PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS

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THIRTIETH MEETING

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TUESDAY,

JUNE 20, 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

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:

MICHAEL SAAG, M.D., Professor of Medicine, Director,

University of Alabama at Birmingham

MYRON S. COHEN, M.D., J. Herbert Bate Professor of

Medicine, Microbiology, and Immunology and

Epidemiology Director, UNC Center for

Infectious Diseases, UNC Chapel Hill

I-N-D-E-X

Page

Welcome Remarks - Co-chair Sullivan 4

Treatment and Care - Member Reznik 5

Healthcare Cost Study - Dr. Saag 7

Seroconversion/Infectivity Data - Dr. Cohen 66

Public Comments 141

Departing Member Recognition 147

Exec. Director Grogan

Council Reconvenes for Motions and Working 155

M-O-R-N-I-N-G S-E-S-S-I-O-N

9:03 a.m.

CO-CHAIR SULLIVAN: Let\'s try and get started because we would like to
adhere to our time schedule for the meeting today. One thing I failed to
mention yesterday, but I\'m sure all of the Council members will agree
with me. I congratulated Joe Grogan and his staff for the book that was
put together for our meeting.

(Applause.)

EXEC. DIRECTOR GROGAN: Thank you but I wish B- I can\'t take any credit
for that. It was really Dana who put this all together and she did a
fantastic job.

(Applause.)

CO-CHAIR SULLIVAN: Certainly excellent, very good papers and good
biographical sketches. So thank you very much for this very fitting for
the 25th year of this epidemic. We also had some very good discussions
and presentations yesterday and I\'m sure that will continue through to
today. Our session this morning will be presided over by the Chair of
our Treatment and Care Committee, Dr. Reznik. So, David, we\'ll let you
go forth.

MEMBER REZNIK: Good morning, everyone. We have some people that are
awake. Today we\'re going to cover a couple of very important issues and
our first speaker, which is actually an honor for me to introduce him, I
think it\'s our first speaker, let me make sure, is Michael Saag.
Michael Saag graduated from the University of Louisville with his
medical degree and then did a residency in infectious disease in
molecular virology at UAB or University of Alabama at Birmingham.

During his fellowship training, actually while a fellow, Dr. Saag
conceived a concept of a comprehensive HIV outpatient clinic dedicated
to the provision of comprehensive care in conjunction with the conduct
of high quality clinical trials, basic science and clinical outcomes
research. This is as a fellow. So that is really very unusual. At least
in today\'s world, it\'s a little bit unusual. Since he established the
clinic, Dr. Saag has participated in studies of antiretroviral therapy
as well as novel treatments for opportunistic infections.

Some of his articles include the description of the first use of viral
load in clinical practice, the first description of rapid dynamics of
viral replication, the first guidelines for the use of viral load in the
practice, the first proof of concept of fusion inhibitors as a
therapeutic option and also making available many antiretrovirals that
were only available through research trials.

In the early days of the epidemic, many of our patients in Atlanta
actually took the trip to Birmingham to see Dr. Saag to get access to
care. And I believe it was last year one of our community group had a
survival project to honor Dr. Saag for his commitment not just to people
in Birmingham but to the people in Atlanta and around the country.

As many of you know, my partner was sick earlier, all of last year, and
when things came down to a crisis, we have a wonderful medical director
at Program, Dr. Jeff Linnox. I called up Dr. Saag because things were
getting to the point where I needed to contact the brains and people
that also have the compassion and the two doctors got together and I can
happily say that my partner is doing much better. Truly a great person,
dedicated to dealing with this disease and facing the problems as they
are emerging, it is my privilege and honor to introduce Michael Saag.

(Applause.)

DR. SAAG: Thank you very much. I\'m going to speak from here if that\'s
okay and I\'m going to take only about 20 to 25 minutes and leave time
for discussion because I know that a lot of you have ideas as well. But
the thesis of what I want to talk about is care, HIV care delivery and
while you may think that this is an exaggeration that in my opinion is
an emerging crisis in care, there really is, and I think by the end of
my remarks, you\'ll hopefully see what I\'m trying to say.

So we\'ll start with our clinic in Birmingham, and what you\'re looking
at is a Kaplan Myer survival plot and to sort of walk you through this,
this is eight years worth of data. These are data from HAART Era and
just to translate this for you, if someone shows up with a CD4 count
greater 200, the majority of them, this is the top two bars, are alive
eight years later. If they show up a CD4 count less than 200 at initial
presentation, don\'t start the HAART regimen until after a CD4 count of
200 and if they\'re between 50 and 199, that\'s their line, and if
they\'re less than 50, that\'s where they go. So that up to almost half
of the patients who show up with a CD4 count less than 50 in the HAART
ERA are dead eight years later still today.

The next slide shows you, in our clinic, the median CD4 count of someone
showing up for care. It speaks for itself. This is in today\'s world
with all that we know about HIV, all the messages that are out,
everything that you\'ve been dealing with personally at whatever level
you\'re at, the median CD4 count of patients. Look at 2003. A hundred
was the median CD4 count of someone showing up in our clinic referred
for care. What it means is that people who are infected with HIV at
least in my part of the world, and I think it\'s a lot of the United
States, are infected and don\'t know it and they don\'t seek care until
they get sick.

So the take-home point is kind of obvious. Mortality is much higher when
patients diagnosed late. The majority of newly diagnosed patients are
diagnosed late. The exception to this are pregnant women. The median CD4
count of a pregnant woman seen in our clinic is 400. Why is that? We
have universal opt-out testing for women. So? Universal opt-out testing
is needed.

Now 20 years ago, I would not have been saying that. Fifteen years ago,
I would not. I\'ve been on the other side. Why? Because 15 or 20 years
ago, all we had to offer somebody who was diagnosed HIV positive, all we
had to offer them, was discrimination.

Now there is still discrimination, unfortunately, but at least we have
therapy and we have a way to keep people alive and in my opinion, if you
can get somebody into to care, especially early, and you treat them,
it\'s like diabetes. Yes, there are complications of treatment. Yes,
there are complications of disease, but the majority of people will live
for decades, and I\'m talking into the 70s, 80s and 90s. So that it\'s a
public health point that we should testing, or at least offering
testing, with appropriate counseling to everyone and if they choose not
to be tested, that\'s their decision. But I would say anyone who has
ever been sexually active in their life should be tested at least once.

Now, that\'s the background. Let me segue into another study out of our
clinic, and this is a cost study that was published a couple months ago
in *Clinical infectious Diseases*. What we wanted to do was to determine
the annual health care expenditures for HIV stratified by CD4 count.

Now this has been modeled a lot, but this is actual data from actual
utilization of our clinic. We described the cost components of health
care, medications, labs, hospital, etc. to analyze the effect of the
changing CD4 count on expenditures. We took our database out of our
clinic that we captured data since 1988 on every patient and this was
looking at mainly the year 2001 and established care January 1994.

In 1999, we had a pretty big change where we could start incorporating
health care utilization which would include all these metrics. So once
we started capturing that, then we could assign costs based on
utilization.

So for inclusion criteria for this study, they had to be receiving their
primary care at UAB. We have a lot of patients who are referred in from
Atlanta or other places. But the only ones we included in the study were
those actually came exclusively to UAB for their care. The baseline CD4
count had to be available and follow-up of at least once and for
hospitalization for that one year period.

We took the actual utilization and assumed that every patient had
Medicare insurance to create a level playing field. So everyone had
Medicare and reimbursements were based on Medicare rates in Alabama,
complete billing for all health care use, and that we collected 100
percent of whatever was charged. For medications, we simply used average
wholesale price. So we had every medication with a start and stop date
and we could assign this.

This is the demographics. This has changed actually in our clinic since
2001-2002. The age is a little bit higher now, fortunately. It\'s about
42. At that time, there were about 40 percent blacks. Now it\'s about 50
percent. Men who have sex with men is now, in our clinic, about 48 or 49
percent, and most of the patients now of the last 300 patients referred
to our clinic in the last year, 50 percent of them had no health
insurance.

So these are the data, and what I\'d like to do is, I\'m going to walk
you through this. Let\'s start with this first column and what you\'ll
notice is that when the CD4 count is high, annual costs are low and when
a CD4 count is low, annual costs are high. And it\'s pretty remarkable
how almost linear that is, so that not only is somebody showing up late
at higher risk of dying. They also cost more money and the overall
average cost was about \$18,600 per year.

If we look at the reason why the costs are higher late versus early,
it\'s mostly in non antiretroviral medications and somewhat in
hospitalization, but hospitalization which everybody focuses on really
is only a small component of the overall cost of care even among those
with less than 50 copies. If you take them as a group, it\'s only about
eight or nine percent of the total health care expenditures. The
take-home point here is that 75 percent of cost no matter how you slice
it, no matter which CD4 count strata you\'re in, is medications.
Seventy-five percent of cost is medications in any CD4 count strata you
look at.

And then finally, look at this. If I charged accurately for a Level
3/Level 4 visit, everyone had insurance and I collected 100 percent, on
average I would only collect for our clinic \$360 per patient per year.
For a 1,000 patient clinic, that\'s \$360,000 a year to do everything,
pay the doctors, nurses, reception, rent, utilities.

This is a statement about our health care delivery system and in HIV
care in particular, you can\'t make money. Why? Because the \$359 per
patient per year is assuming everyone has insurance and our collection
rate is 100 percent. About 40 percent of our patients have no insurance.
Our collection rate is about 40 percent. So in that year, our actual
reimbursement from third parties, not counting Ryan White or anything
else, was about \$130,000 for that year total to our clinic.

The bottom line is you can\'t make it in clinical practice in HIV. And
if you look around the country, a lot of the so-called boutique
practices in New York, Los Angeles, San Francisco, they\'re dying. They
aren\'t, those practices are going away and almost the majority, clearly
the majority of patients who are seeking HIV care today are doing so
through publicly-funded clinics around the country.

Let\'s look at this a little differently. So there is some good news in
here. We simply asked the question, if you took at the six-month point
in the study, you took the original CD4 strata they were in and asked
the question, at six months later were they in the same strata or did
they improve or did they get worse, and that\'s what this graph shows.
If we just focus on the this 50 to 199 group CD4, they started in this
group. If they stayed the same, their annual costs were about \$24,000
per patient per year. If they dropped to the less than 50 group, their
costs jumped to here. But if their CD4 count went up to that group in
the course of six months, their costs were lower and this was
statistically different. That dropped about \$6,000 less.

How do you get CD4 counts to up? Well, you treat them with
antiretroviral therapy and this is just another way of showing that ARV
therapy is cost effective. Good news.

But look at where the cost savings were. Most people would guess it was
in hospitalization, and indeed, there\'s a big difference here. The
antiretroviral therapy medicines costs is about the same and you might
predict that, because you\'re only going to give so many drugs and
that\'s what they cost. But most of the difference in cost was in the
non antiretroviral medications. People got sick and they required
foscarnet or cidofovir or whatever, chemotherapy, and that\'s where the
majority of the costs are and again to reiterate my point, the majority
of the cost no matter how you slice it is in medications.

Look at this. This is my whine. This is us over here trying to make it,
trying to get through day to day. So the conclusions are antiretroviral
therapy is cost effective. Medications are the most expensive component
and physician costs account for less than two percent of expenditures,
even in the most optimal conditions and it\'s certainly much less than
that.

So before I go further, I\'ll just ask the question. If you were a young
physician coming up through training, would you choose to go into HIV
medicine or would you choose to go into dermatology or would you choose
to go into radiology or would you choose to go into some other specialty
that pays a little more? Who in their right mind would choose this
specialty? Which gets to the next question, where is the next wave of
doctors going to come from who take care of HIV patients? Where is that
going to be? So that is one of the questions I want to have a discussion
about with you guys when I get through. So that\'s Point 1.

Another point is when we think about Ryan White, the original
authorization, think about that time versus now. In 1991 when that
authorization legislation was first put through, people were dying of
AIDS everywhere. There were no medicines to speak of, a few, but none
worked very long. Patients were dying. So what did we have to do? We had
to help people learn to live with disability and we had to help them die
with dignity. And the Ryan White Act helped us do that.

Things are very different now. Patients, fortunately, aren\'t dying to
the same degree. The Disability, we have people coming off of Disability
and going back to work. The crisis right now as I see it isn\'t in
providing even case management or social services like it was when this
was first authorized. The crisis is in providing care, in providing
health care.

So your group recently said this, \"Every American who needs HIV
treatment and care should have access to it.\" Couldn\'t agree with you
more. People who are HIV positive need essential medications. Absolutely
true. Without the drugs providing care is difficult to impossible. True.
True. True. But is that enough?

The policy implications or the provision of antiretroviral care and
other essential medications means that we should be funding ADAP to a
fuller extent. I\'ve lived in a state that since the beginning had a
waiting list, had a waiting list for medicines, an embarrassment to our
state. But you know what? There hasn\'t been a single patient who has
gone without medicines out of my clinic ever, not once. Not one time.
Why? Because our Social Service work their tails off to apply for
compassionate use programs when people don\'t have medicines and the
pharmaceutical companies, fortunately, would provide those medicines on
appeal. So there was a stop gap. Where is the stop gap for care if there
is no physician, if there is no clinic?

The reality check.  In our clinic, that\'s why I showed you data from
our clinic, so I could keep it simple. Our operating budget is \$2.1
million a year for about 1,400 active patients. Third party payment, and
this is generous, is \$250,000 a year for care and another \$250,000 a
year for infusion therapy for those who are getting chemo and other
things. Our Title III funding is \$508,000 a year. That\'s been the same
for the last seven years despite a 60 percent increase in our clinic
patient load and last February I was told we were getting a five percent
cut despite funding for seven years, despite clear documentation of
increase in burden. Now that cut was changed to 2.5 percent cut in March
or April, but it\'s still a cut.

It\'s hard to swallow that. It\'s hard to tell my providers, those
social workers and other who are working their tails off every day, that
I can\'t hire another person. I don\'t have another FTE to absorb the
volume and what they\'re dealing with now as a side bar is a tragedy
with Medicare Part D. Why? All the patients in our state who are
Medicaid/Medicare co-insured in December got their medicine through
Medicaid. January 1, they got their medicines through Medicare Part D.

Here is what happens. Let\'s say they have eight prescriptions. They go
to the pharmacy. They\'ve enrolled in Medicare Part D. The pharmacy
tells them, well, we can fill these five but three of these require
prior authorization. They take their prescriptions back to us. We get on
the phone. First, we have to figure out what plan they\'re in. It could
be one of 14. Then they call the 1-800 number, get put on hold for 15
minutes and they\'re told, you dialed the wrong number. Call another
one. Get put on hold another 15 minutes.

Then they say we\'re going to fax you a form. You fill out the form.
Somebody has to. Fill out the form and that\'s a request for review.
That form has to be signed by a physician. So the nurse has to go find
the doctor and get him to sign that and fax it back in. They have 72
hours to respond. They send us another fax form which is actually the
review. They have to go to the chart. They have to find out their
insurance status. They have to find out all this information, fill out
another form, get the physician to sign it, send it back in. Seventy-two
hours later, almost always it gets approved.

That process takes one of my health care providers 30 minutes to an hour
per prescription per patient. I\'m not exaggerating, and I have
providers right now who are on the verge of quitting. If they quit, who
do I replace them with? It is really devastating what\'s going on in our
clinics right now and I see other doctors around the room who are
listening to this nodding yes. So I\'m not alone. This is what we\'re
going through.

So the key points, mortality is higher when the patients are diagnosed
late. I\'ve told you that. The majority of people show up late. Many
patients don\'t know it. Universal opt-out testing. But with more
universal testing, I\'m predicting, at least in my neck of the woods a
25 to 50 percent increase in patient volume. That\'s good that we\'re
finding people who need care, hopefully earlier.

But here is the question; who is going to take care of these folks? So
with the new Ryan White Reauthorization, we\'re getting rid of waiting
lists and I\"m afraid we\'re going to replace them with waiting lines.
Where are people going to get care? Where is it going to come from? Who
is going to do it?

We\'re about maxed out and I\'ll show you this quote. This is from this
month, Laurie Dill. Trained at UAB, running something called Montgomery
AIDS Outreach, a Title III recipient. Let\'s just read it together.
Medical Director, this guy, her co-medical director, Larry Williams,
resigned from MAO on 6/7. \"I, Laurie, will be the acting medical
director while we recruit and hire a new medical director. We are
currently actively looking to fill positions, a full-time medical
director and a part-time physician to see patients mainly in our rural
satellite clinics. As you know, MAO is a Ryan White funded agency. We
currently have myself and two practitioners to provide staff. We have
three clinics in Montgomery and Dothan and hold once or twice a month
clinics in six other satellite clinics. We follow 1,000 patients in a
23-county area in south central Alabama. Please contact me for other
information.\"

What\'s her chance of finding another doc or doc and a half? This is
happening today and the thing that concerns me is that this is probably
news to a lot of you and it\'s because a lot of us in the trenches are
so consumed with day-to-day function we don\'t have time to come to D.C.
and talk. But a lot of us have changed that, at least I have, in the
last several months.

So the policy implications. Funding of ADAPs for sure, but we do need a
dramatic increase in funding to increase clinical capacity. Title III in
my opinion from what I\'ve observed has been largely ignored in the
reauthorization. ADAP has been front and center. Every single thing I
see coming out of D.C., ADAP, ADAP. Great.

What does ADAP do? It provides medicines for patients. How? By paying
for them. But nobody went without before. So the beneficiaries are
predominantly the pharmaceutical industry and the patients. Yes, they
both will benefit. I\'m not saying that\'s bad or evil, but I\'m saying
it can\'t just be ADAP. It has to be a more comprehensive look at care.

So we need to do this by increasing Title III funding and provide
incentives for younger docs to go into practice. We need to do something
loan repayment. The HIVMA which I\'m on the board of directors has put
forward a proposal just to simply put in this some loan repayment for
doctors who commit to HIV care. I don\'t know where the young doctors
are going to come from.

We need creative solutions to encourage more doctors in advance to
choose the skills to treat HIV, tuition reimbursements, insure adequate
reimbursements for care. As we expand our clinical capacity to treat HIV
positive Americans, we must not forget quality. HIVMA called for the
Care Act for a portion, this was actually cut, from the bicameral,
bipartisan legislation so far.

Seventy-five percent of care as we said are on core medical services.
Good. That\'s good. If it were up to me, I\'d say 95 percent, but I\'ll
take 75 percent. That\'s good. We have to put care first and require
that ADAP programs cover a minimum of the formula. Okay. I like that.
But there are no provisions to promote qualified careers, no significant
increase here and no training incentives.

So this is what you guys said. We\'ve already gone over this, but I
would change that. \"Provision of medication\" should be \"provision of
care\" and without qualified HIV care clinics, the drugs mean nothing.
Nothing. The drugs don\'t mean anything unless somebody is there to
monitor them and those of you who practice HIV medicine know that it is
the most difficult type of practice you can possibly deal with.

A cardiologist gets paid \$80 roughly for interpreting an EKG. Most docs
when they finish medical school can do that mostly and in fact, the
computer does it for you most of the time. Right? \$80. What do I get
for interpreting a complex resistance profile? Nothing. What do I get
for filling out prior authorizations for an hour? Nothing. What do I get
for fielding phone calls from distraught patients who are having side
effects of the medicines? Nothing.  What do I get if I charge a Level 4
visit and get audited and only document a Level 3? Arrested for fraud.

This is what we\'re up against. So I\'ll turn it over to you and maybe
we can think together about what types of solutions we can have and I\'m
sorry to bring you such a troubling message, but this is what\'s
happening and this is the truth.

MEMBER REZNIK: Thank you, Dr. Saag. We\'ll take questions, but I do want
to since you quoted from our Presidential Advisory Council blue book
which I happen to keep with me at all times, one of our recommendations
actually was creative solutions must be found to encourage more doctors,
PAs, advanced nurse practitioners to choose to develop the skills
necessary to treat HIV and included in that recommendation was to issue
reimbursement for health care workers who choose HIV care in medically
under-served areas, encouraging recognition of HIV care as a medical
specialty, provide incentives for more nurses, physician assistants,
nurse practitioners and physicians to be certified through their
appropriate associations, ensure adequate reimbursement for HIV care and
promote programs to increase the diversity of health professionals
trained in HIV care.

Now that may not have shown up in Reauthorization, but as long as I\'m
on the Council and I think I have a few months left we\'re going to
definitely push that concept. I mean I think you make some great points,
but I\'m going to get off that little soapbox and see who has questions
since I took over yesterday. Dr. Sweeney.

MEMBER SWEENEY: Thank you very much for that sobering message. I\'m an
internist practicing in Bedford Stuyvesant, Brooklyn and I work in a
community health center and one of the strategies that some health
centers are taking and I\'m hoping to do in the future, all of the
internists who work or are hired now have to agree to be trained to take
care of HIV patients in one of our community health centers, so that
eight people who are adult medicine docs, not just docs, they are mid
levels as well, all have to agree if they want to work in this
particular center that I\'m referring to to be trained in HIV.

Now that is a public institution in the truest sense. We have to take
all comers regardless of their ability to pay and it\'s one of the ways
that we integrate primary care and specialty care of HIV not only so
that we have greater person power, but so that there is not the
discrimination of having an HIV clinic and so if you go to that side of
the room, somebody knows of the building, somebody knows. I was just
wondering what you would think of that as a model to try and have more
primary care physicians trained to be HIV specialists as part of their
primary training.

DR. SAAG: I like the idea of training people. My experience has been
that if people don\'t want to be there they\'ll find ways to circumvent.
So unless you\'re self-selecting for people who want to be there and do
HIV care, there could be a problem in universalizing that as a policy
because people who don\'t want to go someplace won\'t go. They\'ll find
a way to B- They\'ll vote with their feet. So training people who want
to be there is good, but I think the other issue is incentivizing them.
Right?

I\'m sure your clinic is publicly funded in New York and Brooklyn and
everywhere there is much more money typically than in some other parts
of the country. So that\'s good. So I assume your clinic is not running
in the red. Right? So at least, you can pay the folks who are there and
that\'s good. I think training is good and that\'s a nice idea.

MEMBER SWEENEY: I just want to follow it with you talked about the
difficulty in treating patients with HIV because of the complexity of
medications. But you know in many other specialties, internists and
primary care physicians do much of the work-up, diagnosis and beginning
treatment and you refer to a specialist when it becomes too complicated
or to give you a program to follow and then they are followed
concurrently with a specialist and a primary care physician. Why can\'t
that be a model for treating patients with HIV?

DR. SAAG: It works on one critical assumption that I\'m not sure is true
and that is that the competency of the primary provider is such that
they understand the nuances of HIV care. It\'s not a cookbook formula
even for starting therapy. I had a referral from a primary doc who
thought they were doing a great job three weeks ago who diagnosed
somebody in Pell City, Alabama, sent them to me on Combivir, monotherapy
alone.

So I mean harm can be done. You have to assure that whoever\'s doing it
is well trained, not just trained. And so there\'s a lot of harm that
can be done.  It\'s like somebody trying to give chemotherapy when
they\'re not an oncologist and you\'re right. When you have to
incorporate more people, absolutely, but the training has to be there
too.

MEMBER REZNIK: Alan Holmer.

MEMBER HOLMER: Thanks for the powerful presentation. What portion of
your patients are eligible for Medicare and in searching for solutions,
is this a conversation that if Mark McClellan, the head of the Center
for Medicare and Medicaid Services, who is an M.D. and a spectacular
individual, if he were here, are there solutions that we might be able
to talk through with him? But first, what portion of your patients are
eligible for Medicare?

DR. SAAG: Probably less than 20 percent and the reason is they have to
be disabled for two years, etc. And even in our state, Medicaid is
ridiculously hard to get. You have to be disabled earning less than
\$510 a month. And so most people who have worked and they get their
disability check, it\'s over that \$510. So the only person who are
really going on Medicaid are people who are poor and have never worked
or not worked much. It\'s hard in Alabama, but that Medicare/Medicaid is
only a small portion. The majority of our folks, either they have
private insurance or they are totally uninsured.

MEMBER HOLMER: Okay. And what portion would be totally uninsured would
you guess?

DR. SAAG: About 30 to 40 percent and that\'s where the Ryan White CARE
Act comes in.

MEMBER SWEENEY: Right.

MEMBER REZNIK: I do want to make a suggestion and maybe, Dana, if we
could get copies, enough copies of this available for the members
because I would like you to look it over as possibly coming up with a
motion this afternoon based on our recommendation that we had that we
actually wrote last year. Next on the list is our Southern belle, Jackie
Clements.

MEMBER CLEMENTS: Well, thank you, kind sir. Dr. Saag, I have more of a
comment than a question. I worked with a Title III clinic that is
experiencing just what you said. We have about 300 patients, two PAs
that see them, one position we have had to replace three times in the
last four years simply because it\'s a lot of work working with HIV
patients and there are other places that they can go and get more of a
reward other than that heart-felt thing.

The problem with it also is that it is very harmful to the patients to
have to go through that many providers in so short a time. There is a
connection that you make with your provider and they question the
stability of the clinic. They question how well their care is given and
how much people care about them. So our consumers are really going
through a hard time having to go through so many providers in such a
short period of time

DR. SAAG: Has your patient volume increased over the last five years?

MEMBER CLEMENTS: Yes.

DR. SAAG: And has your funding from Ryan White increased?

MEMBER CLEMENTS: No.

MEMBER REZNIK: Dr. Redfield.

MEMBER REDFIELD: Mike, I want to thank you. I mean I think you brought a
number of points to the table which I think unfortunately are more
universal than people want to acknowledge and I think you\'re an
extremely articulate spokesperson to bring to the forefront. Even in the
State of Maryland which is regulated, our inpatient cost gets
compensated by some mechanism I don\'t quite totally understand but I
know that the hospital is not that upset about uninsured patients being
hospitalized, although that obviously they\'re not really enthusiastic
about them being not hospitalized which I think is probably the wrong
incentive.

I don\'t think any of us can make a clinical program function based on
the revenues that we can generate. So this is complicated both for
private practice but it\'s also complicated in the academic setting
where you have clinical individuals that have to basically cover their
salaries based on their clinical activity.

So I agree with your term. I don\'t like to overuse the word \"crisis\"
but I think that there\'s been a lack of attention to health care
delivery systems in general and there\'s clearly a lack of attention to
how to stimulate and incentivize in effective way young people to go
into AIDS medicine.

We\'ve been trying to recruit African-American physicians now in our
program proactively for about the last seven or eight years. We\'ve been
successful with several African physicians, one African-American
physician. Next year, hopefully we\'ll have an outstanding young fellow
who is African-American.

But as I\'ve talked to many of the young physicians who wants to go into
AIDS medicine when they have \$100,000, \$150,000 loan debt and they are
looking at the fact that the only way I can pay them is if they can
bring in the clinical revenue if they want to be a clinical person. The
reality is like you, we have 40 percent uninsured rate. We have probably
a 26 percent reimbursement rate and like you, we\'ve had 40 percent
increase in clinic visits last year and no increase in Ryan White
funding, actually a cut and actually worse than that, a cut from the
hospital from the ambulatory care support.

So I think you\'ve hit something that\'s so universal. It may be less
seen in some of the northern or high volume Ryan White or high financed
Ryan White at this point, but it\'s going to be seen and I think it\'s
something that needs to be really thought through. I think it\'s
unreasonable to expect young physicians to go into a practice where they
don\'t believe that they can be compensated to the point that they can
pay back their loans and raise a family.

You and I went into it because we finished our fellowships. We were
fellows. Everything else was full. It was a new thing.  It was exciting.
But I think you\'ve hit it and I think when we get our nation, you and I
may have disagreed about the advantage of early diagnosis before. I\'ve
always been an advocate of it because at least people would be denied
the discrimination of unknowingly infecting someone who is special to
them and getting optimal care based on diagnosis.

But clearly today, there\'s no doubt about it that diagnosis is key and
we\'re about to see probably a 25 to 35 percent increase in people
needing care. So I think much more aggressive creativity and it\'s not
all the Federal Government. I think medical groups need to be
accomplished.

We talked yesterday about Title III because I\'m of a view, you know, I
have 42 Ryan White grants in the state of Maryland and each one has to
be reported monthly. So I\'m writing two reports a day on average. I\'m
not sure that\'s the best utilization of our people to be writing
monthly Ryan White reports for 42 different grants. We unfortunately
don\'t have a Title III grant which I think is the most comprehensive
way to provide care and treatment.

So I think there\'s going to be both an increased need for support
probably from multiple systems including the Federal Government but
incentivizing young people to go into AIDS medicine in particular and
for incentivizing young people in the south to go into AIDS medicine
which is even another area that\'s even more complicated.

I think it\'s critical and I just want to thank you. I\'ve read what
you\'ve written and obviously published. I read your letter and your
memorandum. I think it\'s well thought through, it\'s fundamental and I
think actually does require much more insightful urgent action. I think
getting someone who is knowledgeable about health care economics in our
nation to really sit down and think about this like McClellan and
others, this is a serious issue and most of us are patching together
care right now and I think patches are going to break. I mean people can
only work so long and not be compensated for what they do.

DR. SAAG: Sorry to interrupt, but there is one thing that I\'ve thought
about a lot and that is the sort of safety net that our country relies
on to capture people when they fall into the cracks. The threads of that
are made up solely of health care providers who give a damn. If they
stop caring, there is no safety net.

They\'re the ones, they\'re social workers, our docs. When a patient
comes back and says, \"I have this prescription that was denied because
I need prior authorization,\" if we just said, \"Sorry,\" that\'s it.
The system assumes that health care providers give a damn and if they
stop giving a damn, God help us.

MEMBER REZNIK: Dr. Saag, before I take another question, you did an
interview with NPR recently and you were asked a question about burnout.
When I listened to it, you paused and I told Mike this on the way over
here during that pause I came up with ten different possible ways that I
would answer the question. Because one of the issues that we\'re facing
is that a lot of providers have been doing this for years. You\'ve
wanted the epidemic change and always wanted to know what was behind
your pause and what do you think about our existing providers who have
all of these forms to fill out who aren\'t getting reimbursed who now
have to learn basically molecular virology in order to figure out proper
treatments for patients? How do you think that impact is B-

DR. SAAG: Real quickly, I mean for those of you B- Michelle Norris has
invited me to the NPR studios just down the street and it was a really
nice interview and she surprised me with the question actually. She said
B- Oh, I was talking about provider burnout. I was referring to a lot of
the health care providers in our clinic who I\'m worried are going to
leave and I can\'t replace and she turned a question on me and she said,
\"Well, are you burning out?\" And I went \"Whoa.\"

Then I thought to myself \"Am I?\" And I really did have to think and
the answer is no. But the fact that I had to stop and think says
something, doesn\'t it? And like you and I were talking, maybe we\'re
just getting tired. I mean this is fatiguing to fight this fight every
day. But no, I\'m not burned out yet.

MEMBER REZNIK: Me neither. Next is Dr. Judson.

MEMBER JUDSON: I think the realities of this are just staggering and
gripping. I don\'t want to drag on but I was in Colorado involved with
the very first cases and at one point our public clinic within our
public hospital system, Denver Health and Hospitals, had seen or
consulted on 50 percent of the AIDS patients in the state up until about
1992 or \`93. I think the remarkable thing is the quality of the people
who were drawn into this struggle from the very beginning and that they
have stayed this long.

You are appropriately pessimistic. I guess looking back it was a
remarkable effort and every year, I would ask the people who directed,
we had directing our clinic when I was Director of Public Health and
head of Infectious Diseases there, is there anybody who we have not been
able to provide the best treatment that we know over the past year and
whether there were waiting lists or whatever else the challenges, most
of these physicians could look back and say no, one way or another we
haven\'t turned anybody away. We haven\'t denied them treatment we
thought was important.

But we\'re clearly at the end of that. Something is going to break.
We\'re still getting interest in some fellows, but I agree with you.
That\'s just B the economic model isn\'t there to allow it to continue.
With Medicaid disproportionate share, we\'ve been able to hold up a
health and hospital system where 44 percent of our patients don\'t pay,
\$220 million a year of unsponsored care. We\'re still in the black. We
have been since we became a state authority, remarkable achievement, but
it\'s just there\`s going to be an end to that at some point.

I think the other side of it though is that we\'re not the only ones who
are beginning to potentially burnout or age out. I think the public
appropriately, the taxpaying public, is beginning to look at AIDS like
everybody out there either does know or should know what they need to
know to prevent HIV infection and should our whole moral effort be based
on how do we marshal the resources to continue to try to treat our way
out of this epidemic, if we\'re not able to begin to show, I think, get
off of this 40,000 new cases a year or accepting that status quo and
proceed towards eventual elimination which I believe we have the means
to do, I think the public support for things like Ryan White is going to
wane. It\'s going to even get worse.

Lots of times people are saying that one out of eight woman will be
subject to breast cancer and we\'re spending \$3 to \$4 billion a year
or so on breast cancer which isn\'t preventable at this point by known
means and we\'re spending \$20 billion a year total, approaching \$20
billion for HIV/AIDS. So I think in a resource constrained society,
that\'s going to balance out.

So it brings us back to the purpose of PACHA and I think for many of us
to get back into making absolutely certain that all of the incentives
not to get HIV infection are out there and all the disincentives to get
HIV infection are out there and to begin to try to get back on track to
the reduction in incidents that we saw for a period of ten years where
we went from 170,000 or 180,000 cases a year at the peak down to the
40,000 or so. We\'re just not going to make it with treatment under
economic models, medical models, anything else.

DR. SAAG: One question that I think remains to be answered and Dr. Cohen
can address this maybe in his remarks is how much does treatment lead to
prevention of transmission and my guess is it\'s a pretty significant
impact, but we need to prove that.

MEMBER JUDSON: I think it\'s a significant impact but the estimates are
that 50 to 60 percent of new cases are still coming from the 25 percent
who are undetected and probably highly as we know disproportionally from
the relatively new, highly infectious cases in the concurrent partners.
It isn\'t possible I think to continue to maintain multiple concurrent
partners during undetected early infection. That\'s the pipeline.

MEMBER REZNIK: Thank you, Dr. Judson. Dr. McIlhaney.

MEMBER McILHANEY: In the meantime, first I agree with you, Frank, about
the exhaustion of the taxpayer, but in the meantime, it\'s obviously
just going to cost money in one way or another to solve that personnel
problem.

The average debt I think for physicians coming out of medical school
ranges about \$75,000. Some of you may know more specifically than I do,
but I think that\'s about what the kids are coming out of school with
now.

CO-CHAIR SULLIVAN: I think it\'s over \$100,000.

MEMBER McILHANEY: Is it over \$100,000 now?

MEMBER CLEMENTS: Yes.

MEMBER McILHANEY: Okay. I thought I might be a little bit behind and so
you know as compassionate as the young people may be finishing up
medical school the reality is that they have that debt weighing down on
them. There\'s a model that I\'m familiar with and it has to do with
Christian Missions. As I understand in Africa, way over 50 percent of
medical care there is provided by Christian missionaries and yet the
number of young physicians who are willing to go do that was decreasing
because of this debt thing and a friend of mine started an organization
that started raising funds to pay off the debt for these kids when they
finished medical school so they would be free to go on over and start
mission work.

It seems to me that might be a model to be considered that we could pay
the debt for young people that are willing to go into HIV work, provide
them their residency funds and then require that they do HIV care for
five years or something like this. So it\'s just a thought.

I think you\'re right. There needs to be some real creative thinking
about what to do because it is compassionate work to do what you\'re
doing and I congratulate you and Bob Redfield and the rest of the people
here that are doing that, Monica, but you just have to face the reality
that people aren\'t going to do if they just flat can\'t do it because
of financial problems.

DR. SAAG: Exactly.

MEMBER REZNIK: Dr. Yogev.

MEMBER YOGEV: I think you have raised the right point, but I think even
you are late to raise the point of the crisis. It was there. It is there
and in Chicago, there are two institutes and we are affecting the
quality of the patient\'s right today because I know in Chicago there
are three hospitals now that have a program and if you\'re uninsured,
that basically does not allow you to admit a patient. You have to send
him to the county hospital which are overwhelmed and the quality of
treatment which was really good there is down and that\'s where are
physicians are living and they have the best salaries by the way. So we
are in the midst of a crisis and it\'s going to get worse.

Part of the population that I\'m aware of that I\'m sure you are dealing
with a little bit is the adolescent. This is the second fastest growing
in our population of new cases. I cannot admit into my hospital. I have
a quota without saying it and what\'s interesting even in the Medicaid
issue if you reach the age of 18, you get Medicaid. But after 18, you
have to be AIDS. So everything which you did to prevent AIDS now caused
them not to get Medicaid or Medicare.

So we are producing a population of uninsured. We have the disease, the
beginning, the spreading, whatever and I think it\'s about time to move
into really a national approach to it and we should consider for example
B- are in the crisis to develop category special and to recommend to our
government of a special entity that you can come and you can go out of
special area in medicine that are in crisis that you need people, if you
need them in the emergency room, there would be funding from the
government to supplement this entity. If we decide the HIV, we need to
recommend that HIV should be identified.

I was a little bit disagreeing with you with all due respect that
training is enough in HIV. There are multiple studies and I\'m sure you
are aware of them that show that if you have less than 10 or 15 patients
the quality of care you give them is not as good as if you have more.

DR. SAAG: I didn\'t mean to imply otherwise. I agree with that
completely.

MEMBER YOGEV: I know, but it came out that training will be sufficient
in the model.

DR. SAAG: No.

MEMBER YOGEV: It will not be sufficient. It will be sufficient to train
the physician when to get the patient to the specialist, but those
specialists should be identified and one issue would be to develop a
system nationwide. You know countries who do it nationally are suffering
less if you look at United Kingdom. I\'m familiar with a system in
Israel. The government is paying for those patients and removing a lot
of the burden. So obviously, we\'ll never get to the government to pay
for everything, but to develop this criteria that an entity like HIV
will become preferred in whatever government, state will be paying on
top of what you suggested.

DR. SAAG: I agree with you. I didn\'t mean to imply otherwise.

MEMBER YOGEV: I\'m sure.

DR. SAAG: Sorry.

MEMBER REZNIK: Next would be Dr. Redfield.

MEMBER REDFIELD: Mike, I want to come back and try to be a little
creative in how we put this together because the only way we run a
financially solid program at Maryland right now unfortunately is it\'s
driven by partnership on the Schedule A\'s for the hospitalization side
which is really the wrong way to do this because as long as there are
undiagnosed people who come in with an average CD4 cell count under 200
like as in Alabama which unfortunately the case in the State of Maryland
also, we\'re still going to have people unfortunately find out their
diagnosis largely probably a third of them by being acutely admitted to
a hospital.

I\'ve tried to create models at Maryland of this concept of cost
avoidance and this is why I want to go back to McClellan and his group
because if you take a clinic of 1,000 people based on Mike\'s numbers
and you just switch their diagnosis from less than 50 to the greater
than 350 for a clinic just with 1,000 patients you just saved on paper
\$23 million. My clinic you would save 4,000 patients. We\'d save \$92
million.

Now we are all of a sudden putting some money into a system and the
problem with some of our health care finance situations is to look
forward how we have cost avoidance. In other words, if we\'re looking
for the current system to finance this, it\'s just going to keep going
the way it\'s going. Schedule As, hospitalizations, are going to be
driving the ability with outpatient clinics to work.

But one has to get more critical in looking at this. Now I couple that
with my own view that I said about Ryan White. How do you do Ryan White
funding? I\'d like to link incentivizing Ryan White funding to those
states to get the average CD4 cell count at the time of initial
diagnosis going up. Those states that can do it at 250 or 350 or 400 I
add I think they shouldn\'t be penalized for that. They should be
incentivized for that.

So again, I think there is a critical need to figure because truthfully
if it\'s just, I hate to say this, compassion or just try to get people
involved, I don\'t think we\'re going to get the momentum to get the
investment in the care system that we need. We need a sustained
investment to build primary care for HIV infection, one, because we now
know this is a process that if you do it right at the beginning, you
could have a good shot at living a natural lifetime. If you do it wrong
at the beginning, you have a good shot of not living a natural lifetime
and yet we also know that we\'re at a climate now that we\'re going to
move to earlier diagnosis. There are ways to begin to go higher CD4 cell
counts, try to make the economic argument to someone that\'s thinking
10, 20, 30 years that the capital that is being used in this in the long
term is actually we\'re saving long-term health care costs which are
substantial for this nation.

So I think someone has to look at it because we\'re not talking about a
band-aid here. We\'re talking about changing the financial hydraulics of
what drives our investment in ambulatory HIV care at a federal level.

MEMBER REZNIK: Dr. Sullivan.

CO-CHAIR SULLIVAN: First of all, thank you very much for coming and
brining us this message this morning because it\'s very dramatic and I
think the discussion has been very good. I don\'t disagree with any of
the things that you say. But the question is how do we dig ourselves out
of this hole that we\'re in. That\'s going to be difficult because you
talk to other areas of specialty, well, David knows that there was some
NPR series on the news I think a few days ago. Some of you may have
heard about the shortage, the crisis, in our nation\'s emergency rooms.
So I think we will see that going around.

As I see it, we really have a situation where our leadership is really
asleep at the wheel, Congress and the Administration. This is very
different from what the situation was in the early \`50s. Those of you
like me who are old enough to remember there were reports of a pending
shortage of health manpower and Congress got busy and passed a lot of
legislation so that now today we have one in three medical schools in
the country today had its origin in the second half of the 20th century.
We\'re graduating twice as many physicians today as we were graduating
in 1950, 16,000 every year as opposed to 8,000 every year.

Interestingly enough, we thought at one point that we had overshot the
mark. You may remember the GMENAC Report in 1977 that said we had
overshot the mark. Well, today, we really are approaching where we were
in 1950. We\'ve had a nursing shortage for several years that we really
haven\'t been able to get serious attention and resources to address. We
now have a pending physician shortage. The Association of American
Medical Colleges I believe about four months ago put out a paper
indicating or proposing that medical schools should increase their class
sizes by 30 percent to avoid a shortage.

So I guess what I\'m thinking is this. We certainly need to concentrate
and bring to the public\'s attention all of these issues about AIDS, but
I think this really should be joined with other issues. We\'re not going
to solve this issue simply by focusing on AIDS when you see how
emergency rooms are overwhelmed, hospitals are, etc. and we have this
pending shortage of health manpower. It seems to me we need to find ways
to join with other organizations like the AAMC, the AMA, the Dental
Associations, etc., to really say loudly to the American people we have
a problem that needs to be addressed because I can assure you many
people are totally unaware of this. Now I think we clearly need to bring
the attention of the American people to this situation in AIDS, but I
think to really get the kinds of situations that we need this has to
become a real national concern.

We have an election coming up in two years. Health care is going to be
on that agenda. This is the time to really find a way to join forces
with others to really try and address that because if this gets to be a
real issue for the American people anyone who wants to be elected is
going to have to address that.

So my suggestion is we need to certainly focus the attention of this
council on the AIDS issue of the crisis that you have outlined so
dramatically. But I think we also need to find ways to get allies and to
join so that those emergency rooms that are overwhelmed, the rural
communities that don\'t have physicians to really see some attention to
their needs. So that certainly is an issue I think this council needs to
be concerned about.

How do we really focus attention on getting solutions when they are
short-term solutions to some of the issues here? But I think that\'s
patchwork. I think we need to find a way to really address this. We did
it as a country back in the \`50s. We really are not doing it today.

The papers, [The New York Times]{.underline}, has front page headlines
about we to solve our nursing problem are really taking nurses from
undeveloped countries and robbing them of their manpower. So we need to
a much better job. I think we need to find a way to make this a more
coherent strategy.

Sorry. One other thing, I think Joe and Frank also made good points. We
spend too little of our resources on prevention because if we don\'t
really change that paradigm we really are 30 or 40 years from now going
to be having the same kind of discussion. So we do need to really find
ways to improve the health literacy of our citizens, change their health
behavior.

I thought we have a very interesting discussion yesterday. At least I
learned something about how the different social patterns in places like
India and maybe China that maybe the epidemic will be different there.
So I think we need to find ways to really increase the effort on health
literacy of our population and prevention as well because without that,
I think we\'re going to be spinning wheels.  They may be larger wheels,
but we still will be spinning wheels some decades from now. So that\'s
my comment.

MEMBER REZNIK: We have time for two more questions. Dr. Bollinger has
been very patient and then Chris Bates.

MEMBER BOLLINGER: With apologies to Dr. Sullivan because I think his
point was extremely important about a comprehensive and long-term
approach to solving this problem, I want to move back to a more short
term. One of the patches if you will and I apologize for that because I
don\'t want to distract from the importance of your message, yesterday
we heard from Marty McGeein about the reauthorization process. Now I\'m
not as intimately familiar with the process. Others here are, but it
sounded pretty pessimistic about the logistics of the process, the
funding that\'s being talked about for that. I didn\'t hear a lot that
would really address some of the issues, the really important issues
that you raised today.

One of the issues that occurred to me was actually brought up a few
minutes ago by Bob Redfield and I wanted to ask a question and maybe
some recommendations from you, Mike, about this. What he was talking
about was incentivizing the process in a way that rewards programs that
save money and one of the ways to save money that you\'ve outlined is to
diagnose earlier, is to get people into care and good care earlier with
a higher CD4 count and right the system does not. In fact, it sounds
like there\'s a disincentive to that.

In my experience at Hopkins in Baltimore and I want to get back to that
question. There are two steps to it. One is testing people and we\'ve
talked about the universal testing. The second is accessing the care. I
want to talk about that second piece or ask you about that second piece
because there are quite a few patients I\'ve seen in Baltimore who I
know have been diagnosed before they came to see me the first time. They
have complicated lives. They\'re active drug users. They were tested in
pregnancy four years ago and never accessed care when they could have
benefitted.

So I think there are sort of two steps to this. We could provide
universal testing, but what suggestions do you have about improving the
access to care or linking care to those earlier access points where we
can actually get people into care at a more economically beneficial
time?

DR. SAAG: Well, I don\'t know that I have a solution and since the
time\'s running out, I\'ll just be very brief. I think that whatever
testing is done has to be linked to care provision and that could be
done out of physician offices with good referral connections to clinics
or it can be done at the clinics themselves which are a little more
difficult, although we\'ve had a lot of success with rapid testing in
our clinic itself and it\'s amazing how well that works and almost
everyone who tests positive goes right into care.

But out-of-physician practices I think is where it needs to happen. I
think free-standing testing is an option, but linking that to care is
more difficult. So as a short answer, I would say that would be an
approach.

MEMBER REZNIK: Thank you and Chris.

MR. BATES: Christopher Bates, office of AIDS Policy. Hi Mike.

DR. SAAG: Hi Chris.

MR. BATES: I\'m really happy to see you here and to hear your comments
this morning.

DR. SAAG: Thank you.

MR. BATES: I just have two comments that I think compliment some of what
you said today. I\'ve served on two panels, both in Philadelphia and
Washington, D.C. attempting to try to recruit physicians and PAs to do
this work and it\'s a bit disconcerting to after lengthy conversations,
in-depth conversations with folks who were highly qualified that
underneath their feeling really was hidden issues of stigma around
working in this population, homophobia.

There was at least one woman in Philadelphia who just expressed to us
that she was not interested in working with gay men or men who had sex.
She was not interested in working with drug addicts in that her
expectation coming out of medical school was to be working with a
different kind of population. I think we can sweep that under the rug.
We can\'t ignore that. This is not the same epidemic that manifested
itself say in African countries and other places around the world. Our
domestic epidemic is a real one based in populations that are highly
disinfranchised and undesired and are general populations. So I don\'t
want us to miss that as a contributing factor to the recruitment.

Furthermore, I would also offer up that as I\'ve traveled around the
country speaking on behalf of the Administration and the Department
about our concerns and needs for HIV what continues to challenge me is
the absence of a serious educational dialogue between legislators, both
at the state level and the Federal level, outside of the AIDS epidemic
center. The states such as New York and Florida, Texas and California,
have very aggressive and very engaged delegations both at the state and
the Federal level who are participating in dialogues about policies and
funding as it pertains to HIV. That is not the case and even in our 14
southern states right now, there are heavily impacted with new
epidemics.

So we have some imbalances here that undermine clearly our capacity (1)
to keep a focus what those challenges are on a very personal way on the
part of the legislatures. They don\'t understand what\'s even happening
in their states. Many of them have not been to any of these provider
offices or to clinics. They haven\'t seen this experience firsthand. So
it doesn\'t mean the same and when talking heads and I don\'t mean to
say that despairingly but when people from Washington, D.C. who are paid
to lobby and paid to have these conversations professionally on the Hill
I think it\'s not the same. It\'s not the same as seeing people from
your district, people from your state, people who live down, who vote
for you engage you in a conversation about the impact of this epidemic
in a very personal, very natural way.

So I just wanted to offer those points up and then my last piece is
it\'s not easy to identify people who don\'t want to come to terms with
a potential HIV status. We have spent lots of time and money and hours
training people to do outreach and going into very seedy and unsavory
kinds of environments to connect with the most at-risk people if you
will in our society and still with them knowing often times that they
have HIV. What\'s the incentive to come? They won\'t be able to get ADAP
in some states.  Some states they may wait up to nine months for their
first medical appointment and even in other places, the opportunities in
terms of choice of where to go and seek services so you have some
anonymity, some sense of confidence around your HIV status not being
exposed, it\'s just not available. So it\'s an either or. It is a highly
complex environment we\'re in right now with lots of challenges on many
levels of which funding is key but not central.

MEMBER REZNIK: Mike, if you would hang on one more second, Dr. Sweeney
promised me she would have two sentences. I\'m holding her to that.

MEMBER SWEENEY: Joe McIlhaney mentioned raising money to pay off loans
for people who wanted to do certain kinds of work. One of the things I
think we should do is just look at the National Health Service Corps and
expand it. The model is already there and it works very successfully.
Some of my prime, my greatest physicians, have come from the National
Health Service Corps. They meet their obligations and they stay on in
the community health center if you make the environment right.

The other thing is there\'s another model that\'s used by the State
Department called hardship pay. They pay special for doing special kinds
of work in special kinds of environments. We can expand that. We can
suggest that. We can\'t expand that. We can suggest it as a mechanism
for getting people to do HIV care because as you\'ve heard it described,
it is special and hard.

And the other one is there is a shortage of physicians going forward,
but there is also a great maldistribution and there is a model. I worked
in Columbia, South America when I was doing an externship there. They
have something that every physician who is going to get licensed to
practice has to do time in what they call Rual. And so everyone, it\'s a
privilege still in 2006 to be a physician. Pay for the privilege even if
you\'re rich by doing some time working in populations that are
health-power shortage areas. So there are lots of models that we could
look at to help while we\'re coming up with better solutions.

MEMBER REZNIK: Dr. Sweeney, if that was two sentences, they were too
very long ones. But thank you. Dr. Saag, I want to thank you for taking
the time out of your busy schedule to come and present to us.

(Applause.)

MEMBER REZNIK: For the members of the Council, please during your break
or during lunchtime look at page 38 which is where we did have some
recommendations on training medical professionals in quality assurance
and hopefully we can come up with a motion today.

I\'m running behind schedule so I have to introduce our next speaker who
I think has to catch a plane. I\'ll do a brief introduction on Dr. Cohen
who is the J. Herbert Bate Distinguished Professor of Medicine,
Microbiology and Immunology and Public Health at the University of North
Carolina at Chapel Hill. This has been a North Carolina few days.

You can see his bio which is pretty much an incredible biography. He is
the Director of the NIH STD Clinical Trials unit. He is Director of UNC
Division of Infectious Disease and the UNC Center for Infectious
Disease. Quite an incredible track record. Over 400 articles published.
Much of Dr. Cohen\'s work has been conducted aboard especially in Malawi
and the People\'s Republic of China. So if the members could come back
to the table and the audience settle back down it\'s been a great honor
to introduce Dr. Cohen.

(Discussion off the microphone.)

MEMBER REZNIK: Okay. Dr. Cohen is being gracious and is going to give us
a five minute break. Did you all hear that in the back? You have five
minutes.

(Whereupon, the foregoing matter went off the record at 10:18 a.m. and
went back on the record at 10:29 a.m.)

MEMBER REZNIK: Okay. Good. That was a long five minute break. I\'ve
already introduced our next speaker. So without further adieu, we\'ll
let him get his system in gear. Are you plugged in?

DR. COHEN: Maybe. Is this working now?

MEMBER REZNIK: There you go.

DR. COHEN: Okay. I think we\'re going to start. Is that correct? Let me
indicate thank you for inviting me. I was in London yesterday. I\'ve
been living in London for awhile.  So my jet lag is enormous. So we\'ll
see how much disinhibition I have this morning. I got here. There was a
thunderstorm. I got here like 2:00 a.m., slept for an hour, came over
here and I\'ve not quite an idea of how this is all going to turn out.

Let me say from listening and being in academics I was restrained for
like an hour listening to Mike Saag and my colleague. Let me say that
what we\'re going to talk about now is really prevention of HIV and I
think one of the big issues without a doubt has been marrying prevention
and treatment as several in this panel already said. It makes no sense
to believe you can treat your way out of this problem without much more
intensive prevention activities where we\'ve not done a good job by any
measure. We\'ve not succeeded in prevention in the United States and
certainly not on a planetary level. So we have to hope for better
strategies for the next 20 years.

Now I\'m going to talk almost exclusively as a biologist, as a
translational biologist. So I\'m going to go slow and show slides and
kind of explain where we think we are in terms of transmission
understanding which leads us to prevention strategics. But let me say
that there\'s not doubt in my mind in terms of physician recruitment and
education and training that the person who goes into HIV medicine or the
next generation has to be somebody who is interested in public health as
well. The responsibility isn\'t just about knowing about the
medications. The responsibility is understanding about the community and
about the issues that surround HIV transmission.

And I think that if I was a fund raiser, there\'s no doubt. Why should
somebody want to pay for HIV treatment instead of diabetes treatment as
Dr. Sullivan kind of was alluding to? Well, the big issue here is this
is a transmissible disease and the more that the treatment and the
activities that surround the treatments are wetted to prevention, the
more it\'s totally different than all the other diseases on the plate of
all the funders and I think it would be a tragedy not to end this
dichotomy and make this an absolute commitment.

In the report that I participated in supported by the CDC, the IOM
Report of 2000, *HIV Prevention in the United States: No Time to Waste*,
there\'s a whole chapter devoted to prevention in the treatment setting
and the obligation of the medical community to learn about preventions.
So having said all that, this is really a prevention talk that I\'m
about to give.

I\'m going to go faster with things that I think you\'ve already talked
about and the slow down when I think there are new ideas and there is no
tradition of interrupting. Is that correct? There\'s a hesitation to
interrupt, but I would prefer actually for this kind of a talk to be
interrupted and Frank I know will be glad to interrupt. But I prefer to
be interrupted because why go on if there\'s something that makes no
sense or that is so argument evoking and so controversial, why go
forward? Why not just have the controversy right then?

So basically, this is the bottom line. This is a biological event. HIV,
you don\'t get a little HIV or a lot of HIV. As far as we know, there is
the transmission event and the transmission event is dependent on
infectiousness and susceptibility. And we\'re really certain that the
concentration of virus in the genital secretions or in the blood, but
especially the genital secretions, are going to explain most
transmission events and this is not rocket science. Most infectious
disease depend on the inoculum. So we\'re very concerned about inoculum.

We\'re also concerned about viral phenotypic factors because we\'re
reasonably certain that the type of HIV we have in the United States,
clade B or Type B is not as contagious as some of the clades in other
parts of the world. So while we see people living in other parts kind of
mislabeled as misanthropic sexual people, a lot of this epidemic has to
do with biological disadvantage and we see that biological disadvantage
at some level in terms of inoculum and phenotypic factors.

We see it played out even more aggressively in susceptibility. We know
that about one out of 100 white people have a hereditary resistance
factor to HIV. Resistance is very rare with people with color. We know
that there is innate resistance in some white people and we know that
there might be some people with acquired immune resistance which would
help us to make vaccines. We\'ll get to that later.

So infectious and susceptibility equal a transmission event and if
you\'re lucky, you don\'t have to a transmission event and if you\'re
unlucky, you have a transmission event. Our job is of course to prevent
this transmission event.

So this is kind of a starting point. Now I\'m going to criticize this
article heavily because it\'s just wrong and this is an article I wrote
in \`97. So as I attack the author, I want full B- If I\'m attaching my
friend, Ward Cates, it\'s because he and I wrote this together.

We knew really with great certainly the transmission probability from
mom to a baby and we knew the transmission probability from needle stick
to the next person and we knew that because we have the mom and we have
the baby and we knew that because we have the needle or the unit of
blood and we have the subject who was exposed. So these numbers could be
decided on with great accuracy and have been tremendously validated over
the years.

But these sexual transmission numbers are an incredible mess and I
won\'t tell you how we got into this mess, but that mess has helped give
a bad message to people. That message that we\'ve sent to people is that
it takes thousands of episodes of intercourse for HIV to be transmitted
and that really is not true basically.  These numbers, and if there is
time for the discussion, I can explain how we made such a mess out of
this, but the methods we used confused the message and we used a set of
methods in the late \`80s, early 90s, that it made an incredible mess
out of our understanding of HIV transmission.

Now how do I know this is such a mess? Well, look at my colleague,
Audrey Pettifor, working in South Africa. She\'s doing a national survey
in South Africa of boys and girls, males and females, and she sees a low
prevalence in young people just as they are becoming sexually active.
This right off the bat gets us into this whole needle stick argument and
almost gets us away from it the idea that the whole HIV epidemic is
being construed on the back of needle sticks just doesn\'t hold water.

So let\'s forget about that and let\'s say these people are now becoming
sexually active and you see the young boys have a low prevalence
sustained over a fairly long period of time, but these girls acquire HIV
at an incredible rate. About one-third of the girls in South Africa by
the time they reach 21 are HIV infected.

Now I would submit to you if that was going on in the United States,
everything would stop in the United States. Somehow people are
tolerating this or at least living through it in South Africa, but the
bottom line is when you ask these girls how many partners they have, are
they having anal intercourse, how old are their partners, you don\'t
find data different than the United States. We\'ve done similar studies
called Add Health in the United States and the data is not different in
South Africa. So some different kind of events are going on in South
Africa.  We would argue that they are mostly biological than behavioral
and that the transmission probably is not 3,000 episodes of intercourse.
It\'s more like 20 or 30 episodes of intercourse. So the first shocking
message is that HIV is not so inefficient.

And we know that most people on the planet have sex about eight to ten
times a month until they started getting older. I\'m not going to go
into that too much. But if you look at the young people here 15 to 24
studies have been done in China, Chicago, France, England and there\'s
all these books, most by a guy named Laumann called [Sex in
France]{.underline} and [Sex in England]{.underline} and [Sex in
China]{.underline} and when you do very careful surveys you find out
that people have sex about eight times, ten times a month. It\'s very
difficult then to get to 3,000 episodes of intercourse for most of us in
this room, maybe even in a lifetime let alone in enough time to have a
transmission event.

Then you see as you get older, we start lumping the numbers because
sexual intercourse really gets reduced and I don\'t want to get too
personal about this. But the number could get below the line. Actually
if you extend this out because you\'re telling people not be sexually
active. So it gets lower and lower and lower. But the point is that we
don\'t think that the transmission probability is published throughout
the \`80s and early \`90 are correct and we think some other better
explanation is necessary.

And that leads us to the idea of amplified transmission.  If the rates
are too low, we think HIV transmission is intermittently amplified by
increased general tract setting of HIV and an amplified transmission
will help us to understand the epidemic and maybe allow us to
redistribute some of our resources for prevention a little bit better.

So these are the ideas about amplified transmission. There are different
sets of ideas. For infectiousness, we are very concerned about the stage
of the disease, co-infections that might drive up the blood and general
tract viral burden. STDs are a huge factor, classical STDs are a huge
factor in the transmission probabilities and then genetic factors that
might lead somebody to have a higher viral burden and remain more
contagious over a longer period of time and I\'ll show you some data
about that.

Susceptibility would depend on STDs, vaginal flora, mystical innate
immunity and again genetic factor that we think we\'ve only scratch the
surface on. Only one or two genetic factors are understood in terms of
susceptibility. Go on.

MEMBER BOLLINGER: Would circumcision go on the list?

DR. COHEN: Yes, circumcision would be on a prevention list.

MEMBER BOLLINGER: That\'s not a susceptibility factor?

DR. COHEN: It will come later. Thank you. So circumcision could be a
susceptibility factor, but it will come up in our discussion of
prevention. And so we think probably this slide is correct that the
concentration of HIV in ejaculate will predict the probability of
transmission depending on the number of endocervical receptors. We\'re
able to measure all three things. We can collect ejaculate from people
who are HIV infected and we can measure how much HIV there is. We can
actually do biopsies of the endocervix and see how CCR5 receptors there
and how many CD4 receptors there are and so on and so forth and we can
calculate these curves and you see that the HIV transmission probability
at an HIV copy number less than 1,000 copies per mil of semen is
probably very close to zero, whereas the HIV transmission probability at
about 100,000 copies in semen is probably about one in 300.

And when you get up to 1,000,000 copies of HIV in the semen or the
female genital secretions, you\'re probably getting much closer to a
transmission probability of about one in 30. So if you have like numbers
of chambers of guns to your head, if you use that metaphor, you can see
it\'s not 1,000 chambers. It\'s not this message and I was kind of
totally shocked to see the Minister of South Africa and I\'m sure all of
you in this room are familiar with this story having sex with so many
newly infected and then quoting an article from the \`90s saying he
quote Nancy Padian\'s article which we think is wrong and said, \"I read
this article. It says that you need 1,000 episodes to get HIV infected.
Therefore this was a low risk event for me.\" So that was the most
misanthropic message I\'ve ever heard sent. We think that this slide is
correct.

We also think this is correct within reason and I\'m going to come back
to this slide a couple of times. So we think that someone\'s HIV
negative here, they acquire HIV, they have ramp-up viremia and in this
early window of viremia, they would be very contagious because of the
very high general tract viral burden, maybe only 30 episodes of
intercourse are necessary and then some people will get very low copy
numbers and those people might transmit at very low level. But then we
suspect that as HIV infection advances people don\'t become so sick that
they\'re not sexually active. They remain sexually active even unto
being admitted to the emergency room with a low CD4 count.  They might
have been sexually active that day. So some percentage of patients with
AIDS or people with AIDS will also transmit disease.

And we only have one piece of data about this but it\'s a very
compelling piece of data. From the Rekai study (PH), there were 14,000
people who weren\'t really couples. They were assembled as couples
later. So all 14,000 people were in a closed community and what they
found was that in this Rekai study as they measured the transmission
events that occurred in this closed population that 43 percent of the
transmission events occurred at the earliest point in time that they
could measure. So that meant that there were two negative people
enrolled in the study and by the next time they measured both people
were positive.

So obviously a third person got into that relationship. The two
negatives both became positive and what we expect happened or suspect
happened was that one person got acute HIV and they immediately
transmitted it to their next partner allowing this event here.

Then in the Rekai study, almost no transmission events occurred in
people with established HIV infection until people became much sicker
and were very close to death. They remained sexually active and then
about 16 to 20 percent of transmission occurred at the end of this
window of time.

Now I just want to remind you that most of our HIV prevention efforts
are focused on the middle of this curve, on people with established
infection with fairly low CD4. We\'ve had no, very little HIV prevention
efforts in people with AIDS and I think the HHS has done a good job in
trying to launch much more aggressive interventions here and we\'ve
certainly not done anything with acute infection for a whole bunch of
reasons. So this is kind of where we are and this is a very compelling
study.

Can you all understand me at this rate of speed? Okay. Then I\'m going
to talk faster. So one issue here is about acute HIV infection. Now
it\'s not to say even if it\'s true that almost half of all the
infections are accruing because of acute HIV infection. It\'s not to say
that we believe that suddenly this could become a giant public health
maneuver.  It is to say that it is something that we really need to
understand in the next five, ten, fifteen years for a whole bunch of
reasons that we might want to talk about later.

So we spend a lot of time trying to develop a way to diagnose acute HIV
infection. Historically, people look for symptomatic subjects who are at
risk and about half the subjects at risk have some sorts of signs snd
symptoms when they acquire HIV infection. But the signs and symptoms are
so vague you couldn\'t possibly separate them out. In an epidemic with
60 million people, less then 1,000 people with acute HIV infection have
been found by diagnosis which is kind of amazing.

MEMBER McILHANEY: Excuse me. Did you say it\'s not true to say that half
of new infections occur in this early stage?

DR. COHEN: I think it\'s true to say B- No. I think if we go back to
this slide we have one piece of data and that one piece of data is right
here and it says that 43 percent, in this study, of all the HIV
infections that were observed seemed to have occurred from the earliest
stages of infection.

MEMBER McILHANEY: But did you say that it\'s not true to say that about
50 percent occur in the early stage?

DR. COHEN: Well, I wouldn\'t generalize it because we only have this one
piece of data.

MEMBER McILHANEY: Okay.

DR. COHEN: In other words, if you were going to say I have a single
study that shows that this might be important this is the study.

MEMBER McILHANEY: Okay.

DR. COHEN: But if you were going to try and extrapolate that to the
whole planet, it would be a problem.

MEMBER McILHANEY: Okay. I just want to be sure.

DR. COHEN: And I think B- I know we kind of oversold this a little bit.
It\'s my group that\'s been doing this work and I think we\'ve oversold
it a little bit and I\'m trying to be a little bit sensitive.

MEMBER McILHANEY: Yes. I understand what you\'re saying now. I just
wanted to be sure.

DR. COHEN: No. Thank you. Other question before I go on? So the
symptomatic idea is never going to work. So we tried another strategy
and we intend to continue to pursue the strategy in the next couple of
years. So here is the HIV negative person and this is actual data of
people being followed in a blood bank. Sometimes people have what\'s
called blip (PH) viremia. They may or may not go on to HIV. So this is
very intriguing. We have about 12 people with this blip viremia and
whether they all go onto HIV or not is not known.

But most people clearly when they get exposed, then within two or three
days after exposure they have ramp-up viremia and for reasons we don\'t
understand completely there is tremendous and rapid replication and
people achieve a peak of a million to a billion copies of HIV and as
they\'re achieving that peak, they\'re antibody negative. So if you went
to a clinical and said test me today, you would be at your most
contagious of your whole life, but you would be antibody negative.

Now of course the antibody test can get better and better and better.
But they can only get so good because the host requires several weeks to
make antibodies. That\'s the rule of our species. So matter how good the
antibody test gets. there\'s always going to be this window period of
high contagion in an antibody negative person.

I should point out to you that it\'s during this window of time of rapid
viral replication that the host is undergoing a terrible destruction and
that is we\'re pretty sure now that CD4 memory cells, the central memory
cells, living in the gut are all wiped out within two or three weeks. We
have this experience now kind of written in stone with monkeys where if
you take a monkey and you infect him with HIV and you follow their gut
lymphocytes in what\'s called the central memory pool, it\'s destroyed
in weeks and now biopsies have been done a humans with very early and
acute infection by again Danny Douek showing the same thing. This is
terrible irreversible damage. So whatever CD4 you end up with after you
recover from your acute infection, you never have the same number of CD4
cells available to you as before this gut pool is wiped out.

This inspires in us a desire to really think hard about trying to
prevent this event. So if you\'re going to say to me how are you ever
going to find all these people and why would you want to find them, one
reason we want to find them is to protect these CD4 cells because this
is the No. 1 devastating event that occurs during this window of time.

The other devastating event that we\'re pretty sure about is the
integration of HIV into the genetic material of the host. So when you
start out, your genome actually has a lot of retrovirus from millions
and millions of years of evolution. About six percent of the whole gene
is retroviruses. But you don\'t have HIV incorporated in your genome and
so in the very earliest days of HIV infection we can see a very small
number of integrated events, but then after acute infection has
transpired, we see a heavy dose of integrated events. The reason we
can\'t cure HIV infection is because of the integrated DNA. So if we
could deal with the integrated DNA, get it all out of integration or
prevent it from ever being integrated, we could potentially cure this
infection. So we have a lot of reasons to be interested in acute HIV
infection, surveillance for instance, prevention and earlier treatment
and so on and so forth.

Now I\'ve argued that we can see a huge coy number and no antibody. So
it\'s not a big leap of faith to do what the blood bankers do. So let\'s
go back to \`87 and almost everybody in this room was working in this
field in \`87. And you\'ll remember in \`87 and Dr. Sullivan will
remember this perfectly the transfusion field was in terrible trouble
and we were able to do antibodies to find contaminated units of blood
but about eight or ten or 20 units of blood would slip the antibody
testing and as soon as the PCR test was available for detection of HIV,
every unit of blood in the country was submitted to a PCR test.

Now it\'s estimated by my friends in modeling that it costs about \$80
million to find the last eight infected units of blood in the United
States, but that had to be done in order to get people to feel that the
blood supply was safe. That was really not an option.

With the blood supply people did was they did pooling and they took 100
samples and they put them all together and if everything was negative in
100 samples, they went on with their business. If one sample was
positive in 100 samples, they would go back and break apart the whole
blood and find the one infected person. This saves a lot of money since
you\'re not paying \$50 a test. You\'re doing \$50 for 100 tests. And
remember because of this ramp-up viremia, there\'s a lot of virus in the
blood of people with acute infection.

So the State of North Carolina led by Peter Leone who talked to you
yesterday, he\'s the Medical Director for the state, they agreed to
screen everyone in the State of North Carolina for acute infection. So
we\'re going to look at all of our testing sites. We\'re going to find
563 people with new HIV infection detected by antibody. Those are over
here and then we take all the negative samples. They go to a robot in
Raleigh, North Carolina and the robot every day does 1,000 samples and
when we do that we find 23 acute infections which seems like a small
number, but that\'s five percent of all the infections detected in the
State of North Carolina. For every one of those people with acute
infection, we start finding a cluster and Peter talked to you yesterday
about social networks from clusters. Right? So you see how powerful this
becomes because of clustering and snowballing. So the state committed to
this and many other states are looking into this for obvious reasons.

The copy numbers are important. Here is the copy number of control
subjects with established infection. We\'re looking at blood, not semen,
but you see in the United States it\'s about 29,000 copies at set point
and the acute infection patients it\'s about 210,000 copies in acute
infection and then this guy has more than a million copies. So the
transmission probability of this group is about one in 800 or one in
1,000. The transmission probability of this group is about one in 100 to
one in 80. So we see a huge difference in the United States of these
transmission probabilities as calculated from the data we collected.

And for every person we find with acute infection, we find a terrible
thing really. They don\'t have one partner. We find three or four or
five partners. And there are three universes for the partner. The
partner can have established infection and they could have given their
established infection to the person with the acute infection or the
partner can have acute infection or the partner can be HIV negative. Of
course, the partner who is HIV negative becomes an unbelievable
prevention effort for us to prevent a transmission event from occurring
and the partner with established infection or acute infection also
becomes important to the overall prevention strategies for our state.

And what\'s important is where do we find these people. So here are the
testing sites, STD clinics, HIV testing sites, prisons and jails and
other. Most of the testing in most states goes on in STD clinics and
remember this is bias because we have opted in testing. This is less
than half than all the people who have come to STD clinics in our state.
So we don\'t know what happened to the other half of the people. We only
know what happened to this half.

But we know that we find established infection, recent infection and
acute infection mostly in STD clinics and as I\'m going to tell you in a
second, this isn\'t surprising because we think HIV transmission is
primarily B- Well, first of all, HIV is another STD. So it\'s the same
behaviors that lead to STDs lead to HIV and second, we think that much
of HIV transmission is actually a two step process. It involves a
classical STD as well as HIV.

But what\'s important here and now B- Is anybody here representing the
CDC officially? Many of us are on a committee. Many of us are on the
same committee where we\'ve talked about this. I can\'t say enough times
how I can\'t believe we can\'t get the STD clinics in the United States
to work to do testing for every subject who goes into an STD clinic
because this would be the biggest no-brainer way to find a huge number
of people who don\'t know their status and to find people with acute
infection and we\'ve been telling the CDC this for at least five years
and, Frank, you might want to comment on this.

MEMBER JUDSON: We\'re already doing it.

DR. COHEN: You personally have been doing it.

MEMBER JUDSON: Yes.

DR. COHEN: You\'re trying to do opt-testing on very client who comes to
your STD clinics. But you realize nationally that\'s not the norm.
That\'s not the national norm.

MEMBER JUDSON: I think it\'s a lot better.

DR. COHEN: The more it\'s done the better it is. Anyhow, this is a
soapbox. My only soapbox for this morning is that B-

CO-CHAIR SULLIVAN: Why has this CDC not responded to that?

DR. COHEN: Do you want B- This is just by sheer option and others in the
room are on committees with me that work with the CDC. I think that
first of all there\'s kind of an internal turmoil for many years about
the STD branch how independent is it or how much does it report to the
HIV branch. The HIV branch\'s interest in STD waxes and wanes. The kind
of belief of the importance of STD, sometimes they believe they\'re
important. Sometimes they\'re not so interested. So the two groups
don\'t really work seamlessly in my opinion, STD and HIV groups. They
should work more seamlessly. That\'s the first point.

The second point is the CDC gets like anything else it\'s an
organization led by talented individuals who get on their kind of issue.
 So they\'ve been very interested in emergency rooms in the United
States and I say, look. If you\'re going to test everybody in all the
emergency rooms in the United States, you don\'t own the emergency
rooms. It\'s a tremendous effort. But you own the, you don\'t own, but
you support every public health STD clinic in the United States. So the
energy necessary to do opt-out testing in the United States is very
small, the catalytic energy compared to testing everybody in the
emergency rooms.

But they\'ve had this internal debate about emergency rooms versus STD
clinics and this is just dragged on and on. I\'ve gone to the CDC
personally three times to give a talk like this to say test everybody in
the United States.

Now to defend the CDC, they\'re trying to do opt-out testing. They\'re
trying to get every STD clinic to lead towards opt-out testing. But I
think a forceful statement from this committee would be helpful.

MEMBER JUDSON: Having started my career at the CDC and been involved
with the CDC ever since, the problem isn\'t so much individuals at the
CDC who get into their own thing and want to protect their turf. I mean
it is, but the primary problem is that Congressmen and Congress people
like categorical programs. They like to have their name affixed to it.
They want to see an outcome. They want to know where the money goes and
that it\'s accountable.

So that some of the biggest attacks on the CDC have come when the CDC
has attempted to use money for one project in another project area. So
they drive it for TB, for respiratory distress syndrome, for anything.

DR. COHEN: Let me say I don\'t it\'s a turf. I don\'t think this is an
issue of like some B- I think it\'s people\'s interest. If you\'re
interested in herpes, you\'re interested in herpes. If you\'re
interested in HIV, you\'re interested in HIV. Sometimes the people
wouldn\'t necessarily see the connection as clearly we might want them
to.

MEMBER JUDSON: It\'s like the silo thinking starts with Congress.

MEMBER McILHANEY: I\'m on Dr. Gerberding\'s advisory committee and one
thing you pick up is that they feel like they obviously cannot mandate
that all STD clinics in the United States do this because they don\'t
control them like that and I think there\'s a little bit of paranoia
about issuing proclamations that I think they\'re wrong about. I think
they should do exactly what you\'re saying and I think sometimes they
underestimate how much influence they\'d have just saying all STD
clinics should do this.

DR. COHEN: Right. Of course, they do B- First, I\'m sensitive to what
you said. But I do think they do issue proclamations all the time
limited by money. They say if you don\'t meet this goal, we\'re not
going to give you Title X money. That is their only control over the
public health plus they provide public health advisors.

But also I don\'t think there\'s a tension here. The STD clinics would
love leadership from the CDC. I can\'t imagine any STD clinic not being
thrilled about being told if you do this is going to benefit the people
of your community and your state.

MEMBER McILHANEY: I totally agree and some of us keep pushing them to do
what you\'re saying.

DR. COHEN: Okay.

CO-CHAIR SULLIVAN: Let me just say I think our Prevention Committee
ought to look at this issue, because I do think that perhaps some
support from this council might be helpful. I can understand CDC really
battered from all side, etc. but it seems to me that one purpose that we
could serve is to really point out to not only CDC but the members of
Congress about the importance of this.

DR. COHEN: I can\'t see how you can B- If you tested all people who went
to visits to STD clinics in the United States you would without doubt
drastically increase the number of undetected people living in the
United States.

MEMBER REZNIK: We\'ll come up with a motion at lunch. That\'s No. 3.

DR. COHEN: All right.

MEMBER REZNIK: I like fast. You talk fast. I write fast.

DR. COHEN: Let me keep going then. Do STDs play a major role? There are
tremendously compelling pieces of evidence that HSV-2 which is really an
aggressive virus trying to fill up the entire planet. Right now, at
least about 20 percent of Americans are HSV-2 infected. That number is
almost certainly going to climb in the absence of some mystical
intervention. So I think for many people HIV transmission looks like
that HSV-2 is transmitted much more efficiently than HIV. Probably it
just takes a few episodes, two or three episodes of intercourse for
HSV-2 to be transmitted.

So an HSV-2 negative young person has their first encounter with an
HSV-2 host. Now the HSV-2 infected host may not know they\'re HSV-2
infected. I\"d say less than five percent of people have symptoms and
signs that would lead to know their status. So they\'ve unwittingly
given HSV-2 to the partner. The HSV-2 causes endocervical and penile
skin changes that render the host much more susceptible to infection. A
really important abstract is going to be presented at the meeting in
Toronto that were biopsies done on the women who had recently acquired
HSV-2 and demonstrating beautifully visibly how many more receptor cells
there are and how many more receptor per cell.

So the first stage is HSV-2 transmission or maybe syphilis transmission
or maybe gonorrhea transmission or maybe trichomonas transmission and
then the next stage is HIV transmission not requiring 1,000 episodes of
intercourse, now only requiring maybe not even 30 episodes of
intercourse, maybe requiring only ten episodes of intercourse because of
the tissue changes inspired by the classical STD.

So there is no doubt about this. What\'s gone wrong in the STD field is
that the clinical trials the STD people have tried to do to demonstrate
that intervening with STDs can prevent HIV transmission, those trials
have failed miserably and that has caused tremendous policy
consternation which is going to be played out at a WHO meeting on July
11, the big showdown between the policy people who don\'t want fund STDs
as part of the HIV portfolio and the people who are saying that\'s
insane. It\'s just that the trials didn\'t work out. It\'s not that STDs
aren\'t important. So this is kind of where we are with that issue right
now and many of us are going to that policy showdown meeting.

So let\'s move to Africa just for fun because I want to show you
something about transmission in Africa. I work a lot in Malawi. We\'ve
worked there since \`90 and we worked there for a very specific reason.
We wanted to see the effects of STDs on HIV transmission. If we\'re
working in a U.S. clinic, we\'d have to work for years to see a
transmission event. But in Malawi, we\'re in a country of 10 million, 90
percent rural, about 15 percent adult prevalence but in the STD clinic
we run, half the people are HIV infected. So one out of two people who
come in are HIV infected.

Obviously, this is a human laboratory where we can learn things very
quickly and we with the help of the U.S. Government and international
funds built a research center called Tidziwe Center that we\'re
extremely proud of. That\'s it in its construction.

And this is just a study that I want to show you. It\'s published with
about five other studies like this, but this is 1,361 men screened and
47 percent were antibody positive. So we take the antibody negative
people and we say these are people who are going to be sent home. We say
do you have acute HIV infection. What we found to our shock was about
two percent of people have acute HIV infection which is a very high
number. Bob Bollinger did the first study like this in India, very
similar study and found more than one percent, greater than one percent.
So Bob actually led the way. Let me give credit to you because it was a
brilliant study using p24 I think.

So the point is this has been repeated over and over. If you go to STD
clinics, you look at the negatives. You\'re going to find some acute
infection and what\'s even more shocking is if you have a swollen gland
and a general ulcer, exposure to sex and you\'re HIV negative you have
about a ten percent chance of having acute HIV infection.

This is the viral burdens now in Africa. The antibody negative people
have higher concentrations than they would in the United States. Here\'s
150,000 copies at set point.  So the Africans are managing to have much
higher concentrations of the virus. Why? We don\'t know. But that
increases the transmission probability. If you look at the acute
infection patients, it\'s one million copies median. This is two billion
and this is three billion of copies of HIV. So the median transmission
probability in Malawi for the acute infection people is about one in 30
and this guy is 100 percent transmission probability.

So what am I saying? I\'m getting you away from the \`97 article that
had one in 1,000 transmission and I\'m saying that\'s not true. The
transmission probability is going to be predicated by where you are in
the disease and whether you have an STD and you shouldn\'t count on
1,000 episodes of intercourse before you acquire HIV. You should count
on one episode of intercourse before you get HIV. It\'s a very different
message than what we sent out in the published articles and not
everybody agrees with this. So you\'re only hearing my opinion.

Here is an interesting unpublished piece of data. Now we\'re actually
collecting semen in the clinic because we want to see what happens over
time. The blood is in red and the yellow is semen and what happens is
the blood is sustained, but the semen viral burden goes down
precipitously after we treat the STD. So the maximum contagant for semen
is only a few weeks. So this is a pretty interesting finding to us from
a public health point of view in terms of how we\'re going to manage it.

MEMBER JUDSON: You\'re saying not everybody agrees with that. Who with
an infectious disease background and who understands simple mathematics
of transmission and inoculum would not agree with that?

DR. COHEN: Let\'s leave this. We have hours to go before we\'re done.
Let me leave your question. We\'ll get to who might not agree with this
and why people might not agree.

Okay. So now we come back to this slide and this is now we have to
dissect this better. So I\'ve kind of made my argument in the most
aggressive way I could make and now I\'m going to break my argument
apart and show you something a little different. I think it is true,
this gets to Dr. McIlhaney\'s point, I think it is true that some
substantial number of infections occur in the earliest days of
infection. Whether it\'s ten percent, twenty percent or it\'s fifty
percent, I don\'t know, but it\'s not a good time to be having
unprotected intercourse with somebody.

And just because they told you I got tested last month, that ought to be
a sign not to have sex with the person because why were they being
tested last month? Obviously their risk behavior sent them to a clinic
to be tested. So it\'s kind of interesting. Remember we had, I mean this
goes back to the \`80s and \`90s, the whole idea that recent antibody
testing sets the stage for a safe feeling. People were going to have a
card to show you they were antibody tested, stamp it on their hand.
Remember all this. Well, that actually to me would be a symptom that you
really don\'t want to have sex with that person for obvious reasons
because they might have antibody negative acute HIV infection and be
most likely to infect you.

Then we have this incredibly idealized vaccinated person or person
who\'s called an elite controller who suppresses virus to few copies and
no transmission events occur. This is not true. So this is what actually
happens. Ramp-up viremia and then set point and only less than one
percent of people who get HIV can do this. In fact, people spread their
virus out over a whole spectrum of HIV concentrations. Now the person
with the highest concentrations sustained at what\'s called set point.
How you achieve set point we don\'t know. Is it genetic? Is it
immunological? Is it virological?

All we know is at six months or nine months or a year into your
infection, you\'ve achieved some sort of state and if the state you
achieve has a very high viral burden, then death is more rapid and
transmission is more likely. But if you\'re lucky and you are lucky
enough to have a very low concentration of virus in your blood, you\'re
probably much less contagious and you certainly will live much longer.

Now there\'s a mathematician named Christophe Fraser, F-R-A-S-E-R, and
he says that \"the virus is seeking an optimal concentration\" and what
he means by that he thinks that the virus wants to spread to as many
people as possible and the way that the virus can do that is to kill the
fewest hosts possible. So what he says is that the virus is trying to
achieve five logs in the blood of people. At five logs, the host lives
many years and the host remains contagious enough to send the virus to
the next person.

What\'s interesting about that five log deal is that the Africans
generally sustain about five logs of virus. That is the most common set
point, 4.9, 4.6. So Fraser obviously modeled this based on what he was
seeing but it\'s an interesting kind of Darwinian evolutionary argument.
So he doesn\'t believe that acute infection is important and he doesn\'t
believe that AIDS is important. He certainly doesn\'t believe that most
people get this low set point. He believes that all over the world where
there\'s five logs, it\'s that five logs that\'s really critical to
sustaining this epidemic.

EXEC. DIRECTOR GROGAN: When you said the Africans are around five in
contrast to what other?

DR. COHEN: U.S. are like 20,000.

EXEC. DIRECTOR GROGAN: And where in the U.S.?

DR. COHEN: About 18,000 to 20,000. So if you look at the U.S., I mean it
depends on the person, but we\'ve not B- If you took 1,000 U.S. people
untreated in Bob\'s clinic in \`90, most would not have 100,000 copies.
Most would, I think, have 20 or 30.

MEMBER REDFIELD: When we looked at the Defense Department a number of
years ago.

DR. COHEN: How many subjects?

MEMBER REDFIELD: It was a large number.

DR. COHEN: Thousands?

MEMBER REDFIELD: Yes, but it was the average viral load was between
9,000 and 10,000.

DR. COHEN: Untreated.

MEMBER REDFIELD: Untreated.

DR. COHEN: So if you took an untreated African population, the average
would probably be between 100,000 and 200,000 copies at the same CD4
count. I\'m only telling you the facts, Joe. I\'m not going to explain
them.

MEMBER SWEENEY: So many people go in and out of treatment with
antiretrovirals.  Given what you\'ve just shown us, if someone is not
going to be able to be on sustained therapy then, it seems that they
reach their set point and it would be better to just leave them at the
set point without treating them instead of having B-

DR. COHEN: Let\'s leave the treatment issue for a second except to say
one thing. We\'re going to come to treatment in a second, but let me
just say, and I appreciate you\'re still awake, but let me say that the
whole issue of treating people earlier, treating them for public health
purposes and starting and stopping therapy is very controversial. But
certainly we know for sure that starting and stopping therapy based on a
study that was just completed is probably a really terrible idea. We
know that if you start therapy early, at least from one or two studies,
if we start therapy early and you can sustain the therapy and people are
adherent, they do very well with very early therapy if it\'s sustained,
but not if it\'s started and stopped, not if they leave it.

MEMBER YOGEV: I hope you put into the argument the guidelines now say
don\'t treat if it\'s 100,000 unless B

DR. COHEN: I don\'t know. I mean guidelines B-

MEMBER YOGEV: From the public point of view for to just showing us B-
Would you address that?

DR. COHEN: Yes. I think the guidelines that we\'ve written are we get
into an issue Mike B- The MP chair is Mike Saag. He is the guideline guy
and the guidelines in general on the treatment of people in general have
not paid much attention to their public health obligations and
responsibilities. When Tony Fauci got into a whole big interruption,
vacation holidays, drug holidays, we called him and said, \"Are you
crazy? This is exactly the most destructive thing you could do, render
somebody feeling better, stop their drugs so they have a rebound,\" etc.
 So we had great trouble with what they called STI, strategic treatment
interruption, which we called sexually transmitted infection. So even
the language is a problem, but I mean complicated.

STDs, one last point about STDs, if you take a person with gonorrhea,
this is from a study that was published in \`97, you take a first week
of infection. We\'re looking at semen. You see 150,000 copies in semen
and over time you see a very rapid lessening of HIV concentration. So
this is what we think is a more realistic picture. Ramp-up viremia, some
control, but not that level of control. But then the person with HIV
doesn\'t remain a newly found virgin.  They go out and have sex and a
substantial number of people who are HIV infected acquire STDs. We know
from most studies in the United States it\'s probably about six percent
a year, five percent a year.

So that is a sign that our counseling in clinics is not optimal because
so many people who are HIV infected acquire STDs and when you acquire an
STD even on ART, you can break through the ART.  So if you\'re not on
ART, you are for sure going to increase your concentration of HIV in
your genital secretions. If you are on ART, about ten percent of people
break through the ART. When they break through the ART, they have
resistant virus breaking through especially protease resistant virus.

So now we\'re beginning to see how we\'re going to blow our drugs.
We\'re going to take all the drugs we\'ve made and we\'re going to see
transmission of resistant virus to the next person. Therefore, we\'re
going to be in a constant race to make drugs that are going to be
effective for newly infected people.

Now this is not completely played out yet. It\'s played out at the level
of 16 percent, 15 percent. So if you went to Bob\'s clinic and we did
single gene amplification, we would find at least 15 percent of his new
patients have resistant virus. How did they get their resistant virus?
Either they were seeing a patient on therapy who got an STD and broke
through or who stopped their therapy either transiently or completely
and had resistance develop.

Somebody had a question or not? Yes. Isn\'t it more fun when you
interrupt? Isn\'t this a lot more fun?

MEMBER GREEN: Putting this in the context of prevention, I\'m thinking
about the multi-site study in Africa that was published in the special
issue of, what was it, anyway in 2001, *Journal of AIDS*, I think. When
they looked for factors that seemed to be causally associated with
higher or lower levels of HIV prevalence as you recall there were
biological factors such as presence of GUD especially HSV too and male
circumcision were the factors. The only behavioral factor that emerged
in the first round of analysis was the pattern of older men having sex
with younger girls and I remember thinking and discussing with people at
the time one reason for that would be that a young girl when she\'s
recently infected she\'s lost her virginity. She probably would be
susceptible to having sex with somebody. Older men are thinking if the
girl is young, she\'s probably not infected, but they are more likely to
end up with a young girl in the three week period of high viremia. So
this pattern is pretty dangerous. Have you thought along those lines
besides prevention?

DR. COHEN: Yes. We\'ve thought a lot about it. So the first issue is the
older men/younger women thing bears fruit in a variety of ways. The
younger woman often has an exuberant cervix, so there\'s more surface
area. The younger woman often has vaginal flora that offers less innate
resistance to infection. There is a lot of biological beggars putting a
young woman at a disadvantage.

But in addition, the chance of running into an infected person would
increase if you did it with an older man and just as you\'ve said. So in
South Africa where we\'re pretty sure that it\'s not older men infecting
younger women, it\'s not that grazing phenomenon, where it\'s much more
complicated, but in Tanzania you might have an infected person who
believes it\'s an advantage to his own health to have sex with an
uninfected virgin and the more years that man has been sexually active,
the higher the probability he is infected. So you\'re increasing the
kind of hits of a molecule just as you\'ve said.

Okay. So this is one other way we\'ve looked this and now I\'m just
going to end up a little bit on prevention just with a couple of things
that I think probably are relevant to your committee. These are all the
prevention strategies going on on this planet that I\'m aware of and I
would welcome Bob who is my kind of gadfly, I want you to look at this
slide because you\'ll always some butterfly.

This ABC, STD interventions and there are still trials ongoing. The most
powerful trials that are being done are the HSV-2 interruption trials,
trials to try and prevent HSV-2 transmission or HSV-2 acquisition and I
can tell you more about those trials if you want. Vaccine trials,
there\'s a bunch ongoing, but I guess it\'s important B- Well, I\'ll say
something about that in a second. Bacterial vaginosis, there are no
trials ongoing. Microbicides, there are many trials ongoing. A very
important diaphragm is ongoing.  The male circumcision trials, there are
three ongoing. One was stopped. Antiviral therapy trials, there are
several ongoing using antiretroviral transmission event. Incentive for
safer sex, we\'re not really doing trials, but there\'s a lot of thought
about how societies might approach this problem.

By way of disclosure, I should say that I\'m chair of a Gates Committee
which is actually going to have temerity. So this is interesting. So
I\'ll just slow down for a second. Gates realizes as it\'s invested its
money its distorted research. Because every time it decides to do
something in research that thing becomes important even if the thing is
not important and these decisions are made by single individuals. So one
issue is what have been the effects of Gates on the whole research
portfolio. Have they done a favor or have they actually damaged the
research portfolio? I don\'t want to say it that harshly but it\'s an
issue.

The second issue is truth in advertising. What are we really going to do
in the next 20 years and who has the courage to tell you the truth about
what\'s really going to happen? And if it does happen, how important is
it really going to be? For example, are we going to make a preventive
vaccine in the next 20 years? Bob, is there any way on earth?

MEMBER REDFIELD: It\'s successfully B- distributed B-

DR. COHEN: I mean even we don\'t have the capacity right now.  Any
vaccine that\'s being tested is not a vaccine to prevent HIV infection.
It\'s a vaccine to lower set point. That\'s all we\'re trying to do
right now. But no one wants to tell the public that. It\'s like kind of
an anathema to tell the truth. So instead we just keep doing this stuff
and pretend like we\'re not doing it.

Diaphragm trials. There is a diaphragm trial almost complete. If the
diaphragms work to prevent HIV transmission, that\'s a huge finding with
immediate impact because that\'s just a little piece of plastic over the
endocervix. The circumcision trials, those will be done this year. So
we\'re trying to make a molecular clock. We\'re trying to say with the
Gates Foundation how have you distorted research, what research is going
to be done, when is it going to be done and what are the possibilities
of the outcomes and how powerful could the outcomes be and I think that
will be an interesting committee. That committee is just meeting this
year.

Having said that we can\'t make an HIV vaccine that\'s preventive, I
need to introduce you to an organization that you might not be familiar
with that I\'m one of the leaders of and that\'s called the CHAVI, the
Center for HIV Vaccine Immunology. So recognizing, the NIH recognizing
we weren\'t really making a preventive vaccine, they made a giant award,
\$300 million and the purpose of the \$300 million for the CHAVI is to
try to help us to enable development of a vaccine, to start over
essentially and say what do we need to know to make a vaccine, why have
we failed, where are we right now and why have we failed, not to make a
vaccine, not to test a vaccine, but to do the science necessary to
develop a vaccine properly.

So these are the kinds of things we need, subjects with acute infection
for longitudinal studies, large numbers of transmission pairs, the
infected person and the person who got the infection, HIV exposed and
uninfected subjects. Who are HIV exposed and uninfected subjects? Do
they really exist on this planet or is this another one of the big lies
that we might be subjected to? What about genetics? We only have just
tiny scratched the surface.

So the CHAVI has enough money to do the entire genome for very large
numbers of people. So there is 30,000 snips in the human genome. We have
enough money to do 30,000 snips of a very large number of exposed
uninfected subjects and then there\'s studying mucosal samples in much
greater understanding and depth than has been done before. So the CHAVI
is worth knowing about, the NIH Center for HIV Vaccine Immunology. The
leader is a guy named Bart Haynes. The principal investigator is Bart
Haynes.

And lastly antiviral therapy to prevent transmission. Bob Bollinger and
I have been working on this and many of us in this room have worked on
this for a very long time. We do know how to make antiviral drugs. This
came up already and there are three ways you could use antiviral drugs
to prevent transmission. You could do post exposure prophylaxis which
we\'re going to do whether it works or not because we have guidelines.
You could do pre exposure prophylaxis with a pill or pills and there are
randomized trials ongoing right now to test whether a pill before sex
can prevent HIV acquisition.

And lastly the most important question is when the person is HIV
infected takes their pills are they rendered less contagious and if so,
how long are they less contagious and can we develop drugs for this
purpose much as we\'ve tried to do in the tuberculosis field. Over the
next 20 years, can we actually focus on not just treatment for the sake
of improving the health of the host, but also treatment for the sake of
public health.

In summary, we can measure the concentration of drugs in general
secretions and what\'s important about this is not all the drugs get in
the same.  So when you make a therapeutic decision, the therapeutic
decision might be good for the host, but you might actually be giving
the host a drug that actually renders them more likely to develop a
resistant virus. So over the next few years, we expect physicians of
drug companies to be more sensitive to this. This has to do with B- And
Joe, you\'re giving me that confused look.

This has to do with compartmentization. Protease inhibitors don\'t get
into semen or female genital secretions. They are too highly protein
bound. So if you use a protease inhibitor alone you would be giving a
subtherapeutic concentration to that compartment. So we always use
combinations, but some of these drugs actually concentrate in the
genital secretions. This is constant percent greater than blood in
genital secretions, here the male genital tract.

There have been 14 studies looking at the effects of B-

MEMBER REDFIELD: Could you just go back for one second because if I see
that slide just to point out that the most common regime used in the
world would then be d4T nevirapine and 3TC.

DR. COHEN: d4T very poor penetration.

MEMBER REDFIELD: Nevirapine.

DR. COHEN: Yeah, very poor penetration.

MEMBER REDFIELD: And 3TC.

DR. COHEN: Excellent.

MEMBER REDFIELD: So you would argue that if we were doing that that this
could B-

DR. COHEN: It\'s probably not the best public health. Right.

MEMBER REDFIELD: But this is the regime that\'s probably used around the
world.

DR. COHEN: I understand but this is an unpublished slide.  This is an
article coming out in the Annuls of Internal Medicine. But again, I\'m
giving you where we are in research right now today. But your point is
well taken and obviously prefer tenofovir, 3TC, FTC that they be used
for all regimes for prevention, that they be included in all regimes
especially for post exposure prophylaxis in the emergency room. We\'re
trying to get the CDC right now to go back to their guidelines and say
the guidelines ought to focus on some drugs and they ought to focus on
some drugs because of drugs that get into the genital secretions.

MEMBER REZNIK: I\'d like to say we actually brought that up yesterday as
a point when we had a person here from Gilead.

DR. COHEN: Good. Who was here from Gilead? Jim Rooney?

MEMBER REZNIK: Jim B-

MEMBER YOGEV: Nevirapine you cannot say is not very poor.

DR. COHEN: No.

MEMBER YOGEV: It has a very good track record.

DR. COHEN: It\'s comparable in general secretions to blood.  It\'s not
poor. He said it. I didn\'t say it.

MEMBER YOGEV: Okay.

DR. COHEN: He\'s saying it has 70 percent there.

MEMBER YOGEV: Yes, and I was wondering where you got your data on the
efavirenz because there is some data to suggest that it\'s as good as
nevirapine and it\'s fascinating. It\'s the only one which you have a
three percent and that it\'s almost the same molecules. So I\'m
wondering where that for efavirenz is coming from.

DR. COHEN: You know I would have to break apart. There is a lot of data
that goes into this slide. This is a summary slide. So I can send you
the raw data. If you send me an email, I can send you the raw data.

MEMBER YOGEV: Please.

DR. COHEN: Angela Kashuba, K-A-S-H-U-B-A.

MEMBER YOGEV: Because efavirenz as you know now is one of the
considerations to go into because of liver disease in multiple studies
and it would be very important to have it.

DR. COHEN: Of course. I do understand that. Combivir and efavirenz is
what we\'re using for B- Actually you\'ve raised a good point. So let me
just show you. If you take semen and if you go before therapy and after
therapy, before therapy you can easily detect HIV in semen. After
therapy, you have trouble detecting HIV in semen. You can still detect
HIV DNA in semen and as I\'ve said, some of the drugs concentrate in
semen and they can also concentrate in female genital secretions.

We\'re doing a study for seven years called HPTN 052 designed to
determine whether if you treat the host you can reduce transmission of
the infected partner. These are the study sites for HPTN 052 and the
bottom line of HPTN 052 is that the anchor tenant in HPTN 052 is
Combivir and efavirenz, sensitive to what you\'re saying. But the
Combivir would be believed to achieve at least the concentration
necessary to cause suppression and the efavirenz you need because you
need a well-tolerated third drug. But that\'s the anchor tenant. Other
drugs are possible. So we expect equipoise and evolution over the seven
years of the study.

So I\'ve said a lot of different stuff and a lot of this is unpublished
and this is exactly where we are right now and these are our belief
systems. They are not like B- This is controversial. This is like what
Frank was getting at earlier. If I took ten epidemiologists who did
among the 26 studies of transmission we would argue about the methods
and why they might be right or they still are right. They certainly are
B-

For example, let me give you the most common error and this is an
amazing error. This kind of boggles my mind that most of the studies
done for transmission were done with discordant couples. So a person
would come to the clinic and they would say I\'m infected and I have a
partner. So we would say bring your partner. And if the partner was
discordant, they would enroll in a trial and they would be followed for
two or three years and then you\'d measure whether transmission occurred
over the two or three years and you would see no transmission events.
You come up with the one in 1,000 or one in 2,000, one in 3,000.

But remember you never studied concordant couples. You took away all the
concordant couples that all transmitted instantly. So you were biasing
this towards people who already were not going to get HIV and it\'s very
comparable to this. If you were looking at pregnancy, if you looked a
young 25-year-old woman who was going to get pregnant and she had sex
twice, she\'d get pregnant. You would say \"Whoa. Look how fertile the
species is. They get pregnant so quickly.\"

But if you looked at breast feeding woman with one child and then you
went and studied her to see if she was going to get pregnant, it might
take two years for her to pregnant. And you would say \"Whoa, how does
this species survive\" because if you didn\'t know anything about the
effects of breast feeding on hormones you would draw a totally different
conclusion. So in the \`80s when we were doing all these studies somehow
we got incredibly misled. Enough.

So it\'s not somebody who\'s trying to do this wrong. It\'s just that\'s
how it came out and these are other errors. There is a whole series of
errors.

So in summary and then I\'ll stop and entertain any real dialogue,
genital tract viral burden determines HIV transmission. I think we can
probably agree on that and there\'s not a lot of disagreement. STDs and
HIVs are likely sequentially transmitted and large numbers of subjects
with acute HIV infection will present with STDs especially ulcer
disease. So I think we could probably agree on that, that STD are
important, although I\'ve already indicated to you it\'s been hard to
demonstrate that you can treat your way out of the epidemic.

Recurrent risk behavior allows subjects with established HIV infection
to be detected in STD treatment settings. What do I mean by that? Why do
we find all of these people in STD clinics who are HIV infected? It\'s
because the very behavior that allowed them to acquire HIV is just
another sexual behavior that allows acquisition of STDs emphasizing the
point I made earlier.

HIV transmission is almost certainly amplified early in disease and late
in disease and subjects early and late help to fuel the epidemic. How
much they fuel the epidemic is the point you could argue about.

HIV prevention in my opinion will increasingly focus on the most
contagious subjects and biological behavior and interventions will be
developed to reduce HIV transmission probability. And those
interventions I think have to be developed marrying treatment and
prevention and getting back to the preceding talk, getting treatment
much more involved in the public health of HIV. Because that is most
people we see who want to go to training in HIV now have masters degrees
in public health and are actually very interested not just in being HIV
providers, but also in fully realizing public health opportunities and
both domestically and internationally.

That\'s the last things I\'ll say. This is a globalization thing. We\'re
so focused right not today on the U.S. and its 600,000 or 800,000
patients. But in fact, this is a global epidemic and I don\'t think you
can separate the global from the domestic and I understand my colleague
from HHS earlier made the point that the epidemic in the U.S. is quite
different. The patients are much more difficult to reach sometimes. But
still it is a global epidemic. Yes.

MEMBER GREEN: I\'m really interested in what you said earlier about the
biological disadvantage that Africans may have. It\'s widely believed
among my colleagues in AIDS prevention that Africans start to have sex
at an earlier age than in the west and have more partners. So I was
interested to hear you say something that I\'ve long held. In my book of
a couple years ago, I have a table comparing DHS data on two common
measures, one, the proportion of youth 15 to 19 sexually active and
secondly, life time members of partners and just as you said there\'s
not that much difference between Africans and Americans.

The one difference that has emerged if you look a little more closely is
a pattern in Africa maybe especially in Southern Africa of multiple
concurrent partners rather than serious monogamous partners and maybe
that\'s something that you could do something about.

But getting back to this biological disadvantage B-

DR. COHEN: May I B- Before you go on, so we have two pieces of data and
we\'re trying to write this up now. We have Ad Health which is 22,000
U.S. adolescents followed for almost 14 years now and their HIV
prevalence was just published last month by Martina Morris in the
*American Journal of Public Health*, very low prevalence in the U.S.
adolescents.

MEMBER GREEN: Right.

DR. COHEN: But we have an incredibly rich dataset from the U.S.
Comparing that directly to the Audrey Pettifor dataset, national, cross
sectional for South Africa, what I can tell you is it supports what
you\'ve already said. Unless the young women are lying in either
country, they are very similar not very different and the age
discrepancy is 2.5 years not ten years in South Africa. Rectal
intercourse is zero unless they are lying which may be a big factor and
concurrency doesn\'t appear to be a major factor.

So you either have to say that they are lying or that there are things
we don\'t understand. So those two datasets need to be compared.

MEMBER GREEN: Right. So the biological disadvantage, are you suggesting
that some of it might be compromised immune system health from endemic
tropical diseases?

DR. COHEN: So March 30, 2000 *New England Journal*, I wrote an editorial
about this biological disadvantage. First of all, let me cite an actual
editorial. It\'s an editorial about the biological disadvantages.

MEMBER GREEN: This summarizes what you think.

DR. COHEN: It summarizes some of my thinking five years ago, six years
ago. But then I think it\'s more complicated now. I think that what am I
really concerned about. First I\'m really concerned about bacterial
vaginosis for women. Mos Taha (PH), our collaborate at Hopkins, did a
very good study that said that flora that most African women are
sustaining which is rich in anaerobes and poor in lactobacillae offers a
threefold odds ratio of acquiring HIV relative to women who don\'t that
flora and there are three studies like that. So this vaginal flora thing
is probably a pretty big deal and we\'re trying to work on that more.
There\'s at least ten studies about vaginal flora and HIV.

MEMBER GREEN: And that\'s not in your earlier material.

DR. COHEN: It is an earlier thing, but it needs to be better and better
refined. I don\'t know. Bob may have feeling about this, but it was a
very good study and it\'s not the only cite. So there\'s the vaginal
flora issue. There\'s the clade issue that we talked about.

MEMBER GREEN: Right. You mentioned that.

DR. COHEN: And then there is the genetics.

MEMBER GREEN: Most of my colleagues don\'t believe in the importance of
clades.

MEMBER REZNIK: I hate to interrupt this conversation but we have time
for one more combined question from that side and because we have people
waiting for public comment.  I hate to have to do this because it\'s
engaging. So whoever is going to grab the mike.

MEMBER BOLLINGER: Mike, can I just ask you to say a little bit more
about the relative impact? I mean you\'ve talked about host factors and
susceptibility factors and borrow factors and you did a great job. By
the way, you do just as well as when you\'re jet lagged as when you\'re
not jet lagged. I\'ve heard him speak when he\'s jet lagged and not jet
lagged and he sounds great both times.

DR. COHEN: I have a feeling I\'ve said more wrong things per square
meter. You have the voracity probably down to about ten percent.

MEMBER BOLLINGER: One of the things that you said B-

PARTICIPANT: (Inaudible.)

DR. COHEN: That\'s what I\'m thinking. What did I say?

MEMBER BOLLINGER: One of the really important things that you talked
about was the higher viral loads both in the acute and the chronic
infection in the African studies compared to the U.S. and that gets to
viral factors which I think is really behind a lot of your emphasis on
the 052 study and the actual impact.

DR. COHEN: And CHAVI.

MEMBER BOLLINGER: And CHAVI on treatment and its impact on prevention.
So I\'m wondering if you could talk a little bit about your thoughts
about the relative impact of host susceptibility factors and borrow
factors.

DR. COHEN: I think that the CHAVI got \$300 million to sort that out. No
one and in my opinion it is not known. Most of the stuff done in
virology has not been done with single gene amplification. Everything in
virology is moving very fast now in a very different way. The genetics,
we\'ve not even touched the surface of the genetics. We\'ve done kind of
few snips here and there on some HLA. That\'s not the way to approach
the problem. We\'re going on the world\'s biggest fishing expedition and
the geneticists they are going to find fish.

MEMBER BOLLINGER: What is the implications on whether treatment of virus
B-

DR. COHEN: I understand, but I don\'t know the answer. I\'m telling the
truth, my first truth.

MEMBER YOGEV: You know it\'s interesting because the genetic, 60 percent
of outpatient is genetic from African and I wonder if we\'re ever going
to look into the new activation of those patients. You know there are
studies from Helman for example.

DR. COHEN: Yes. The B-

MEMBER YOGEV: TB. Malaria. You have too many people in Africa who
(Inaudible.) activated to receive the virus which do we have any data on
teenagers and so forth in the U.S.?

DR. COHEN: The Israeli colleague, Veben Benvich (PH), he has a paper
that embraces the Helman hypothesis. There have been five studies since
including one we did. I don\'t think the Helman hypothesis is going to
bear fruit. The malaria hypothesis bears a lot more fruit. That\'s
already kind of written in stone and TB probably bears fruit as well.
But you said it exactly right. I think Dr. Reznik\'s going to B- Let me
answer Frank\'s question and then I\'ll stop or I\'ll stop.

MEMBER REZNIK: Dr. Redfield and then we\'ll have to end.

DR. COHEN: You\'re okay.

MEMBER REZNIK: Short, Dr. Judson.

DR. COHEN: I\'ll be brief too. I can be brief.

MEMBER JUDSON: Mike, these are always great and I certainly always I
think recently agreed with your view of the biologic-viralogic world.
And I think where we may disagree although probably not is what you do
with this information from a practical standpoint in terms of public
health control programs.

One thing I\'m sure we\'ll agree with is as Thomas Perron said many,
many years ago \"When you\'re faced with a diabolic enemy, you use every
weapon at your control\" and wherever there\'s a reasonable possibility
for efficacy we should pursue that.

The next thing that comes to mind in my varying experiences is that in
looking at epidemiologic information that would attempt to show
causation between co-infections with other STDs and HIV
transmissibility, in my view none of these studies has ever been
constructed in a way that can prove causation.  You don\'t know even
what the order of infection is and in most of them, the majority of the
easiest ones to do has been cross sectional and you simply cannot do it.
So that accounts for the huge variability and results from study to
study, location to location, organism to organism.

Then I take that information and I try to say what do we do with that.
The people who believe that other STDs, there are some who believe that
HIV doesn\'t need any help from the other STDs and I probably fall
closer to that. But I\'m not willing to B- I\'m not attempting to
exclude in any role at all for them.

But I think the question then is what you do with it and I don\'t think
that as I think most here don\'t think that it\'s really possible,
practical, economically feasible to treat our way out of the HIV
epidemic. That means either directly or indirectly. I don\'t think we
can do it directly with antivirals without changing fundamentally
exposure behavior and I would be even less certain that we could ever do
it indirectly by attempting to eliminate other STDs.

For this I go back. Some of the most formative experiences in my career
go clear back to gay men. In 1970s, when there were such incredible
rates of STDs, all STDs in gay men, but we\'re owing to bathhouses and
multiple concurrent partnerships, the same thing, gonorrhea, syphilis,
hepatitis B were 20 to 40 times more common.

We thought we had in Denver practically as good of clinics as you could
have, outreach to the bathhouses, to the gay groups, homophobia was not
a major issue. We through every resource did everything we could. There
was open access.  We treated thousands and thousands of cases of
gonorrhea in gay men every year and we never got anywhere. By the end of
B-

DR. COHEN: With HIV.  Never got anywhere with HIV.

MEMBER JUDSON: Yes, we never got anywhere before fear of AIDS and fear
of AIDS managed to reduce over a three year period looking backwards
through sero-archeology (PH) incident rates for HIV probably 70 to 80
percent then, by the end of the decade probably close to 90 percent.
Within three to fours, the incidence of gonorrhea, syphilis had dropped
by 90 to 95 percent.

This is the power of change in behavior. We couldn\'t measure it. There
were no CDC prevention programs at the time. These were gay men
understanding how their sexual behavior probably spread this deadly
condition. So I think we\'re faced now with the same things in the
developing world and everywhere. Unless we come to terms with the
fundamental driving factor of multiple concurrent partnerships often
during the early most acute stage of infection, often before infection
has even been detected, our success is going to be limited and to
continue to I think debates approaches if we treat gonorrhea \-- I\'ll
ask you. Do you think we can treat our way out of HIV by simply treating
gonorrhea or syphilis?

DR. COHEN: I\'m going to give an eight word answer. One is no one is
going to disagree about embracing all the tools in the toolbox. It\'s
the first five words. Second is I think using the gay sex thing in
Colorado is probably a bad idea because the efficiency of rectal course
changes everything because of the number of dendrite cells, receptors
and trauma. So you can never overwhelm, you can\'t win against anal
intercourse. It\'s almost impossible.

Not gay. Anal intercourse is a really bad sexual practice for HIV
transmission. It changes the equation.  The efficiency is probably one
in ten or one in eight.

MEMBER REZNIK: Final word goes to Dr. Redfield.

MEMBER REDFIELD: Mike, I just wanted to comment briefly. We had a number
of your group here over the last two days and part of it just from the
respect of both HHS and others. Clearly, I think you make a compelling
argument. Policy always has to be based on imperfect or incomplete
information.

But I think there\'s a compelling argument now that most people can
sense this is moving towards, Mike said it and others, that we\'re
moving towards sort of opt-out policy. You made a compelling argument
that we should really also concentrate on STD clinics.

The United States, the kinetics of the epidemic could really be driven
and I think you make a pretty good argument for that. The kinetics of
the epidemic could be done by the zero negative viremic group, the acute
infection period. I mean you make an argument for that at least if you
believe inoculum maps and you could also make an argument in the United
States that the other part of the inoculum might be is you get more
advanced disease. The United States has policies to treat advanced
disease. We don\'t try to identify acute infection as our public health
policies.

So it seems to me again with the desire to blend prevention and
treatment we actually really ought to critically reevaluate our policies
to be looking a little more aggressively.  There are so many times you
have to B- And some people have to see a chicken cross a highway before
they can see a chicken cross the highway I mean even though they\'ve
seen it cross a road or they\'ve seen it cross a street.

It seems to me that trying to go after the ability to diagnose this
infection during the acute infection and trying to move treatment early
sounds like a sounder public health approach in the United States. It
may be in Africa because you\'ve shown that established infections drive
in that epidemic.

DR. COHEN: Let me in the interest of time what we have to do, it\'s a
very simply model. It\'s the same as the blood bank decision. We have to
decide how many acute infections we want to find for how much money and
if we want to spend that much money to find that number of acute
infections with the predicted outcome whether it\'s curing a person or
treating him earlier or preventing an additional X number of infections,
we can do it. At this point, I don\'t think we have enough B- I mean the
policy has to stem from the data we collect. We don\'t have enough data.
But I agree with what you said. It\'s like we can model and say do we
want to spend the money and that\'s what the blood bankers do.

MEMBER REZNIK: Dr. Cohen, thank you for a very engaging presentation.

(Applause.)

MEMBER REZNIK: And you didn\'t speak as fast as I do.

DR. COHEN: I can speak faster than you.

MEMBER REZNIK: I don\'t know. I\'ll turn it over to Dr. Sullivan.

CO-CHAIR SULLIVAN: Let me add my thanks to you for a very informative
and challenging presentation. We\'ve now come to the Public Comment
section of our meeting where the members of the public are invited to
address the Council. The rules are as follows. Those of you who wish to
address the Council if you come to the microphone, identify yourself and
the organization which you represent and proceed with your comment. Each
person will have three minutes for comments and we\'ll ask you to
observe that limitation so that we will have ample time to respect
everyone who is here. With that, we will proceed. Yes.

MR. WILSON: My name is Mel Wilson. I represent the National Association
of Social Workers and what I\'m going to do just sort of give you a
little background of who we are but then hit some highlights of concerns
and issues that we want to talk about. So I\'ll be reading from my
little paper and hopefully we can get some comments back.

The National Association of Social Workers is pleased to submit the
comments.  We were founded in 1955. NASW seeks to enhance the well-being
of individuals, families, communities through its work and advocacy.
Social work is suited for addressing complex problems associated with
the HIV/AIDS epidemic because of its comprehensive approach and
commitment to social justice.

Now a couple of key points we want to hit on. NASW believes that federal
resources must ensure that all person living with HIV and AIDS have
access to comprehensive services. Therefore, we support the language
addressing treatment and care within committee\'s publication,
*Achieving an HIV Free Generation: Recommendations for a New American
HIV Strategy* in which the right to such access is clearly stated and
that\'s something that the NASW supports.

We agree that all persons living with AIDS must have access to a core
set of services to facilitate their remaining end care. This include
primary medical care, medications, case management, oral health, mental
health, substance abuse treatment and support services. But adequate
resources must be available to ensure that comprehensive services are
available to person both living with HIV/AIDS and those affected by
HIV/AIDS.

One of the ways we want to define comprehensive services is a broader
definition. We want to include services such as suitable and affordable
housing, for us to care for both children and adults, access to accurate
information including comprehensive sexuality education, legal services,
transportation and culturally-appropriate and language-accessible care.
The little fact that we want to share is that the NASW or social workers
are the largest provider of mental health services in the United States
and that we feel strongly that mental health services, substance abuse
treatment and adherence counseling and case management should be a major
goal for ongoing treatment and care of a person living with AIDS. So my
little note about shortness of time.

Therefore, we strongly encourage again going back to your document
recommendations outlined in achieving an HIV free generation regarding
training professionals that would be expanded beyond simply medical
professionals. One of the positions that the NASW takes is that often
times nonmedical professionals are assumed by ignored and we want to be
sure that we are included in any attempt to improve the level of care
that we provide.

There are several examples of enhancing the care of this workforce, the
social services workforce, things such as tuition reimbursement for
social worker and other professionally trained mental health care
providers who choose to provide HIV mental health and behavior health
care in under-served communities. In conclusion, we do encourage this
committee that it does support the reauthorization of Ryan White and
specifically NASW recommends that the Minorities HIV Initiative be fully
funded at \$610 million in fiscal year 2007. Thank you very much.

CO-CHAIR SULLIVAN: I failed to note also that if you have a written
document that the committee invites you to leave that document with us.
Yes.

MR. SCHMID: Hi. Good morning. I\'m Carl Schmid, Director of Federal
Affairs for the AIDS Institute. I\'ve given I think the staff a copy of
my written comments and hopefully you\'ll receive them.

Today we\'d like to discuss three issues with you, the authorization
levels in the proposed one-time ADAP booster fund and the proposed Ryan
White Reauthorization Bill and ADAP funding in FY \`07. While we\'re
generally supportive of the reauthorization legislation currently before
the Congress, we\'re extremely concerned about the unrealistically low
funding levels proposed over the next five years. Depending on the
title, it\'s either flat-funded or an increase of 3.7 percent per year.
These levels don\'t even keep up with the medical inflation rate, let
alone the growing demand for medications and health care services.

In the years ahead, the number of people who rely on the CARE Act will
continue to rise. People are living longer. There are 40,000 new
infections every year. More people are being found to be positive
through increased testing efforts. There are several new drugs coming on
the market and health care costs and drug costs continue to climb.

We\'re particularly concerned about the propose flat funding of Title IV
when there is an increase of more women and younger people affected with
AIDS. We\'re also concerned about the extremely low increases proposed
for ADAP when the role of medications continue to grow.

While the Bill has taken steps to help alleviate the ADAP crisis in
certain distressed states such as increasing the ADAP supplemental from
three to five percent, the overall ADAP authorization is not increased
in FY \`07. Since more money will be going to the supplemental, less
money will therefore be available in FY \`07 through the ADAP formula.
As a result, many states will actually see less funding next year.

So we would like to see at least an B- Sorry.  As a result, many states
will see less funding in FY\' \`07 and an B- increase after that in FY
\`08. It will translate into only \$30 million a year which is a too
little amount of money. We ask you to join us in asking the Congress to
increase the authorization levels proposed in the Bill.

Also any funding for ADAP has to be more than just one year. There\'s a
proposal to do just a one year booster fund. You know that people have
to maintain their medications and we\'re afraid when those patients or
when the state stop receiving that money, they\'re not going to have the
continued funds for those medications.

And finally, as I said earlier, we\'re very concerned about no increase
for ADAP in FY \`07. So we would ask you to encourage the Appropriations
Committee to find ADAP an increase in FY \`07. Thank you.

EXEC. DIRECTOR GROGAN: Do you have Daren Dosier? Is there anybody else
for Public Comment? That\'s it. Okay.

CO-CHAIR SULLIVAN: All right.  That concludes then our Public Comment
section. I\'m going to suggest because we want to be sure that we finish
by 4:00 p.m. because I know some of you have commitments. Yes. So we
will work to see that we will finish by 4:00 p.m. Before we break, Joe
Grogan has just reminded me of a ritual that we really need to go
through. So, Joe, why don\'t you proceed.

EXEC. DIRECTOR GROGAN: As I said yesterday, we\'re losing some valuable
members of the Council and it\'s a sad day for me personally and for all
of us. I want to take the opportunity before I present those departing
members with their service to read a letter from Secretary Leavitt that
was sent today to Dr. Sullivan to his office. But I just wanted to share
it with the rest of the Council and with the official record and the
public.

\"Dear Dr. Sullivan, It is with deep regret that I am unable to thank
you in person for your years of service as Co-Chairman of the
Presidential Advisory Council on HIV and AIDS. For over four years, you
have distinguished yourself through steady envisionary leadership in an
area of deep concern to the President of the United States and to all of
us here at the Department of Health and Human Services.

Under your leadership, PACHA has provided invaluable advice to President
George W. Bush and the team of people working across the Federal
Government to fight this disease. Your tenure has seen progress that
five years ago would have been unimaginable. During your tenure, the
President launched the Emergency Plan for AIDS Relief, the largest
international public health effort in history, called for the renewal of
the Ryan White CARE Act in two State of the Union Addresses, delivered
emergency medications to those on ADAP waiting lists, unveiled an
ambitious HID testing initiative, called for greater funding of
prevention and testing resources and brought a renewed focus to the
disproportionate impact this dreaded disease is having upon African
Americans. Your leadership played a central role in all of these efforts
and your legacy will be an unwavering determination to achieve the dawn
of generation free of HIV.

Your time on PACHA is but a small part of a public health career marked
by self sacrifice and service to public health. Not only as Secretary of
this great Department, but as a physician, administrator and public
servant, you have contributed immeasurably to the health of all
Americans.  In your capacity as an advisor and counselor, I have come to
rely upon your experience and wisdom.

My sadness at marking the end of your tenure as Co-chair of PACHA is
mitigated by the certain knowledge that I can look forward to working
with you in the future on many areas of public health concern. I know
that you will continue to be a valuable resource to the President and
myself as we work to help Americans live longer, healthier, more
productive lives. God bless you and your continued work. Secretary
Michael Leavitt.\"

(Applause.)

CO-CHAIR SULLIVAN: Thank you very much. A quick comment which I will
certainly share with Secretary Leavitt. I think all of us are here
because we want to serve the public. We want to see that those things
that interfere with our ability of our citizens to live healthy,
productive lives that we make changes so that their lives will be better
and we\'re also here because I think we receive gratification from
service. We are because we do really benefit ourselves I think
psychologically and otherwise from seeing the result of our efforts.

And I would like to say to my colleagues that I leave behind I think
that the Council will continue to do excellent work. I think this
session has been really quite outstanding and I\'m sure that this will
continue to improve. So thank you very much. It\'s really been a
pleasure and I\'m sure that I will interact with many of you in the
coming years in many other capacities, but the bottom line is serving
the public and we\'re very privileged to have that opportunity. Thank
you.

(Applause.)

EXEC. DIRECTOR GROGAN: So, Dr. Sullivan, I\'m going to give you your
plaque here and I have a set of cufflinks. My suspicion is you may have
a pair of these already probably, probably a stack of them somewhere but
thank you very much.

Dr. Sweeney was the only one to make a demand of me that not only would
she get a lapel pin as the women normally get but she demanded cufflinks
because she\'s that type of pushy New York broad she said. So here is
your lapel pin and your cufflinks as well.

(Applause.)

MEMBER SWEENEY: I just wanted to say two sentences, David. Dr. Sullivan,
you\'ve already received your comments from our Secretary, but they\'re
not mine. I want to say thank you very much for all of your leadership
during these four and a half years that I\'ve been here and how much
I\'ve learned from being on the committee and to Joe Grogan and the
wonderful staff, Dana, who did so many things to you that I won\'t even
tell you now some of the things she had to do to me and for me and to
our staff who is our recorders who sometimes I would think how can they
stand us. They ask us one simple thing, just put our microphones on and
say our name and we didn\'t do it and they still were very pleasant. So
I thank you, Joan, and the rest of you very much.

And for all of my fellow PACHA members, I\'m really deeply sad for two
reasons. One is that we continue to need to be here. There\'s a
disconnection between what we know and what the public knows. There was
a major research study that showed only 17 percent of Americans think
HIV is still a major issue. In an African American press that same week,
it showed that over 60 percent think it\'s a major issue. So there is a
major disconnect. So all of my fellow PACHA members, there is a lot of
work left to be done and I\'m sure you will.

And my sadness is mitigated by the fact that I hope to continue to work
with many of you in a different capacity. I will leave with something
the Churchill said that I often use is that \"You make a living by what
you earn. You make a life by what you give.\" And for all of you for all
that you give, I\'m very thankful to have been able to work with you.
Thank you.

EXEC. DIRECTOR GROGAN: And Dr. McIlhaney, I have your plaque and your
cufflinks for you.

MEMBER McILHANEY: Very briefly, I think that what David Reznik said, I
think it was in *Blade*. Was that the magazine where you made your
comment about the fact that this group had worked together well? I
really thought that was first a very kind thing to say and I think also
it reflected what people can do if they have a desire for the good of
the public and are willing to sit down and work together and I think
that he reflected what this group has done very well in what he said.

It\'s been a privilege to be a part of it. I\'ve learned a lot.  I\'ve
enjoyed working with every one of you and I agree, Dr. Sullivan, that
you\'ve done a wonderful job of guiding this group and, Joe, you and
Dana and the rest of you, have done just a wonderful job of corralling
us and thank you for doing that. It\'s a privilege to have been a part
of this and I\'m glad to know you people that are new in the group and
to know that you\'ll continue what\'s already been begun and I just hope
and pray that the number of people infected with this horrible disease
just goes down dramatically as a result of the work that you\'re going
to do. So thank you.

CO-CHAIR SULLIVAN: We will take ten minutes for our break, but then
we\'d like to begin a working lunch at 12:10 p.m.

EXEC. DIRECTOR GROGAN: We\'re going to go to break and they\'ll bring us
lunch. So we\'ll go directly to the room.

CO-CHAIR SULLIVAN: All right. Correction. We\'ll go to our breakout
rooms where we\'ll have lunch there and the International Committee is
at Room 742G and the Treatment, Care and Prevention Committee are 325A.
So the lunch will be provided to you there.

EXEC. DIRECTOR GROGAN: Treatment, Care and Prevention are together in
325A.

CO-CHAIR SULLIVAN: We are scheduled for reconvening at 2:15 p.m. Should
the committees finish earlier, we will indeed send word to the rooms for
reconvening here earlier. But the scheduled time is 2:15 p.m. Off the
record.

(Whereupon, at 12:02 p.m., the above-entitled matter recessed to the
breakout room for a working lunch to reconvene at 2:06 p.m. the same
day.)

A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

2:06 p.m.

CO-CHAIR SULLIVAN: On the record. I think the way we plan to proceed is
to receive the committee reports, there will be two reports, from the
Prevention and Treatment and Care Committee and with discussion and then
from the International Committee with discussion. So I think we
commence.

David, are you ready for your report? Then we will let Dr. Reznik give
us a report from the Treatment and Care and Prevention Committee.

(Pause.)

MEMBER REZNIK: Okay. Are we ready for motion time? I actually put up
Resolution No. 2 which really does deal with Dr. Saag\'s presentation
that we heard this afternoon. I don\'t think I need to read it out loud.
Actually, reading these out loud is sort of spooky. But if everyone
would take the time and let me know when they want me to go a page down
and then we\'ll go through edits.

(Pause.)

MEMBER REZNIK: There\'s been a request to read the \"Be it resolved\"
part. \"Be it resolved that PACHA strongly recommends that the President
of the United States and Secretary of Health and Human Services use all
means available including expanding existing programs such as the
National Health Service Corps for medically under-served specialties to
ensure that creative\" I didn\'t fix the sentence, sorry, \"to ensure
that creative solutions be found to address the shortage of primary care
providers properly trained to manage HIV disease consisting of but not
limited to the following:\" and there\'s a problem with the sentence
that I have to fix, we forgot about that, \"tuition reimbursement for
health care workers who choose HIV care in medically under-served areas,
recognition of HIV care as a medical specialty, incentives for more
nurses, physicians assistants, nurse practitioners and physicians to be
certified through their appropriate associations, ensure adequate
reimbursement for HIV care and promotional programs to increase the
diversity of health professionals trained in HIV care. Be it further
resolved, the Secretary of Health and Human Services put a team in place
including expertise in health care economics to consider long-term
solutions to address the shortage of qualified health care
professionals, nurses, physicians assistants, physicians and other key
providers of care throughout the United States.\"

That was in reference to Dr. Sullivan\'s comments that we heard earlier.
I do need to fix this sentence though.

MEMBER YOGEV: When you say \"shortage of health care professionals\"
specifically for HIV or in general?

MEMBER REZNIK: Our charter is an HIV advice so I would have to leave for
interpretation.

MEMBER YOGEV: I would just add it.

MEMBER REZNIK: But there are shortages in medical providers and nurse
providers.

MEMBER YOGEV: That\'s my point.

MEMBER REZNIK: So I think we\'re limited into what we can advise. I sort
of left that a little broad.

MEMBER YOGEV: What I\'m saying is just to allude to HIV because there is
a shortage all over in nurses for example and you want this specific in
HIV.

CO-CHAIR SULLIVAN: I would agree with David\'s focus that we\'re making
these recommendations as the President\'s Advisory Council on HIV/AIDS.
But I think there\'s a way we could perhaps address this that is
\"shortage of health professionals for care of AIDS patients\" which is
complicated by the recognition, the increasing general recognition of
shortages health professionals, in other words, somehow saying that this
is occurring within an environment of shortages, but we are focused on
the shortage for HIV care.

MEMBER GREEN: Can I ask a question just because it was raised earlier.
If part of the problem in recruitment is a disinclination for whatever
reasons to work with gay men, injecting drug users and maybe poor
African Americans, what kind of incentives would be needed to over come
that whatever that is, disclination?

CO-CHAIR SULLIVAN: Yes. If I could comment on that because what we heard
this morning also was a lot more than this. That is the inadequate
reimbursement for care that is the environment here that\'s creating the
problem here. So it seems to me that we were to have a sentence such as
\"better reimbursement for care and again streamlining the bureaucracy\"
because we also heard about the inordinate amount of time to have
prescriptions filled, etc. So the manpower issue is part of it,
inadequate resources to pay for care being another, but then the
environment in which these health professionals have to work with all of
the bureaucracy being another. So somehow it seems to me that we need to
recognize that as part of this resolution.

MEMBER YOGEV: I don\'t see where is the increasing number of patients
with the new policy of opt-out anticipated to increase 25 to 30. I
don\'t see that.

MEMBER REZNIK: I\'m sorry. I can\'t type and listen at the same time.

MEMBER YOGEV: I can\'t type. You see that\'s my luck. I don\'t see the
\"whereas\" and maybe it\'s hidden there that with the new policy of
opt-out the anticipated increase in 25 to 30 percent of HIV infected
individuals who are going to increase the burden acutely.  Is it there?

MEMBER SWEENEY: It\'s not there. It\'s an excellent point and we didn\'t
think of it. Thank you.

MEMBER REZNIK: How would you like me to word this? \"The CDC\'s effort
to identify those of unknown status.\" How would you like it?

MEMBER YOGEV: \"Whereas universal HIV testing is expected to increase
the number of HIV infected patients known to the system by 25 to 30
percent which increases burden.\"

MEMBER REZNIK: Did that type right? Yes, I see it. Does that address the
concern appropriately?

CO-CHAIR SULLIVAN: If I could make another editorial suggestion.

MEMBER REZNIK: Yes sir.

CO-CHAIR SULLIVAN: The next line where you say \"HIV medicine is not a
lucrative profession\" I would prefer it something perhaps as not a
\"well-paying profession\" because by implication this means that the
rest of medicine is lucrative. But some would argue with there, but
there could be other ways of saying that.

MEMBER REZNIK: Does that work if I delete? If I can find the delete
button and maybe I can\'t.

MEMBER BOLLINGER: David, scroll down just a little bit. I have a very
quick question about.

MEMBER REZNIK: Okay. Think on this one.

MEMBER BOLLINGER: It\'s right there. \"Be it resolved that creative
solutions be found to address the shortage of primary care providers.\"
Do we want to restrict that term of primary care providers? It just
seems to me that\'s B-

MEMBER REZNIK: Health care providers.

MEMBER BOLLINGER: I think we\'re talking about people who care for HIV
patients. It\'s not just primary care providers. It\'s specialists in
HIV care. It\'s a broader issue.

MEMBER REZNIK: I agree. There\'s the dental thing I left out for a
change. For those of you wanting to know this is dental plaque under a
microscope which I did have to get my dental thing out.

MEMBER SWEENEY: David, dental is primary care.

MEMBER REZNIK: I know. Who are you telling that to? Don\'t type that.
Okay.  Dr. Sullivan, did we address your concern because there is
something on B

CO-CHAIR SULLIVAN: Well, it\'s simply a phrase.

MEMBER REZNIK: And you want?

CO-CHAIR SULLIVAN: Near the bottom you say \"ensure adequate
reimbursement for HIV care.\" It\'s there but I guess for my view it
doesn\'t have sufficient emphasis because what we heard this morning I
thought was an environment in which the reimbursements are so poor that
it\'s affecting the whole system. So it\'s a question of emphasis here.
Is that adequate?

MEMBER REDFIELD: Just to follow up on that, I think that is the driver.

MEMBER REZNIK: So it should be at the head of the list.

MEMBER REDFIELD: I mean the fact that HIV care and treatment right now
doesn\'t provide the economic return to the system such that it\'s in
most centers it\'s a lead loser. So I think you want to emphasize that
that is the driver.  If we can correct the reimbursement issues related
to care and treatment that other things will follow.

MEMBER REZNIK: Okay. So I moved it but that doesn\'t mean we\'ve fixed
the language yet. So we only have \"adequate reimbursement.\"
\"Appropriate reimbursement\" or how would we like to? I\'m open for
suggestions.

MEMBER YOGEV: Incentivize.

MEMBER REZNIK: Incentivize reimbursement.

CO-CHAIR SULLIVAN: What about something like \"sufficient reimbursement
to cover costs of care\" because I think B-

MEMBER HOLMER: (Inaudible.) This is Alan Holmer. Including \"first and
foremost\" if everybody agrees it\'s the most important item.

CO-CHAIR SULLIVAN: Yes, I could agree with that because for those are in
the system now, that if we can get some relief, that certainly would be
it, whereas the manpower issue is going to take time to address. So it
seems to me the first thing is to try and keep the system that we have
now from falling apart by adequate reimbursement, but also streamlining
the system of the bureaucracy because it means we are wasting precious
manhours of time on bureaucratic things as we heard. So we could use the
people we have in the system now more effectively if we somehow got rid
of it and they didn\'t have spend all the time waiting for approval of
prescriptions on the telephone etc.

MEMBER HOLMER: So how about \"ensuring sufficient and streamlined
reimbursement\"?

MEMBER REZNIK: Well, I have it down here.

MEMBER YOGEV: You have the same language.

MEMBER REZNIK: This is a lot of pressure.

MEMBER HOLMER: You\'re up to it.

MEMBER REZNIK: You\'re seeing my computer skills or lack thereof. \"To
access medications\" because part of the bureaucracy is the reporting
requirements included in the CARE Act just so you know. That\'s part of
the paperwork that needs to be filled out on a daily basis for each and
every patient. Do you not find that the case?

MEMBER REDFIELD: No, it\'s substantial. It\'s substantial.

MEMBER REZNIK: So that\'s why if we just leave this \"bureaucratic
requirements\" but Michael was talking about was accessing ADAP or
patient assistance programs.

MEMBER REDFIELD: Yes, what drives most of us that are in this business
and have been in it like Michael is that B- And I agree with Michael.
There\'s no patient at the University of Maryland that\'s never got
access to a medicine that they need. But it\'s because people spend
literally hours to make sure that we are the thing of last resort and
what you\'re hearing from him is a frustration and I was going to get at
it and when you say \"whereas medicine is not well-paid medical
specialty\" the real frustration that\'s starting to crack for all of us
is that the allocation of resources meaning people, nurses,
administrative people that people in and out of the clinic, the system
is cutting them back and back and back because we\'re not profitable.

So now the one group that\'s not getting cut is the doctor because he\'s
responsible for his own salary. But what\'s happening now is you\'re
getting less and less support people. So even the good support people
are burning out and now choosing to quit because we\'re just
inadequately staffed and why are we inadequately staffed because
ambulatory HIV care and treatment and I mean ambulatory is basically you
cannot collect the resources required to run the business, bottom line,
even with substantial Ryan White support. Most of our clinics are
operating if you did a business pro forma on any of our ambulatory
clinics I think in this country, many of them are non profitable.

Just to editorialize while he\'s finishing, to give an example, this
year I literally had a 40 percent increase in clinic visits and for
that, the institution cut me 1.5 nurses. Okay. So a 40 percent increase
in workload and I lost 1.5 nurses.

MEMBER REZNIK: I added that.

MEMBER REDFIELD: I just started my 16-year-old daughter. She is working
there as a volunteer and you think I\'m kidding. She\'s there right now
as we speak.

MEMBER YOGEV: David.

MEMBER REZNIK: I actually just added something to maybe make it read a
little bit better which is B-

MEMBER YOGEV: You want to address the financial and bureaucratic
pressure.

MEMBER REZNIK: Right. So \"ensure creative solutions we found to address
the financial pressures placed on ambulatory HIV care and the shortage
of health care providers properly trained to manage.\"

MEMBER YOGEV: But it\'s not only the financial pressure. It\'s also the
bureaucratic pressures. That\'s what I\'m saying. Put \"financial and
bureaucratic pressures placed on\...\"

CO-CHAIR SULLIVAN: What about \"financial pressure and bureaucratic
obstacles\"?

MEMBER SWEENEY: That I get.

MEMBER JUDSON: We were just reflecting that there\'s probably an inverse
relationship between the length of a resolution and the likelihood that
it will have any impact and I don\'t know how simply you can get. One
might be that there is an emerging critical shortage of qualified health
care providers for HIV treatment and we would simply urge the Secretary
of Health and Human Services to address the problem and solve it, fix
it.

CO-CHAIR SULLIVAN: I think you could make a good argument for that
because the details of what are the mechanisms certainly the Secretary
and his staff are fully aware of what those mechanisms are. So I don\'t
think we necessarily have to spell those out. So I think that could
streamline it and keep the focus.

MEMBER REZNIK: And they actually are spelled out already in our
publication. That\'s where they came from, the blue book on page 38. It
wasn\'t something that we just thought up. So I literally can take that
out if there is agreement. Okay. Not agreement?

CO-CHAIR SULLIVAN: As long as you\'re consistent.

MEMBER REZNIK: Let\'s let Dr. Sweeney.

MEMBER SWEENEY: Just having all of the information in sort of one place
as long as we can keep it one sheet of paper, I think their attention
span might B- I mean I think they might have enough time to read one
sheet if it doesn\'t go over one sheet. But I think having the facts
there as we see them contributing to this problem and some of our
recommendations as long as we can get it on one sheet of paper, I think
it might be good to leave some of it in.

MEMBER YOGEV: I agree because if you just put general it just would take
a long time to get to what you\'re suggesting. It would be very
difficult to say no you cannot use that. So I agree we should leave it.

MEMBER McILHANEY: I just wonder if we couldn\'t do a simple resolution
and then have this an addendum to it because we gained a lot of
information today. Put a lot of that down in facts and it would be
information the Secretary probably wouldn\'t really have or his staff.

MEMBER REZNIK: Well, my argument against that concept just to give the
other side of the argument with Monica is (1) at least 80 to 90 percent
of what we have in here was discussed in previous iterations. The
diversity in the workforce was something that Dr. Primm had been
championing and that\'s they made it into our treatment and care portion
of our paper.

The other thing is there is something in here that Dr. Sweeney suggested
that\'s not in our paper that is quite unique and it is \"expanding
existing programs such as the National Health Service Corps for
medically under-served specialities\" because for instance the city of
Atlanta is not designated health shortage area but when it comes to
providing HIV care, we are. So B

MEMBER REDFIELD: One of the things B- I\'m sorry.

MEMBER REZNIK: No.

MEMBER REDFIELD: One of the things I just want to throw out because the
ultimate issue here is impact in terms of B- and I know all of us
that\'s what we\'re committed about and we\'re talking about whether
someone\'s going to get through this, one of the things we discussed in
the International Committee because we were trying to look at some of
the areas that were important and we\'ll talk about that when we get our
chance.

But actually Dr. Sullivan proposed and the committee really thought it
was an important thing to do is that the out-going chairs, themselves
and Anita Smith, would meet with the Secretary and articulate several
high priority issues. From my point of view of Secretary Sullivan went
to meet Secretary Leavitt and eyeball to eyeball articulated this
concern with the request that this committee had for him to address it
that would carry a lot. In my view that would probably carry a lot more
impact and it\'s something to think about because we were going to ask
him to do that on a couple of the international issues and I know he was
going to do that also on these domestic issues. So I don\'t know if he
wants to comment or other people would like to comment.

CO-CHAIR SULLIVAN: Well, I guess my comment would be this that I think a
lot of the details of this such as tuition reimbursement and expanding
the National Health Service Corps are things that really could be part
of a discussion because one of the things we want to be sure is that we
don\'t have our resolution hijacked by other people. So in other words,
I think on any number of these which are very meritorious we could find
the press somehow focuses on the Council recommends expansion of the
National Health Service Corps. Well, that will create its own dynamic.

So my thought is what we want to do is to be helpful in getting some
solutions. So that why my thinking was we could point what the issue is
in a general way in the resolution but then in the discussion, assuming
we have this meeting, we would then get into those kinds of discussions
as a somewhat private conversation with the Secretary. These are the
things that we think could be helpful as you look at this, etc.

MEMBER REZNIK: Okay. So any opposition to me hitting the delete button?
Well if there is opposition, I\'ll hear about it.

MEMBER REDFIELD: One of the things you could say then is \"Be it
resolved that the President\'s Committee,\" I don\'t know if you said it
earlier. Maybe you said it at the very beginning \"recognizes a current
and growing,\" you said that, maybe, \"recognizes a current and growing
loss of health care professionals\...\" and then you tell the Secretary
basically to solve it.

MEMBER REZNIK: And maybe we should move this particular bullet up a
little higher or do you like it where it is?

MEMBER YOGEV: That should be the second bullet. The first one is exactly
what I thought Dr. Redfield is suggesting, instead of a developing
crisis already in taking care of those patients and whereas 25 is going
to be added and then everything else. But there is no sentence that
there is a developing crisis, an emerging crisis already.

MEMBER BOLLINGER: I don\'t know. Again, we want to keep it short. Dr.
Sullivan raised the issue about the administrative, the bureaucratic
hassles. I mean do you want to have a whereas there that basically lays
that out as an issue or is that something that gets discussion
privately?

MEMBER REZNIK: I could put \"already overburden system of care\" but
that\'s going to raise flags or two.

PARTICIPANT: Bureaucratic barriers B-

MEMBER REZNIK: That\'s in there. I think we have that.

PARTICIPANT: (Inaudible.)

MEMBER REZNIK: It might not be a whereas but it\'s definitely in the
\"be it resolved.\"

CO-CHAIR SULLIVAN: I think it might be helpful to have a whereas related
to that because this is one of the fundamental issues here and you also
say that if the Council agrees with this strategy, I would like to be
sure that all of these details I would be given those. So I don\'t want
to have the meeting with the Secretary and then walking out his office
and remember the four things that we forgot about. So I think the help
of this Council in really being sure we have those issues.

MEMBER REZNIK: Any thoughts?

MEMBER BOLLINGER: I would suggest using the term like \"cost
effectiveness\" or \"bureaucratic obstacles reduce the cost
effectiveness of the current investment in HIV care.\"

MEMBER REZNIK: Okay. \"Reduce the cost effectiveness of\...\" Is that
right, Bob?

MEMBER BOLLINGER: That\'s fine.

MEMBER REZNIK: That\'s fine.

MEMBER YOGEV: Will you have the \"it\'s a developing crisis already,
emerging crisis\"? Just use the \"Whereas, there is a complicated
disease. Whereas already the HIV care system is an emerging crisis.\"

MEMBER REZNIK: I mean it could be worded into this sentence if there is
a desire to add that. I think the universal text is we could put \"into
an already overburden system.\"

MEMBER YOGEV: But put it by itself. This is the message we got today
that there is a crisis.

MEMBER REZNIK: We have a message from one clinic.  Is that B-

MEMBER YOGEV: No. Everybody agreed. I mean the clinic here we agreed.

MEMBER REZNIK: I mean if we say that there is a crisis and in the next
motion we have left out a funding issue, then I\'m finding a conflict in
what we\'re saying. Is there a consensus that there is an emerging
crisis in the management or are we in a crisis already or are we
expecting a crisis? I mean I know we\'re overburdened. There is no
question about that.

CO-CHAIR SULLIVAN: I think it\'s a question of definition. I think it\'s
fair to say that in some areas of the country we do have a crisis.

MEMBER REZNIK: Okay. And somebody is going to have to help with this
one.

MEMBER YOGEV: Put it before the 25 percent.

MEMBER REZNIK: Ram, I\'m going to have you come up here and do this any
second.

MEMBER YOGEV: Then you will sit here until 10:00 p.m. because my skills
are even less than yours.

MEMBER REZNIK: \"Whereas\...\"

MEMBER YOGEV: What it is already.

MEMBER REZNIK: No, I need help with the writing. Don\'t think you\'re
going nowhere here.

MEMBER YOGEV: Sorry. Because can we raise toward the end an issue I
discussed with a couple members of the Council about response to our
resolution. We produced the resolutions. They are going somewhere. Some
of them are not reflected and there is no accountability from what we
recommend why they were not accepted, what was the reason. It might be
political. It might be no reason. Is there any mechanism that we can
develop to hear back what resolution we worked so hard to develop?

EXEC. DIRECTOR GROGAN: It\'s a legitimate concern but there is a couple
things with that. If say for this resolution, there\'s a mechanism in
place to get a response. Guaranteed the first response is going to be
form letter because so many of these things take so much time. So the
first mechanistic bureaucratic response would be we received the
resolution and we\'re considering it and then what does that get you? So
many of these things either have to take place over a number of months
or six months or nine months and it\'s my personal opinion that the best
way to deal with the resolutions and your feedback is to have the people
who are responsible those decisions come back and report to the Council
when they\'re ready to do it and then you have the Executive Director
follow up personally.

The resolutions do go the Secretary, but frequently more importantly
they go to the Secretary\'s staff responsible for putting the policy in
place. So you\'re absolutely right to expect that people take these
seriously and that they should come back and report, but if we set up a
process by which we demand a response, it doesn\'t necessarily do
anything for us and frequently can hurt our efforts more than not
because the first response will be we sent a letter. Let\'s not deal
with this issue. When what should happen is we keep pressing until we
get an action on the resolution, somebody reporting back to us in a
subcommittee or in full committee about why this is taking place or not
taking place.

MEMBER YOGEV: I\'m 100 percent in agreement with you, but we don\'t have
this mechanism and we should say okay this is the resolution and we come
to you on this one. We expect a response from the staff or check on it
in six months. So our agenda will start \"Welcome to\...\" and part of
our agenda will be resolutions X, Y and Z are now here, there and there
or not moving.

EXEC. DIRECTOR GROGAN: I can do that. I mean if you want me to report
back at a certain B-

MEMBER YOGEV: Not a letter.

EXEC. DIRECTOR GROGAN: No, I know. If we want me to make sure that you
get a response at a certain time, maybe for some resolutions it\'s
important that you get a response back in one month, other ones three
months, other ones six months. I\'ll be happy to follow up on any one of
those.  But if you want to set up a defined mechanism, I would think
that that\'s a bad decision.

MEMBER YOGEV: No, exactly what you just said. That\'s a mechanism. You
come back in a month for example. You work very hard on this universal
testing of newborn whose mother\'s B- and specifically to talk to CDC or
whatever. They will start out for a political reason which I totally
understand. Nothing happened as far as we know. Maybe it did. So this is
one for example that it will be within a month or three months and you
need to announce it because it\'s coming out. This one may be a little
bit longer and I leave it to you to make the decision. But to come back
to the Council, let them know great, not so great, failed so we know
where we are.

EXEC. DIRECTOR GROGAN: I\'m happy to report back to you on any
resolution passed by the Council on any subject matter and the full
committee. I\'m happy to do it and follow up with anything you want me
to do.

CO-CHAIR SULLIVAN: Joe, let me comment on this and really get your
reaction. Certainly, there is a mechanism in place and that includes
your responsibility. The idea that we talked about in the International
Committee was to really have a mechanism to alert the Secretary that
these are some of the real concerns of the committee here in really a
friendly way, not in an accusatory way and to not interfere with the
process. But when we talked for example on the Ryan White funding as I
mentioned to the group, from what we heard I\'m not sure that Congress
is going to really finish that this year.

So whether having a discussion with the Secretary to express to him in a
way that we would not want to in a resolution which is a public
document, some mechanism of bringing this to his attention and by
extension bringing this to the attention of all of those people who
would be reacting and responding to the resolution, we saw that as a
way, hopefully a positive way of saying we have some real issues here
that we think that deserves some significant attention and these are
they and we want you as Secretary and if Mark Dybul should be a part of
that meeting and you to be aware of this, at least the Council has these
concerns we wanted to share with you in a way that we would not want to
do in a resolution. So that\'s really I think the thinking is.

EXEC. DIRECTOR GROGAN: Yes. I think that\'s a great approach and I spoke
with Dr. Redfield about that briefly that it would be a good idea for
you and Anita and maybe the incoming chairs, all four, to go and meet
with the Secretary and Mark Dybul and whoever else is appropriate on the
domestic front to discuss what the major concerns of the Council are and
have a little bit of a discussion back and forth and I can work with you
to make that happen.

MEMBER REZNIK: That gives continuity actually as well. I think B-

CO-CHAIR SULLIVAN: David, could I make one other quick suggestion?

MEMBER REZNIK: Yes sir.

CO-CHAIR SULLIVAN: And that is universal testing. I would suggest we use
the word \"expanded testing\" or something like that simply again
because we put universal in. That\'s going to set off some other
reactions here which we don\'t want to get into that fight.

MEMBER REZNIK: Okay. What about the title because I think that\'s a
little on the red flaggish too? Well, I had to change the title because
we basically changed the motion. \"Pending Ambulatory.\" \"Impending.\"
\"Emerging.\"

CO-CHAIR SULLIVAN: I think \"emerging\" would be appropriate because it
is a crisis already in some areas and others it\'s not. So nationwide,
this kind of covers the waterfront. Sure.

MEMBER REZNIK: Okay. Let\'s everyone take a look at the order, what\'s
in there, as we\'re soon going to vote on this one and put it to bed or
on its way to the Secretary.

MEMBER SWEENEY: This is the one I think I was talking about when we were
in our subcommittee. It\'s in the, I think, fifth \"whereas\" last two
words, three words, \"improving the quality of an access to effective
HIV medical care\" and that\'s the one I was talking about.

MEMBER REZNIK: Where are you? I\'m sorry. Third okay.

MEMBER McILHANEY: Whether or not we wanted to say \"medical care\" or
\"health care.\"

MEMBER REZNIK: Okay.

MEMBER SWEENEY: Because we want nursing, nutrition, social workers,
everybody.

MEMBER REZNIK: Health care.

MEMBER SWEENEY: Yes.

MEMBER REZNIK: I think we decided to use health care throughout.

MEMBER SWEENEY: Yes. Okay.

MEMBER REZNIK: I just missed that one.

MEMBER SWEENEY: Thank you.

MEMBER REZNIK: Big eyes, but they need magnification these days and we
did shorten the \"Be it resolved\" when you were out of the room. You
might want to look up, Monica. We shortened the \"Be it resolved\" while
you were out of the room.

MEMBER SWEENEY: Yes.

MEMBER REZNIK: Okay.

MEMBER SWEENEY: I don\'t know if we\'re voting exactly or not but I
think we\'ve wordsmithed this an awful lot and if we keep on, we\'ll
never finish so maybe we should call the question.

MEMBER REZNIK: I call the question. All in favor? Raise your hand or say
aye or whatever.

(Chorus of ayes.)

MEMBER REZNIK: Anyone opposed? If you are B-

(No response.)

MEMBER REZNIK: Great. We can save this one. It has the wrong title.
Shoot. This is one, isn\'t it?

PARTICIPANT: Two.

MEMBER REZNIK: Two. Okay.

PARTICIPANT: (Inaudible.)

MEMBER REZNIK: No, I probably did. We want to thank Troy for use of his
B- This is a short one. I need to make it bigger so you all can read it.
I got it.

PARTICIPANT: It\'s a little hard to read.

MEMBER REZNIK: Not anymore. Do you need the dark to read it or is it
showing up? I can\'t see.

PARTICIPANT: (Inaudible.)

MEMBER REZNIK: The need to this resolution is that we\'re trying to get
it done this session because we all heard Marty\'s words that if it\'s
not done this session the bicameral/bipartisan administration process
collapses.

(Discussion off microphone.)

MEMBER BOLLINGER: Could I ask? What were the concerns, David, about B-
Obviously, we don\'t want to say anything specific about the funding but
there is no mention whether the funding is adequate, inadequate?

MEMBER SWEENEY: Tell him B-

MEMBER REZNIK: You tell him what you did. I\'ve had the fun of getting
things in there.

MEMBER SWEENEY: We had a big discussion in our subcommittee meeting that
if we started dealing with what was flat funded, what was 3.7 and how
the funding was to be changed or what we\'d like to see changed that it
would muddy the waters and we would possibly delay the chance of us
getting it out of authorization this session. So we decided to take it
out.

MEMBER BOLLINGER: So what you decided to take out was specific
recommendations, but what about a general comment about the level of
funding in light of what we just heard about the change in, I mean, just
the overall level? Bob, you should really be the one to comment since
you know more about the practicalities of this.

MEMBER REDFIELD: I guess there are two issues I should of agree with.
With Monica obviously from a starting over point of view, I would like
to see a lot of changes. The reality I think is if we suggest any
changes that we\'re going to guarantee that this bill doesn\'t get
passed. So I think even though it\'s hard, that\'s why I kind of read it
and don\'t fully support the bill, but it doesn\'t say that I fully
support the bill. It said I fully support the authorization during this
Congressional session and I think if we start to suggest that they\'re
not close to the goal line those people who want to block it and I gave
you my perspective on where I think that\'s going will just use it.

MEMBER REZNIK: And we actually heard that there are certain things that
are being negotiated at the last minute that the Appropriations
increases are not and if it were earlier in the process, I might have
fought harder, but we\'re at the end game. We\'re trying to get the ball
over the goal line for you football fans from the south here. Go Gators.
Any suggestions?

MEMBER BENAVIDEZ: David, the reference to the House and Energy Commerce
Committee I think limits the time frame that this resolution is
effective. I mean if it\'s not acted upon soon or there\'s a change of
committee assignments. I mean to me it seems very limiting by putting
that reference in there.

MEMBER REZNIK: So?

MEMBER BENAVIDEZ: I would just remove the whole \"Whereas, Energy and
Commerce Committees\" and it may be said \"Whereas the Congress is
currently considering it.\" Leave it more broad.

MEMBER REZNIK: So you would like me to take this out. Let\'s see if we
have agreement on this. Some info in here I don\'t think would hurt
because many of the -B We didn\'t get everything we wanted or everything
that we talked about but a lot of what we did talk about as a Council is
included. I think that we should incorporate some of that. But the key
is we want this to be done with. Yes sir.

CO-CHAIR SULLIVAN: I just have one suggestion. I would B- That next to
the last B- Well, the last \"whereas\" the last line, I would delete
everything after PACHA because you\'re already said this is consistent
with the recommendations made by the Advisory Council and the President
has mentioned that because then I think that takes a little out of the
potential for being seen as a political document.

MEMBER REZNIK: Okay. Questions? Concerns? Monica.

MEMBER SWEENEY: Maybe we can find out which Congressional session we\'re
in. Is it 112th?

CO-CHAIR SULLIVAN: It\'s my understanding from Mosa yesterday that if
this doesn\'t pass this time it will start all over.

MEMBER SWEENEY: I know but I just wanted the number in there.

(Several speaking at once.)

MEMBER SWEENEY: This blank, blank specifically put a number in there.

MEMBER REZNIK: During the 201st or whatever.

MEMBER SWEENEY: Something. Yes.

CO-CHAIR SULLIVAN: Well, I don\'t know.

MEMBER REZNIK: It\'s not summer session. I think Congress B-

PARTICIPANT: Whatever session.

DR. WASSEF: Whatever session. Whatever number it is.

CO-CHAIR SULLIVAN: Why don\'t you just say \"conversation in 2006.\"

MEMBER REZNIK: I like putting in the number.

MEMBER SWEENEY: Joe said he would fill it in if we would like.

MEMBER REZNIK: During the XXX and it would then be Congress. Right?
Wouldn\'t it? The 231st Congress. Isn\'t that how it should be worded or
is it session?

MEMBER YOGEV: Put it during the \"current XXX Congressional session.\"

MEMBER REZNIK: Well, the current B- Okay.

MEMBER HOLMER: We\'re in \"The second session of the XXX Congress\"
whatever it is.

MEMBER REZNIK: \"During the Second of the XXX Congress.\"

CO-CHAIR SULLIVAN: I suggest we get out of the bureaucratic mode and let
our staff fill it in.

MEMBER REZNIK: Not a problem. I\'m just getting the outline for them. Is
that good? We have the intent. Are we all in agreement? I called the
question. All in favor say aye and raise your hands.

(Chorus of ayes.)

MEMBER REZNIK: All opposed?

(No response.)

MEMBER REZNIK: That ends the Treatment, Care and Prevention section
motions.

(Applause.)

MEMBER YOGEV: (Inaudible.)

MEMBER REZNIK: I run a very large website.

CO-CHAIR SULLIVAN: Why don\'t you go ahead?

MEMBER REDFIELD: Thanks. Just an update on the International
subcommittee. We really addressed and discussed several issues, but
really focused down on two and as I mentioned before, the question was
really how to proceed. I think the group as a group didn\'t feel at this
stage any particular resolution would necessarily be required but rather
what we proposed is really first focused on in a fairly focused way in
the International committee the importance of the current PEPFAR program
and in particular, the importance as we can see from our domestic Ryan
White situation with the reauthorization on the PEPFAR reauthorization.

So in that context in the discussion, Dr. Sullivan suggested and the
committee concurred that as the outgoing chairs, himself and Anita Smith
would meet with the Secretary and in the context of that underscore
PACHA\'s view of the importance particularly of the PEPFAR program from
the point of view in particular the reauthorization process and that the
committee would, PACHA would, be happy to provide assistance
particularly if the Secretary would find it helpful to do a strategic
review of some of the critical issues related to the PEPFAR as would
pertain to the potential reauthorization process particularly focusing
on structural issues, impact assessment issues and balance of funding
issues. So really that was the discussion. It\'s the plan of the
International Committee to begin to try to address some of these issues
as we move forward and it\'s the anticipation that the Secretary\'s
office will find the input something that would be helpful and therefore
request it. I don\'t know. Dr. Sullivan, do you want to comment any
further on that?

CO-CHAIR SULLIVAN: No, only that it seems to me that if we were to have
this discussion it really would be with the purpose of saying to the
Secretary these are issues which we are very concerned about. We want to
bring them to your attention. We would like to offer our assistance to
you if this would be helpful, to really to offer to try and help get out
in front of some of these things and as I was saying earlier, we could
really have some of the detailed issues here and of course, we will have
these resolutions here to form the basis for our conversation.

So I can\'t speak for the Secretary but I would think that he would find
this kind of discussion helpful because we\'re dealing with a lot of
difficult issues. He\'s dealing with the tug of war between what the
President wants to do and what the Congress is willing to do and other
issues like. But the purpose of this would be really to say to the
Secretary we are concerned about these. We want to be helpful to you if
you see that the Council can be in trying to address issues in an
effective way. So that\'s really the spirit of the discussion that we
had.

MEMBER REDFIELD: And then the intent would be really to take the lead
from what the committee had done in the past from the document that was
prepared. It was suggested that we would go forward and hope by the
first quarter of 2007 to have an Executive white paper that PACHA could
prepare with really addressing some of these key issues and proposed
analysis or input from them that could then be used as a helpful
document to move forward with this reauthorization process.

I think the clock is ticking. My own assessment would be that this has
to be locked out about 18 months before the program is over. So 18
months from the time the program is over is about the summer of 2007. So
the reauthorization process really needs to be moving forward pretty
aggressively in the spring, summer and fall of 2007.  So that was really
the first action item that we thought we\'d pursue and again pending
feedback that Dr. Sullivan and Anita Smith gets from the meeting.

The second issue that was raised and there was some discussion about
whether we had a resolution or whether we got more information and tried
to move this forward potentially with the opportunity for a resolution
or inclusion in this white paper is the concern that continues to be
recognized of the persistent limitation of the availability of
antiretroviral therapeutics particularly for children that require
alternative formulations from the adult formulation. And again the
Committee was encouraged by the First Lady\'s recent announcement and
facilitating the gathering of really a number of the pharmaceutical
companies in our country as well as the generic companies to meet
together to begin to try to create innovative ways to address this
requirement.

So at this stage rather than have a distinct resolution, there was some
discussion. The commitment was to work together, Joe, to try to get sort
of an update. I know the original meeting of the group was in late April
and there was a follow-up meeting trying to get a sense of where that is
and then determine if there\'s a way that we can help just reinforce
that process to sort of continue to highlight the need to move forward
with given access to these medicines and the pediatric formulations. So
those really were the two areas of discussions and summary in the manner
in which the group as a group decided to proceed. I don\'t know if there
is anybody else from the committee who would like to make a comment.

MEMBER YOGEV: Just that we agreed I presume to discuss a decision,
identify an expert and discuss the issue at the next meeting.

MEMBER REDFIELD: Yes, Ram bought a third area that we did bring just in
general just for the topics for discussion coming up at the next public
meeting was there was significant discussion as there was in our
previous conference about the whole issue of circumcision and what its
role is as a prevention strategy and the recognition that it would be
extremely useful like at this meeting where we had some different issues
raised to try to look and identify many several individuals that may
come different points of view to come present these issues before the
committee.

CO-CHAIR SULLIVAN: Thank you very much. Any questions or comments?
Discussion? Is everyone comfortable with the proposal? Then we\'ll
proceed according. I\'d like to go back to the Prevention and Treatment
Committee to raise a question to David. Two of the issues we talked
about yesterday was the problem we heard about in our prisons and did
you decide to defer that? Now that was one and then the whole issue was
the college B-

MEMBER REZNIK: The colleges we decided to defer. These motions were
written pretty quickly as I think everyone could tell and the college
issue is a very sensitive issue and we wanted to make sure that that one
is managed appropriately. I think we have probably enough knowledge to
write it, but we also want to make sure that it\'s handled in a fashion
that won\'t cause a greater problem I think is the most appropriate way
to word that.

And the prisoner issue actually does need to be addressed as well.
We\'re talking about an issue that\'s addressed that\'s seriously
impacting an important community especially in the south. So considering
that we had an one and a half to write the motions, I think that it was
very difficult for us to come up with something quite that quickly.

With that being said, I think we can be more prepared after hearing the
testimony and having our books. I think that we can write during off
period and have something ready to go, but it\'s a very sensitive issue.
When it was first brought up, I remember there were some who were very
concerned that it would be only associated with HBCUs and it really
wasn\'t. There were other schools that were involved but we do know that
it\'s impacting African American youth and we do know it has to be
addressed.

CO-CHAIR SULLIVAN: Okay. Thank you very much. Any other issue to come
before the Council? If not, then I think that concludes our business and
as I said earlier, it\'s been a pleasure to work with all of you and
also thank my fellow outgoing members of the Council, Monica, Anita and
Joe. It\'s been a pleasure to work with all of you. I certainly have
learned a lot during this process and thank you for helping educate me
on this process and, Joe, thank you for great support and your staff and
we\'ll certainly see if we could be helpful by hoping for a meeting with
the Secretary. The meeting is adjourned. Thank you.

(Whereupon, the above-entitled matter was concluded at 3:10 p.m.)