
ongoing mental health care either for depression, other mood disorders,
or psychoses. Almost all need substance abuse counseling, especially
HIV-infected individuals who have largely incarcerated for drug-related
crimes; job training; parenting classes; go without saying.

And then ongoing HIV transmission risk reduction is becoming an
important feature, we think, in people who are HIV infected. Certainly
everyone who is HIV infected needs HIV care.

So I\'m going to capitalize a little bit more and expand upon the last
two points that are being made here. We\'ve done some work looking at
the effective release of people who are HIV infected on behavior and
access to care. So this is a prospective observational study of over 170
HIV-positive persons; 74 percent were African-American reflecting the
population in North Carolina Department of Corrections, and almost 60
percent were women. Again, more women are incarcerated for shorter
periods of time, so there are more women who are released relative to
men, even though their numbers are smaller in the prison system.

So there are two groups we were studying. In blue is the group that we
interviewed before they got out of prison, and then an average of around
36 days after they got out of prison.

So the blue will code for people who were interviewed in those two time
points. We also took advantage of people who were coming back into
prison after a delay, so these were people who were released and then
came back into the prison, and we interview them when they came back
into prison. These two groups are mutually exclusive; these are not the
same people. So we have the two cohorts that I\'ll go over.

So for people who are released, when we interviewed them about a month
after they were released, 100 percent had received HIV medications at
release, and that\'s pretty standard at most department of corrections.
You\'ll get a 30-day supply or basically what\'s left over in your pill
bin and given to you when you get out the door along with prescriptions
and maybe some appointments.

The mean number of days of the supply was about 32 days, which is about
right. And then since release, though, 17 percent have gone without
medicines of a lapse of at least two days. And most of these when we
asked them more about it is, they run out or they lost it. And as far as
accessing care, 41 percent had not seen a health care provider since
they\'ve gone out. This is any type of health providers, emergency room
or routine appointment. And 46 percent felt that their health was better
than when in prison. The other proportion obviously felt the opposite.

When we at recidivists, people who had been incarcerated and then were
freed for a period of time, and the mean duration of freedom was a
little over a year, you see a greater opportunity to have more trouble.
Thirty four percent, or a third, who were on medicine run out of
medicine while they were free. And the mean time from release to running
out of medicine is about 159 days, and the length of time offered
therapy of course is over 200 days.

They did not receive care while free, a third of them; hospitalized,
almost a third as well. And most people agree, you could read this
yourself, but they had trouble accessing and using care while they were
out.

Again homelessness being in a halfway house or shelter was common as was
substance abuse, relapse.

Importantly we asked these people about their sexual behaviors, and for
the people when we interviewed them prior to their release, almost 80
percent had indicated they had unprotected sex during the year that they
were - the year before they were incarcerated, and then when we followed
up with them a month after they were out, already 26 percent had had
unprotected sex. And I should tell you, there is quite a bit of
counseling that does go on in the North Carolina Department of
Corrections regarding safer sex.

When you looked at recidivists who epidemiologically were no different
from the cohort listed in blue, but had more opportunity to practice
unsafe sex, again, we\'re seeing numbers approaching 70 to 80 percent of
people who indicated they had unprotected sex while they were outside of
prison. All these people knew that they were HIV infected.

Rates of unprotected sex were fairly high, especially among their main
partners as opposed to casual partners; and they believed - most of them
believed that about half their partners were HIV uninfected. And a third
of each group felt it was somewhat or very likely they would infect one
of their partners.

So Dr. Kaplan went over this, and this has implications. If we see that
there is increased risk behavior when people leave prison, and this
slide shows you - these are couplets, so each of these colors are one
person. So the yellow represents the viral load in the blood fo someone
getting out of prison, before they get out of prison, and the red is
what their viral load is when they got reincarcerated. And about 42
percent of people in North Carolina get reincarcerated who are released.
So you can see the people who stay low are yellow and red are at the
same level. You can see the majority of the slide is red, and that
people that started out with a very low viral load or undetectable, and
then came back in prison with a very high viral load.

So you can see this is a perfect storm of increased risk behavior, and
high levels of virus, probably also in general secretions.

And that\'s important, because other data, I won\'t get into it, that
the amount of virus you have in your blood predicts whether or not
you\'re going to infect your uninfected partner.

So what can we do to make transmission more successful? I don\'t really
have any very good answers, because we don\'t have a very broad
collection of data to guide us.

Education certainly is something we could center our thoughts on. And
there are different types fo educational interventions, motivational and
skill building, educational counseling has been found to be effective
for risk reduction, both for HIV infected and for HIV uninfected
persons. This can be done in jail, and in prisons. The challenge is
doing it also after people get out.

We could spend a lot of time and money educating people and counseling
people while they\'re incarcerated while they have limited access to
some of the things we\'re asking them not to do, as opposed to when they
get out of prison where it\'s a free for all and the intervention stops.

So things that can bridge that period of time from incarceration to
community release might be more effective, although again we don\'t have
a lot of data yet.

I think community partnership is a big part of this, and this is kind of
a commonsense move. We\'d need buy-in from communities, from AIDS
service organizations, work out ways to get them inside of correctional
settings so they could work with people before they get out.

It\'s going to take some buy ins from leadership. Faith-based programs
may be particularly effective, and there are pilot programs that are
going on, but I\'m not aware of any results to date.

Again, I want to center our discussion on HIV therapy, because we know
that it\'s effective for the individual, but also has a public health
role in reducing infectiousness. For many of our people who get out of
prison, they have limited access to HIV medicines. In our state when
people get incarcerated they lose access to the AIDS drug assistance
program, and if our AIDS drug assistance program is no longer taking new
applicants, they cannot get medication through that program.

And also lastly, I\'m going to talk a little bit about new approaches to
traditional case management, and end on that point.

As most of you appreciate, case management is a comprehensive approach
to providing services and coordinating services and mental health and
other services that are used. It\'s considered a glue that holds
together a bunch of different needs that people may have, and the
setting of HIV case management, it\'s been shown to be effective in
creating benefits advocacy, supportive services, home health, and it\'s
been also shown to decrease recidivism, reincarceration, both in Rhode
Island and in Massachusetts in studies that have looked at it.

So there are a number of improved health outcomes that can come from
quality case management. Currently, we\'re doing an NIH-NIDA sponsored
randomized controlled trial of a novel case management program that
begins before people are released from prison, and continues with that
same case manager after release for six months.

This is different than traditional case management, in that it\'s a very
motivational strengths model, case management that\'s very motivated and
tries to let the client lead where the case management is going within
limits.

And this is a randomized study, so people not randomized to the bridge
in case management receive standard discharge e planning, which I
described as, here\'s your medicines, here\'s your prescriptions,
here\'s your ADAP forms, don\'t forget to send them in.

And we are following people for a year after they get out, the bridging
case management program will exist for three months before they get out,
and then six months after release.

So to date we have 102 participants enrolled. They\'re all HIV infected.
Again, 76 percent are men, 81 percent African-American, fairly
consistent for all our work. Seventy five participants have been
released to date, and the median time out is about 130 days. And I\'ll
show you some preliminary data that we put together for the purposes of
this meeting.

Re-incarceration in prison so far in the standard of care arm, the
standard of practice, five people have been re-incarcerated today, and
only one bridging case management participant has been re-incarcerated
in prison so far. Utilization of emergency room care, which is one of
our outcomes, standard of care has used ER at least once 44 percent of
the time in the three months after release, versus 28 percent of the
bridging case management.

And our primary outcome that we\'re interested in, although the case
managers are not privy to that necessarily, is access to HIV care. And
again, this is just an early look, but in red, or pink, is the standard
of care, and in blue is the bridging case management.

We\'re seeing some separation here where time to access the care is
favoring people in bridging case management, and by week 12, 21 percent
of people in bridging case management have not seen an HIV provider as
opposed to 43 percent of people in the standard of care who have not
seen an HIV provider for any reason.

So I think we\'re seeing some overlapping converging data that indicate
that probably this kind of intensive case management intervention for
example can be effective. And Dr. Redfield has experience with sort of
kitchen sink approaches as well, and has very nice data showing that we
can impact recidivism and other health outcomes if we package services
and make it available.

So I\'m going to end on just a few quick notes, and this will take about
15 seconds.

As was talked about, there is a lot going on with people who are
incarcerated. There\'s a lot going on with HIV-infected people who are
incarcerated. We have an obligation to them and to the community to try
to reduce their having trouble after they get out, whether that be
trouble accessing meds, trouble getting training, trouble staying out of
prison.

I also want to talk a little bit about their communities of origin,
because I think we ignore what happens with the people who get left
behind. And we know again with that altered perturbed ratio of men to
women that that leads to all sorts of things that are not good when you
think about HIV prevention including partnerships that may be
concurrent; that means a partner - someone having a partner, and having
another partner at the same time. That mathematically has been modeled
to show to spread the HIV virus much more efficiency than other modes.

Many of the men who are available who are not incarcerated at that
moment may be underemployed or financially unstable, and they are
sexually mixing wearing women who normally would not be hooking up with
these men are hooking up with these men because there are less men
available in that community.

And work that has been done again by our colleague, Dr. Adimora,
indicates that a substantial portion of African-American women who are
HIV positive have relatively few risk factors for HIV infection, and
posits that that is a clear sign of how endemic HIV infection is in
communities of color.

So schematically one thing that we\'re very interested in exploring is
whether or not in a partnership where the man gets incarcerated, not
focusing so much on him for the moment but on her, and if he\'s gone out
of the picture for awhile, are there pressures that lead her - whether
they\'re community pressures or personal pressures - to hook up with
another individual, thus placing her at risk for acquisition of an STD,
HIV included, and then of course her partner comes back out, she hooks
back up with him and may have other partnerships in addition to that.

So we think that this sort of cycling could theoretically lead to her
being exposed disproportionately to HIV infection, especially of her
relationship now breaks up because of the stress of incarceration. And
in a community where there is a lot of HIV and there is a lot of
incarceration, I think this could multiply, and we might see spreading
of HIV amongst the women, and I think that may reflect what we\'re
seeing.

So I\'m going to end there, and open it up for both of us to take your
questions. And I appreciate it.

DR. SWEENEY: We\'re going to take questions, but I\'ve been given strict
instructions about lunch and breaking and getting started this
afternoon. So I\'m going to start in order of people that didn\'t get to
go last time, if there are any people who want to ask questions, and we
hope that Dr. Kaplan and Dr. Wohl will stay through lunch so that we can
have additional questions answered if we don\'t have time now.

Dr. Sullivan.

DR. SULLIVAN: Really a question to Dr. Leone. Is he here?

You mentioned the survey that you did I guess educating men who I
believe if I remember correctly frequenting bars; during the course of
one year there was a significant drop in the rate of infection.

Why was that study not continued?

DR. LEONE: So the study I referred to was called the Popular Opinion
Leader Model. And it was funded through CDC post our outbreak
investigation. And we were told that that was all the funding they had
available on that, period.

To be blunt, it took a lot of pushing. I think the folks at the CDC were
very supportive; certainly the epi branch agreed with our data on the
college outbreak. And I don\'t know where the problem was about
continuing it or coming up with more funding, but it took literally a
battle in the press in order to get that funding to begin with.

So there is more than a little bit of frustration on my part that we
have a program that\'s been successful and the plug has been pulled on
it after a year.

DR. SULLIVAN: We can discuss this tomorrow. But it seems to me that
really is an issue that concerns me, and I think we need to discuss it
further.

MR. BENAVIDEZ: Thank you, Dr. Wohl. I appreciate that. I found it very
interesting.

A quick comment. I think you mentioned the mental health problems of
people leaving prison were significant, over 50 percent I believe. So
obviously that will have an impact on compliance, seeing a physician,
having access to the medication.

How do you incorporate I guess that mental health component in your
studies and how you\'re looking at these patients?

DR. WOHL: At this point, up until very recently we were observing this,
and were quite surprised to see how much mental health needs our
patients had.

With the case management intervention that we\'ve applied, the case
managers are well equipped to refer people to the available resources
that exist in the community.

The problem is if there aren\'t resources available in the community,
and then it takes a lot of creativity. So I think what you\'re getting
at is a really important point of the lack of what I call good, clean,
well-lit places where you can get mental health care, and that is
certainly a problem.

Our case managers many times will tell us they physically drove someone,
sat with them at a mental health center, and tried to get them care just
to ensure that it happens.

DR. SWEENEY: I just wanted to ask a question about contact tracing and
partner notification.

Is it done? Are people who are incarcerated, and who know their
partners, do they get notified that they may have been exposed and
offered testing?

DR. WOHL: Yes, so when people are diagnosed with HIV in the North
Carolina Department of Corrections, contact tracing follows just as it
would in the community. And Peter, I don\'t think you have any
indication that there is any difficulty with contact tracing of
prisoners.

I know that there is - we\'re talking about contact tracing of people
who are diagnosed with HIV in prison, and I think that system seems to
work very well, and I don\'t know if you\'ve heard of any problems with
it.

DR. LEONE: I think it works well. The problem that I\'ve seen from my
perspective, and Andy and Dave can comment on it, is, actually
empowerment for a lot of these in particular women about negotiating
either not having sex or using condoms.

So second paper that was published a year ago on black AIDS awareness
day, MNWR looked at women in North Carolina and HIV as an outgrowth of
the college outbreak.

And what we found was, again, very little empowerment for these women,
either around poverty or being able to negotiate with their men condom
use.

So even though they\'re notified, it frequently doesn\'t seem to change
in the results of protection in that couple. So it\'s an ongoing issue.
But to be clear, North Carolina law requires partner notification. So
everyone who is newly diagnosed will be interviewed. If they give us the
names of partners, we will locate them and notify them. But we\'ve seen
it, and maybe Dave and Andy can comment, where women know that their
male partners are infected, and they continue to have unprotected sex.

DR. KAPLAN: But I think you\'re talking about within prison.

DR. LEONE: Within prison.

DR. SWEENEY: I was talking about within prison, while the partner is
within prison.

DR. LEONE: Yes, absolutely. I think that one works much easier than the
community link, because they know who they are. So they will easily call
someone over - the prison has complete control. So if someone mentions
another person that they had sex with when they were diagnosed, they
will find that person and then offer them HIV testing.

DR. WOHL: The only problem I see, if you are talking about in prison,
their partners, is that you may not get information about who they had
sex with.

So the bottom line in all of this is, you\'re stuck with someone giving
you a name or letting you know what happened.

And I would think - I don\'t know, because there is no data - that in
prison there is a lot of pressure not to talk about what actually
transpired.

DR. KAPLAN: Well, it\'s illegal to have sex in prison. That will extend
your time in prison.

DR. SWEENEY: No, I wasn\'t talking about tracing the partners in prison.
I was talking about tracing their partners who are in the community, and
notifying their partners in the community.

DR. WOHL: That happens. But Peter\'s point is well taken, and our data
show that men who come out of - men and women who come out of prison and
go back to their main partner, frequently don\'t use condoms even though
their partners are HIV uninfected. But say they\'ve disclosed their HIV
status to those partners, as opposed to their more casual partners.

And most of our people when they get out have on average about seven to
eight partners. And when we ask them about this, they say that their
main partner si the one that they are least likely to be safe with.
Their casual partners who they are, A, less likely to disclose to, they
are more likely to use condoms with.

And these are data that we thought were very odd. There is another
research group that is similar to ours in San Francisco that has found
very similar results in San Francisco.

DR. SWEENEY: Thank you.

I see Ram, David. Before we have any other questions, Joe Grogan has to
make an announcement.

MR. GROGAN: It\'s a new wrinkle for us here. We\'ve got a little extra
time for questions, because the catering van bringing the food got
stolen.

(Laughter)

So the members do have a guarantee that the sandwiches will be super
fresh this time, because they are working as quickly as they can.

(Simultaneous voices)

DR. YOGEV: I was just wondering with the new recommendation of the CDC
for universal testing, do you think it\'s about time for the committee
to consider recommending mandatory testing of incarceration, not only
when you come in but also when you come out, with partner notification?
Because it\'s not. You got a refreshing, but I\'m coming from a state
you can\'t even talk about it.

DR. KAPLAN: I think we\'re in agreement on this.

DR. WOHL: I think we\'re in agreement on this. I don\'t know if our
group is unanimous on this, and it\'s a divisive issue about testing
inside of correctional settings, especially prisons.

And I think that - and Andy can speak up - I think testing in prison has
a lot of value, and as I mentioned provides a lot of opportunities.

I think one thing has to be very clear, though, is if you are going to
test in a correctional setting, how, A, those data are going to be
handled. Can it be done confidentiality and not coercively as much as
possible.

And B, what are you going to do with the data as far as treatment? If
you don\'t have treatment available as is the case in many jails, why
are you testing? And can you apply therapeutic and prevention
interventions? If you can\'t, then I don\'t understand why you are
testing?

Part of the problem is, we don\'t have uniform quality of HIV care in
prisons, and especially in jails.

DR. YOGEV: I\'m raising exactly that issue because of what you just
said. It\'s interesting that I belong to the International Subcommittee,
and we\'re committing HIV testing to treatment in Africa, and it\'s
about time we do it here in the United States. And that should be part
of the resolution is, what\'s fascinating to me is, one out of five who
have HIV is going through the system that can help us to identify and
connect to treatment, you are also correct.

And the only way to do it is incentive, and maybe connect to Ryan-White
or whatever, just the issue of mandatory is so controversial, and
that\'s why I was raising it.

DR. WOHL: We see both sides. Certainly if we have mandatory testing we
see that there are more people that will be identified. But we also know
that before you mandate, before you do HIV testing against someone\'s
will, you betting think long and hard about it and make sure the
benefits are there.

It\'s very interesting about the Georgia outbreak, they had a voluntary
system for two years during that long period of time where people were
offered annually HIV testing. Half of those 88 cases were detected ,
seroconversion in prison, were detected during those two years, out of
25 years of this program going on where they test people.

So clearly we know that we can raise the level of people that we can
identify with very good voluntary testing programs.

I think mandatory testing is something that\'s not off the table in
prison, but we haven\'t even explored expanding voluntary testing in a
way that I think \-- to its full potential.

DR. KAPLAN: Yes, I think we could do a lot without that testing. We can
do a lot without forcing people to get tested before we decide to go
that route.

The other thing you need to keep in mind is that when someone is
diagnosed with a treatable illness, the Department of Corrections is
obligated to provide treatment for them free of charge, so it\'s very,
very expensive, and I\'m sure there is a tremendous financial
disincentive. They are only going to be there for three years, so this
idea of preventive care is really not on the table.

There is a tremendous disincentive to identify people that will then
require expensive care.

As just sort of an anecdote, the medical director of the North Carolina
Department of Corrections has to go before the state board - I\'m sorry,
the state legislature, every year and rationalize her budget. And I
guess one of the legislators asked her, said, look, the food service\'s
budget decreased by 15 percent last year, but your budget went up 20
percent, why is that? So maybe they\'re related, but it is the kind of
pressure that they face. So this is one way of not having to pay for it.

DR. SWEENEY: Sandra, did you have your hand up?

MS. McDONALD: Thank you for your presentation.

Our agency in Atlanta has been doing a lot of work in corrections. In
fact we had a program in county jail where people got released to our
program. My hands are off to you. It is tedious work.

Did you link in the services for substance abuse and housing? We almost
babysat. We had very good outcomes, but one of the persons in that
program told me that he was better off incarcerated than being with us,
because we really do hands-on stuff to get the results.

DR. WOHL: That\'s exactly right. And again this is a plug. Everyone has
their own agenda. This case management and intervention that we are
piloting we\'ve received funding which was wonderful from NIDA.
Unfortunately our funding is running out, so we\'re going to end this
program very soon. And we were hoping to implement it, and not just be
something that someone could look up in a dusty issue of a journal. We
want this to become a reality, so we\'re really looking hard to make
this happen in real life, and not just in an academic setting.

And your example is very good. When I go to the literature, I go to
these boards and I try to prove to people that this works. They say,
show us the proof. We don\'t have studies, rigorously controlled
studies, that show that this kind of intervention and others that are
like it work, because a lot of people have put the effort into it. So I
think we\'re really trying to make this happen and have a breakthrough.
We could say, this is the model we should be following. We should be
having a link.

Right now there is this huge gap between incarceration and the
community, and no one is bridging it; we\'re just doing it piecemeal,
and we need a more comprehensive system to make sure that people can
stay, keep their weight on, keep their viral loads low and their CD4
cell counts high, and remember to use condoms; that\'s what we\'re
trying to implement.

DR. KAPLAN: And Ryan-White funds can\'t be used for people who are
incarcerated, so that\'s another problem for us.

DR. SWEENEY: David.

DR. REZNIK: Actually, I think you have the data to support at least the
linkage.

If I heard some of your materials correctly, the people who were able to
obtain care in your program, there was this long period of time where
they were no longer able to access medications, which to me means that
we\'re creating resistance. We\'re also increasing viral load,
increasing transmission, and therefore increasing resistant
transmission.

The Ryan White dollars can be used - the reasons they said, at least in
the study, that they couldn\'t access care, but Ryan White would cover
them once they\'re no longer incarcerated.

So there needs to be - so there seems to be, and this is Dr. Primm\'s
point, and he\'s not here, and it\'s hard for me to speak for Bennie,
but there seems to be an issue with linkage from when they get out of
the corrections into Ryan White, and that has to be a priority for the
community itself, when you\'re talking about such a high percentage of
males that are incarcerated in the minority community, where not only
are we fostering an epidemic among those less fortunate, but we\'re
creating a more complex epidemic because of resistance issues, and
attached with mental health and substance abuse.

So I think that there needs to be a priority put, maybe not exactly, or
in your case, maybe in the model that you created, the six-month model.
But at least some kind of model that links people upon release into the
Ryan White system of care, because the qualifications in any state they
would fit that. That\'s got to happen.

DR. KAPLAN: We\'re both trying very hard to raise money to continue this
project.

DR. WOHL: You\'d be surprised how hard - this is like the obvious point.
We\'re going to private foundations. We\'re applying to different grant
sources. This sort of obvious case that we need linkages.

And you could count on your hand how many systems of formalized linkages
that start before people get out, and continue after they leave, and
we\'re being told, it sounds like a good idea, but we\'re not so sure
about it.

DR. REZNIK: It sounds like medical case management, which is a core
service under the hopefully soon to be reauthorized, correct.

DR. SWEENEY: Dr. Sullivan.

DR. SULLIVAN: I have a more fundamental question. I\'m sure that this is
something that you talk about, but here you have a system as I
understand it of individuals going into prison, really being exposed and
being infected with HIV, and of course it fosters the epidemic.

What is done in prison to try and prevent that spread? Because it seems
to me that it\'s a head-in-the-sand philosophy that years ago we
quarantined people with tuberculosis to prevent the spread of the
infection.

So I know this must be an issue, but what is being done, or what can be
done, to really stop the spread of the infection in prisons?

DR. KAPLAN: Well, there is aggressive counseling of people that are
infected. But in terms of unprotected sex, it\'s an infraction. But
there isn\'t a lot of supervision.

I think one story - David and I went to a medium security prison not far
from where we live, and we were on the yard with the captain of the
guards, and we just sort of were walking across the yard, and there were
maybe 2-300 men just sort of very buff kind of men walking around. It
was David and I and this guard. And I said, well, what happens if they
decide to grab us? And he said, well, there\'s a guard in the tower with
a rifle, but other than that, the numbers aren\'t good.

(Laughter)

Which is very comforting you can imagine, but there isn\'t a lot of
supervision. I mean these guys have a lot of time on their hands.

DR. WOHL: I think when you look at state prison systems, it\'s
federalism at work. What we see is every system takes their own
approach. So some systems have said, the way that we\'re going to curb
this problem is, we\'re going to mandatorily test everyone who comes
into prison. Those who are HIV infected we\'re going to have centers of
excellence, segregated units, where there will be care, social work,
whatever, and that way, they can have sex with each other if they want,
but there is no HIV transmission going on, and we\'ll sort of cull from
the general population before they check in.

That system has been very hard to implement in many places, and you have
to have a lot of safeguards in there. Are we segregating? Are we taking
away privileges? Are we taking away opportunities? It could be done very
well. It can be done very, very poorly as well, and there are states
that have had a lot of trouble providing services to people who are
congregated in a situation where everyone has the same infectious
disease.

There are public health aspects of that, too.

So I think testing, letting people know that they\'re HIV infected, is a
major part of that. The majority of people who are HIV infected don\'t
want to give their HIV to anyone else. I think there is a lot of data on
that. There\'s exceptions.

The majority of people who come into prison, the majority of people with
HIV in prison come into prison with their HIV, so I think we have to do
more about identifying who\'s HIV positive, counseling them, and
allowing them to have the opportunity to be in prison, and I think
personally I think allowing people to have access to condoms, the
intervention that we know works very well outside of prison should be
applied in prison as well, especially given the circumstances that are
existing.

Will it obviate transmission that occurs during rape? No, just like in
the general community. But I think there\'s more that we could do to try
to do that.

Increased security is not going to be an issue. You can\'t keep it
secure enough to prevent these episodes from happening.

DR. SWEENEY: We have two, Dr. Judson and then Dr. McIlheney.

DR. JUDSON: Well, I think we appreciate even more the challenges of
turning prisons into HIV prevention and treatment centers, of the
highest order.

But it still seems, using the PP analogy, and maybe the sexual
predator/sexual assault analogy, where people who are known to be HIV
positive when they\'re released, a condition of their parole or
continuing parole would be that they not have anyone who is HIV positive
not have sex or contact with anyone without their prior knowledge and
consent.

And we would follow somebody with active TB, and it wouldn\'t be their
choice as to whether they go back and infect others in the community, or
in their homesite.

So where has there been any progress on that?

DR. WOHL: It\'s already state statute that you can\'t knowingly spread
your HIV to anyone else. So everyone signs a form that says they
recognize it. When they leave prison, every single one of our known HIV
positive inmates signs a form that says, I\'m aware of North Carolina
law that says if I do this I\'m breaking the law.

The other thing that we have to realize, a lot of people get out not on
parole or probation. They\'re out, scott free. In fact our HIV positive
inmates prefer to complete their entire sentence rather than get caught
in the trap of parole violations.

So we have very, very limited contact or control of people who get
released in many, many circumstances.

MS. CLEMENTS: Can I speak a little further to that? The control
measures, North Carolina control measures, not only say you must use a
condom, but you must also inform your partner that you have HIV even
though you do use a condom.

DR. KAPLAN: And you can incarcerate them for violating those.

DR. WOHL: And that happens. It\'s not very often, but we do have people
incarcerated now. Usually it\'s for sex work.

DR. JUDSON: But that\'s been the law?

DR. WOHL: Yes.

DR. McILHANEY: Have you - if you said this I didn\'t hear it - have you
tried to calculate how much of the HIV burden, the new HIV infections of
the 40,000 a year in this country might be attributed to the whole penal
system and what you\'ve been talking about today?

DR. WOHL: It\'s a real - like Peter said, it\'s the million dollar
question. The reason that we formed this working group is because a
group of us at the university who were working in separate areas started
to realize we were all finding the same thing. Whether you look
microscopically or microscopically, from a behavior approach or from a
medical model approach, all arrows started pointing towards
incarceration.

Dr. Adimora\'s work that showed that HIV positive people were more
likely to have had a partner who was incarcerated really lit the flame
and we started to see incarceration is playing a major role in what is
going on in these people\'s lives.

When we do qualitative interview it comes up every time. If you get a
group of African-American women living in the South together, and you
start talking about STDs and HIV, invariably, the shortage of men, the
type of men that are available, and incarceration will emerge during the
discussion.

We think we\'re on to something big here. We don\'t think this is the
pie, and we\'re a little small dot. We think this is a big deal, and
really fueling HIV epidemic, especially in the South.

DR. KAPLAN: I think if you believe that the context in which someone
lives influences their spread of - whether or not they\'re going to
spread HIV or STDs, and then this plays a tremendous effect on minority
communities; tremendous.

DR. McILHANEY: Do you think you could draw lines to as much as 25
percent of new HIV infections, or are you just not there yet?

DR. WOHL: Well, in certain communities, I think it\'s rampant. I think
it\'s a major role.

Now these might be small communities. We\'ve done some work in small
urban areas in North Carolina, Jackie knows what I mean, there are these
small mega-centers like High Point and Greensboro where we go and we
interview people, and half the people just going to a nightclub and
interviewing them, have been incarcerated themselves.

So incarceration has become sort of a rite of passage or a natural thing
that happens, usurping other natural things like joining the military or
graduating from college or getting married; it\'s become a normal life
event.

And we think there is some interplay here between risk behavior and that
event. So I think you\'re right. I think we\'re talking clearly double
digit percentage of maybe people who wouldn\'t be HIV infected were it
not for incarceration.

DR. SWEENEY: My question is, Canada has made condoms available in prison
for years, as has a couple of states and a few municipalities in the
United States. And I wonder if you have any data from any of them about
the effectiveness of their making condoms available, particularly Canada
who has done it for a very long time.

DR. WOHL: There are no data that have been reported. If anyone in the
room has something more up to date, but I belong to a group of people
who write a newsletter about prison issues, and we ask this question of
our board just a few weeks ago, and there were no data that anyone had
access to.

Canada reports on their success of implementing it. Vermont has a
program as well where they implement it. Even Riker\'s Island, condoms
were available for a short period of time. So we know that these things
exist.

But again in corrections we see the same thing over and over and over.
People do something, they report about it, but they don\'t study it. And
so we\'re seeing a real acute shortage of the kind of data that would be
wonderful to see.

The good news is, horrible things haven\'t happened. People haven\'t
used them as weapons. We\'re not hearing reports of people smuggling
contraband using condoms and swallowing.

These are the things that, rightly so, security officers, correctional
officers, were very concerned about. We haven\'t seen that.

DR. SWEENEY: We\'re going to have to stop now, even without lunch Joe
says we have to stop. And he\'s going to tell us what to do.

And thank you both and Dr. Kaplan very, very much.

(Applause)

REV. LUSK: Can I say one thing please? I\'m listening to this, the
previous study and this study, what\'s going on now. It\'s obvious to me
and to all of us that the African-American community is being affected
disproportionately.

And it just seems to me when you have these kind of numbers that some
special intervention ought to take place. You know, even the Ryan Act
where you can\'t use money for this, you can\'t use money for that, I
think we really have to think seriously about recommending some kind of
intervention that\'s different than what we\'ve been doing.

Obviously if we don\'t, many African-Americans and children are going to
go by the wayside, and I just wanted to go on record saying that.

DR. SULLIVAN: If I might second that, I want to thank our colleagues
from North Carolina for coming.

I agree. It seems we have a major issue here, and we can\'t be asleep at
the wheel, and act as if this doesn\'t exist. I think we have to really
work with our colleagues in the medical community to really address
this. Otherwise, why are we here?

So thank you very much.

(Applause)

MR. GROGAN: It doesn\'t look like they\'re going to get the food here
unfortunately.

So what I\'m going to recommend that we do is just walk over to the
cafeteria and we\'ll reimburse you for your lunch.

But try and be back on time, because Mark Dybul is on at 1:10, and I
know he\'s got a meeting at the State Department, so we got to nail
that; we\'ve got to start at 1:10.

So thanks.

(Whereupon at 12:38 the proceeding in the above-entitled matter went off
the record, to return on the record at 1:17 p.m.)

INTERNATIONAL

DR. REDFIELD: I think if we can get started now, if I can get everybody
to gather around the table, that\'d be great.

I want to thank Mark Dybul for taking time to come. I think everybody
knows Mark. He\'s now the acting U.S. global AIDS coordinator, NOGAC,
and Mark is going to talk about the U.S. response to global HIV
infection, particularly some challenges and opportunities.

Mark, thanks for taking time to be with us today.

U.S. RESPONSE TO GLOBAL HIV/AIDS: CHALLENGES AND OPPORTUNITIES

MR. DYBUL: Thanks a lot, Bob, and it\'s very good to be here. Thank you
for letting me spend a few minutes with you.

Joe asked me to go over a couple of hot topics. And I guess the most
recent hot topic is the annual meeting PEPFAR had last week in Durbin,
South Africa. About 1,200 people from around the world came. Fifty
countries were represented. And President Bush opened the meeting with a
video. As I think many of you know, he doesn\'t particularly like doing
such videos; the fact that he was willing to do it really highlights his
commitment to PEPFAR and the administration\'s commitment.

The president outlined the results so far, through March 30th of this
year. The U.S. government, the American people, are supporting treatment
for 560,000 people in sub-Saharan Africa. 552,000 of those 560- are in
sub-Saharan Africa. 560- covers 15 countries, the 15 focus countries. We
are certainly supporting more in other countries, but our reporting
beyond the 15 countries is only on a yearly basis, not an mid-term
basis.

We are supporting care for 3 million individuals, including 1.2 million
orphans. We supported PMTCT services for 4 million women which resulted
in the counseling and testing and services to those women resulted in
350,000 receiving short-course preventive therapy, which probably
averted in the neighborhood of 65,000 infections.

We\'re spreading behavior change messages throughout the world. We\'re
supporting now counseling and testing for 13.6 million individuals.

This is all in two years. So this is what the president outlined in his
talk, but mostly thanked people for being here, particularly the people
from the countries, the 50 countries that were represented, particularly
the people from the focus countries.

The meeting was heavily African, because the epidemic is heavily
African, and a lot of our response was there. About 80 percent of the
individuals were from Africa.

And importantly many of the presentations were from Africans themselves
or other in country folks, which demonstrates the capacity that is being
built. For those of you who have been to other international meetings,
this is not the norm. And so we are very excited to see more and more
people from the countries presenting their work, and the capacity that
is being built to do that to understand what they\'re doing in order to
aggregate information and present it.

But we can do better on that. We still have too many international
organizations presenting in my opinion, so we\'re going to focus them in
the coming year on technical assistance to help grantees, particularly
the local folks, feel more comfortable with their data, feel more
comfortable writing abstracts and presenting them, so that they\'re not
only comfortable for our meeting, but international meetings, to put
together their work and present their work, and we are going to do a
little more capacity building there.

There was a lot of good emphasis on the meeting on what\'s been
accomplished, but also looking at questions. On what has been
accomplished, it was the first international meeting I\'ve been to where
the ABCs were fully represented in all three components, including two
plenary talks which presented both an overview from an African on the
effectiveness of ABCs and what she\'s seeing, particularly in Kenya the
country where she\'s from, where we have seen dramatic results over a
five-year period; and then a member of USAID actually presented the
evidence base, and I think it actually provided a lot of people with a
view of what the evidence for ABC are, and I think it had a significant
impact, including among our European colleagues who came up to me and
said, I didn\'t realize that there was that much data behind this.

So we\'re making some progress here, and some good press reports came
from it.

There was also some very good coverage on utilizing community health
workers, and nontechnical experts to do counseling and testing, to do
things that people can do.

One of our biggest challenges is utilizing the resources that are
available, the human resources that are available, because there just
aren\'t enough human resources for a Western-based approach in a place
like Mozambique where there are 600 doctors total for 19 million people,
you can\'t have something like Washington, where you have six university
medical centers within spitting range.

So you have to use the resources that are there. And there were a lot of
good data presented on this topic.

I was recently in Ethiopia, and in many of the clinics I visited, 20
percent of the nursing workforce in every clinic was being utilized to
do counseling and testing.

Anyone in this room can do counseling and testing, and can do a finger
stick to show HIV positivity with some training.

So you could tomorrow have 20 percent of your nursing workforce doing
more clinically based work if we could change some of these policies.
And there was a lot of discussion about effective utilization of
community health workers, or nontechnical folks for things that they can
do. A lot of data on the challenges to that, but the need for policy
changes. So that was a very impressive highlight.

Another important highlight is the success some countries are having
integrating HIV and TB. Rwanda now is testing in the neighborhood of 70
percent of TB patients for HIV, and that\'s doubled since - in a year.

A number of countries, Kenya, Tanzania and others, have instituted
what\'s called routine counseling and testing, or diagnostic counseling
and testing. So most people entering TB clinics are almost routinely
offered counseling and testing.

Namibia introduced such a policy, and these data were presented in a
nationally for PMTCT, and they doubled the uptake of counseling and
testing by the women by having that policy.

So some of these things are happening and changing in terms of better
utilization of policies, and it seems to be working quite a bit.

The two big surprises, I think, from the meeting, and those of us who
spend a lot of time with international meetings, I won\'t say if that\'s
a good utilization of time, but nonetheless, we have to spend a lot of
time at international meetings, there is this attempt to link poverty
with HIV/AIDS, and to say, rather than addressing direct prevention care
and treatment, let\'s just solve poverty.

Well, there were some very impressive data from very careful analyses
from two sites that showed that if you looked at people who were
relatively poor in the country, they actually had a lower prevalence of
HIV infection.

Now as people gain access to resources and other things, they engage in
activities or become urbanized in a way that actually increased the
prevalence rate.

Now it is true that the people in those countries that are relatively
well off are still poor by U.S. standards. But we\'re not going to get
countries in Africa to U.S. standards economically for 25 - 30 years,
rather than spend - if we\'re lucky - so we need to concentrate on
saving the lives there. And that was a message that challenged a lot of
people, but it was very important to hear. To be honest this isn\'t
rocket science. South Africa and Botswana, two countries with very high
prevalence rates, are two of the wealthiest countries - and Namibia -
are three of the wealthiest countries in sub-Saharan Africa. Yes,
they\'re not as wealthy as we\'d like them to do, but it\'s a
demonstration that this attempt to say, let\'s just solve poverty,
isn\'t going to save HIV/AIDS lives in the near term.

The other very surprising thing is, there\'s been lots of efforts to
link nutrition to clinical benefit in HIV/AIDS, particularly in
treatment. There is no question nutrition in the early stages may -
well, I wouldn\'t say there is no question, but there are some data that
nutrition in the early stages may delay when you need to start
antiretroviral therapy.

But from Malawi they\'re actually doing a randomized control trial
introducing food with antiretroviral therapy, some food supplementation
in the same populations, and not introducing food, just giving
antiretroviral therapy. And the preliminary data showed no benefit
clinically to adding the food supplementation.

That doesn\'t mean food isn\'t important, and people aren\'t hungry.
There is no question; everywhere we deal people are hungry. The question
is, how should HIV/AIDS resources be utilized. So we\'ll be following
this closely. This is not a definitive word, but I think the two
challenging things to most people in terms of their perceptions were the
link between poverty and prevalence and the link between nutrition and
clinical outcome when added to antiretroviral therapy, not to care.

But overall I think it was - and unfortunately to a lot of people it was
challenging, was the database for ABC. But we\'re making progress on all
of these things, and I think it was overall a very good meeting.

The reason I wanted to go through the meeting because I think that
summarizes to a large degree where we are in terms of gains that have
been made, but also some of the significant challenges that remain.

And this meeting really brought those out. John Donnelly even did a
piece surprised that we would have people question what\'s going on.

Of course you need to always question what you\'re doing, and self
analyze what we\'re doing, because we\'re not going to reach as many
people and save as many lives if we don\'t. And I think this meeting was
a good demonstration of that.

We began the meeting in fact by pointing out that PEPFAR and the
successes of PEPFAR have become the base for the role model for the
president\'s malaria initiative, for what is now happening with the
director of foreign assistance, by pointing out that if you look at a
business model, the first company out of the box in most fields doesn\'t
do so well in the long run. And they reason they don\'t, they kind of
get bogged down in their ways of doing things, and don\'t innovate,
don\'t constantly innovate.

So what we\'re trying to do is ensure that in PEPFAR we constantly7
innovate, that we are constantly out ahead of the curve, that we are
challenging and looking at what we are doing, so we are a successful
startup, and we don\'t get overtaken by others.

And we spend a lot of time talking with them. So I think ti was a very
good meeting, that highlighted both the successes and the challenges.

The successes I don\'t want to lose sight of, are extraordinary, are
absolutely - they\'re breathtaking, they are extraordinary. But we have
a long way to go. We need to almost quadruple the number of people
seeking therapy to meet the president\'s goals; almost triple the number
of people receiving care; and expand our prevention program.

So lots of great work has been done; extraordinary hope. But we still
have a lot - a long way to go.

One of the issues Joe asked me to address specifically is the GAO report
on our prevention strategy. There was, as many of you know, a report at
the request of Congress, but then turned into a Comptroller directed
report rather than response to the congressional inquiries regarding our
prevention policies and what it\'s doing in the field. And there was a
lot of activity around that, probably more than was in the report. In
fact the person who headed the report, David Gutnik, had a meeting at
CSIS, and most people who walked out of there were wondering so much
noise was made about this report.

There were a couple of important things in the report that pretty much
dropped when the press was covering it. I think the most important thing
is, in three or four places, the report stated that there was a
consensus among U.S. government employees that ABC is the most effective
prevention strategy in generalized epidemics.

That would never have been the case three years go. So the evidence base
is getting out there.

There was not a single statement in the report, and I have no doubt they
looked pretty hard for it, from a U.S. government professional who said
that they wished they could do less AB, or that the AB programs weren\'t
working. It wasn\'t anywhere in the report.

So I think from that we can conclude that ABC does work well; the field
believes it works well. But there are resource constraints, and this is
what the report focused on, the need to balance resources in the country
when you don\'t have unlimited resources.

And while President Bush\'s emergency plan is an extraordinary
initiative, the largest international health initiative in history, \$15
billion over five years, we are currently as a people providing about as
much resources as all other international partner governments combined,
so that the resources are huge, but it\'s not going to solve all the
problems of the world, so there are resource constraints.

One of the issues that was pointed out in the report was PMTCT, and
whether or not our sexual transmission activities were squeezing out
some PMTCT activities, prevention of mother to child transmission, and
had some comments, as well as data from a number of countries of
relatively level resources for PMTCT.

I think there are a couple of important points on that. First, we\'ve
had a massive increase in PMTCT resources under PEPFAR, and actually to
go back to the president\'s first initiative, which was the prevention
of mother and child initiative.

Second, a lot of resources for PMTCT are not counted in PMTCT for
bureaucratic reasons. PMTCT - prevention of mother to child
transmission, as it implies - is counted in prevention. But there are
aspects of PMTCT that were shifting rapidly out of that direct
prevention, which is single dose therapy for HIV/AIDS.

First of all, much of the counseling and testing that is accounted for
in PMTCT is now accounted for in what we call care, because all of our
counseling and testing is counted in care.

Secondly, we\'re trying to move as rapidly as possible, from single dose
therapy to combination therapy for pregnant women, because it probably
has a much better effect in terms of preventing infection.

There are clear data that just adding one drug significantly reduces
prevention, or significantly reduces transmission. But if you can get to
three drugs in full therapy to the women who need them, you will
probably reduce transmission further.

All of that type of therapy is counted in treatment, not in PMTCT. So
there are significantly more resources for PMTCT than are counted for in
the budget line for PMTCT, which is bureaucratic in many ways, but it\'s
important programmatically because it means there are a lot more
resources than were accounted for.

But overall, we would agree with the report. There are resource
constraints, and you have to balance them. And to be honest, had the
president received his full request for the focus countries, none of
this would have been an issue.

Congress has over the last couple of years reduced the amount - although
the top line number, the total number the president has requested has
remained the same or been slightly increased, the total dollar amount
for the focus countries has actually not met the president\'s request as
they have been redirected towards other priorities.

It\'s one of the reasons we\'re advocating so strongly this year to
maintain the president\'s full request for the focus countries so that
we don\'t have as much need to balance resources.

But I think importantly again, nowhere in the report did it say, anyone
thought we should spend less on the AB component or it wasn\'t working.
There was just concern that we didn\'t have enough resources to do
everything we need to do.

And I\'d be happy to answer any questions on that.

So actually I\'d like to save most of the time for questions and
answers, because I know you just had lunch, and most people don\'t want
to hear people talk anyway. And your questions are more important;
they\'ll probably bring out some key issues that you are concerned with.

But I would have to say, the state of PEPFAR is very strong. The
president\'s vision is holding up, and his bold and decision action are
having a tremendous impact on the field.

I\'d like to end by saying that the impact we\'re seeing is not limited
to numbers. What we\'re really doing is building local capacity, and
country ownership, to fight the epidemic. And that\'s having spillover
effect.

The numbers are but a reflection of a higher goal, which is to save as
many lives as rapidly as possible, and to serve our global brothers and
sisters in a compassionate and humble way.

Those are our goals. The numbers are a numeric reflection of that, and
the president stated that goal beautifully in his state of the union
address.

We are achieving the higher goal, and by achieving the numbers. And the
change in the ground is night and day, the hope that has been created
doesn\'t come reflected in the numbers.

And it is the hope that\'s being created that is transforming Africa in
particular.

So Secretary Rice\'s vision of transformational diplomacy,
transformational development, is happening. What we\'re seeing is local
people who now have resources to fight their epidemic, take control of
their community, take control of their epidemic.

It\'s creating a culture of accountability that you can\'t describe
unless you are there, and we have trouble describing it numerically,
which is why you don\'t get a sense of it. It\'s creating a culture of
accountability which is leading local folks to question their government
and hold them accountable.

To wonder why don\'t we have the same accountability for water programs
and food programs and malaria programs. It\'s leading to an account of
people holding governments accountable.

In a word, as a young Namibian told me, it\'s creating democracy. And so
there is a fall out effect that you don\'t capture in the numbers, which
is inspiring and breathtaking, and those who have had time to be there
would see it.

So things are strong. We have a lot of obstacles. But things are well on
track to achieve the president\'s goals. And we appreciate your insights
and comments you have, questions you have, on PEPFAR.

So with that, Joe, Bob, however you\'d like to handle this.

DR. REDFIELD: Are there some people who would like to ask questions?

So we\'ll start here, and then Frank.

DR. SWEENEY: Thank you very much. That was a very nice overview.

I was very struck by the statistic that you did that people who live in
poverty are not as effective as people who are I guess middle class, or
whatever the class you call them. And I was wondering if that indicated
a lack of incidence, or a barrier, to being found in terms of the
testing and so forth.

Because I went to visit David\'s program in Georgia, and it was very
much like the people that I often seen in New York City, that the people
who are most affected are from the lower socioeconomic groups, and I
just wonder if you\'d comment on that.

Ninety percent of his patients are at 100 percent or more below poverty;
is that right, 92?

MR. DYBUL: I\'m speaking about Africa. You can\'t apply the poverty
situation, and compare people in poverty in Africa to the United States,
or people in the middle class in Africa to the United States.

In Africa it\'s not a difficult in finding them. They actually - and
these are effectively randomized controlled looks, looking at the same
number of poor people and relatively wealthier people.

Now by a U.S. standard those relatively wealthy people are still poor.
So it\'s really within Africa, and Africa is a much different place, and
you cannot apply what I said to the United States. And I don\'t know the
data in the United States, because I don\'t work here. I work
predominantly in Africa.

Now why that would be the case in Africa is probably remarkably
different than here. The poorer people tend to be in more rural
communities, for example, and in the rural communities the family
structure is stronger, and there is a system of support that is much
stronger than you would find in many sections of the United States,
particularly in the inner cities here.

As people start to get more money in Africa, they tend to migrate to the
cities, where some of that rooting and family and support disappears.
There is a four season phenomena where young girls will have
transactional relationships with older men to gain goods, clothing, cell
phones, cars, things like that that you don\'t see so much in the rural
communities.

So it\'s a much different situation; it\'s a much different situation.
And the - and I\'m talking internationally here, not domestically.
Internationally there has been this push to say, let\'s not focus on
HIV/AIDS. It\'s not a unique thing, because of poverty, that people are
becoming infected. So let\'s just put all our resources toward poverty
reduction, and then HIV will go away.

Well, these data are kind of a wakeup call to people who are arguing for
that, saying, until we get to wealth levels such as the United States we
are unlikely to have a significant impact on the HIV infection, so over
the next 20 or 30 years, which is what it would take under the best of
circumstances to get most of these countries to level like the United
States, tens of millions of people will die, so we need to focus on the
HIV piece, that it is exceptional right now, and we can\'t have a huge
impact if we fight the epidemic directly.

But I would not take anything that I said as applicable to the United
States.

DR. JUDSON: I\'d just give a commentary on my own personal experience,
just to underscore what Mark was saying.

Many years ago I wanted to start a program to do HIV care and treatment
in rural Malawi. We estimated based on prevalence rates that the
infection rate was going to be between 20 and 30 percent based on the
urban community.

Our initial first year prevalence rates an hour from the capital city
came back 3.7 percent; I didn\'t believe them. Seven years later our
average prevalence rate is between 3-1/2 and 4 percent.

We are going to get a little into this with the next speaker as we kind
of follow up on the Washington Post articles, et cetera, about did we
overestimate the epidemic. I think what Mark is trying to underscore is
that there has been a bias that this is something we can\'t just focus
on, and that is, confronting AIDS, because we\'ve got to confront all
these other problems.

And that bias can keep us from confronting AIDS, and I think, just being
open, I mean I know in my own personal experience, I was shocked,
because trying to find the resources to treat this village, the 60
villages which I calculated had 75,000 HIV positive people in rural
Malawi could have been overwhelming. It turns out in reality it\'s only
7,500.

So that is overwhelming, and I think I would have stopped if I thought I
had to do 75,000 people.

DR. GREEN: Thanks, Mark, that was really exciting.

We\'re three years along now?

MR. DYBUL: We\'re three years from the president\'s announcement, but
two years from the first funding.

DR. GREEN: A comment and then a question.

As far as the poverty wealth issue goes, for some of us that was laid to
rest a long time ago just from very obvious correlations. In developed
countries white gay men have the highest disposable per capita income of
any other, most other identifiable groups, and in Africa, early on, I
think 12, 13 years or so, they did just a crude correlation of per
capita income, and HIV rates, and there was no association or perhaps a
negative association to poverty, and then more recently, the studies
that have come to the deeper or obvious conclusion that wealth gives you
mobility, choices, options, and time to pursue sexual exposure
possibilities.

The question is, is - are there a set of cutoff values for when a
country would be viewed as potentially not achieving the goals? And what
are they? When would you decide this isn\'t working here, we knew it was
going to be tough, we are going to have to divert resources elsewhere.

MR. DYBUL: Thank you, those are excellent questions.

And on your commentary I really appreciate it. Unfortunately, there is a
lack of willingness to face things you don\'t want to face. And having
been accused many times of ignoring evidence, the propensity of many
people to just ignore evidence on many different topics, because they
want something to be a certain way is rather mind boggling to me. But
nonetheless it\'s there, so we fight this on many different fronts,
because we want to be based on the evidence; we want to base our
activities on what the data show.

In terms of your second one, it\'s actually an ongoing process. And I
think an important part of this is, we never anticipated that every
country would be on the same trajectory.

So in Uganda because they have a national strategy, not because they
have resources - the number of people around the world who think Uganda
is wealthy because of their success in prevention, treatment and care is
rather amusing to me sometimes. But it was because they had a national
plan and a national commitment that predated availability of resources,
so they had resources to go.

Namibia moved rapidly because the government coalesced rapidly with the
partners, including faith-based and community-based organizations, to
set a plan, so they\'re taking off.

South Africa, now that they\'ve gotten going, is taking off, probably
because of infrastructure.

Rwanda looks a little bit more like Namibia, the government and the
civil society is coming together to move rapidly.

So those are countries we kind of put in what we expected to be a first
rapid upswing. So we expect different swings. One is a very rapid
upswing to get to where we intended it to be, and then a leveling off.

Other countries were not quite in the same situation, such as Ethiopia,
or Nigeria, where infrastructure was very weak and there wasn\'t much
leadership . And there you would expect exactly what we\'re seeing, a
slow upswing, but we\'re starting to see the uptake after two years of
concentrating on building the infrastructure, and building the support
that is necessary to expand programs.

And then you have countries in between like Tanzania and others that
have some, a little bit of the Ugandas, Botswanas, Namibias, South
Africas, but still weren\'t quite there. And there we\'re seeing a
faster initial uptick, but also a much faster upswing now.

So we expected all of that. So what we do is ask each of the countries
to predict on an annual basis the progress made toward the five-year
goal. And when we look at that, many of the countries are exactly on the
trajectory we expected.

Our resources are based on that trajectory, so our annual appropriations
to the countries, our annual allocation to the countries, is based on
that initial trajectory, but also where they are.

So if they for example have big pipelines, a lot of money that has been
allocated to them but not used, or if they are not reaching their goals,
as we put together the next year\'s allocation, there - we actually
reduce the dollar amount that we give them for that year as they\'re
building the infrastructure that\'s necessary to utilize the resources.

That\'s built into everything we do. It does cause us some problems, for
example with Congress. We have to put it in what\'s called the
congressional budget justification, start that process almost 18 months
before we actually allocate resources for that year.

So we put provisional numbers, but based on the results that come in and
our evaluations of where the countries are, we radically modify the
dollar amounts that will go to that country that year.

So we do this on an annual basis. We look at the results, and where
people are, and then allocate money for the coming year based on that.

So far most of the countries are achieving the projections or the
direction that we anticipated. Some of them are moving a little bit more
slowly. Ethiopia and Nigeria were moving a little more slowly initially,
but now they\'re taking off; they\'re starting that upswing. So we
increase resources as we see that happening.

But it\'s an annual effort using both the March report - that\'s one of
the reasons we ask for the half year way number in terms of where they
are on the way to their goals, but also the annual report, so we have
both those sets of data to help us in those determinations.

DR. JUDSON: Thanks, Mark. Exciting news coming out of the most recent
PEPFAR conference.

This will be sort of a rhetorical question, because you know my answer
to this question. But in light of the accumulating empirical basis for
ABC, why is it we still have leading AIDS experts who say that fidelity
and abstinence, sure, we\'re all for it, but such behaviors have little
relevance in the actual lives of women today in Africa.

What do you say when you hear that?

MR. DYBUL: Well, as to motivation toward why people have these views, we
actually try not to attribute motives to people. We try to hope that
everyone is trying to do their best with the information available and
come up with a good decision.

Unfortunately most people don\'t accord us the same respect, but our
view is that everyone is working to try to do the best thing they can.

So why people are in that situation, I don\'t know. I think some of it
has to do with the early epidemiology. You know the early epidemics and
the early control were in concentrated epidemics, and there is this
effort to apply lessons learned from concentrated epidemics to
generalized epidemics, and you can\'t do that.

I understand the propensity to do it, but it makes no epidemiological or
medical or clinical or scientific sense, but if you grew up with a
certain mindset it\'s going to be hard to change when the underlying
situation changes.

So I do think there is an attempt to bring lessons from a concentrated
epidemic to a generalized epidemic, and you just can\'t do that.

I\'ve heard the head of the AIDS program in Brazil say if South Africa
had just done what they did they wouldn\'t have a prevalence rate. Well,
there is no evidence that Africa ever had an epidemic that looks
anything like Brazil\'s. So you have to apply lessons to a situation and
use the evidence base. And I think there is just a lag in that.

There may be other motives, but we\'ll hope that that is the major
reason.

There is no question that gender plays a role in HIV/AIDS, just as there
is no question that, writ large, the basic situation of joblessness -
there are many things that play a role. But that doesn\'t mean you
don\'t use concentrated approaches where you\'ve seen the data.

So on the small issue of how does gender interact, and gender is not
relevant to ABC - well, to some degree it\'s not, but we know if we can
focus on men\'s behavior toward ABC, that will take care of that to a
large degree.

So you have to target the men, and we have a lot of programs that target
the men for responsible behavior, because if the men aren\'t abusing the
women and following those approaches, you get a much different response.

But there is no question we need to work on the underlying culture and
gender issues, too. And we do do some of that.

I think one of the best recent examples is, there was a church in
Zimbabwe that had throughout its history taught polygamy, and because of
the links between partners and multiple partners and the spread of HIV
our folks in country and some others worked intensively with the church
to show them the relationship between HIV and multiple partnerships and
the spread, and this year, because of HIV/AIDS, they revoked their
policy on polygamy, and said that you should not be polygamous because
of HIV/AIDS.

So you do have to deal with some of these underlying issues, if you are
going to overcome and get to the best results you can get to, which is
what we\'re trying to do, not just to get a good result, but the best
possible results.

So we are also dealing with some of the underlying gender issues,
whether it\'s targeting men. One of the other things we\'re working on,
there is one place stigma is good, and that\'s stigmatizing older men
who prey on younger girls. And we actually have some programs designed
to try to stigmatize transgenerational sex.

So we do have to deal with some of these underlying social issues while
we\'re putting forward the best possible programs that we can in a
focused way as well.

So it\'s balancing and mixing, which gets again to why we need the
president\'s full request for the focus countries.

DR. YOGEV: The question I have is, I was a bit surprised to hear that
you move money from mother to child transmission, they are focusing on
the treatment. And when you are also correct, when you give three drugs
you prevent 90 percent plus. When you give one drug, you prevent 70
percent. But if you do the simple mathematics with the enormity of the
program it doesn\'t make much sense to give one drug for 4 million women
versus two drugs to 1 million women, you are going to save more kids and
insist on moving into the treatment to help to really get the number
that the president was hoping to get.

MR. DYBUL: That\'s a very good question, and it gets to resources. Maybe
you can\'t do the best thing; you can only do what gets you the furthest
along.

And I think it\'s a very important and good question.

First of all, money is an accounting issue in a lot of ways - where do
you count, where do you put the money, not is it really PMTCT.

Most countries are moving towards full care and treatment for the mother
as well as the child, because the goal is to have a healthy and happy
child to prevent transmission, and one of the best ways to do it is to
keep the mother alive, and to keep the family alive.

One of the pieces of data that we\'re presented at this last meeting
which really shocked me is that in households where the child lost a
parent, even if that child were HIV negative, there was a threefold
increase in death in the first five years, because there is no one to
care for the kid.

And then of course what will happen to these orphans over time without a
family structure, without someone to take care of them, we\'re seeing
more and more orphan-run households.

So the purpose of preventing transmission is not just to prevent
transmission. In some ways it\'s to have a broader picture.

So even under the president\'s initial initiative, the goal was to
utilize resources where possible, to save as many lives as possible now,
because you can get single dose therapy out there much more rapidly. But
to move towards, as rapidly as possible, where resources and
infrastructure allow, towards that full care and treatment. And that\'s
what we\'re trying to move towards.

But even in the short course therapy, we now know that for not much more
money you can have one drug, and for a longer period of time that will
cut that transmission rate down further.

I was in a meeting in South Africa at a meeting in McCord Hospital that
has gone in this direction, and they went from a 50 percent transmission
rate to an 85 percent transmission rate, to a 90 percent transmission
rate, to zero over the last six months. And that\'s what we\'re trying
to get to, not only for transmission, but also to keep the parents alive
so that the children will have healthy and happy lives.

But it\'s a very difficult balance, and we leave it to the countries to
sort that out.

DR. BOLLINGER: Thanks, Mark.

I have a comment and a question. Comment is about the association
between poverty and HIV. My experience obviously is not in Africa; it\'s
in India. So I\'m not sure how relevant this experience is.

But certainly as you\'ve described in Africa, there has been a long not
only an association with the lower HIV prevalence in poor rural
communities than in more economically higher level urban communities.

And yet I\'ve never interpreted that to mean poverty isn\'t important in
India in the HIV epidemic, because in fact it\'s the poverty in the
rural areas in India that forces women into the cities; that forces men
to seek economic opportunities in the urban areas, where the risk
increases.

Because again, I agree, they leave the traditional relationships that
are present in those rural communities that provide support for lower
risk behavior, but are also in situations where the poverty is so severe
that it drives them into the city seeking other economic opportunities.

And certainly in the case of women, opportunities where they are not
empowered to protect themselves.

So while I agree there is lower HIV prevalence in poorer communities,
and particularly rural communities in India and maybe in Africa, I\'m
not yet convinced that necessarily means that poverty is not an
important driver in the HIV epidemic.

I\'m not suggesting PEPFAR needs to fix that. But I think we have to be
careful about suggesting that poverty is not an important driving force
in the epidemic, even in Africa and Asia.

My question is about some of the really encouraging things you said
about the ownership that some of your in-country partners are beginning
to demonstrate for the programs, some of the additional benefits of the
program.

And one of the issues that we\'re thinking about as a group is sort of
the transition period, the longer term sustainability of this great
initial effort. And that\'s going to require us more buy in, more
ownership from your local partners.

I\'m interested in your thoughts. My question is about your preliminary
thoughts about how that can be done effectively, so that not only is
there greater ownership emotionally and spiritually to these programs,
but also financially, and whether there are incentives in place to help
assure the sustainability of what you\'ve initiated in some places,
beyond simply the hearts and minds issue if you will.

MR. DYBUL: Thanks, Bob.

On the first point, I actually agree with you. There are many underlying
issues. There is almost no underlying issue in Africa or India that
doesn\'t have some relationship to AIDS. I think what these data show
over and over again is that we\'re not going to solve the AIDS epidemic
in the next short term by focusing the resources on poverty, and there
is an effort to do that, to say this is not an exceptional epidemic,
that it should just be poverty reduction, and that\'s true, you do need
that, and we\'re very pleased that the president has supported the
Millennium Challenge Corporation so heavily, and other economic drivers
within USAID to build those economic bases so that over time we can
advance not only against HIV/AIDS but the basic condition in these
countries.

I think it\'s more important - what we draw from that is not that
poverty is irrelevant, because it\'s not, but that the almost panacea
that\'s being proposed is that if we just move people up a little bit up
out of poverty that HIV will disappear is not accurate either. And so we
need to work on all these things simultaneously, using the incredible
programs the president and Congress has supported to build some of that
economic aid. So I don\'t think anyone is disagreeing with your first
comment.

In terms of the sustainability, there are two pieces of sustainability
in our view, and we\'ve actually just issued some guidance on this. In
development terms, sustainability means basically freedom financially
and in every other way.

In our terms, at least for the near term, in most places, sustainability
is going to be local ownership completely where our need is more
resources and a little bit of technical exchange. But we need to get to
the point where the country and the local folks fully own the program.

To do that we\'ve done a number of things. One is the new partners
initiative which the president announced on World AIDS Day to bring more
and more leadership up.

The other is to push heavily for sub-partners who have moved towards
competency to be full partner status, to get them out from
subpartnership into individual partnership, so that it\'s a local group
that is fully managing it.

The other is to emphasize on local umbrella organizations, because you
don\'t want a lot of small groups that are doing great to have to build
a bureaucracy over and over again to manage grants, so we\'re creating
new umbrella grants that will cover those for kind of budgetary
accounting purposes, but let the smaller local groups do the work, so
that gets more ownership there.

We\'ve instituted a policy that Ambassador Tobias instituted initially,
and that no more than 10 percent of any country\'s total budget could go
to a single organization; we\'ve dropped it to eight, to try and spread
the money out so it\'s not all held in large international
organizations.

We\'re putting contractual language in after two years of fighting with
lawyers and contracts officers, which has been just the funnest part of
my job and most time consuming I would have to say. But you actually
have benchmarks within contracts, within grants now, so that you not
only have to report on your success in achieving your numbers; you have
to report on what you\'re doing to turn over what you\'re doing to local
organizations, whether it be government, faith-based, community-based,
or whatever organization.

So we\'re doing all these mechanistic, bureaucratic steps to get to that
local ownership.

Now in terms of sustainability beyond that in the development sense of
financial sustainability where you work in India that is probably
possible. In China that is probably possible. In Russia that is probably
possible, and in a number of other places, mostly in Asia and a few
other places.

In Africa, South Africa can probably get there. Botswana can probably
get there. Namibia can do a lot more. There are some countries that can
do a lot more.

But the fact of the matter is, going back to the first issue on poverty,
we have to build an economic infrastructure that can support massive
costs.

You know this year in many of these countries PEPFAR will be supplying
\$200 million sometimes more than that; Kenya is \$300 million; South
Africa - the countries will not get to the economic development to
support those types fo dollars for a long time.

You can do things underneath that to support the local infrastructure,
which is to try to get government to spend more money on their own
programs.

So we\'ve been working very carefully with Namibia in this way, to say
basically it should be a third global fund, a third PEPFAR, and a third
government. We need the government to pick up, and they\'re starting to.

We\'re doing some fascinating work within the, for example, government
structures, where we will support on a contract basis employees in the
government.

For example in Namibia we\'re supporting pretty much everyone doing
counseling and testing in the public sector, and about 80 percent of the
people doing care and treatment in the public sector.

And we\'re working on agreements \-- and we\'re doing this in Botswana
too - we\'re working on agreements so that over time the civil service
absorbs those people into their civil service structure.

So we pay for them on a contract basis, and they have a process in place
over time they\'re absorbed into the civil service.

So there are a lot of these things we are doing to lead towards that,
but outside of a few countries, we\'re going to have to foot the bill
for quite awhile.

DR. REDFIELD: Maybe before Joe I just wanted to follow up with a
question that leads into it.

Mark, could you sort of tell us, this morning we had a long discussion
about the reauthorization of Ryan White. Where are we with beginning to
get the reauthorization for it?

I understand that the PEPFAR was a five-year authorization, so maybe you
could comment on that, because that plays into this, and then Joe, and
then Reverend.

MR. DYBUL: Well, we\'ve begun the process internally. The fact that
Ambassador Tobias left has put us back a little bit, because I think we
really need not an acting but a full coordinator to push that forward.
It will be our office\'s responsibility to present the president with
options, but ultimately it\'s going to be the president\'s decision to
lay out his vision for the next five years, even though he won\'t be in
office. He began this, and he will I would imagine want to lay out a
vision of where he would see this going, and of course working with
Congress.

Timeframes, we\'re still okay, probably. You know just on - no one is
going to want to get into this in 2008. As you all know there\'s lots of
other stuff happening in 2008.

So we\'re probably going to want to begin the process, so a vision is
presented sometime in 2007, and then start working through the process.

We have not gotten in full swing in that, yet, but that would be the
normal process, unlike the first time, of course, there is no secret
that there is going to be a next phase. So there will be more public
discussion.

DR. REDFIELD: Joe.

DR. McILHANEY: Thanks, Mark. Work is so important.

I understand that in Uganda years and years ago a very very popular
singer developed HIV/AIDS and died, but was very influential because he
went public.

That led me to think, as you were talking, about another popular singer,
Bono, and his emphasis on forgiving debt, and also HIV.

In your opinion do you think he\'s a distraction or an asset on all of
this? Or do you want to comment?

MR. DYBUL: Thanks a lot.

(Laughter)

Anyone who highlights global HIV/AIDS who has access to us is an
advantage. There is still a great deal of lack of understanding of the
scope of the epidemic and urgency of need to respond.

And I think it\'s probably less so in the United States. I mean the fact
that the United States is now providing as much as the rest of the world
combined, we don\'t say out of pride, we say out of almost astonishment
that after the 2001 UN special session the president is the only one in
the world who stepped up to say, you\'re right, there is a massive
problem and we need to respond.

And so the American people are doing that. We need the rest of the world
to respond in a similar way. And anyone who can get the rest of the
world to do that I think is important to have everyone step up who can
do it.

You know we don\'t always agree with everything they advocate for. I
don\'t know that we agree with anyone all the time on what they advocate
for. But they do play an important role in pushing some of these
initiatives forward.

And sometime attribution of successes might be an issue for some people,
but it\'s not for us. As many people as want to take credit for what
happens, it\'s great with us, because then they feel more ownership, and
will push forward even more, so I think that\'s great.

The fact of the matter is that this administration was interested in
debt relief for a long time and worked hard on it, worked hard on many
of these issues, the malaria initiative, and many other things too.

So I think what he brings to this is very important in terms of getting
the word out, spreading the message, and trying to get others to
respond.

And we work very closely with their organization, they have great
people.

REV. LUSK: One of my questions you just answered. I was just curious, I
thought I heard you say that the president\'s initiative has given more
money than perhaps all the developed countries together; is that what I
heard?

MR. DYBUL: Yes, as a matter of fact that is true. As the accounting
goes, if you add up what everyone else in the world - I\'m talking about
developed countries, countries that are considered donors normally. We
don\'t like using that term, because that is not the true relationship;
it\'s not donor-recipient; it\'s partner.

But if you look at other donors the United States is giving about as
much as all the rest of them combined.

REV. LUSK: Just wanted to just commend the president and the work that
he\'s doing as it relates to the resources that he\'s allocating. I
think that\'s commendable, being an African- American and knowing that
some of those monies are being directed to Africa. And in that way it\'s
encouraging.

I\'d also just say, I have two questions. One question is, we have an
organization, Stand for Africa. We\'re in Malawi, South Africa,
Mozambique, and we\'re going to Swaziland and Tanzania and do some work
there as well.

One of the things that we\'ve noticed is how resilient the people in
Africa are, and the indigenous people there actually can do a whole lot
of things that I think a lot of people perhaps think they can\'t do. I
mean this whole idea of having missionaries coming from America to do
some of the work that needs to happen over there, we\'ve found that the
people in Africa, the indigenous people, can do things like some
testing; they can do some things that would cost us an awful lot of
money if we tried to do them another way.

Could you comment a bit about that? And also, that would involve faith
based initiatives, some churches and faith-based organizations in Africa
that we\'re working with, we found them to be extremely helpful.

The last question is, the new partners initiative, just wanted you to
talk a little bit about that, and when the RFP is going to come out.

MR. DYBUL: Thank you, pastor.

I think you put your finger on a very important thing, and why we
emphasize the importance of having everyone respond to the global
epidemic, including community and faith-based organizations. Because
they are in the communities. They have credibility in communities. And
they can frequently do things at a much lower cost, and get a reach that
you cannot get otherwise.

And that\'s why we\'ve encouraged so much the inclusion of faith-based
and community-based organizations. Because we won\'t achieve the
president\'s goals, you cannot get to national scale up without it.

The countries that are doing rather well, their national plans, in
Namibia and in Ghana, and in South Africa, the scale up of mission
hospitals, Kenya, the scale up of mission clinics and other centers and
the use of mission centers and faith organizations to expand prevention,
care and treatment, is part of the national plan.

They incorporate the mission hospitals into their rollout schemes, and
that\'s one of the reasons that we\'re moving so rapidly.

So we agree completely, and so we\'re very pleased to continue to see an
increase in the faith-based percentage of partners, and also the
dollars; there\'s actually been a doubling in resources for faith based
organizations in the past year. And we think that\'s important, because
we\'re not going to achieve results, we\'re not going to save as many
lives as possible unless they\'re included.

In terms of the new partner initiative, the first request for
applications is actually out and due - responses are due July 16th I
believe, although I could be wrong about that.

There\'ve been a number - there have been four preliminary bidders\'
conferences around the country to let people know about it, and this is
just since the president announced it on World\'s AIDS Day.

There have been two or three more intensive three-day sessions to
provide information on how to apply for U.S. government money. One of
the problems is, many organizations out there doing good work, to them
the United States paperwork is like a massive wall that\'s
inpenetratable. So what we\'re trying to do is provide information for
people to learn how to jump over that wall and break through to explain
grants; how to apply for a grant; what is necessary for a grant.

We\'re using a system for the NPI which decreases the burden required
for concept papers and things, so you don\'t have to do 70-page
intensive concept papers to get the ball rolling.

And then we\'ll have post-award technical assistance to help build the
capacity within the organizations to help maintain that process.

This is not new. The U.S. government has been doing this for quite
awhile. Some of the large international partners started exactly the
same way 20 years ago. They\'re often the groups now who say you
shouldn\'t be doing this, when that\'s how they got their start.

So it\'s a way to effectively level the playing field. So that everyone
has equal access to dollars, everyone has equal competition.

And we think it\'s essential just like for the faith based groups, we
think it\'s essential to bring in all these partners to achieve the
goal. We need everyone engaged.

And I hate to get too far off the track, but in 2001 there was an
historic document in development. It basically said what we\'ve been
doing in development hasn\'t been working. We need four things to get
where we need to go.

And everyone in the world agreed, but it\'s kind of falling away as
everyone wants to talk about harmonization and alignment, as if that is
going to solve our problems.

The four principles were country ownership, good governance, all sectors
and all people responding; private sector, public sector, faith based,
community based, everyone, because we are not going to overcome these
massive problems unless everyone gets engaged; and results based.

And that summarizes what we\'re trying to do with everything, and it is
one of the reasons we\'re pushing forward with the new partners
initiative and these other approaches to build local capacity, because
you are not going to get country ownership, good governance, all sectors
involved, or the results you need, unless you do.

DR. REDFIELD: One last question or comment, Mark, and then we\'re going
to move on. And we want to thank you for the time.

You mentioned several times the importance of trying to get the full
funding for the president\'s request for this. You know, again, some of
us just sort of hear whether there is money that is going to be moved
from the president\'s initial to the global fund, or the global fund.
Obviously both avenues are very important. Is there still tension there?
Is there any question about whether the president is going to get full
funding on PEPFAR program? Anything this committee could do to help in
that regard?

MR. DYBUL: Well, the House has already passed their bill. And our
budget, at least from the State Department piece - we have multiple
buckets of money, but the State Department piece, which is the biggest
piece, which comes in foreign operations or foreign affairs, that falls
within something called the 150 account which covers all development
assistance.

And that 150 account in both the House and the Senate is down
considerably from what the president\'s request is, a couple of billion
dollars.

Now and that means some money has got to go somewhere. So the House bill
is fairly close to the president\'s request, with a decrease for the
focus countries of a couple of hundred - a little over \$200 million.

But we\'re in a process now where the Senate will pass a bill, and then
there will be a conference. And we work extremely well with our
colleagues on the Hill. There is a bipartisan dedication to HIV/AIDS
which is extraordinary. I mean when President Bush took office, the
American people were committing \$840 million for HIV/AIDS globally. In
2001, only five years ago, \$840 million.

The president\'s first request for PEPFAR was \$2.4 billion, around 2.4.
Congress actually exceeded a little bit the president\'s request. The
second was \$2.8 billion, then \$3.2 billion, and now the president is
asking for \$4 billion; more than a quadrupling of where we were when
President Bush took office.

You don\'t get that without bipartisan congressional support, without
incredibly good working relationships, without good advocacy by folks
like Bono and others.

So the money has been there. The money has been coming, but we always
have to work within the top line budget to try to get what we can.

But both pieces are important. I mean the global fund is part of our
strategy. It\'s part of the president\'s vision and part of our
strategy.

But given our bilateral strength, we believe our proper contribution is
more heavily towards bilateral and global fund. Getting to the question
of where the rest of the world is, most of the rest of the world
doesn\'t have that bilateral strength, so if they are going to give,
they should probably give to the global fund.

DR. REDFIELD: Well, I know I speak for everyone, Mark, we want to thank
you for your commitment, and your continued leadership.

(Applause)

I think our next speaker, James Shelton, is an acting deputy director
for the Office of Population in USAID, and Jim is going to talk to us
about directions and level of the global HIV epidemic. I think we\'ve
all seen some publications recently in some of the major media trying to
suggest whether we overestimated or underestimated the epidemic, so -
James, he wants me to give you five minutes to get everybody awake, to
go to the restroom, and then we\'re going to come back. We\'re going to
start in five minutes.

(Whereupon at 2:14 p.m. the above-entitled

proceeding went off the record to return on the record at 2:25 p.m.)

DR. REDFIELD: Again, I want to thanks James Shelton for coming. Again,
as I introduced him, he\'s the acting deputy director for the Office of
Population at USAID. He\'s going to talk about directions and levels of
the global epidemic.

Thanks, James.

DR. SHELTON: Okay, so let me start off by saying that these are my
views. They are not the views of the U.S. government or the Agency for
International Development.

I happen to think they\'re pretty insightful, but they are just sort of
my take on things.

I\'m an epidemiologist public health person by profession. And my
passion is actually prevention, so that\'s the lens that I\'m focused
through. I mean I love all the rest of the work, but I\'m really
interested in that core of HIV transmission, especially in what I call
the hyper-epidemics.

So I was asked to talk a little about the trends, I suppose in the
aftermath of this Washington Post article that came out in April
sometime. I didn\'t actually go back and look at that. I remember
reading it, and I thought, yeah, there\'s some truth here, but it\'s
kind of exaggerated.

In a way, I was actually surprised, there was a very vigorous response
from UN AIDS, and I actually have a statement that I\'m going to quote
from on that.

So I\'m going to talk a little bit about the numbers and how you arrive
at them, but also what it means programmatically, because I\'m just
going to take this opportunity to kind of make a pitch for what I think
is the most important approach to prevention.

So if you will bear with me, I think one of the key points, which is
like epidemiology 101, but it\'s funny, myself I didn\'t pay enough
attention to it. But in HIV the relationship of incidence, which is the
rate of new infections per population, and prevalence, turns out to be
pretty profound.

And this is the example of Kenya. And here\'s incidence of new cases.
Now this is modeled. This is part of the problem. We can measure
prevalence reasonably well. Incidence is basically either modeled using
computer modeling, but there is a lot of consistency in the data. Or
sometimes infections in young people is used.

But I\'ll show you, there\'s actually two major groups of modelers in
the world that are kind of interrelated, one at the Bureau of the
Census, and one at UN AIDS, and they kind of work together, but they
also work somewhat separately. They have separate estimates.

But anyway for the sake of illustration, here is Kenya which probably
peaked in \`93, \`94 in incidence. So notice that at the same time
incidence - I\'ve lost my arrow - was actually declining. Prevalence
continued to increase, so obviously - for some time - and it wasn\'t
until about 2003 that actually people kind of woke up and said, hey,
prevalence has been declining in Kenya for years. I mean I never heard
anybody saying that before that, and I\'ll try to explain that a little
bit as we go on.

So obviously prevalence is important to understand the burden of the
disease, potentially to some extent estimating treatment; but if you are
interested in prevention, you\'ve really got to focus on incidence.

And if you are looking up here at prevalence, you are literally behind
the curve, if you will.

Now these are - this is actually UN AIDS modeling. I got this sort of
unofficially. They are not really officially available. But these are
basically all the countries in Africa. This is one that we know well,
which is Uganda, and then the subject of - can you see that? \--
subject, it\'s kind of got its own nice little early peak.

One of the things I wanted to point out though, this is incidence. It\'s
modeled. It could be off slightly, but I don\'t think it\'s off a lot.
But notice that incidence always peaks, and everyone of these African
countries. Now it may be a gentle low peak, or it may be a peak that
ends in sort of a kind of tail off, but incidents always peak, which of
course is true of all infectious diseases at some point.

Now just to kind of get away from some of that kind of spaghetti in a
way, here\'s - I\'m back to Census modeling. I picked these out because
they are not - are you having trouble seeing the screen?

This is just kind of illustrative. Again, here is I think Uganda. If you
want to evaluate prevention efforts, too, you can\'t just look at the
peak. What is really working, since it always peaks, the real question
is how fast does it come down?

So notice that Kenya comes down, but also Uganda comes down. But some of
these other hyper-epidemic countries - notably here is Botswana,
Lesotho, and South Africa, which is sort of a later one, these sort of
had a peak, but they never came down. They\'re still like - here is
Botswana. Maybe the modeling is off. But it\'s got incidence of
something like four percent of the adult population per year. That\'s
horrendous. So what\'s happening in HIV/AIDS is that some countries are
getting a lot better, especially in East Africa. Some countries never
really took off in West Africa. And the real epicenter is in southern
Africa, most notably, South Africa.

So the question is, why is HIV so high in southern and eastern Africa,
but especially now southern Africa, and why were there these peaks in
incidence?

So part of the explanation, and this relates a little bit to what Mark
was saying, is that there\'s come a realization that concurrent - this
is a belief; this is - it\'s justified by the modeling and a lot of
data; I would say it\'s still something of a theory in a certain way,
but it explains a heck of a lot, which is the concurrent partnerships.
And Mark was absolutely right. The knowledge about concentrated
epidemics and intervening with sex workers and so forth which was
absolutely and still is pivotal to a lot of prevention efforts, notably
in India, as well as Cambodia and Thailand and so forth, that model is
not what was really going on in southern Africa. It\'s more an issue of
concurrent partnerships and the relationship with poverty is sort of
interesting.

And one of the things that in all likelihood that feeds that is the fact
that when people are newly infected, they are much much more infectious
than at other times.

So this is only part of the explanation, and I don\'t pretend to
understand all the modeling. But the part of the problem with concurrent
partnerships is that when people are newly infective, and if they have
regular partnerships, then you can basically have new infections
spawning new infection over and over again, and causing much higher
rates.

And just to give you a feel for that, there may be also an issue at the
tail end when viral load goes up again.

Now this is from Malawi, and it\'s only illustrative, and if I don\'t
purport to make it say that it\'s totally representative of Africa at
all, but this is just to give you a sense. These are actual data. This
is a sexual network in Malawi, a study, a published study of seven
villages in Malawi. It\'s actually rural Malawi, and this is actually
the two-thirds of the population in these seven villages are actually
linked together in kind of one big ball of yarn of concurrent
partnerships.

Now, I don\'t want to exaggerate this. It\'s not as if you just sort of
light a match and all of a sudden the whole thing takes off. It doesn\'t
work like that at all.

But it really is the risk of concurrent partnerships that I believe is
sort of one of the major factors in southern Africa.

So what you have in effect is something of a perfect storm in southern
Africa of factors, first of all lack of circumcision, which is very
common in West Africa, sort of intermediate to some extent in eastern
Africa, not that common anymore in southern Africa, networks of multiple
concurrent partnerships of men and women.

Let me just go back to that one. This is men and women. It\'s not as
though one person has 20 partners, or something like that. It\'s more
like many people have two, three partners, that sort of thing. It\'s not
a youth thing. It\'s not all that the youth are hypersexual or something
like that. It\'s a societal thing, or phenomenon.

And it plays out in different ways.

In addition to those two factors I\'ve already mentioned it\'s possible
that the presence of other STIs and also potentially a different clade,
for example, the C clade is I guess thought to be more infectious in
southern Africa. I don\'t happen to think that that is probably all that
important.

So what is the reason for those peaks in incidence that I pointed out?
Well, the most important one is probably simply the epidemic natural
history, which is that at some point the people that are most
susceptible get infected, and they are no longer able to get infected.
And it\'s compounded in my view by this role of acute infection. Because
once acute infection sort of passes, for most people, no longer can
acutely infected people infect other people.

So the main thing is simply the epidemic natural history.

The second most likely thing in my opinion is really just self adopted
behavior change, which is essentially fear based. And I know Ted has
made the case for fear-based behavior change, and I think he\'s right. I
don\'t think it has to be all fear based, but I do think fear plays an
important role, and we\'ve kind of done a misservice by the sort of
dogma in public health school 101 you don\'t do fear-based behavior
change. Well in fact that\'s wrong, and that\'s not what the evidence
shows. I think you can overdo it, but I think basically what\'s
motivated this behavior change is, people think that they could die if
they don\'t change their behavior.

Then I do think, then there is a small effect of programmatic effects.
And I don\'t think we\'ve been nearly as focused as we could have been.
I think we\'ve kind of been sort of not being as knowledgeable or as
focused or as action-oriented as we could have been or as precise in
this.

But I think there have been some program effects.

So as I was saying incidence will always peak. The effectiveness of
prevention is actually reflected more in the rate and the decline, the
depth of decline. So again my thinking of this has evolved. At one time
we were trying to explain what happened in Uganda. So the big question
was, well, why was there this peak around 1998, 1999. And I now think
well it\'s not really so much about the peak in \`98 or \`99, but rather
the decline that occurred thereafter and continued on.

I still think part of the reduction was the main thing that contributed
to that, but it is a slight change in thinking.

Okay, now I\'m going to shift a little bit to the numbers, because
that\'s actually what Joe wanted me to talk about. And if you are
following along in you8r books, this will sort of spoil the suspense.
But these are all estimates for the year 2003, it just happens that
actually about every six months, UN AIDS, WHO, puts out their estimates,
and they have estimates for various years.

In 2000 year itself the estimate of new infections was 5 million. The
following year, again talking about 2003, they downshifted to 4.8
million. And then in 2005 downshifted again to 4.6 million, and then
into 2006 report 3.9 million.

So that\'s all for the same unit. That\'s quite a downshift for the same
year. So something is definitely going on here in terms of global
estimates.

Let me also point out that parenthetically the 2005 estimate and the
2006 report was 4.1 million. So if you compare that to the 2.9 million
that they were saying for 2003, what happens every year is that you
still see this rising curve. It just sort of gets ratcheted down.

So every year the headline is, HIV is increasing, even though the
headline in a way could also be, HIV is decreasing. Depends on how you
look at it.

So to understand how you get to this, it is important to understand the
way that these data are collected. And there are really three different
ways. I\'m going to talk about two ways. There\'s antenatal care,
antenatal settings; there is population based. And then there\'s also
testing among folks at highest risk, which we\'re not going to talk
about.

But the two main ways, traditionally the main way was antenatal sites to
estimate prevalence, and I think over time the methodology has gotten a
lot better with that.

It\'s not easy trying to do these estimates. My hat is off to these
people trying to do them. It\'s difficult to sort of look at the data
and try to come up with good numbers.

More recently in the last five years or so, we\'ve been using more
population based, representative surveys, especially the demographic and
health surveys, which have a long history in my own field, family
planning, going back well over 20 years. And we basically have added
child survivor and now HIV/AIDS in the last five years.

Notice that - I guess I\'ll go ahead and bring out the antenatal care.
The advantage of antenatal care is you can do it more often. That\'s the
major advantage. And there are not many refusals.

But you have a very select population. You have women, not men. You have
pregnant women. You have pregnant women who happened to go to antenatal
care sites.

So there is a lot of bias if you will about who goes for antenatal care
and where the sites are.

And it turns out that even, sort of getting to this previous discussion
abo8ut poverty, and I very much agree with the point, I actually
published on this about a year ago, that actually wealth is more of a
risk factor than poverty per se, but there is a very important
economic/financial/poverty dynamic that I\'m convinced still induces HIV
infection. But the fact is that sites that are more urban, and where
antenatal sites are, they tend to be district hospitals, so they tend to
be places where there are more people. There are more people that are
commercially and socially interactive and so forth, and potentially of
higher socioeconomic status.

The main thing, though, is gender, sex. It turns out that many of these
places, the sort of conversion factors if you will that people use to
extrapolate from women to the general population had to be readjusted in
a major way.

The classic example is Kenya which in 2003, and when the DHS survey came
out in 2003 for Kenya, the estimate for HIV prevalence dropped from 13
to 7, and a lot of that was just because men in Kenya have one-half the
HIV prevalence as women.

So a lot of what\'s been happening in these changing numbers is simply
that the methodology is getting better, the methodology of the
population based surveys is a lot better, and causes a ratcheting down
of the estimates. Now that\'s not the only explanation, but that\'s a
lot of it.

So I\'ve already talked about this with the - you have this problem that
the antenatal care sites are more urban, they\'re around areas of
social - of higher social interaction and so forth.

I also think that there has been a tendency, and I\'ve done it myself,
there\'s been a tendency to look at prevalence, and not look at
incidence. And that\'s partly because incidence data hasn\'t been
available.

But if you are kind of worried about HIV, and you see that the rates
have been going up, and now it looks like they might be turning down,
and you\'ve got a methodology with antenatal test sites that are - is a
bit iffy anyway, you are not going to want to say right away or that
quickly, it looks like things are getting better. And to some extent
rightly so. I mean I do think you don\'t want to send the message that
everything is a lot better all of a sudden.

Another sort of similar thing is that I think there\'s been actually a
major misconception that HIV was going to sort of take off in India and
China and other parts of the world in the way it did in Africa. And I
think that\'s just really not the case. And the evidence, I\'ll show you
a little bit of the evidence. But also, they\'re different sexual
patterns, especially for women the number of partners.

Then I think - this is kind of a euphemism in a way - I think there is
still processing going on in the minds of people that do these numbers.
One of them is that for example China which I\'ll talk about briefly I
guess in 2003 they had an estimate from the government that it was about
800,000 total cases, and they didn\'t have a lot of basis for that. So
they sent in a special team in 2005, this is UN AIDS, you know, very
painstaking hard work, and they decided 650,000 was a better estimate,
just based upon - I don\'t actually know what methodology they did, but
I respect their methodology. So when that happens, again, people are
afraid, I don\'t want to give the message that HIV is going down.
Because I don\'t know that that\'s true.

But I also think, I have a little bit of evidence I\'ll show you, I
think we haven\'t quite caught up yet in terms of the estimates. And
I\'ll show you a little bit on that.

So in response to the Washington Post article, this was a statement that
they put out, and you\'ll notice that all the data that I show that came
from UN AIDS and from the Bureau of the Census really showed, if you
believe the modeling, that incidence did peak around 2004 or a little
bit before in southern Africa. So in fact they\'re agreeing with that.
They\'re saying that incidence in southern Africa peaked - I went to the
website; I couldn\'t find this document, but I saved it, so if anybody
wants it I can share it with you.

But then notice it says for the last three years there have been 1.1
million new infections per year. So I don\'t - I think there\'s probably
been some decline in the last year. Now granted there\'s another
subtlety in a way. Numbers of new infections is not quite the same as
incidence, because incidence has population as the denominator, and
population is growing a little bit. But that is kind of a refinement.

But remember I said that their estimate for 2005 was an increase in
global new cases by about 200,000 I guess. I don\'t know how you get to
that. If HIV new cases is stable in southern Africa, and I think it\'s
at least stable in India; there are estimates in India that -
sub-Saharan Africa is five-eighths of the number of HIV infected; India
is another eighth; that\'s three-quarters of the world. Their estimates
for new cases in India did not go up, and we\'ll talk about China. I
don\'t know actually know how they\'re getting to those higher numbers,
and they don\'t give you the breakdown by country systematically.

Okay now, this is - I was talking to Bob before the meeting about this.
This was published in Lancet I guess in early April online, and this is
antenatal care data from India. And Bob\'s concern that there may be a
dilution by this here, in that - that\'s my term - that as you add more
antenatal test sites, and they are in lower prevalence areas, you may
actually kind of dilute your numbers down.

Notice also that these numbers are really - this is 1.1 percent, and for
northern India it\'s point three percent; that\'s three per thousand.
Think about the precision of that estimate. It\'s not real good, if you
are testing 1,000 women in order to find three cases. It\'s obviously
susceptible to a lot of small numbers.

Nonetheless, at face value, if you look at - these are infections in
younger women. In southern India, which is four states in southern
India, including a couple where we have pretty active programs, in Tamil
Nadu for example, HIV prevalence among younger people which is taken as
an indicator of incidence is actually falling fairly substantially.

And don\'t forget that the way the sort of epidemic evolves, even if
it\'s stable, if it reached a point of stability, you\'d probably come
to a point of declining incidence already.

So I don\'t think we really know entirely what\'s going on in India, and
I still worry about it, but to me it\'s much more of a concentrated
epidemic phenomenon.

And China the estimate as I was saying is 650,000 HIV positive, and
70,000 new infections. So if you just sort of divide 70,000 into 650-
you get something like nine. That ought to tell you that this is a
relatively stable, based on the numbers, a relatively stable epidemic,
and it\'s primarily intravenous drug users.

So my view is, incidence has peaked, although it\'s not this sharp of a
peak.

Okay, now I\'m going to shift a little bit to the programmatic, if
you\'ll bear with me. I heard ABC mentioned a bunch of times in this
meeting. I will probably not use it too much, and I\'ll tell you why.

The reason is from where I see, mostly what I see is kind of a battle
between the forces of A and the forces of C. And it\'s unfortunate, and
it\'s - the problem is with that is, first of all it\'s a lot of wasted
energy, but secondly, with some merit, actually, it\'s always good to
have some diversity of views, the real tragedy to me is that actually
what is the most important component, which is the B, the partner
reduction, which is far and away the most important part of this, has
actually been neglected quite a bit, both in terms of the sort of global
discourse, but also programmatically.

And one of the reasons why I worry about saying ABC, ABC, is because I
think people hear A. They hear the A, they don\'t hear the rest of it.
That\'s been my observation.

And then I don\'t know how many op-ed pieces I\'ve read where people
talk about ABC and then they say abstinence, and they sort of make that
jump, which is unfortunate, which is not to say that A and C don\'t have
important roles; they do. I think they have extremely important roles. I
just think they are more like supportive roles.

And again as Mark was saying, I don\'t know if any of you got a copy of
it. I\'ve got a little piece called \"Confessions of a Condom Lover.\" I
have spent almost 30 years promoting condoms, and I feel like I have
good condom credentials.

And I feel like condom promotion in sex workers has maybe been the most
important intervention in the entire global pandemic. I mean it has
helped containing what could have been very, very bad epidemics
primarily in southeast Asia but also India and other places.

However, I don\'t think that translates necessarily to the epicenter of
the epidemic, and I\'m going to talk about South Africa a little more.
Here is a place that is literally flooded with condoms. And believe me,
I spend a good deal of my life trying to help flood these places with
condoms, and I think it\'s actually been a useful thing.

But here, with a population of 48 million, 346 million condoms provided
by the public sector alone - now this is from the national survey. And
in the survey, also, among single youth aged 15 to 24, 69 percent said
that they used condoms in their last sex act. But still the epidemic is
raging on, notwithstanding.

So here are some of the limitations of condoms. They are 90 percent
effective, but they have to be used correctly and consistently - I\'m
probably telling you stuff you know. And this is a virus that is not all
that infectious to begin with. So in the right situation that can do a
lot of good.

But they are often not used consistently. More often they are not used
consistently, or correctly. There is some data to support that.

Also quite importantly, they tend not to be used in these longer term
relationships, so that if you believe the concurrent partnership model
for southern Africa, if people are not using these in their established
multiple relationships but only in sort of sporadic ones, then you are
not getting a lot of benefit.

And then the last kicker is that I truly believe that as with basically
any other prevention modality, they are subject to risk compensation, to
disinhibition, such that people will use condoms, and there again there
is enough evidence for this that\'s in this little essay, that rather
than limiting partners, people will use condoms. And then it becomes
kind of a tradeoff to some extent.

Now, lest I spare abstinence either, the problems I see with abstinence
are, of course we already talked about young women. Women may be subject
to coercion. My main issue with primary abstinence is it\'s actually a
very narrow effect that you can have on the epidemic directly. Because
the average time period between sort of setting aside whether or not you
can change that behavior, which I think you can to some extent, the
actual time between the initiation of sex and marriage for example is
actually a fairly narrow range, specifically for women. In some other
countries, it\'s a bit broader than that.

But also, people have the belief that adolescents are sort of the engine
of these epidemics. Somehow I think people generally - well, it\'s an
STI, and it must be young people having a lot of partners or something
like that.

And indeed that is quite important. But in fact these are generalized
epidemics, and it\'s a sexual behavior not just of youth but of
basically a lot of people that are at issue.

So just to show you now a little bit of data, this is condom use. Now
for Kenya. So we now have - I should have said this - in addition to
Uganda, we now have two major successes in sub-Saharan Africa: Zimbabwe,
which is not as clear as Kenya; and Kenya.

And it turns out though that for Kenya, that serendipitously, or maybe
not that serendipitously, but for \`93, \`98 and 2003, there are these
DHS surveys which are right smack in the middle of this decline in HIV
incidence, and are somewhat instructive.

This is sort of evidence based judgment we\'re talking about here; still
a judgmental thing. One problem is the methodology change, but you can
see that between \`93 and \`98 actually there probably was a fairly
substantial increase in condoms. So you can give condoms some at least
in terms of correlation some credit for the effect.

Between \`98 and 2003 however there really isn\'t much increase in
condom use among men - as reported by men, I should say. Again the
denominator changes slightly. If you were to adjust for that, it would
actually increase that second bar probably a little bit, because what\'s
missing is the cohabiting nonspouse who tend to have lower condom use.
So there is not really much difference.

My judgment of this is this sort of correlates with some benefit, but is
probably not enough in and of itself to have that much impact.

Now here\'s primary abstinence. And I actually did this two ways. It
turns out primary abstinence is kind of tricky to measure, because it\'s
a cohort phenomenon, and if you want to sort of measure it over time,
sort of what time does the initiation start. So it\'s kind of - and you
can\'t look back at people when they\'re age 40, and sort of look back
and see - you can to some extent, but it becomes difficult.

There\'s not a - I won\'t spend that much more time - there\'s not that
much change in primary abstinence during this time period, either if you
look at it sort of survey by survey, or actually if you look back sort
of in time, by people older cohorts if you will.

Now in contradistinction to that, this is maybe one of the most
important sites I have to show, this is in those three surveys, changes
in the number of people, men, reporting multiple partners. And if you
remember that sort of slide of all the different partnerships, basically
of all age groups, the number of partners that men say they\'re having -
in the first instance, it\'s the first six months; and then it\'s the
next 12 months - these are really quite profound changes in my opinion.
It\'s judgment. You can form your own judgment if you like. But to me
this is fairly profound. It\'s actually the number of partners that has
a major impact on the epidemic.

And of course the example of Uganda was much, much cleaner, because
there really wasn\'t that much condom use or change in abstinence.

Now in contradistinction, and these are not DHS surveys, this is
actually South Africa, and there is a different research group that does
these surveys, and I have a little trouble making the numbers add up,
but at face value, these are between 2002 and 2005, these are from these
two surveys, what percent of men and women having more than one partner.
You can see there is a little bit of a decline in women, but if anything
there is an increase in men.

So you are free to draw your own conclusion. My conclusion is that South
Africa has had sort of a situation within inundation by condoms, and not
much partner reduction. And the reasons why that might be. And that
hasn\'t been enough to turn the epidemic around.

Whereas I think if you have a platform of partner reduction, and you add
condoms, and you add abstinence, and you add a lot of counseling and
testing, and you can - and I\'ll have a slide on that - you can have a
major impact. That\'s the ideal way we should be doing these epidemics.

So that\'s what I\'m calling the overall B strategy. And the question
is, how do you get to that? How do you support the behavior that people
are largely in my opinion doing on their own?

I\'ll skip down here. I think we ought to be using behavior change best
practices to reinforce that behavior, and by and large we\'re not doing
that. By and large our prevention efforts are not really focused on job
A, if you will, job one. I don\'t see that happening in the field nearly
as much as I would like to see that happen, and to me this was the most
important thing we could be doing for HIV globally that could have an
impact on the pandemic is trying to reinforce partner reduction and
other supportive kinds of activities, and it\'s beginning to happen a
little bit, and some of it is happening on its own, but we\'re not doing
nearly as much as we should.

Part of the reason for that is, I think, many people that are working at
HIV, if you say, well, we want to change the general social norm to
reduce partners, don\'t really have a programmatic sense about how you
go about doing that. You know a lot of people have medical training and
they know you have some feel for counseling, so how do you change a
societal norm?

Now there\'s a way to do that. There\'s actually a fairly
straightforward way to do that, the behavior science people can tell
you. It begins with an open environment by the government about HIV;
that people are dying of HIV. And it\'s clear messages about concurrent
partners and numbers of partners and condom use and abstinence, and so
forth.

But we really ought to be doing it, and I think we\'re starting to get
there.

Let me just digress a second, because I think there are sort of three
main strategic thrusts about trying to affect these epidemics. One is
the one you\'ve already heard about, which is, if you reduce poverty,
you\'ll take care of it. And I think we know that will probably not
really solve the problem.

The second is that if we only test everyone - and I\'m exaggerating this
a little bit - if we just do voluntary counseling and testing, then
everybody - there was an article in Science this past week for China,
sort of just talking about testing. I think testing is very important,
but I think unfortunately the way it\'s carried out, we don\'t get the
counseling we need to get the behavior change that we really need.

And part of the problem, I mean these research studies show you can do
it, but in real life it mostly doesn\'t happen that much. So it\'s not
just enough to do the testing.

But the third major thrust is changing the overall behavior, which is
daunting to many people. But part of the solution is that you do mass
media, but you also use every fiber of social capital, which means the
faith based groups, the schools, the military, I\'ve listed some of
these people, and try to get that consistent message of reducing
partners, which is to some extent what happened in Uganda.

So I think we ought to be leading with B, and I do think that - the idea
is that condoms then have this residual high risk sort of role. And even
though I\'ve talked a lot about concurrent partners and so forth and the
evolution of these epidemics, it\'s important to not fight the last
battle, because to some extent that\'s - even though it\'s still
happening - a lot has happened, and we\'re going to see more mature
epidemics where there\'ll be less in my opinion new transmission, and
more people that are HIV infected either with treatment and so forth.

So this point about discordant couples ends up being quite an important
point. And part of the testimony to the fact that it\'s not as
infectious as we think, this virus, is there are a lot of discordant
couples that are having a lot of sex, and they\'re still discordant.

Okay, so an abstinence programming helps set the stage, forced in and of
itself, for responsible initiation of sexual debut. Secondary
abstinence, which I should have mentioned, actually is on the increase
in a lot of places in Africa, but also sets the general social norm of
sort of responsible sexual behavior, and when you do start having sex,
have one partner.

I\'m getting a lot of head nods from Ted over here.

And then counseling and testing has got to support the message, and
then - oops - sorry. Male circumcision which is right around the corner,
it\'s got to have a strong B component. If the men who get circumcised
are then subject to risk compensation such that they then start having
more partners or not using condoms or something like that, you\'ve got
to have that platform.

I happen to think male circumcision, regret that we are not doing a lot
more than we are already, because I\'m convinced it\'s quite effective.
But vaccines, same point. It\'s not going to be 100 percent effect.
Microbicides, same point. You\'ve got to have that sort of prudent
partner platform if you will.

So where does the global epidemic stand? Mature generalized epidemics in
eastern and southern Africa. Actually a fair number of bright spots. In
addition to Zimbabwe and Kenya, and Rwanda, Haiti and probably in
Ethiopia there have been some significant declines as well.

But it\'s still raging on in the southern African countries. West Africa
is stable. In the Muslim world, I think because circumcision is so
prevalent, I find it hard to believe that there will be a whole lot of
HIV in really any Muslim country, and that also includes other countries
like Madagascar and Philippines where circumcision is close to
universal.

But in the rest of the world I think what we\'re facing, and this is a
pretty key point, is a lot of pernicious intransigent low level sort of
concentrated type of epidemics, that are not going to go away, and we
ought to sort of get away from this idea that AIDS is going to explode
or the former Soviet Union is going to explode a la Africa, but rather
we\'re going to have this burrowing difficult kind of epidemic to kind
of deal with.

And my last message is just simply to lead with the B.

(Laughter)

DR. REDFIELD: Thank you, James.

(Applause)

Okay, Dr. Green.

DR. GREEN: Yes, I was nodding a lot. Fantastic presentation, Jim. After
hearing you and Mark Dybul, one after the other, I feel like I can
retire.

And I agree with everything you\'ve said. I think it\'s supported by the
evidence, except there is only one comment that I would maybe raise a
question about, and I\'m sure you know which one it is, and that is that
in your estimation the single most important intervention so far, and
keep that slide, because it will keep the minds open that need to hear
what you\'re saying.

But just for the record, and I\'m sure we\'re thinking of countries like
Thailand and Cambodia, from what you yourself said about the nature of
the epidemic in Asia, women tend not to have multiple concurrent
partners, I think that the reproductive number is always going to be
less than one. Yes, sometimes a man will infect his wife from going to a
sex worker, but she is not going to infect someone else. So I think the
prevalence would have fallen because of the natural dynamics in Thailand
and Cambodia.

DR. SHELTON: You could well be right.

DR. GREEN: Also in both countries at the same time we had very high
condom use in commercial sex, we had a significant decline in the
proportion of men reporting going to sex workers, and even reporting
casual sex. So we don\'t know how much of that decline was due to high
levels of condom use, and how much to other more fundamental types of
behavior change.

DR. SHELTON: No, I\'ve made that latter point myself, and it\'s in the
little essay, that in fact what we\'ve got - and this testifies to the
ability to influence behavior - people were promoting condoms and yet we
also saw - with sex workers - but we also got a behavior change where
men went less to sex - even though there wasn\'t - there was a little
bit of promotion of that, but not a lot.

So there\'s a lot of quote unquote agency. There\'s a lot of ability to
influence this kind of behavior. My own view is that people actually get
it. Even if there is all this vague stuff out there about protect
yourself, which really doesn\'t tell you anything or what have you, to
some extent people get that this is sexually transmitted. And I better
be a bit careful.

I just wish we were reinforcing that message, and telling people
specifically this issue of concurrent partners in sub-Saharan Africa.
Because I don\'t think people know that at all.

DR. GREEN: I totally agree. I hope these slides will be made available?
Can we get them in electronic form?

DR. SHELTON: Sure, or I can send them to you, Ted. I\'ve got your email
address.

DR. REDFIELD: Dr. Sullivan?

DR. SULLIVAN: Thank you very much for a very informative presentation.

You went by rather rapidly the comment that you don\'t expect the
epidemic or the pattern of the spread in India or China to be like
Africa. So I wonder if you would comment a little bit more, because I
would have to plead guilty to being one of those individuals whose been
saying, if we don\'t do things we\'re going to see that. And so it\'d be
very helpful to understand that.

DR. SHELTON: I think the heterosexual - as Ted was just saying - the
heterosexual patterns are not like this. My counter to Ted\'s point was,
I think there was sort of a culture in Thailand and Cambodia where men
went a lot to sex workers, and I think you can get a fairly high level I
think just by that.

But the extreme example was China. I mean those women, to some extent
they are kind of - here\'s a situation where social isolation protects
you. That women just do not have that many partners. Not that many women
have more partners in China; it just doesn\'t happen. I mean that\'s
what I\'m told.

So to get this kind of explosion it might only take five or 10 percent
or women or something that are having multiple partners. But if you\'re
down in the half or one percent of women, it\'s a heterosexual epidemic;
you\'ve got to have men-women, men-women. And you know men may be the
same everywhere, but if women are different or made to be different -
sorry, I\'m on thin ice here - if they are made to be different by the
social situation, then it\'s not - you have men having sex with men, and
you have all these other things. But you are not going to get to a
heterosexual epidemic at this level.

DR. REDFIELD: David.

DR. REZNIK: Just a follow up. I understand the concepts that you\'re
saying about China. And although I\'ve never been to India like my
colleague, Dr. Bollinger has, from what I\'ve read there has been a
pretty substantial increase in an epidemic that started in the IDU
population and it\'s now moved to heterosexual means as its number one
way of passing. And although it\'s 5.7 million cases out of 1.1 billion
people, that\'s a lot of cases. And I think that epidemic to me is
somewhat worrisome.

DR. SHELTON: Oh, I\'m worried about it. I think my very last slide said
I\'m still worried about India, by the way; or the one before that. But
to me it\'s not a generalized heterosexual epidemic. You don\'t see that
level; that\'s why the antenatal care levels are still so low. You\'ll
see it spike up in IVUs and then having sex with men and so forth.

It takes more to have it spill over, not to mention all the Muslims,
which is something like a fifth of India or something like that, they
are all circumcised, so that\'s going to help keep it down.

DR. REDFIELD: Joe and then Robert.

DR. McILHANEY: Jim, great presentation, thank you.

What\'s your reflection on the U.S. epidemic and why - of what you\'ve
said?

DR. SHELTON: No, I\'m sorry, no. Well, it never went generalized. It\'s
interesting. Fifteen years ago you heard the same, it\'s increasing in
women. And it does. But it starts from such a small base that it - and
circumcision is about 50 percent in the U.S. or so. We\'re just really
lucky it\'s not that transmissible I guess, and it hasn\'t evolved to be
more transmissible.

Yes.

DR. BOLLINGER: Just a comment about India, where I\'ve been working
since 1992. Like Dr. Sullivan, when I started there, the first case of
AIDS was reported in \`86, \`87, and in the early \`90s we saw just
tremendous increases in prevalence rates among sentinel high risk groups
of sex workers, STD patients. And I was one of the people expecting to
see a similar pattern to what was seen and beginning to be seen in
southern Africa at the time.

But I was finally convinced a couple of years ago to actually write an
editorial in Lancet questioning my own presumptions from that time. And
I think it\'s exactly for the reasons that we\'ve just heard.

You look at large behavior studies, I mean again, it\'s not a major
problem. They\'re number one and number two in the world as far as their
burden of infection, but the epidemic is very different, because there
is not the bridging group of heterosexual women other than sex workers.

You look at large behavioral studies in India that were done a few years
ago and they\'re now being repeated, about 11 percent of men, or married
men, in India report extramarital sex, and less than two percent of
women. Now compare that to the United States or some other populations,
and I think you\'ll see that particularly for the women they\'re not a
bridging population. Their only risk factors if they\'re married is
their husbands.

And that\'s one of the reasons why you\'re seeing for instance the
antenatal clinic preference in Bombay and Mumbai in 1992, when we
started, was the same as Durbin, South Africa; it was one percent. It\'s
not 1 or 2 percent in Mumbai in most places. So it\'s been a flat
prevalence in antenatal clinics.

Obviously Durbin has gone straight up. So it\'s a very different
dynamic. It\'s not that it\'s not an important public health priority.
It should continue to be a public priority. But it\'s a very different
epidemic.

DR. SHELTON: When you have serial monogamy, in other words you have
multiple partners, but they are spaced if you will, then presumably
there\'s considerably less risk from that.

DR. McILHANEY: Could I just throw a word in right here? Actually the
best studies we\'ve seen about sex outside of marriage in this country
show that it\'s really rare for people in this country when the marriage
is intact to have sex with anybody except their marital partner. So that
could be one of the factors in this country that has kept it from
becoming such a problem.

DR. SHELTON: But our lifetime number of sex partners actually is pretty
similar to some of these countries as it turns out, because people have
serial monogamy.

DR. REDFIELD: Monica.

DR. SWEENEY: I was very interested in your statistic about the
prevalence of HIV in women being double that in men, and I don\'t
remember where you used -

DR. SHELTON: This was Kenya.

DR. SWEENEY: Kenya. And then you talked about changing social norms to
change behavior. Were you also talking about Kenya or Uganda or both.

DR. SHELTON: Both.

DR. SWEENEY: In this country we have used changing societal norms to
change the way we think about and accept smoking.

DR. SHELTON: It\'s a good example.

DR. SWEENEY: Do you think we could ever do that with HIV and still not
be accused - in smoking no one accused you of being homophobic or
whatever the other negative terms they say when you\'re trying to talk
about changing behaviors both in heterosexuals who have multiple
partners and men who have sex with men.

Can you see any relationship of how we could maybe change societal norms
using the smoking model here to try and impact HIV?

DR. SHELTON: I think there is a similar phenomenon such that if it
becomes socially declasse to indulge in risky sex or - I can see where
there can be a social norm where - I don\'t want to exaggerate it, but
in certain contexts it\'s not done, it\'s not socially done. It\'s not
cool. It\'s just no one would think about doing that.

And obviously it\'s sort of a continuum of behavior, but in fact when
people talk about social norm, they\'re not just talking about all the
individuals and their behavior. To some extent they\'re talking about
how the group kind of looks on that behavior, and thereby influence the
behavior.

So yeah, that\'s part of the objective, and if you push all the buttons,
I believe, if you - I really think you can do that.

But it\'s - you got it.

DR. REDFIELD: Frank.

DR. JUDSON: We previously I think discussed the parallels between
tobacco prevention and HIV prevention, and there are really many from
the biochemical addictive nature of sex, and nicotine, both play out in
dopamine reward pleasure pathways to some extent, so they are hard to
give up. They are pleasurable; they\'re addictive.

For tobacco, I think what we have learned over the years is that there
have only been two major factors in a developed country that have really
caused us to have the success that we have had. One is the cost of
tobacco which has been taken care of somewhat by taxes, somewhat by
litigation, which is sort of an indirect tax.

The other has been the nonsmoker\'s rights and laws to back
environmental tobacco smoke and indirect tobacco smoke regulations,
which really have turned this thing around from smoking was normal,
desirable, supportable, to the point where smoking is viewed as socially
undesirable and unacceptable; there aren\'t many places you can do it;
your peers don\'t think it\'s cool any more.

And that same thing hopefully could apply in Africa. When you look at
the motivators for people changing sexual behavior, one of them is, far
and away the biggest one is understanding AIDS and being afraid of
getting it yourself, and believing that you can change behavior to
reduce your risk.

Another part, though, would be from just as your looked on poorly if you
light up and expose somebody to tobacco smoke, the same thing can be
turned around where somebody who is exposing someone to HIV against
their behavior, or claiming large numbers of partners, unprotected, that
becomes just really a source fo stigma, of positive stigma; you\'re an
outcast if you are out there spreading HIV or getting HIV. And I think
we\'ve moved closer to that.

DR. SHELTON: And I can see it for example in the behavior of younger
women and older men. This is a reciprocal exploitation going on. It\'s
very complicated. But to some extent, young people have strong social
group norms, and if the group norm is that that\'s dumb, or what have
you, then I think that that is possible to happen.

The nice thing about this is, you know, nobody is saying you can\'t have
sex. People are saying you just need to have one partner, or one - you
know one - that\'s what most of us I think do most of our lives. I
don\'t think it\'s totally that unreasonable to try to promote that as a
social norm.

DR. REDFIELD: Ram, and then I think this will be the last question.

DR. YOGEV: Very quick, would you kind of speculate on the economic boom
which now is going in China, some places in India. This is a B but in
the wrong direction.

DR. SHELTON: Yes, I think that would be expected to increase risk for
STIs. I mean it\'s already known for I think for STIs.

DR. YOGEV: But just one question, in Shanghai for example there is an
increase, and I just wonder how that works against the norm that you
traced.

DR. SHELTON: I do think in concentrated epidemics you still try to
promote this norm. And it relates to sex workers, it relates to condom
use and so forth, but yes. In China, even though that is happening, the
vast majority of people are still rural. The vast majority of women are
still sort of in this sort of situation. I don\'t think it\'s going to -

MR. HOLMER: Not so much a question I guess but a follow up to Monica and
the discussion we had earlier.

This is an international discussion because it relates to the United
States, and your emphasis on being faithful and engaging in responsible
sexual activity and the group norm.

Some of us are old enough to remember when the group norm was engaging
in promiscuous sex with multiple partners was something very much to be
frowned on. And sadly, that\'s not as much the case today as it was 30
or 40 years ago.

But those norms could change again.

DR. SHELTON: I would argue that the norm in the \`60s was much more
permissive than it is now. So that pendulum has swung back to some
extent. And it\'s a social norm to some extent. I mean I think we\'ve
seen it to some extent in this country, to some extent.

DR. JUDSON: In Sex in America -

DR. SHELTON: Yeah, I read that. I did read that book.

DR. JUDSON: The most recent edition their survey had, and this has been
surprising to most people to see America is a totally permissive, maybe
promiscuous place: 95 percent of adult men and women in the United
States have one or zero partners a year. That is an enormous barrier to
the spread of this infection to general population spread.

Same thing I think is from living in India for a period of time. When I
thought back to what I learned about the culture of India, it is fairly
conservative at a family level.

The same thing in China, despite communism, it\'s actually maybe more
puritanical than we are.

So I think there is an enormous barrier for heterosexual spread I would
guess in most of Indian society, Chinese society, U.S. society. We shun
that.

DR. REDFIELD: Well, Jim, I want to thank you for your time and your
comments. Thank you very much.

(Applause)

DR. REDFIELD: I think since we had a break between we\'re going to go
through, right?

So I\'d like to ask John Martin, who is the CEO for Gilead Sciences, to
come up. I think people know I\'ve expressed my own point of view that
as a practicing physician the early patients I took care with AIDS in
1981, \`82, \`83 had about a 10-month survival. Now many patients can
live in that for a lifetime.

Largely that is because of the pharmaceutical industry. And I think John
Martin and his company has been a very important part of it.

When we asked Mark Dybul about the issue of sustainability, I\'ve also
expressed to a number of people on this committee, one of my concerns
is, the long term sustainability of keeping the pharmaceutical industry
engaged in the effort, as it becomes more and more an epidemic in
resource limited areas.

And the challenge is to keep that pharmaceutical industry fully engaged
so that the best weapons for HIV therapeutics are available to our
government\'s programs I think are fundamental, and I think the
opportunity to have a dialogue with the pharmaceutical industry to see
how to keep them engaged, the same way we do the defense industry, and
our defense technology, I think is fundamental.

So John, I want to welcome you.

MR. MARTIN: Okay, thanks, Bob. Am I ready to begin?

So thanks for inviting me today. I don\'t know, maybe I shouldn\'t use
the mike?

(Audio difficulty)

So I am pleased to have the opportunity to be here today. Thanks for
inviting me.

I was assigned the topic, the future of HIV treatment. But of course
I\'m presenting to the group that has come up with these
recommendations, and I congratulate you on these. I think they are very
good, and in some cases somewhat controversial, that you are making
points that will work in fact toward achieving an AIDS-free generation.

My title, I believe, refers more to the fact that at Gilead we\'re
working with Bristol-Myers and Merck to come out with a pill that\'ll be
all three drugs taken once a day in a single regimen that will be
available probably well before the end of this year.

So to begin with, I think a lot of stuff I\'ll review in the context of
this talk are things that have been discussed by others here, and I even
heard them today.

We have a number of challenges. New therapies are necessary to simplify
treatment, decrease long-term toxicities and resistance, and increase
tolerability.

And that\'s what we\'ve been working toward at our company. There\'s
also an awareness now that late diagnosis and lack of awareness
increases transmission rates and/or mortality and morbidity. New
infections are more prevalent among low income populations.

And then some of the challenge we face in emerging work means that there
are additional challenges there.

So the single tablet regimen is our two drugs, tenofovir and Entriva,
combined with efavirenz, which is provided around the world by Bristol
Myers and Merck.

And the story begins of the development of this regimen begins at the
time we filed for Truvada in the United States and Europe in March of
2004, so just over two years ago.

Truvada, I believe most of you know, is a combination of tenofovir and
Entriva, both once daily medications that have long duration of action,
so they combine very nicely together.

The filing and approval of Truvada has led to a very successful product.
Tenofovir in its forms, in Truvada and Viread, is now the number one
molecule in the United States. Last month in May it surpassed lamivudine
in sales. So that\'s lamivudine as lamivudine, Combivir, Epzicom and
Trizivir.

So this regimen of having a combination product with very well tolerated
drugs is in fact been well adopted by practitioners in the U.S.

At the time we filed on Truvada we were already talking with Bristol
Myers and Merck about putting together a combination product that would
be the first single triple given once a day. And what we realized, it
would take some time to negotiate the agreement, because of all the
commercial and regulatory complexities.

So Gilead we requested from Bristol Myers and got a very substantial
supply of efavirenz, and started that spring working on that triple
combination product, because we wanted to stay on the critical path of
getting this product approved.

Also at this time, Truvada by FDA regulations was under a 10-month
standard PDUFA review.

The two individual products already being on the market meant by
regulation there wasn\'t an unmet medical need for a combination
product. And of course everyone recognizes, including government
scientists, that this combination product would make a real difference
to patients, to improve adherence and make sure that we minimize
development of resistance.

So the FDA hosted a meeting with us, and Bristol Myers, and Merck, to
talk about ways to expedite the review of combination products. And in
fact DHHS announced guidelines for that expedited review in May, and at
the same time we with Merck and BMS announced our plans to develop the
triple combination product.

Subsequent to that, Truvada was approved after only a 4-1/2 month
review, so that really was a very impressive effort by DHHS to change
the regulations and to work with the FDA, and the FDA to expedite a
review, where the product was approved very quickly and on less
stability data than would normally be required, but you extrapolate it -
accelerate stability to estimate what the shelf life would be.

I said working on an agreement was tough. We actually didn\'t finalize
our joint venture for the U.S. until December of 2004, but we did not
lose any time in the work of the product, but it did take awhile to
establish bioequivalence. That was done in January of 2006, and I think
maybe many of you know the story of how this bioequivalence turned out
to be very difficult.

Most people think that making a bioequivalent combination, or making a
combination product, you just mix them together and press a tablet and
ship it off somewhere, and that is certainly not the case. It took us
five tries to come up with a pill that was bioequivalent to the
individual components. And FDA has a very strict definition that
bioequivalence has to be in a narrow range.

And that\'s really important when you think about it, because if you
have suboptimal ability, a broader range of exposure, that\'s what\'s
going to give rise to resistance.

So the FDA is right to have a very high standard of bioequivalence so
when you\'re given a combination product, you know you\'re getting the
same amount of drug as if you\'re taking the individual ones.

It turns out efavirenz, the third drug in the regimen, is quite
insoluble, and it needs to be specially formulated with excipients. And
what we tried to do was use tenofovir and Entriva excipients to minimize
the size of the pill, and that simply didn\'t work at all. The
bioavailability is very low.

So what we went to for the final three tries was to have a bilayer
tablet with efavirenz on one side; our two drugs, Truvada, were on the
other side.

The third pill we did was actually pretty close but it was a little bit
low, just out of the range of what the FDA would approve.

The fourth pill was off, and the fifth pill actually was very good
within the range, and that\'s what we filed for approval in April when
we garnered sufficient stability studies for the FDA to be able to
review.

And now discussions with for the ex-U.S. markets are still ongoing with
Bristol Myers and Merck.

I would like to say there is another aspect of this that the FDA was
very creative on. Earlier, with Viread, to make Viread or Tenofovir, the
brand name is Viread, to make it available in Africa for instance in
PEPFAR countries.

We were concerned about importation back into our major markets. Viread
is a blue pill. The FDA approved another Viread pill that\'s white for
export only, and this is the first product that the FDA did that for,
and they really did it within weeks or our request of doing that. It was
very much an expedited review, and it comes with a label saying for
export only; it\'s not for use in the United States.

That was an example. In the pharmaceutical industry we talk about
innovation all the time, and how important innovation is. But other
aspects of the U.S. government, throughout their efforts on global AIDS,
has been incredibly innovative. And that\'s one of the ways that the FDA
has been innovative.

And in fact the day we got Truvada approved, we had a different colored
pill approved for export only on the very day. It\'s part of the same
package that was approved in 4-1/2 months. And with the triple we also
expect to have approved by the FDA a different colored pill for export,
so the day the product is approved for use in the United States, there
will be a product approved for export only.

So the partnership that we have with Bristol Myers and Merck, as I
indicated, the formulation work was led by Gilead. We just, rather than
have a delay, we went ahead and made the entire investment with Gilead
resources to make sure we had this product out there as quickly as
possible.

BMS though has worked very closely with us on the technical aspects, and
of course the regulatory filings. The manufacturing is also being led by
Gilead, and once the product is commercialized, we will work together
with our commercial efforts, medical efforts, to provide immediate
access. We\'ll work together to educate physicians on the product
profile, and partly securing formulary approvals as quickly as you can
do that. That allows for patients to get access.

And finally we have what we believe to be the best in class patient
assistance program to make the product available free of charge for
individuals who cannot get reimbursement. This program we put together
working with people who deal with this on a day-to-day at medical
institutions around the country, including Dr. Redfield\'s at the
University of Maryland.

So what we call the single tablet regimen addresses treatment
challenges. It greatly simplifies treatment. And that type of
simplification has been published to increase compliance by up to 30
percent.

Also recently published was a survey, a patient survey, indicating that
in one week an average of 17 percent of patients missed one dose;
another 17 percent missed two or more doses of more complex regimens.

We by doing this these products can decrease long-term toxicity and
improve the resistance profile. And it\'s important to come up with
products that have increased tolerability, and I want to show you a
little data on that.

We compared, and this was published in the New England Journal earlier
this year, tenofovir versus Truvada essentially, so AZT lamivudine,
versus tenofovir Entriva, both in combination with efavirenz. And you
can see the efficacy at one year is 84 percent versus 73 percent.
That\'s a highly statistically significant result.

And so - and that\'s a real difference in terms of the number of
patients that are benefitting, and that is entirely driven by the
adverse events profiled. There are fewer adverse events on tenofovir,
and that\'s why the efficacy is higher at that one year time point.

Another study, and this is quite an old study - as you can see the
number of weeks goes out to 240 now - we compared d4T to tenofovir in
combination with lamivudine in this case, and efavirenz, and looked at
limb fat. Unfortunately when we started this study, less was known about
the issue of lipoatrophy, and we do not have any slide numbers. But you
can see at 96, 144, 192, and 240 weeks the difference in limb fat is
approximately three kilos. That\'s more than six pounds. That\'s a
pretty dramatic difference.

And what - we do have weight gain at the earlier part of the study, and
what you see in the course of one year is both arms gain weight as you
expect for AIDS patients, followed by a decline in weight on the d4T
arm, and it continued to increase on the tenofovir arm.

And this data versus d4T has really helped to highlight some of the
concerns about d4T.

Okay, well, we\'ve heard a lot about this, education and early diagnosis
are necessary to reduce transmission. Many patients are diagnosed late.
The Kaiser Family Foundation showed that 39 percent of those diagnosed
received an AIDS diagnosis within a year of testing positive for HIV.
You heard from the health commissioner of New York City recently than 25
percent of AIDS patients - or HIV cases are diagnosed with a concurrent
AIDS, and those are serious problems, and these patients have mean
survival of only four months.

So there is, again, the theme of many presentations here, a need to
support a diverse portfolio of prevention strategies. And we and others
are involved with routine testing initiatives to help with early
diagnosis.

Early and continuous treatment is the most - with the most effective and
tolerable treatments will successfully suppress HIV, and the lifespan as
Bob mentioned in his introduction, with drugs, has really been improved
with the advent of antiretroviral therapy.

Many of the things that are thought to be complications of drugs are
really complications of HIV, and it\'s important to have uninterrupted
therapy.

However, less than half the patients in the United States that are
infected are actually being treated.

I want to sort of digress here and talk about something else about
Viread. The study of AIDS drugs, because so many are on the market,
start out in the most advanced patients. Our first two studies that led
to approval of this product in the United States and Europe were done in
patients with an average of 4-1/2 years of prior therapy.

Then we were able to study the product in naive patients, subsequent to
that we were able to go into children, and also studies have started in
HIV negative individuals, studying the potential of tenofovir for
prophylaxis.

And this is all based on data that I\'ll share with you that dates back
more than a decade ago indicating that this product can completely
prevent infection in monkey models.

Clinical studies with Viread, as I said, began with advanced patients in
\`96. The product was approved by the U.S. FDA at the end of 2001.
Subsequent to that a variety of organizations - you\'ve heard from the
CDC I think several meetings ago about the use of tenofovir in some of
their studies. The NIH, UCSF, Family Health International, and Gates
Foundation have all supported these types of studies.

There have been - these studies have, to say the least, been
controversial, especially for some individuals concerned about how the
patient populations are being affected.

But they are important studies. Just this year the CDC has also
announced data indicating that Truvada, as you might expect, is even
more potent than Viread in preventing infections or preventing disease
in animal models. And we expect the first human clinical data to become
available this year.

The concern of course is that by the reduction in the number of
experiments and the scope of the experiments through a variety of
different types of protests that we may not have enough - the number may
not be enough to be definitive.

So this is data generated by Che-Chung Tsai at the University of
Washington, published in Science in 1995, showing that by a variety of
measures, antibody virus and PCR, monkeys that are infected with SIV
develop AIDS, or monkey AIDS, and of course die. These are very high
lethal does. And yet patients that are given tenofovir, and in this case
tenofovir is given 48 hours prior to inoculation, but it even works if
it\'s given 24 hours after, were completely protected by all these
measures.

And that of course was very exciting data at the time, and it\'s
continued to move forward in studies that are sponsored by major
organizations.

Well, so government programs are critical for success, moving back to
the main theme. More than half of diagnosis were in African-Americans by
CDC in 2005, and many patients rely on government assistance.

The ADAP program or Ryan White, and I believe Marty talked about that
today, provides medications now in this country to 96,000 patients, and
eligibility to these programs are administered state by state and
municipality by municipality and the eligibility range is from 100 to
500 percent of the federal poverty level, but in point of fact, 62
percent are people of color, and 80 percent have incomes below the 200
percent FPL.

And the majority are uninsured. So our program provides a link to
treatment. It provides same day access and reimbursement counseling.

The approximately 860 U.S. patients are now receiving drug through our
access program, and as of February, 2006, the patients who had been on
the program who transitioned out of it, 80 percent went to ADAP and 13
percent went to Medicaid. And that\'s out of - since we launched Viread
in the year 2001, late 2001, we\'ve had 7,000 patients move through this
access program.

And importantly, more than half of our access patients reside in the
nine states with ADAP wait lists. And the point I\'d like to make here
is that although we\'ve worked to make this access program as
user-friendly as possible, lack of normal types of reimbursement is an
impediment to getting on drugs.

Many patients are not in a situation where they can get access through
an access program. The health care providers don\'t have the resources
or the know how. We spend quite a bit of time training people on that,
but as much as possible, I\'d really like to encourage the members of
PACHA to work to make sure that Ryan White is appropriately funded, and
also importantly that states do their part to make sure we minimize
these wait lists that really are a barrier to access in the United
States. And that\'s important if we\'re going to be bringing more people
in to care.

So challenges for the emerging markets as we see them, and I think
others do, is the - again it\'s impacting lower income populations, and
the financial resources to treat patients are limited.

We also have issues around access in emerging markets. This is
challenging, middle tier companies that can afford a middle tier
contribution or price. And one example is, we recently announced a
partnership with the Brazilian government where we continue to ensure
access to tenofovir, that we have lowered the price based on Brazil\'s
economic development level to allow for more of their patients to be on
tenofovir.

Brazil has had a very successful free program that has about 170,000
citizens on AIDS treatment with another 20,000 expected to enter this
year. And this has been a successful program for sometime. So as you
might imagine, many individuals fail in the regimens they\'re on, and
there is a great need for tenofovir.

The prevalence rate is similar to the U.S., and the benefit - a recent
NEJM article has indicated that savings to Brazil has been \$2.2 billion
in reduced hospitalizations.

It\'s easy to make the pharmacoeconomic benefit of the treatment with
antiretroviral agents. It\'s very cost effective.

China just came up. Again, the conservative number for China is 650,000
people living with HIV. However only 20,000 patients are currently
receiving treatment, and some of those are - need another regimen.

We\'ve been in discussions with the Chinese government to make both
Viread and Truvada available through government programs in China, and
are optimistic we can work through the issues to do that.

And other emerging markets, also, like Brazil has done, can make a lot
of progress by prioritizing HIV/AIDS.

There\'s tens of millions of people, 30 million infected in the
developing world, and that\'s 70 percent of all cases. The number is
growing, quite a bit, of patients on treatment, to 1.3 million, as you
know. Yet many of these patients will eventually fail therapy and
develop resistance.

I enjoyed hearing Mark Dybul\'s comments today. I think he and others
are doing a tremendous with PEPFAR that - providing direct assistance,
and importantly, assuring that the products are FDA approved, whether
they\'re branded products or generic products.

It is important, and having worked in a pharmaceutical for a number of
years, I feel it\'s really critical that the products that are given to
people do have th potency they are what they expect to be, and that the
manufacturer who makes it not only has demonstrated bioequivalence, but
has demonstrated good manufacturing capabilities, so batch after batch
is produced at that same high level of quality.

And the FDA is a very good gatekeeper for that.

We provide our product now to 98 least developed countries at no profit,
and we now have about 45,000 patients receiving our drug through the
program. About 80 percent of that is through PEPFAR, and more of that is
Truvada that Viread. We actually are disappointed in that number. We
thought it would be a higher number at that time, and have built up a
more, we\'ve actually had to do a writeoff on some inventory that I
would have liked to see the product get to the patients.

And we are as a result considering other models for access, and we\'d
appreciate any feedback you have on this topic.

What we\'re started doing is talking with Indian generic manufacturers
about voluntary licensing for our API in tablet. And a concept is that
the not-for-profit aspect of our program may not quite incentivize
people to get the largest number of patients on drug, and with multiple
manufacturers that do do business in these countries, they could ensure
competitive prices in the broadest access as possible.

So what we\'re prepared to do is do technology transfer to enable
production and improve the quality and get the product out there faster,
but we\'re working with the Indian government to make sure that we do
that in a way that protects our IP, and that is a critical aspect of
this for us.

So my final slide, for the future HIV treatment, is the simplified
regimens that we and others have been working on definitely will
provide - has been providing better outcomes for patients. We\'ve shown
that in clinical studies. And is working to help address access issues
in the U.S. and around the world.

The U.S. treatment market has grown about three percent year after year
for a number of years in terms of patients coming into treatment. Last
year I don\'t think it\'s a coincidence with the better tolerated drugs
and combination regimens, the number of patients on treatment actually
increased by eight percent in the United States last year after those
multiple years of three percent.

So with that I can close, and I believe we\'ll have time for questions
and comments.

Thank you.

(Applause)

DR. REDFIELD: John, I want to thank you, and we\'ll open this up for
some questions right now. If you feel more comfortable sitting up here
at the table, you can.

Alan.

MR. HOLMER: Under Robert\'s leadership our international committee has
had some discussions about what he has termed the importance of a
pharmaceutical industry strategy, that is, to make sure that we are able
to discover the vaccine.

And the question there is, how do you ensure that companies continue to
invest in HIV/AIDS. I think it would be particularly useful for me, and
I think members of the council, just to hear the thoughts of a CEO of a
company like yours. As you\'re making decisions, you don\'t even have to
apply it go Gilead, what your sense is of other CEOs of other companies.
Because they\'re trying to balance decisions. Do I invest in cancer or
diabetes or cystic fibrosis, or do I go with HIV, invest in HIV/AIDS?

But particularly what the impact is if you know that with respect to
HIV/AIDS there is a risk that at shareholder meetings you are going to
be attacked by critics; that some are going to demand that you give the
product away; or that you really don\'t deserve intellectual property
protection for what you\'ve brought to market and what you\'ve
discovered.

So how do you approach those constellation of issues, or how do you see
your colleagues in the industry approaching those?

MR. MARTIN: I think for Gilead we\'ve built a company that has the
capabilities. And we have a lot of people that worked at - you know,
ours is a business - people don\'t realize, you can\'t possibly realize
how complex drug development is unless you\'ve worked in the field for a
lot of years. It\'s extraordinarily difficult.

When we were a smaller company I met with all new employees after
they\'ve been on board for six months and talked to them about the
complexity of our industry, and how building a jumbo jet for instance is
easier, because the design is based on previous designs. You just put
the parts in there, and it\'s actually very complex.

But our industry day-in and day-out, the years it takes to develop a
drug, we\'re making decisions that could go either way on how drug
works. And many companies have done less and less in the field of HIV,
and we were able to recruit the people who were dedicated to this area
to come to Gilead who can make a real difference, and that\'s how I
believe we got to the forefront.

So for us we\'re comfortable working in this area, but it does take - it
is quite a distraction. The vast majority of individuals and
organizations greatly respects what Gilead has accomplished, and what
our commitments are. We\'re a very small company, and a small part of
the resources that are being employed to combat global HIV, and we feel
like we\'re doing really a very good job of that, and we\'re very proud
of what we\'ve done, and what we could do in the future.

Yet the plain fact, our last shareholder meeting had demonstrations.
There are people, it\'s just that type of area. I spend a lot of time
dealing with access issues, and my senior management team does too, that
is an opportunity cost about working in other areas.

So you can sympathize with companies that say that the challenges of
this area are just too much. We can deal with that. We really love the
contribution we\'re making, and the response to this.

One thing, an example is of how we\'re trying to work, it\'s sort of a
trial and error thing to go through the iterations, so we recently came
up with this Indian generic strategy, because we think that for-profit
competition in Africa for generic drugs will increase access and drive
down the price.

It\'s not a market that we\'ve been able to grow exceptionally with our
no-profit product just doing it by ourselves.

We have worked for hard for registrations in all these countries. It\'s
an art. There are reviews. We\'ve had reviews going on in countries for
over two years. Several years after Viread has been on the market, after
FDA review of only six months.

So I think there are a number of activities that you end up getting
involved in as a company when you work in this therapeutic area. You
can\'t begin to imagine when you start, but it just keeps growing as you
go along.

So we\'re continuing to work in HIV. We feel like we can continue to
make contributions in this area. And we\'re not giving up on this.

The way we very simply think of our products is, AIDS is treated with
three drugs, A, B and C. Viread is A. Before Viread, d4T and AZT were A.

Entriva is B. And before Entriva lamivudine was B.

We don\'t have a C, and given the patient experience in the United
States with NNRTIs and protease inhibitors, we need new classes.

So we have two products in development for integrase inhibitors now,
because patients have been exposed to those.

And one is already in the clinic. It\'s in phase two, three type study,
given once a day because we had phase one data showing it to be very
potent.

I don\'t know, it\'s sort of a rambling response to your question, but
it gives a perspective.

DR. REDFIELD: James.

DR. HU: I\'m very happy that you work with the Brazil government to make
drugs, and negotiating with China, and also working with the Indian
government to make the generic drugs; I think that is a very good
approach to help the world.

And I just want you to know that the Chinese government recently
organized more than 100 generic pharmaceutical companies, Chinese. Maybe
you should also approach the Chinese government how to make generic
drugs.

MR. MARTIN: I wasn\'t clear I guess. That\'s in fact that we\'re doing.
We\'re working directly with the Chinese government.

And we actually have quite a few operations in China, but through
Chinese organizations. As you might imagine, Gilead is a company where
much of the work we do is done outside the company. Most of our
manufacturing we do with other companies, and we manufacture our drug
product in Asia, North America, Europe - I mean API, active
pharmaceutical ingredient; drug product in similar markets; and we\'re
also doing it in South Africa.

But it\'s through other companies. We have probably created well over a
thousand jobs in China, because we buy and source much of our raw
materials for the manufacturing from China, so we have knowledge of
China.

We are also able, just as an aside, we\'re the inventors and developers
of Tamiflu for influenza that became a high profile drug because of
avian influenza. We worked with Roche to secure additional raw materials
out of China to be able to manufacture that.

So we are definitely working with the Chinese government.

The one thing I\'d like to emphasize here is, we and others don\'t
believe it\'s appropriate for the U.S. and Europe, the citizens of these
countries, to bear all the costs of the innovation of drug discovery.
And so the middle tier markets according to their ability to pay, should
actually pay for drugs. And that, the negotiation with Brazil was fairly
difficult, but it did end up with a successful outcome that we concluded
after about 18 months of negotiation.

DR. REDFIELD: Before I call on Frank, maybe you could just follow up on
that comment.

How do you see tiered pricing? So there\'s a U.S.-European price.
There\'s a no-profit price. Now you\'re getting into this, well, we\'ll
figure out what your market can bear price.

Particularly with the United States, and I\'m going to assume maybe
Japan, some of the - Germany, France, England, several of these
countries deciding to fund these global health requirements like PEPFAR,
like the global fund, those citizens paying it.

Do you think it\'s really a long term sustainable strategy where we have
multiple prices of drugs for different individual countries?
Particularly in light of the way our health care access issues are going
in this country as it is?

MR. MARTIN: I think around the world there are concerns about health
care, and the prices of various components of health care.

The one thing that - and there is a lot of pharmacoeconomic research on
this - is that the HIV products are extremely cost effective. When we
launched Viread, we priced it in a range of HIV products that it more
reflects sort of what the accepted prices become as opposed to pricing
at a premium, because it\'s a drug that provides a lot more benefit.

And that\'s not necessarily true in other therapeutic classes where you
see an escalation of cost. So I also believe that it\'s - I know the
model is, well, maybe we should have a lower price, and then have the
subsidies from the richer governments go to the drugs. But we don\'t see
a way that that has been workable, so we think a better way is to make
it available at the lowest possible price without profit in many of the
countries around the world, but then make sure that the intermediary
countries do pay a fair share, that I acknowledge is kind of a gray
calculation how you do it, it does involve some negotiation.

We\'ve worked very hard to make sure that the price bands for Europe,
Canada and the United States are very similar. We did not launch the
product in Canada, until we had a price that we thought was similar to
the U.S., because we all know that U.S. citizens get pretty unhappy when
there is a lower price in Canada, and rightfully so.

DR. REDFIELD: Lower prices everywhere.

When you speak of no profit on your slide here, first of all let me say
I\'m not trying to corner you or anything. I\'m a strong believer that
invested capital should have competitive returns, and if we don\'t - if
that isn\'t provided for we\'re not going to have new drugs, new
vaccines, anything else.

But there\'s a very narrow way of saying - of defining no profit. One
would be just simply the incremental costs of the incremental production
of a drug that you\'ve long realized most of your other costs on.
Obviously a much broader definition would include proportionate research
and development and marketing and distribution and regulatory and
everything else that goes into that.

So are you somewhere in between when you say no profit?

MR. MARTIN: Just cost of goods of manufacturing. And we\'re using our
current cost of manufacturing, but the product we\'re shipping is from
earlier in inventory. It\'s first-in first-out, that\'s how they do the
accounting. And that means that we\'re actually selling at a loss on an
accounting basis.

DR. REDFIELD: So it\'s really at a loss by any other definition, right?

MR. MARTIN: Well, it\'s at a loss by accounting. But it\'s the price
we\'re basically at in our manufacturing now.

The one thing we underestimated was all the cost of our regulatory
efforts which are huge, and they are not included in that. Maybe they
should have been, but they\'re not.

DR. BOLLINGER: I would like to follow up to Bob\'s earlier question. One
of the issues we\'ve talked about is how to incentivize this process
over the longer term, and I guess what I heard you say is that the
current model would be - if I can simplify for my own purposes - is that
this nonprofit or loss tier is subsidized by other tiers that can absorb
and may actually contribute to subsidizing the cost in other countries.

Is that a long-term strategy for subsequent drug development? Are there
other - I\'m just wondering if that\'s enough incentive to drive the
kind of drug development that I think all of us are interested,
particularly for the developing country needs.

What I was thinking about, for instance, is - I know Bob is concerned
about this as well, and it was actually in one of your slides, is the
resistance issue.

And while we expect and really look forward to having a single drug,
single pill per day, we\'ve got issues in India and elsewhere of the
interaction of these drugs with diabetic treatment, with herbal
treatment, with nutrition, with bioavailability issues, that are all -
and in fact in my clinic at Hopkins if I have a patient or situation
where compliance is an issue, I try to avoid the single-dose drugs
because of the pharmacokinetic issues and the risk for resistance. So
these are complicated issues. We don\'t know how they\'re going to fall
out. What it really comes down to is, we need a lot of things in the
pipeline, so that if we run into problems with one drug we have some
second or third salvage regimens.

So we want to incentivize the process, not just for the U.S., but for
the PEPFAR program. And maybe that\'s a long question, but maybe you
could tell us whether you think there are enough incentives in the
current system, or what else we could be thinking about.

MR. MARTIN: I think in response to Alan\'s question, I covered some of
that. Probably not very articulately, because it\'s complicated. We keep
going through layers - what we believe to be true today seems to be
changing tomorrow, and there are a lot fo forces in the world that talk
about not wanting to have IP protection at all for our industry.

Obviously all of you are aware, and most people are aware, that the IP
protection is what allows us to have future products.

Yes, I\'m very pleased that the administration has very much understood
this, and has also stated that we don\'t want, with our programs, to be
giving people regimens that aren\'t the best regimens that we want to
have in the United States. And I think that is a very important concept.

We have had a lot of support from Commerce, USTR. The Commerce
Department is involved in a lot of foreign trade issues, and the United
States Trade Representative is an office of the U.S. government that
also helps us and advises us on how to make sure our intellectual
property is protected abroad.

The U.S. government has in fact been quite helpful in these things, and
it\'s really important to maintain that type of environment. There are
so many big issues in the world, but the trade issues and IP issues
associated with pharmaceutical products are very critical to the future
of the industry; there\'s absolutely no question about it.

DR. REDFIELD: Ram.

DR. YOGEV: I\'m unfortunately or fortunately the only pediatrician on
the committee, so you can see the question. It\'s not Gilead, but all
pharma companies somehow, because of multiple issue, production, and
profit and so forth, put into pediatrics so much behind. For example you
are talking about a triple drug when your own drug is not yet available
for the pediatric. And how much was the formulation. Also the
pharmaceutical companies as a group almost refusing to go with a group
which is NIH supported to try to get to some liaison to help the
pediatric to be at the same place so it doesn\'t come two years later or
not at all.

Is there any thought in that direction of expediting the pediatric and
start working with it with other agencies of the government?

MR. MARTIN: So I should have said, and maybe you all know, my background
is chemistry, so I\'m not a physician, and my knowledge may not be as
good as yours on these.

So but I do know about the timeline of our product. Our product,
Entriva, has a pediatric formulation. Tenofovir has had more
complexities. When we were developing tenofovir, we were really
appropriately only allowed to study it in adults, because there is
concern about bone toxicity related to our animal safety studies.

The bone toxicity is secondary to very high dose - probably - secondary
to very high doses that cause kidney toxicity and then allow for
demineralization of bone. But that concern delayed our ability to take
it into children until we garnered very significant human clinical
experience. And I alluded to that when I talked about how we first
studied the product in very advanced patients; then in naive adults;
then in children and HIV-negative individuals for prevention.

So the other aspect, our first pediatric product, we didn\'t like it. We
thought it was okay, but the taste was not good. The limitation, we were
not able to achieve the stability we wanted, because it needed to be
brought up in water, suspended in water. And it just didn\'t have quite
the stability we needed there, and especially for Africa where it would
require refrigeration.

So we\'ve now come up with a product we like quite a bit. It\'s
encapsulated sprinkles that can be spread onto food for instance and
taken that way. And we do have ongoing phase three studies to get this
product out there, and those studies are in fact being conducted,
obviously, outside the United States. There just aren\'t enough
patients. The main sites are in fact in Brazil.

One thing that I wanted to make a comment, I didn\'t get to it, is that
countries that do support IP tend to get a lot more investment; that\'s
been shown over and over by economists. So for instance in Canada we
have a reasonable price for our products. We also do a lot of work in
Canada. We own a manufacturing - we just bought a manufacturing facility
in Canada. We\'ve manufactured drug and drug product in Canada since
1992. We\'ve carried out a lot of research in Canada on scaling up of
manufacturing. We\'ve done a lot of our safety assessments and
pharmacokinetic studies in Canada, clinical studies in Canada.

It\'s also true that we\'ve invested in Brazil, a number of our adult
HIV studies have had sites in Brazil, and we\'re doing the pediatric
studies, a large percentage of studies in fact, is in Brazil.

DR. YOGEV: I appreciate what you\'re saying, but the NIH or NIAID has no
system that takes the benefit of knowledge in the United States with
sites in different places in Africa, Brazil, for the pediatric.

And there is a tendency of pharmaceutical company not to go there
because of the IP -

MR. MARTIN: No, we work with NIH all the time.

DR. YOGEV: I know, but it took us a long time for us to get you to work
with us.

MR. MARTIN: Is that right?

DR. YOGEV: And you\'re not unique, by the way. It\'s not a personal
attack. I\'m trying to find out why pharmaceutical companies now, is all
their really openness, are now trying to take the best in the United
States, bring it to the rest of the world.

But one thing which - it wasn\'t your company, another company -
acknowledging pediatric is not inn the people who are helping, because
that is the nature of the beast.

How can that be changed to make it more efficient, both for the company
and for the children of the world, because the United States, they\'re
very low, and so it\'s really mainly for them.

DR. REDFIELD: And maybe one comment to add to that as you talk, because
I want to ask you a question or two about that, but one of the
complexities as I understand this right now for a pharmaceutical company
to make pediatric formulations of a product, whereas I\'m going to
suggest is, they really have to look at it, what tier is that product
going to be marketed in. I don\'t think there is going to be a
Canadian-Germany-United States tier. They might be able to get Brazil
and this middle tier to pay the R&D cost. I don\'t think that the third
tier is going to be able to do it.

It gets at that question, your company has chosen to make some
formulations, even though there isn\'t a pediatric population for you to
test it in this country, and there isn\'t a pediatric market.

My addition is, 10 years from now, 15 years from now, how do we have
pediatric formulations of the new products?

MR. MARTIN: I mean clearly, to work in to the pediatric formulations is
a personal commitment where you really care about making sure your
product is available, because the financial gain, that\'s clearly been a
limitation.

One of the things that is also really important, and I don\'t know about
this specific instance that y0ou\'re talking about. I do know that we
early on engaged in NIH pediatric study that failed to enroll patients.
And it just didn\'t work.

So I\'m not aware of the current one. I\'m just out of the loop on that
particular issue. But we do have often freely worked with the NIH. There
periodically becomes concerns that if you accept government money in the
development of the products that there should be some sort of control of
pricing, but we\'ve never really felt that at our company. We\'ve had a
very good collaboration with the NIH, in pretty much all our critical
studies.

One thing I will say is that it\'s our experience, and I\'d be happy to
talk to you more about it after the meeting, is that the quickest way to
get a product to the market is for a company to do those types of phase
three studies.

Because companies are geared up to know how to do it. And in the past
when we\'ve thought about doing other things, it just hasn\'t worked out
as well.

So we very much believe that even though NIH would provide the financial
resources to do it, the quickest way to get these things out to people
is for the company to make that direct investment.

DR. REDFIELD: Maybe just as a clarifier on that, for some of us to
think, recognizing that in order for you to get a formulation approved
for pediatrics, studies are going to have to be done, recognizing your
goals to make it at no cost, so therefore the R&D cost you don\'t want
to roll into the cost, am I to understand if we want to accelerate the
ability to have pediatric formulations for not only the current
medications that are approved, but the future, we need to figure out a
mechanism in which somebody funds that clinical development path.

Because is it realistic to ask the pharmaceutical industry to fund that
African clinical development path?

MR. MARTIN: Well, that\'s the way it works now of course.

DR. REDFIELD: I know that. I\'m trying to go long term. You know, those
are really - I don\'t know the answer to that question. Those are
important policy debates.

With a lot of things we do, we find that we with good intentions come up
with stuff that has unintended consequences. But I do think that is an
important debate to have, the one you\'re proposing there.

DR. REZNIK: Just a few questions to get some clarification. One, we
haven\'t completely eliminated perinatal transmission. We still have
about 300 children a year, and every life in this country is important.
So thank you for continuing to work on a formulation fo this that will
work.

I have two questions. One, there is 1.3 million people in less developed
countries on therapy, but only 43,000 are on a safer less toxic
medication. And my question is, are there tariff barriers in place that
are causing this? I know there are country-level decisions based on
treatment. But when you look at the treatment out there, it\'s usually
AZT/3TC or d4T/3TC. You don\'t see these drugs popping up. That\'s one
part of it.

And then the other part would be post-exposure. I know you\'re working
on pre-exposure. On post-exposure prophylaxis, this is also doesn\'t
come up as your first line, and I had an exposure in one of my staff a
month or two ago, and I literally had to go through a little bit of a
battle with the main hospital to get my staff member on your drug.

MR. MARTIN: That\'s too bad.

DR. REZNIK: Well maybe you have some marketing issues here.

MR. MARTIN: I do know that shortly after Viread was approved New York
City put it as recommended for that for instance. So it varies I think
in various places.

DR. REZNIK: Well, it\'s a CDC guidelines, I think, that needs to be
worked on.

MR. MARTIN: Yes, the CDC guidelines, I agree with that. And
unfortunately, I think a lot of guidelines around the world follow
practice.

The barriers are, there are just endless barriers I think. Probably the
number one barrier to our product being readily accepted in places like
Africa is that Viread is still not on the WHO essential medicines list,
and probably will not be until the end of 2007. So whatever influence
you guys have on the WHO I think that\'s something that is really
important, and something that I\'m certainly talking a lot about now,
because I think that could help with access.

We are working through regulatory processes country by country, we
underestimated how complicated that would be. And so we\'re really
committed to doing that, but that\'s a barrier.

I don\'t know, perhaps some of you know more about the economic
barriers. Certainly tariffs and taxes and one of your recommendations
about not providing drug to countries that do that I think is a
reasonable recommendation; or maybe that\'s some other group\'s
recommendation, but I think that dilutes the economic contribution we
make when we pay for those drugs.

DR. REZNIK: My final question is about Medicare Part D. Have you all
filed - has Gilead filed - has Gilead filed for an exception in the
OIG\'s office at HHS to allow patient assistance programs for people who
have Medicare Part D who are in the donut hole?

MR. MARTIN: I don\'t know about that; I just don\'t know. I haven\'t
been aware that we have any issues there.

DR. REZNIK: Because some companies have been very proactive, I believe,
and have done that. Because there are people who are getting stuck with
\$3,700 that they can\'t pay, and Americans are not getting access to
drugs, you should be aware.

DR. REDFIELD: Joe, last comment.

DR. McILHANEY: John, thanks. We all know that one of the true successes
in this whole field has been pharmaceuticals. So thank you. You\'ve used
the word, commitment, a lot, and thank you for the commitment.

David, it seems to me that the care and treatment committee ought to
consider a resolution something like you know the pharmaceuticals are
really important. It cost \$100 million to develop a new one. If
resistance develops we\'re going to be needing new drugs, that we might
give him some cover, and other pharmaceuticals, some cover with a
resolution like that.

Because it\'s such a huge and important part of this whole thing.

(Off-mike remark)

DR. REDFIELD: David, you\'re off mike.

DR. REZNIK: I was trying to be not on the mike for that.

The integrase inhibitors seem to be quite potent with minimal side
effects, and can help out even the most multi-drug resistant patients.

DR. McILHANEY: The whole thinking is that particularly with these people
that are coming to their meetings and causing trouble, it might be of
some help if we did something like this.

DR. REDFIELD: John, I want to ask you one last question and then turn it
over to Joe to close.

I want to go back to this issue, probably I\'m as frustrated as anybody,
about the United States government facilitating access to care that is
profoundly less optimal than the care that we facilitate for our own
American population.

And while the most immediate reality is that even in my own PEPFAR
program that I\'m involved in, probably of the 42,000 people we put on
therapy, probably 37,000 went on a regimen that we wouldn\'t use in the
United States.

Better than nothing, but not a regimen that we would use concurrently in
the United States. And you mentioned one of the difficulties with
getting optimization has been guideline issues, and I think that\'s
true.

I want to take that, and I also want to look forward realizing that five
years from now the optimal regimen in the United States may in fact, at
least in certain circumstances, be slightly different than what it is
today. And there may in fact be optimizations of regimens that are more
optimal in certain environments like Africa than would ever be optimal
here. There could be a different path.

How do you see the issues that are the most critical to you, as one fo
the more successful pharmaceutical companies in this area of AIDS
therapeutics in particular. Because we want you to stay engaged. We
don\'t want to have optimal and less optimal therapy; at least I don\'t
think that is in the American public\'s long term interest particularly.

How do you see us avoiding that in the future, or how do you see that
that doesn\'t become reality in the future?

MR. MARTIN: When Bob Redfield has that type of distribution of products,
I think that there are issues around the system that I don\'t
understand. I\'d ask you, what do you need from us.

I think you need things from just work that all the people in this room
are doing over time to try to influence how these decisions are being
made.

It\'s obviously a very challenging and complex arena.

DR. REDFIELD: But you see it largely still in sort of the political
guideline issue, the WHO guideline, you know many of these countries as
you said, you\'ve applied for - we can\'t get maybe another strategy
because the drug is not registered. It\'s not registered, because even
though it\'s been two years. So you see it as just a process issue. You
don\'t see it as any fundamental economic hydraulics that need to be
corrected?

MR. MARTIN: One thing I mentioned that I\'d like feedback from this
group on, although some of you are probably going to the airport and
thinking about your flight delays at this moment, right? Oh, okay,
that\'s right; you\'re here tomorrow. No problem.

So I do think that the profit motive allows things to work better, and
having the no-profit motive for - and we ask our partners that we work
with to deliver profits at a minimal profit does hamper access to some
degree. Because people will work harder if there\'s competition and not
opportunity for profit.

So what\'s why we\'re approaching the Indian generics, and willing to do
technology transfer to them.

I hope that\'s a good idea. It\'s kind of one of those ideas I\'m sure
we\'re going to second guess, but if we did the alternative, we\'d be
second guessing too.

And I tend to think of almost everything in our industry as process
oriented some. I give a lot of talks or interviews to the media, as I\'m
sure many of you do, and the media is always looking for that ah-ha
moment where you actually know something, and it just doesn\'t happen.
Our business is a process where you go step by step, and sometimes
you\'re up and sometimes you\'re down, and sometimes you\'re up. And
eventually you get to a certain point.

And I know that people in a variety of parts of the U.S. government are
working extremely hard on these issues to make sure that we get the best
possible care to these people in other countries, because that will give
the best outcomes. That\'s the best value for the dollar.

DR. REDFIELD: John, I want to thank you very much.

And Joe, I think I\'ll turn it back over to you.

MR. GROGAN: I just want to thank for coming.

This is pretty much it for the day. The bus will pick up up downstairs.
It\'s supposed to be here at 4:40, so you\'ve got a little bit of time
to make phone calls and find your way down there.

So we\'ll see you tomorrow morning at 9:00 o\'clock. Thanks very much.

(Whereupon at 4:23 p.m. the proceeding in the above-entitled matter was
adjourned)