Pages 1 thru 157

  

TRANSCRIPT OF PROCEEDINGS

NATIONAL COMMISSION ON

ACQUIRED IMMUNE DEFICIENCY SYDROME

* * *

Washington, D.C.
March 16, 1990

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NATIONAL COMMISSION
ON

ACQUIRED IMMUNE DEFICIENCY SYNDROME

FRIDAY, MARCH 16, 1990

9:15 a.m.

Pan American Health Organization
Meeting Room B
525 23rd Street, N. W.

Washington, D. C.

 

 
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COMMISSIONERS PRESENT:

| JUNE OSBORN, Chairman

DAVID ROGERS, Vice Chairman
DIANE AHRENS
SCOTT ALLEN

HARLON DALTON

EUNICE DIAZ

DONALD GOLDMAN

DON C. DES JARLAIS

LARRY KESSLER

CHARLES KONIGSBERG

BELINDA MASON

EDWARD D. MARTIN (Representing Richard Cheney)

IRWIN PERNICK (Representing Edward Derwinski)

JIM ALLEN (Representing Louis Sullivan)

STAFF PRESENT:
MAUREEN BYRNES, Executive Director
CARLTON LEE, Chief Liaison Officer

THOMAS BRANDT, Director of Communications

 

 
CONTENTS

@ AGENDA ITEM: PAGE
Chairman’s Overview 5
Commission Initiatives and Legislative Update 59
Working Group Report: Social/Human Issues 89
General Discussion 131

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PROCEEDINGS
[9:15 a.m. ]

CHAIRMAN OSBORN: Let _me call the Commission to
order.
I understand that two or three of the Commissioners
will be here shortly, but I think we probably ought to start,
in the interest of time. And let me make a couple of
inquiries while we’re getting ourselves launched here. I’ve
talked to some, but not all, of the members of the Commission,
but I get the sense that we would all be less tense about our
late afternoon schedules if we ended no later than 2:30, but
possibly even by 2:00, depending on how we can get work to go.
I know that when I have a tight schedule, I start
thinking about it rather than what I’m doing toward the end.
T mean, if we loosen people’s constraints a little bit, that
may be helpful. So let’s aim for 2:30, at the latest, and
even sooner if we were all in agreement about some things. I
don’t think that’s unrealistically, actually, because we've
got things that we can do quite efficiently.
We'll get to the working group summary as a first
item of business after I take a very brief period--I don’t at

all intend to take the time that’s on the agenda there--to

 

 

 

 
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bring you up to date on a few things that have been happening
on the biomedical side of things, which I had said that I
would do from time to time and which I thought would be of
general interest. I will do it very briefly, but we can
pursue anything that people are interested in.

As a general plan, then, we have three tasks, I
think--maybe four, if you want to count it--that we definitely
want to accomplish today. We want to finish the discussion
from yesterday of the report that Chairman Ahrens and her
group had put together and which has been discussed at quite
good length.

We want to talk about the next working group
report, which we inverted, and I think that we can get that
discussion started. It may go very smoothly. If, however,
we run into the kind of situation that we did yesterday where
some redrafting would be of help, we may break into that
discussion and have some redrafting done while we then turn
to a major additional item, which is both dates for future
meetings, sites for visits and discussion of that in the
context of meetings, and agenda and work plan issues that we
have begun to discuss.

I think those are very important goals to achieve

 

 

 

 
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during this meeting, and we, as we mentioned yesterday, had
purposely scheduled the work for today to be largely inclusive
of those issues because it has been so packed in what we’ve
done up until now that we haven’t had a chance to think about
those things as a group.

So those are my goals. I would hope by the end of
the day that we would have proceeded to an appropriate point
in all of those matters. Some of you have made inquiry about
the financial circumstances, and so on. I think at lunch
I’1ll ask Maureen to bring us up to date on that, too, I think
in an informal way today because there will be some formal
material available at a later date, but we will touch on that
as well.

Okay. Does that sound reasonable to everybody as a
general plan of work?

Belinda, I was saying that we will see if we can
try and finish up by 2:30, at the latest, and possibly 2:00,
in order to loosen up the deadlines that people are facing.

COMMISSIONER MASON: I’m sorry, June. I got caught
in a crossfire. It was Don Goldman’s fault.

CHAIRMAN OSBORN: It was Don Goldman’s fault?

COMMISSIONER MASON: Yes. I’m really sorry. I

 

 

 

 
 

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lost my watch this morning, and that’s why I’m late. I’m so
neurotic, I couldn’t leave until I found it.

CHAIRMAN OSBORN: Did_you find it?

COMMISSIONER MASON: Yes.

CHAIRMAN OSBORN: “Good, good.

COMMISSIONER MASON: It made my day. It put a
whole new light on the situation. It’s going to be a good
day after all. I found iy watch.

[Laughter. ]

CHAIRMAN OSBORN: Well, it’s very pertinent because
I was just saying that for people who were feeling some time
pressure in travel, we might try and finish by 2:30, at the
very latest, and even 2:00 if we were all well behaved--.
COMMISSIONER MASON: Okay.

CHAIRMAN OSBORN: --in order to take some of the
pressure off people who have tight connections.

David.

VICE CHAIRMAN ROGERS: Could I add one other thing?
June and I talked about it this morning, and I think with the
general discussion we’ll try and move in, also, to all of the
suggestions that we discussed yesterday about issues you’d

like to see, how you’d like to see priorities set, moving

 

 

 
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toward the development of that work plan that we’ve agreed
will be coming back.

CHAIRMAN OSBORN: Okay. Under what is billed as
the Chairman’s report, what I wanted to do was to--rather
than billing it that way, you might want to say my individual
report because one of the things that we talked about early
on was trying to keep track of things both at the Institute
of Medicine and in the U.S. Public Health Service; in
particular, the FDA and NIH. There have been a series of
interesting meetings that I thought you might like to know
had happened, and then we can discuss the content to the
extent you like.

First of all, so far as the Institute of Medicine
is concerned, there are, I think, six different activities
that they have going on in various stages of activity or
completion dealing with AIDS, and one of those had been an
oversight committee, an AIDS oversight committee that was a
continuation of the Confronting AIDS group from 1986. There
was a group that followed along and put in an updated report
in 1988, both of which have served as a very valuable
resource, I’m told from people all over the world, actually,

but certainly in this country.

 

 
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Dr. Ted Cooper had been chairing that, and they had
continued the existence of the AIDS Oversight Committee until
our Commission got established. This kind of a Commission
was one of the major recommendations of the original report
and it was reiterated in the ‘88 report.

I was somewhat startled. I guess we should all be
pleased that when Maureen and I then met with them for what I
thought was going to be an ongoing set of meetings to keep in
touch between our Commission and IOM activity, they happily
announced that they were now dissolving the AIDS Oversight
Committee because we existed and they were very happy with us.

So the Institute of Medicine’s AIDS Oversight
Committee is no more. We have, in that rather formal way and
in several informal ways, been tossed the ball, as huge as it
is, in all of the kinds of areas that we’ve been focusing on,
actually. I mean, it has all happened. It’s just that we
didn’t know that’s what was happening.
In the areas of health care, access to care, a lot
of the social dynamics of the epidemic, the human issues--all
these things that we have been talking about, we are now
looked to by the Institute of Medicine for the leadership in

that area. So it’s good news; a little awesome news at the

 

 

 
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same time. So, that is one set of meetings, and that
dispenses with one committee.

IOM does have several_other committees, and they
have very persistently and devotedly asked for participation
and we’ve been trying to do that. Maureen, sometimes
Carlton, and I have tried to be at most of the stuff that has
gone on, and they have been making some good progress that I
wanted to tell you about.

Now, there’s been a new committee formed at the--
well, let me go in order here. The AIDS Program Advisory
Committee to the National Institutes of Health had one of its
meetings. Each year, they do kind of an updated overview of
what they stand and what they’re doing, and they did that
again on December llth and 12th at the NIH.

Out of that comes mostly a base-checking so far as
they’re concerned--where do they stand, and does everybody
who is listening think that they have been covering bases
pretty well; are there things that aren’t being discussed in
the research planning that’s going on, and so forth.

That kind of activity is more for an internal
cross-check for them, and I don’t think had--at least the

portion of that that I heard didn’t have anything that you

 

 

 
 

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wouldn’t already know from either press coverage or journal
coverage or our discussions. So, while it did happen, I
don’t think that was so newsworthy.

There were a couple of meetings dealing with the
so-called parallel track that are of considerable interest,
and those were the ones I thought you’d like to know the most
about.

First of all, the FDA has created a new Anti-Viral
Drug Advisory Committee, and that had a meeting a few weeks
ago in which they reviewed the data. Some of you have heard
the complaint that the data concerning early intervention
therapy for people with early symptomatic disease and then
for people with asymptomatic disease--that those data had not
been published, and indeed still have not been published in
readily accessible form.

But in an effort to try and bring that process
along faster without journal publication dates in mind, there
was a first meeting of that group, of the Anti-Viral Advisory
Committee, back in January, I guess it was, in which those
data were reviewed, along with the early indication that
there was a very low level of carcinogenicity of AZT--I'll be

happy to talk about those things--but then mostly the data

 

 

 

 
 

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concerning the effect of using AZT either early in symptomatic
disease or in asymptomatic disease.

In addition, at that meeting for the first time the
earliest experience with didioxyinticine, DDI, was presented.
And following right along from that there was a meeting at
the beginning of this week, now put on by the Institute of
Medicine Drug Vaccine Roundtable on AIDS that was created to
try and make sure that was moving along.

Those data were re-presented with quite a bit more
information and, of course, with the stimulus of last
weekend’s news stories, and I thought you might be interested
in a summary of where that all stands from the vantage point
of those two discussions now, both the FDA discussion and
then this Monday-Tuesday meeting at the Institute of Medicine.
I’1l get back to that as the main thing I thought you'd like
to hear in more detail.

In addition, there is a vaccine advisory group.

The Institute of Medicine has one going; there’s an FDA one.
The Institute of Medicine had a very detailed meeting, a very
intense, detailed scientific meeting about the status of AIDS
vaccine research not too long ago, out of which came the

general conclusion on the part of all there that while there

 

 

 

 
 

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has been some progress with the simian model, that progress
is very limited.

And instead of being back to the drawing board,
we’re on a new drawing board, but no further than that in
terms of vaccine development. Again, if you’re interested,
I’ll be glad to talk that through a little bit more. But I
thought for sure you'd be interested in a brief summary of
what was Monday and Tuesday, and let me just do that and
then, please, I’d be happy to talk in more detail about some
of the other things.

So far as Monday and Tuesday were concerned, the
experience--well, first of all, the data with AZT which have
been dealt with in the press have been well dealt with in the
press. There is good evidence that you can extend the well-
being of people with either early symptomatic or, even more
SO, asymptomatic HIV infection by the early deployment of AZT.

More interestingly in some ways, using doses that
are about one-third of what had been the dose that was
experimented with and prescribed as sort of the legitimate
dose for treatment of very symptomatic people--that’s about
15, 1,600 milligrams--going down to 500 milligrams a day,

still spaced in fairly short segments, but nonetheless at a

 

 

 
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much lower milligram-per-dose level and, of course, dollars-
per-dose level, you could achieve not only the same effect,
but markedly drop the toxicity.
It doesn’t eliminate the toxicity, but it brings it
down to a level where probably AZT is more tolerable to more
people. It very substantially cuts into the severe hemato-
logic toxicity which had many people who could otherwise
tolerate the drug having to have repeated blood transfusions
in order to tolerate it. |

Of those roughly half who could tolerate the drug,
about a quarter would end up having to be repeatedly trans-
fused to overcome the toxicity for the bone marrow. That
actually has also been helped and is en route to being helped
by the development through biotechnology of a synthetic
Substance called erythropoietin, which is now on its way, is
licensed for use in people with renal failure, and that
process is moving along so that it can be available to
overcome the bone marrow effects that both HIV, but also AZT
have.
So, while that is less far along in terms of
recommendations, it is happening, and so for a couple of

reasons AZT is becoming more usable in terms of its toxicity

 

 

 

 
 

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and ways in which it can be used.

COMMISSIONER ALLEN: I was wondering, was there any
discussion about the potency level and the range of how long
it remains potent?

CHAIRMAN OSBORN: There’s been a lot of discussion
about the wearing-off of the AZT effect. From my vantage
point as a once-upon-a-time virologist, the most important
part of that discussion is one of the development by the
virus of resistance to the drug, and that is something that I
think should concern us.

There are fragmentary bits of information right
now, but what they say is that in people who have been on the
standard kind of AZT for serious disease, in a couple of sets
Df studies if you take the virus from them late in treatment
and when they are not doing so well on AZT anymore, all of
the doses needed for those virus isolates to inhibit them
will have increased greatly.

So, in essence, the amount of drug necessary to
inhibit the virus is now much greater, which is a definition
bf resistance on the part of the virus itself. That has not
yet been closely correlated with the observed clinical effect

that if you have somebody on AZT for a couple of years, which

 

 

 

 
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is between one and two years, they stop having beneficial
effect from it to the extent that they had before or maybe
altogether, which is what you’re asking about, which has been
referred to as clinical resistance.

The correlation is only a correlation, and whether
that is occurring because the virus is resistant or because
you’ve worn out something else is not yet established. So
the phrases are a little bit too close in connecting them.

It may turn out that that’s the mechanism, but that hasn’t
been established so well.

A thing that worries me a lot, especially if DDI
Should turn out to be less optimistic than we think, is that
even in people on asymptomatic or early symptomatic therapy,
if they are in treatment for a long period of time and you
start taking virus back from them, to some extent consistent
with dose but not invariably, you’ll start finding two or
three out of ten people will now have virus that has increased
its tolerance, if you like. It takes more AZT to inhibit it
by a factor of three or five than it did before.

We’re playing so close to the tolerable human

levels in terms of the initial dose that these things are of

Some concern. The ongoing argument, therefore, is a very

 

 
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important one, and that is there a finite interval during
which you can use AZT so that if you moved it forward to the
asymptomatic stage, you would have run out of its usefulness
just about the time you needed it. That’s a terribly
important question, especially now that the recommendation is
to start using it early.

The answer to that question isn’t known, and that’s
where the action is, if you like, at the moment, and I am one
bf the people that worries a lot about it. Jim may want to
make some comments, too, because since my background is in
virology and anti-virals and, to some extent, viral im-
munology, I am very concerned about that.

Whether we are buying enough time in using it early
to make up for losing it late, if that’s what the tradeoff
is, is a very important argument, and it has been going on in
these fora, but it needs to go on some more. The data are
accumulating to help answer that. We need to find out
whether that clinical resistance and viral resistance are
connected.

It sounds like they ought to be, but I should tell

jyou that microbiologically there are a lot of examples in

which--tuberculosis, for instance; tuberculosis will develop

 

 

 

 
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resistance to the anti-tuberculosis drugs, but it also
attenuates as it does so and becomes less of a disease-
producer. There are examples of any kind of association and
they just haven’t been established right now. So those are
very lively and important issues.

Let me tell you about DDI, and then I’d be eager to
respond to more of those things as we go. With DDI, what was
done was the beginning--and you’ve read about it in the
context of parallel track. It was, in a certain sense,
nothing new for FDA, except it’s bigger and it’s more
systematized.

It has been true for a long time that FDA could
have compassionate-use protocols for people to have access to
drugs that were still experimental. Now, let me just say
right off there’s an enormous fiscal impact of doing that
that we can get back to because that is more our business in
the technical sense.

But, nevertheless, it’s been possible for a long
time for people to have access to drugs that had not yet been
licensed. The parallel track mechanism was devised because
partly people couldn’t tolerate AZT or DDI and the experimen-

tal drugs or they couldn’t get close to a medical center that

 

 

 

 

 
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was running an experimental drug protocol and they had worn
aa

© put their AZT.

| There were a lot of things that made it hard for
everybody who would like to have access and who couldn’t take
advantage of AZT to be able to get access to DDI. So Bristol
Meyers sort of facilitated things--they are the makers of
DDI--by volunteering to help establish a so-called parallel
track protocol in which clinical trials are designed the way
they always are, and then in parallel to that people who
didn’t qualify for these strictly-defined clinical trial

© sets--and they are strictly defined--could nevertheless have
access to what--it turns out the easiest way to do it for
them was to make it free--DDI in so-called parallel track
protocols.

It requires that you have a physician who has
Hecided you should do that. It requires that the physician
keep some minimum safety data--a little bit of Tuesday was
spent arguing about what kind of efficacy data, if any, you

could get out of such circumstances--but some safety data to

@ help augment the data coming from these more rigidly-defined
Clinical trials, and all of this to start at a stage con-
© siderably earlier than one usually starts using experimental
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drugs in large groups of people, which meant that the people
undertaking the parallel part of the track had to be well
warned that they were taking more chances than usual.

Let me say a few things about the news items
because it helps to summarize. People who went on to the
parallel track by and large were very much sicker because
some of the criteria for being in the clinical trials made
that almost by definition. One of the reasons you couldn’t
go into the clinical trials is you were too sick for them.
So if you still wanted DDI, then you could go into the
parallel track mechanism. And so just starting with that,
there was a very great discrepancy, really quite a great
discrepancy, between the groups.

| Another concern that was voiced and is still an
open-ended issue, although it was not considered a serious
pne by the presenters on Monday and Tuesday, was could you
get people into the clinical trial protocols if they had the
parallel track option, since it is somewhat less onerous to
pe on the parallel track, with one important exception.

In either case, you need to have certain clinical
tests--T-4 cells and that kind of stuff--at regular intervals,

and if you were on parallel track, you had to pay for them

 

 

 
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yourself. If you are on the research protocol, it’s part of
the research protocol.

There are some very worrisome inequities that seep

into this system that we did discuss quite a bit on Monday

and Tuesday, and it made a very interesting meeting. But for
the moment, to finish off the medical side, DDI turns out to
be unpleasantly toxic in two important ways that are still
evolving.

One that has been evident for some time is that not
immediately, but after some sustained use, people on DDI with
fair frequency will develop a so-called peripheral neuropathy,
which is to say that the neurologic function as it affects
particularly arms and legs, and occasionally other things,
may begin to be damaged. |

Now, the mechanism of that isn’t clear, but the
association with DDI is. That’s one of the hazards of that

drug, just like bone marrow toxicity is one of the hazards of

AZT. So, that’s an unpleasant sort of a surprise and one

that is going to limit its usefulness. It’s not going to be
penicillin.
The other thing that is just emerging is that

pancreatitis is a much less common event that can occur

 

 

 

 
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associated with DDI use, and that was part of the weekend’s
news stuff, was that in the clinical trials group there had
been one case of pancreatitis and in the parallel track
patients there had been six that had resulted in people who
had died. |

Now, the thing that wasn’t so well reported in some
of the reports--.

COMMISSIONER DALTON: June, what’s the on?”
CHAIRMAN OSBORN: That’s what I was about to say.
The thing that wasn’t so well reported is that there are ten
times as many people in the parallel track as there are in
the clinical trials, and they are much sicker. It’s perfectly
possible that the pancreatitis effect is a combination drug
effect. That hasn’t been parsed out, and it may not be
possible to tease it out of the much less well documented
clinical trials group.

So there are a lot of issues there. At the start
of things, with ten times as many people in one as in the
pbther, and six-to-one is the pancreatitis thing, I think the
most that one learns from that is that pancreatitis is
another unwelcome event that can occur in the context of DDI

usage, along with peripheral neuropathy.

 

 

 
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That was absolutely the sense of the group, a very
large group and very good group that discussed this Monday
and Tuesday at the Institute of Medicine. It got a very full
airing by virtue of the timing of that report. The thing
that was much more distressing in terms of news coverage was
this business of ten times as many deaths in the parallel
track as in the treatment group. That is almost for sure a
non-statistic in the sense that they are absolutely not
comparable groups.

It was nevertheless well discussed Monday and
Tuesday, and there was no sense that either of those news
items should influence the thinking about parallel track.
The one that might influence it in the longer haul was if it
was so hard to accrue cases on the clinical case because
everybody wanted the parallel track, that could jeopardize
drug development in general. And that’s a serious problem
because drug development--acceleration of all kinds of drugs
for all kinds of things--is not sort of poised on the success
or failure of this DDI experiment.

COMMISSIONER ALLEN: June, I have a question about
that.

CHAIRMAN OSBORN: Yes.

 

 

 
 

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COMMISSIONER ALLEN: Is there a difference with the
physician’s energy as opposed to those in the clinical trials
and those on parallel track? Is it more advantageous for a
physician not to be a part of the research? Is that also an
issue? .

CHAIRMAN OSBORN: Up until now, I’ve been talking
as if I were the person who knew all about this one when, in
fact, the guy two doors down from me knows a lot about it and
is coordinating the whole thing.

Jim, I wish you would not only answer that question,
but if you could correct anything that I have mis-emphasized,
in your view.

DR. ALLEN: I think you’ve given a very nice
summary. Unfortunately, I got tied up with other things and
wasn’t able to attend nearly as much of the meeting as I had
hoped.

I think the hope, Scott, with a wider availability
type program is that many more physicians will get involved.
The clinical trials are basically a very cumbersome, very
rigidly controlled type procedure. For the most part, they
are totally carried out by people in major medical centers in

selected areas around the country.

 

 

 
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To a lesser degree and as almost a new phenomenon
associated with the AIDS epidemic, we are seeing the develop-
ment of community-based clinical trials groups, a few that
started on their own without government support. The
National Institute of Allergy and Infectious Diseases is now
Supporting, I believe, 18 such community-based clinical
trials groups around the country.

Some of them are about ready to start on their own
protocols. In other words, they've got enough background and
sophistication in conducting clinical trials that they’re
ready to move ahead directly. Another sub-group is going
through a training phase before they will be ready to
participate in the clinical trials.

SO, right now, with the clinical trials, you’re
looking at a very--you know, you’ve got to be a patient ina
geographically selected area and have access to that, be
willing to put up with the vagaries of going through, you
know, the major hospitals, one of the major hospitals in the
country, and it’s a very cumbersome process.

On the other hand, for the most part you ought to
get premium, quality care. I say ought to; that certainly

isn’t always true. And, certainly, the cost is an advantage

 

 

 
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to you, in that most of the costs associated with receiving
the drugs, the physicians’ costs, laboratory tests, and that
sort of thing are going to be picked up as part of the
Clinical trials process.

With the parallel track concept, you don’t get any
of that. The drug under most circumstances will be provided
free of charge by the company or by the sponsor, but any
administrative costs--that is, going to the physician however
Many times a month you may need to, other clinical or
laboratory type tests or monitoring that may need to be done
in order to assure that you aren’t getting toxic effects, or
trying to pick them up early if they are occurring--probably
are going to be your own. It may or may not be picked up by
insurance, depending on what you’ve got, what type of
coverage you’ve got, and so on. There are a lot of unanswered
questions with that.

Does that answer your basic question?

COMMISSIONER ALLEN: What I’m asking--that’s
basically from the consumer’s point of view of the advantages
Df the research track. What I’m wondering is are the
physicians-~--are there enough incentives for physicians to be

A part of the more formal research, or is it just easier to

 

 

 
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cop out and say, look, let’s just do it on our own time.
DR. ALLEN: Most physicians are not part of formal
research trials now. It would take far too much of their
time.

COMMISSIONER ALLEN: Okay.

DR. ALLEN: You’ve got to be in a major medical
center, literally, full-time.

COMMISSIONER ALLEN: All right, but that’s not
going to be a reason why there might be diminishing roles
within that.

DR. ALLEN: That’s correct.

COMMISSIONER ALLEN: All right.

DR. ALLEN: The only other comment I’1l make very
quickly, June, is that with DDI it really is on a treatment
IND basis, and we’re trying to make the point that it’s not
really, truly parallel track because there are some differ-
ences between what we envision. The net effect is very
Similar, but it isn’t quite that yet.

The other point I will just say in terms of the
Clinical trials--and I’m not an expert on this and I certainly
don’t want to be considered to be waving a banner, but I

think we need to look very, very closely at the design of the

 

 

 
clinical trials.

The ones that have been done so far have--you know,
they’re probably models of what they should be in terms of
complexity and the pristine nature of the patients coming in.
You can’t have had this, you can never have had that, you
know. And one of the reasons that we’ve got a ten-to-one
distribution of patients receiving DDI through the treatment
IND as opposed to the clinical trials is that many of the
patients who otherwise might have qualified for the clinical
trials protocols were disqualified because their lab values
were out of line here or didn’t meet something there or they
had already had aerosol pentamidine.

CHAIRMAN OSBORN: One of the things that would
please you is if there was a change-oriented conclusion at
the end of Tuesday afternoon’s discussion, it was that point.
DR. ALLEN: Yes.

CHAIRMAN OSBORN: It was agreed on the part of the
drug vaccine roundtable group, which, by the way, is quite

proadly constituted with attorneys--it’s intended, as a

@ matter of fact, as a discussional rather than--attorneys such

As Peter Hutt, for instance, who is the former general

© counsel of FDA; it has got people from FDA, from NIH, from

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various research groups. Jim Igo is a member, from ACTUP,
and Marty Delaney, although he wasn’t there for this one, and
Jay Lipner. I take it back. Jim Igo was part of the group,
but Jay Lipner is the official representative from ACTUP on
this. But it’s a very good and freewheeling discussion group.
Their chief take-home lesson was that the clinical
trial design was too restrictive for DDI, and to the extent
there was a dynamic that could be readily identified as a
problem, that was it.

DR. ALLEN: And the NIAID AIDS clinical trial
group, ACTG, has established what they call their protocol
diet committee that is intended to take these very complex,
ponderous protocols and try to look very critically at does
this need to be in there, does that, and to pare them down so
that we really can make them as flexible and as available to
the patients as possible.

CHAIRMAN OSBORN: Belinda.

COMMISSIONER MASON: I don’t want to beat this to
death. I know I always do. Jim, I’m encouraged about a lot
of the stuff you said; it sounds good. I like to hear
government people saying yes, well, maybe we screwed up about

these trials because, you know, it has been the feeling in

 

 

 
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pur community for all these years that we were sacrificing
people to science, you know; that we’re going to have this
really elegant, wonderful science that is built on the
framework of the bodies of people that we love, you know.

So, that’s encouraging.

And I wanted to, you know, kind of say to Scott I
don’t know if this is exactly what you’re asking, but one of
the barriers--and this is probably too esoteric to pursue
here, but, you know, I have to like spend my life apologizing
for what I’m about to do.

But I think that it’s probably really hard for
primary care physicians in communities to access the DDI IND.
tf mean, for instance, my doctor--it just happens that she’s a
very sophisticated woman, you know. She’s from St. Louis. I
mean, she has dealt with these things before, but it’s a
vOluminous amount of paperwork.

She’s a very dedicated woman and she only does it
because of being, you know, kind of sophisticated to these
things already. But I think for the most part the very
things that were designed to remove--you know, the IND
program, as June said, was designed for people who live far

away, who were too sick. But some of those people are still

 

 

 

 
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going to be, just by virtue of where they live--their access
to the kind of primary care that is available in the places
where most of us live in this country is still not going to
be, unless you’ve got a physician that’s really wiling to--
you know, so it’s a big job of work and it takes a lot of
dedication, I think, on the part of the doctor because they
don’t really--you know, except for getting a lot of extra
money in their office for all those lab tests you have to pay
for and stuff, I don’t know otherwise that they really, you
know--.
COMMISSIONER DIAZ: You can imagine the interest on
this subject in California, and I have been asked repeatedly
after the news article got out a week ago whether or not this
Commission would be listening formally in testimony to
anything from the other group, June. We know you serve on it
And it is broadly constituted.

Mario Marich Soliz from Los Angeles serves on it

and has been a spokesperson for the consumer community of Los

Angeles, and Dr. Fauci came personally to L.A. when parallel

tracks were being developed for a broad discussion with

AACTUP, gay groups, AIDS groups.

But I just wondered what your feelings were on

 

 

 
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this, or how we should answer to constituencies asking
whether or not this Commission will support the work that is
being done intergovernmentally or whether we will give an
Opportunity for a discussion, being that we are, in fact, by
Congressional mandate, the body that will be advising
direction for this country. I just really would appreciate
knowing what to say as a Commission member about this.

VICE CHAIRMAN ROGERS: A suggestion, Madam Chairman.
Eunice, it seems to me as we move on in the day one of the
things this group ought to do, and said they were going to do
yesterday, is to say here are the things we think the
Commission should focus on. It would seem to me that would
be an appropriate time to lay out our laundry list and then
struggle about which are the most important. What are the
things that are doable, what are the things that this
Commission can be creditable on, what are the things we
Should leave to other groups. My suggestion would be that you
bring that back at the time you go to that discussion.
COMMISSIONER DIAZ: The reason I’d just like for us
to think about it, though--in contrast to some other issues,
this one already has an organized and good constituency

working on it, and you are a regular liaison with that group.

 

 

 

 
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The report and feeling that I get is very positive in terms
of what is being done on a widespread basis. Where there are
other issues that are just kind_of hanging, you know, this
one is--.

CHAIRMAN OSBORN: To the extent that I was trying
to do anything more than just touch bases, I wanted to give
you a little sense of what was going on so that as we think
about the agenda later in the day, you can decide as Commis-
sioners.

I could make an argument 180 degrees that we
Shouldn’t do it because there are a lot of people doing it.
We should do a little more than we are now, but not get into
it too deeply. You know, I could talk my way into any of
those, and I think the Commission should think about it
because it certainly is one of the things that would be on
the list of agenda items that we want to prioritize, as we
have decided.

Let’s see; Diane next, then Irwin.

COMMISSIONER AHRENS: I would just wonder, Madam
Chair, if you would just describe very briefly for us the
composition of particularly the clinical trials in terms of

sex, age, ethnicity, et cetera; just give us a sense of who

 

 

 

 
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is on, who can take advantage of this or who is taking
advantage of it.
CHAIRMAN OSBORN: Yes. That was extensively dealt
with Monday and Tuesday. In fact, I really wish I had had
everybody there Monday and Tuesday because some of these, I
must confess, have not been quite so rich experiences, but
this was, and there was some marvelous discussion about that
issue.

Again, I'll get Jim Allen to help me with this if I
misstate, but, in general, whereas the epidemic is really 50
percent minority, 50 percent white, non-Hispanic, the
experimental activities are involving roughly 90 percent
white, non-Hispanic, 10 percent minority.
Whereas the epidemic is thus far 11 percent women
and the experimental group now is up to 9 percent women,
that’s a fairly recent increase and is a response to that
kind of concern. There’s been some effort to bring women
into experimental protocols because of their notable absence.
However, that is a complicated issue because it is
still true that epidemiologically the distribution of women
involved in terms of large enough numbers to pull into formal

clinical trials is very uneven, mostly East Coast, in terms

 

 
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of substantial groups of women among whom there might be
enough to want to participate in a group that was forming.
In addition, there are some very tough problems
about treating pregnant women and women of child-bearing age.
About, at the moment, 50 percent of the--I think that may be
a little high, but 50 percent of the women are or have been
caught up in illicit substance use as well, and that’s
another level of discussion.

In fact, the most heated discussion, I think,
Monday and Tuesday was the failure to build into trials
people who had a history of illicit substance use, with a
very real possibility that that might be a different dynamic.
Jim, how am I doing on the numbers there?

DR. ALLEN: I think your rough numbers are very
close and I don’t have anything more precise.

COMMISSIONER AHRENS: What about children?
CHAIRMAN OSBORN: With children, it looks as if it
will continue to be extremely difficult to work through the
problems associated with the use of experimental drugs under
the age of 12, and it’s a little difficult even over the age
of 12, a gray zone there where parental consent--there may

not be parents to consent, but there are a lot of difficult

 

 

 
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issues.

The AZT development for children is certainly
moving its way along, but exactly the same things that slowed
it down are now slowing DDI. There is no pediatric formula-
tion, so that, in fact, it’s not even possible for very small
children to be treated with DDI at the moment, if one decided
in all other ways that it was desirable.

There is no particular way to force the hand on
that because the number of children that you could pull |
together is small. There is clearly now getting to be some
knowledge of substantial risk, and there’s expanding awareness
that children may have a very sustained interval of well-
being before they become ill.

So, that one is going to be tough at least to push
through because you’re not quite sure which agendas to choose
to push. That’s a tough one, and the same is true of
treating pregnant women. That’s a very tough one. It’s not
a straightforward thing where you’d want to get out ona
barricade and say it ought to be done and it hasn’t been done

and we want to make sure it is. There are too many diverse

lithreads to that.

What was clearly stated and beautifully stated--I

 

 
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don’t know how many of you have ever heard Dr. Mark Smith
talk, but Mark was at his most. He was absolutely marvelous,
and he had a very beautiful set _of statements about the need
to do two kinds of things; one, to involve people of color in
experimental experiences so the data would surely pertain,
but then an equal counterpart--and Dr. Larry Brown did
likewise--an equal input about the very great sensitivity of
people of color to the guinea pig business.

And so those themes were beautifully brought out in
the discussion and, as I say, if I had known that it was
going to be so good, we would have videotaped it and we could
all sit and--that was sort of a surprise in the middle of
what might have been a very dry meeting.

DR. ALLEN: June, let me just pick up and go back
very briefly to the problems with the kids, which I think you
addressed well. I don’t think that those problems need to
mean that we should back off and not push. We need to look
at creative ways to take kids that are in foster care or who
are border babies and find ways to get appropriate advocates
with legal authority to sign consent for them to have
experimental types of treatment.

I think I learned a lesson in the last five or six

 

 
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months, however, in dealing indirectly through and with the
FDA with some of the major companies. When we talk about
people being stressed because they don’t have enough time to
do everything, you know, we often think of government
agencies where there are ceilings in terms of hiring. We
think of medical centers where there aren’t enough staff and
people to do it.

Surprisingly, it also applies to private industry
when you're talking about qualified people to carry out a lot
of these very complex things, to analyze mounds of data very
quickly. June, you’ve worked with the FDA on their advisory
committees. You’ve seen literally the carts full of data
that are pushed in in support of applications.

I mean, what is required--the documentation is
incredible, and when we ask a company to quickly move ahead
pn getting a treatment IND protocol for this one type of area
pr study or that one, then we ask them simultaneously to do
something else for the children, to formulate, you know, their
drug in a new suspension or new dosage levels, when everything
Still is not cranked up for the assembly line, but it’s still
being individually formulated so you’ve got the right dose

and the right capsules and that sort of thing for all of

 

 

 

 
 

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these different trials.

They run out of qualified people to do it, too, and
we want to make certain that we_don’t compromise safety by a
screw-up in people not analyzing data properly, in overlooking
something, or in formulating materials badly. That’s just
the facts of life and it’s one of the things that we have to
be sensitive to and aware of. It doesn’t mean we have to
stop pushing, but there are some realities of life in this,
too.

CHAIRMAN OSBORN: Irwin, then Don.

MR. PERNICK: June, why was the lead on the DDI
weekend story the toxicity of DDI? Why was the stress on its
toxicity? Was it purposefully put out that way? I mean, my
wife came away from hearing that and said, boy, there’s a new
drug on the market and it’s killing all these poor AIDS
people. I said, what?

And I think she fairly represents the layman. I
mean, I’m the layest of the laymen in our group, but, you
know, at least I pay a little more attention and I have a
little more knowledge than that. She represents the rest of
the world, I think, on this issue. Was it purposefully put

put that way, that kind of a slant or twist?

 

 

 
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CHAIRMAN OSBORN: Nothing was put out. David wants
to comment, too, but let me tell you what I know about it and
then get him to add to it.
MR. PERNICK: Sure.
CHAIRMAN OSBORN: “Nothing was put out. It is
required in all of these situations that adverse reactions be
reported. A reporter, whom I consider to be very responsible,
picked up the phone, called Bristol Meyers, and said what are
you getting, and got the pancreatitis data and reported that,
in my opinion, modestly and responsibly with appropriate
caveats.

Another reporter, whom I will quote other reporters
as saying was wildly irresponsible in this, then picked up on
the mortality data, and that’s the story that then overwhelmed
the pancreatitis story. It was entirely separate, and I have
never seen working journalists so willing to say something

bad about a fellow working journalist as on Monday and
Tuesday. They were furious that that story took off and went
that way.

So it was a two-event thing and the original story
got drowned. The original story was a news item that got

modest coverage, but suddenly toxicity got amplified because

 

 

 

 
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the two went together.

David, do you want to comment?

VICE CHAIRMAN ROGERS: Yes. fThat’s an accurate
portrayal, and it’s an all too human story, too. I guess the
only thing I would add to what June said was this also was a
reporter that had gotten fairly beat up by some of the ACTUP
people, was feeling kind of punitive.

I had an opportunity to sit down the next day with
the editorial staff of the New York Times and told them how
destructive that had been, because patients were calling,
people were terrified, saying I’ve got to get off this drug,
I’m going to die. It was a totally irresponsible kind of
piece, as I pointed out in some interviews.

MR. PERNICK: Of course, there hasn’t been a third
step.

VICE CHAIRMAN ROGERS: Well, we don’t know who died.

MR. PERNICK: Yes.

VICE CHAIRMAN ROGERS: We don’t know quite why. As
has been indicated, they were ten-plus sick people, not
three-plus sick. Maybe 600 would have died rather than 290
if they hadn’t been on the drug. I mean, the evidence just

isn’t there, and I thought I was kind of troubled by Tom

 

 

 

 
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‘iChalmers’ statement that kind of fanned the flames there in

terms of saying this was a disaster.

We have no idea, and my guess is that it’s not that
they were just dreadfully ill people, but that it was blown
all out of proportion. .

MR. PERNICK: If you even look at the figures that
you mentioned, June, a ten-to-one ratio in terms of patients
in the parallel track as opposed to the clinical trials, and
only a six-to-one difference in deaths, my God.

CHATRMAN OSBORN: You can’t do that with those
numbers.

MR. PERNICK: I realize you can’t, you know.

CHAIRMAN OSBORN: Yes. Those numbers just simply
don’t mix. I think perhaps the take-home message and the one
that the media will now have to join us in getting more
sophisticated about is that when you have parallel track and
an ongoing clinical trial, they are not comparable groups by
definition and must not be compared.

They could come out in either direction distorted
if you try comparing them. So, that was the fundamental flaw
in that, is to look at experience on parallel track and try

and line it up with people who, in this instance, had an

 

 

 

 
 

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exceedingly tight control on their eligibility for the
clinical trials. So to the extent that you could amplify a
difference in experimental groups, this was done not system-
atically, but it was an automatic event.

Let’s say. I’ve got Don DesJarlais, Harlon, Larry.
COMMISSIONER DES JARLAIS: Earlier in informal
discussions, there’s been some talk about forming a special
subcommittee to look at scientific issues in the epidemic,
current science, funding levels, potential future funding
levels, social justice issues in the conduct of science.

In the hope of getting out of here by 4:00 this
afternoon, I would like to suggest that we form such a
subcommittee, hold hearings, if need be, draft reports, and
such. I think it’s much too important for us to ignore.
There is not going to be any other national body that tries
to get an overview of how science is going in the epidemic.
Certainly, in the initial Institute of Medicine
reports and National Academy of Science reports that recom-
mended a national commission, that was one of the major
charges to the Commission, was to provide oversight to the
scientific issues, and I think we really ought to form such a

sub-group and have full reports covering the science of it

 

 

 
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because I think it’s really too important for us to ignore,
but it’s going to require too much work to do as a committee
of the whole. 7

CHAIRMAN OSBORN: I think that’s quite a helpful
comment. .

Harlon, then Larry.

COMMISSIONER DALTON: Actually, I had a technical
question which my fellow Commissioner Mason answered for me.
The other comment was just that--and you’re not a camera,
June, but I do have a real sense as of I was at the meeting,
and I appreciate the report this morning.

CHAIRMAN OSBORN: Thank you.

Larry.

COMMISSIONER KESSLER: I wanted to support Don’s
proposal, but I also think that this whole incident is a
perfect case study of the media’s role, and sometimes their
irresponsibility, in terms of covering this epidemic. And it
brings us back, I think, to an earlier discussion we had six
months ago about possibly doing something where we talk to
the media or they talk to us, and vice versa.

I’m not sure how to structure it, whether it be a

hearing or a special task force that gathers some data and

 

 

 
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analyzes it, and that has been done on a certain level by some
people. In fact, there’s a new book out that just documents
the first seven years of the epidemic.

But regardless of which clipping you’re looking at-
-the New York Post, the Wall Street Journal, or the Times--
they all basically make the same mistake and have it rein-
forced by not only Chalmers, but by Fauci. That kind of
coverage really does create incredible anxiety for the
clients that we care about, but also for those who are off in
the wings trying to decide whether they want to be clients or
get tested or access treatment. You know, they don’t know
who’s on first. Somehow or other, this Commission has to
call the media in and nail their butts to the wall.
CHAIRMAN OSBORN: I think that also is a very
strong and appropriate suggestion, and I think that there was
some discussion somewhat earlier. In fact, I think it is
floating around on a list somewhere that a full Commission
hearing in that instance might be--not necessarily for a full
Commission, but in a committee of the whole--might be the way
to do that because that’s where we take very good advantage
of the diversity of our expertise, and the different ways in

which we receive the same kind of message becomes an enriching

 

 

 

 
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thing.

So I not only think that’s a terrific idea, but we
may want to have that on the list of things that we prioritize
for a whole Commission session or part of a whole: Commission
session.

David.

VICE CHAIRMAN ROGERS: I think, again, this is part
of that agenda of not only what do we put on the list, but
how do we do a number of things where the expertise lies not
mecessarily within this group. So I wanted to simply again
nighlight Don’s suggestion. It seems to me one very effective
mechanism would be to set up some task forces and some
subcommittees that had Commission members, but had people of
absolutely impeccable credentials that could feed back to
this Commission.

I will simply indicate that, as many of you know, I
chair the Governor’s Advisory Council for the New York State
Advisory Board. In finding we weren’t getting listened to
very well, I found a magnificently effective device--and no
one ever turns me down--is to put together a subcommittee
where I say, Harlon, help us with prison health to put

together a blue ribbon group, or help us with Hispanics, or

 

 

 
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help us with women and children.
I can put together ten people, all of them names
that the governor knows, and so_does the entire science

community. They can come back in several months with a good,

tough report. We can have control over those sorts of

things. We can decide what we want to use. But I think that
would add an enormous amount of muscle, and I know anyone we
ask to help us would help us.

We can ask any distinguished scientist, or what
have you, in this country to say help us on this thing and
they will, and that would really extend our effectiveness, I
think, enormously because we can’t do it all with what we've
got inside, and we don’t need to. We’re the ones that should
be the final monitor of what moves out.

In our discussion of priorities, we may decide
here’s one we can’t handle, but we could put up a group that
really could bring us back in two months the information we
need to deal with.

CHAIRMAN OSBORN: Identify yourself for the record,
if you would.

MR. ALLEN: Bob Allen, Department of Veterans

Affairs. June, I wanted to ask--at the NIH meeting when we

 

 

 

 
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were there talking about AZT use, one of the very important
things they were going to draft was information to clinicians
about how to use what dose of AZT. There was supposed to be
a draft report.

CHAIRMAN OSBORN: “ters in my briefcase for review
between here and California this afternoon.

MR. ALLEN: We’ve been asked Congressional ques-
tions.

CHAIRMAN OSBORN: The people who were participants
have been sent the draft. It arrived just before I left for
this meeting, and I think it’s due Monday.

MR. ALLEN: Okay.

CHAIRMAN OSBORN: It’s on its way. There is going
to be a document that comes out that tries to regularize and
help physicians in the context of these various recommenda-
tions. But I wasn’t part of the discussion drafting, so I
can’t give you an overview of what it is because I haven’t
read it yet. It just came before I left the office.

MR. ALLEN: I would just like to put--even though,
as we said before, the Department of Veterans Affairs is not
a part of the Public Health Service, we would like to have

pur policies be consistent, and we can do that faster if we

 

 

 
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get information as early as possible.

 

CHAIRMAN OSBORN: Yes. It doesn’t technically
exist yet until the drafters have a chance to see it.

MR. ALLEN: But we will be able to get one of the
early copies so we can--. |

CHAIRMAN OSBORN: Yes. I’m not the right one to
ask, but I’m sure you can through the NIH convening group
because I think it will be very widely disseminated as soon
as it has achieved full review by the people who wrote it and
the collective group.

What they did basically was to pull together--I
didn’t mention this as a separate meeting, but they had sort
of an emergency weekend meeting the weekend before last, I
guess it was, in which they got sort of a--they called ita
state-of-the-art conference on AZT, and then had people who
had done the clinical trials re-present the data. They had
other people who were on the front lines discuss what was
meeded in terms of information.

They had different communities represented quite
well, I thought, and they had a bunch of us called senior
scientists who sat around and listened to that and helped

with it. It’s the product of that that I was referring to,

 

 

 
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which will extremely quickly--I mean, I mention that only so
you know the intensity of response that the unwieldy federal
bureaucracy is really trying to_mobilize to get that done in
a way that’s accessible and very usable to clinicians on the
front lines as quickly as possible, Still before the actual
publication date of the data themselves. So it’s whipping
along in a remarkable fashion, and it’s a contribution,
really--a sad epidemic, but a major contribution of the
epidemic to things overall, I think.

I feel uneasy because I think we’ve got so much
work to do, and several very good suggestions have been made
as to how to proceed with this line of discussion which is of
intense importance and interest to everybody.

If it’s all right with you, I would suggest--David
had a suggestion about how to proceed with the working group
summary report that we worked on yesterday which has been
passed out to you. I don’t know whether everybody has had a
chance to glance. If there are specific places where you
were concerned, you may want to take a couple of minutes to
do so.

But, David, while people are paging, why don’t you

go ahead?

 

 

 

 
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VICE CHAIRMAN ROGERS: Yes. Let me make a sugges-
tion here because one thing that drives me up the wall is to
watch a group try and edit a document. My feeling is we've
got a very good document. It is imperfect, as are most such
pieces of paper, but we are not trying to write the Declara-
tion of Independence.

A distinguished subcommittee has worked valiantly
on a report to put before this Commission. My suggestion,
unless there’s something that makes somebody have a convul-
Sion, is that we accept with gratitude the elegant work of
bur subcommittee; that we recognize that over the next year
this is going to serve as grist for our mill in terms of
Subsequent reports, and so on.

I do not feel it is imprinted in stone. Over the
next six months, we may get smarter and we may wish to modify
in one way or another a few of those recommendations, but we
have gnawed at them enough so that I think they’re close to
what we want. And rather than go through what we did for the
last hour-and-a-half yesterday, I think we should let Charlie
and Diane and the group off the hook, thank them for their
labors, accept the report, and go on about other business.

COMMISSIONER DALTON: I told Diane if I don’t have

 

 

 
 

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to call her distinguished, I can go along with what David has
to say.

(Laughter. J .

COMMISSIONER DALTON: But it would be useful just
to know what the changes are Since yesterday just so people
don’t have to page through it.

- COMMISSIONER AHRENS: Madam Chair, let me just call
your attention very quickly--.
| VICE CHAIRMAN ROGERS: As long as that isn’t

driving a great big truck through that takes us another hour.

COMMISSIONER AHRENS: Yes. Page one, the middle of
the page, we took out the sentence on silence; it’s that
second paragraph. Flip over to page four, and we added
something there in terms of strategic planning for counties.
On page five, under federal, the first sentence, we put the
words "overall leadership" in.
Same page, page five, partnership, sort of the
middle of that paragraph--I believe this was all added, and I
think it was Don, I believe, that was concerned about this.
Implicit in the concept of collaborative partnership, et
cetera--the two sentences there were added.

Am I moving fast enough?

 

 

 
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VICE CHAIRMAN ROGERS: Don’t let anybody stop you.
[Laughter. ]

VICE CHAIRMAN ROGERS: _ Ride over them like a truck.
COMMISSIONER AHRENS: Page eight is the critical
bne, in that the top two paragraphs are--.

VICE CHAIRMAN ROGERS: Don’t even tell them that;
just do it.

{[Laughter. ]

COMMISSIONER AHRENS: There is new wording at the
top two paragraphs.

Madam Chair, I would move the acceptance of this
document. Acceptance--is that the word we want?

CHAIRMAN OSBORN: That sounds like a very ap-
propriate word because I think the point David was making
besides that of driving a truck through was that that is what
We're doing, is accepting a conscientious report from a group
Df people who have studied the issue. So I think that’s a
nice way to put it and one that we should look on as a way we
go with small working groups.

COMMISSIONER KESSLER: I second her motion.
CHAIRMAN OSBORN: Thank you.

COMMISSIONER GOLDMAN: I just have a point of

 

 

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inquiry. Do I understand it correctly that even though we’ve
had a certain substantial role in making suggestions to the
working group that by accepting this report, we are not
necessarily adopting these recommendations as recommendations
of the Commission as a whole, or are we, and are we publishing
this and what do we intend to do with the document? That’s
why I said it’s an inquiry.

CHAIRMAN OSBORN: Those are excellent points to
bring out in this context. By accepting this report, we’re
doing just that. How we then proceed in terms of its
amplification and use would be analogous to what we did
earlier. In the document that we didn’t yet circulate that
was going to be a second mini-report, we had taken pieces of
this, and that’s something that we can discuss, and so forth.
But from this would grow either that sort of a
communication or it could become a piece of what would be an
interim report in August, somewhat intact, probably. I mean,
I’ve been advocating that we may want to look at the interim
report writing as something that is just that, rather than
having the staff have to divert enormous amounts of time and
basically put us on hold for a month. The legislative

language is not much more compelling than that.

 

 

 
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So it’s conceivable that for the moment we can
decide what we want to do with it, but it is a report of a
small working group to the Commission. When the Commission
accepts the report, I think it probably means that we don’t
find anything egregious in it, but it doesn’t say what we do
next or how we go from there.

Is everybody--.

MR. PERNICK: June, I think even that has gone too
far, it seems to me. Gnawing in the back of my mind has been
the question why are we involved in the report of the working
group’s report. It is their working group. They are
presenting it to the Commission. We shouldn’t be nit-picking
their language.

You know, if they make errors, fine; we can discuss
that when incorporating their language into the interim
reports or into a final report. But this is their report
and, to their credit, they’ve done a very good job. But we
Shouldn’t be involved in telling them where the dots are.
COMMISSIONER MASON: Hear, hear, Irwin.

MR. PERNICK: And, of course, I’m speaking for a
non-voting member, so I’m not sure--.

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VICE CHAIRMAN ROGERS: You have my vote.

CHAIRMAN OSBORN: We will not listen to you, in
that case.

Eunice, and then Don.

COMMISSIONER DIAZ: I just wanted to ask one
question. I still think that the task force we’re asking to
be developed--were we intending with the new write-up and
input from yesterday that it put forth a plan and it also be
the implementors of that, because the two paragraphs are not
saying the same thing? That is my only question. I have no
quarrel with the whole report, except that.

You talk about the President designating this
Cabinet-level task force to develop the plan. Right under-
neath, there is a need for all these government agencies to
come together to implement. So, is it both, and if it is
poth--.

COMMISSIONER AHRENS: Madam Chair, in terms of
accepting the report, that’s just what it is. I think,
Eunice, your concerns will come about, but if anything in
this report is then picked up by our staff and put through as
aA recommendation in the interim report, then we have to hash

this through.

 

 
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But I think what we're doing today is simply
receiving--maybe we should use the term "receiving"--receiving
this report. We’re not recommending it in any way to anybody
and we’re not putting our stamp of approval on it. All we’re
doing is accepting this report because it’s the report of a
working group. Then what is done with this document later
will have to have a stamp of approval by this entire Commis-
Sion, and that’s what my understanding of the motion was.
CHAIRMAN OSBORN: Don Goldman.

COMMISSIONER GOLDMAN: Yes. I would just like to
say two things. One is that whether or not we like it or
mot, I think all of us will have to be aware that even
comments by one of us individually, much less a working
group, do, in fact, in some way, whether it be by the media
or otherwise, get attributed to the Commission by the press.
Our merely saying that we’re accepting it and not adopting it,
and receiving it and we’re not doing anything with it is not
necessarily going to be accepted by all the rest of the world
with which we deal.

I think we do have to be careful, and I think the
kind of exercise that we went through was appropriate and

therefore I don’t think it was inappropriate to have gone

 

 

 

 
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through. And I think it’s important that even the working
group, although this is a product of the working group--and
don’t forget, the working group_submitted this draft ori-
ginally with a request for input and comments from the rest
of the members of the Commission. And it got that input and
comment and respectfully tried to incorporate those comments
with which it agreed within the context of the report, and I
think that’s an appropriate process and I don’t regret it or
the time spent one minute.

CHAIRMAN OSBORN: I must say I agree with that.
That’s why I said that we have to be sure there’s nothing
egregious in this kind of thing. That level of discussion is
appropriate when a working group brings a report forward
because if it clearly represents something that the Commission
finds very uneasy to accept, then it needs to be worked
through.

I think what David is commenting about, joking
aside, is that when we recognize areas of that sort, we
probably need to learn to have redrafting done out of the
committee of the whole, and that was, I think, what the
comment was about the discussion.

I think it is a little bit more than thank you, we

 

 

 

 

 
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receive it. I think we do need to receive it with a general
sense of comfort. The issue that Eunice raises is one,
however, that probably, in its activation, we couldn’t
influence anyway.

As long as the direction is okay, Eunice, I’m not
sure that I would get stalled on that any further than the
careful reworking that it has now had. It is less directive
by a long shot.

And, Jim, you may want to comment wearing your
Public Health Service and pseudo-Cabinet hat, or whatever,
Since you’re sitting in Secretary Sullivan’s chair. But I
think, in general, that unless you say otherwise, that
concern was met that we perhaps had been too prescriptive in
the way that was phrased. But that’s one of those things
that will evolve, and I’m not sure that we should get hung up
on that now. |

It has been suggested that the report be received
by the Commission in the context that we just said. All
those in favor, please say aye.

[A chorus of ayes. ]

CHAIRMAN OSBORN: Opposed?

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CHAIRMAN OSBORN: Abstaining?

[No response. ]

CHAIRMAN OSBORN: Wonderful, okay. Now, I think
the coffee is ready. We should take a break. We’re going to
have a brief legislative update when we get back, turn to the
second working group’s report, and get to the point where we
can see if redrafting is needed. At the point at which it
might be needed, we will then turn to discussing agendas,
dates, and whatever, while the redrafting--.

COMMISSIONER GOLDMAN: Redrafting what?

CHAIRMAN OSBORN: Well, in that case, okay, it’s a
report, right.

Recess. ]

CHAIRMAN OSBORN: ‘Let me propose that we get
Started again, and let’s proceed in the following way. I
will ask Carlton and Maureen to give us a legislative update,
and they said that won’t take very long, although I certainly
would enjoy any comments and discussion that you have. I
think we do have abundant time for our work today, and having
worked well so far I think we can keep on going.

After they are done and after we have had a chance

to discuss whatever we like there, we will proceed to Scott’s

 

 

 

 
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report for the other working group. He has proposed the
following thing, which sounds like a good idea to me, that we
have about a 45-minute discussion interval plan. The first
15 or so, Scott will present and summarize where the group
stands, and that leaves half an hour for good discussion and
the sense of what else needs doing with the report.
Obviously, at that point there will be some
decisionmaking that we can revise. But if that all went
well, we would have moved that along in such a way that we
have both lunch and the afternoon to talk about a whole
series of things, including dates, substance, locale of
Commission activities, and a couple of very interesting
suggestions this morning that have been made about the
possibility for focusing some of the Commission’s great
interest in smaller working groups.

Again, I think that whole issue needs to be
revisited because we’ve had such good products from several
pf those kinds of activities--the immigration activity that
Don was--sort of his own working group, but that worked
extremely well when it can be focused like that.

And I think that the federal-state-local working

group just distinguished themselves with the quality of that

 

 

 
 

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initiative, and has added greatly to our overall Commission
capability by so doing. And I think that that will turn out
to be true of the report that Scott is introducing.

So as we think about priorities and how to proceed,
we need to keep that mechanism in mind because that can allow
us to double or triple our time under certain circumstances.
And it’s as big as all outdoors, of course, so that’s always
a useful thing.

Anyway, I think we’ll have time for all that, and
let’s get started now with the legislative update from
Maureen and Carlton in whatever way you’d like to proceed.

MS. BYRNES: I/’1l1l just introduce Carlton. He’s
going to review the initiatives of the Commission, indicate
where some of the current legislation is pending or planned
and anticipated for this session of Congress, and then I'll
review the Public Health Service, DOD, and Department of
Veterans Affairs appropriations requests for FY '9l.

MR. LEE: Okay. You should have just received a
list of Commission initiatives which lists all the statements
of support, statements on various bills, the resolution on
immigration, et cetera. The only exception is the last item.

I took off and put on your desk earlier the latest statement

 

 

 
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we issued yesterday concerning whether or not the epidemic
has peaked.

I will start with the_first initiative we took,
which was the endorsement of the Americans With Disabilities
Act back in September, on the 6th of September. That bill,
of course, is the bill that provides protections from
discrimination for all people with disabilities, including
people ‘with AIDS and HIV, as well as those who are regarded
as Or perceived as having HIV or AIDS.

The Commission made clear at that time that such
protections were not only necessary to enhance the quality of
life for people with AIDS and HIV infection, but as the
Presidential Commission on the HIV epidemic and the Institute
of Medicine have reported, were the lynch pin, quote, "of our
nation’s efforts to control the HIV epidemic." That same
month, the Senate went on to--in fact, the next day the
senate went on to overwhelmingly approve that legislation. I
believe it was 76 to 8.

In the House of Representatives, the Americans With
Disabilities Act has moved much slower than anticipated at
that time. There were a number of controversies mostly

centering around transportation issues. A number of members

 

 

 

 
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were concerned about the costs involved in that area. HIV
and AIDS have not been a real controversy in the House, for
sure. -

There was just this past week action by the Energy
and Commerce Committee, which has jurisdiction over most
transportation issues. There was a mark-up of this bill,
finally, and it was approved, 40 to 3, in that committee. So
we're very pleased with that news. That was the major
stumbling block in the House. And I think maybe in the next
week or so, Judiciary will mark the bill up. We anticipate
mo problems there, as well as in Public Works.

In the Energy and Commerce Committee mark-up,
Congressman Dannemeyer offered several amendments relating to
HIV, one being that people regarded as having AIDS or HIV
should not be included in the bill, as well a provision
excluding all currently contagious diseases from the bill.

SO any sexually-transmitted or contagious disease would have
been excluded by the other Dannemeyer amendment. Those were
defeated by a show of hands, so there was no recorded vote,
although my understanding is, at most, he had five votes on

any one of those amendments.

So, therefore, we could see this legislation on the

 

 

 

 
 

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floor of the House of Representatives within, I would say, a
month or so, which is great news for all of us and all people
with AIDS and HIV. .

The next item we did was, of course, a statement on
the FY ‘90 appropriations bill. That was just a show of
support for the increased funding, as well as a message that
we would hope Congress would be deliberative in its policy-
making around AIDS and HIV and shun amendments that were just
on the floor of the Senate at the time that we anticipated
might come.

The monies in that ‘90 appropriations included $30
million for AZT monies and about $20 million for home care.
The monies were added by the Congress and were not included
in the President’s ‘91 request, and that was very unfortunate
mews. In fact, the HRSA budget was cut about 35 percent,
which Maureen will probably refer to again.

The next item we did was we issued a statement
supporting treatment on demand for drug users. Not much
action has happened on that issue, as well know, and it’s
clear that that is going to continue to be a tough row to

hoe, as we say back home in Texas.

The next thing we did was a statement on bleach and

 

 

 

 

 
 

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HIV control research. Don was very active in this particular
issue at the time. There were efforts by various members of
Congress to not fund programs that were looking at the use of
bleach and bleach distribution in controlling the HIV
epidemic.

Through the efforts of many people, including Don
and I believe several other Commissioners, we were able to
fight that and, at the last minute, save those programs, and
they are funded as of now. One important thing that happened
during that time was Assistant Secretary Mason sent a letter
Over to the Appropriations Committee chairman indicating
administration support for those programs. So, that was very
instrumental in that victory, of course.

The next thing we did, of course, was a resolution
on U.S. visa and immigration policy, which is one of the
issues that has received most attention in terms of our
initiatives. Again, that was in December. The press
conference that we had was well attended by members of the
media and representatives of national and international
organizations.

I think it would be fair to say the Commission’s

statement regarding immigration was well received and of some

 

 

 
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significance in focusing national attention on the need for
immediate administrative steps to end this infringement on
human rights and dignity of persons with HIV infection and
AIDS.

Since that time, Dr. Osborn, Dr. Rogers, Don
Goldman and several other Commissioners have been active in
trying to secure satisfactory resolution to the problems of
discrimination and the incoherent public health message that
U.S. immigration policy presents.
In early January, members of a task force comprised
of representatives from PHS, the Public Health Service, the
Department of State, and the Department of Justice met and
began discussions to ease restrictions. As a result of those
discussions, steps have been taken to expedite visa applica-
tions and ensure confidentiality.
It is as of yet unclear exactly what the new
regulations are. After the initial report of these changes
to the press, a number of groups met with representatives of
the administration to talk about these changes and trying to
get further clarification of what the policy is. The success
of these meetings is yet to be determined.

As recommended by the Commission, Assistant

 

 

 
 

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secretary Mason has called for, and did call for a comprehen-
Sive review of public health concerns regarding diseases
designated as contagious or dangerous. Recently, the PHS
announced that their recommendation is that HIV infection and
all other contagious diseases, except active tuberculosis, be
removed from that list.

While the PHS recommended the removal of HIV from
the list, it has maintained that it does not have the power
to remove HIV infection from that particular list because it
was mandated by the Congress in ‘87 in a supplemental
appropriations bill that the President add this to the list
of dangerous contagious diseases.

There are some legislative initiatives underway,
nothing introduced as of yet, to try to assert that the
Public Health Service does have the authority, should have
the authority, to make this determination.

June and David might want to comment on this. I
know they’ve both very active. Don, if you have any comments,
feel free to chime in on this one, or Jim.

COMMISSIONER GOLDMAN: I just want to say it’s a
continuing effort, it’s a continuing battle, one that I’m

confident that we'll ultimately succeed in. It’s one that

 

 

 
 

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we'll ultimately succeed in because there is--and I’m
particularly appreciative of the efforts of the Public Health
Service and Secretary Mason and-Secretary Sullivan in terms
of their efforts, and Jim as well, to work together on this
issue.

It’s a good demonstration of how, if a lot of
people work together on an issue, effective changes can be
had, and are potentially in the works. I think the problem
will be solved, and hopefully certain aspects of it will be
solved sooner. All of us are impatient, but I think there’s
a general agreement as to what’s right, and when everybody
gets together and agrees what’s right and agrees to work
together, it eventually gets done.

CHAIRMAN OSBORN: I think it might be worth
commenting that in addition to the letter that I think you
got in yesterday morning’s packet, in the context of the
upcoming March 29th speech, each time that has had any
Opportunity for input or discussion, we have tried to urge
that were this issue resolved in anticipation of that, it
would add greatly to the reception and credibility of that.
So as a last resort, we’ve urged that it be in that

speech, but, in fact, rather than leaving it there, have

 

 

 
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tried to suggest that since all of the hard background work
did, in fact, get done through rather strenuous efforts on
the part of the Health Service so that there isn’t that lying
put there as what should be on that list and everything,
that’s something that could be done that is basically dollar-
free and would, in fact, send a strong message that would be
received very warmly by people who have been concerned about
attitudes.

MR. PERNICK: Where is the issue buried, then, at
State or INS, assuming that it’s past HHS?

DR. ALLEN: There are two sides of it. One is what
might be done in terms of an administrative solution on a
short-term basis until we can get the second component, the
long-term solution, which is a legislative resolution. Right
how, the Department of Health has, I think--the Department of
HHS has gone on record as stating very clearly that from a
public health point of view, there is no reason to restrict
the travel of HIV-infected persons to the United States.

The Department of State is on record as believing
that this should be resolved because HHS has said that it
isn’t really a health issue and they see no reason to,

therefore, put forward restrictive measures if they’re not

 

 

 
 

 

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mecessary.
The changes that need to be made have to be agreed
to by Justice, and where we get-the disagreement is in terms
of how much flexibility there is in the interpretation and
application of the law. And we’re continuing to work on
that, but have not gotten resolution from Justice that
they’ve got the flexibility to make further administrative
changes. We hope that they will change their position on
that.

COMMISSIONER DES JARLAIS: It is not really a
Mollar-free issue. There are substantial dollars to be lost
if the policy is not changed.

I understand there was a meeting in Frankfurt last
Friday as to whether or not WHO would officially endorse
boycotting of conferences in the United States. Does anybody
have--Jim, do you know the results of that?

DR. ALLEN: The meeting was of the Advisory Board
for the International AIDS Society. It really wasn’t the WHO
at all, although, obviously, WHO was following carefully what
Nappened at that meeting. There were a number of represen-
tatives from the U.S. government; in particular, Dr. Ron St.

John from my office, Dr. Alan Hinman from CDC, and Dr. Peter

 

 

 

 
 

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West from the Department of State, who did attend as advisers
in terms of giving the most current information and letting
people know where the discussion was going.

After very intense discussion throughout the day, a
lot of different positions that were fielded and options that
might be taken, the decision was to put forward a strong
Statement that condemned the current position of the United
States, that said that there was very strong support for the
Sixth international conference as a vehicle for sharing
important scientific information, that people wanted to
attend that conference, and that as long as there was visible
progress made toward resolving the problem by the U.S.
government, there would not be further withdrawal of support
from that conference, but it’s all pending.

The second part of it clearly was that if we have
not resolved this issue, there will be no further support for
international conferences in any country that has dis-
Criminatory practices in terms of HIV-infected travelers.
What that translates to is that if we do not have a permanent
SO0lution in place--the dates are a little flexible, but I
think you can read sometime in December 1990--i.e., if we

don’t have it by the end of this Congress, if we don’t have

 

 

 

 
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things in place by the end of this calendar year, there will
mot be a conference in Boston in 1992. It will be moved to
some other country of the world-if indeed they continue to be
held, you know, as a major international gathering.
COMMISSIONER GOLDMAN: If any member of the
Commission would like, I have a copy of the resolution that
was adopted in Frankfurt on March 9th.

- CHATRNAN OSBORN: Thanks very much.

MR. LEE: The next item was the letter to President
Bush that was issued December 5th of last year. That was the
first report in a form of a letter to the President. The
report highlighted the testimony we heard at the November
hearing on health care and financing. The Commission noted
in that report about the growing complacency about the HIV
epidemic; that the 1990s will be much worse than the 1980s.
The link between drug use and HIV infection must be ack-
mowledged, and there is no national plan for helping an
already faltering health care system deal with the impact of
the HIV epidemic.

Several weeks later, the Commission received a
letter from Presidential adviser Bill Roper expressing

appreciation for the letter, the report, and that was the

 

 

 
 

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extent of our response from the administration. Sadly, the
FY ‘91 administration budget recommended a 35-percent
decrease, as I mentioned earlier, in the HRSA budget. So
that was very disappointing, given our report. HRSA, of
course, is the lead agency in developing models of HIV health
care delivery.

The next item we--I don’t know if David or June
wanted to comment on that report, or respond to it.

[No response. ]

MR. LEE: The next thing we did was, of course, the
Statement on the Care Act of 1990. That’s the bill introduced
by Senators Kennedy and Hatch and numerous other Senators
which provides disaster relief to areas hardest hit by the
epidemic, as well as monies to rural areas for the purpose of
providing more effective and cost-efficient systems for the
delivery of care, treatment, and early intervention. By now,
you probably have several copies of that legislation. I
think we’ve been saturated with that bill here at the
Commission.

The bill authorizes $300 million for emergency
relief to about 13 metropolitan statistical ee many of

which, I think, are represented around this table--those MSAs

 

 

 
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with greater than 2,000 AIDS cases. According to the
relative number of cases and per-capita incidence within the
MSA, about 50 percent of those dollars would be distributed
based on that. The other 50 percent would be awarded by the
secretary of HHS as supplemental grants to MSAs with greater
than 2,000 cases of AIDS based on need, local investment,
potential for immediate utilization, and the development of a
-omprehensive plan for the organization and delivery of HIV
care, treatment, and support services.

The bill also authorizes $300 million for the
development of comprehensive care programs. The funds would
be distributed in block grants to the States based on the
number of AIDS cases reported to the CDC by the State in the
preceding 24 months as a percentage of all AIDS cases
reported in the same period. All States receiving funds
would be required to develop a comprehensive plan for HIV
health and support services.

A hearing on this bill is scheduled for next week.
The Labor Committee hopes to mark the bill up the week of
April 4th, so this bill could very well be on the Senate
floor within the next month or so.

With the exception of yesterday’s item, which I

 

 

 

 

 
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believe you have in front of you, regarding whether or not
the epidemic has peaked, that sums up the Commission initia-
tives that we’ve done thus far. -

In terms of legislation, I believe Mr. Waxman also
talked yesterday about his Medicaid bill which has been
introduced, H.R. 4080. You have a summary of the bill and a
copy Of the bill in your packets.

This bill basically has four components, the first
being a prevention and early intervention proposal which
would amend existing Medicaid eligibility rules to create a
new category of patients that States may elect at their
option to cover. The new group basically would have to meet
three criteria. They must meet the current standards of
poverty established by the State, they must be infected with
HIV, and they must have serious immune deficiency for which
medical intervention is needed to prevent further decline or
ATDS-related illnesses.

I won’t go into a lot of detail on this. I know
Mr. Waxman did a very thorough job on this yesterday. Other
issues, though--one major issue is the disproportionate share
adjustment for Medicaid payment. This proposal would require

states to pay a higher rate to hospitals that care for a

 

 

 
 

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larger number of Medicaid AIDS patients.

This bill, I believe Mr. Waxman hopes to move
fairly quickly in the next several months, and I don’t know
if Maureen has anything to add on that. I know you heard Mr.
Waxman. I was out of the room, unfortunately.

Eunice has a question.

COMMISSIONER DIAZ: In regard to these two bills,
the Kennedy care and the Waxman bill, could you just outline
for me some of the very basic differences? If one is
Supported, does that exclude support of the other, or is it
just two different ways of coming at financing?

MR. LEE: No. In fact, there’s been a lot of
progress. Senator Kennedy and Congressman Waxman have had
discussions. There is agreement on a common direction to go,
so that these bills will be conferenced in the end, and so
we'll have a very nice, comprehensive AIDS bill in the end.
The Kennedy bill will be, through the committee
process, expanded in terms of the early intervention piece,
which Senator Kennedy certainly is very interested in having
happen on the Senate side. Mr. Waxman, on the other hand, is
also adding to his bill a disaster relief title. So there

will be a number of common areas to the bills.

 

 

 
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COMMISSIONER DIAZ: The Kennedy bill does not speak
to assisting hospitals.

MR. LEE: Yes, it does.

COMMISSIONER DIAZ: It does?

MR. LEE: It does, yes, through the emergency
relief, primarily, and, in fact, both titles.

MS. BYRNES: In a different way than the Kennedy
bill does. And to some degree, Eunice, it has to do with
committee jurisdiction.

COMMISSIONER DIAZ: Okay.

MS. BYRNES: If you’re dealing with Medicaid
reimbursement on the Senate side, those changes go through
the Finance Committee. Labor and Human Resources doesn’t
have jurisdiction over the entitlement health spending. On
the House side, the subcommittee that Mr. Waxman chairs has
jurisdiction over both, discretionary impact aid types of
legislation and assistance to hospitals, as well as enhanced
Medicaid reimbursement either to an individual or a person.
I think in this case it has more to do with
jurisdiction than any difference of opinion between the two
members of how to respond in sort of parallel manners, both

in terms of reimbursement as well as discretionary assistance

 

 

 

 
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to heavily-impacted areas.

COMMISSIONER DIAZ: It has been very helpful, that
explanation. -

MR. LEE: Belinda had a question.

COMMISSIONER MASON: Carlton, I think you do a
great job. I really appreciate the work you do.

MR. LEE: Thank you.

COMMISSIONER MASON: This is a lot of work, you
know. I mean, look, it’s like from September until now and
we’ve sort of kind of jumped on most of the major things and
Kind of led some of the major things. I think Carlton has
peen carrying the water for us a lot. So, you know, a big--.
MR. LEE: You’re too kind.

COMMISSIONER MASON: Yes. I’m also too stupid to
think of what I want to say next. |

MR. LEE: I don’t think they can handle both our
accents for very long.

COMMISSIONER MASON: That’s it.

[Laughter. ]

COMMISSIONER MASON: I guess this is sort of
something that Don Goldman brought up yesterday. Is there

some reason that we haven’t particularly endorsed the Waxman

 

 

 
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bill the way that we have the Care Act.

MR. LEE: Yes. Let me indicate that there is the
early intervention piece that Waxman is working on. The
Medicaid piece is separate; that is a separate bill. I did
confuse things a little bit. The Waxman plan is to introduce
probably in the next week another bill that is early inter-
vention-focused only.

The Medicaid stuff, he separated because of various
rules, reasons, et cetera, committee issues. But his plan is
to introduce a bill in the next week or so which would
authorize about $400 million for the next three years--each
year, $400 million--for early intervention programs, and I
think he may have touched on that yesterday as well. There
is a summary of that planned bill in your packet, entitled
AIDS Early Intervention Legislation, Grants and Entitlements.
CHAIRMAN OSBORN: David.

VICE CHAIRMAN ROGERS: And a quick answer, Belinda,
might be that Mr. Waxman is just coming up to the plate, and
Mr. Kennedy was at the plate when you were dealing with
Elizabeth Taylor.

[Laughter. ]

VICE CHAIRMAN ROGERS: I think we can decide how

 

 

 
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we'd like to deal with this one. I would just recommend that
you leave Belinda out of the: testimony.

[Laughter. } -

COMMISSIONER MASON: One more thing, and this is
decent, I promise.

[Laughter. }

COMMISSIONER MASON: Carlton, can you give me some
kind of realistic assessment about what’s going to happen
with both of these? I mean, how many friends do we have on
this, and are people really going to--you know, is money
going to be forthcoming? What are we looking at here in
terms of the reality of having both of these things or parts
of them adopted, and when is the time frame?

MR. LEE: As I mentioned, the Labor Committee plan
is to try to have the bill out of committee in early April,
sO that there could be Senate action on a bill fairly soon.
The Waxman plan, I think, is to move as expeditiously as
possible as well.

I think in terms of the Care Act, the bipartisan-
Ship is very obvious between Kennedy and Hatch. You can’t
get much more bipartisan than that. Senator Hatfield, who is

ranking Republican on Appropriations, is also on the bill.

 

 

 

 

 
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There are a number of key Senators on both sides of the aisle
Supporting that bill. Waxman, I also think, has encouraging
Signs of support for his legislation from both sides of the
aisle.

So I think--you know, jump in if you need to on
this, but I feel confident that maybe by early summer we
could have a bill that we could get through by the end of the
session, which will probably be sometime in late September,
early October. So I think we’re all optimistic at this point.
“CHAIRMAN OSBORN: Don Goldman.

COMMISSIONER GOLDMAN: Also, I think there’s an
important thing that I’d like to say, Belinda, and that is
that I think it’s important that except in rare circumstances
that we not get involved and bogged down into the details of
legislation, and that we not--and I think the statement that
the Commission ended up making very carefully did not endorse
the bill. It endorsed the process, the concepts, the ideas
behind the bill.

I don’t think that, except rarely, we want to get
embroiled into literary language, debates over what clause
belongs where and how it should work out. I know, in

Speaking to Roy Rowland, he feels strongly. As a matter of

 

 

 

 
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fact, I asked him, why weren’t you--you know, is there any
reason why you weren’t a cosponsor of some of the Waxman
legislation, and he indicated that one of the things he
wanted to do was as a member of the Commission--and he didn’t
think it would be appropriate for the Commission to get
itself involved in endorsing specific pieces of legislation
rather than dealing with principles. |

He thought it would be more appropriate if he, as a
member of the Commission, you know, stayed away from any
specific endorsement of a specific piece of legislation at
this time, and I think that says something that we ought to
consider as we go along this process.

MR. LEE: Okay. I think that wraps up my piece,
and I’ll turn it over to Maureen to talk about appropriations.

MS. BYRNES: This is, in fact, a good place, I
think, Belinda, to pick up in terms of what the prognosis for
the legislation is, and then the next question always is, if
you get the law, do you get the bucks? Sometimes yes,
sometimes no; usually, not everything you want.

We will be moving, as always, at the same time with
trying to get the Kennedy bill, the Waxman bill, other bills

that may be pending--those move at the same time that the

 

 

 
 

 

 

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appropriations committees and the budget committees are
looking at how much available dollars there are to spend on
overall health care spending and, in particular, for HIV and
AIDS-related programs.

Those are things we need to monitor very, very
carefully, and I promise you both Carlton and I will keep you
very much abreast of that because things happen real quickly |
and when you’re talking about legislation maybe getting
passed by early summer and signed by the fall, appropriations
bills determining how much money is actually going to be
spent are getting marked up in early summer, sometimes
eventually decided on in the fall. So you’ve got conceptual
policy, good goal-setting, where we want to go in terms of
the programs, moving at the same time that we’re looking at
Spending money in the traditional way that we have through
the existing NIH-CDC-ADAMHA-HRSA programs, and they take a
very careful balancing act of trying to get the dollars into
the most effective programs as opposed to simply getting the
dollars in the first place.

A few things real quickly, and I don’t want to
belabor the obvious. We’ve handed out the budget justifica-

tions for the Public Health Service, talking about their

 

 

 
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proposal for how much money there should be and how it should
be spent in FY ‘'91. I don’t know if you have these in front
of you, but we also have the VA-and the DOD numbers.

| By way of overview, I would just suggest that you
may well, as you all have over the last couple of years,
often see a lot of different numbers thrown around. If
there's any confusion, we're here to clarify what, in fact,
got tossed into the pot.

Usually, when you’re talking about overall budget
for FY ‘91, you’ll see relatively large numbers presented
because the federal government will promote an overall
Spending number through DOD, through VA, through HUD,
perhaps, although as Congressman Green told us, very little
specifically designated for AIDS-related beds, Public Health
service, and entitlement spending--how much Social Security
money, how much Medicaid money is being spent. So it really
is, when you look at an overall budget number, the kitchen
Sink; it has everything in it.

If you’re looking at the investment in research,
prevention, and the minimal dollars that the federal govern-
ment provides for service delivery, you’re looking at

essentially the Public Health Service budget, which then

 

 

 

 
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become the numbers that you mostly see reported in the
mewspapers.

Last year, the Congress appropriated approximately
$1.6 billion in the Public Health Service. The President’s
budget for FY ‘91 for the Public Health Service is ap-
proximately $1.7 billion, a relatively small increase. One
of the programs within the Public Health Service that is
increased--there are other programs that are certainly
proposed for elimination and drastic reductions--but albeit a
relative increase when you look at what the need is, is for
the area of HIV and AIDS.

In particular, you’ll see the biggest change, if
you will, from the FY ‘90 to the FY ‘91 year in the HRSA
budget. It is a cut. It is not a slight, small increase.
And I think, again, it’s an area when you look at the budget
that will help us as a Commission enter the debate that the
Executive Branch is having with the Legislative Branch, and
that is what is the federal government’s role in service
delivery.

The federal government will clearly indicate their
responsibility in terms of reimbursement through the Health

Care Financing Administration. But if it comes to the actual

 

 

 
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delivery of programs, you see this with HRSA and ADAMHA, in
particular. We’ve heard this discussed now at a number of
our different hearings that we use demonstration projects to
provide service delivery because there ain’t no federal
government service delivery program, or very little.

Usually, it would come in a block grant format that goes to
the States, who then, in turn, can determine the best use for
their particular jurisdiction.

That’s why I think--and this is sort of an editorial
comment on my part, but I think that’s why you see cuts in
the HRSA program. It was not the administration, either the
Reagan administration or the Bush administration, initiative
to provide home health care services or to provide drug
subsidy programs for AZT and other drugs, which I think is
important. We now have aerosolized pentamidine and other
drugs that can be reimbursed under that drug subsidy program.
| It was not the administration or the Executive
Branch that proposed planning grants to local communities
that needed to think about what the impact of HIV and AIDS
may be prior to a large case. It was the Congress that has,
for the last couple of years, taken the initiative through

legislation as well as through the budgetary process and the

 

 

 

 
 

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appropriations process, to say we simply have to provide the
services in even the minimal way that we do, in addition to

recognizing our continual role in education, prevention, and
investment in research.

It comes as no surprise to me that the funding for
the drug subsidy program and the home health care program
were not proposed in the administration’s budget. I think
it’s also very interesting for us to take a careful look at
the ADAMHA budget because it hasn’t been one of the agencies
getting the larger increases as well when you look at HIV and
AIDS.

Again, to some degree, you’1ll see the bulk of the
money going into basic research and some money going into
service research through the opportunity of the demonstration
programs. But I think HIV and AIDS and where the increases

go in terms of research and prevention and education is a
really good way to look at the debate, I think, that currently
exists about what’s the federal government’s role in service
delivery.

And I would hope that as we look at what the
growing need is for people with HIV infection and AIDS, both

people who are sero-positive as well as people with full-

 

 

 
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blown AIDS, we'll talk about what the federal responsibility
is in terms of funding and the actual delivery of those
services. -

We've given you the PHS justification that talks
about where the dollars would go under the President’s
request. We’ve also provided you with a draft NORA document,
the National Organizations Responding to AIDS. They propose
about a $2.8 billion budget right now, a draft. I don’t
think it’s been signed off by all of the members, but it’s
circulating. It’s certainly something they would all want
you to be very well aware of.

And the bulk of the additional dollars, if you look
at the numbers in the packets that we gave you, go into
prevention and education at the Centers for Disease Control
and the service delivery programs at HRSA. They also would
be very supportive of--I believe I would be speaking for them
as part of the document--supportive of initiatives that would
look at the expansion of Medicaid reimbursement for people
who are currently not eligible with HIV infection.

Eunice?

COMMISSIONER DIAZ: Just one statement regarding

HRSA and their role. Dr. Bob Harmon, the new Director for

 

 

 

 
 

 

 

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HRSA, has just created a special body to advise him regarding
HIV within the HRSA responsibility. And the chair of that
body is Molly Coy and I’m a member of that task force, and it
might be important.

Their initial discussion on the very first meetings
was to at some time in the near future combine their efforts
with ours in perhaps looking at the service aspect of HRSA.
And Dr. Harmon seemed very open to this and it’s something I
think we should look into.

MS. BYRNES: One of the things that we try to do at
a staff level, when we’re aware of the meetings or are given
notice of the meetings, is to attend in an observing capacity
SO that we’re aware of what activities may be happening at
HRSA. We don’t necessarily actually participate because I
think there may be a difference of opinion about exactly
where the agencies should be going or what the roles of the
different agencies are.

We’ve also at a staff level conducted staff study
groups where we as a staff--we try once a week to invite
representatives from agencies, organizations--NORA has come,
the AMA has come, other organizations--to come and talk to us -

about what they’re doing so that we’re kept abreast of that.

 

 

 
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Jason and Carlton and others have really done a nice job of
getting an array of people to come, and it may well be a good
idea for us to do something like that with the HRSA advisory
committee, or at least attend the meetings that they’re
holding. That’s a good suggestion.

CHAIRMAN OSBORN: As a wrap-up comment on this, I
was very grateful to Belinda for initiating what I want to
finish off here in her comments just a little bit ago about
the amount of work that is encapsulated in this brief report.
It doesn’t even mention the staffing that has been done for
the site visits, for the small working groups.

I think I mentioned very quickly yesterday that we
didn’t even have durable office space until about the
beginning of November, and it is now only middle March. And
I think that the accomplishments of the staff under Maureen’s
leadership are beyond my belief, quite frankly, in the
smoothness that we have experienced, with very few major
exceptions, in our function as a Commission, sometimes even
pretending that we were running on something like office
Space, and so forth, when we really didn’t even have the--we
will all think wistfully of the day when we didn’t have a fax

machine, for instance.

 

 
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But, nevertheless, I think you won’t mind if I take
the prerogative of thanking the staff at this particular time
because that summary stands out-as something that has to be
something of a record-setting accomplishment for a small
group of people who have been working against some tough
start-up circumstances.

Given that they’ve worked that way in start-up
circumstances, I think we have every reason to anticipate a
very exciting potential for the Commission as we continue.
And I think when we talk this afternoon about things that we
want to do and the priorities, and so forth, we now have a
sense of real security and pride that a staff and a foundation
for our operations has been brilliantly laid.

So from my personal point of view, but I think on
behalf of the Commission, all of whom are nodding as I say
this, I want to say thank you.

[Applause. ]

MR. LEE: I will send a copy of the Waxman bill as
soon as it’s introduced, the early intervention, testing and
counseling bill, to all of you for your information.

CHAIRMAN OSBORN: Let’s turn, then, if you’re

agreeable, to Scott’s report and to some discussion of it

 

 

 

 
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before we break for lunch.

COMMISSIONER ALLEN: Let me share with you some of
the structure. I plan on, within the 45-minute structure,
sharing with you a little brief history of how we got to this
point of dealing with testing and all of its ramifications,
describe a little bit about the Boston meeting, and open it
up to Commissioners to give their impressions that were in
attendance, and then to look at what the working group is
going to have for future activities along the subject matter
of testing and its ramifications. Hopefully, that will be
half or less than half, and then the other portion of the
time, we will be in full Commission discussion about what we
are doing.

We decided, after getting together a laundry list
of what we wanted to look at in the Human and Social Issues
Working Group, that testing would be our first issue, and the
potential uses of HIV testing and screening include helping
to ensure the safety of donated blood, tissue and organs, the
epidemiological surveillance part of the public health
strategy, to identify contacts who may be infected; foster
individual behavioral change as a component of infection

control policies in hospitals and as an important adjunct to

 

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patient care.

We decided to start out with patient care and early
intervention. As you have heard quite a bit about, and we’re
going to look at legislatively, we're looking at early
intervention as a major issue, and testing is a large
component of that. So we decided to tackle that first.

We met in Boston, dealing with the early interven-
tion, on February 15th and 16th, and it was basically to deal
with early intervention and the psychosocial aspects of
testing. Marc Roberts was our facilitator, Professor of
Public Health at Harvard.

The morning sessions were testimony time, and then
roundtable. I believe you probably have a list of who was in
attendance on the roundtable, so I don’t want to take up the
time dealing with that. But let me just share with you some
of what the testimony--the types of testimony we had.

It was an overview of testing issues by Dr. Paul
Cleary, types and standards of tests by Dr. John Ward, State
legislative trends by Dr. Kate Cauley, and the challenge of
testing in different populations by Marie St. Cyr. Then we
looked at the programs of the Public Health Service, the

Centers for Disease Control and HRSA programs dealing with

 

 
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the testing issue. Then the roundtable centered around the
role of testing and early intervention.

The next day, we started out with the continuum of
psychosocial needs, and a presentation by Dr. Marshall
Forstein, and then a roundtable dealing with the psychosocial
issues.

So I’d like to open it up to the Commissioners.

The Commissioners that were in attendance were Larry Kessler,
Eunice Diaz, Don Goldman, and Harlon Dalton. So I'll just
open it up. Larry, do you have impressions? Do you want to
just go around and share with the folks?

COMMISSIONER KESSLER: I think the number one
impression is that we couldn't do it all in one session. We
opened a very complex can of worms here. In spite of all our
efforts to sort of keep it narrow, there is no way to keep it
marrow and concise, at least as far as where we are right now.
The issue that comes up more and more, even when we
talk about testing, like everything else we talk about, is
money. Where does the money come from for early intervention?
How is it administered? What is the access like for primary
care, for monitoring, and so on?

But I don’t think we also probably spent enough

 

 

 
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time looking at the psychosocial issues. While we got into
it, the more we got into that we realized fairly quickly that
that, too, needed more time if we were going to put together
a report that talked about the complexities. We really
scraped the surface.

COMMISSIONER ALLEN: Do you want to share, Eunice?
COMMISSIONER DIAZ: I think the most insightful
testimony for me to hear was that of Marshall Forstein from
outpatient psychiatry at Cambridge Hospital. In my opinion,
he articulated the short and long-term implications and
psychological factors on getting people into testing that may
mot be so readily obvious when perhaps a large portion of our
mation would be encouraged to do so without the proper checks
and balances in the system to support that kind of action or
behavior.

I frankly had never understood it as well as Dr.
Forstein presented it, and I’ve heard a lot of presentations
on the psychological and mental health support and counseling
Support needed by people that make a decision to be tested.
But in looking at the whole testimony, I think that that
particular presentation stands out in and of itself as

something that really opened our eyes in terms of the kinds

 

 

 

 
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of things that could happen to people that have not been
counseled properly and the types of mass communication of a

message in which a society has not yet set a response in

|place to be able to support the individual’s decision to test

or not to test. —

So I would say, from all the things we heard, that
one seriously made an impact on me in terms of the knowledge
base that it came from.

COMMISSIONER GOLDMAN: Much of the--first of all, I
want to suggest that despite the best efforts that I thought
that the--I would seriously question reusing the format that
we used a second time around. We had tried to work out a
roundtable with the idea that we would get an open and frank
discussion of views from the participants there, and I think
most of the participants there were good, careful, effective
advocates and, for the most part, gave the party line and
were not open about any doubts that they might have about
their own positions.

The kind of openness and frankness that really was
mecessary as part of that process really wasn’t there, nor
was--and no criticism of anyone, but largely because of some

last-minute changes in terms of scheduling, there were some

 

 

 

 
 

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disproportionate segments in terms of different points of
view in different kinds of communities that were dispropor-
tionately represented, and particularly in terms of service
delivery people.

Obviously, if you get a bunch of service delivery
people, you’re going to come up with a conclusion that there
are not sufficient funds Or resources available to provide
the necessary services they provide. And I’m not saying that
that’s wrong; I’m just saying that that’s what we were faced
with. As a result, as I think Scott will discuss, we have
decided or suggested that there be some other areas that we
will be looking to focus on.

It was a very useful meeting. We did get some very
effective--as Eunice pointed out, some very effective pieces
of testimony from some of the participants there, very moving
discussions. But it clearly was not complete, and I regret
that unlike the well-organized group that Diane led--you were
able to move it up, open it up, close it up and wrap it up in
one session. I’m afraid that we’re not as efficient as you
were and we’re going to have to keep on going.

COMMISSIONER DALTON: I suspect that Don’s expecta-

tions may have been too high for any two-day meeting. I

 

 

 
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didn’t walk away feeling nearly so disappointed. I was
disappointed that some folks didn’t show up, and we need to
find a way to hear from them, particularly public health
Officials.

I don’t know if it’s a mystery to people that we
don’t have a written report, just because we didn’t feel we
were at a point to present, or whatever word we’re using--to
have a report received, which is why we’re proceeding in this
fashion.

The draft report that Jeff did prepare, I think,
did a terrific job at the beginning of talking about the
nexus between testing and early intervention. The reason
that we focused on testing is because, with the apparent
advent of treatment methods that can be employed early in the
game, there seems to be a push from lots of quarters, from
the Gay Men’s Health Crisis in New York, from parts of the
federal government, to encourage people to be tested so that
they can access early intervention. Our interest was, given
that this issue was now being revisited--the issue of testing
in this context--to take a look.

I did think that we got fairly uniform testimony,

not about the precise way in which these issues ought to be

 

 

 
 

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linked, but a pretty substantial consensus that early
intervention is not available everywhere and to everyone, and
that insofar as early intervention is not available to a
particular community, whether that’s defined in geographic
terms or gender terms or race terms or risk factor terms--
where it’s not available, then some hard thought needed to be
given to the question of encouraging people to be tested
under the justification of early intervention.

This, then, tied in with the testimony on the
second day about psychosocial issues and, in particular, the
powerful testimony by Dr. Forstein, that asking people to be
tested is not simply a matter of--that the activity of being
tested for HIV is not simply a matter of drawing blood and
having test results given to you, but that it brings up for
people a host of concerns of a psychological nature that are
really often very difficult to mediate and modulate and deal
with. Therefore, testing is not exactly a free enterprise, a
cost-free enterprise, on a kind of human level for people who
are tested--wonderfully complex and textured testimony about
that.

Larry said we scratched the surface. I think we

got a lot of very rich testimony, but what it did for us is

 

 

 
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it made us realize how much more there is out there; I mean,
how truly complicated all these issues are. I think I at
least walked away sort of proud-of what we had accomplished,
but a little bit chilled at what else there was to learn. So
I think we’re really in mid-process on this first of the
issues that we have on our perhaps too ambitious agenda.
COMMISSIONER ALLEN: I would say some of my
reaction to all of this was that, along with what Harlon’s
impressions are, it’s a kind of a smoke and mirrors right now
that early intervention is there. It’s not there for the
indigent. It’s not there for those even with insurance
because of the discrimination, because of the issues of
workplace, as well as other factors. And insurance companies
may not be paying for it, and then all of a sudden you access
your insurance plan and it’s gone; you lose it.

So we have a real problem when we’re talking about
early intervention. The funding is not there, and if we’re
going to be advocates we need to really examine--advocates
for the justification of testing in early intervention--we
need to examine what the system is. We can do smoke and
mirrors with budgets and deficits, but not with human life,

and that’s a very cruel system.

 

 

 

 
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And I think that what we came away with from that
meeting is we still have more to do on early intervention as
well, so let me share with you some of what we are looking at
bf the areas that we’re going to examine. We will put this
in Outline form and a timetable, and then to examine where
the balances are, and then move with that into where we need
to get more testimony of what type of framework that will be
in and keep you all updated on that.

Also, this is the time for your input on where you
see we may be lacking in some areas, or we need to highlight,
pr what your reactions are with this list. This is the
initial list of when we walked away from the meeting saying
this is more. It does begin with more clarification of the
early intervention.

The first is to what extent is early intervention
available or unavailable--the Medicaid, the drug subsidy
program, and so forth--to continue that process of looking at
the availability.

The second is a summary of average cost of early
intervention and data and other sources of materials, to put
that together for you all; risk of loss of credibility of the

public health system if it advocates testing using an early

 

 

 

 
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intervention rationale where early intervention is not
available or not accessible; then moral and ethical implica-
tions of advocating testing using an early intervention
rationale where early intervention--this is one of Don’s;
hang with me here, folks--using early intervention rationale
where early intervention is not available or not accessible.
Is it moral or ethical to seek to create a demand for early
intervention through widespread testing, knowing that such
services are not available, hoping that the created demand
will increase resources devoted to early intervention, which
is something that really came up at the meeting.

Number five would be a continuum of care models.
What are we actually talking about with early intervention?
Are we talking about just medical intervention? Are we
talking about the psychosocial needs, the entire gamut?
Let’s see. Six would be the drug treatment, what
kinds of drugs are on the horizon--again, it goes back to
cost factors, and so forth, and availability; seven, the
efficacy of counseling in the absence of HIV testing; eight,
informed consent; nine, partner notification and name
reporting; ten, monitoring and evaluating the amount of CDC

funds spent on education versus testing; eleven, home test

 

 

 

 

 
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kits; twelve, other aspects of testing such as blood bank
Standards, and so forth.

So those are some of the things that we’re looking
at, and we have not put together the outline and timetable,
but that is our first project walking away from this. If you
have any input on content, this is the time to just open it
up, and we’ll get back with you on the timetable.

VICE CHAIRMAN ROGERS: Scott, that’s very elegant,
and it also makes me realize, wow, you’ve got a tough, tough
area. I’ll ask one question of the group, and I’m going back
to some suggestions that were made earlier. Is this an area
where it would be helpful to have some other experts join
you, or are you too far along?
COMMISSIONER ALLEN:

Oh, no, no.

VICE CHAIRMAN ROGERS: Well, I mean there’s a group
process, and you obviously are already involved in it. Would
the addition of three other people that could do some of the

work--would that help? I mean, should we use this special
subcommittee kind of device with you, or is it simply you

just need to hear more testimony? It’s such a tricky area.
COMMISSIONER ALLEN: I think it could be both. I

think where we're really missing some of the expertise is,

 

 

 

 
 

 

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unfortunately, Charlie couldn’t be there in Boston, and I
think we really need Charlie’s input into some of these
things. -

CHAIRMAN OSBORN: A Kansas blizzard, as I recall.
COMMISSIONER ALLEN: Yes, right. When you talk
about adding folks or getting expertise, there’s one right
there, and other public health folks. I think that we can
expand along that line and to examine where we could bring in
some folks. But what was very disappointing was that Charlie
couldn’t make it, because there are some public health issues
in here.

CHAIRMAN OSBORN: Jim, and then Charlie.

DR. ALLEN: Just in the last 30 seconds, the issue
tf wanted to raise has surfaced very clearly. I think the
information that all of you have presented today is very
useful. It supplements the information that I got back from
Ron St. John on my staff, who was there, and I think raises a
lot of--I think the right word was the one, Larry, that you
used, complex--the complexity, the intertwining of issues
that just surrounds the one issue of counseling and testing.
But in the discussion that I’ve heard so far,

except for the last 30 seconds, I’m concerned that there

 

 

 

 
 

 

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wasn’t much at all about the public health aspects. When the
test was first licensed in 1985, from a public perspective,
obviously, the primary use to which it was put was to make
the blood supply safe. Then people very quickly began to
realize also that, well, there are people are going to be
interested in whether they’re positive or not. Therefore,
we've got to have what were then called anonymous counseling
and testing centers, and so on.

Finally, it got around to the point that many of us
realized very early that this was going to be an extraor-
dinary--the antibody test was going to be an extraordinarily
useful tool to detect very early, to identify people who were
positive so that we could much better target the educational
message. To those people who were clearly infected or
positive, the message is modify behavior so that you don’t
transmit further. Also, the medical aspects that are now
known as early intervention are becoming much clearer even
though they aren’t widely available.

The other side of it, however, is for people who
are antibody-negative, and I realize that you can’t just
Simply easily classify people positive or negative based on

one test if they’ve had high-risk behaviors that may have

 

 

 

 
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exposed them, you know, throughout that period of time. The
point is that there are very clear educational messages that
meed to be gotten out. -

You raised right at the very end the issue of
partner notification, and so on, and we know that in areas
where this has been done on a limited basis with selected
populations that we’re finding a population that is at
extraordinarily high risk. Twenty to thirty percent of the
sexual partners, in particular, who are subsequently, through
the partner notification process, brought in and counseled
and tested--20 to 30 percent are already antibody-positive.
The others have continued to be at high risk, many of them
mot having realized that fact.

We have got to focus much more on the educational
aspects of this, and I hope one of the areas of testimony
will be the efficacy of counseling. I was impressed, again,
with the statement that there is a lot of psychological down
side to the counseling process. Too much, we have focused on
sort of single-episode counseling. We need to look at what
really needs to be done in order to make it effective.

And I think that there just hasn’t been enough

public discussion about all of these, and if we’re going to

 

 

 
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devise and put forward budgets to try to reflect what is
needed, you know, I hope that you’ll help us get a lot of the
information that we need from a-public health perspective.

‘CHAIRMAN OSBORN: Charlie Konigsberg.

COMMISSIONER KONIGSBERG: Jim has brought up, I
think, a number of very critical points about the HIV
antibody tests, and I at various times have had to spend a
lot of time, as I think a number of us have in public health,
about the history of that test and then this rapid-fire
introduction into the clinical and public health scene, which
it really wasn’t designed to do, and I think this has put a
lot of pressure on us.

I think a number of good points, very important

points, have been brought up by the group, Scott, and I think
there are some things that need to be taken very seriously.
And I, in the absence of a written report, took notes as fast
as I could. I don’t write very fast or very well.
Just a couple of thoughts on how to continue the
process, and this afternoon, given the opportunity, when we
get to the agenda-setting aspect that June has mentioned, I
Will bring up the prevention as a major agenda item.

I think that if the Commission agreed to do that,

 

 

 

 
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what we need to do is come up with some sort of a--I’m not
Sure the word "coordination" conveys what I’m after--an
interlocking process that makes-sure that the ethical and
moral issues are running in tandem with the public health
issues, which isn’t to say that there shouldn’t be separate
groups. I think there needs to be for a variety of reasons,
but there needs to be a lot of overlap in some fashion, and I
think that can be done.

Speaking as a practicing public health official,
there is a constant balancing that goes on when we deal with
many of our issues. And there’s been a lot written by, for
example, the Hastings group and others, and this is not say
that all public health officials pay as much attention to
that as they should. So I want to, you know, throw a caveat
out there, and I think that’s where the Commission can have
an impact.

In order to do that, we have got to come up with
one or more structures for bringing public health officials
into the discussion, and that can be done in more than one
way. In fact, I would urge that because--and I'll say this
again this afternoon--when you get down to where the respon-

sibility lies in the States and the localities, who usually

 

 

 

 
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take their authority from the States, it lies with State
health officials. It lies with State health departments, or
whatever name these go by. -

We’ve got to bring, also, the public health
practice aspects into this, the real world. A lot of what I
do in groups--and I assume the reason I was repeatedly asked
back to CDC in spite of taking jabs at them occasionally--Jim
Allen was at quite a few of those meetings--is to bring the
real world in. Now that I’m at the State level, there is
some question as to whether I’m still in the real world.
But, nonetheless, I haven’t been gone from it very long. So
we’ve got to take this into account, and I think there are a
lot of very serious issues.

I know that I got involved with some things in Fort
Lauderdale with respect to testing that were done differently
than anything else we do; for example, a passionate insis-
tence on my part that we were doing to have special written
and oral informed consent drafted by our staff attorney, no
less--that’s how seriously we took it--before we would
institute expanded testing and counseling even in the STD
clinic, much less some other settings. I was asked many times

why. You don’t do it for syphilis, you don’t do it for a

 

 
 

 

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whole variety of things. And I think you can probably guess
why that had to be done.

I also think--and I don’t know whether this is the
appropriate setting--the one thing that’s occasionally
lacking, I think, with this Commission--we’ve got a tremendous
balance--is the practicing clinical physician, the one that’s
actually seeing patients with HIV disease on a daily basis.
For some of us, it’s a struggle to try to act like
maybe we're actually able to discuss that, and that’s
different than the research angle. We need to start figuring
put how to bring those in, and they won't necessarily come
from big, major teaching centers in New York City or Boston.
They may come from Wichita, Kansas, and I could make a good
Suggestion--St. Louis--excuse me. Well, Kansas City would be
our equivalent; that’s the big time.

So somewhere along the line if we can come up with
some way to make sure that we've got this interlocking, I
think it was difficult for me to be real comfortable with the
absence of public health people up there. And in order for

me to access those people, there’s got to be lead time.

They’ve got to know what they’re getting into and what’s

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COMMISSIONER ALLEN: Go ahead, Harlon.

COMMISSIONER DALTON: I’ve been waiting for a
while, Scott. -

A short response to Charlie. I, too, have really
penefitted from hearing from doctors who are treating AIDS
patients on a daily basis. In Los Angeles, all of us got the
benefit of, for example, spending time with Dr. Wilbur
Jordan, but there are any number of other doctors and I agree
that we need to find ways to hear from them not only in this
working group, but in lots of ways.

But, Jim Allen, you’ve actually, I think, been
Spared the various forms of my lecture about the bifurcation
Of public health concerns and other kinds of concerns.
Charlie has not been spared, but it may not have taken as
well as I had hoped.

I think this really matters. I think it’s not just
a matter of rhetoric to refer to public health concerns as
Somehow separate and apart from the kinds of things that the
working group is dealing with. I think it’s dangerous to
refer to what Charlie did when he was a local public health
officer each and every day of his life as involving at the

real world, but looking at the kinds of concerns that we were

 

 

 
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dealing with, like the psychosocial aspects of AIDS and like
discrimination, as not involving the real world. I think
that’s both wrong and dangerous.

COMMISSIONER KONIGSBERG: That’s not what I said or
meant, by the way.

COMMISSIONER DALTON: But I think there’s a great
risk that when we talk about public health concerns as
against ethical concerns or as against legal concerns, then
we reinforce the notion which is certainly out there broad in
the land that, on the one hand, we have people who care about
the public health and on the other hand we have people who
care about civil rights.

One of the forms that takes is that, for example,
the organized gay community is viewed as people who care
about civil rights or individual rights, but not about public
health, and that is profoundly wrong. What group cares more
about public health than a group that has been so deeply
affected by this disease in terms of their own health as a
group of people? So I think we need to watch our language
and not reinforce that idea. That’s one point I want to make.

secondly, Jim, if what you’re talking about is

prevention, which is the word that Charlie used, or behavior

 

 

 

 

 
 

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change, then maybe it’s better to talk about that rather
than, quote, "public health." JI think early intervention is
public health. I think being concerned about the psychosocial
aspects of HIV is public health. I think being concerned
about confidentiality is public health, and every good public
health officer knows that, as Charlie has indicated.

The working group, as I said before, chose as the
prism for this first cut at the problem of testing early
intervention, and so in many ways that drove a lot of what we
heard. We did not choose behavior change, which has for a
long time been a justification for testing, as has been
protection of the blood supply, as have been epidemiological
concerns.

But we tried to focus on early intervention, the
nexus between that and testing, and as a result we didn’t get
into as much of the other issues, as you suggested. Never-
theless, we got some quite useful testimony, not enough
because we didn’t focus on it, on behavior change and the
nexus between testing and/or counseling and behavior change.
Marie St. Cyr--those of you who haven’t had a
chance to spend some time with this woman--I know some of you

have--she’s extraordinary. But one of the things that I

 

 

 
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remember her saying--others said it, but I remember her
unique way of saying it--was that for the group of people
that she works with, largely women of color who have, among a
raft of problems, HIV as a real or potential, when you think
about testing as a way of sort of getting them to think about
behavior change, it’s actually only one of a group of forms
of outreach and often not the most effective.

Sometimes education, not even necessarily about
HIV, but about prenatal care, is the way to sort of get women
sort of thinking about their health, and then in the context
of working with them about that and other family issues or
life issues, one can then begin talking about HIV.

Her point was that this idea of sort of testing as
somehow an all-purpose hook for getting people--and I’m not
Saying that you’re saying that, but I’m just talking about
some of the testimony that we heard. Thinking of testing as
a talisman for getting people to think about behavior change
doesn’t work everywhere for all people.

Now, aS I say, this was almost a by-product of what
we thought we were there for to talk about early intervention,
but it suggests, again, some of the complexities in thinking

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And it’s a rich field and we need to hear from lots of
people, and I think we know that. It’s just that we didn’t
Structure the session so that we could go very far in that
direction.

DR. ALLEN: I think your comments are well taken,
and let me just point out that in terms of focusing only on
one component--i.e., early intervention--in a way, you are
creating a bit of a dichotomy, too, because it then forces us
to talk about the other side of it. And if you look at early
intervention as an isolated event, then Don’s comment that
was read by Scott--i.e., you have to, you know, wonder if
it’s ethical to test when you don’t have early intervention
available everywhere--that’s why you can’t separate it in
that way.

Let me just pick up very briefly in terms of what
you said about looking at testing as the entry point.
Absolutely, it should not be. It should be one component of
a much broader focus of care that is being provided to a
person where every health care provider considers in terms of
the context of who the individual is, the person is, that is
coming to him or her as a provider, is it appropriate, how do

we introduce it, and so on.

 

 

 

 
 

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That’s why testing and counseling need to be part
of the repertoire of every practicing physician in the United
States and other health care providers, why it needs to be
considered in terms of STG clinics, tuberculosis control
clinics, drug abuse treatment centers, primary care centers
throughout the country--prenatal clinics, women’s health
centers, and so on. It needs to be part of our routine
medical care and not as separate, except for that small
Circumstance of people who, for whatever reason, don’t want
to use the regular medical care system and want a separate,
free-standing counseling and testing center.

COMMISSIONER DALTON: Just a brief follow-up. I
realize I’m poaching on you, Don. Some of the other testimony
that we heard was really quite detailed and interesting
testimony about the deficiencies in certain locations in the
country of the kind of counseling that’s provided in certain
Settings. That’s something we need to think a lot more
about; that is, we heard folks who have had experience with
STD clinics talk about what it means when you have somebody
who has got a job already--go down a whole list of things and
tell them that there’s HIV counseling on top of it and how it

comes out in the real world. We need to think about those

 

 
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kinds of very practical, grounded details as well when
thinking about testing.
| CHAIRMAN OSBORN: We have a nice line-up here: Don
Goldman, Scott, Diane, Larry Kessler, in that order.
COMMISSIONER GOLDMAN: Thank you. In our statement
on the fiscal year ‘90 appropriations on September 19th of
1990, this Commission said and pointed out that the most
compelling incentive for individuals to step forward for HIV
counseling and testing is the availability of effective
treatment and appropriate medical care. That was in the
context of seeking additional funding for appropriate care.
One of the things that I think that we found at the
meeting that is most disturbing to me is that the way that the
Public Health Service budget ends up being proposed for the
new year is that the major increase, as Maureen reported, is
in the area of information and education. The most extreme
drop is in the area of providing care, and particularly the
drug subsidy, which is the major effective treatment.

Of course, the other side is that the most important
part of the new public relations campaign that the additional
$60 million is going to be used for is to promote testing

because all of a sudden there is care available. With the

 

 

 
 

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same dollars, they simply took away the care.

The distortion of priorities and the unmanaged way
in which that kind of system ends up working out raises both
practical, moral and ethical implications that I think are
some of the things that we ended up discussing and, from my
way Of thinking, are simply unacceptable, and even from the
point of view of the public health system aren’t acceptable
because ultimately I think that a public health system can
mever succeed any further than it maintains its credibility
and its believability within the communities that it’s trying
to deal with.

If the public health system attempts to promote a
certain avenue of conduct on the basis of the availability of
service, when that service is only a fiction, then its own
credibility is lost, and that’s the worse than any one
particular battle because that’s the entire war. I think we
have to focus on those kinds of areas, and I think Harlon is
right in that context. Public health concerns and care
concerns for individuals are not separable. We're not
talking about different interests versus each other. We’re
talking about the same thing together.

COMMISSIONER AHRENS: At the risk of introducing

 

 

 

 
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some very simplistic concerns--I’m just fascinated by this
discussion, but it seems to me that outcomes depend on
inputs. And I guess what concerns me a bit about the
discussion in terms of the meet ing that you had in Boston was
my assessment of this list, and when I look down it, most
people are identified by where they come from. That doesn’t
necessarily mean that they view the world from their geo-
graphy, but that would, I think, reflect their geography.
There are only three people outside of the northeast
area that I can see on this list, other than those of you who
were actually on the panel.

CHAIRMAN OSBORN: Diane, let me .just interject.

tT ’ve joked about the Kansas blizzard, but indeed there were
people from Colorado who were--.

COMMISSIONER AHRENS: I understand that there were
those invited, but I’m just looking at the list because I
think what is heard is what perhaps is reflected, and that
concerns me as you look at future meetings.

I think that Don has reflected the concern that the
public health system is inadequate to address this issue
because of the dollars involved and the numbers of people,

and so forth. But when you look at the Northeast, it’s

 

 

 
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understandable that you would hear about the unavailability
of services. The numbers are overwhelming.

But if you look across this country, most of the
places the numbers are not overwhelming. The services, by
and large, are available, and the testing is available and
the counseling and treatment after the testing is available
in the total sense. If you look at the pockets, absolutely
right, but I think when we develop whatever we develop we
have to look at the nation as a whole and not just the
pockets. I guess that kind of is my concern.

I think that the public health issues absolutely
should not be separated from the total context, but the sense
here was that--and I can say this because in the area which I
operate in, NACo, the county health officials are part of
NACo and they have some very clear directions and impressions
about what is being done and what ought to be done.

It’s just terribly important that all of that
become a part of the discussion that we hear, and I was just
concerned about both the geography and perspective.

CHAIRMAN OSBORN: Larry gets his turn first.
COMMISSIONER KESSLER: A couple of things strike

me. One is in partial response to Jim Allen and his vision

 

 

 

 
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of the world in terms of physicians, and so on, and the whole
testing thing. While we didn’t get into this at our hearing,
tT think we need to at some point address the question of who
is going to deal with the training of the physicians. Is it
the responsibility of the feds, through some mechanism in the
CDC or others, or the local medical societies or the AMA, or
whatever?

There is definitely a gap, and as we promote
testing what we’re finding--and I can only speak for our hot
line, but it’s, I think, a good sampling because Massachusetts
iS a good mix of not only urban, suburban and rural, but you
have the medical mecca at Boston versus Springfield, Worcester
and then lots of smaller towns. But no matter where, the
kinds of calls coming in our 800 number, which is Statewide,
reflect that physician understanding of the tests in early
intervention, psychosocial issues, and so on, is just dismal.
This is nine years into the epidemic where people
are still telling spouses you don’t have to worry, but just
don’t use the same shower, you know, or you’ve got HIV and
you'll be dead in six months; on the flip side saying, you
know, you’re HIV-positive, but don’t worry, it doesn’t mean

anything, you’re a long way from AIDS, and no education about

 

 

 
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safer sex, about sharing needles, what have you.

I think that’s happening all across the country,
and we need to address that as part of the down side of a
testing drive. And then we also just this week heard from
Our Massachusetts Medical Society that there’s absolutely no
way you can mandate education; we won’t stand for it, and
we've had too much of this. It’s the constant gripe of
physicians now that they're overregulated.

The other thing that we talked about in some degree
of detail at that hearing, but I think we need to go further,
is we talked about the psychosocial impact on the individuals.
IT think it’s time for somebody to start looking at the
psychosocial impact on the community.

As larger numbers within given groups get tested, I
think we’re going to have a different kind of community
psychosis around HIV than we’ve seen before where it was the
tightly-guarded secret, an individual decision, an individual
burden that was felt with a few people. But my sense is that
we may find soon that the whole community may be impacted,
and I don’t know how that will work out.

It would be good to try to figure out where that’s

going. You know, will that result in more despair, more

 

 

 

 
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disengagement from the system rather than engagement? Will
at lead to a different kind of activity? I think on one
level we can see a model of a community that has been
impacted, and that’s the gay community, but traditionally
throughout this epidemic the gay community is only the model
for the gay community, not for people of color communities or
rural communities, what have you. That’s going to shift, too,
as more and more people get tested--mental health needs, and
what have you.

And then in response to Diane, I think I know what
scott is going to raise, so I’ll try not to take his thunder
here. But on a certain level I agree with you, Diane, that
depending on where you sit you have a different perspective,
and it would be important for us to draw in those other
perspectives. But I don’t think they are particularly
consistent when you’re looking at the county level or the
State level or the city level.

I mean, in a way, we sometimes preach to the choir
and sometimes we only hear from choir members, and we've got
to get out of our pews and out into the streets and the
byways and talk to those folks who are not part of national

associations, not part of federations, and not part of

 

 

 

 
 

 

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associations that really are doing some of the education.
Woefully inadequate as it is, they at least know how to spell
AIDS, with capital letters, you_know. But there are others
put there who still think it’s a bi-coastal problem and,
after this week, that it’s over.

CHAIRMAN OSBORN: Scott, you had waived your rights
before.

COMMISSIONER ALLEN: Go for it, Charlie. I’1ll come
back.

COMMISSIONER KONIGSBERG: We could get real formal
and I could yield my time to the colleague from Texas, but
let me try to clarify, I guess, kind of what I’m coming from.
I’m not sure it’s completely clear.

First of all, my remarks related to the laundry
list, not one specific thing. I think that’s important that
we look at that, and I would not want to presume that the
public health officials out there wouldn’t be willing to

engage in a serious dialogue about that. I’ve been involved

jin many discussions with ASTO groups before I was a State

health official, with NACHO, also NACo, and other health
officers, where these very same subjects come up. There are

differences of approach and opinion; there’s no question

 

 

 

 
 

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about it.

What we sometimes run into--and I sent one of the
most graphic examples of that to June and Maureen--is the
misinformation that is put out, or misinterpretations. It’s
somewhat killing the messenger, but actually that’s not
exactly what it is. I’ve seen various things put out and
statements made that make the leap of faith that expanding
testing and counseling, in fact, is mandatory testing, which
is something that is, I think, abhorrent to all of us and was
certainly a dismal failure in Illinois with respect to
marriage.

So I think the listening process goes both ways. I
think the credibility issue goes both ways. You know, we are
all under pressure from constituency groups that either did
sort of elect us, in a way, in terms of nominating us, or
we're not, or we feel that we relate to those, and that’s as
true for me as others. But I think that kind of dialogue can
occur.

In response to you, Harlon, part of the real world-
-I made the comment about the balancing act. Sitting at a
desk in the health department in Fort Lauderdale and hearing

a report from Miami that two people committed suicide after

 

 

 

 
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learning of their HIV test at the Dade County Public Health
Unit--it does kind of get your attention and it does make an
impact. -

The other thing I would say, ina little bit of
disagreement with Diane--I can’t speak for Minnesota, but I
can speak for Kansas and many other areas, I suspect. The
care is not out there, and I think we need to be sure that
when we set up the early intervention model as a public
health model as well as a clinical model that we are careful
about it. I think that’s a message to the feds as well as to
the States.

I can tell you right now I’m not about to go out in
Kansas and start pushing this as public health policy,
knowing the problems we’ve got out there. But what I am
trying to do is prepare the private physicians, the hospitals,
and the health departments for what I know is coming down the
pike.

One way or another, there’s going to be federal
money. If Kansas doesn’t want to put up a dime, if the care
bill passes, I’ve got $900,000. We can actually do something
with that, not enough, but it’s a start. So, again, I think

we ought not to knee-jerk on every end of this, and when I

 

 

 

 
 

 

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see some of the things that are written, it just scares the
willies out of me.
You know, I don’t know what Steve Joseph said up in
Montreal, okay. I don’t know how he came across, but I am
absolutely amazed at things that are not at all out of line
With what is said around the country or that is carefully
thought out that all of a sudden there’s a firestorm. Let’s
find a way to make sure that within this Commission everybody
gets heard, and I don’t think that has quite happened yet
with this list. And I understand that there is plenty of
time, Scott, and I was really pleased to hear that the
process isn’t through. |

CHAIRMAN OSBORN: You get the last word before
lunch.

COMMISSIONER ALLEN: Don’t get your expectations
up, Okay, guys?
Just a comment on the various things that were
going around. First off, Diane, about some of your assessment
of the people and the location, we were trying to have some
cost containment on that process, and that was one of the
factors. However, our evaluation of early intervention and

whether it’s there or not was not really based on locale as

 

 

 

 
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much as on the CDC’s testimony, on HRSA’s testimony, and the
governmental agencies that were there saying it’s not in the
budget, and the FDA saying a 500-count T-cell.

I wanted to clarify that because what we’re basing
it on is what is happening governmentally in the federal
system, and that, wait a minute, here we are moving toward
this momentum of early intervention. So I wanted to comment
on that because that was the major factor. We heard it loud
and clear.

I think that we saw in L.A.--and I’d try not to
draw too much on past experiences, but the Legislative Task
Force on AIDS in the State of Texas went to eight different
sites and had public hearings all over the State of Texas, in
rural Texas and in large cities, in places like Lubbock that
are not that hard-hit, and everyone was crying out.

So in my own personal experience, I’ve seen it’s
mot just New York, it’s not just L.A., it’s not just the
Northeast; it’s all over. The county systems are being
inundated and the finances are just astronomical and the
system is close to collapse.

So I wanted to add that, and that is also the

reason--Charlie, I appreciate your seeing that we have not

 

 

 

 

 
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finished, by any stretch of the imagination, early interven-

jtion. You notice we start out with saying, wait a minute, to

what extent is early intervention available and not available, .
because we saw the deficiencies in that process. That’s why
we don’t have something in writing for you because we are
Saying wait, this is a good start.

And we didn’t get the public health folks we
wanted. Some folks just didn’t come. Some folks turned it
down. I want that dialogue to take place. I, too, agree,
Charlie, that we can’t compartmentalize an approach to this.
That is disastrous, and that has happened. We have isolated
certain aspects of this and all of a sudden it gets out of
balance.

We came at it with the approach of early interven-
tion for the basic reason of saying people are dying. People
have the chance of life, and we came at it from that saying
this test is a part of that, but we need to find out how we
can prevent the progression of this disease, and this is the
forefront.

It seems to be our society is moving toward this
early intervention method or modality, whatever I’m trying to

say. We’re moving in that direction, and we need to stop and

 

 

 

 
 

 

 

 

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really closely examine this. So that’s why I was disap-
pointed. I would like for you to be a part of reevaluating
this outline because you have some insights that we really--
and choosing speakers, foruns, because it would be absolutely
instrumental.

CHAIRMAN OSBORN: Well, let me--.

COMMISSIONER KONIGSBERG: June, just a very quick
response. The answer is yes, I’d like to do that, and then
on the other side of it--not the other side; that’s a bad
phrase. If we, in fact, adopt two things, either a prevention
agenda or an examination of the public health system, I think
we need the same kind of overlap so that we’re not working
Separately. That’s what we need to avoid.

CHAIRMAN OSBORN: In closing up for our lunch
interval, I would like to thank Scott and the group for
having done an exceptionally succinct job with the most
difficult set of issues, in many ways, that we need to
grapple with. It’s been a really helpful start.

I want to make a technical point so that there
isn’t any unease. I think there was room for unease in one
part of the conversation. When Charlie is talking about

public health, changing for a moment to the hat I think I

 

 

 

 
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Still have from people who pay me, that is a system. And
when Charlie is talking about public health, in very many of
his contexts he’s talking about public health officers, State
public health departments, not the public health--sometimes I
say the health of the public in order to try and get away
from the technical things.

So to the extent there was any sense of confusion
there, I would like to be sure that we are all sensitive to
two things. People are quite aware that there is a medical
profession and a nursing profession. People are less aware
that there is a public health profession, and I think a lot
of what Charlie is talking about, and about the burden of
some of the epidemic, and what Jim Allen was talking about,
have to do with the public health structure and public health
profession, with no value-laden stuff in there.

So as we discuss this, that’s a sub-category of
health professions, if you like, and I’ve been trying to push
us-—-.

COMMISSIONER KONIGSBERG: And system.
CHAIRMAN OSBORN: Well, just as there’s a medical
profession and a system of medical care, there is a public

health profession and a system of public health structure.

 

 

 

 
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Nevertheless, the only thing that I didn’t like in the
discussion in terms of moving us forward was a sense that
somebody might have misunderstood that. And since it’s not
widely acknowledged in the same sense that some of the other
health structures are, I think that’s important to keep track
of.

I suggest we break now for lunch and reconvene in

one hour.

[Whereupon, at 12:28 p-m., a luncheon recess was

taken. ]

 

 

 
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AFTERNOON SESSION

 

{1:50 p.m. ]
VICE CHAIRMAN ROGERS:_ June sends her apologies.
She’s still busy dealing with the press and Jonathan Mann’s
sudden and sorrowful departure from the scene, which is a
tragedy for all of us.
I think we’ve accomplished more than I would have
thought we could have at this session. Let me put three
things before you, if I can get the attention of anybody.
[Laughter. ]
VICE CHAIRMAN ROGERS: One is our meetings. Don
has pointed out that this meeting on March 29th, which will
star President Bush, Belinda Mason, and Lou Sullivan, as well
as the CEOs of Time-Warner, in the person of Dick Monroe,
Levi~Strauss, and a bunch of the business community--it’s at
the Willard, I believe, and I think members of this Commission
are--.
COMMISSIONER GOLDMAN: Crystal Marriott.
VICE CHAIRMAN ROGERS: Excuse me--I’m thinking of
the wrong meeting--at the Crystal Marriott. And I think
members of this Commission are warmly invited. It is my fond

hope that that will be an historic meeting, and all of you can

 

 

 

 
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take some of the credit for it in terms of what we put in
with our first mini-report. I think that had a significant
impact.

Yes?
MS. BYRNES: It’s my understanding that everyone
got their own individual invitation and that you should be
sending back very important information so that they can
confirm your attendance. If that hasn’t happened, please let
me know because I know, in fact, you all are invited.

VICE CHAIRMAN ROGERS: Yes, and they will be fairly
Stiff about that by virtue of the fact that it’s a meeting
that the President will be talking at.

COMMISSIONER GOLDMAN: They need your Social
Security number and date of birth to check into their
computer.

VICE CHAIRMAN ROGERS: That’s right.

Second, we have a planned rural site visit meeting
in April, and then we have our next meeting planned on May
7th and 8th. The tentative plan, but give any input you wish
to this, because of a number of things that are coalescing,
was to look at the personnel issue, was to look at supply of

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Maureen, do you want to explain that any more?
Well, I’ll just ask if you’ve got any response to that.

There are a series of requests from nursing, from others, SO
we thought that was an issue that we should deal with fairly
swiftly. |

COMMISSIONER DALTON: How far along is the planning
for that meeting? In other words, if we were contemplating
doing something different, does it require unsettling many
settled expectations?

VICE CHAIRMAN ROGERS: No, I don’t think so. If
you would like, why don’t I suggest--I would say if you have
other things you feel are of critical importance, get back to
staff swiftly with it.

COMMISSIONER DIAZ: You mean like other sites?

VICE CHAIRMAN ROGERS: No, not other sites, but
other agenda items for May 7th and 8th.

COMMISSIONER DIAZ: Where is that meeting?

VICE CHAIRMAN ROGERS: That meeting is tentatively-

MS. BYRNES: The plan is to have it here. Congress
iS very actively in session at that point in time, and to the

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Commission may or may not want to respond to, that was the
plan. The timing of that--we tentatively thought we’d need
to be in Washington, with a site visit in April somewhere
else and a possible site visit in June somewhere outside of
Washington, D.C. .

VICE CHAIRMAN ROGERS: If there are other things
you’d like to put on that agenda, get them back to Maureen as
promptly as you can.

COMMISSIONER MASON: Dave, how are we determining
the content of that? I mean, now primary care provider--the
provider perspective?

MS. BYRNES: Broadly, yes; personnel, I guess.
COMMISSIONER MASON: Personnel.

VICE CHAIRMAN ROGERS: All manpower issues.
COMMISSIONER MASON: Okay. How was that decision
made to take that up? Is there some kind of urgency related
to that topic?

VICE CHAIRMAN ROGERS: Yes.

COMMISSIONER MASON: I just need some kind of, you
know, input about that because, you know, I have my Single
horse that I ride to its exhaustion and, you know, there’s an

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VICE CHAIRMAN ROGERS: There is indeed.
COMMISSIONER MASON: Research and treatment and
drug development and clinical trials.

VICE CHAIRMAN ROGERS: Put it in.

COMMISSIONER MASON: But, you know, I’1l be glad to
hear some--I don’t want to like--I mean, I don’t want it to
be like, you know, just sort of tacked on as an after-
thought, and it needs to kind of grow thematically out of--so
if there’s some kind of rationale that I need to hear about
why we're taking up the provider aspect next, especially
because in some of the parts of the country that I visit
there’s not anything to provide, let alone the providers to
do it with--I’m belaboring the point, so you might explain to
me.

VICE CHAIRMAN ROGERS: No. That’s perfectly
appropriate.

Larry.

COMMISSIONER KESSLER: I think we can actually

incorporate that if you look at human resources in the

|broadest sense of care providers, researchers.

VICE CHAIRMAN ROGERS: Well, I think part of

Belinda’s comment is her concern about availability of

 

 

 

 
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medication.
COMMISSIONER KESSLER: That’s different, okay. I
thought you were talking about--.

VICE CHAIRMAN ROGERS: Is that right, Belinda? am
I reflecting your concerns properly?

COMMISSIONER MASON: Yes, but also, you know, the
broad questions of science and research because, you know,
there’s a growing--just some of the things that Jim Allen
Said today about how trials are conducted and how it’s really
kind of costing people’s lives, and we shouldn’t just be kind
of sitting, you know, around about it and saying, well,
everybody is doing the best they can unless we satisfy
ourselves to that, and I’m not satisfied to that. And I
don’t feel like I can answer to the people that I need to
answer to about it until--see, for the PWA community, the
issue of treatment and drug development is like the most
compelling, the very most compelling.

COMMISSIONER DIAZ: Two of us have got to leave.
Is it possible we can give a statement?

VICE CHAIRMAN ROGERS: Sure.

COMMISSIONER DIAZ: Some of us are concerned.

We've had a longstanding invitation to site visit or commis-

 

 

 

 
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sion part of a visit in Puerto Rico. I don’t know that

has been set.

VICE CHAIRMAN ROGERS:_ It has not.

COMMISSIONER DIAZ: And I think that we ought to
probably either get back to these people or in some way say
this is not a priority for the Commission at this time, and
give a justification, or it is a priority and we’re not going
to do it this way, or whatever we decide. But that’s an
invitation that’s been there going on six months.

And the next one would be still the focus of a
prison. Both Diane Ahrens and I felt it was somewhat hanging
pecause we had thought of discussing the situation in
prisons, but had not actually formalized it. I would say
some of us, again, that have not had the opportunity to visit
South Florida feel that is important. I would second her
input to you before she had to leave.

VICE CHAIRMAN ROGERS: Thank you. Bye; safe
journey.

Harlon?

COMMISSIONER DALTON: I want to say one brief thing
About Puerto Rico, since Eunice just brought it up. I mean,

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Eunice; however, Puerto Rico would not be the place I would
go if I wanted fun in the sun.

Maybe I was just too short in the other room, but
the incidence of HIV in Puerto Rico rivals that in Central
Africa. And as Karen pointed out, it being a territory, its

relationship to our national health care system and to our

legal system is really quite different than other places, and

it is a place apart from any other place we are likely to go.
It is still ostensibly a part of this country, and so we can
sort of make light of it, but not to the point, I think, of
being submissive.

But I really had my hand up because I wanted to
build off of what Belinda said. I guess as I heard Don
DesJarlais earlier before the lunch break, he had suggested
that maybe the best way to deal with drug treatment issues,
science issues, drug trial issues, drug research, drug
development was perhaps through a working group. And I
think, David, you suggested the inclusion in that working
group of some experts who happen not to be sitting on the
Commission.

I think that certainly is a good idea in terms of

deepening our knowledge and working our way toward a set of

 

 

 

 

 
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recommendations, if any. But I also think that it’s impor-
tant, quite apart from that, to as a full Commission hear
from a range of people on these_topics, both to inform
ourselves--and by that I mean myself and some others,
obviously. I mean, I learned a hell of a lot this morning.

I was serious when I said that hearing June talk about those
couple of meetings was a little bit like being there and very
helpful to me. |

But I also think that we as a Commission need to
hear more, but we also need to signal that we are hearing.
And it seems to me to devote some of our joint time as a
Commission to these issues sends a very powerful message that
these are important issues to us. And then it seems to me,
after that, if we spin it off to a working group to do,
wherever that working group’s nose leads it--I mean, I would
wholeheartedly endorse that. But I think it’s not--I mean, I
think there are reasons to do both of those.

VICE CHAIRMAN ROGERS: Charles, and then let me
respond.

COMMISSIONER KONIGSBERG: Not on that topic. I
wanted to comment on the site visits.

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that, too, and then let me respond on that.

COMMISSIONER KONIGSBERG: Okay. Let me echo
Eunice’s comments about South Florida. There are two
specific areas down there that I think are quite unique.
There are probably three. We’ll say Miami is, and I know
that Miami is much visited. I also know that Belle Glade is
much visited, but for those who have not visited Belle Glade,
it will be just as interesting and disturbing as New York
City.

Then there’s Key West. Now, that may get back into
fun in the sun again. There’s a very unique situation down
there in a community that doesn’t seem to attract private and
federal grants because it’s a low-population area. And I
just want to mention that, in addition to the fact that
Florida is, in fact, one of the high-incidence States, which
is kind of a political thing. But there are some unique
Situations.

I worked in Fort Lauderdale, and I’m not sitting
here telling you there’s anything unique to see there. But
those other three communities, particularly Belle Glade and
Key West, are critical.

VICE CHAIRMAN ROGERS: Let me make a suggestion.

 

 

 

 
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We have two suggestions, and it seems to me staff could take
a look at this. One, we do want to hit the personnel issue,
and I won’t go through all of the reasons for it. Belinda, I
hear you in terms of where the concerns of the group we’re
most concerned with are. Let's have the staff explore that a
bit in terms of whether that would be possible to do in this.
We’ve had two suggestions about areas for potential
Site visits. You might explore those, and then June and I
and all of us can discuss that.

MR. PERNICK: David, Puerto Rico and Florida can be
run together.

VICE CHAIRMAN ROGERS: Yes, I think they can, too.
MR. PERNICK: That’s one of the conveniences.

VICE CHAIRMAN ROGERS: Yes.

MR. PERNICK: And Florida is important, and while
Puerto Rico may be almost subsidiary, a sub-group of a sub-
group can sort of hop over for a day or two.

VICE CHAIRMAN ROGERS: Fine. I agree with you.
scott.

COMMISSIONER ALLEN: Just on the site visits, it
would be helpful, Since we’ve gone through this process of

looking at what are priorities, if we could have some

 

 

 

 

 
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specifics like we had in New York of the homeless, of why
we're going there and how we can incorporate that into the
larger picture, and some justification for that of where we
can come out of that with a good report or something that may
help alleviate some of the energies of going in different
directions.

CHAIRMAN OSBORN: I feel a little funny about
popping in, since I apologize for my absence through so much
of this, but I’ll add things, with your indulgence. In the
context of Puerto Rico, one of the issues that had arisen was
that something like 70 percent of people in prisons are sero-
positive in some of the prison statistics.

I participated in the Puerto Rico think tank in
August, and it becomes a little less startling when you start
thinking about the almost completely free travel between New
York and Puerto Rico and the drug problem that’s burgeoning
in Puerto Rico. So the combined effect has resulted in some
extremely unusual but perhaps prototypic circumstances that
are among the many reasons for concern there.

There is also a great--the issue of rural health,
interestingly, comes up there, too, in the sense that there

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of structure, a public health one and another one. I forget
the right names, and Eunice is gone.

But there’s a disassociation, so that some that
Should be involved are essentially totally uninvolved, and
the access to care issue gets intensified far beyond what it
otherwise might because of a very strong degree of non-
coordination.

So there is, in fact, a great deal of room for
concern about the circumstances in Puerto Rico, and there are
things that feed into some of the other issues that are
looking at in other contexts. My sense has been if we wanted
to talk about prisons and jails, we should do more than one
Visit. Also, I think that has come up in the context of
Alabama that that might be a way to look at it. So that’s
part of thinking that went into that line of suggestion, and
f think that that kind of thing is worth knowing.

In terms, Belinda, of the concerns about health
care providers, you, in fact, are one of the people who has
sensitized me to the very great problem with the under-
educated status of present health providers, and many people
have educated me to the fact that nothing much, nothing

appropriate is happening to increase either the quantity or

 

 

 

 

 
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the quality of health care provision capability as these
numbers double.

That, coupled with the expressed concern for input
from the American Nurses Association, the American Dental
Association, the American Medical Association, and the
American Hospital Association, in terms of timeliness for an
interim report and a first year’s worth of work, to have not-
-several of those organizations were under the impression
that we had appointment authority, so our first contact from
them was why isn’t there a nurse on the Commission.

I think if we listened to that kind of testimony,
Ht would not be useful. But if we took that stimulus to
phrase the questions of what are your problems with respect
to health care provider training, attracting people into the
health care workplace, there are a lot of answers there. I
know that much. What are you doing to overcome those? What
are you doing to train people specifically in universal
precautions care in some instances, or compassionate response
to the epidemic in other instances, or counseling in other
instances?

I think if the questions are well framed, we could

meet a certain amount of what you might call constituent

 

 

 

 
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148

pressure in ways that would move an extremely crucial part of
the agenda along. I would kind of turn around a little bit
what you said and say if all those drugs are accessible and
there’s no one to deliver them and nobody who knows how to do
SO wisely, it won’t do us any good to have the drugs.

So both of them have an urgency that makes me think
that, you know, in a very important sense the urgency is in
balance, and perhaps within one or two meetings it ought to
be a matter of what can be set up when, since I share your
sense of urgency.

The only thing I would say is that there are far
more people talking about the issues that you raised, many of
whom are conscientious, than there are the issues that I’m
trying to activate about health care providers. I become
frantic about the fact that in the medical school at my
institution, for instance, still it is a matter of a very few
hours mostly devoted to retroviruses as this epidemic just
explodes.

People need compassionate care at a level of new
sophistication at least about immunologic phenomena that they
hadn’t gotten trained for if they had been out of medical

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as fast as it should, and I think that’s an area of broad
concern.

VICE CHAIRMAN ROGERS: _ Thank you.

Harlon?

COMMISSIONER DALTON: Actually, that was very
helpful. I was wanting to respond to Belinda’s question and
that is really very helpful. June, I just wanted to say that
when you first mentioned the organizations that were clamoring
to speak--and, indeed, I heard from a nurse as recently as on
the plane coming down, why wasn’t a nurse appointed, and I
hear it most nights at home.

But when I heard the names of the organizations, I
got that sinking feeling that we were going to hear the party
ine. But as you talked, it sounded wonderful, and I think
that ought to be a model from now on of us, when we invite
people, sort of giving them, in a sense, a set of questions
that we would like to have them answer, given their expertise,
So that they don’t just simply tell us--.

CHAIRMAN OSBORN: The party line.

COMMISSIONER DALTON: --the party line, but really
help us get where we want to go. I was just so pleased to

hear that, and I think it’s not just for this group whenever

 

 

 

 
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we hear from them, but from every group from now on.

CHAIRMAN OSBORN: With, of course, the caveat that
having been provided the list of questions, the deadlines,
and whatever, as you know as well as I, humans will sometimes
be humans. So we won’t guarantee the result, but it’s
important to try. I strongly agree.

VICE CHAIRMAN ROGERS: Go ahead.

COMMISSIONER KESSLER: I just have a suggestion on
that level. I think it’s sort of like getting references for
an employee. You don’t necessarily go to the first one that
people tell you to go to. We know of people out in the
industries--nurses, physicians, psychologists, whatever--who
may belong to some of these associations and are recognized
within the associations.

For instance, a Jeannie Martin, I think, would be
invaluable to talk about the whole VNA level, but not
necessarily speak for VNA of America, but can give us the
perspective and the credibility without being biased or
programmed by the board of directors of VNA. If we can find
comparable levels in the nursing profession, psychologists,
whatever, we may get just as much mileage and a more real

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VICE CHAIRMAN ROGERS: Jim, last comment, and then
I’m going to wrap this up here.

DR. ALLEN: One other_tactic that might be used in
terms of trying to address the issue, particularly when you
want action taken and it isn't the responsibility of the
Commission to take action, is to perhaps empower a working
group that includes not only a few Commissioners and staff,
but also people from the AMA and others.

Particularly with the professional education
component, to the extent that we can get each of the profes-
Sional societies to buy into this and own it as their problem
and begin to take action, we’ve succeeded in beginning to get
the train moving.

VICE CHAIRMAN ROGERS: Harlon?

COMMISSIONER DALTON: David, I thought I heard you
Say to Jim--that’s the point you made before, and I think his
point was a little different. I think he wasn’t simply
talking about being able to augment our own expertise, but
that insofar as we have the consumer pressure and insofar as
we want these people themselves to carry the ball, involving
them in working groups that won’t necessarily produce a

product for the Commission might serve those goals as well.

 

 

 

 
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VICE CHAIRMAN ROGERS: I think we owe you, on the
basis of what you did this noon, a listing of an array of
areas you think are important to explore, filled out in ways
that the staff feel appropriate so that you can make some
judgments about it. For the next meeting, we will explore,
Belinda, your area, as well as the whole health personnel
manpower issues, for reasons that June has just explained.
As you know, the staff has been working on a paper
which we would encourage you to input on. It is currently
our plan to make use of that as a second mini-report, with
any other suggestions you have with it, probably modifying it
on the basis of what the President does on the 29th. So
we've delayed the output of that. That ought to give people
plenty of time to look it over and decide what they would
like to add to it. I think our first one went very well. I
think this one will, too.

I’ll turn it over to June to let her close our
meeting.

CHAIRMAN OSBORN: I get the feeling that maybe we
missed a very important function while everybody was here,
which was to extend the dates of the next meetings. We only

go through July, and that’s a little scary because I don’t

 

 

 

 
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know about your calendars, but mine is filling up fast.

I think given that we have only, I think, seven of
the Commissioners here that it may not be a productive
exercise to try and do that now, but that instead we should
take very seriously a quick turnaround time on calendars so
that the staff can work with them and look for Commission
dates.

I would appreciate any comments you have about the
general pulsing that we’re doing, which is every two months
this kind of a meeting, generally in Washington. The
possibility of moving elsewhere is not out of the question,
but certainly with some of the exigencies of, certainly, Roy
and Secretary Sullivan, when he can be with us, and so on,
it’s a good idea to be here some of the time, but then
alternating with that some site visits so that there is a
pulsing of activity that the staff can cope with. We will
try and look at that.

Is that general pattern of behavior that we’ve
established reasonable so far as you’re concerned in terms of
the work plans that you’ve talked through, and so forth?

Site visits may not be able to be simultaneous with

small working groups, so that it might not turn out to be

 

 

 
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monthly site visits. But I think in terms of monthly tasks,
if that seems to you like an appropriate pace, I think it may
be just about all the staff can_bear, and that would be an
important question to have in mind.

So as we look for dates, you’d be looking for

|lSeptember or November, you know, like we did the first year,

for a two-day hearing kind of a thing, and then the staff may
look for dates when site visits are appropriate.

COMMISSIONER ALLEN: I have a question. With the
annual report, will there be a need for, since that is part
of the--one year is the interim report. Do you see any need
for extra time or anything like that?

CHAIRMAN OSBORN: Well, let me ask your thoughts
about that. My sense was in the language of the bill that
there was at least some effort not to constrain us to a
Strictly report-writing mode. And in that intent, the
language requiring an interim report at one year and a report
at two may have been intentionally somewhat permissive.

I would myself be a bit concerned to have the staff
suddenly turn around, take what we’ve been doing, stop the
forward progress long enough to redo it all, and put it into

some kind of a compendious format, as opposed to keeping on

 

 
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going. But that certainly is something the Commissioners
should comment on. And, Maureen, you may have a comment as
well. We’ve talked only briefly about that.

MS. BYRNES: I think to some degree when we get
back about other dates and outlining what the current dates
are and where they will be and what the topic is for May, at
least, in looking at the other issues we’ll also indicate a
timing for at least how to deal with an interim report.

I mean, I certainly would follow Dr. Osborn and all
of your direction as to how to handle that. My feeling is
that people will expect something from us, and my sense is
that we have already done a lot and that we need to weave it
together. And we’ll do that as we identify what the other
issues are, what we’ve done, how that fits in the plan, and
in that way we’ll almost be writing what we’ve done and where
we we’re going.

And, to me, that sounds like an interim report, but
we'd need to approve that and promote that and at least have
some sort of session that really indicates some summary
mature, if you will, of what the Commission has done after
One year and what our plans are for the coming year.

I think we can share some of that with you when we

 

 

 

 
 

 

 

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get back to you on what some of the follow-up issues are,
when the meeting dates are convenient for everyone, and
target when that discussion about the interim report and
structure would be, if that sounds acceptable to everyone.

CHAIRMAN OSBORN: “Harlon?

COMMISSIONER DALTON: I agree. It seems to me the
only reason to do an interim report is if we can get some
mileage out of it. And the idea of having the interim report
be essentially a compendium of our greatest hits, with kind
of a nice sort of intro, is fine, but I would hope that we
would be sort of too busy in some ways to sort of do anything
different than that.

CHAIRMAN OSBORN: If there’s no strong objection to
that, I think that gives the staff at least a range of ideas
as to how to proceed. It was important, I think, to be sure
that you didn’t feel that we should, in good conscience, try
and do a very thorough reprise in this first-year interval.

I think that we are at a position to adjourn.

Thank you very much.
Here is your moment.
MS. BYRNES: I haven’t quite said it this way and

I’ve been dying to say it. As the duly-designated government

 

 
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MILLER REPORTING CO., INC.
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Washington, D.C. 20002
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official, I hereby adjourn this meeting.

[Whereupon, at 2:25 p.m., the meeting of the

Commission was concluded. ]

~

 

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