THE PRESIDENTIAL COMMISSION
on the
HUMAN IMMUNODEFICIENCY
VIRUS EPIDEMIC

Hi EARI N G O N Incidence and Prevalence

December 10 and 11, 1988

 

 

 
 

 

August 24, 1988

TO OUR READERS:

The Presidential Commission on the HIV Epidemic held over 45
days of hearings and site visits in preparation for our final
report to the President submitted on June 27, 1988. On behalf
of the Commission, we hope you will find the contents of this
document as helpful in your endeavors as we found it valuable
in ours. We wish to thank the hundreds of witnesses and
special friends of the Commission who helped us successfully
complete these hearings. Many people generously devoted their
volunteer time in these efforts, particularly in setting up
our site visits, and we want to fully acknowledge their work.

The staff of the Presidential Commission worked around the
clock, seven days a week to prepare and coordinate the hearings
and finally to edit the transcripts, all the while keeping up
with our demanding schedule as well as their other work. In
that regard, for this Hearing on Incidence and Prevalence, we
would like to acknowledge the special work of Jackie Knox and
Daniel Wartonick in putting together the hearing, and Jackie
Knox in editing the transcript so it is readable.

For the really devoted reader, further background information
on these hearings is available in the Commission files, as well
as the briefing books given to all Commissioners before each
hearing. These can be obtained from the National Archives and
Records Administration, Washington, D.C. 20408.

One last note--We were only able to print these hearings due

to the gracious and tremendous courtesies extended by Secretary
Bowen's Executive Office, especially Dolores Klopfer and her
staff, Reginald Andrews, Sandra Eubanks and Phyllis Noble.

Sincerely,

Hog Z. er line fb Drie
Polly }L. Gaul Gloria B- Smith

Executive Director Administrative Officer

 

 
 

 

PRESIDENTIAL COMMISSION ON THE

HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC

COMMISSIONERS

ADMIRAL JAMES D. WATKINS, CHAIRMAN
UNITED STATES NAVY (RETIRED)
COLLEEN CONWAY-WELCH, Ph.D.

JOHN J. CREEDON
THERESA L. CRENSHAW, M.D.
RICHARD M. DEVOS
KRISTINE M. GEBBIE, R.N., M.N.
BURTON JAMES LEE, III, M.D.
FRANK LILLY, Ph.D.

HIS EMINENCE JOHN CARDINAL O'CONNOR
BENY J. PRIMM, M.D.
REPRESENTATIVE PENNY PULLEN
CORY SerVAAS, M.D.

WILLIAM WALSH, M.D.

 

 
 

PRESIDENTIAL COMMISSION ON THE
| HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC

HEARING ON INCIDENCE AND PREVALENCE

Department of Health and Human Services
First Floor Auditoriun
330 Independence Avenue, S.W.
Washington, D.C.

Thursday, December 10, 1987

COMMISSION MEMBERS PRESENT:
ADMIRAL JAMES D. WATKINS (RETIRED), CHAIRMAN
JOHN J. CREEDON
THERESA L. CRENSHAW, M.D.
RICHARD M. DevOS
KRISTINE M. GEBBIE, R.N., M.N.
BURTON JAMES LEE III, M.D.
BENY J. PRIMM, M.D.
PENNY PULLEN
CORY ServVaas, M.D.
WILLIAM B. WALSH, M.D.

POLLY L. GAULT, EXECUTIVE DIRECTOR

 

 

 
 

 

I-N-D-E-X

WELCOME

Admiral Watkins, Chairman

PANEL ONE

DATA BASE QUALITY/STAGING OF THE DISEASE

Presentation by Dr. Anthony Fauci
National Institute of Allergy and
Infectious Diseases, NIH

Presentation by Dr. Donald Francis
California State Health Department

Presentation by Dr. Steven L. Sivak
New York Medical College

Presentation by Dr. George Rutherford
San Francisco Department of Public Health

Presentation by Dr. Robert Redfield
Walter Reed army Institute of Research

Presentation by Dr. Richard Vogt
Vermont Department of Health

PANEL TWO

PUBLIC HEALTH PERSPECTIVE/FUTURE TRENDS

Presentation by Dr. James Curran
Centers for Disease Control

Presentation by Dr. David Axelrod
New York Commissioner of Health

Presentation by Dr. Alexander Langmuir
Chilmark, Massachusetts

Presentation by Dr. Michael T. Osterholm
Minnesota Department of Health

ADJOURNMENT

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37

46

62

79

93

112

131

140

163

 

 
 

 

P-R-0-C-E-E-D-I-N-G-S
[9:10 a.m. ]
OPENING

MS. GAULT: Good morning, ladies and gentlemen, members
of the President's Commission. My name is Polly Gault, and I
serve as the designated federal official. In that capacity, it
is my privilege to declare this meeting open.

Chairman Watkins.
WELCOME

ADMIRAL WATKINS: Good morning. It's a pleasure to
welcome our members, distinguished panelists and all of you in
the audience who have joined us this morning for this meeting of
the President's Commission on the HIV epidemic.

As many of you know, the Commission submitted its
preliminary report to the President on December 2nd, and in that
report we indicated that we would be proceeding expeditiously to
address several issues we feel demand early attention.

The incidence and prevalence of HIV infection amongst
Americans is one of our first priorities in this regard.

Today, under the leadership of two of our
Commissioners, Mr. Richard DeVos and Mr. John Creedon, we have
organized this public hearing to receive testimony from many
individuals who are considered experts in the fields of
epidemiology, biostatistics, public health and medicine.

In hope of coming to a better understanding of this
disease and its future course, we have assembled five panels over
a two-day period to focus on important issues such as the staging
of the disease and the quality of the epidemiological data; the
public health perspective in future trends; populations at risk;
community-based organization perspective; and mathematical
projections.

Determining the incidence and prevalence of HIV
infection is critical for projecting the economic impact and
developing a meaningful response to the epidemic.

Before I temporarily relinquish the chair this morning,
I would like to set up operating procedures.

When the panelists have finished their testimony, Mr.
John Creedon will lead off the questioning, and then other
Commissioners, with me asking the last set of questions.

In this way, all Commissioners will get a chance to ask
their questions within the time frame that has been allotted, and
I will be able to close up each panel session.

 

 
 

So without objection from the Commissioners, we will
use this procedure for today's and tomorrow's hearing.

At this time, I will defer to the chairman of the
subgroup for finance and economics, Mr. DeVos.

MR. Devos: Thank you, Admiral. I also would like to
welcome all of you here today as we prepare to get down to some
of the hard numbers and the financial aspects that are attached
to this challenge that we face.

We are going to try to get some numbers that carry us
out to the year 2000 in order to have cost projections based on
some realistic numbers.

I also owe you an apology, for I have engagements in
New York today, and I will be going there; but I will be back
here again late tonight.

It is a tribute to our staff people in the preparation
of much of this data today. Carol Abrams, who did a lot of it,
and Jackie Knox; Carol Abrams, who works with Mr. Creedon; and
Jackie Knox of the Commission staff, have put together most of
the material that you're going to be hearing about today. I
want to commend them and thank them.

We've heard a lot in the past about the makeup of this
Commission. From my personal viewpoint, it's an honor to be here
and to be associated with people who are willing to give so much
time and effort to this particular effort.

One of those is the man who is the chairman of this
particular panel today and tomorrow, the president of the
Metropolitan Life Insurance Company. We not only salute him, we
thank him, and we wish him well in his hearing today.

Now, I turn it over to John Creedon.
John, it's all yours.
MR. CREEDON: Thank you, Rich, and thank you, Admiral.

It seems to me that today and tomorrow we will be
examining a number of different issues.

First of all, we'd like to know as best we can how many
people have the virus right now. We'd like to try to determine
how many people will get the virus between now and the year 2000.

 

 
 

 

In connection with both of those questions, is an
additional question; how reliable is the data that now exists?
How reliable is the testing process?

How many who have the virus or will get the virus will
get AIDS itself or some other disabling condition which will
require medical care and how soon will they get AIDS or a
disabling condition after the time they contract the virus?

Who are the vulnerable groups? What are the sizes of
the vulnerable groups? Are they growing or diminishing? Are
they likely to grow or diminish between now and the year 2000?

Will the disease spread, or is it spreading to the
heterosexual community as well as to the vulnerable groups?

Reliability of the testing, reliability of the process
that we're using to make estimates; these are the key questions.

I think we recognize that there are conflicting views
on some of these questions, that the situation is necessarily
fluid; that there may not be as much certainty as we would like;
that it's complicated and that, to some extent, everything
depends on a lot of different variables.

But this is a situation with which we are confronted,
and in that atmosphere we have to try to develop as much good
data as we can.

As the Admiral said, we have set up four different
groups, two today, one in the morning and one in the afternoon
and two tomorrow. The first one this morning will deal with the
quality of the data that exists out there and the various stages
of the disease among people who have the virus.

We have a number of panelists, and the first one is
Dr. Fauci.

Dr. Fauci.
PANEL ONE
DATA BASE QUALITY/STAGING OF THE DISEASE
PRESENTATION BY DR. ANTHONY FAUCI

DR. FAUCI: Thank you, Mr. Creedon, Mr. Chairman,
members of the Commission and ladies and gentlemen.

What I'd like to do this morning is to spend 10 minutes
discussing in a broad outline the spectrum of infection with HIV,
what the mechanisms are whereby a person can go from an

3

 

 
 

 

asymptomatic infection to developing symptoms and ultimately
full-blown disease, and what the known data of the conversion
from asymptomatic to full-blown disease is and what some of the

projections are.

I'd like to start off by very briefly outlining the
process that occurs when an individual is infected with the human
immunodeficiency virus shown here on this slide in which the
outer coating, the area which is designated gp 120, is actually
the site of the virus which has a specific affinity for certain
cells in the body, the most important of which is the human
lymphocyte, which is responsible for protecting the body against
invaders that are microorganisms as well as certain cancers.

I reviewed this with the Commission a few months ago,
so I'll be very brief in this regard, but these lymphocytes,
particularly T-lymphocytes, are responsible for what we call host
defense mechanisms.

The virus, as I mentioned, on the right-hand side ina
magnified form binds to a specific receptor on the T4 lymphocyte
which we call the CD4 molecule. That molecule is predominantly
expressed in a very large amount on T4 cells but also on
monocytes and on certain cells of the central nervous systen.

So monocyte macrophage lineage cells can also be
infected and probably serve as an important reservoir for the
virus.

The reason this T4 cell is so critical to the entire
process of understanding the devastating effects of HIV is that
the T4 lymphocyte is the cell that is literally responsible for
the orchestration of virtually all aspects of the immune systen.

This slide schematically diagrams arrows coming from
the T4 lymphocyte to all of the known important immunological
functions of a variety of cell types; therefore, the very
interesting and somewhat diabolical situation of this virus is
that by eliminating one specific cell type, it can in essence
completely immobilize and destroy the immune system, leading to
the devastating effects that we know as AIDS and AIDS-related
conditions.

Now, it's also important to understand when you think
in terms of infection versus symptoms versus disease is to
understand that upon infection of the T4 lymphocyte on the top of
the slide, two major events can occur:

Either the virus can immediately kill the cell, as
shown on the left-hand side of the slide, by active replication
leading to cell death and ultimately suppression of the immune
system; or

 
 

 

As demonstrated on the right-hand side of the slide,
the virus can exist in what we call a latent or a low-level
chronic form. In this situation, there can be virtually no
detectable immunological abnormalities, or there may be subtle,
if not frank, immunological abnormalities that do not necessarily
lead to full-blown disease or symptoms.

Nonetheless, in both those states, when the virus is
latent or when the virus is fully expressed, an individual can
pass the virus on to another individual by the well-established
mechanisms of sexual contact, blood or blood products, or mother
to child.

If you look at the progression of effect -- and this is
important to understand the whole process -~- and you measure
total number of T4 cells as shown on this slide and you look at
the progression from normal individuals on the left-hand side of
the slide to healthy seronegative homosexual men to chronic
lymphadenopathy, Kaposi's sarcoma and then all the way in the
right-hand part of the slide, you see opportunistic infections.

In other words, it would be almost invariable that if
an individual has his T4 or her T4 cells decreased below a
critical number -- and that arbitrarily usually is about 100 to
200 per cubic millimeter -- sooner or later that individual is
going to develop an opportunistic infection.

Interestingly, with Kaposi's sarcoma, you need not have
such profound immunological suppression to see the onset of
Kaposi's sarcoma.

Of great interest and importance is the fact that
healthy homosexual men that we have followed at the clinic at the
NIH who are seropositive -- namely, they're infected with the
virus but they have absolutely no symptoms -- we plotted on the
side on the vertical axis the total T4 cells and a certain immune
response to a particular antigen on the horizontal axis.

As you can see, there are a number of individuals who
are down around the 200, 300, 400 mark who are completely
asymptomatic; yet, they are significantly immunosuppressed. That
means that even though you're talking about large numbers of
asymptomatic individuals, they may not, in fact, be perfectly
well. We'll get into that in a moment.

This is the CDC classification scheme looking at
various groups. The first group is acute infection. Some
individuals, particularly the few health care workers who are
infected with the virus, undergo an acute syndrome, usually
mononucleosis-like syndrome, from which they recover, and then

 

 
 

 

after that they're essentially asymptomatic and then can go on to
develop full-blown disease later.

Group 2 is asymptomatic infection.
Group 3 is persistent generalized lymphadenopathy.

Then Group 4, we get into what we call other types of
disease.

The subgroup A is constitutional disease, or what we
call R, and I'll get back to that in a moment.

Group B is neurological disease.
Subgroup C is secondary infectious diseases.
Subgroup D is secondary cancers.
Subgroup E are other conditions.

It's important to point out, as you'll probably hear
from Dr. Redfield, that the Walter Reed classification breaks
that down into even more subgroups, where you can actually look
at subtle immunological changes before you even see any symptoms.
That really becomes an important categorization to look at, as
I'll explain on some of the subsequent slides.

This is a slide you've seen many times, the iceberg
slide that Jim Curran and his colleagues have put together from
the cCDc.

If you talk about full-blown AIDS, that's the 47,000
plus that's going on in this country right now. There's a
projection of about 150,000 individuals with symptomatic disease
who do not have full-blown AIDS, and then there's the projection
that there's a million to a million and a half individuals who
are infected but asymptomatic.

Working from the bottom up, what do we mean by
"asymptomatic?" Just that. They're infected with the virus.
They have no symptoms. But an important statistic is now a known
fact. If you plot the number of individuals who are asymptomatic
who develop full-blown disease, about 20 to 30 percent of them
within five years will develop disease. We know that. That's
not a speculation. That's not a projection.

The important aspect is what is that curve going to do?
In 20 or 30 years, is it going to be linear as the open dots that
go up? In other words, there will be 80 or so percent of the
individuals at the end of 20 years with disease, or will it
plateau?

 
 

 

We don't know, but looking at the Walter Reed
classification in which you measure immunological changes, even
those individuals who are asymptomatic, a vast majority, 80 or 90
percent of them, over a period of a few years will develop some
sort of immunological deterioration. That immunological
deterioration doesn't necessarily mean disease, but it does
indicate that there is a deleterious effect of the virus on these
individuals even if they don't yet have disease, which makes one
get concerned that a much larger percentage than 20 to 30 percent
will ultimately develop disease.

MR. CREEDON: Will those people require medical care?

DR. FAUCI: Those people will not require medical care
if they're asymptomatic with immunological abnormalities, but it
is likely that if they progress in their immunological
deterioration that they will ultimately require medical care,
yes.

Now, then you move on to the next phase, which is
symptomatic HIV infection without AIDS, what we call the AIDS-
related complex. That's a complex characterized by fever, weight
loss, diarrhea, fatigue, night sweats, you may or may not have
lymphadenopathy and certain immunological abnormalities.

It is likely that a substantial portion of these
individuals will go on to develop full-blown AIDS within a period
of a couple of years, probably over 30 percent of these
individuals.

MR. CREEDON: Again, those people will require medical
care when they have that condition?

DR. FAUCI: Many people with ARC will, in fact, require
medical care, because ARC can be a very serious condition even
though it does not fulfill the criteria that we set up for
full-blown AIDS. There are individuals who have ARC who are
seriously ill and require medical care.

MR. CREEDON: In trying to determine what the needs are
going to be for caring for people who have the virus, at what
point do they need medical care? Are they likely to need
medical care of some kind?

DR. FAUCI: Yes. With ARC, they are likely <--
MR. CREEDON: Pre-ARC, maybe or maybe not?

DR. FAUCI: Maybe not, right.

 

 
 

 

Now, this is the standard number that you've seen many
times. As of just last week, there are approximately 47,000
cases. The breakdown among the different groups and subgroups is
essentially the same. You'll probably be hearing more of that
from other speakers.

Moving on very quickly, the typical infections in
patients with AIDS, this is a list of them. We need not go
through them. You've heard about them, one of the most important
of which is obviously pneumocystis carinii pneumonia, which
affects about 60 percent of individuals who have full-blown

AIDS.

But let me give you some examples of the devastating
effects of some of these opportunistic infections. This is a
normal retina looked through an ophthalmoscope. This is what you
would see if you look into a normal eye.

This is one of -- oops, we don't have it. We missed
that, I'm sorry, but there was a destruction of the retina by
cytolmegalovirus

This is an esophogram, which should be a very smooth
channel of dye coming down, and you can see it's ragged at the
edges. That's an individual with candida esophagitis.

This is a normal chest X-ray in one of my patients who
developed a full-blown pneumocystis carinii pneumonia; as you can
see here, devastating effects and one of the highest causes of
mortality in full-blown AIDS.

This is a series of CT scans of the brain, and if you
concentrate on the upper left and the lower right, you'll see a
dark white area on the righthand side there. That's toxoplasma
gondii, an important cause of central nervous system disease.

Even more importantly has been the realization over the
past year or two that HIV can actually infect the human brain.
These are multinucleated giant cells from the brain of an
individual who died with AIDS and cephalopathy, and the dark
grains that you see scattered around the cells are a probe
looking for HIV. So HIV is actually present in these cells.

Individuals who develop HIV in the brain can have
anything from an asymptomatic infection, and we know now in our
studies at the NIH and at Hopkins and elsewhere that about 50
percent of individuals who might even be asymptomatic, can grow
the virus from the central nervous system.

They might not have any central nervous system
symptoms, but individuals with AIDS, if you study them, for
example individuals with Kaposi's sarcoma or individuals with

8

 

 
 

opportunistic infection, when you do a lumbar puncture, 50
percent of them will have virus grown from the central nervous

systen.

Other abnormalities include cognitive and psychiatric
abnormalities, frank dementia, meningoencephalitis or localized
or diffused neurological abnormalities.

This is a classic example of tutanious Kaposi's sarcoma
in one of our patients, and as I mentioned, the immunological
abnormalities that you have when you have Kaposi's sarcoma are
usually not as profound as those that you have when you have
opportunistic infection.

Finally, a recent article in the New England Journal of
Medicine, looking at thousands of patients from New York City,
the one year following diagnosis survival was 49 percent, whereas
five years following diagnosis it was 15 percent, with
individuals with Kaposi's having better survival than those who
present with opportunistic infection.

If you look at the data compiled by the CDC in fatality
rates throughout the entire epidemic, you see here it's 57
percent. It has remained relatively constant.

But if you look at individuals who have been infected
and who had the disease in 1981 and 1982, between 80 and 90
percent of those individuals are dead today.

So, finally, in summary, HIV infection can exist in a
number of forms. It is important to distinguish the difference
between asymptomatic infection, who have a 20 to 30 percent
chance in five years of developing disease; symptomatic
infection, who probably will need care, who have a greater than
that percentage of going on to full-blown AIDS; and individuals
who have full-blown AIDS which now constitute the sum total of
approximately 47,000 people in the United States up to this
point.

MR. CREEDON: Dr. Fauci, you said that 20 to 30
percent will develop AIDS within five years.

DR. FAUCI: Right.
MR. CREEDON: What about the others?

DR. FAUCI: Again, what I showed on the slide is that
at this point, we can not precisely predict whether, in a linear
fashion, you have 40 percent in 15 years, 50 percent at 20 years,
60 percent -- we don't know that. But if you look at the
immunological deterioration, and you find -- and this you'll
probably hear more from Dr. Redfield -- that over a period of

9

 

 
 

years, most of those individuals will have immunological
deterioration, which suggests that if they are not treated over a
period of time, they may go on to develop full-blown AIDS.

MR. CREEDON: Penny, do you have some questions?
MS. PULLEN: Not at the moment.

MR. CREEDON: Ms. Gebbie?

MS. GEBBIE: No.

MR. CREEDON: Any questions from the other end? Yes,
Dr. Crenshaw?

DR. CRENSHAW: Of the different classification systems
of HIV infection that I'm familiar with, the four point one that
you mentioned, Walter Reed which is six phase and AMA which is
seven, can you comment on the relative value of each and which
you think should -- which you would recommend become the adopted
standard?

DR. FAUCI: Well, it's very difficult to say that one
should be adopted standard. What has happened unfortunately,
they have all become so complex that if you look at it, it
becomes almost very difficult to read, of all of the different
infections that constitute one subgroup versus the other.

We use the CDC classification of the various groups and
subgroups. But I think that the Walter Reed classification has
merit in that it gives us insight into the immunological
deterioration that you would not pick up on the other. So I use
really a combination of both of those.

DR. WALSH: Tony, on the HTLV-I, are the tests that
we're using today sensitive? Will they pick that up as well?

DR. FAUCI: For HTLV-II?
DR. WALSH: Yes.

DR. FAUCI: The adult T-cell leukemia one. The test
that we use, we are not universally screening the HTLV-I at this
time, but the tests that are available are sensitive tests and do
pick it up.

DR. WALSH: And has that been identified with AIDS at
all, or is it primarily just leukemia?

DR. FAUCI: Well, there are individuals who are doubly
infected with HIV causing AIDS and HTLV-I either causing or not
causing a secondary lymphoma. But there is not AIDS caused by

10

 
 

HTLV-I. You can have both infections, but there are no reported
cases of someone who has AIDS, and the only thing they have is
HTLV-I.

DR. WALSH: Okay. Thank you.

DR. SERVAAS: Dr. Fauci, do you think it's important
that we start testing for HTLV-I?

DR. FAUCI: I think that it should be given serious
consideration, given the fact that now with the individuals --
for example, the leukemics who have received multiple blood
transfusions, it's starting to show up that there is a proportion
of those individuals, small but nonetheless it's a significant
proportion, would have antibodies to HTLV-I, which would indicate
that in massive blood transfusions, there's a chance, a very
small chance, but there is a chance of getting HTLV-I. So it
would be appropriate to at least examine that issue of whether or
not, in fact, that is being addressed at this time.

DR. WALSH: Tony, is there any credibility to the fact
that reexamination of some of the blood that they had from the
days of Hiroshima showed HTLV-I positive?

DR. FAUCI: Well, I wouldn't be surprised. If you look
at the fact that HTLV-I has existed in Japan probably for a very
long period of time. It was only recently recognized by the
Japanese investigators and by Gallo and his colleagues within the
last couple of decades. But, in fact, if you look at it, it is
very likely an ancestral virus that was in the population for a
long period of time. I wouldn't be surprised at all if you went
back to sera in Japan and you found antibodies to that virus a
very long time ago.

DR. WALSH: Thank you.

DR. SERVAAS: Does it have a 20-year average latency
period, the HTLV-I?

DR. FAUCI: HTLV-I can have an extraordinarily long
latency period. In fact, if you look at the populations in the
endemic area, there is a significant proportion of individuals
who are infected with the virus, who are asymptomatic, and a
small percentage of them may go on to develop lymphoma and
leukemia later on.

MR. CREEDON: Dr. Primm?

DR. PRIMM: Dr. Fauci, a friend of mine, who is in New
Orleans, Louisiana, submitted a number of blood samples to the
National Institutes of Health from a drug treatment program, Mr.
Vernon Shorty, and indicated to me that out of 250 samples from

ll

 

 
 

 

his addicted population, about 50 of those samples were positive
for HIV -- well, HTLV-I. None were positive for HTLV-III, but
about 50 were positive for HTLV-I.

My question is, since the population has shown no
incidence and prevalence of leukemia whatsoever, nor is there any
problem of leukemia in the New Orleans area, particularly in the
Desire housing project where these samples were taken from --
that drug treatment program, how do you explain that kind of
seropositivity for an antibody in that population without any
disease whatsoever?

DR. FAUCI: Yes. If, in fact -- I haven't seen that
data, Dr. Primm, but if, in fact, the data is correct, that there
is X percentage of individuals in an IV drug-abusing population
who are positive for HTLV-I with no disease, that's not entirely
surprising, because if you look at the Japanese population, the
conversion for antibody positivity to full-blown disease is a
very, very small percentage. In other words, there are many,
many, many more individuals in Japan who are antibody positive
than have disease. In fact, you can, in some endemic areas, up
to 10 percent of the population is positive, but the incidence of
disease is very low.

It's not like AIDS, where already after five years you
know that 20 to 30 percent are going to develop disease. When
you're talking about HTLV-I and T-cell leukemia, a very small
fraction will develop disease.

DR. WALSH: Is it a sufficient fraction, Tony, so that
it's knocked out on blood products?

DR. FAUCI: Excuse me?

_ DR. WALSH: The HTLV-I. Is the significance of the
positivity such that they would not use it in blood products, if
there's positivity on the testing?

DR. FAUCI: Oh, I would be certain that if, in fact,
there was a broad universal screening of blood in the United
States for HTLV-I, and a unit was found to be positive, it would
be eliminated in exactly the same way as HIV-positive is
eliminated, because it's a blood-borne and sexually transmitted
disease.

MR. CREEDON: Dr. Fauci, are there any other
recommendations that you have for the Commission, either in the
specific areas that we've discussed or otherwise?

DR. FAUCI: No. I think I've essentially made the
points that I wanted to make about the differences in the group,

12

 

 
 

and I think an appreciation of those differences is very
important in formulating recommendations and policies about them.

MS. PULLEN: In terms of the opportunistic infections
that an AIDS patient is subject to or an HIV-positive person as
they progress in the disease is subject to, could you define
specifically what opportunistic infection is, and would you
indicate whether any of the infections that are common in these
persons goes beyond the definition of opportunistic infection to
a more transmissible infection?

DR. FAUCI: Right. An opportunistic infection, by
definition, is an infection which a person, normal person in the
sense of normal host defenses, would not be expected to get, and
only when the person's defense mechanisms are severely impaired,
either iatrogenically through chemotherapy, through a cancer or
through a virus like HIV, that the body's defenses are so
dismantled that the particular microorganism, which under most
circumstances would be harmless, seizes the opportunity to then
invade the body. Hence, we use the terminology opportunistic
infection.

The opportunistic infections that are very common in
patients with HIV are usually the kind that are endogenous to
them, not the kind that you would consider highly transmissible
from one to the other.

In certain populations in the United States,
tuberculosis is one of those opportunistic infections,
particularly in individuals in the poorer socio-economic areas
where you would find higher incidence of tuberculosis. It's a
common opportunistic infection in African AIDS and a common
opportunistic infection in AIDS in Haiti. That is one that's
communicable from one to the other.

But pneumocystis carinii pneumonia, M-avium. CMV is
probably reactivation of CMV they already have. Toxoplasmosis is
probably reactivation of infection they already have. Herpes is
probably reactivation. So more of it is infection that's part of
the normal environment of the body.

DR. SERVAAS: Dr. Fauci, could you tell us how
difficult it is to treat AIDS patients who have tuberculosis? Is
the medication as effective?

DR. FAUCI: Well, whenever you have a situation in
which the body's defenses are significantly suppressed, there
will always be less of an effective response to standard
chemotherapy. For example, part of the defense against
tuberculosis would be your own body's immune system plus therapy,
like Isoniazid and Rifampin and Ethambutol. If you take away the
body's defenses and just give the person the drug, that person

13

 

 

 

 
 

 

would have a much more difficult time clearing an opportunistic
infection such as tuberculosis.

MR. CREEDON: Dr. Primm?

DR. PRIMM: Yes. Dr. Fauci, you know, in Harlem, for
example, we rank number two in the Western world for the
incidence of tuberculosis in the population there.

I think that people in Harlem are far more susceptible
to the HIV virus than would normally be, because of the high
incidence of tuberculosis, only second to Haiti, which is the
poorest country in the Western Hemisphere, and, you know the
incidence of tuberculosis in Harlen.

Yet very little is reported about this, and I like the
fact that you have offered to the Commission what you just
offered, and I think we need to look at the incidence and
prevalence of tuberculosis in Harlem. A lot of our patients
die, by the way, from tuberculosis before they are even diagnosed
to have, or be positive for the human immunodeficiency virus
antibody.

So the point I'm trying to make is that ought to be
made public, and physicians ought to know about it, and I'm
going to particularly ask Dr. Axelrod about that this afternoon.
If you would comment on that a little bit more, I would
appreciate it.

DR. FAUCI: Sure.

DR. PRIMM: I want to apologize, too, for not having
been here a little earlier. Our plane was late from New York
this morning. You might have already commented on that. But as
you know, how much I appreciate very much your offerings to this
field.

DR. FAUCI: Dr. Primm, I think what's important is not
necessarily that if you have a high incidence of tuberculosis in
an area, that would predispose you to developing HIV if you come
into contact. I think it's important that, as in Harlem, if you
have a high baseline prevalence of tuberculosis, individuals who
are infected with HIV will very likely develop tuberculosis as an
opportunistic infection before another individual in a different
area, which did not have that basic high prevalence.

And I think it's very important to address the issue of
tuberculosis. In fact, paradoxically enough, tuberculosis
research has been really kind of a sleeping area over the past
several years, and there's been an emergence of interest now. I
know at the NIH in our own Institute we've set several new
initiatives to do some more basic research in tuberculosis for

14

 
 

 

that very reason, that in populations such as in Harlem or in the
South Bronx or in areas of Miami where you have high incidence of
tuberculosis, that is becoming a very important problem.

So I agree with you completely that is something that
should be addressed as an important issue in the whole picture of
AIDS.

MR. CREEDON: Dr. Fauci, are you going to be able to
remain with us for the rest of the morning or not?

DR. FAUCI: Until the end of the morning, yes. I'll be
here for the morning but not for the afternoon.

MR. CREEDON: That will be great. Okay. Jim, did you
want to --

ADMIRAL WATKINS: I just have one question, Dr. Fauci.
The Centers for Disease Control have just broadened their
definition of the ARC/AIDS relationship, and they've included now
in AIDS chronic progressive weight loss and dementia. And the
question is, are we seeing a migration out of the gray zone of
ARC; between asymptomatic and, you might say, full-blown AIDS
being redefined, and if so, what is the impact of that on the
prevalence and incidence database?

DR. FAUCI: Well, just this past report from the cDc,
which probably Dr. Curran would be better to address, but there
has been an increase by a small percentage of the cases. Ina
sense we did a jump. We're at now between 47 and 48,000, and we
took a jump over a week of an extra 1500 or 1800 cases out of the
total. That's all the difference was.

So what it is, is that some things that were not called
AIDS, particularly some of the neurological abnormalities that
are now falling into AIDS, have increased the numbers of AIDS on
the transition week or month or what have you, and I think you're
going to then start seeing it just leveling off.

ADMIRAL WATKINS: But do you see the potential for more
migration from ARC to AIDS in other areas, because it seems to me
that is germane to entitlements, for example, for certain AIDS
patients? So what is really happening there, and how much more
attention is being given to that "ARC to AIDS" transition as
being more AIDS than ARC, if you will?

DR. FAUCI: I think that's something that's still in
the process of being looked at, because we're constantly trying
to redefine and finetune the definitions. These are, as you
know, empiric definitions, but it was clear that some of the
things that were not called AIDS before have not been
reclassified as AIDS, and perhaps some of the more serious ARC.

15

 

 
 

 

As you can see in the subgroup now, they've listed it as
constitutional disease and then infections and neoplasms. So
constitutional disease, which is essentially ARC, is now in the
subgroup that includes the other AIDS categories.

DR. CRENSHAW: Dr. Fauci, in relation to the Admiral's
question, you indicated that, if I understood you correctly,
approximately 50 percent of asymptomatic HIV-positive
individuals had a virus that could be cultured from the brain; is

that right?

DR. FAUCI: No, I didn't say it's asymptomatic. I said
approximately 50 percent of people with AIDS, who have no central
nervous system symptoms, when you routinely do a lumbar puncture,
you can find virus in the central nervous system. But they have
AIDS; they're not asymptomatic carriers.

DR. CRENSHAW: I understand that virus-positive
cultures are quite common in those that are otherwise
asymptomatic and that the CNS can be one of the presenting
symptoms of the disease.

What I'm wondering is, if you culture virus out of
someone who is otherwise asymptomatic, may have fine motor
coordination problems or something subtle neurologically, are
they automatically classified as AIDS, or at what level of
symptomatology of CNS involvement is the AIDS diagnosis made, or
is culturing the virus sufficient? If they find virus in the
spinal fluid, does that make someone qualify for AIDS?

DR. FAUCI: No, no. The answer to that is, the
neurological classification is neurological symptoms,
neuropsychiatric abnormalities of the categories that I listed on
the slide. The actual culturing of the virus out of a variety of
body fluids itself does not constitute the diagnosis of AIDS.
There has to be involvement in a clinical pathological way, such
as symptoms.

Now if there are subtle cognitive changes that could be
listed as dementia, that person would be considered to have AIDS

then.

MR. CREEDON: Just one more question, Ms. Gebbie, and
then we'll move on.

MS. GEBBIE: You made mention briefly of the most
recent CDC report that just was issued. For purposes of making
projections toward the end of the century, is that a document you
would use for making those projections, and if not, what critique
would you make of it?

DR. FAUCI: Which CDC report are you referring to?

16

 

 
 

MS. GEBBIE: The one that was just issued last week or
so that gives projections, recritiques the incidence and
prevalence data and the possibility of projecting for the end of
the century.

DR. FAUCI: Yes, I would use the CDC material
definitely. ,

MS. GEBBIE: Thank you.

MR. CREEDON: Thank you very much, Dr. Fauci. Our
next witness is Dr. Donald Francis from the California State
Health Department. Dr. Francis?

PRESENTATION BY DR. DONALD FRANCIS

DR. FRANCIS: Thank you, Mr. Creedon, Mr. Chairman, and
Commission members. It should be pointed out that I am assigned
to the Department of Health Services in California from the
Centers for Disease Control in Atlanta, however.

First, I would like to thank you for allowing me to
testify before this important Commission. Second, I want to make
it clear that the testimony I give here is my opinion, and does
not necessarily represent the opinions of either the Centers for
Disease Control in Atlanta, or the Department of Health Services
in California.

And, last, I would like to express my admiration for
the Committee in their preliminary report. The recognitions of
the need for more societal commitment was refreshing, but the
statement that too much time has elapsed, and too many people
have become afflicted while questions remain unanswered was
really spectacular. The call for collective dedication was truly
magnificent.

Since I am sure that many in the next two days here
will fill many of the details of AIDS prevention, including
prevalence, incidence estimates, et cetera, I -- as a young, but
well-bruised veteran of serious epidemics -- would like, if I
may, give some insights into the broader issues.

The overall gist of what I will say is that, one, we
really know a great deal about HIV, its transmission, and how to
prevent it. Two, we in public health want and should move ahead
with a scientifically-based aggressive prevention program.

And three, there are some obstacles that inhibit us

moving ahead in such programs. I think the most useful is that
most of these obstacles really are relatively readily removable.

17

 

 

 
 

 

First, let me outline, in brief, what we know about
HIV. HIV, from Tony's -- and I'm sure from George Rutherford's
and other information you will see today, Bob Redfield's -- it is
clearly one of the most virulent viruses that infects humans.

Any virus that is going to kill over ten percent would
worry us in public health. Even one that would kill over one
percent would be of major concern, actually. When you start
getting up to 20, 30, 40, 50 percent, it becomes an issue of
health care planning in a big way. _

But, in terms of public health, they are all very
severe percentages in terms of death, and need appropriate
reaction.

Two. This virus has a long and silent incubation
period, during which time infected persons remain infectious to
others. And last, it is transmitted exclusively through sexual
intercourse -- both heterosexual and homosexual; through sharing
of blood, especially during intravenous drug use; and from
infected mothers to their babies.

The first two of these, linked with the high mortality
and the silent infection, make this an especially difficult agent
to deal with, in terms of public health. It has got considerable
opportunity for spread.

The combination of high virulence, long silent
incubation period, and sexual transmission make this virus a
major concern for those who have watched similar epidemics
before.

Indeed, evidence to date indicates that the virus has
already extensively invaded the United States. Regardless -- I
think this important -- regardless of what estimate it takes, we
have a major tragedy on our hands.

The good news is that we, as a society and as
individuals in a society, have it in our power to stop
transmission of this virus. Preliminary evidence from both the
homosexual male community and intravenous drug using community
suggests strongly, I think, that well designed intervention
programs can effectively reduce the transmission of HIV.

I want to repeat that. Well designed, aggressive
intervention programs can effectively reduce the transmission of
HIV and, as a result, eventually reduce the cases of AIDS.

Given this information, a broad consensus has been
reached in the public health sector. Reports from a wide variety
of individuals and groups, such as the Surgeon General, the
National Academy of Sciences, the Association of State Health

18

 
 

Officers, the Conference of State and Territorial
Epidemiologists, et cetera, have basically all agreed on the
approaches that are necessary.

There is a very broad consensus on what needs to be
done. Yet, despite the major problem and the consensus on what
needs to be done, there is -- at best -- only a skeleton of AIDS
prevention programs actually in the field.

Why is this? I see several obstacles to fielding a
successful AIDS prevention program. First is the perception,
from the public and public health workers, and from much of the
society, asking does anyone really care?

Using your own words, it appears that instead of having
a solid prevention program based on modern science, we have a
program that is fragmented and sometimes confused by, quote,
"prejudice and fear."

Second is the confusion centering around the question
of whether AIDS prevention should be a police action of the
government against the people, or a cooperative effort of the
people with their government.

The consequences of these obstacles have been the
absence of necessary resources and effective leadership, slow
delivery of basic prevention, and an absence of the usual
positive American We-Can-Do-It approach.

We can, and should, rebuild this can-do spirit. Use
modern science to generate policy. Let me repeat that. Use our
modern science to generate policy. Supply the resources, and
quickly mount an effective, aggressive prevention program.

I think we, in the public health sector of this
society, at all levels can do it. Indeed, from my experience at
local, state and federal levels, everyone wants to do it. I am
confident that, given the spirit, the leadership, and the
resources, we can launch an AIDS prevention program which could
severely inhibit further extension of this virus into the
American public.

It is now six and a half years since the discovery of
AIDS. It is time to act maturely, ignore all the peripheral
distractions, and mount an effective AIDS prevention program.

Regarding some of the issues that you, Mr. Creedon,
asked for early on in the introduction, the estimate of
prevalence in this society: the test is extremely good,
extremely accurate, extremely sensitive, extremely useful.

19

 

 
 

 

Sampling techniques are available, and we could go out
and actually sample individuals. What the problem is, again
leads these national attitudes regarding the leadership, the
protection of the individuals, and the help that you will provide
these individuals, should they be found to be infected.

I think you just have to turn it around and think
about yourself being an infected individual in a household, or at
least in a risk group in the household, and this individual
knocks on your door from the government to do a test on you.

If the spirit in this country, by the highest
authorities, is that this is our people's problem, a world's
people problem, and we as societies are going to work together to
do this, and we need to know the prevalence of infection, if
someone knocks on your door, stick up your arm and get bled, we
will counsel you, we will take care of you, and we sure won't
throw you in quarantine or lose your insurance, or whatever it
may be, if you participate in this thing. If you don't have
that, you can imagine what the reaction is going to be.

We have clearly seen it in our California prevalence
information, that the more restricted the environment, the less
confidential the testing, the lower prevalence of infection we
find. It is only logical.

Questions of a heterosexual epidemic constantly come
up, and end up throwing great confusion on us in public health.
We have tried to make relatively straightforward recommendations
towards heterosexual transmission. The quote "absence of the
heterosexual epidemic" is only a matter of what your expectations
were regarding heterosexual transmission of this virus.

There is a huge epidemic amongst homosexual men, on top
of what I consider a really very significant epidemic in the
heterosexual community. But no doubt 500 or 1,000 cases, or
however we want to count it, is diminished by 47,000 cases of
others in the epidemic.

All we need to do is pull away and say, take away
those cases and say, are we concerned about having all these
infected heterosexual people, and look at the data that is
available on heterosexual transmission. And clearly we have a
problem. It is a matter of expectations, not of scientific data.

You asked about medical care regarding seropositive
individuals. I think every seropositive individual is going to
require medical care. Again, turn it around to yourselves on the

panel.

If you were infected with a virus that Dr. Fauci says
has a 25 percent, 30 percent chance of killing you in three or

20

 

 
 

four years, and Dr. Rutherford is going to tell you 40 percent in
seven years would you want to be all by yourself and not get
medical care?

If the doctors tell you that early intervention now
could help keep you out of the hospital, prolong your life as a
productive and healthy individual, would you not want to get into
a medical system to care for you?

Yet, we as a society tend to isolate these people. If
they come in they get discriminated against by their doctors, by
their health care system, by their neighbors. We need to provide
that kind of protection so that individuals can come forth and
get into medical care systems.

I say that not as a physician, but I put on my public
health hat and say that I want these people coming in who are
serologically positive so we can help work with them to modify
their behavior, because they are the source of infection for the
next generation of cases.

All of this requires a true spirit of cooperation with
these individuals. Some say, why do you want to cooperate with
individuals as a public health individual, when you -- and I --
have used quarantine, been thrown in quarantine for infectious
diseases?

I say I use quarantine for diseases that are
transmitted in nonconsensual settings, where an individual is at
risk in this society from, let's say, walking down the street or
coming to a meeting like this, or whatever.

But if two individuals are undertaking mutual,
consensual activities, that either one of them could prevent,
then it is our job to give them the information, the motivation,
and the skills, to make that individual decision, work together
with them, so that no more transmission exists. This is a very

important determination between consensual versus non-consensual,
in terms of government intervention.

Thank you.

MR. CREEDON: Thank you, Dr. Francis.
Ms. Pullen, any questions?

MS. PULLEN: No.

MR. CREEDON: Ms. Gebbie?

MS. GEBBIE: One of the major purposes in my line of
this discussion is to get straight what incidence and prevalence

21

 

 
 

 

rates we could use to make subsequent calculations, so I want to
pin you down a little bit in that area.

Based on current numbers, and what you said, you would
indicate that if, indeed, a million people are currently infected
we need to plan in illness treatment costs for that whole batch

of people.

My first question is, are you comfortable using that
kind of number as a currently infected population? Or do you
have some reason to say we should adjust that upward or downward?

DR. FRANCIS: Two things. I am confident with the
numbers as they exist now, with wide confidence, because of the
way they are derived, obviously. We can refine those, and CDC is
in the process of attempting to do that, as Jim Curran will get
into.

The problem I have is these are perfectly fine
projection numbers, considering where we are and where we need to
go to. If we were planning for health care of these individuals
and were moving ahead today, and we are thinking, well, are we
going to get overwhelmed tomorrow, and we need to find out just
exactly how much that adjustment would be, then I would say, gee,
let's get together and it should be our major priority to refine
that number.

We are so far from using this quick and dirty data that
we have now, in terms of our progression. If I want to know
exact numbers, if I knew that we would societally adjust and
appropriately tune our system.

But I think what you are doing is having a six-
cylinder car that is running alright on four cylinders, and you
are saying, well, gee, maybe we should put two more spark plugs
in this when, in reality, the car is up on blocks.

MS. GEBBIE: I am not taking issue with that planning.
I am trying to pin down -- again, I will do this consistently all
morning -~- whether those numbers are good.

The other piece I think I have heard you say is that,
for purposes of looking ahead toward the end of the century,
whether we can use some kind of straight line progression in the
number of people who are infected; just assume it is going to
keep growing at the present rate, or whether we could assume that
we will somehow drop that rate off, is dependent upon the degree
to which we launch programs, educational programs, deal with the
societal attitude.

DR. FRANCIS: Clearly.

22

 
 

 

MS. GEBBIE: Absent that, are the current projections
ones that you would live with?

DR. FRANCIS: The difficulty we have, as Tony pointed
out, is that we have only limited years of follow up of
individuals of a recently reported outbreak into this country,
obviously. So the oldest data you will see from the United
States comes from San Francisco, and George Rutherford, I am
sure, is going to present that.

From then on it is all guess. You will hear data from
both George and from Bob Redfield that, as Tony pointed out, the
rest of these folks don't look so good, immunologically.

But Tony could have made 17 different more lines on
that curve. Is it going to level out at 40 percent, or level out
at 50 percent, or 60 percent. That is a clearly important
variable in terms of, ultimately, the number of cases that are
going to come out from these infected people.

MS. GEBBIE: I am more interested in the conversion
from non-infection to infection.

DR. FRANCIS: Sorry.

MS. GEBBIE: That question, I think, is very good for
dealing with illness treatment costs --

DR. FRANCIS: Let's say hospitals. Right.

MS. GEBBIE: In the relative short term. The major
question is, can we hold the total number of infected people at
the current million, or -- as some have projected -- two million,
or somewhere, or are we just going to lead that on.

DR. FRANCIS: No. Since the major number of infected
people in the United States right now are Gay men, and the
remarkable change in incidence of infection -- starting at 20
percent peak down to -- everyone is reporting, really, in the
United States, and outside, and cohorts infected.

Infection rates, formerly 20 percent, now down to one
percent a year. That is a remarkable change, and that clearly is
due to behavior change. So you will not see this continued
enlargement of the largest segment.

The question now comes, especially from the IV drug-
using community, the poor, inner-city primarily Black and
Hispanic communities, of the rates of infection that are clearly
increasing at remarkable rates, and can we stop that.

23

 

 
 

 

Therefore, now we have this big bolus of homosexual
men. Are we then going to have a big bolus of IV drug users and
their sexual partners? That is a very challenging public health

problem.

But I think we can have a major effect. Whether you
can turn that around to one percent in three years, like the Gay
community did, I am not sure.

MR. CREEDON: Dr. Primm?

DR. PRIMM: Dr. Francis, on the one hand you talk about
this big bolus of homosexual men who are infected; and, on the
other, you say that there is a possibility that there is a
similar bolus on the side of intravenous drug users, particularly
among Black and Hispanics.

But you don't say for sure. What does it take to
convince someone in your position that it surely is out there?
Because, from my perspective on a daily basis, from testing
people in my program -- who, in one clinic, may have 72 percent
seropositivity for the antibody; another program in another part
of the city, maybe in Harlem, they might have a 60 percent -- I
know that that bolus is there.

We need people like you to say that, rather than to say
perhaps there is a bolus there. When, indeed, good data should
certainly signify that there is a bolus already there.

DR. FRANCIS: I agree. I am sorry if I implied that
there was not a bolus already there. The question that I had the
unknown on was, can we drop the very high transmission rates we
are seeing in those groups now to, let's say, the 10 percent
seroconversion that we see a year in those groups now down to one
or less percent next year?

I think that was the question that Ms. Gebbie asked--
can we inculcate that behavior change in these individuals? I,
not being a behavioralist, as an infectious disease
epidemiologist, am really getting more and more impressed with
the truly hard data of the soft data people in terms of
behavioral change.

Programs tailored to the appropriate socio-ethnic
groups, with all of the language, et cetera, that might be
offensive to some people -- but those behavioralists, if they do
that, and tailor those programs, can really have remarkable
effects in large populations, including IV drug users.

These are people who can understand the risks of this
infection. It is a tremendous motivator. If we can assist them
in that process of -- as the behavioralists say -- information,

24

 

 

 
 

 

which is the education part; motivation, which is saying how
dangerous this is and this will ruin your day if you get
infected; and the skill-building, in terms of how they, as
individuals, part of the society norms, and as individuals, can
actually develop the skills to do whatever is necessary to modify
their behavior, add in protective IV drug use, sexual barriers,
et cetera, et cetera.

That process is remarkably effective. I continue to be
impressed, even with programs that, by-and-large, the
behavioralists say are not using all the wisdom that we have
gained from seat belts, cardiac disease studies, et cetera, et
cetera.

We have not really, I don't think, applied our big guns
in behavioral medicine yet to this disease.

DR. PRIMM: As you know very well, I have been a
proponent of that all along, at the risk of being called a black
racist myself. I would like very much for those of you who are
in positions, who know the data and so forth, to begin to
orchestrate that, so I will not be alone when the forces come for
me.

{Laughter. }

DR. PRIMM: The other thing that I would like to
comment on that I think is really important is co-factor
behavior. We have talked about that among Commission members,
and when we talk about progression of infection on to full- blown
AIDS, I am thinking very strongly that a number of my patients in
my treatment program go on to full-blown AIDS because they do not
control their co-factor behavior.

I wonder what you feel that plays in further
development of opportunistic infections, and even other less than
opportunistic infections that can, when combined with a weakened
immune response, go on to cause death -- and not be diagnosed as
an opportunistic infection, particularly among intravenous drug
users, i.e., subacute bacterial endocarditis,
glomerulonephritis, and diseases of that nature.

DR. FRANCIS: I would like to give two answers to
that. One using my clinician's hat, and the other using my
public health hat. We know in the laboratory that this virus, if
you infect lymphocytes, let's say, in the laboratory, the major
target in the immune system that, if those lymphocytes are not
stimulated with some sort of equivalent of a foreign antigen,
they wlll take in the virus, and the virus will not kill these
lymphocytes. They will carry on.

25

 

 
 

 

But if you stimulate those lymphocytes with the
equivalent of drugs, or foreign infectious agents, they will
multiply. The virus likes that when the cell multiplies, and,
ultimately, you will eliminate that population of cells.

I think it is very logical, in terms of clinical
recommendations for individuals who are infected with this virus,
to prolong their health hopefully that they not expose themselves
to multiple different antigens, continue to have multiple sexual
partners, continue to shoot drugs, et cetera, et cetera.

Both for exposing themselves to diseases, and to
stimulating their lymphocytes. However, as a public health
person who wants to motivate people ina very logical sense, the
data that I see on progression of disease in infected
individuals, whether that individual is infected by homosexual
sex, heterosexual sex, blood factor receipt, blood transfusion,
et cetera, that curve that Tony put out there, these different
groups controlled from time of infection are just different spots
up above or below that line.

It gives me so much concern to say that, regardless of
co-factors that may affect this a few percentage points either
way. This is such a dangerous viral infection that you just
can't take a chance of getting infected with it.

That message is delivered towards the uninfected
individual you want to maintain ininfected, versus the clinical
prescription for the infected person that you would like to
remain as healthy as long as you can.

I think it is an important differential that we don't
say, well, go ahead and get infected with this virus, and carrot
juice and good thoughts will keep you from getting AIDS.

MR. CREEDON: Dr. Crenshaw?

DR. CRENSHAW: A comment that I frequently hear that is
used as an argument against the perception that there has been a
major slow down in the homosexual community is the following, and
I would like you to respond to them, to help clarify this.

One is that in our major cities, depending on what
statistics you believe, 50 to 70 percent of the homosexual
population is infected, and the slow down is more a reflection of
the saturation rates than a genuine slow down.

In some cities, such as New York, there is still a
prevailing view among many of the homosexuals as they have become
more sophisticated about AIDS, to avoid knowing, and not getting
tested.

 

 

 
 

 

Some recent figures that I read were that the number of
sexual partners -- although it wasn't mentioned within what
sphere of time -- in San Francisco, for the Gay community, had
been reduced from 10 to 4.6. In a population where over 50
percent is saturated, if condoms and really effective prevention
measures are not consistently used, then you have a greater than
50 percent chance of becoming infected if you have more than one
partner.

In San Diego, we have five bathhouses open and
functioning, two of which began business this last year.

In addition, the one other argument that comes to mind
is that the rates of gonorrhea and other sexually transmitted
diseases have gone down. People contradict that by saying that
those are treatable diseases; and, since people are coming in to
be checked more often, it is getting eliminated.

They can still transmit AIDS, but they are not passing
gonorrhea. I would like some reassurance. Can you address some
of those points for me?

DR. FRANCIS: I think, Dr. Crenshaw, that your comment
-- let me start with the most significant concern you had, and
that is that bathhouses are opening, instead of being closed. If
bathhouses are continuing to -- our health education method
should, through the free market processes, eliminate bathhouses
-- at least those where there is at-risk sexual activity going on
-- as a profitable entity in the free market systen.

It concerns me that if that exists, and you know the
rates of disease in San Diego are considerable, that maybe that
is a place where you need to target your additional efforts, no
doubt.

Let's deal first with the issue of the high prevalence
of infection, because that is a very important point, in terms of
looking at the potential effect of a prevention progran.

Let's say the gay men in San Francisco, where
probability samples have shown that 50 percent of the population
is infected, I really was not terribly optimistic of getting the
rates of infection down to one percent a year, because there you
really have to control your activity.

It is not like when there is one out of 100, or one of
out 1,000 people infected, where you make a mistake and you can
get away with it. There you don't make many mistakes. Indeed,
you do get infected.

We, aS a cooperative association of the epidemiologic
groups in northern California, have actually all the groups,

27

 

 
 

 

cohorts of men that are being followed, and examined every single
seroconverter. That is, every person who, in recent 12 months,
got infected with the virus.

Indeed, they all had some violation of the practices
that are recommended. Very frequently due to people who have
made a commitment, have clearly changed their behavior, and then
have, so to speak, gotten off the wagon, and ended up getting
infected with remarkably few sexual encounters. So that is true.

The saturation effect let me deal with that. Ina
place like San Francisco, 50 percent of the population of Gay men
remains susceptible. Thank goodness. So there is plenty of
substrata for this virus to continue to chew on.

We have seen from, let's say, our hepatitis-B studies
in the gay community, where we were looking for susceptible
people, actually set up the cohorts that George Rutherford put
forth, that 70, 80 percent of the population coming into the door
of a sexually transmitted disease clinic were infected.

We were looking for people who were susceptible to get
into hepatitis-B vaccine trials. We would cull out only the
uninfected individuals, and then follow them. The rates of
infection were still 20 percent infection a year.

It is not like these are different people. They are
clearly still at risk.

Sure, there is some saturation effect. But from our
experience with this virus, if they went ahead and opened up the
bathhouses again and continued to have unprotected sex in San
Francisco, you could get a lot more than 50 percent of the people
infected, I guarantee, with this virus.

DR. CRENSHAW: I think your point is well taken,
particularly given that San Diego has the number two attack rate
in the nation.

DR. FRANCIS: Let me deal with the last point, though.
That is that everything goes together. The gonorrhea rates you
can see going down; the telephone surveys of their self-reported
behavior go down; and the infection of HIV go down.

It all fits very nicely, scientifically.

DR. CRENSHAW: Is hepatitis-B also going down?

DR. FRANCIS: Yes, in the Gay community. Sure.

MR. CREEDON: Dr. Walsh?

28

 

 
 

DR. WALSH: You commented on the accuracy of the test
and so on. Also, one of the things that still concerns me is
that I keep hearing projections, estimates, and the like, of the
incidence of disease and so on. You tell us that the percentage
in the homosexual community, no new cases has dramatically --

DR. FRANCIS: New infections.

DR. WALSH: Of new infections has dramatically dropped.
This brings me to that very sticky wicket about testing. In the
homosexual community in San Francisco, is it correct to assume
that a large majority have already submitted to voluntary
testing?

DR. FRANCIS: At least the telephone surveys estimate
that somewhere in the neighborhood -- George, correct me if I am
wrong -- that somewhere between 25 and 40 percent of the men have
been tested.

DR. WALSH: On that basis? This is the basis of your
projection? The second thing that concerns me about the optimism
is that I rarely believe what I read in the newspapers, but if
one is to believe the article that I think was in the New York
Times a couple of weeks ago, about 40 percent of the homosexual
males are still engaging in rectal, sexual habits without any
protection.

Isn't this a rather remarkable optimism, or a
remarkably optimistic statistic, if the habits are still
continuing in that community?

DR. FRANCIS: I didn't make it clear about where this
one percent figure comes fron.

DR. WALSH: That is what I would like -- that is what I
am after.

DR. FRANCIS: These are not random surveys of people.
These are very extensive groups of Gay men that have entered in
studies for years and are being followed, asked about their
sexual activity, and bled periodically and tested as research
programs.

The question that you asked is a vital one, though.
Are these men that come into these studies immediately biased by
the fact that they are in the studies, and therefore you get this
group of concerned individuals?

I think there is some truth to that. You have to say

that one percent is probably the optimistic figure, but realize
that the rates of infection in these men was 10, 20 percent

29

 

 

 
 

 

 

seroconversion a year, so that at least these men as
representative are models that behavior can be changed.

But saying that in all of the Gay communities that are
not involved, that have not been tested, that is it one percent
seroconversion a year--I think that would be optimistic.

DR. WALSH: That is why I am trying to understand. On
the basis of education and prevention programs, are we seeing --
other than those control groups, in effect -- any increase in
voluntary testing among the high risk groups? In your
experience?

DR. FRANCIS: There is a lot of confusion. The sticky
issue of testing is not the sticky issue of testing. Testing is
an inherent part of our society; it is there; it will be here
forever. And people want to be tested, by and large.

There are some individuals that cannot deal with that,
but it is clear as early intervention programs come, and some
benefit comes out of testing, that everyone is going to come
forth to be tested, unless there is severe risk to come forth to
be tested.

I am a great proponent of serologic testing, as many
others are in the Gay community, outside the Gay community. But
the reality is, you just can't do that. When you get the news of
being infected with this virus, it is a very, very heavy bit of
information.

You need help with it. You need assistance with it.
That process alone, in many studies, shows that you can improve
behavior and it is very beneficial for the society.

But if the society puts restraints and controls and
disincentives on that, then the balance goes the other way.
That's all. What we hear now is that we have to get out there
and test everybody, and throw them into jail.

It only takes two people in the country to do that, to
throw my program off in the field for three weeks.

DR. WALSH: No one is interested in going out and
testing everybody and throwing them in jail.

DR. FRANCIS: No, but two people say that, and the
newspaper picks it up, and off we go.

DR. WALSH: No, we are not. No one is interested in
that. What I am trying to get at is the purpose of this

30

 

 
 

 

meeting--to see how accurate a projection of incidence we can
get.

I am trying to find out from those of you who are in
the trenches how much you really believe your own statistics.
You have already qualified one of your reports, very factually
and very honestly. And I am glad to hear that.

But what I am trying to find out is what can we do
about the projection of incidence, so that we can do the planning
that you are talking about? And we can recommend the planning
for care that you are talking about?

This is one of the real problems with which we are
faced. As our preliminary report indicated, we are vitally
interested in helping to plan, particularly in the area of care
and prevention.

But I am trying to find out what numbers, as I say, we
can believe. I think that CDC is to be commended, for example,
on what absolutely is limited data to my mind, and skimpy data --
that their projections have been so blessed accurate. This
encourages me.

But as a physician and a scientist, I also understand
that you both have indicated a lot of it is now guesswork. Yet
we have to make a recommendation on what is anticipated, and how
to get better data? That is what I am after.

DR. FRANCIS: How do you get better guesses? I mean,
they are all guesses.

DR. WALSH: That is right.

DR. FRANCIS: If you had to design a better progran,
the one percent seroconversion that I told you about is actually
not a CDC study, but is an NIH-sponsored study at the University
of California by Warren Winkelstein.

They went in and randomly selected houses in San
Francisco and knocked on the doors, and had people stick their
arms out, and got remarkable cooperation at that time. You are
not going to get any better data than that.

Now you are going to ask me, are those people different
because they volunteered? I am going to say, well, probably.
But can you design a better study? That costs a million dollars
already, and I don't think you are going to get better data than
that.

But I think you will have to say, yes, there might have
been some artifact in that study, that one percent may be a

31

 

 
 

 

little higher than the actual seroconversion. But if you look at
randomized telephone surveys in the same area of self-reported
behavior and compare those to the people who are in the study,
there is remarkable overlap.

So I think for those data, they are the best you are
going to have. Now, is that true in Detroit? Is that true
around the world? You would have to guess.

DR. WALSH: No, San Francisco is way ahead.

MR. CREEDON: I think we are going to have to move on
here.

DR. SERVAAS: Dr. Francis, I wanted to tell you that I
am very impressed with the work you have done. In JAMA, in July,
you reported that in Alameda County, one's chances of coming in
contact with a woman who is infected may approach one in 200.

These weren't -- Alameda County wasn't high risk. You
also mention in that report that this was preliminary. I am
asking you if you have done more work on that? The other
question is part of this question. These women in Alameda County
aren't prostitutes, to a large extent I don't suppose; but just
by chance in that same JAMA it also mentions that there are women
who use other than vaginal sex.

Is that a very important factor in the spread of AIDS
in the heterosexual community? Is that something in prevention
that we have been neglecting? There are more of those individual
women than all the homosexual population together, according to
this letter we see in JAMA.

DR. FRANCIS: These are women whose serum was submitted
to the County Health Department for premarital syphilis and
rubella screening. We scrambled the identifiers on these
individuals, and have no other information on them, other than
their age and sex and race.

We do not know their behavior, whether or not they are
prostitutes. All we can say is that, in women applying during
that period of time, approximately one of 200 -- with quite large
confidence limits, mind you -- were seropositive at that time.

I don't know if they are prostitutes, I don't know if
they are IV drug users. I am presuming they are just exposed to
that high risk somewhere, but the infection was clearly there.

Regarding the article on anal intercourse, I put on two

hats. One is my scientific investigator hat, and one is my
public health hat, again. The scientific investigation would

32

 
 

 

show that putting the virus on rectal mucosa of both men and
women is really quite an effective way to transmit the virus.

But I would also say we know from several laboratory
studies, or at least laboratory observations, that putting the
virus on the female vaginal tract, or cervix most likely, is also
an extremely effective way of getting the virus into an
individual.

If you had to rank those, you would probably rank them
in terms of anal intercourse, vaginal intercourse, and then
receptive vaginal intercourse, and insertive vaginal intercourse
next down the line.

But we don't have data to be able to tell you totally
if one is one-and-a-half times, two times more effective than the
other. So, in public health, my comment is that when you put
penises into various orifices of the body in sexual relationships
that are unprotected, you have a major risk of transmitting the
virus.

I think the only hedge on that is oral sex, and we
don't know the answer to that, to be honest. It is clearly much
less than vaginal or anal sex. But I have this terrible fear
that if you say, well, I don't practice anal intercourse -- which
at least the data shows is remarkably common amongst
heterosexuals -- then I am not at risk.

That is a very dangerous thing. Clearly unprotected
vaginal intercourse -- did I say anal intercourse -- that anal
intercourse, if I don't do anal intercourse then I am not at risk
of HIV infection. That would be a dangerous thing to get out
there.

If you are having vaginal intercourse or anal
intercourse with whatever sexual combination you are doing, then
you are at risk of HIV if there is infection in that population.

Did I totally confuse you now?

DR. SERVAAS: I just wondered how much more dangerous
the former is than the latter?

MR. CREEDON: Mr. Watkins?

ADMIRAL WATKINS: Dr. Francis, let me close out the
questioning of you in a couple of ways. You opened up your
statement this morning in an area that we are not focusing on
today, but one which is extremely vital to the Commission. We
have hearings planned in a little over two months that we are now
preparing for.

33

 

 
 

 

3

It is going to be one of the most extensive that we
hold, because we know it is so important. You said that well
designed intervention programs which can substantially reduce HIV
infection are essentially in hand by a group of experts who have
designed these, and I assume have tested them and demonstrated

them.

I would like to have a report from you, if you could
possibly give it to us now, in the very near time frame, of
exactly what you mean, what you have tested, how you have
measured it. It is going to be important for us to lay
groundwork for those hearings that could be very meaningful.

We may want to talk to you again about that. If you
could provide us with a follow up on your opening statement in
more specific terms by letter, we would like that very much.

But I would like not to focus on that right now,
because it is prevalence and incidence that we are talking about
today, primarily, and I would like to keep the focus on that.

DR. FRANCIS: I have a reprint that I will give you now
that I think will be useful.

ADMIRAL WATKINS: Have you had a chance to read the
latest CDC report to the Domestic Policy Council in the White
House that was aired here a week or so ago about the family of
surveys, and so forth?

DR. FRANCIS: I have it and have not read it.

ADMIRAL WATKINS: Are you familiar enough with it to
know whether you are satisfied that the progression from family
of surveys to a national seroprevalence survey by household is as
expeditious and as efficient as it could be from your experience
in doing proper sampling, assuming you can find mechanisms to
eliminate the obstacles?

I am asking you to assume we can eliminate those
obstacles, can it be done faster? In other words, 1990 is when
the report would come out on the national household
seroprevalence survey, as laid out by CDc.

Do you think it is necessary to wait that long? Or are
there other techniques that could be used to get us closer to the
real world, rather than relying on the mathematical models that
we are now using?

DR. FRANCIS: I frankly have not sat down and worked
through it all enough to be able to answer that question. I
think Jim Curran probably could deal with it. The major problem
that I see is not fielding the survey. The major problem that I

34

 

 
 

 

 

™

see is your assumption. You don't want ‘to spend the money for a
‘ large survey without that assumption.

ADMIRAL WATKINS: The next question -- the last
question -- that I have is that the incidence reflecting the new
cases of infection can obviously change with effective
intervention as you mentioned.

How is this very important measurement going to be
monitored on a continuing basis? And this measure of incidence
is really one of the only ways, it seems to me, we can know if
our interventions are working. We need to have that.

How organized is that now? Does it need an
institutional process that is cleaner than it is today?

DR. FRANCIS: That is a question that we have been
dealing with a lot now, because as we get these family of
surveys, while we have plenty of prevalence information, you
have good surveillance on good cases, but what is your actual
incidence of disease?

The studies that I mentioned are a million dollar a
piece studies. Then everyone says, well, how good are they?
They are people in studies.

There are several ways around it. One, I think you
need to spend money for incidence studies of large cohorts,
despite them being very expensive. But then when you start
thinking about these cohorts and low incidence groups where you
need thousands and thousands of individuals, they get even more
expensive.

It is clearly going to be limited to the number of
those that you can really put out there. But there are other
surrogates that I think are important to watch. Behavior surveys
of individual, self-reported behavior are remarkably effective.

It always amazes me what people will say over the
telephone. But you can do relatively inexpensive surveys.
Unfortunately, we don't know the real validity of them. But at
least they pardllel, let's say, in the Gay community what we see
on the people in the actual prospective studies.

I think those are useful. I think looking at things
like sexually transmitted disease, increasing the surveillance of
sexually transmitted diseases like gonorrhea and syphilis, to see
if these surrogates also go down, to corroborate your behavioral
and your few incidence studies that you have in a few cities
around the country.

35

 

 
 

And then to continue to monitor that will be part of
our society as groups come in, like the military data that you
will hear from Bob Redfield. I am sure you will see more and
more prenatal data coming through, as more and more babies are
monitored. You will see the prevalence of infection. Mothers
coming to clinics. You will have an idea if that prevalence is
actually -- it won't drop, because these women will be there for
quite a while. But at least it won't go up.

And to continue to do prevalence surveys. Now, the
difficulty with prevalence surveys, which is that prevalence is
just a cut in one period of time -- you get different people
Tuesday than you do on Wednesday. To actually say that you have
an incidence from those is difficult.

But I think we have to design inexpensive prograns,
because they have to be very, very broad. You are not going to
be able to spend a million dollars in every city in the United
States to get a group under an incidence study.

It is a very good question, and we are dealing with it,
and seeing if there are inexpensive ways to monitor that by
surrogate methods.

ADMIRAL WATKINS: Do you have any data now on your
surrogate techniques already imported that show that there is
correlation between the data you are now tracking from actual
measurements against that behavioral survey?

DR. FRANCIS: I think all the surveys that have been
done -- be they behavioral, incidence of sexually transmitted
diseases, or HIV incidence -- indeed do track very, very well.

ADMIRAL WATKINS: Can you give us any specific data
along those lines?

DR. FRANCIS: Sure. I think they are referenced in the
manuscript that I will give you.

ADMIRAL WATKINS: The military experience has been the
same. We said we did not have a drug abuse problem in the Navy.
The behavioral survey said we had a 55 percent, or 60 percent
rate.

When we actually had the urinalysis examinations, it
was 58 percent. So clearly there is other data, from other
behavioral surveys. I don't just mean it on this one particular
infectious disease. But there may be other data from other kinds
of problems that we have had, behavioral correlation that may
give enough strength to the proposition that maybe that is a way
to go in the near term.

\

36

 

 
 

 

Maybe that kind of a survey is something that we could
have sooner, and give us a better feel for where we really are,
relative to the modeling that is now used. Put those two
together to see how close we may be. What do you think about
that?

DR. FRANCIS: I agree. Actually the State of
California has launched that program through a private telephone
survey company in San Francisco. It would be very worthwhile for
you folks to talk to, to get a prevalence of behaviors, instead
of prevalence of infection, across California; and then be able
to link that up through the family studies survey to show the
prevalence of infection by behavior, and then see if you can make
some sort of guesstimate projection that way.

ADMIRAL WATKINS: Thank you very much.

MR. CREEDON: Thank you very much, Dr. Francis. You
mention the fact that a million dollars is a lot of money for a
survey, but in relation to what we are talking about here, it is
not. We are talking about medical care of $8 billion to $16
billion by the year 1991. It seems ta me that the Commission, at
least, has to consider what additional types of surveys need to
be taken in order to get a better fix on exactly the nature and
extent of the problen.

PRESENTATION BY DR. STEVEN L. SIVAK
NEW YORK MEDICAL COLLEGE

DR. SIVAK: Mr. Creedon, Committee members, ladies and
gentlemen, I have been asked to speak about the work that I and
Dr. Gary Wormser, also from the New York Medical College, have
done in trying to estimate the prevalence of HIV infection in
this country. I will read my written report.

Since widespread testing for human immunodeficiency
virus infection is not performed in large groups of Americans at
different risks for HIV infection and since those cohorts which
have been tested may not accurately represent the groups to which
they belong, it is impossible to determine precise figures for
the prevalence of HIV infection in the United States.

This matter is compounded by the fact that HIV
infection, except in the form of acquired immunodeficiency
syndrome or AIDS, is not a reportable condition. Furthermore,
obtaining exact figures as to the total population of risk group
members is difficult. Determination of prevalence must therefore
at this time be considered an estimate based upon inferences from
potentially biased data.

Using the numbers of the known cases of AIDS based upon
surveillance data collected by the Centers for Disease Control,

37

 

 
 

as well as reported data regarding prevalence of HIV infection in
several risk groups, we believe that one can estimate, and I
underscore that word, the prevalence of HIV infection in the
general U.S. population as well as in identified subgroups.

The critical assumption in our calculations is that the
ratio of the number of living patients with AIDS to the number of
individuals infected with HIV is constant within different
groups. We believe that this assumption is reasonable and has
been used by others in attempting to estimate the prevalence.

Since the epidemic of HIV infection in this country is
probably in a dynamic state, we chose to use the ratio employing
the number of currently living patients as opposed to the total
number of patients with AIDS since this may give an even more
accurate cross section approximation of information relevant at
this particular point in time.

In 1985, we demonstrated, using the best available
information regarding the prevalence of HIV infection in two well
studied groups, as well as the surveillance data from the CDC,
that for every intravenous drug abuser or hemophiliac alive with
AIDS, at that time there were approximately 300 IV drug abusers
and 300 hemophiliacs infected with the virus. We applied this 1
to 300 ratio to each of the then identified risk groups and
obtained a total estimate of approximately 1.7 million Americans
infected with HIV of which about 64,000 individuals were at no
known risk.

Using census data for adults in the United States and
subtracting approximate numbers of known high risk group members,
we estimated a prevalence of HIV infection for U.S. adults at no
known risk to be 45 per 100,000. At that same time, the United
States Red Cross reported that the prevalence of HIV infection
among blood donors at presumably no known risk for HIV infection
was 38 per 100,000. We felt that since the ratios of those alive
with AIDS to those infected in two well studied groups were
similar and that the estimated U.S. adult prevalence of those at
no known risk was similar to that actually seen, our assumptions
and data were reasonably accurate, and these results were
reported in November, 1985.

Other estimates for that same period of time of the
prevalence of HIV infection ranged from 500,000 to over 2
million. We recently re-examined the data in a similar fashion.
We again determined the estimated prevalence of HIV infection in
high risk groups where data was available in an attempt to obtain
the current ratio of those alive with AIDS to those infected. It
is clear that this figure is subject to change over time due to
many potential factors.

38

 
 

As those at high risk modify their risky behavior, the
prevalence of infection in that group is likely to change. As
more infected individuals develop AIDS and insofar as the
survival currently may be different than it was in the past, this
aspect of the ratio may change as well. Change in the definition
of AIDS may also have led to a change in this ratio.

In one well studied cohort of homosexual men, the
reported ratio of those with AIDS to those infected changed from
1 to 825 to 1 to 28 over a four year period. Another study
revealed in 1985 that the ratio of those with AIDS to those
infected with the virus was 1 to 30. This group of homosexual
men attended a sexually transmitted disease clinic and may not
have been representative of all homosexual men because of a
potential bias towards individuals with early manifestations of
AIDS.

At this time, we chose to determine the ratio in
question in well studied populations of New York City. Here,
reasonably accurate figures for prevalence of HIV infection exist
and estimates of the total numbers of members of high risk
populations are available.

It is estimated that in New York City, there are up to
700,000 homosexual men of whom approximately 50 percent or
350,000 are infected with HIV. We obtained data from the New
York City Department of Health AIDS Surveillance Update of
October 28, 1987, which reports the cumulative cases of AIDS in
New York City by risk group.

According to this report, 43 percent of all patients
with AIDS since the epidemic began remain alive. Because
survival data for each risk group was not available at the time
of this report, we assumed that this figure applies to all risk
groups. Since there are an estimated 3,021 homosexual men in New
York City alive with AIDS, then it follows that for every
homosexual man in New York City alive with AIDS, there are
approximately 115 homosexual men in New York City infected with
HIV.

It is also estimated that there are approximately
200,000 intravenous drug abusers in New York City of which an
estimated 65 percent or 130,000 are infected with HIV. It is
further estimated that there are approximately 1,500 + New York
City IV drug abusers alive with AIDS, and hence, for each New
York City intravenous drug abuser alive with AIDS, there are
approximately 85 New York City IV drug abusers infected with the
virus.

If then an average ratio of 1 to 100 of those alive
with AIDS to those infected is applied to all risk groups, one
may obtain a current estimation of the prevalence of infection.

39

 

 
 

 

Although we have assumed for the purpose of calculation that the
ratio is the same for all groups, this obviously need not be the
case. For example, the ratio for those who receive blood or
blood products is probably lower since heat treatment of factors
along with the screening of donated blood has resulted ina
decline in the HIV infection in this group.

In fact, our calculation of the ratio in hemophiliacs
is 1 to 57. The ratio of those at no known risk or heterosexual
partners of high risk group members may be higher since the
epidemic of HIV infection in these groups is probably not as old
as in other risk groups. The ratio appears to tend to decline as
the epidemic ages since there would be more cases of AIDS,
hopefully prolonged survival of those infected and hopefully a
decrease in incidence of infection.

If one applies the ratio to New York City cases of
AIDS at no known risk, one can estimate the prevalence of HIV
infection in this group. Since there are approximately 34 New
York City adults at no known risk for HIV infection with AIDS
based upon the data from the New York City Health Department, we
estimate that approximately 3,400 New Yorkers at no known risk
are infected. The U.S. Census reports that there are 5,306,000
plus adults living in New York City. By subtracting estimated
numbers of high risk group members, one can estimate that there
are approximately 4,161,000 New York City individuals at no known
risk for HIV. This translates into a prevalence of 80 per
100,000. The actual prevalence of HIV infection in blood donors
in New York City is 90 per 100,000. The similarity here again
appears to support the accuracy of the calculations and
assumptions that we have made.

If the ratio of 1 to 100 of those alive with AIDS to
those infected with HIV is applied to the U.S. population, then
the new approximation for adults infected in the United States is
just short of 2 million. This represents an overall increase of
11 percent from the data that we calculated in 1985 and is
probably consistent with the reported incidence of infection in
high risk group members of 2 to 20 percent of the remaining
uninfected population per year. There also appears to be
approximately 25,000 children infected with the virus if the
ratio holds true in this group.

I don't know if the members of the Committee have
received a copy of my report, but if you have, I will draw your
attention to the table on the second to last page, just a couple
of comments. We compare the data for 1985 and November, 1987 in
tabular form. It appears, if our assumptions are accurate,
again, that may be a big "if," that there are currently
1,467,100 homosexual men in the United States infected; 307,400
intravenous drug abusers in the United States infected. This

40

 

 
 

makes up the bulk of the 1,953,000 adults infected in the United
States.

Again, from Census data, we know that there are
approximately 191 million adult Americans and this translates to
a prevalence overall, including all groups, to 1 percent, 1
percent of Americans, if these figures are accurate, are infected
with HIV.

In summary, the ratio of cases of AIDS to those
infected with HIV appears to have change from 1 to 300 to 1 to
100 from 1985 to 1987. It does appear, however, to remain
relatively constant in two high risk groups in which reasonably
accurate figures concerning the prevalence of HIV infection in
the total population exists.

The total number of Americans infected is estimated to
be just less than 2 million and has increased by 11 percent since
1985. More accurate estimations of the prevalence of HIV
infection could be made if more data concerning HIV infection in
other groups was available.

This perhaps could be accomplished through the
reporting to local Public Health Departments individuals who are
infected with HIV in addition to those who have developed AIDS.

We recognize, however, that this is a controversial
issue and must include protection for the rights of those
infected. If such safeguards are not enacted, high risk
individuals and others may refrain from being tested, thus
potentially increasing the risk of transmission to other
individuals.

We also feel that aggressive attempts to educate the
American public about HIV infection would be an effective means
to decrease the incidence and prevalence of the infection. Thank
you. —

MR. CREEDON: Thank you. Any questions for Dr. Sivak?

DR. WALSH: No, I think his paper is very clear.

MR. CREEDON: Dr. Primm?

DR. PRIMM: I would like to reserve my questioning
until Dr. Redfield talks about the military study, because then I
can compare the two and ask Dr. Sivak really what population
groups he is talking about. I think the prevalence is quite

different. It might be higher in certain groups, particularly
blacks and hispanics.

41

 

 
 

 

DR. SIVAK: Certainly, but if I could address perhaps
what I think is a question. When we state that the ratio is
similar among groups, by no means does that imply that the
prevalence among groups is similar. In fact, it is rather
dissimilar. There are a couple of infectious diseases which do
appear to maintain a constant ratio among various subgroups, of
those with clinical disease to those with sub-clinical disease.

The classical example would be St. Louis encephalitis,
where the ratio appears to remain constant at 1 to 200. Of
course, in different groups, there is a higher prevalence of
infection. It is sort of a back door way to get back at the
prevalence, since as mentioned by the previous speakers and also
the opening remarks of my comments, we really don't know the
answers. We are using data that is extrapolated from potentially
biased information.

The prevalence is greatly different in different
groups, but we think, we postulate or assume that the ratio of
those with clinical AIDS to those without any clinical disease
but infected remains constant.

DR. PRIMM: Unless those technical definitions are
given, I think your studies could be misleading to laity, and
that is my concern, that you must do it in the manner in which
you just explained it to me, when you recognize that was indeed
going to be probably my question.

I think it is an excellent piece of work but it must be
put into the proper context by proper definition. It is nota
criticism as much as to say that to be clearly understood by
people not involved with the technical language that you use, it
must be done a little more simply.

DR. WALSH: I just have one question. Did I understand
you to say that AIDS is not reportable in New York?

DR. SIVAK: No. AIDS is reportable. The presence of
HIV infection is not. I suggested that perhaps if that were, we
would have better data.

DR. PRIMM: Nor is the antibody status reportable.
Infection is not reportable nor is the antibody.

MR. CREEDON: Any other questions?
{No response. ]
MR. CREEDON: I had a discussion this morning with

some of our actuaries about their using a similar technique to
arrive at estimates. I found it quite interesting. I think it

42

 

 
 

is kind of indirect compared with getting: direct information

_ about the people who have the virus.

 

What about the heterosexual aspect of it? Did you
reach any conclusions about that in the work you did?

DR. SIVAK: In terms of this particular ratio?
MR. CREEDON: Yes.

DR. SIVAK: We did not study that group. There is
simply not very good data in those populations at least that I
could find, to try to compare the ratio in those populations.
Most of the data on prevalence of infection comes from the
classical high risk group members, homosexual, bisexual men,
intravenous drug abusers, hemophiliacs.

Furthermore, it is very difficult to get the
denominator in many of these populations. Even if one knew the
prevalence, it is very difficult to find out how many individuals
are in a particular subgroup. For the group that you mentioned,
it is very hard to know that answer.

MS. GEBBIE: Looking toward the future, because one of
our tasks is to try to figure out what incidence rate, prevalence
rate will apply toward the end of this century for program
planning, based on the study you have done so far and what you
have seen here, would you continue to use the ratio you have
identified of infected persons to ill persons for a figure for
the year 2000 or would you make some shift?

DR. SIVAK: Clearly not. I think as the epidemic
progresses and insofar as the pathogenicity of the virus appears
to increase the longer one is infected, in other words, the
longer one is infected, it appears as though the more likely one
would develop clinical disease.

This ratio may change dramatically with time. I
mentioned the one study which was actually reported by Dr. Curran
a couple of years ago, in which the ratio changed from 1 to 825
to 1 to 26 over a four year period. Clearly, this ratio may not
be applicable even tomorrow, let alone the year 2000. I think it
would have to be looked at, if better data wasn't available by
then, and hopefully it will be. That ratio will have to be
recalculated.

MS. GEBBIE: It certainly can be recalculated every
time we get new data but given today and in an attempt to write a
report that predicts at that level, what number would you apply?

DR. SIVAK: We haven't even thought about what the
ratio might be in the future. We have less information that

43

 

 
 

 

would enable us to determine that. We barely have enough
information to develop the current ratio, let alone the future
ratio. I really can't answer that question, except to state I
would not be surprised if it was vastly different in the future

than it is today.
MR. CREEDON: Penny?

MS. PULLEN: Do you think it would be helpful if the
CDC collected the HIV infection reports in places where it is
reportable rather than just case surveillance?

DR. SIVAK: I think that would be helpful to this type
of endeavor. Again, I must stress that is a rather controversial
area, as you know. If that information becomes a part of the
public record and those individuals who are infected aren't

protected, then --

MS. PULLEN: I am not talking about identified reports.
I am talking about incidence reports; statistical incidence
reports.

DR. SIVAK: Yes, I think it would be helpful to have
that information.

MS. PULLEN: Thank you.

MR. CREEDON: Do you have any comment, Dr. Sivak, on
other studies that have been done that have suggested a lower
level of prevalence of the virus?

DR. SIVAK: In some of the reports on the prevalence of
the virus, they are merely stated and a lot of the data used in
calculations isn't made available to the reader. I really can't
comment. Dr. Rees, in an issue of Science, used a mathematical
model to project total number of infected individuals based upon
the mean latency period between the time of infection and the
time of AIDS development, based on people who had received blood.
That appeared to be a study that was based on reasonably good
mathematical models. That prevalence was actually higher. In
1985, he projected 2.5 million infected at that time. I can't
comment on the other studies. I'm not familiar enough with how
they derive their figures.

MR. CREEDON: Thank you.

ADMIRAL WATKINS: Let me finish up the questioning, Dr.
Sivak. Was your data among those considered by the Centers for
Disease Control in their latest analysis of a variety of inputs,
which ranged all the way from .45 million up to 2.3 million
infections but clearly the density was nominally in the 1 to 1.5,
I think it was .95 to 1.4 in the curves they showed in their

44

 

 
 

data. If it were not, do you have any idea what the fundamental
differences are in approach that perhaps in principle we could
deal with?

The numbers are considerably different than the
weighted centroid of what the CDC have projected. What is the
difference?

DR. SIVAK: I don't know if they used the data we had
reported in the past. If you are speaking of the recent report
from CDC that was mentioned this morning, I have not yet seen it.

ADMIRAL WATKINS: Would you be willing to do that
analysis and let us know what fundamental differences in
approach are causing the very significant difference in the
projection of the numbers infected?

DR. SIVAK: Certainly.

ADMIRAL WATKINS: We have to come to grips in making
any recommendations with what is wheat and chaff on some of these
projections. If we can't get better data, at least the data we
do have, we need to be able to verify it, whether we are right in
the middle or whether we have that kind of 25 percent
differential in the upper limit.

DR. SIVAK: I would be happy to do that. I'm not sure
that 1.5 and 1.9 million, in terms of the scope of this illness
is that significantly different when one considers the methods
that by design had to be purely inferential and little hard data
was available to determine these numbers. I would be happy to
look at that.

ADMIRAL WATKINS: The range of costs and some of the
health care facility projections will affect it significantly
because of what we are dealing with here. It is significant, I
think.

MR. CREEDON: Especially if you look to the lower end.

DR. SIVAK: Economically, yes. Statistically
significant, I'm not sure.

ADMIRAL WATKINS: Have you tried to engage in any kind
of surrogate survey concept, behavioral surveys, for example,
along the lines that Dr. Francis talked about, to see whether or
not your model tracks reasonably well with behavioral surveys?

DR. SIVAK: No; we have not.

ADMIRAL WATKINS: Is there any intention to do that in
the future?

45

 

 
 

 

DR. SIVAK: We have not thought of it but it is
something to be considered.

ADMIRAL WATKINS: Do you think it may have merit to do
that?

DR. SIVAK: Yes.
ADMIRAL WATKINS: Thank you.

MR. CREEDON: Dr. George Rutherford from the San
Francisco Department of Public Health.

PRESENTATION BY DR. GEORGE RUTHERFORD
SAN FRANCISCO DEPARTMENT OF PUBLIC HEALTH

DR. RUTHERFORD: Mr. Chairman, Mr. Creedon, members of
the Commission, ladies and gentlemen, thank you for asking me to
address you today on the subject of the prevalence and incidence
of human immunodeficiency virus infection and the rate of
progression from HIV to AIDS.

Today, I'll be discussing data from the San Francisco
city clinic cohort study, prospective epidemiologic study of AIDS
and HIV infection among San Francisco gay and bisexual men
conducted by the San Francisco Department of Public Health and
the Centers for Disease Control.

I'd first like to describe how we've gathered the data
that I'll be discussing. The 6709 gay men who participate in the
study were originally recruited between 1978 and 1980 from the
San Francisco City Clinic, our municipal sexually transmitted
disease clinic, for studies of the epidemiology of hepatitis B,
an important sexually transmitted disease of gay and bisexual
men.

359 participants who had never been infected with
hepatitis B were subsequently enrolled in a trial of hepatitis B
vaccine. Blood samples were drawn from each participant every
six months, and unused blood was frozen. Later as we reenrolled
these men in AIDS studies, we were able, with their permission,
to defrost their frozen blood and test it for HIV antibodies,
thus establishing when an individual became infected. By
aggregating these data, we're able to establish the prevalence
and incidence of HIV infection and also the risk of developing
AIDS as a function of the duration of HIV infection in this study
population.

This slide shows the prevalence -- that is, the
cumulative proportion of study participants infected with HIV --
by year from 1978 to 1986. In 1978, the prevalence was 1

46

 

 

 
 

 

percent. By 1982, it had risen to 43 percent. Since 1982,
however, the prevalence has risen only slightly with the 1986
prevalence being 46 percent.

Data from the other two large cohort studies of gay and
bisexual men in San Francisco, conducted by Professors Warren
Winkelstein of the University of California-Berkeley and Andrew
Moss of the University of California-San Francisco, have found
similar prevalences, thus leading us to estimate the overall
prevalence of HIV infection among gay and bisexual men in San
Francisco to be approximately 50 percent.

Another way of examining the spread of HIV infection in
this cohort is by calculating the annual incidence of HIV
infection -- that is, the proportion of study participants newly
infected with HIV per year. This slide shows the annual
incidence of HIV infection expressed as the percentage of
previously uninfected men who seroconverted or who became newly
infected during each year from 1978 to 1986. As you can see, the
percentage of men becoming newly infected rose rapidly from 1
percent in 1978 to 21 percent in 1982. In 1983, however, this
percentage fell dramatically to 2 percent and has remained very
low ever since, with only 0.8 percent of previously uninfected
men becoming infected in 1986 and none in 1987 to date.

Data from Professors Winkelstein's and Moss! cohort
study show similar dramatic changes. Together, these studies
indicate that the incidence of HIV infection among gay and
bisexual men in San Francisco who participated in these studies
increased rapidly until about 1982 or 1983 and subsequently fell
abruptly and has remained low ever since. And parenthetically, I
might add that this virtual cessation of HIV transmission
predated HIV antibody testing programs by two years.

How representative are these study participants of all
gay and bisexual men in San Francisco, a concern that you quite
rightly have voiced? Or put another way, can these findings be
extrapolated to the entire San Francisco gay male population?

In short, we feel that our study participants are quite
representative of gay and bisexual men living in San Francisco at
the times the studies were begun. Professor Winkelstein's study
population, for instance, as Dr. Francis has point out, was
recruited by a random house-to-house survey. Reproduceability of
the finding of declining incidence in all three studies,
moreover, is very compelling and strongly suggests that this same
decline has occurred in the gay community at large. Furthermore,
these changes in HIV incidence can be corroborated by changes in
the incidence of other sexually transmitted diseases in San
Francisco in gay and bisexual men.

47

 

 
 

 

For instance, the incidence of rectal gonorrhea in men
diagnosed at San Francisco City Clinic between 1978 and 1985 fell
from almost 1500 cases per quarter in 1980 to 100 cases per
quarter in 1986, a decrease of 93 percent. During the most
recent quarter, there were fewer than 30 cases. These data
thus corroborate the changes in HIV incidence seen in the three
cohort studies and clearly support the conclusion that HIV
infection has decreased markedly among gay and bisexual men in
San Francisco.

In summary, we have observed a marked decrease in the
incidence of HIV infection among gay and bisexual men in San
Francisco, with very low levels of new infection since 1983.

This decrease has been accompanied by a similar dramatic decrease
in high-risk sexual practices within the gay community, which I
have presented in written testimony and which appears to have
causally contributed to the decline in HIV infection. But what
part of behavioral change can be attributed to fear and what part
to health education is less clear, although I think it is quite
certain that health education helped to channel gay men's desires
to reduce their risk of AIDS into safer sexual behaviors. I
would now like to turn to the question of what is the risk of
developing AIDS once a person is infected with HIV.

MR. CREEDON: May I ask a question, Dr. Rutherford?
DR. RUTHERFORD: Please do.

MR. CREEDON: Going back to your prior slide, was the
gay community in San Francisco sufficiently aware of the danger
in 1981 and '82 to have changed their behavior, so as to produce
the results in '83?

DR. RUTHERFORD: Yes. Actually I have brought the
slide of rectal gonorrhea changes, but it won't fit into this
newfangled carrousel. Actually the rates of gonorrhea started to
fall in late 1981. It actually predated --

MR. CREEDON: So it related to that. In other words,
it was the rectal gonorrhea that maybe caused a change in
behavior rather than AIDS?

DR. RUTHERFORD: Oh, no, I don't think so. Gonorrhea
was widely viewed as a treatable disease that was just, you know,
sort of like getting -- I don't want to be overly flip -- it was
like getting parking tickets. I mean, it was just sort of the
lifestyle that you'd have to go and get treated.

MR. CREEDON: But my question is, was the gay community
sufficiently aware in 1981 and '82 of the danger of AIDS to have
changed their behavior dramatically, so as to produce the change
in '83 and '4?

48

 

 
 

DR. RUTHERFORD: Yes. Our survey data from 1983
suggests that there was widespread knowledge -~ the change
occurred between 1982 and 1983. But there was widespread
understanding and knowledge of AIDS and a lot of theories about
what caused AIDS and how one contracted it.

DR. PRIMM: Dr. Rutherford, this N is 359?
DR. RUTHERFORD: That's correct.
DR. PRIMM: Thank you.

DR. CRENSHAW: And one other point. The dramatic
change that you see there, can you give us, for our
understanding, I think one of the most important things? What
has been the breakdown of behaviors, and what in particular --
how many of those who are not getting infected are having more
than one partner, regardless of what safe sex measures they're
using?

DR. RUTHERFORD: In the written testimony, I've
presented data collected in 1978 and 1984 and 1985, which spans
this period. In 1978, the mean number of sexual partners -- I'm
sorry -- the median number of sexual -- non-steady sexual
partners in the four months preceding the interview and the blood
collection was 16, and in 1981 it was 1.

Dr. Doll from the Centers for Disease Control has
developed a product called an exposure product, which is
basically -- you get by multiplying the numbers of sexual
partners times the percentage of time they practice a certain
sexual behavior, so if you have 10 sexual partners and you
practice insertive anal intercourse 50 percent of the time, your
exposure product is 5. That data is in the written testimony as
well. That's decreased about, oh, 95 percent during this same
time period. As to whether we have year-by~year information from
this cohort, no, we don't. We have year-by-year blood samples
from this cohort.

DR. CRENSHAW: But basically if I understand you, what
you're saying is, I think, really important, and that is that
numbers of -- in order to achieve these results, the number of
partners haven't been remaining at a multiple partner level, but
it's really approximating 1; is that correct?

DR. RUTHERFORD: I'm not inferring that causally. I'm
saying what we've observed is that both the numbers of partners

have declined, and the specific types of sexually activities have
changed as well.

MR. CREEDON: Thank you very much.

49

 

 

 

 
 

DR. RUTHERFORD: Now I thought I would turn to the
question of what is the risk of developing AIDS once a person is
infected with HIV. This question has not only important clinical
ramifications for the individual patient with HIV infection, but
also can provide us with a framework for more exact forecasting
future numbers of AIDS cases.

Among a 20 percent random sample of all San Francisco
City Clinic cohort participants, there are 63 men for whom we
know the approximate date of HIV infection and have detailed
medical records. On average, these men have been followed for 76
months, since HIV seroconversion. These 63 men, 19 or 30 percent
have developed AIDS with a mean interval of 55 months between
seroconversion and diagnosis of AIDS. 13 or 21 percent have
developed AIDS-related conditions, including oral candidiasis or
hairy leukoplakia, weight loss, fever, diarrhea, and 17 or 27
percent have developed persistent generalized lymphadenopathy
without other signs or symptoms of HIV infection. Only 14 or 22
percent of this group have remained asymptomatic.

114 men from the vaccine trial who were seropositive on
entry into the cohort or who seroconverted within a known
24-month period during the study were included in a Kaplan-Meier
survival analysis of the cumulative proportion of men who will
develop AIDS by duration of infection. From analysis of these
men, we estimate that 11 percent of HIV-infected men in this
cohort will develop AIDS within 48 months of infection, 15
percent will develop AIDS within 60 months, 22 percent within 72
months, 28 percent within 84 months, and 35 percent within 86
months with a 95 percent confidence interval of 16 to 54 percent.

Stated another way, we estimate that the average annual
incidence of AIDS in this cohort will be less than 1 percent per
year during the first two years following HIV infection, 5
percent per year during the next three years, and 7 percent per
year during the next 26 months, which is as far out as this
cohort goes at the present time.

Two questions need to be addressed. First, can these
progression estimates be applied to other HIV-infected gay and
bisexual men, and second, can these estimates be applied to
non-gay or bisexual populations infected with HIV?

With regard to the generalizability of the study group
to other gay and bisexual men, all the men in this study were
recruited from a sexually transmitted disease clinic, and
repeated venereal infections or reexposure to HIV are important
cofactors in the progression of HIV infection to AIDS. These men
may be at higher risk for disease.

50

 
 

However, these men were seronegative for hepatitis B
virus when they were recruited in the vaccine trial, and
therefore probably had less cumulative exposure to other
venereal diseases than the other men in the cohort. If venereal
diseases are a cofactor, then one would expect a prognosis of
vaccine trial participants to be better than that of the
remainder of the cohort. ©

However, analysis of a random sample of the entire
cohort showed virtually the same time progression to AIDS as
vaccine trial participants. Additionally, other epidemiologic
studies of gay and bisexual men in New York City, Washington,
D.C., and Denmark have shown similar rates of progression,
although none of these studies have followed their patients for
as long as this study.

With regard to the question of how these data compare
to similar studies in other risk groups, the rates of progression
following infection with HIV have been estimated amongst
recipients of HIV-infected blood and blood products. Data from
both transfusion recipients and hemophiliacs demonstrate very
similar rates of progression with 7 percent of transfusion
recipients developing AIDS after between 10 to 63 months of HIV
infection and 13 percent of hemophiliacs developing AIDS after 60
months of infection.

In summary, our data suggests that 35 percent of gay
and bisexual men with HIV infection will develop AIDS within 84
months following HIV infection -- I'm sorry ~-- 86 months
following HIV infection. They also suggest that over a similar
time course, the majority of HIV-infected men who have not
developed frank AIDS will develop other signs and symptoms of HIV
infection. Furthermore, our findings are consistent with those
from other studies of the natural history of HIV infection among
gay and bisexual men, transfusion recipients, and hemophiliacs.
Again, thank you for the opportunity to speak with you this
morning.

MR. CREEDON: Penny?
MS. PULLEN: No questions.
MR. CREEDON: Ms. Gebbie?

MS. GEBBIE: If you were going to use more information
to try and estimate or predict the seroconversion rate in the
currently uninfected gay population of the United States at large
over the next few years, would you use the figures from early in
San Francisco with a seroconversion rate of 10 and 20 percent a
year or the current figures of 1 and 2 percent a year and why?

 
 

 

DR. RUTHERFORD: I don't think anyone can possibly
answer that question. You have to realize that there are three
large cohort studies in San Francisco that have been carefully
measuring this for several years. The multicenter collaborative
studies which are conducted in -- and Dr. Fauci can correct me --
I think it's Pittsburgh, Los Angeles, Baltimore, and Chicago --
have been gathering similar data since 1984. Outside of those
cities, I don't think anyone has a real handle on what the true
incidence of HIV infection is among gay men.

I think that it would make sense to say that the
epidemic in San Francisco probably started about a year after the
epidemic in New York, and the epidemic in other large gay
metropolitan urban communities started somewhat later than San
Francisco. But as to putting an exact handle on it, I don't
think anyone can really do that accurately.

MS. GEBBIE: I know it isn't specific. We're trying to
make calculations. If you can't -- if you're not willing to make
a guess of which of your numbers you would use to apply
nationally, would you comment then on your view of using the
current CDC report, the most recently released one, as being a
good estimate to use, or where would you turn to get good
estimates that we can use for the end of the century calculations
that we need to make?

DR. RUTHERFORD: Well, I think that I agree with you,
that it's important to make these estimates. I think the
estimates have to be made with the best data available, and if
there's not good data available, which there is not, then I think
that data has to be generated de novo, and Dr. Francis spoke
earlier about the need for recruiting and doing these kinds of
cohort studies in other cities and flinch somewhat at the price
tag. I'm less of a flincher these days.

And I think that you really basically, to make accurate
estimates, you know, you'll be faced with questions. Do we need
to open up -- do we need to build $300 million hospitals in
Houston, for instance? And I think one of the -- my
recommendation would be to generate these data de novo if they
don't exist, rather than try to extrapolate.

MR. CREEDON: Do you have any comment on that, Dr.
Fauci?

DR. FAUCI: I agree. I think perhaps the slant of your
question, if I'm not mistaken, was if you're going to -- could he
use the data from early on in '82, ‘83 about the yearly incidence
of new infection, could we use that in other parts of the
country? Were you asking that?

MS. GEBBIE: That was the import of my question, yes.

52

 

 
 

DR. FAUCI: Again, we don't have the answer to that,
but I would think given the current state of knowledge of the
dangers of certain types of risk behavior among the male
homosexual population throughout the country, I would think it
would not be unreasonable to presume that people in Chicago and
Houston and Miami and Baltimore are as aware of the problems of
risk behavior, male homosexuals, such that I think the yearly
incidence of new infection in those communities you could
extrapolate from your early data. Would you agree?

DR. RUTHERFORD: With some caution, yes, you could
extrapolate it. I would also point out -- and I'm sorry the
slide doesn't fit -- that there's a fairly tight correlation
between cases of rectal gonorrhea in men and this observed
incidence, and that's something that's available right now. It's
collected nationally. Those data are available, and we've used
those data quite a bit in our planning efforts. And if you want
to look for an easy way to do it, that's a much easier way than
trying to take these data and extrapolate then.

MS. GEBBIE: I'm well aware there's not a simple, easy
way. I'm just trying to push to look at what ways different
people would do it as a basis.

MR. CREEDON: Dr. Fauci and Dr. Rutherford, would you
comment on Dr. Sivak's approach? Did you follow his
presentation?

DR. FAUCI: I think that the data from Dr. Sivak's
presentation is reasonable and sound. If you look at it, it does
not differ significantly from the kinds of projections that have
-- in fact, it's more confirmatory of the type of projections.

MR. CREEDON: Well, there is a difference, as Chairman
Watkins pointed out. There's a significant difference really
between the most recent CDC range -- well, it depends on what you
call significant, but it looks significant to us. Dr.
Rutherford, do you --

DR. RUTHERFORD: I'm sorry. I didn't hear the entire
presentation. But hearing the discussion of the methods, it
seemed a perfectly reasonable way to generate the data. I also
took great comfort in the fact that Dr. Sivak used the no
identified risk data from New York where the analysis of cases
and the assigning of cases to risk groups is probably the best in
the country.

MR. CREEDON: Dr. Primm?

DR. PRIMM: Dr. Rutherford, you continue to refer to
the slide with GC that won't fit. I mean, you can take the
carrousel off and put it in there. I'd like to see it.

53

 

 
 

 

DR. RUTHERFORD: Sure. It's in the written testimony.

DR. PRIMM: I'm sure other Commissioners would like to
see it, too. But I have another question for you. Since your
figures have indicated very encouraging results for intervention
strategies for one population group at risk, and that's your
homosexuals, I think certainly San Francisco and other parts of
the country have a unique opportunity now to -- certainly, as you
know, I was just out there recently, and one of the big
complaints that I had from meeting with 30 people out there was
indeed that they didn't have the same kind of thrust for the
intravenous drug-using population as you have had for the gay
population in San Francisco.

DR. RUTHERFORD: Yes.

DR. PRIMM: And as a result, I wonder what the
incidence and patterns in IV drug users are in your city -- I
mean, what is the incidence when you compare the two groups?
I've heard that it's very low, and that we could even keep it low
in San Francisco, even keep it low in Houston and Los Angeles, by
employing some of the same things that your cohort group
employed.

DR. RUTHERFORD: Yes. That's correct. The incidence
of HIV infection among heterosexual intravenous drug users is
approximately 3 percent per year in San Francisco, but that's
based on -- I'm sorry ~~ this is the gonorrhea slide, and you can
see that the slide starts to take place -- the peak is in - - the
highest peak is in '80, and there starts to be a downward plan
that becomes markedly exacerbated between '82 and '83, and I
think it parallels that other data fairly dramatically.

I'm sorry. Getting back to your question, we think
that the overall prevalence of infection among heterosexual
intravenous drug users in San Francisco is approximately 15
percent and that the incidence of new infection is approximately
3 percent per year. We're not seeing, as measured in primarily
clinic-based studies, we're not seeing this rapid acceleration of
disease, of infection among intravenous drug users. And it would
be my guess that should our control programs not be as successful
as they were among gay men, that HIV infection among heterosexual
intravenous drug users, their sexual partners, and their children
will become an endemic disease principally of the black and
Latino, to a lesser extent the American Indian, community in San

Francisco.

DR. PRIMM: It's three times higher now in intravenous
drug users, as you admit right now.

DR. RUTHERFORD: That's absolutely correct.

54

 

 
 

 

t

DR. PRIMM: So it would seem to me that there ought to
be such a concentration on that population in San Francisco at
the moment, which does not exist. I mean, I heard people talk to
me from Contra Costa County and from all over San Francisco in
drug treatment programs. Dr. Whittaker was at that meeting, as
you probably know, and I was shocked that we don't have the same
kind of thrust, and I think that it's because that group does not
have the political clout that the gay community has in San
Francisco, and indeed that if they did, and if there was a
greater voice in San Francisco, that there would be greater
concentration in terms of setting up programs of intervention for
that group as well as the other.

DR. RUTHERFORD: I strongly disagree with you. To
start with, the San Francisco that I'm speaking for is the City
and County of San Francisco and not Contra Costa County and
Alameda County and the other counties in the Bay Area.

There are -- probably more money is being spent now for
prevention and treatment of intravenous drug users than there is
for prevention services for gay and bisexual men. There's been a
major revamping of the programs that's gone on in the last 12
months with the new clinic, for instance, that's being opened in
the Tenderloin area of San Francisco, which is roughly equivalent
to the Lower East Side, and I think we've made a major
commitment.

We have not recruited cohort studies, the cohort kinds
of studies that we have recruited in the gay population, and have
based our estimates principally on in-treatment clinic
populations, which is indeed a shortfall.

But in terms of the prevention efforts, I think that
they are there. San Francisco, for instance, pioneered the use
of bleach, dispensing bleach and teaching people how to clean
their needles with bleach between sharers.

So I think we have made that commitment, and obviously
we could always use more money to open up more treatment slots,
and that is, in fact, the real shortfall of our programs, that we
need several hundred more treatment slots, which I think is true
if you multiply it -- you know, add an extra zero to it, which is
also true in New York.

MR. CREEDON: Dr. Fauci, you wanted to comment?

DR. FAUCI: Yes. I have a general comment in response
to what Dr. Primm said, and that is I think that many people on
the outside really do not appreciate the fact that what is
required for change in behavior among IV drug abusers is
certainly much different than among the homosexuals, because the

55

 

 
 

 

responsiveness of the male homosexual population to education has
been outstanding and really a model in behavioral change.

When you are dealing with IV drug abusers, there is a
misperception sometimes. This has nothing to do with San
Francisco, I agree with Dr. Rutherford that the San Francisco
system has actually done quite well from both areas, both IV drug
abusers and male homosexuals.

In a system where you are dealing with IV drug abusers,
there is sometimes a misperception that the same sort of
educational campaigns that would have a significant impact on
male homosexuals would also have a similar impact on IV drug
abusers, failing to appreciate that IV drug abuse is a medical
disease that needs to be treated and the way that you can get to
the IV drug abusers is to have intensive treatment programs as
well as education programs. Education alone is not going to do

it.

I agree with you, Dr. Primm, that we really need to
have nationwide much more intensive efforts at the IV drug
abusing population that is more than just education. Education
to a person who has a medical disease is not going to cure the
medical disease. That is what IV drug abuse is.

DR. PRIMM: Dr. Rutherford, perhaps you could supply
for the Committee some follow-up statistics on when monies were .;
put into an intravenous drug user community and what was the
results of the infusion of those dollars.

I know Haight-Ashbury certainly has done a lot in
passing out bleach in small bottles. I have certainly heard
about it, two and a half years ago, long before it was done on
the East Coast.

I'm not doing a comparison or being critical as much as
I see a need for greater concentration in those areas. I know
the program in Bay View. I know Ron Kletter's program. I know
Al Comparo's program. I just had a meeting at the Cadillac Hotel
with Leroy Luper, who was constantly working with intravenous
drug users.

What I am talking about is what people have actually
said to me that I have on tape. I'm quite surprised that you
should say today that there is great concentration and good
results and so forth, when indeed there is a difference of
opinion among other people who are working with intravenous drug
users.

DR. RUTHERFORD: I am equally surprised you said it.

MR. CREEDON: Dr. Crenshaw?

56

 

 

 
 

 

DR. CRENSHAW: Based on your cohort study and whatever
other knowledge you can draw on in San Francisco, how many, what
percentage of individuals, gay men, acquired the infection as
teenagers, number one. Secondly, what percentage of the men you
work with or what do you estimate from your current knowledge is
the percentage of any degree of bisexual or heterosexual activity
among homosexual men?

DR. RUTHERFORD: In terms of what percentage of men
acquired the infection as teenagers, all these study cohorts
basically used a bottom age cutoff of around 25. We really can't
answer that question. That was one of the points, and I'm glad
you raised it. I said that we feel these data are representative
of the types of men who would have been enrolled in these
studies. We really don't have data on younger men. I think that
is a need as well.

I think nationally, if you look at people who are 20 to
24 years old with AIDS, the large majority of them presumably who
acquired the infection during adolescence and adolescents
themselves. The large majority of those people, certainly in
excess of 70 percent, and I'm not sure of the exact numbers, are
gay or bisexual men. I think adolescents are at risk, gay
adolescents are at risk of the HIV infection.

They may more properly fit the Freudian term, bisexual,
and they may be supporting themselves as gay prostitutes, for
instance, but nonetheless, that is the predominant mode of
acquisition of the virus among people who are between the ages of
13 and 24.

DR. CRENSHAW: Which is the predominant mode?

DR. RUTHERFORD: They are classified as homosexual or
bisexual. I am talking about AIDS patients now. That's the only
thing I can infer fron.

In terms of how many gay men are bisexual, I think the
real question is how many are bisexual in a period of time of the
epidemic rather than historically. Is that correct?

DR. CRENSHAW: Yes. I also mean specifically. I don't
mean bisexual necessarily, equal numbers of each partner, but any
heterosexual activity regardless of how infrequent.

DR. RUTHERFORD: In our studies, it is between 10 and
15 percent, depending on how you cut the cohort into different
sample sizes. I am talking about the people who are enrolled in
these cohort studies now, the three cohort studies. It is

57

 

 
 

 

 

between 10 and 15 percent, within the period of time the
questions are asked, which is usually in the last -- basically
since the beginning of the epidemic.

MR. CREEDON: Dr. Walsh?

DR. WALSH: Has the behavioral change in the homosexual
community been as good in other cities as in San Francisco or is
San Francisco unusual?

DR. RUTHERFORD: San Francisco is certainly unusual,
I'm sure. I really can't answer the question. I don't have
firsthand knowledge of a lot of other cities. What I can tell
you is there are declining rates of rectal gonorrhea in men who
were first reported in New York City in 1983 or 1984, and have
also been reported from Seattle.

I think Dr. Fauci's thought that these sorts of changes
are being seen in other large urban gay communities is probably
true.

DR. WALSH: Have they been as dramatic?
DR. RUTHERFORD: There is not data to support it.

DR. WALSH: Dr. Fauci, do you know? Has the
behavioral change in the gay community been as dramatic in other
cities?

DR. FAUCI: It is very difficult to say that. We do
know that if you look at sexually transmitted disease clinics in
other cities, for example, in Denver, where it has remarkably
decreased with rectal gonorrhea, 80 to 90 percent, you wouldn't
consider Denver as one of the major cities in this country with
AIDS and yet there is clearly objective data showing a decrease
in that kind of activity.

DR. WALSH: Denver has had a lot of things like contact
tracing and everything else, which has also played a role.

DR. FAUCI: Possibly.

DR. PRIMM: I have one more question for Dr.
Rutherford. You spoke with pride about the use of the Clorox
being handed out in shooting galleries or wherever people
congregate to shoot drugs. I wonder how much emphasis is placed
on the stopping of the use of drugs period and intravenous drugs
period, wherever they are handed out.

DR. RUTHERFORD: Yes, I'm glad you asked the question.
Certainly, our take on it is in terms of overall AIDS prevention
strategy, as Dr. Fauci says, that intravenous drug addiction is a

58

 

 
 

 

i

medical disease and needs to be medically treated and the only
true way to stop it is to stop addiction. We place our primary
emphasis on the treatment of intravenous drug use.
Unfortunately, the majority of our treatment slots are funded by
the federal government and they have been fairly fixed over time
and in fact are being reduced.

We are faced with the decisions, should we cut down on
the number of detoxification slots to open more methadone
maintenance slots, to try to trade the more expensive means of
treatment for the less expensive, more expeditious means of
keeping people from sticking needles in their arms. That's a
problem.

In terms of the bleach, that is obviously a second
level of advice. Our advice is if you use intravenous drugs,
stop using intravenous drugs. If you can't stop using
intravenous drugs, don't share needles. If you can't stop
sharing needles, at least do this.

DR. PRIMM: I think there should be some emphasis also
on primary care in those already existing treatment centers,
where you have a greater contact with health care givers and
those people receiving. Like Dr. Fauci has indicated, this is a
disease and unless we begin to look at it as such and not only
expand our treatment efforts within the center itself by greater
contact with the patient, more sophisticated care for that
patient population, than is now being witnessed anywhere in the
United States, I think that could happen in San Francisco. San
Francisco is such a magnificent model, there is no question in my
mind that it could be demonstrated right there. The drug
treatment programs are intact, maybe one needs to put more
emphasis in that area, along with just saying stop using drugs
and greater concentration. That in itself will give the addict
the feeling that indeed they are cared about within the
population. I think you would see quite a behavioral change.

DR. RUTHERFORD: I agree. I thank you for your
comments. We are always lobbying the Alcohol, Drug Abuse and
Mental Health Administration for demonstration project monies to
open up new treatment services and to expand existing treatment
services. They have been disinclined to provide those sort of
funds in the past. I think that is a recommendation that would
be very worthwhile.

DR. PRIMM: AIDS is a window of opportunity.
DR. RUTHERFORD: I agree.
MR. CREEDON: I would like to move on, if we can.

Could you hold your questions and come back if we have time?

59

 

 
 

 

ADMIRAL WATKINS: I would like to close. First I want
to make sure that what we saw on the screen, on the rectal
gonorrhea cases, is your Figure 3 in your report.

DR. RUTHERFORD: Yes.

ADMIRAL WATKINS: I would like to ask Dr. Francis, if
this data on rectal gonorrhea has a close correlation, which is
almost remarkable from what Dr. Rutherford is saying, why isn't
that among the surrogates, perhaps a family of surrogates that
would give us even more accurate data than we talked about in
behavioral surveys, where now we have indication of a more direct
correlation. I would like to ask your opinion on that.

DR. FRANCIS: I agree.

ADMIRAL WATKINS: You are the advisor to Centers for
Disease Control. What have you done to talk to Centers for
Disease Control with this data being reported as an infectious
disease, to do more studies and gather more data to confirm that
correlation and perhaps with the largest segment nationally being
in this category, this may be a very near term opportunity for
us. What has Centers for Disease Control done about this kind of
correlation?

DR. FRANCIS: I am Centers for Disease Control advisor
to the state, not the state's advisor to Centers for Disease
Control.

ADMIRAL WATKINS: I understand.
(Laughter. ]

DR. FRANCIS: At least the State of California's
recommendations is increasing their watch on the rates of
gonorrhea so we can monitor them. Unfortunately, it is
interesting that some areas do not separate rectal and non-
rectal so you have to start that program up. That is nota
difficult thing to get in place.

ADMIRAL WATKINS: Is that already one of your programs
at Centers for Disease Control, to take this on, to take a harder
look at this data or perhaps even other data, maybe other kinds
of infectious diseases that have some sort of correlation with
the HIV infection process.

DR. FRANCIS: Clearly, as you say, this is one of the

pieces and the family of surrogates I think is a good way to put
it.

60

 

 
 

 

ADMIRAL WATKINS: Should the Commission try.to dig
deeper into a family of surrogates as a more near term, closer
prevalence and perhaps even incidence projection model?

DR. FRANCIS: Surely. I would keep behavioral in there
also.

ADMIRAL WATKINS: Absolutely. When I say the family, I
mean it would include a variety of things where we have technical
correlation, like this, as opposed to behavioral. It seems to me
that has some merit to it.

DR. FRANCIS: With really very small resources, you
have a huge amount of data.

ADMIRAL WATKINS: Another question, the participants in
your cohort study, Dr. Rutherford, probably received some
intensive education in that particular cohort and are involved in
their own medical care process.

I'm not saying it is the best case but I know when you
have a closed community like that, that you are intensively
looking at, there tends to be a bias to say that is a special
group. What I am saying now is do you have any kind of
indication from those not in cohort studies, what the incidence
in the non-cohort study might represent as opposed to something
more confined and more closely controlled?

DR. RUTHERFORD: You are describing the phenomenon of
cohort bias, which is clearly operative in these cohort studies.
Just to reassure you, on this cohort study to start with, the
AIDS follow-up study started in 1984. Prior to 1984, this had
been a Hepatitis B vaccine trial with emphasis on basically the
vaccine mediated prevention of Hepatitis B and basically these
people came in every six months and had blood drawn and little
else.

I think the cohort bias you are worried about clearly
is in effect after 1984 and later, but were not in effect when
this decline occurred.

The question about generalizing it to people outside of
cohort studies, I think the gonorrhea data, after all, HIV
infection is a sexually transmitted disease and you look at
another sexually transmitted disease which does not confer
immunity, so you can become infected multiple times, that is
clearly supporting data and again, there are behavioral data
which support the notion of changing sexual practices in the gay
community.

a

ADMIRAL WATKINS: Thank you.

61

 

 
 

 

MR. CREEDON: Dr. Robert Redfield of Walter Reed
Medical Center.

PRESENTATION BY DR. ROBERT REDFIELD
WALTER REED ARMY INSTITUTE OF RESEARCH

DR. REDFIELD: I appreciate the opportunity to share my
experience of the AIDS epidemic with this Committee. The views
that I present are my own and do not purport to reflect the
position of the Department of the Army or the Department of

Defense.

My perspective on the AIDS epidemic is the product of
the opportunity that I have had to practice medicine in the
military hospital in the early years of the AIDS epidemic. Asa
physician, scientist and military medical officer concerned with
public health, I was placed in an unique position to integrate
these disciplines to comprehend the magnitude of the problem that
the AIDS virus is causing and will continue to cause our nation.

First recognized in 1981, AIDS was a new and mysterious
syndrome. Today, AIDS is no longer a mystery. It is an
infectious disease caused by a retrovirus. Within three short
years, science has identified the etiology, elucidated the
pathogenic mechanisms of how this virus causes disease, defined
the methods of transmission, and developed accurate diagnostic
tests for HIV infection.

Yet, despite these unprecedented advances by scientists
and the Public Health Service, the AIDS epidemic has escalated
from a medical curiosity to an isolated public health problem, to
what in my opinion is a worldwide crisis of potential
catastrophic proportion requiring an urgent coordinated response.
Yet, the magnitude of the problem remains a subject of
controversy, definable yet undefined, resolvable yet unresolved.

Why? Unfortunately, the original case definition of
AIDS identified only ‘the late clinical stages of the disease and
thereby underrepresenting the magnitude of problems from the
very beginning. The clinical spectrum of HIV infection, if you
look at the first handout, really ranges from acute retroviral
syndrome, as Dr. Fauci said, to chronic lymphadenopathy, to
subclinical damage of the T cell system and finally, the systemic
evidence of T cell dysfunction, as manifested by an opportunistic
infection.

This spectrum of disease can be reduced to six stages
of infection which are provided in the second handout, which
really, for practical purposes, represent advancing stages of
immunological dysfunction, caused by this virus. Although early
studies reported progression rates of asymptomatic seropositive
to AIDS of only 5 to 10 percent, the natural history of the AIDS

62

 

 
 

 

: pe no aval,
_virus has been clarified: Today, multiple cohort studies
demonstrate progression rates in excess of 30 percent.

Our own cohort study, which is outlined in the third
handout, demonstrates that actually greater than 75 percent of
all the patients in any stage followed for greater than 18 months
demonstrated progressive immunological disease as accessed by
this pathogenic framework staging system.

For example, patients that were evaluated for greater
than 18 months that were Walter Reed Stage 2's, 10 percent
developed AIDS, what we would refer to as Stage 6 disease. If
the individual began at Walter Reed Stage 3, it was 29 percent.
If the individual began when he first was evaluated at Walter
Reed Stage 4, it was 71 percent and if the individual presented
with what we refer to as Walter Reed Stage 5 in the follow-up
period, 100 percent developed AIDS as defined by an opportunistic
infection.

If one was to look at it in terms of death, followed
for 18 to 42 months, if you started out at Walter Reed -Stage 2, 5
percent of the individuals died in the follow-up period. If
started out at Walter Reed Stage 3, 14 percent died in the
follow-up period. If they started out at Walter Reed Stage 4, 57
percent and Walter Reed Stage 5, 87 percent.

If you refer to that graph, you can see that despite
what stage you started at, over 90 percent of the 62 patients
that were entered in that cohort in 1984 in fact developed
progressive immunological disease as assessed by this staging
systen.

My conclusion for one of your first questions, from the
available data to date, is that in the absence of a scientific
solution, HIV infection is a progressive infectious disease in a
Majority and possibly all individuals that are infected with the
virus, characterized by progressive immunological dysfunction
which may require 5, 10 or even more years from the time of
infection to the time of death.

In addressing the accuracy of our information to date,
another problem is that our understanding of the epidemiology of
AIDS was originally incomplete, which contributed to the
underestimation of the problem. Today, scientific investigations
have unequivocally documented the following modes of
transmission~-sexual, both heterosexual and homosexual;
parenteral and perinatal.

Sexual transmission is and will remain the major mode
of transmission of this virus. It is critically important to
recognize that the sexual transmission of HIV is not dependent
upon a risk behavior. For the HIV virus to be transmitted from

63

 

 
 

 

one human being to another, all that is required is that one
human being is infected with the virus and the other human being
isn't and they communicate by a method efficient for
transmission.

Despite this scientific understanding, some still focus
AIDS as a high, risk group disease. I would argue that we all
recognize today that homosexuality does not cause AIDS and
heterosexuality does not protect it. Today, there is only one
common risk group for HIV infection and that is a human being
that has been sexually, parenterally or perinatally exposed to

the virus.

I think that is the message we must communicate.

Despite our knowledge, some still underestimate the
ultimate importance of heterosexual transmission and I will take
a minute just to make a comment.

Individuals speculate that HIV will be unique among
sexually transmitted diseases, rather than assume that the laws
of nature as they have been described, will.continue until
definitely proven otherwise. Worldwide heterosexual transmission
is the major mode of transmission of this virus, yet some
individuals hope that the United States somehow will be unique.
Unfortunately, I believe that in the absence of a scientific
solution over the next decade, the heterosexual transmission of
this virus will become the major mode of transmission in our
country. We have to recognize it for what it is, because we have
an opportunity to make a major impact on that process.

Today, the AIDS cases represent an historical account
of the magnitude of the epidemic actually in the late 1970's, but
fail to give us any understanding of what the problem is today.
If one continues to focus on AIDS as the magnitude of our
problem, we will recognize the magnitude of today's problem in
1997, and I know you are all aware of that.

Likewise, we appreciate now that the epidemiology of
AIDS today is really a historical reflection of the epidemiology
of human to human transmission of this virus a decade ago,
probably five years before we even knew this virus existed, yet
fails to inform us about the epidemiology of viral transmission
today.

I think it is critical that we change our focus from
AIDS and the problem in the 1970's toward the virus and the
problem today. We should embrace the scientific advances that
were made by the Public Health Service from 1981 to 1984.

Serological testing gives us that opportunity to define
today's problem today rather than debate the issue. I believe we

64

 

 
 

 

should define the problem and redefine it again in the following
year and the following year. The logic that elects to confront
the problem undefined when definable should not be embraced by
our society.

What do we know about the extent of HIV infection
today? It is with pride as a military physician that I reflect
on the approach that the leadership of the Department of Defense
has executed in response to the AIDS epidemic. HIV infection has
been confronted by the military as an important medical, public
health and military problem that it is. The Department of
Defense policy has been guided by science coupled with important
medical and public health issues.

It is also with pride as a military researcher that I
reflect on the foresight exhibited by the leadership of the
Department of Defense in developing a system to collect this
operational data and provide that to our nation as it is an
estimate of the extent of HIV infection in our nation's young
sexually active people.

One of the programs I am going to comment on, and I
will comment on two of them today, is the civilian applicant
screening program. All civilians applying for the Armed Forces
undergo a medical examination which includes, with other medical
testing, screening for the AIDS virus as part of their medical
evaluation for fitness for duty. It should be noted that the
test results are available within 24 hours for those individuals
negative by the ELISA screening, and 72 hours for those requiring
confirmatory testing, despite where the serum is obtained
throughout the United States.

Some have criticized that the HIV testing is too
expensive. It should be noted in rebuttal that the DoD program,
including confirmatory tests, costs less than $5.00 per
individual tested. Some speculate that serological testing in
low prevalence populations would generate prohibitive numbers of
false positives and in rebuttal, as reported by Colonel Burke in
his recent congressional testimony, the scientifically documented
false positive occurrence following the DoD algorithm was less
than 1 in 100,000 in our program.

In addition, it should be noted that the DOD has
provided test linked education to over 4 million individuals to
date, without precipitating a social crisis, so that large scale
timely, accurate, inexpensive HIV screening can be done. It is
done every day by both the American Red Cross and the Department
of Defense.

Between October 1985 and if you look at the first table
there on civilian applicants, the numbers are there, between
October 1985 and September 1987, over 1.2 million civilian

65

 

 
 

 

applicants for military service were tested for the presence of
HIV antibody. The overall prevalence of HIV was 1.5 per 1,000.

In light of the demonstrated efficient sexual
transmission of HIV, the fact that 1.5 per 1,000 of Americans who
desire to serve their country are already infected with the AIDS
virus, I perceive as a national tragedy.

The prevalence for infection among males was 1.6 per
1,000 and among females, .7 per 1,000, for a male/female ratio of
2.4 to 1. This is in sharp contrast to the male/female ratio of
the cases of AIDS reported to the Centers for Disease Control.

The prevalence increases linearly with age, as you see
the numbers, 17 year olds, .16 per 1,000. By the time an
individual is 20, .98 per 1,000; 22, 2.17 per 1,000; 24, 3.25 per
1,000. For individuals 26 and over, it was almost half a .
percent, 4.4 per 1,000.

It is of interest that among the 17 and 20 year olds,
the male/female ratio was actually 1.6 to 1. Race and ethnic
groups also had different prevalences, such that in the Caucasian
population, the overall prevalence was about .75 per 1,000 and in
the Black population, it was about 3.8 per 1,000.

Prevalence rates also differed by geographic location.
I gave you a mountain map there, which is really just plotting
the lowest confidence intervals by county throughout the United
States. One can see that in the United States, at least in 1986,
this was a relatively geographically restricted epidemic.

New York State led with about 4.2 per 1,000 of the
young men and women from the Empire State that wanted to join the
Service were infected with the virus followed by Maryland and New
Jersey. Certain metropolitan areas, like New York City, Newark,
San Francisco and Washington, D.C. all included counties where
the prevalence rate was greater than 1 percent for both male and
female applicants, with a male/female ratio actually approaching
1 to l.

For example, in Manhattan, the male prevalence was 2
percent and the female prevalence was 1.7 percent.

As you moved into these metropolitan areas, no longer
was sex or race a predictor of whether or not you were infected,
the most important predictor was whether you were 18 or 25.

Analysis of overall temporal trends of the military
applicant program by birth year cohorts, by Dr. Bundage,
unfortunately also documented a substantial increase in HIV
infection among our civilian applicants from birth year cohorts

66

 

 
 

 

between 1962 and 1969, i.e., those individuals really basically
between the ages of 17 and 25 years of age.

For example, male applicants between the age of 18 and
20 had a 30 percent greater likelihood of being HIV infected over
an one year period. This was true for both white and black
applicants. The estimated doubling times of the HIV in young men
born between 1962 and 1969 throughout the United States is less
than three years.

These data demonstrate that a substantial proportion of
America's youth are already infected with the AIDS virus and
unfortunately continue to be ignorant of their ability to
transmit this virus to others.

Another source of information that we can get a
glimpse of what the epidemic is today is a result of the U.S.
Army's HIV program. Preliminary analysis by Major Kelly at WRAIR
demonstrated the overall prevalence of HIV infection among male
soldiers currently in the U.S. Army is 1 in 500 and among female
soldiers currently in the U.S. Army, is approximately 1 in 1,000.
Again, the male/female ratio is 2 tol.

Age is’ the most important variable with prevalence
rates ranging from .4 per 1,000 for those under 20 to basically 3
per 1,000 for those 30 to 34. Again, analysis by race and ethnic
group show that caucasians were infected on the order of 1.1 per
1,000; blacks, 2.6 per 1,000; and hispanics, 2.5 per 1,000.

If one was to do a by variance analysis, by race and
sex, the prevalence rates range from .4 per 1,000 for caucasian
women to approximately 4.7 per 1,000 for black males.

I think it is notable that currently the prevalence of
infection among black and hispanic women in the United States
Army on active duty is greater than that of caucasian males, 1.6
per 1,000 versus 1.1 per 1,000.

Also to interest to me is the fact that in 1983 and
1984, as a physician at Walter Reed, I had the opportunity to
understand this epidemic largely because of the patient
population I cared for. Half of the patients I cared for with
symptomatic disease back then were, in fact, married men and
women. I was forced to confront the grim reality of this
epidemic and the impact it would have on the American family
eventually back then.

Although many critics challenged our findings on
heterosexual transmission, few acknowledge the uniqueness of the
Walter Reed patients in 1984. That is, of the patients we cared
for with AIDS, 50 percent were married men and women and actually
20 percent were female.

67

 

 
 

 

As a result of our HIV program, it comes as no surprise
to us that over 40 percent of the soldiers currently on active
duty infected with the AIDS virus are in fact married men and

women.

The philosophy behind the HIV program simply put is
that we believe that knowledge of HIV infection is better than
ignorance of HIV infection. Each member of the U.S. Army is
provided several and very important opportunities based on what I
consider to be an important medical agenda. That is the
opportunity if infected to receive medical care based on all the
medical knowledge available in 1987. I think all patients should
expect that same right -- The opportunity to face the future
without blinders based on full knowledge of their body and the
illnesses it has; the opportunity to no longer unknowingly
transmit this deadly virus to another human being; and again, the
opportunity at least to have the right to be informed, if they
have been unknowingly exposed to this deadly virus.

The HIV screening programs were responsible for
providing this knowledge 70 percent of the time, less than 3
percent of the total infections identified in the Army were
established because of voluntary self referral testing.
Actually, about 26 percent were established because a doctor put
it in his clinical diagnosis at some stage. Therefore, greater
than 70 percent of all HIV-infected individuals in the United
States Army only became aware of this and then therefore
benefitted from that knowledge as a consequence of one of the
military screening programs.

The Department of Defense has a firm grasp on the
extent of HIV infection in the Department of Defense. The U.S.
Army also has in place procedures that will not only ensure
earlier accurate medical diagnosis of HIV infection in its
members but also to define the dynamics of the epidemic within
the Army over time. Guess work will not be required.

Preliminary analysis of direct measurements of the
incidence within the United States Army, a population where all
the members are provided specific test linked education is in
excess of 1 in 2,000. I believe that the data provided by the
U.S. military provides America with its best guess, but it is
still a guess. However, because of our selection biases, it
should be recognized that the military data is likely to
underestimate the HIV infection rates in the "general population"
of young sexually active Americans.

What is the magnitude of HIV infection in America
today? That was one of the questions posed to me. What will it
be next year? How will it change? Is our current policy
effective? How will we know?

68

 

 
 

 

In closing, I say that never before in the history of
the human race has society been given the opportunity to have all
the scientific knowledge at its disposal than at the time of the
emergence of a new infectious disease. We have been given that
rare and treasured opportunity and it is our responsibility not
to waste it. In the year 2000, neither you nor I will be held
accountable for whether or not an AIDS vaccine is developed or
curative therapy discovered, these scientific advancements will
come with time. No one knows when.

However, we will be accountable to Americans in the
21st Century, our children and theirs, for our utilization and
implementation of the knowledge that was available to us in 1987.
No matter how excellent the alibis for why we do not have a firm
grasp on the magnitude of HIV infection in 1987 in our nation, we
can obtain this crucial information. I believe it is crucial.

We must define the extent of HIV infection, because if we
continue to mount our national response to meet the challenge of
AIDS in 1987 based on the cases of AIDS in 1987, we are doomed to
failure. Our national policy should be based on the knowledge of
the extent of HIV infection in our nation today and not limited
to guesses, models or opinions.

We must ensure that we don't lose the war against AIDS
just because we underestimated the enemy, or having committed all
the necessary resources, apply them to the wrong front. The only
way that I know to ensure the generations of the 21st Century, my
children, our children, and beyond, that we confronted this virus
to the best of our ability, is to first be sure that we
accurately define the problem. This is the only way we can
optimize our national response, providing all the resources when
they are needed, where they are needed. Some people say it can't
be done. I don't accept that.

I believe that with presidential leadership, we can
assess what the extent of HIV infection is in our country today
and we don't need to wait until 1990. This virus will steal the
lives from more young Americans over the next decade than those
who gave their lives to defend our country in the last four wars.
We can hope for an early scientific breakthrough from Dr. Fauci
and others, but unfortunately, the AIDS epidemic of the late
1990's has already occurred. However, the epidemic of the 21st
Century is preventable. We have at our disposal all the tools we
need to eliminate ignorant transmission of this virus today. Yet
to date, we have failed to take charge and accept our
responsibility to challenge this virus with the vigor and courage
and the commitment that has made our nation so great.

We only need to use our knowledge to recognize our
compassion, to exploit our ingenuity, to demonstrate our courage,
and then to persevere. To paraphrase Teddy Roosevelt, "At best,

69

 

 
 

 

we will know the triumph of high achievement measured in the
reduction of human suffering, or at worst with failure, know we
failed while daring greatly. " It is important that we recognize
the problem for what it is so we can begin to develop a solution
for a better tomorrow. I think we need to define the problem and
remove the uncertainty. I think we should change the debate from
is there a problem, where it is, how great is it, to now that we
know the problem, what can we do.

In closing again, I think it is important to reflect on
what I said before, more Americans will die over the next 10
years from this virus than lost their lives in the last four
wars. Beyond that, the losses will probably be greater. You
have to ask, what is an appropriate response to the reality of
such a preventable loss of American life? I think we must
recognize it as what it is, no matter how excellent the alibi's
for why we have done so little to limit the impact this virus
will have on our nation. We have all the tools to do it.

fhe epidemic of the 21st Century is preventable, yet we
have been slow to take charge as I said. Public health is a
responsibility of government, the cooperation to maintain public
health is the responsibility of each citizen in that government.
Any infectious disease knowledge of the infection is paramount
to its control. Routine test linked education, I believe, to be
the cornerstone of our medical national response. I would hope
that soon every sexually active American will be given the same
opportunities and provided the same rights as provided to those
members of the Armed Forces. Vigorous leadership coupled with
accurate education, classical public health measures will limit
the spread of this deadly virus in our nation. First, we as a
nation must define and recognize the problem as it is. We must
have the courage to develop effective national policies and the
resolution to mobilize the resources necessary to combat and
defeat the enemy. Again, the epidemic of the 21st Century can be
prevented and I firmly believe we can do it.

I thank you for the opportunity to share my point of
view and I would just tell you there is an extensive amount of
data available in the Department of Defense, far more than I
could present to you in this short time and probably I am not the
appropriate person to present it. We know exactly what it is in
the civilian applicant pool and we have investigators following
that. We know what it is in the Army and we have investigators
following that. The Navy knows what it is and they have
investigators following that. The Air Force knows what it is and
they have investigators there. The National Guard data is coming
in now. We are getting basically what the prevalence is in the
National Guard by state. All the Army Reserves now are also
being evaluated and all that is available, too.

70

 

 
 

 

I would encourage you basically just to make formal
requests through the Department of Defense to really get access
to all the data that is available. I don't even have access to
all of it. There is an extensive amount of information that is
available. Thank you very much.

MR. CREEDON: Thank you, Dr. Redfield. I think
everyone on the Commission would agree with the fact that there
is a problem. We certainly recognize there is a problem. We
think the appointment of the Commission itself is a
manifestation of the recognition of the problem by the President
and others. I guess the important thing is having recognized the
problem, what do we do about it. Do I understand correctly --
you feel there should be widespread testing outside of the
military? Is that one of the suggestions you would make?

DR. REDFIELD: I think the critical thing you are
trying to address today is what is the extent of HIV infection in
the United States. You would like to have that information
today. I sort of reflect the old idea, and you are a
businessman, if you could have as accurate information as
possible, you would like to have that information. I argue that
I think we have asked the wrong question. We have assumed that
we can't get the information. That has basically been the
debate, not that we don't need the information. Everyone agrees
we need the information but we have moved to modeling and
guessing and what our best guess is.

The recent reports to the President suggest that we
will have a family of studies that will estimate the prevalence
and incidence of HIV infection in our country and the answer will
be available in the year 1990. My position is that I really
think that if we are going to have an adequate national response
to this disease, not spend more money than we need, but not spend
less money than we need, not put our resources in the wrong
areas, the best way to ensure that we don't do that is to
actually define the problem and know it, and I believe we can do
that. Again, the first question is can we get it. You have
asked how. I think there are several methods. One is, and I
think it is really just a matter of time, that the medical
community will begin to promote the medical agenda, and in fact,
the practice of medicine will be such that many of these studies
of routine sampling in VD clinics and drug rehabilitation clinics
in different cities will be the practice of medicine, so we will
have that operational data. Right now, we don't have it so we
can design a family of studies. Eventually, I think it will
become the practice of medicine, most doctors will recognize
that they have the responsibility to accurately diagnose their
patients.

MR. CREEDON: Eventually might be beyond 1990.

71

 

 
 

 

DR. REDFIELD: Again, that is where we come to the
sample of studies. JI would make the argument that you have two
approaches. One is to basically do a sample of what I call high
prevalent/low prevalent groups, i.e., those individuals who come
into VD clinics, very similar to what the Centers for Disease
Control designed as their family studies, VD clinics, drug
rehabilitation clinics, hospital admissions. Those are
individuals in the "general population," that would be likely to
be the upper boundaries of the epidemic. Then you could also
sample in different counties individuals who have physical exams,
prenatal visits, football exams, and those could be the low

prevalence boundaries.

Where we have the debate is I think the President
could have this answer in six months, not in two and a half
years. The other way one could do it is even probably more
scientific, as you may argue that is a selective approach. I
think if the President of the United States said he doesn't know
if he needs to send a platoon to Butte, Montana and call up the
Guard in New York or vice versa. Some people say we have a big
problem. Some people would say we have a small problem. Some
people say the problem is just here, some people say the problem
is everywhere. I need to know to make the decision.

I am sure if he wanted to, and if he told the American
people he needed their help to decide how much we need to put
towards this virus and we did do a national survey and we did it
by a non-government agency and we convinced people on both sides,
and some people argue that people infected won't come forward, I
think if the President of the United States said, listen, this is
how we are going to decide how much money we are putting into
this, if you are called on by an non- government agency to donate
blood, totally anonymously so we can get a handle on it, do your
part as an American and help us understand what our defense
strategy for this virus will be.

I don't think the gay community won't come forward. I
think anybody who thinks they are infected would come forward. I
bet you if that was done, you would know right now what the
prevalence of HIV infection is in the United States, and we could
get some very talented epidemiologists to put the sample size
together, and you would know that answer in 1988.

. I think that is crucial and doable and I think one of
the debates has been that it is not doable. I can tell you that
if the President of the United States put it that way, listen, I
have a problem, I don't know how much to put into it, I don't
want to take away from these other important programs, but I
don't want to undercut this epidemic either, because I realize
the opportunity we have to confront this epidemic. As Dr. Primm
said, it is a window of opportunity that is closing.

72

 

 
 

 

I think the American people would come forth, all the
American people. Then you would not ask us to guess what we
think the epidemic is today, you wouldn't be forced to guess.
You would actually know. That's my position.

MR. CREEDON: How do the other panel members feel
about that?

DR. RUTHERFORD: I agree with Dr. Redfield on this
score. I think that a national serosurvey, a random household
serosurvey is the only way to answer the question. I point out
that in Mexico such a survey is going on now. They have enrolled
50,000 patients in six months and have 22,000 to go. Even next
door, it is doable.

DR. PRIMM: Those people who have come forward in
Mexico, are those people who have had high risk behavior?

DR. RUTHERFORD: No, it is a random household basis
survey.

DR. PRIMM: Strictly voluntary?
DR. RUTHERFORD: Voluntary.

DR. PRIMM: You don't think they would be influenced by
past behavior?

DR. RUTHERFORD: I can't answer the question directly.
I am just saying that as an example of a nation that has gone on
to try to establish these sorts of numbers, that is the kinds of
numbers they are dealing with. Those are the sorts of timeframes
they are dealing with.

MR. CREEDON: Dr. Sivak?

DR. SIVAK: I would agree also that if the proper
studies were developed, to avoid the great potential for
selection bias, this would really be the only effective way of
determining the extent of the infection in the United States,
rather than us sitting up here guessing with various models, you
would have firm information as to what the extent of the disease
is and prevalence of infection.

MR. CREEDON: Dr. Francis?

DR. FRANCIS: I agree. I think if the President took
the leadership and if this was done in a very positive way--that
this is a community problem of the entire American community, if
. not the world, and we are going to help, we are not going to
jeopardize you, we are not going to do all the negative aspects
that have gotten more air than the positive aspects about moving

73

 

 
 

 

ahead--this would be a critical move and would lead ultimately to
the leadership that we need to have a positive American type
spirit in the entire AIDS prevention progran, including serologic

surveillance.

ADMIRAL WATKINS: By that same token, Dr. Francis, we
have just had a report from the Centers for Disease Control, who
seemed to think they couldn't get there from here for a variety
of reasons. You are connecting that.

What is the problem between what you are all saying
here and what the Centers for Disease Control has just reported,
that they can't really do this until 1990? Is it bureaucratic?
Are there manpower obstacles in there? Is that what we are
talking about? Are we talking about attitudinal changes
necessary in the country to build the confidence that we can have
the anonymity and the concern for the human rights, the civil
rights aspect and protection of confidentiality, without
discrimination.

I am trying to come to grips with this. We are hearing
the words here and they all sound wonderful but the top outfit in
the nation comes forward and says, there is no way we can get
there from here until 1990 and we have to go through this
evolutionary process going through 30 pilot cities, we have to
have the updating of the family of surveys, and we want to run
three pilots just before we run our seroprevalence survey
nationally. We are confused now. What are you talking about?

DR. FRANCIS: The way I view it, if you went out there
today, whether it was a government program or non-government
program, government funded, private program, went out and asked
people to stick their arms out, we have very strong data in
California to show you are going to get a major bias toward low
estimate of prevalence for people who are known high risk not
volunteering for the program.

You need that leadership. That is true, if you did it
today, if we just took the millions of dollars it would take to
go out there and do that today, you would waste your money.
There is no doubt in my mind, because the spirit is not there
that this is something we are going to do for ourselves and as a
community of Americans moving forward, instead of a community of
Americans divided. Clearly, there are an awful lot of attitudes
from wherever it comes at high levels, but it gets an awful lot
of publicity that this is a divided country and we are not going
to move ahead together.

ADMIRAL WATKINS: Why would CDC make that
recommendation? Are they already factoring in their judgment
that the American people would not respond to that leadership?
Why didn't their recommendation say, Mr. President, with your

74

 

 
 

 

- leadership, we could doithis faster? ‘It ididn't. say that. I

don't really understand where CDC stands on this. If they are
already biasing their own report to the President by not taking
this into consideration, then it seems to me they have thrown a
variable in there that we don't understand. You have a whole new
variable thrown into their equation that I don't understand.

~ DR. FRANCIS: I would defer that to Jim Curran later.
Sorry, Jim.

MR. CREEDON: Dr. Fauci, could we hear from you on this
question?

DR. FAUCI: I agree completely that we need the kind of
data discussed just now by various members of the panel. I might
add that what we also need if we are going to tell the President
that this is the kind of thing we need--I ‘think we also need a
strong move towards what we don't have legislation to protect
not only confidentiality but the rights of individuals who turn
out to be positive, because what Dr. Francis said, if in fact you
can guarantee in statute, that an individual will not be
discriminated against, if in fact that person turns out to be
positive, and you would offer counseling, then you would have the
coming forth of individuals who would volunteer to take part in
these mass screenings.

If you don't have that kind of protection, people are
not going to come forward. I think all you have to do is look at
the amount of discrimination against the male homosexual
population in this country and IV drug abusers. You are going to
see the same thing, individuals afraid to lose their jobs, afraid
to get thrown out of school, afraid to lose their health
insurance. If you can guarantee that won't occur, I think you
can do it in six months. We need a law.

DR. WALSH: You are not going to guarantee that by
legislation. Legislation doesn't guarantee attitudes. I think
the point that the Admiral makes is a sound one to this extent,
that you have the example of the military giving us a rather
sobering report, while here we are getting publicly displayed
reports that rectal gonorrhea is down, so let's run a flag up,
everything is fine. That's misleading when one then hears what
Dr. Redfield tells us.

Were they misled by the fact that a certain high risk
group in a certain city has less rectal gonorrhea, yet we read
from Dade County or wherever it may be, that there is a 35
percent increase in sexually transmitted disease. Obviously, our
education program isn't working either.

I think what we are getting at is maybe the word
"mandatory" is a horrible word. I think what they do in the

75

 

 
 

 

military is what I call "conditional testing." In other words,
if you want to get into the Army, one of the conditions is you
have to take a test and you make a free choice if you want to

get in the Army.

Why not, if you are going to buy life insurance, if we
want to buy life insurance, the condition is we take a
conditional test, not a mandatory test. We can buy life
insurance if we are willing to do it. Instead, we get
legislation that is so heaped on this emotional latitude of
discrimination and so on, that we are going to protect the few
and jeopardize the many. Somewhere along the line, I think CDC
does have a real opportunity to create a proper climate for the
President and the legislators to do exactly what you want them to
do. I think that is what the Admiral is talking about.

MR. CREEDON: I thought Dr. Redfield's proposal was
this be completely anonymous.

DR. FAUCI: If it is completely anonymous, then what
you are going to have to have is the cooperation of people
wanting to get involved in a completely anonymous study. If you
can convince them that in fact they can trust that, then I would
be absolutely in favor of doing that study right now.

DR. WALSH: That's the answer.

DR. REDFIELD: If I could just clarify the position. I
think it is important about what you are trying to study. What I
think the President of the United States needs to understand in
how to mobilize the resources of this country, he needs to know
basically what the prevalence of HIV infection is in our country
by age, sex, race and geographic location. It doesn't need to be
a scientific study about the behavioral characteristics of
Americans.

What the President of the United States needs to know
now is simply what is the extent of HIV infection in age, race,
sex, geographic location and probably geographic location is
going to be of far greater importance than sex or race. I think
by doing an anonymous survey by a civilian, non-governmental,
private sector group, that we have talented people that could put
together a random sample of this country which we sell. If you
don't come forward, we are going to underestimate this problen.
I think that many people that say the government is not
responding to the AIDS epidemic will have to deal with that in
their own minds.

MR. CREEDON: Dr. Curran is here from CDC. Would you
like to make a comment?

76

 
 

 

.DR. CURRAN::. :I,want ‘to comment a little bit on the
process by which Dr. Mason and the rest of CDC and the National
Center for Health Statistics came to our conclusion that pilot
studies would be needed. It was not done based on our
presumption of the power of the presidency in influencing
Americans to participate in the survey. It was rather based upon
data that came from a pilot study of the health interview survey
in which some 50,000 Americans that were randomly selected are
being asked specifically now whether they would participate in
such a survey. The preliminary data is that only 67 percent of
them said they would do so on an anonymous basis.

This fundamental problem is not the ability to bleed
Americans. There are probably going to be 20 million Americans
bled this year, many of whom will be in the military, many of
whom will be blood donors, many of whom will be in family
surveys, many of whom will be tested in doctors' offices.

The question is how can we take that data and tell you
what the age, race and sex specific prevalence of the virus is.
The problem is that when you look at the populations that are
bled, you come up with different answers.

If you take the military applicant data and you
extrapolate it to the general population of the United States,
you come out with a number something like 300,000. All of us on
this panel would acknowledge that is far too low, because we
don't know what the extent of deferral from applying to military
service is. That is after doing 700,000 tests a year. The number
of tests done doesn't give you the answer.

If you take American blood donors, 20 million tests a
year, and you extrapolate that to the American population, you
come up with a number of 90,000 infected Americans. We know that
is wrong.

If you take hospitals and Job Corp applicants, we come
up with a number of something like 700,000. We think that is
closer. We don't even think that is right for a number of
reasons. Active intravenous drug abusers, for example, can't get
into the Job Corp.

The problem is you do need to know who isn't
participating in your survey and what their risk factors are
compared to who is participating in your survey and what the
risk factors are. We shouldn't confuse the use of testing for
prevention purposes, for insurance purposes, for health care
purposes, with the need for an absolutely fundamentally good
scientific survey.

A survey could be done very quickly. We could go out
and test 1 million Americans. I think it would be garbage. The

77

 

 
 

 

reason I think it would be garbage is we have had three major
consultation groups in of people who do these surveys and they
tell us there is too many uncertainties to know whether what we
got at the end was accurate or not.

What we want to do is get good information and do it as
quickly as possible. We don't want to do it as quickly as
possible and then find out whether it is any good.

MR. CREEDON: I think to some extent we will be
exploring this subject a little bit further after lunch.

DR. CURRAN:: I suspected you would. My tongue was
nearly bit in half.

(Laughter. ]

DR. REDFIELD: My only point is not for us to waste
American dollars, but I still think the ability of this President
to generate an understanding that we are all in this battle
together and that we need to define the extent of the problem and
he needs to ask for the help of the American people, if he only
gets help from 99.999 percent of the American people or even
less, I think you will have a better understanding of the AIDS

epidemic.

ADMIRAL WATKINS: Let me close out by saying, Dr.
Redfield, that one, I can assure you the President is on your
wave length. Back in May, he asked for this. In October, he was
shocked to find out we couldn't get the information on
recommendations from his best advisors for a couple of years. He
doesn't like it either. He wants to move and he is waiting for
guidance from somebody to say, this is the package, this is the
strategy we have to get that data, and this is what has to be
done and here are the obstacles to doing that.

That is why we picked it up as the first element in our
near-term interim report that we plan for February, so that we
can get through these hearings which are absolutely critical to
carry out the rest of our charter which cannot be done in many
cases for health care facility planning, for financial planning
across the board, that we are chartered to do, until we get this
information.

That is why we are working on this issue today. We
need to take what your recommendations are and what the general
consensus is and try to find the practical strategy to execute
that so we don't have the individuals that we talk to on the
street, and we have been out and I can tell you that many of
those people will not participate on the statement that we can
guarantee you anonymity at this point in time. The credibility
isn't there yet.

78

 

 
 

 

-f
How do we build that credibility is extremely

important. That is the strategy we are looking for, not the
rhetoric alone that gets to the bottom line before you can
transition and get the American people to believe that they can
have an anonymous test that isn't going to affect their jobs,
isn't going to affect their health care, the discriminatory
things that frankly people with AIDS tell us about in spades.

We can't sit here and say we can do these things and
have these people come forward. Then we will find out the survey
was inaccurate and that isn't going to help us either. How do we
get from here to there is the reason we are holding these
hearings. Those are the kinds of things we need to talk about.

I would like to close it out now, because we are really behind
schedule.

MR. CREEDON: I would like to ask Dr. Vogt from the
Vermont Department of Health to proceed.

PRESENTATION BY DR. RICHARD VOGT

DR. VOGT: Mr. Chairman, Commissioners, thank you for
the opportunity for testifying before you today. I have been
asked to provide you information about the accuracy of HIV
antibody testing in both high and low prevalence populations. To
review, there are two testing procedures used to attempt to
identify persons infected with the AIDS virus. The first
procedure is the ELISA test, which measures human
immunodeficiency virus antibody levels in serum. The ELISA test
was originally designed to be as sensitive as possible to pick up
all those persons who may have antibodies to the virus so that
there blood could be removed from the blood donor pool.

As a result, this test creates a significant pool of
individuals who may not have the antibody but test positive
anyway. Therefore, it is recommended that the blood sample be
reanalyzed with the ELISA technique to determine if the sample is
repeatedly positive. If a sample is repeatedly positive through
two analyses, the level of suspicion is raised that this may be a
positive test.

If the blood sample is repeatedly positive on ELISA,
the blood sample is subjected to another test, the Western blot
method. This is a very laborious and costly procedure which
identifies specific particles of the HIV antibody in a person's
blood, as is shown in the next slide. Each band shows a
reaction to the antibody to the specific components of the HIV
virus. Researchers currently feel that positive tests of both
the ELISA and Western blot should be considered as probable
laboratory evidence for infection with the virus. However, as we
shall shortly see, the accuracy of that determination depends on

79

 

 
 

 

who was tested. If the test is considered positive by the
testing laboratory, the person submitting the sample would be
notified of a positive test result, and the person is counseled
in the likelihood for exposure to the virus. Turning to the
accuracy of the HIV tests, all laboratory tests need to be
evaluated for their accuracy and are usually measured against the
comparison called a gold standard. When the ELISA test was
originally licensed, they were evaluated against patients who
have AIDS and evaluated against the Western blot test.

Most determinations about accuracy of HIV antibody .
tests are made by comparing ELISA with Western blot procedures.
Test comparisons with the recovery of the virus, the true
evidence of infection, are technically difficult and usually do
not enter into the discussion about test accuracy. One of the
dilemmas that confuses all discussions about HIV test accuracy
concerns the disagreement within the scientific community about
what constitutes positive Western blot tests. The next slide
shows the different criteria for test positivity by different
scientific groups using this test around the country. As you can
see, the bottom shows the Red Cross, DuPont, ASTHO, NIH, and the
others are reference for what may be considered positive for HIV.

Laboratories also use different preparations for
conducting their Western blot procedures. It is no wonder that
there has been a great deal of discussion about the accuracy of
HIV antibody testing when we have disagreement over the criteria
for the positive Western blot test. Most statements about
accuracy of laboratory tests are made in terms of two
determinations: sensitivity and specificity, as shown on the
next slide. The gold standard is listed at the top of the 2 by 2
square, and the test result is listed on the lefthand side. The
numbers of the tests for each category will be placed in the
respective cells.

The published sensitivities -- that is, C/A+C -- or the
chance of correctly identifying a positive test in those who have
AIDS, the specificities, D/B+D, or the chance of correctly
identifying a negative test in those who do not have AIDS, of the
ELISA test look fairly good. The range of published ELISA
sensitivities is 93.4 percent to 100 percent, and the range of
specificity ranges from 99.2 percent to 99.8 percent. There
were similar agreements when comparing the ELISA test with the
Western blot analysis.

When considering whether a medical test is meaningful
in high or low prevalence populations, you need to turn to two
adifferent measures of accuracy, as depicted on the next slide.
The comparison cells are the same as those used for sensitivity
and specificity determinations, but different equations are used
to determine a more important measure, predictive values.
Predictive values answer the following questions. What is the

80

 

 
 

chance that a person with a positive test is truly infected with
the virus? That is A/A+B on the slide. Likewise, what is the
chance that a person with a negative test is truly free from the
virus, D/C+D on the slide?

These are very important questions to be answered when
a patient wants to know the meaning of his test result. Whereas
sensitivities and specificities remain relatively constant with
both low and high prevalence populations, predictive values are
widely different, depending on the characteristics of the
population screened.

This stands to reason, because if you screen a
population that has no chance of being infected or inflicted with
a disease, all the positives generated from a test will be false
positives, since no laboratory tests or series of tests are
perfectly accurate. *

For example, you could test 1,000 men to see if they
were pregnant. The laboratory tests will identify a few that
will be test positive, even though there is no possibility that
the positive results will be accurate. In this situation, we
would refrain from testing an inappropriate population such as
men, so we would fail to generate erroneous information. We
need to consider the test accuracy with the combined procedures
of both the ELISA and Western blot tests. Sequential testing
will tend to further limit the number of false positive tests but
will not eliminate them. The number of false positive tests for
both ELISA and Western blot will still escalate when you screen
populations without much infection.

This is an exaggeration of testing errors that occurs
with any laboratory tests or sequences of test which tends to be
magnified in populations that are sparingly infected.

The next slide helps to describe the value of the
combined ELISA and Western blot analyses when they are used to
screen different groups. The likelihood of combined correctly
positive tests is depicted on the vertical axis. The horizontal
axis is the estimated infection rate in different populations.
Populations with a greater likelihood of infection will tend to
be further to the right on the horizontal axis.

Two assumptions for the sensitivities and specificities
of the two tests are given in the legend. The exact values do
not have that much importance; however, the curves that they
generate help demonstrate the principle that the value of
combined positive test results will deteriorate if they are used
to screen low risk populations such as those seeking marriage
licenses or routinely seeking medical care.

81

 

 
 

 

Looking at this situation in another way by using data
in an article published by Meyer in the New England Journal of
Medicine, the overall best estimate of the false positive rate
for the combined tests, the ELISA, first ELISA, second ELISA and
confirmatory Western blot is estimated to be one per 20,000
samples in that article. The article also states that
seroprevalence of a low prevalence population, such as female
blood donors, is also approximately one per 20,0000.

That means that for every 20,000 tests run, there will
be a total of one false positive test and one true positive test.
Therefore, half of all positive tests will be inaccurate when one
screens this population; that is, the positive predictive value
of the test is 50 percent.

Sequential testing presents another dilemma that often
fails to be addressed when HIV testing is discussed. Persons may
be ELISA test positive but Western blot test negative. It is
difficult to sort out whether the patient is infected, and the
result is frequently considered indeterminate. The likelihood of
an indeterminate result increases dramatically when populations
who are unlikely to be infected are screened.

Using strict criteria for Western blot positivity has
the appeal of minimizing the number of false positive results;
however, this will increase the number of indeterminate test
results as well. One can see that one runs the real risk of
generating inaccurate seroprevalence data when low risk
populations are screened. Even more importantly, one also runs
the risk of labeling someone positive who is not really positive
if widespread screening of low risk populations are undertaken.

The tests as developed are extremely useful when used
to screen appropriate populations; most notably, those persons
who are engaging in high risk behaviors such as intravenous drug
users and persons who are having unprotected sex with multiple
different sexual partners.

But the tests can and will fail when applied to
incorrect populations. Tests have to be close to 100 percent
sensitive and 100 percent specific to be applicable for all
groups. The ELISA and Western blot tests are not that accurate
for universal applicability.

Thank you.
MR. CREEDON: This is a very important discussion and
one which I, at least, have some difficulty with. If you test a

million people in a vulnerable group and a nonvulnerable group,
will the number of false positives be the same?

¢

82

 

 
 

 

ese pes POE RPT ET s
1 + *

v sO \

- DR. VOGT: When you say "vulnerable" and
"nonvulnerable", I'm sorry, I don't understand. -

MR. CREEDON: Well, high risk.

DR. VOGT: High risk groups? The number of false
positives, no, they will not be.

MR. CREEDON: The number of false positives will be
different?

DR. VOGT: That is correct. The number of false
positives will be far greater in your low prevalence population.

MR. CREEDON: Why is that?

DR. VOGT: It's a function of the testing scheme.
What you do, if we could go back to -~- if you could turn the
slide back on -- The estimates of high risk -- if you could put
people in the high risk category in the right-hand side of this
particular graph and low risk people on the lefthand side, you
can see the likelihood of coming up with an accurate positive
test dropping dramatically. The predictive value of the
positive test can also be equated with --

MR. CREEDON: I guess I don't understand why. I
understand what you're saying, but I don't understand why.

DR. VOGT: It's because you're generating so many
individuals and you have so few positive tests that you're going
to identify that the possibilities of having a laboratory error
increase dramatically.

MR. CREEDON: Why?

DR. VOGT: It is the situation -- if I may explain,
it's the same situation of testing 1,000 men for pregnancy. You
will have perhaps one, two or three individuals who will -- they
are at no risk for infection or affliction with the disease.
They will have one or two perhaps that will test positive under
those circumstances. Under those circumstances, 100 percent of
those individuals will be test positive and false positives.

DR. CRENSHAW: So what about women? How many false
positives for pregnancy? I think that's the point that you're
getting at.

DR. VOGT: In women, it's going to be a lot lower.
You're going to have a situation there where you're not going to
have the false positivity rates that we're talking about. We're
talking about -- I'm not an expert in pregnancy exams, but I use
that as an example. I would say that we're talking, depending

83

 

 
 

 

upon what stage of pregnancy you're in, in the vicinity of zero
to 5 percent tops.

DR. SERVAAS: Under that theory, could we ask Dr.
Redfield to explain in actual practice how he didn't have the
false positives? How is it that the Minnesota Blood Bank doesn't

have the false positives?

DR. REDFIELD: Again, it depends when you're dealing
with this in terms of how you set your criteria in terms of your
philosophy. The Department of Defense's philosophy is that
specificity of this test will be maintained.

If you want to say in your philosophy that you want to
maintain sensitivity at the expense of specificity, then I think
I could probably come up with data consistent with what was

presented.

The Department of Defense, in applying this test in low
prevalence populations, has developed an algorithm that maintains

specificity.

DR. WALSH: What is the difference between specificity
and sensitivity, please?

DR. REDFIELD: Basically, specificity -- sensitivity
is the ability in population -- Don's the epidemiologist. I'm
the clinician. If he wants to describe it, but it's the ability
in a general population to tell those individuals who are
infected that they are infected. Specificity is the inability in
a population to tell those individuals who aren't infected that
they aren't infected, and you look at the accuracy of that.

So that, for example, when we use sensitivity -- if we
wanted to say, okay, we wanted to make sure we picked up every
single person that was infected even if we knew we had some false
positives, we could set criteria that was more sensitive at the
expense of specificity. Or we could set criteria that is
extremely specific, recognizing the tradeoff is we lose a little
bit in sensitivity. As we've decided to go in to provide
test-linked education to low prevalence populations, we've said
that the critical thing to do is to maintain specificity at all
costs.

MR. CREEDON: Suppose we were going to test two groups
of a million people each, and we said we want to maintain
specificity? Would you get a different result in a high risk
group and a low risk group, given that criteria?

DR. REDFIELD: I personally don't think you would, but,
you know, again, I don't want to put myself off as an
epidemiologist. We have tested 6 million people. We have

84

 

 
 

 

assessed our false positive rate in the.low. prevalence
populations. We're not» ‘guessing what it.is. We've done it.

Again, I've told you that I will provide the testimony
of Colonel Burke that he provided before the Congress of the
United States. It was one in 135,000 when we basically assessed
it in our first assessment. We assessed exactly what it is.
Rather than debate what we think it may be, let's go out and
measure it. I do agree, though, without careful quality control
and criteria to maintain specificity, we could have a real
serious problem on our hands, and I don't think we disagree.
That's a fact of the case, and we need to get the specificity
into the program before we really expand outside. |.

ADMIRAL WATKINS: But, Dr. Redfield, you said earlier
that if we just got some leadership on this thing and got it
going and we calmed people about anonymity, we could get all the
data we need. Now we're saying that we're possibly not ready
because of the false positive problem that we may have, that we
don't have the quality control out there, and that we have to say
part of the strategy to get ready to do the very thing you want
to do may well have to be a reappraisal of where we are on the
quality analysis of the testing we'd be doing.

So you see, what I'm saying is we need to get out of
the rhetoric phase and into the specificity in this context of
what steps do you have to do to get to the point where we're not
going to shock a lot of people.

DR. REDFIELD: Can I respond? Can I respond, because. I
did have a response, and I didn't get an opportunity to do it. I
will provide you an outline of a program that really went to the
family of studies as is proposed in the document that went to the
President. The only difference was the time course for providing
the answer was six months as opposed to two and a half years.

I would like to just comment. From the time the
Deputy Secretary of Defense Taft decided that the civilian
applicants of the service would be tested for the AIDS virus, it
was six and a half weeks. He actually said it would start
October list. We all said it was impossible because the cost of
the test was too expensive. We couldn't quality control it, and
logistically it was going to be a nightmare.

All I know is on October 15th we did get a two-week
extension. By November we had tested the first 50,000 samples.
Within the next month, we were at a quarter of a million samples
a month that were being tested basically with a 24 hour
turnaround turn at less than $5 with an accuracy rate of 1 in
135,000.

85

 
 

 

So I agree, we need to do that. Where I debate it, I
don't think it's going to take six months. I think with
leadership it could come in place in six weeks to eight weeks to
12 weeks, and that's where I think the difference is.

MR. CREEDON: Dr. Sivak.

DR. SIVAK: I would just like to make a comment.
Included with my written statement was an article that Dr.
Wormser and I wrote about the predictive value of the test. In
there is a very in-depth explanation of Bay's Theorem, which is a
mathematical theorem to which all this information comes from.

Basically, the specificity does not change from group
to group. What happens is the proportion of individuals that
truly have the problem to begin with.

Considering the pregnant situation, 1,000 men who are
not pregnant obviously, if the specificity of the test was 95, 5
percent of those 1,000 men would be identified erroneously as
being pregnant, or 50.

Women who subject themselves to tests for pregnancy,
let's assume that 70 percent are, in fact, pregnant. We know
that by the gold standard of the crying baby nine months later.
Hence, there are only 300 out of that group of 1,000 who are not
pregnant. Five percent of 300 is 15.

So in two different groups with a different probability
of having the condition being sought to begin with, the
specificity doesn't change. The predictive value changes.

MR. CREEDON: That was the main point I was trying to
make. That's true.

DR. VOGT: Thank you for clarifying that.
MR. CREEDON: You said it better than I.

DR. FRANCIS: Again, to move away from the theoretical
aspects, none of us are laboratorians where we deal with them day
in and day out.

This is not a pregnancy test. The ability of these
refined tests using modern biochemical techniques to
differentiate between antibody negative and antibody positive is
absolutely phenomenal.

Now, you use a combination of tests, whatever
combination specific labs use, when you pool the data together
and they share their hard specimens, I think it's the consensus,
as I understand it from the laboratory people -- and I certainly

86

 

 
 

 

|

find it from the person who has to refer to the problem specimen
individually, if we're dealing with the individual -- that we've
got this refined now where, as Mike Ascher at the State Health
Department in California would say, the sensitivity and
specificity of this test have at this point exceeded our clerical
mistakes in the testing procedure.

I think that military experiences in those laboratories
that have done large numbers of specimens who have to really work
at it, because many of them at this point have to tell the
individual -- that's what Bob was talking about, making sure that
a positive is a positive -- they have to tell the individual the
result, so then you really have to know this because it's a very
important piece of information.

It's still an issue that you have to keep in mind, but
that is not the issue in my mind regarding either a treatment
prevention program or a serologic survey. If you get the right
laboratory doing these, we can tell you what's positive and
what's negative.

DR. VOGT: I think the key question is if you get the
right laboratory doing it. Right now, we don't have that
capability.

The other issue, too, that is often skirted in this is
that what do you do if you're going to set up your very strict
criteria for your positivity, what do you do with the ELISA
individuals who are positive and the Western blots who are
negative?

We really don't know what to do with that population.

DR. FRANCIS: We do in the laboratory. You add
another test to it, and you figure out your algorithm, and you
can find out who's positive and who's negative.

MR. CREEDON: This is very helpful. I guess what we
want to tell the Commission is that they're taking their own
lunchtime if they ask questions now.

{Laughter. ]

DR. WALSH: I want to ask just one question.

First of all, you know, there are multiple laboratory
tests that we do in medicine. I gather from what you say, this

is among the most accurate of all that we do in medicine.

If we applied your reasoning, we would abandon all
laboratory testing in general physical examinations. I mean, why
not?

87

 

 
 

 

Secondly, I would like a comment on the false
negative, because I think that's more important than the false
positive if we're going to combat this disease.

What is the incidence of the false negative? Isn't it
relatively the same?

DR. VOGT: Did somebody work this out? I have worked
this out using one of the JAM articles using viral recovery in
terms of --

DR. FRANCIS: You can't use that. The sensitivity is
too low.

MR. CREEDON: Dr. Sivak.

DR. SIVAK: Based upon a mathematical model again,
sensitivity and specificity does not change according to the
group that you're testing. What simply changes is the proportion
of the individuals in the group that are likely to be infected
before you test them.

Just as the predictive value of a positive test, in
other words, the likelihood that a positive test is truly
positive, goes up amid high risk individuals, the likelihood that
a negative test represents a true negative goes down in high risk
individuals.

In fact, in some high risk group members, the
predictive value of a negative test may be as low as 90 percent.
That means that 10 percent of individuals who are high risk who
are infected may be infected, but yet their test would be
negative.

If you test a low risk population, the predictive value
of a negative test, the likelihood that an individual who tests
negative is truly negative, is 99.999 percent. It's highly
accurate when the prevalence of the disease or the pretest
probability of the infection is low.

When you have prevalences as high as 70 percent, say,
in a test that's only 95 percent sensitive, in that population
specifically the predictive value of a negative test may be as
low as 90 percent, indicating that up to 10 percent of
individuals who test negative in that group are really positive,
and those negatives are false negatives.

DR. WALSH: Dr. Redfield.

DR. REDFIELD: Just to follow up, because what you see
based on that logic is that as the seroprevalence of the

88

 

 
 

infection goes up, the power that serological testing for HIV has
given us to basically allow people to know if they're infected or
not will begin to go down.

Again, one of my points that I try to make over and
over again is that the way we have approached this in the old
days is we define sort of a risk group. The risk group here, if
you're antibody positive for the AIDS virus, the person at risk
for being "seronegative" uremic is the individual who has had
sexual exposure to somebody who is basically infected with the
virus.

So I still make the point that serological testing for
the AIDS virus coupled with public health follow-up basically is
one of the mechanisms that we have until there is a scientific
solution to identify the seronegative uremic and to have some
handle on this "false negative."

MR. CREEDON: Ms. Pullen, Penny.

MS. PULLEN: First, I'd like to ask Dr. Redfield
whether he can be with us this afternoon while Dr. Curran is
testifying.

DR. REDFIELD: Unfortunately, I would love to hear Dr.
Curran's testimony, but we are having a program review today by
the Public Health Service, and I have to be back there.

{[Laughter. ]

MR. CREEDON: Each of the panelists is certainly
welcome to stay this afternoon because we will be involved in
related matters.

MS. PULLEN: I have another question, please.

Dr. Redfield, would you please provide us with a
county-by-county breakdown throughout the United States of the
infections that you have found in your testing of this low
prevalence population?

DR. REDFIELD: I will make the request of the
Department of Defense to provide that to you and give you the
updated data. I'm sure that they will provide that, and I will
provide that to you.

DR. SERVAAS: Dr. Redfield, you said that it was $4,
and you had two ELISAs and two Western blots in the Army and the
Department of Defense.

89

 

 
 

 

Now, Damon Laboratories, I believe, a commercial
laboratory, did this for that low cost when Dr. Vogt said it was

very expensive.

My question is this. If they are no longer doing
Department of Defense tests, isn't this perfectly good
organization available to do the surveys for that price if we did
enough of them? They are accurate, and we hear that in Minnesota
they have a good lab and in Iowa they have a good lab.

Could you tell us how many good labs are there
available if we wanted to do these surveys?

DR. REDFIELD: Again, I think that Admiral Watkins has
sort of jumped out at me there if we're not ready.

The point is I think that most laboratories could be
quality controlled to the level of the Department of Defense
laboratory within about six weeks of some effort.

It's something I think, when someone said let's do it,
it could be done.

The Damon Labs, please don't tell me they're not doing
some of our testing. We have multiple programs they're still
involved in.

But I think a number of labs could do it if you got the
standards the Department of Defense has developed. They work,
they're doable.

I think the other point, in follow-up, about the real
problem, when you're testing a quarter of a million samples a
month of more, it's not that the test is having any problems. I
agree with Don Francis. This is the best test that we've ever
had in Madison. It's the fact that our technicians or our clerks

make a mistake.

That's why the Department of Defense requires, before
someone's told that they are infected with the AIDS virus, to
have two separate samples drawn on two separate occasions. When
the first one is positive, they're not told they're infected with
the AIDS virus. They're told they have an abnormal blood test,
and we do a quarter of a million samples a month and we may have
made a mistake, and we now need to do another test. That test is
done, and the results are usually back within 72 hours.

So I think the technology is there. Again, ata
federal level, I think there has to be some oversight on the
quality control.

MR. CREEDON: Dr. Primn.

90

 

 
 

DR. PRIMM: I just wanted to ask Dr. Redfield a
question, since he won't be back here this afternoon, at the
expense of starving a little longer.

That is, isn't your testing of military recruits a bit
biased in this sense -- they have to have a certain education
standard, they can't be intravenous drug users, they can't be
homosexual or bisexual?

Isn't it also so that this is sort of creaming that
whole group when they come in to you initially? Isn't it also
true that if you look at the progressive age and seroprevalence
or seropositivity among that group, that if you looked at ethnic
groups, blacks and Hispanics, that it would be far different and
far greater in terms of what you have listed here on the
demographic characteristics?

DR. REDFIELD: My answer to your question is yes, it's
a biased group. In addition to all the other exclusions, you
have to actually have a high school diploma. That's why I think
relying on the military data basically probably underestimates
the epidemic in certain areas.

DR. PRIMM: That high school diploma has to be a
diploma, not a GED?

DR. REDFIELD: My understanding now is it's a diploma,
but, again, I don't set the program. It used to be an
equivalency, but it's a diploma. We would have to check on that
and get back to you. But I agree with you. It's a biased group,
and I think we underestimate the epidemic.

MR. CREEDON: Admiral Watkins.

ADMIRAL WATKINS: We are going to recess the morning
hearings now. We want to thank each one of you for coming. I
think it's been an extremely worthwhile exchange for us. As Mr.
Creedon indicated, we'd love to have any of you back this
afternoon, and when the level of intensity gets high and you
want to stand up, much like one of our esteemed candidates for
the presidency did the other night and as Dr. Curran did earlier,
we would hope you would stand up. You're also asked to be
continuing witnesses by exchange of correspondence with us.
We've asked you for certain information. We want to have the
dialogue between now and the time our report come out.

Remember, we're trying to get to the President with
some recommendations about prevalence, seroprevalence surveys in
the country, between now and February, so you have an opportunity
here to give us, a strategy that would take us through the very
obstacles you just mentioned. Dr. Redfield's comments are the

91

 

 
 

first time I heard it would take six weeks to straighten out
laboratories so we can feel that the false positive rate would be

within bounds.

You see, that's an element that we need to hear about.
So maybe if you have a plan that would get to the six-month
seroprevalence survey in the country, let's have the plan,
because we would like to review that.

So, please, we'd like you to continue the dialogue with
us, and thank you very much for appearing today.

(Whereupon, at 12:55 p.m., the hearing recessed, to
reconvene at 1:45 p.m. this same day.]

92

 

 
 

 

n - AFTERNOON SESSION —
[1:45 p.m.]

MR. CREEDON: I would like to call the meeting to
order, if we may. All the Commissioners are here except Ms.
Gebbie. We started the session this morning talking very
generally about some of the questions we are trying to get at
through these series of hearings today and tomorrow; really
pretty basic questions such as how many people have the virus
now? How many do we think will have it between now and the year
2000? How reliable is the data on which the estimates are made
with respect to the incidence of the virus? How reliable is the
data on the estimates of the way the disease is likely to spread?
How many who have the virus will develop some form of AIDS or
other kind of medical condition requiring medical care and
attention? Who are the vulnerable groups, the at-risk groups,
and are those groups growing or diminishing in size? To what
extent has the virus spread to the heterosexual community other
than partners of IV drug users? What are the stages of the
disease and the time periods between when the virus is incurred
and.the various stages take place? Are we doing enough as a
society to find out about the virus? Do we need to do tests
other than those that have been done or are being contemplated?
Recognizing that there are conflicts and differences of opinion
and that the situation is fluid and complicated and so forth,
what about testing? Is testing reliable? Should we test large
portions of the population that have not been tested and so
forth?

These are the kinds of questions that the Commission is
trying to form a judgment on, and we very much appreciate each of
you being here and helping us out. I think this morning, while
there are necessarily overlaps and conflicts between and among
the different categories this morning, we've tried to focus more
on the data base quality and the staging of the disease, and I
guess the people with us this afternoon are public health
specialists. But we recognize that this is not tightly
compartmentalized, and is overlap, as Dr. Curran recognized this
morning, between at least two other groups. So if we may, Dr.
Curran, we'd like to start with you. The process will be to
have each person giving testimony speak for such time as he or
she would like, and then we'll have some questions from the
Commission.

PANEL TWO
PUBLIC HEALTH PERSPECTIVE/FUTURE TRENDS
PRESENTATION BY DR. JAMES CURRAN

DR. CURRAN: Thanks, John, Mr. Chairman, Commission
members. It's my privilege to be here today. You could tell I
could hardly wait to speak and came early. I'd like to

93

 

 
 

 

congratulate you on your preliminary report, and what I've seen
in the press about it and a lot of the language that gives
confidence to all of us that you've got your priorities in good
shape. I'd like to thank you for making incidence and prevalence
of infection a priority and congratulate you for making
intravenous drug abuse a priority, I'm sure over the strong
objections of Dr. Primm. I'm going to say one sentence about
that, and that's all, and that is that intravenous drug abuse is
at the very root of our epidemic in heterosexual men, women and
children in this country. The concern, if we have one, about the
heterosexual population has to begin with intravenous drug abuse.
You've got the priority straight, as far as I'm concerned.

What I'd like to do in a few minutes here, since I know
that all of you have the President's report and virtually no one
else in the world does, is provide you with a few charts that
I've organized in a way to go through rather quickly; say a few
words in preparation of looking at these reports; and answer
three things that came up this morning that I wanted to mention
that won't be answered by going through the reports. First of
all, I think there's some confusion in all of the discussions --
many of the discussions that’ I've been involved with in the last
few years about AIDS. Because of the amount of concern about the
problem, which is appropriate, people are always looking at half
empty glasses and half full glasses, and it is very difficult to
say something is half full and half empty. So you usually end up
with a lot of people telling you it's empty and a lot of other
people telling you it's full. That's going to happen and I'm
sure it's happened already; but what is being done, what is not
being done, and what do we know and what don't we know about the
extent of the problem in the United States? I would like to say
that I think we know quite a bit about it already and that we're
on the right track to learning what we need to know.

The second thing is the issue of what are the key
questions. Let me just reemphasize them from what you've said.
The key question is not only how many Americans are currently
infected with the AIDS virus, how many of them will progress to
AIDS, but how many Americans will become infected with the AIDS
virus. That is something that is a very, very difficult thing to
know. It's a little bit like projecting the economy for the year
2000. It's going to depend upon the behavior of Americans, among
other things, over the next 15 years. The fundamental thing that
is going to determine how many people get AIDS after the year
2000 will be how effective we as a society are in preventing the
virus infection between now and then. I think the incidence
question and how effective are current programs and evaluation of
behavior changes are really what really gnaws at all of us in
terms of what we need to know. No modeler who is honest or no
epidemiologist who is honest is going to say the glass is all
full in terms of what we know. It's very, very empty in terms of
what we know about behavior change, our ability to create

94

 

 
 

behavior change, our ability to deal with things like heroin
abuse in our society, et cetera, et cetera.

We do know, I think, fairly well, how many Americans
are currently infected, and we will be on track to learning an
awful lot more through the surveys that are proposed and under
way in many communities throughout the country. The last thing
is that I'd like to stress -- well, first of all, let me run
through a couple of quickies. The TB situation in New York City
is very important, and I wanted to alert you that this week in
the MMWR there will be a report from New York City on
tuberculosis and AIDS in that city. It will be coming out
tomorrow. Actually, it comes out today. Tuberculosis is up 35
percent in New York City over the last two years, and this is the
first year in the history of my life when there has been an
increase -- last year was the first year there was an increase in
tuberculosis nationally. Almost all of that increase can be
attributed to HIV infection in Florida and New York where the
biggest TB increases have occurred. So that is a very important
problem that Dr. Primm brought out, and there's a report on that
in the MMWR this week. The next thing is that the report that
many of you have referred to will also be published next week in
the MMWR and will be available to virtually everybody then. We
are scheduling the Christmas breaks to try to get it out, but
that will reach 100,000 health professionals and others. The
second to last thing was the issue of the case definition. You
are faced with many different classification systems for
infection. AIDS surveillance is aimed at reporting as honestly
and accurately as possible the severe morbidity and mortality due
to HIV infection. That is something which is much more easy to
get at because it results in hospitalization, it results in
death, you can validate that with death certificates and things
like that.

The word "ARC" has never been defined by anybody. It
means something different to everybody, and no honest
classification system even contains it. So when you even ask the
question does this contain ARC, no one can answer because no one
knows what ARC is. ARC means AIDS-related conditions. Severe
ARC is included in the new case definition that CDC puts out;
that is, the severe weight loss, wasting syndrome and someone who
has evidence of infection with the virus. Our attempt with the
consultants that we had in was to capture everything that results
in death or severe hospitalization morbidity that can be
attributed to AIDS. How well did we do that? Well, the main
breakdowns are the places where the medical system breaks down or
reporting breaks down. It's not a function of case definition.
The case definition is pretty good in capturing that. The
problem is people like drug addicts who die in the streets of
unexplained pneumonia. In New York City, a recent report from

95

 

 
 

 

Dr. Stoneburner saying that mortality was up in inner city drug
abusers who didn't go to the doctor who couldn't have been
diagnosed with AIDS to begin with.

The second problem is the fatigue in reporting. The
same health departments and the same doctors that we've got
putting everybody on AZT and taking care of them and being
concerned about their social and medical welfare are the same
ones that are reporting. Now we're going to be asking those same
people to do our serosurveys. We're right in our priorities, but
we can't expect surveillance of AIDS and reporting of AIDS to be
as good as it has been in the first six years. This year, we're
starting to see longer reporting lags and less adequate
reporting, and we have ways, we hope, to deal with that. The
last thing is the question of test reliability. That has to be
broken down into two things: the test itself and how well it's
performed. I think Dr. Vogt and others gave very good examples.
Dr. Sivak gave a very good example of how good the test can
perform when it's done by very good laboratories, and most of the
tests had been performed by very good laboratories. When you
consider there have been 40 million blood donations tested in the
United States, six million military people, millions of people in
the private and public sector and relatively few problems about
the test itself when it actually gets back to the patient, then
things must be done well in those good laboratories. However,
not all laboratories are good, and not all batches of the tests
have the same reliability. It's important to continue to
evaluate laboratory performance. CDC has a laboratory
performance evaluation program, and we now have 750 laboratories
in the program. All of the laboratories that are involved in
public testing and counseling can be involved in this and are
encouraged to be involved in this program at the CDc.

In addition, all the laboratories involved in this
family of surveys will be involved in this. The answer to this
at the back end is Dr. Walsh's answer. It's up to the doctor.
That's one of the key problems we have in prevention and control
of AIDS in the United States. We have a test. We test somebody
and, unlike the military where everybody is guaranteed a doctor
because they have guaranteed medical care, when you test somebody
in another circumstance, there may not be a doctor to be the
final bottom line. This is not something that the laboratory
should decide. It's like a positive VDRL. There are a lot of
positive VDRLs for syphilis. When you have one, you don't go to
the laboratory or get a letter and say should I commit suicide or
shouldn't I and have somebody go back to the lab and tell you.
You go back to your doctor, and your doctor helps evaluate
whether you might be infected, whether auxiliary tests are
needed, whether testing is to be repeated. A lot of drug abusers
and others don't have such doctors. So, ultimately, there needs
to be a doctor for all the positives and probably for a lot of
the negatives. That's a fundamental problem in our lack of

96

 

 
 

 

distribution of adequate available medical care for the people
who are infected with the virus.

Now, let me get to what I was going to say, and that
was to go over is the issue of several epidemics. One of the
things that's very confusing to try to talk about is that we are
obviously looking at several epidemics when we're talking about
AIDS. There's the epidemic of AIDS, which looks like the numbers
of reported cases in your first chart. We know that that's not
the epidemic of HIV infection. The easiest way to conceptualize
this is to think about hemophiliacs. You can change the scale a
little bit, but we know that hemophiliacs are essentially not
being infected with the AIDS virus at all anymore. There might
be a case report here and there, but essentially there is no
epidemic of HIV infection in hemophiliacs. But the curve of AIDS
looks like this, so we know that in hemophiliacs, this tells us
absolutely nothing. If the United States epidemic of HIV were
like hemophiliacs, then you wouldn't have any kind of prevention
message. All you'd have to worry about is treatment and health
care and things like that, caring for the families and
transmission to sex partners. So we know that we're not
measuring the epidemic of HIV infection when we look at AIDS.
That doesn't mean that it's not useful. It's extremely important

to look at from the point of view of health care. It's extremely
important to look at and compare to what we know about incidence
and prevalence of HIV to see if there are any big surprises. If
there aren't big surprises, then that can be reassuring in a
sense, but it is a different epidemic.

The second epidemic is the epidemic -- the differences
in epidemics are differences by risk groups. What is the
epidemic of HIV infection in homosexual men? What is the
epidemic of HIV infection in San Francisco homosexual men versus
Chicago homosexual men and homosexual men with a graduate degree
and homosexual men who have no high school education and black
and Hispanic homosexual men and white homosexual men, 40 year
olds, 18 year olds? What is the epidemic in intravenous drug
abusers? What is the epidemic in sexual partners in heterosexual
men and women?

Finally, there are going to be differences in
geographic areas, different epidemics by city and by state. The
ratios that Dr. Sivak talked about were derived from New York
City primarily for New York State, but they're obviously going to
be somewhat different in different communities where the
infection came later and AIDS has not caught up as much. That's
analogous to saying that the changes that he describes over time
are differences throughout the country geographically. You could
say that the epidemic in the midwest started a few years later
than the epidemics on the coast, for example, to be simplistic
about it. With that, let me run very, very quickly through these
charts that were meant to accompany the report. I think they are

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part of the report but some of them aren't. The first refers to
sources of information of data on AIDS cases and HIV infection
for the report. I'd like to point out that as much published and
unpublished information as could be found was put into the
report, and the information was not largely CDC information. It
was collected by CDC, the Alcohol and Drug Abuse Administration,
NIH and by state and local health departments. Most of the
information was not published and was shared very generously by
the people who did it. In addition to national reporting of AIDS
cases, there are surveys and studies in high risk and general
population groups. They will include STD clinics, drug treatment
centers, hemophilia treatment centers and a variety of sources of
information down the line there.

The next graph is an epidemic curve of reported AIDS
cases. To date, there are now 48,200 cases of AIDS reported;
approximately 20,000 cases in the past 12 months alone. Now, of
that 48,250 cases, about 2,200 fit the revised case definition of
AIDS. That doesn't mean that the 2,200 were all diagnosed since
September 1, however, because many of these are backlog cases
which had been reported to CDC previously and which had driven us
to change the case definition to begin with. But we are keeping
very good track whether cases fit the old case definition or the
new case definition so that we can tell that.

The next graph is the so-called coolfont curve, in
which yellow represents the numbers of cases projected based upon
projections from previously reported cases. From that, it was
estimated that there would be 270,000 cases diagnosed and
ultimately reported through 1991. You can see by the black dots
that the black dots are still within the 68 percent confidence
bounds. They are about 5 percent lower than would have been
predicted in the past 16 months but still pretty close.

The next graph is curves of males and females with AIDS
Now, the female curve is made larger so that you can display it,
but basically 92 percent of cases are still reported in men, and
you can see from this that in both groups, the 20 to 50 age group
is most often affected. But if you look down you can see that
the women are about five years younger on average than men. That
has several implications. One, I think, relates to the fertility
of the women. Since they are quite a bit younger, that puts them
smack in the middle of a very fertile age group for having HIV-
infected infants.

The next graph is a pie chart of the race specific
percentages of the U.S. population in the 1980 census as well as
the race specific percentages of AIDS patients through November
2nd. You can see basically about a two and a half-fold increase
in the crude percent for blacks over the population estimate and
about twice as many two and a half-fold also in the Hispanic
population. I will discuss this briefly later. The next graph

98

 

 
 

is the Venn diagram by transmission category of AIDS cases
through the first 44,000. I think there's a few things
remarkable about this, having shown this Venn diagram now for
about six and a half years. I can say that it hasn't changed
very much over the six and a half year period. Most of the
patients with AIDS have been homosexual and bisexual men who are
not intravenous drug abusers; the intravenous drug abusers have
remained a very steady one-sixth in the heterosexual intravenous
drug abusers and about 10 percent of the homosexual and bisexual
men have such a history.

Another way to look at the issue of heterosexual AIDS
is to remind ourselves that everybody who isn't homosexual or
bisexual is heterosexual. That means that 27 percent of the
cases are heterosexual men and women. You can see that in the
heterosexual men and women group, the vast majority are
intravenous drug abusers. That should tell you about where the
heterosexual epidemic is now and where you should look for it to
go first and why we're seeing such high rates of infection in
pregnant women in cities where intravenous drug abuse AIDS has
been a problem. It is not at all surprising to me to see 1 to 4
percent prevalence rates among pregnant women in cities like New
York City, Baltimore, Atlanta, and people shouldn't be surprised
about that. Nor is it surprising to see high rates in minority
military applicants from those same cities where there is an
enormous problem of AIDS in intravenous drug abusers.

The next one is a state map of AIDS cases. I'd like
for you to look at the next two at the same time. I want to
apologize for having different denominators. I did that mostly
to confuse you. The AIDS case map is the cumulative numbers of
AIDS cases per million population. The second map is the
prevalence of HIV antibody in civilian applicants for military
service in the United States. The Department of Defense has
worked very closely, has been very, very generous and worked very
closely with CDC in providing up-to-date information on the
prevalence in military recruit applicants. You can see by these
maps that the states that have the high rates of AIDS also have
high rates in military recruit applicants. There's no surprises
from these maps. Generally, if you were to make this per million
population, the national average is about 200 per million for
AIDS, and it's about 1,500 per million for military recruit
applicants, about seven times higher.

Military recruits, as Dr. Redfield says, represent an
absolute bottom line low estimate of the number of infected
Americans. So we can put military recruits as the absolute
bottom line estimate of infected Americans at around 350,000.
It's got to be higher than that, and I could make the point that
it's got to be higher than 2.5 times that high. It cannot be
lower because these people are self-deferred from even attempting
to get into the military to begin with. But basically, you can

99

 

 
 

 

look at the ratio by state, by city, by county and not only get
the number of HIV antibody positives by age, race and sex for a
county but also the numbers of cumulative AIDS cases by age, race
and sex by the county. The key point that we make in a
collaboration between state health departments and the Department
of Defense and an outside contractor will be to determine what
risk factors the military recruit applicants have. This is
really not adequately known yet. It's irresponsible, in my view,
to conclude that they all acquired it through heterosexual
contact, or most of them did. It's also irresponsible to
conclude that none of them did or that we know. We simply do not
know. That is a very high priority for determining. There have
been selected studies, but nothing on a national basis yet.
That's sitting around OMB now waiting for clearance.

The HIV prevalence among Red Cross blood donors is the
next chart, and this shows the difference between the rates in
all donors and the rates in first time donors. You can see that
the rates in all donors have steadily declined from about 4 per
10,000 or .04 percent down to what is now about .015 percent.
This has been largely by the cleansing of the donor population;
repeat, donor population. The first time through you get all the
positives out, and you tell them not to donate again, and then as
all people who donate blood know, they keep your name and they
get a hold of you, and they keep getting a hold of the negatives
over and over. So 80 percent of the donors on a given basis are
repeat donors. One would expect them to have a much lower rate
after they've been screened a couple times. You can see that
that's encouragingly getting lower. The first time donors are a
better estimate of what's going on in donor deferral and what's
going on in the other population. You can see that bounces
around a little bit, probably related to changes in donor
recruitment for employment purposes and summertime when it goes
up for hepatitis and other things when everybody takes their
vacation and they have to go elsewhere to get blood because the
companies don't have as many donors, things like that. It's not
totally known, but these rates are very, very low, at any rate.

The next two surveys, I want to mention very quickly.
This is the numbers of surveys and studies from which CDC was
able to obtain data on antibody prevalence in homosexual and
bisexual men. This represents some 25,000 or 30,000 homosexual
and bisexual men and shows a range with most in the 20 to 50
percent level. It's important not to just average those surveys
out and say that's the average of the country de facto. But in
homosexual and bisexual men, that's less of a problem because
there's not that much difference in the country. But in
intravenous drug abusers, there's a big difference, and the next
chart I want to point out is misleading. The largest number of
surveys in intravenous drug abusers would suggest that the
prevalence in 33 surveys is between zero and 4 percent, and
there's very few in the 30 percent and above category. Now,

100

 
 

 

don't be misled to think that most intravenous drug abusers
aren't infected, because the first cities to do the surveys and
the first cities to recognize the problem were cities like New
York City, Washington, D.C., Baltimore and New Jersey and San
Juan, Puerto Rico, where probably 75 percent of the heroin
abusers in the country live. They did their surveys.

Everybody said, hey, we better find out what's going on in our
population in 1986 and 1987, and the cities where there's a much
lower rate of infection came in later. So if you were to weight
these by the numbers of drug abusers that each survey
represents, you'd find a much higher rate of infection in
intravenous drug abusers. I think cities that have a 5 percent
prevalence in IV drug abusers have an opportunity, but they
shouldn't be all self-congratulatory and say, well, we only have
a 3 or 4 percent infection rate per year. Ask Dr. Primm and
others in New York City what the hell they're going to do when
it's 50 percent and try to prevent it. When you have 3 to 5
percent, you have an opportunity, but it's going to take a real
concerted effort to deal with it.

The next chart is a comparison of what the intravenous
drug abuse problem largely means to blacks and Hispanics. You
can see that looking at the epidemic of AIDS cases and the
epidemic of HIV infection, there would appear to be a difference
in the relative risk for intravenous drug abusers. Let me
explain that in those tested, in those populations tested for
HIV, you can see that blacks and Hispanics are 3 to 12 times more
likely to be infected with HIV. With AIDS, it is as high as
25-fold for children of IV drug abusers, sex partners of IV drug
abusers or for heterosexual IV drug abusers themselves. That's
factored in by multiplying the difference in prevalence among,
say, black IV drug abusers compared to white IV drug abusers and
simply the number of IV drug abusers in the black community and
the white community. I guess what I'm saying is that IV drug
abuse itself as a societal problem is a disproportionately black
and Hispanic problem, and the rates of infection are also higher
in those groups. You multiply them together, and you have a very
serious problem in black and Hispanic minorities. The next graph
is pretty but also confusing. It's got a lot of purple bars
around the United States.

To summarize this, this summarizes the prevalence in
homosexual men, IV drug abusers and hemophiliacs around the
country. It shows that the hemophiliacs are all about the same
everywhere, and that's because they all became infected the same
way, through national distribution of contaminated products for
about a five-year period from the late '70s to early 1980s. So
one would expect them to have about the same rates throughout the
country. Homosexual men, there's about a two-fold difference
from about 20 percent to maybe two and a half or 50 percent
around the country; not as big a difference as there is in IV
drug abusers where there's a massive difference, but the East

101

 

 
 

 

Coast cities and San Juan, Puerto Rico, have very, very high
rates of intravenous drug abuse positivity, high prevalence
rates. The western cities like New Orleans and others, again,
have very low rates now. But that's not likely to be true

forever.

The next chart is a summary, a very quick summary, of
the HIV prevalence in high risk and general population groups.
Now, the prevalence in the general population group should not be
confused to saying that we know how those people got it. When
you interview first-time blood donors, for example, who represent
the .04 percent, you find that about 85 to 90 percent are
homosexual men, intravenous drug abusers or sex partners of one
of the above. So that even that low prevalence rate does not
necessarily represent random unexplained spread.

The next graph is another somewhat confusing curve of
what we know about HIV incidence. Now, again, the number of -
people becoming infected with the AIDS virus is one of the most
difficult things for any of us in public health or epidemiology
to determine. I call it the epidemiologic equivalent of finding
a safe and effective vaccine. I do that on purpose because it's
almost impossible to know on a national basis. People don't have
symptoms. All they do is sero convert. They don't go to
doctors, and you sort of have to be there to watch their
antibodies come up on an individual basis. We can get that from
the cohort studies. From the large cohort studies in homosexual
men, there's evidence that in those cohorts who are being
followed and who are not necessarily typical of other homosexual
men, there's been some consistent declines that have been
measured. On the one hand, you can say the cohorts are not
typical. I think the pattern is encouraging that they all show
declines. On the other hand, you can say the so-called Hawthorne
effect is what we want. That's the kind of attention we want our
prevention programs to give. We want people to be in cohorts,
followed and counseled to change their behavior. So even if it
is atypical, let's do more of it. It doesn't have to be a
million dollar study. You don't have to draw blood every week,
but you could do the same kind of tender loving care that gets
people to have this kind of infection rate. Now, it's still not
down to very low. Three percent, on average, is not low enough.
If I had a 3 percent chance of getting AIDS virus infection this
year, I'd think that was terrible. So I don't think anybody in
the gay community or anybody here ought to say that's good
enough; nor is it representative of all the subepidemics that I
talked about, black and Hispanic minority, homosexual men, young
homosexual men, people who haven't decided whether they're
homosexual yet, et cetera.

The next table represents a smattering of the so-
called surrogate information, and this is primary and secondary
syphilis rates in homosexual men from 1980 to 1987 in six cities

102

 

 
 

 

in the United States. It shows, comfortingly somewhat, that
syphilis rates are down in homosexual men in all of the cities.

I used to run the program in Columbus, Ohio about 15 years ago,
and we had lots of syphilis in homosexual men. There was one
case in 1987. So people working in the field are speaking
empirically. They're saying, hey, wait a minute. I was involved
in a Hepatitis-B vaccine trial in San Francisco also, and in
doing that, I went out to the San Francisco Health Department VD
Clinic, which had the very highest rates of Hepatitis B in the
entire industrialized world in homosexual men. Seventy-five
percent were infected. The thing was conducted in the VD clinic
there, and they had 400, 450 patients a day. You couldn't get in
the place. They had to move to a much larger building. I was
out there about three months ago, and there's nobody there. The
clinic is almost empty. People are not getting VD in these
communities.

You can say is this an education campaign? Does it
result from simply being absolutely scared to death and watching
all your friends die? But many people in the homosexual
community have changed their behavior. It's been replicated
throughout the industrialized world. Everybody hasn't. I'm
concerned particularly about adolescents and about minorities,
homosexual and bisexual men, and I'm also concerned that 3 to 4
percent a year is not low enough. But the glass is at least half
empty in this regard.

The next three tables represent the estimate of
infected Americans done in two ways. The first table was the
Coolfont estimate, which takes arguably bad data about the size
of the population groups. No one has any idea how many
homosexual men there are in the United States, but that isn't the
only important question. The question is how many are homosexual
and are acting out in their homosexual behavior with someone else
who might be infected. That's the true denominator. But these
were the best estimates in June of 1986 of the experts that were
assembled, and that's where we came out with the one million to
one and a half million estimate. This has been scrutinized in a
variety of different ways. Using the same method, taking the
best prevalence estimates from the 300 or so surveys that are
summarized in the report, you come out with a number that's about
the same in 1987. What that means is, on the second chart, that
1.5 million was too high in June of 1986. It doesn't mean that a
million was too high in June of 1986, but we believe that 1.5
million was too high in June of 1986.

The last chart, I'll just explain -- you can sort of
ignore the numbers except to notice that they go from 276,000 to
1.5 million. This represents the ability of modeling to tell us
the number of infected Americans. There are now something like
60 to 65 scientists throughout the industrialized world again who
are actively involved in scientific modeling of HIV. They will

103

 

 
 

 

do that no matter how definitive our numbers are, and they will
continue to help talk about spread and things like this. These
three models, these three curves, the logistic curve, the log
logistic and the exponential curve, all fit reported case data
very, very well. They're all compatible with what's happening
with AIDS. In predicting the number of infected Americans using
these three models which all fit, you can see the range goes from
276,000 to 1,650,000. The major reason for that is that
virtually nobody gets AIDS in the first two years or three years,
so none of these models can tell you who's been infected since
'84 or '85. In fact, isn't that the question we really want to
know most? Who's getting infected now?

So the models may be able to help you, and it might be
somewhat reassuring that they come out 1 million to 1.5 million
when you use the best estimates, but they're only telling you the
point prevalence, and you know that they're telling you nothing
about how many people have become infected, which is a very
important point. The last table is the comprehensive HIV
surveillance plan that CDC is conducting with the nation's state
and local health departments. These will be concentrated in 30
standard metropolitan statistical areas. Lest you think that
this is a small 30-city survey, let me remind you that these 30
SMSAs have about 80 million people living in them, and they
account for about 85 percent of the reported AIDS cases in the
United States. So there's a lot of places we aren't sampling,
but the top 20 cities in the country have about three-quarters of
the cases. So we're getting a lot of the places where the
problem currently is. The intention is to blanket these cities
with a large variety of surveys which will allow the people
concerned about public health in those cities and in those states
to develop their programs and conduct them.

The last thing I'd like to say about these serosurveys
is they do far more than come up with a number. They get people
to take the problem seriously. Atlanta, Georgia, at a hospital
in Atlanta, Georgia, people had a couple cases of pediatric AIDS.
The director of OB/GYN there did a very bold thing. She decided
she would offer routine testing and counseling in her prenatal
population. A lot of people for a variety of reasons are afraid
to test pregnant women and tell them their results because
they're afraid of trying to deal with the positives. They don't
know what to do. Well, this director of OB/GYN found that 1
percent of the pregnant women were positive. It only had three
or four cases of perinatal AIDS. Now all of a sudden she knew
that 75 women would be delivering babies who were positive that
year in her hospital. It forced a lot of things to happen--
education of the doctors and nurses in her hospital to protect
themselves from infection; consultations with the family planning
clinic to say, hey, why didn't we stop them from getting pregnant
or give them advice and do some testing in your clinic before
they reached our clinic. So these surveys which will result in

104

a

 
 

 

testing of 1.6 million very high risk people, a lot of whom don't
have any idea that they're at risk or aren't infected, is going
to drive a lot of public health action, and it's going to drive a
lot of positives into the health care system. There's going to
be a lot of people here who need doctors, who need medical care,
who need hospice care, and a lot of these people are going to
need drug treatment. So these surveys are going to do more than
just tell us where the problem is. They're going to lay it in
our lap.

Finally, the last page is propaganda. This is a
chronology of major events specifically focused on those that the
Public Health Service has been involved in over the last six
years, beginning with the first cases that have been reported,
the discovery of the virus and a few other things. Thanks. We
probably don't have any time for questions.

[Laughter. ]

MR. CREEDON: In the discussion this morning with the
panel that was here, Dr. Redfield from Walter Reed seemed to
think that the best way to find out how many people have the
virus would be to do, I guess, a nationwide survey. What is your
reaction to that in relation to what CDC is proposing as outlined
here?

DR. CURRAN: It's partly a question of terminology. We
are doing a nationwide survey. I consider doing 30 surveys and
30 SMSAs a nationwide survey.

MR. CREEDON: I assumed that they knew --

DR. CURRAN: There will be a national random
probability sample household survey. That is also being
undertaken beginning with the request for contract in the next
week to go to an outside contractor, a nongovernmental
contractor, to look at the feasibility of that. In my view, what
will happen with the national probability sample is two things.
One is that we will find that there will be some
nonparticipation, and we hope with the pilot studies to find out
whether the nonparticipants are more likely to be infected than
the participants. If we can do that and proceed with the study,
then we will have a decision to make about how much money we want
to spend on it. If we want to do a study of, say, 50 to 100,000
Americans an@ if we got even a 100 percent participation and
everybody was infected, and let's say the true number of infected
Americans is one million, the confidence intervals around that
million would be about three-quarters of a million to 1.5
million. So you can see the problem we get into. If you want to
narrow that range from a million to 1.5 million to, say,
1,200,000 plus or minus 50,000, you're going to have to test
about 300,000, 500,000, a million people in the United States at

105

 

 
 

 

rs |

the cost of perhaps $500 each. Now, if you're going to test that
many people --

MR. CREEDON: Why? Dr. Redfield said it was costing
them $5.

DR. CURRAN: It costs them $5 for the laboratory part,
but he's already hired the doctors and nurses and interviewers
and the people --

MR. CREEDON: Maybe we could get the Army to do it for
us.

(Laughter. ]

DR. CURRAN: They don't have a good reputation in the
gay community. But you're right, though. Maybe we could
discharge the people in the survey into the Army for medical care
would be a way to do it. I think the Army program is very useful
from telling us how many infected Americans there are, but it's a
low number. Now, the Job Corp applicant data would give you
numbers that are about 2.5 times as high as the Army. They do
not exclude homosexual men from the Job Corp. They are slanted
toward minority people, but even when you adjust that for the
United States population, you come up with a rate of about 2.5
times as high as the military.

We already have information down to the census track
level on age, race, sex data on a quarterly basis from all
American Red Cross blood donors, U.S. civilian military recruit
applicants, Job Corp applicants. We have information from about
20 million tests a year by census track, and we can track that ©
over time to see what happens to it as well as track the
prevalence in each of these surveys over time. Now, the problem
is in some areas, the prevalence goes down. The prevalence of
HIV infection can't go down because the only way out is death.
You can't -- increases in prevalence like Dr. Redfield was
talking about, you can say, well, the 20 year olds have a higher
prevalence than the 19 year olds, so you subtract 19 from 20 and
you get a one-year rate. That sounds okay for one year, but when
you think about that over a 10-year period, you're saying that a
29 year old who applies to the military has the same
characteristics as a 19 year old. We know that's not true.
Someone who is 29 is quite different from somebody who is 19. So
it has to be made up of yearly differences that are cumulated
over a 10-year period. So there are problems with indirect
interpretation of incidence by doing those kinds of subtractions.

a
~~

Another problem is that when you look at the military
recruit data over two and a quarter years, there's actually been
some decline. Now, how do you explain a decline in prevalence in

 

106
 

the United States? It doesn't make any sense. The only thing
you can explain from that is that they have been more effective
in deferring people from applying to the military. The people
who are in risk groups, for example, have caught on and don't
apply, and they tell their friends. They go back to their
communities and say go get tested first before you apply or
things like that. That would be my first explanation. The
answer is we don't know why the prevalence is starting to go
down or staying flat. So it's important not to overinterpret
data just on the incidence, too. That probably was fairly
confusing.

MR. CREEDON: I think not, but it does raise a question
as to the reliability of the data.

DR. CURRAN: The reliability of the prevalence data?
MR. CREEDON: Yes.
DR. CURRAN: The total number of infected people?

MR. CREEDON: Right. Which, from our standpoint, it
seems to me we have to try to find a reliable figure.

DR. CURRAN: The best that can be done is a range of
estimates of the total number of infected Americans that cannot
be below three-quarters of a million and is very, very unlikely
to be higher than one and three-quarter million.

MR. CREEDON: One of the witnesses this morning, a
doctor from New York He said it was a little bit higher.

MR. CREEDON: He seemed to come in at 2 million. I
suspect we may have at least one witness this afternoon who would
come in with a much lower figure. I don't know. It's kind of
frustrating.

DR. CURRAN: It's very hard.

MR. CREEDON: The range is so big, and the consequences
of the range being so big is that you can't get a handle on the
cause.

DR. CURRAN: I think it's very hard to get lower than a
national probability sample would give you. I think if we dida
national household survey now, we'd come out with a fairly low
estimate. That's the purpose of the pilot studies, to see how
low that would be, because we Know that many people in risk
groups would not participate from the surveys that have been
done. How can we increase the participation rate by people in
risk groups? Can we or do we need to test people separately?

107

 

 
 

 

Are the homeless more likely to be positive than the people who
live in households? Things like this.

MR. CREEDON: Well, one of the suggestions of Dr.
Redfield was that the Commission urge the President to get on
television and say this is important, that in order to get a
handle on --

DR. CURRAN: I think any presidential -- see, I think
that the focus on our household survey to provide an answer is if
the question is how many infected Americans are there and you
want to know that within a range smaller than a million to a
million and a half, which I think is adequately defended in the
CDC report, and you're not that interested in incidence, how many
are becoming infected, which is the next question --

MR. CREEDON: I think we are interested.

DR. CURRAN: But I'm saying that if that is of
secondary importance than the number, than a household survey, in
order to do that, would have to be extraordinarily large as well
as being accurate. There are major concerns about its accuracy
because of participation rates. There's a large number of
Americans who wouldn't let you draw their blood no matter who you
were. They don't want their blood drawn. They don't want their
fingers stuck. So you have to ask the question are people who
give you their blood and people who don't give you their blood
more or less likely to be infected. How do you find that out
unless you get their blood, for example? You can say you don't
need to have risk factor information, but if you have risk factor
information on blood donors and military recruits and you know
most of them who are positive turn out to be homosexual men and
intravenous drug abusers, you do a national survey that's
anonymous and you find out that the number is fairly low and you
don't have any risk factors, is that doing a service to the
American public by saying we have all these infected people out
there who don't acknowledge any risk factors? Whether they
acknowledge them and whether they have them is two different
matters. I don't think any president could get a homosexual man
to acknowledge these risk factors. It's too big a risk. It's
not worth it. You might lose your job. It's too tough.

A lot of people don't want to know if they're positive.
These things all apply to surveys as well, but I think we know
how many Americans are infected within a small enough range, and
we know how many people are currently hospitalized, and we're
continuing to keep track of how many people are hospitalized.
It's time to get down to the business of how effective we are in
preventing infection and figuring out ways to measure how many
people are becoming infected with the AIDS virus and to do that
at the local level where the prevention programs need to occur.

108

 
 

>t +

‘ ' - et Yo oy. ' La
" co State 3 bh

MR. CREEDON: ‘Cory? co
DR. SERVAAS: Jim, could you tell us, the OB/GYN in
- Atlanta, did she have any problem in getting the pregnant women
to have their blood drawn? Do we know how many refused?
CURRAN :

DR. A very small number.

DR. SERVAAS: We used that information and referred
these women to doctors?

DR. CURRAN: They come in for their prenatal care, they
have a very good high risk prenatal testing program at that
hospital. They offer all kind of STD tests, chlamydia,
gonorrhea, syphilis. They just offer this as another test.
of the women who were positive were intravenous drug abusers.
Many were not but lived in the same communities.

Many

DR. SERVAAS: Do you have any problem throwing away the
positive serum and not notifying the people -- do you have
problems with this?

DR. CURRAN: I have a lot of problems with knowing the
results from someone's test and not telling them. There has been
some confusion about blinded testing and non-blinded testing.
Blinded testing refers to getting serum that are obtained for
some other purpose for which there is no identifier. You
couldn't tell the person if you knew the result because you don't
know the person's name, you don't know whose it is. These
surveys are often done for a couple of reasons. One is the
survey can't be done any other way. Many of the surveys that
have been done, that have been blinded, simply would not have
been done because of all the barriers to getting testing done
with people.

The original survey, I believe, in the emergency roon,
that Dr. Baker was involved in, was a blinded survey, where they
took excess blood drawn from patients coming in. That survey was
another example of a survey which really drove medical care and
drove the emergency room physicians to deal with the problen.

Had they had to go through an institutional review board and get

 

permission from each emergency room patient with
came in comatose from an accident, to draw their
survey never would have been done. People never
realized that a high percentage of people coming
Hopkins' emergency room were positive and nobody
to deal with the problem. Once you find out the

tells you there is a problem you have to deal with.

a trauma, who
blood, the
would have

into the

would have begun
results, that
I'm the

first one to argue that you ought to go back to that same

109

 

 
 

emergency room, that same OB clinic and start doing something
about it, testing, counseling and family planning referral, sex
partner referral and other things.

Dr. Baker can tell you whether they are doing that now.
That is not easy, even after you find out. It is the first step
in many cases. A lot of times the blood is drawn for other
purposes, like a VDRL. Blood may be drawn for PKU filter paper
testing as in Massachusetts, where excess blood is available, you
can find out which hospitals have higher rates of infection in
their pregnant women and then you can go in and target those
hospitals for active programs to prevent perinatal AIDS and
prevent sexual transmission. That may be the first step. Once
you know a person's name, you have to tell them.

MS. PULLEN: Are you familiar with the CDC sponsored
study that is about to take place in Illinois prisons on the rate
of transmission in the prison? Do you know how that study is
designed?

DR. CURRAN: Generally; yes.

MS. PULLEN: I have been told that the blood that is
drawn initially is preserved for testing later, when the second
blood sample is drawn and tested. Could you tell me why the
blood isn't being tested when it is first drawn?

DR. CURRAN: CDC is involved in a number of surveys in
prisons. We are working with the Bureau of Prisons and federal
prisons to look at the prevalence rate in prisons. About two
years ago, there was a great deal of concern, there began to be a
great deal of concern about HIV infection in prisons. All of the
prison consultants, medical consultants and legal consultants,
got together and shared and devised their policies. Dr. Axelrod
may want to discuss this more in the New York State Prison. CDC
took I think a fairly aggressive approach about what ought to be
done. We made an argument that what is good for the civilian
population is good for the prison population. The prison
officials felt there were additional problems in terms of
staffing prisons, in terms of isolation of inmates and other
things and they said the question they wanted us to help them
answer was what is the incidence of infection in prisons, how
many people become infected in prisons, and that the only way
that could be done would be to draw blood on entry and exit from
the prison, counsel people on exit, not test the blood until
exit.

The survey was designed. It has taken about a year to
get approval by the various IRBs and others to get this done, but
it has finally been funded in Illinois. This next year we will
be doing a survey with the National Institute of Justice of the
prevalence of HIV infection in at least 10 or 12 state prisons.

110

 

 

 
 

I still personally believe that prisons and jails represent -- I
mentioned to Dr. Primm before -- there are probably more
intravenous drug abusers in prison or jail than there are in
treatment programs. Isn't that a sad statement if it is true?
Somebody ought to find out if that is true. Isn't that
something? We are trying to prevent an epidemic and there are
more people in jail and prison who are intravenous drug abusers
than we have in treatment programs. If we have all of them now
and most of them are going to get out in two years, why don't we
do something about it in the next two years? They are there.
What an outreach program -- prison. We have them. You can't
find them on the street. You have them in prison and jail. All
you have to do is test them and put them in a treatment program,
give them testing and counseling and a good doctor.

MS. PULLEN: Amen.

DR. CURRAN: The reason the prisons don't want to do it
is because they don't know what to do with then.

MS. PULLEN: If you don't find out who is seropositive,
you don't do anything with them either.

DR. CURRAN: That's right. The prisons that have done
that, like the Georgia Prison, has tested their prisoners.
Generally the prisons that have been most active in testing
prisoners are those that had the fewer cases of AIDS. The
prisons that have very large rates in IV drug abusers are those
prisons on the East Coast, whose states I won't mention, but Dr.
Axelrod is sitting next to me, and I believe they are afraid to
test the prisoners because they wouldn't know what to do with the
tens of thousands of them that are positive.

MS. PULLEN: So is Illinois.

DR. CURRAN: Georgia has tested people because they
have only had a handful of AIDS cases and they found about 150 so
they have got a prison for HIV positives. They have filled up
one, now they are going to go to another one and they are talking
about building one. Rather than treatment programs, we will have
prisons for IV drug users.

MS. PULLEN: Let me ask you one other question about
the Illinois prison survey. It was my understanding that
something like the first 3,000 inmates that were taken in after
the survey was set up were to have their blood drawn initially
and then again in a year or two. Are you aware that the survey
is limited at this point to three adult male correctional
facilities and therefore, does not include any females or
juveniles?

111

 

 
 

 

j

DR. CURRAN: I am not aware of the details of who is
included. The experience has been the overwhelming majority of
prisoners with AIDS have been men. If you were going to start in
one place, I would start with men. I think it would be good to
include women if that could be done.

MS. PULLEN: Juveniles may not have a long enough time.

DR. CURRAN: I don't know whether that was Illinois’
choice or whether that was a funding issue.

MS. PULLEN: I would be interested in knowing whether
that was Illinois' choice or whether it was the CDC's decision.

DR. CURRAN: If the State of Illinois would like to
change their policy and test all their prisoners on entry and
exit, we will give you the money that was going to be used for
the study. You can do it that way. That isn't going to happen
until you build more prisons.

MR. CREEDON: If the Commissioners are agreeable, I
would propose that we move on now to Dr. Axelrod. Dr. Curran is
still going to be with us, I take it, and we can come back and
ask him questions after we have heard from the other speakers.
Dr. David Axelrod, who is the Commissioner of Health for New York
State.

PRESENTATION BY DR. DAVID AXELROD
NEW YORK COMMISSIONER OF HEALTH

DR. AXELROD: Thank you very much. I appreciate the
opportunity, Mr. Creedon, Mr. Chairman, members of the
Commission, to present a view from one of the states which has
clearly been affected to the greatest degree by the AIDS
epidemic. The questions, Mr. Creedon, which you have been
putting to Dr. Curran in the last several moments I think are
indicative of the problems that are being faced by public health
officials because of our lack of information. The difficulties
are multiple, as you have heard from Dr. Curran. There has been
some confusion as to what the questions are that we as public
health officials should be answering and we are not sure or have
not clearly identified the importance of those questions and
their relationship to the public health initiatives that need to
be pursued. When you talk about the information, the accuracy of
the information, the problems with the interpretation, I think
that is indicative of the fragmented incrementalism, if I can
call it that, that has characterized a large part of the AIDS
initiatives that have occurred in this country.

I think the Commission has an opportunity to bring
about a major transition with respect to federal policy and to
provide for the kind of epidemiologic data that are going to be

112

 

 
 

 

required for us ‘to attack a public health problem. Epidemiology
is the basic tool of public health and I think our ability to
attack it has been hampered by the kinds of questions that you
have in fact raised in the course of your questioning. We need a
very concerted effort, a clear definition of what the hierarchy
of priorities are with respect to the information that is going
to allow us to take the kinds of actions that are absolutely
essential if we are to deal with the AIDS epidemic that we are
faced with at the present time more effectively. There is
clearly a need for information. Again, I think in the questions
you were asking Dr. Curran, you also identified a very major
problem with respect to epidemiologic curves, subepidemiology,
epidemiologic populations, and what we are ultimately dealing
with in any epidemiologic event is a series of infinite
subpopulations, no matter how it is defined. In this instance,
there may be a real and valid reason for separating some of our
subpopulations and dealing with them perhaps separately in terms
of their predictive ability. I think we have to be cautious in
dissecting the epidemiologic evaluation which we are doing into
an infinite number of subpopulations and thereby defeating the
purpose of some of the questions and supposedly some of the
answers that we need to address.

The Commission, I think, also has an opportunity to
foster the development of a policy which requires participation
at every level, whether it is federal, state, local, there does
need to be a clear commitment for a greater level of assessment,
a greater level of monitoring, a greater level of surveillance
than we have had up until now. We also have to provide for an
assurance that there are services that are going to be available
within the community, that they are going to be accessible, that
they are going to be of high quality for all citizens, and to
develop a capacity building process, which I think again provides
the Commission with an unique opportunity.

MR. CREEDON: When you talk about federal, state and
local cooperation, what type of a vehicle do you envision for
having that happen?

DR. AXELROD: -I think the Commission has recognized the
need for a single coordinated effort rather than the kind of
fragmentation that currently exists with respect to the large
number of entities that are involved, whether it relates to drug
and substance abuse, which is a very major arena, whether it
relates to the activities of the Centers for Disease Control,
whether it relates to the Public Health Service generally, and
clearly there have been conflicting messages from within the
federal government with respect to the appropriate role of
preventive activities that are the appropriate purview of public
health officials throughout the country. I think there are
conflicting messages. They serve to demean public health
generally. They serve to confuse the process and raise serious

113

 

 
 

 

questions about the credibility of many of us who are engaged in
efforts to change the process and to certainly have an impact on
the populations with respect to behavior modifications. I think
it relates to technical formulations. It relates to the
political process that provides for our ability to do the kinds
of things that are the responsibility of public officials. I
think it relates to our educational capabilities, whether it
relates to providing education within the school system or any
other element of our society; physicians, health providers.

There is no shortage of individuals within our society that do
not fully understand the nature of the epidemic with which we are
currently faced. It extends from the lowest level of education
within our society to the highest level of education. There are
clearly many positions within our society who do not clearly
understand what the process is, who do not clearly understand the
threats it represents. There are major issues with respect to
management of the whole of the process. There are questions
about programmatic organization, and clearly there are major
issues, associated with the fiscal capabilities of states, that
affect the Health Care Financing Administration or other areas of
government that are clearly responsible for assisting at least
localities and states in their abilities to deal with the
epidemic.

MR. CREEDON: Are you saying the federal government is
not cooperating as you think it should with the states in trying
to deal with this?

DR. AXELROD: I think there is not a fully coordinated
effort to address the various areas that deal with epidemiology,
that deal with the organization of basic research, that deal with
prevention and education, that deal with service availability,
that deal with manpower, training and development and that deal
with the burdens of cost associated with the AIDS epidemic; yes.
That's exactly what I am saying. I think that needs to be done.
I think it needs to be done quickly. I think the Commission
provides a vehicle for achieving a coordinated effort to deal
with the multiplicity of problems that we face and for once and
for all to establish a clear hierarchy of what our priorities are
with respect to dealing with the problems at every phase and
every level of the AIDS epidemic. One of the interesting aspects
of all this is we have dealt and you have dealt with the whole
aspect of testing. Testing of itself is only a small component
of the public health process. Testing is important with respect
to the blood supply. That is indeed a public health effort.
Testing is important only as a tool with respect to reaching out,
with respect to identifying populations that we can target.
Testing is important because we educate and counsel individuals
by virtue of the testing process. Testing is not an end in
itself. It is distressing to hear the kind of focus on the
testing process without a full recognition that testing isn't
going to solve anything, what is going to solve things is the

114 -

 

 

 
 

 

kind of education and counseling that can be provided to
individuals who avail themselves of testing opportunities,
whether it is in a sexually transmitted disease clinic or whether
it is in a family planning clinic, wherever it happens to be.
That is where the basic public health impact is going to be
realized and the process of testing.

Sure, we have made major progress with respect to
public health by virtue of the limitations that have occurred as
a result of testing our entire blood supply. There are other
circumstances in which this has been critical. I think the
importance of the testing process is that it is a tool for doing
what is the most important thing that we can do and that is
educating and counseling and hopefully effecting the kind of
behavior modification that we are going to achieve. I think with
all due respect to the concerns about testing, the testing is not
of itself a public health initiative except as it relates to our
ability to prevent the disease, to prevent the transmission, to
prevent recruitment of IV drug abusers or drug abusers into the
IV drug abusing population.

MR. CREEDON: I think one of the thrusts of the

questions that we had with respect to testing was if testing is a
way of finding out how many people have the virus and we know how
many people who have the virus are eventually going to require
medical care, then we can start to estimate at least how many
hospital beds you need, how many hospices, what the costs are
going to be, who is going to pay for it. These are all things we
are looking at. Testing is one way of helping us form a judgment
on that.

DR. AXELROD: Yes. What I am trying to do, Mr.
Creedon, is to separate our assessment of long term resource
needs from basic public health initiatives that relate to the
prevention of the transmission of the disease and the
opportunities that testing affords us with respect to the
education and counseling of the populations that are at highest
risk. Our seroprevalence testing allows us to target those
populations, those localities, as already indicated by Dr.
Curran, those subpopulations, where we can indeed have an impact
or hopefully have an impact on behavioral modification. Those
are the kinds of things that can come. Certainly we need as a
government, as a federal government, a way in which we can assess
the resource requirements and to develop those resource
requirements. That is an after the fact activity. That relates
to a population that is infected. That relates to a population
for whom we have an obligation. There is also a very, very large
population out there for whom we also have an obligation, and
that population is one which needs to be counseled, and that

115

 

 
 

 

population is one which needs to be educated, if indeed we are
going to see a drop in the seroprevalence rates as a result of
deaths rather than an increase. We are going to have to take

advantage of the opportunities that testing affords us.

MR. CREEDON: Coming back to your comment about the
effort not being coordinated adequately. There are so many
associations in the world. There must be an association of the
Commissioners of Health from the various states.

DR. AXELROD: She sits with you.

MS. GEBBIE: I refuse to be a whole association all by
myself.

MR. CREEDON: Is it your opinion that that association
or the Commissioners who belong to the association would share
your view that there is not a coordinated effort and somebody has
to get the states and the federal government and localities
together and provide some type of vehicle for them to work more
effectively?

DR. AXELROD: I would allow Ms. Gebbie to speak for
herself since she represents the Association of State and
Territorial Health Officers. I think there has been a general
thrust of the state and territorial health officers and they have
indeed met with a number of arms of the federal government to try
to provide for a more coordinated strategy to deal with some of
the issues that currently confront us.

MR. CREEDON: Thank you.

DR. AXELROD: I have given you a series of charts and
tables that relate to specific problems in New York State. I am
going to go through them very quickly. I think your head is
probably spinning as a result of the extraordinary amount of data
Dr. Curran has provided. As I have indicated, New York State
represents in many ways a microcosm of the problem, although it
does represent some 27 percent of the national total at the
present time. As all of you clearly recognize, New York State
has reported more AIDS cases than any other state. The New York
City metropolitan area has reported more than twice as many AIDS
cases as San Francisco; some 2,170 cases as opposed to 1,050. As
of a week ago, New York State had a reported cumulative total of
12,500 CDC defined AIDS cases, roughly 27 percent of the total
47,000 cases.

The New York State's share of AIDS cases has been
declining, whereas its share was 40 percent just three years
ago, it has obviously continued to decline. Additionally, the
IV drug risk group represents a particularly difficult challenge
to New York State, where it represents at the present time

116

 

 
 

 

roughly one-third of the total number of cases as opposed to the
numbers that you heard from Dr. Curran. Clearly, the problems
that we are facing with respect to the IV drug abusing population
forces us to focus on efforts to provide for behavioral
modification within that population. The estimates of the
numbers of infected members of that population range up to 65
percent at the present time. The rate of seroconversion of that
population has been estimated to be on the order of 7 or 8
percent. There is only a small population left that we can save
and we do indeed have an obligation to provide for an accelerated
effort to deal with them.

It is also of concern to us that there has been a
continuing outbreak of oral drug abuse which frequently leads to
the conversion to IV drug abuse. That appears not to be
occurring in new recruitment into the IV drug population at this
time, it appears not to be as great as it has been in the past,
although it still appears to be occurring in some subgroups of
our populations.

MR. CREEDON: Is this because of educational efforts?

DR. AXELROD: Educational efforts and fear. Street
groups within New York State as part of the Division of Substance
Abuse have found that more than 95 percent of IV drug abusers are
aware of the threat of AIDS by virtue of needle sharing. It is
not a matter of their not knowing about it. It is a question of
their ability to break the habit or the percentage of individuals
who are already infected. Clearly, the problems also are
identified with respect to potential cohorts or collaterals of
those individuals who are IV infected, in terms of the numbers of
individuals who are likely to be born, children born as a result
of transmission from that heterosexual IV population to their
children. That remains a very major factor. We also are very
much concerned with something else which is distinct from what
Dr. Curran has told you in terms of the syphilis problem. We are
currently encountering in New York State a very major increase in
syphilis. The increase in syphilis has been substantial. The
first quarter of 1987 as compared to 1986 represents a doubling
of the cases of primary and secondary syphilis.

The reason for the significance of that doubling, I
think it is obvious to all of those who have followed the African
problems and the potential for transmission to the heterosexual
community and the potential for a breakout of the existing high
risk groups on which we have concentrated up until now. As we
look at the problems, we find ourselves confronted with two major
areas in which there is the potential for additional transmission
to those groups which have not generally been characterized as
high risk groups. Again, a need for emphasis on preventive
activities and the use of the testing for education and
counseling --

117

 

 
 

 

MR. CREEDON: I am not sure I understood.

DR. AXELROD: Sexually transmitted disease and IV drug
abuse.

MR. CREEDON: Do we know why there is an increase in
syphilis?

DR. AXELROD: There have been a lot of suggestions as
to why it has occurred but does anyone really know? I don't
think anyone really knows why there has been an increase. It is
not as Dr. Curran has indicated within the homosexual community
which has had generally a decrease in primary and ‘secondary
syphilis.

MR. CREEDON: We had some testimony this morning that
indicated some of these diseases have been going down rather than

going up.

DR. AXELROD: Yes, the New York experience would be
similar to that which Dr. Curran has identified in terms of the
homosexual population, that there has been a very major reduction
in venereal disease generally. Overall, the number of primary
and secondary cases in the first half of 1987 compared to 1986
has effectively doubled. It is still a relatively small number.
It is one that is of very great concern to us because of the
potential implications.

MR. CREEDON: How many?

DR. AXELROD: I think it is about 2,200 cases in the
first half of 1987.

DR. PRIMM: I was going to ask you, Dr. Axelrod,
weren't those cases concentrated in the minority communities,
Harlem, South Bronx, Bedford-Stuyvesant, Brownsville, New York?

DR. AXELROD: Yes, but that doesn't change their
significance. I mean, yes, that is true, but I still think that
our concerns nevertheless have to remain with the potential route
that may provide for extension into the heterosexual community in
manners that have been attributed, at least, to the spread within
our African countries.

DR. PRIMM: But, too, there has been very little, if
any, expansion in drug treatment in those areas. And I'm
particularly concerned about that in New York.

DR. AXELROD: There are currently some 40,000 methadone
treatment slots in New York State. The estimated drug population
is someplace between 200,000 and 250,000. 10,000 additional
slots have been added by the Governor this past year, and we are

118

 

 

 
PT

about to add additional slots for methadone treatment. You have,
in a sense, anticipated some of my comments with respect to drug
treatment and the need for the federal government to recognize
that it also has a major obligation with respect to its expansion
of assistance to the states to provide for additional drug
treatment activities. The AIDS problem is very much an IV drug
problem. It relates to the allocation of resources that has been
made, the priorities that have been established by government
generally with respect to the treatment of those individuals who
are currently addicted and are part of our intravenous
drug-abusing population.

Now there is clearly an absolute need for everyone to
recognize the need for a major new resource commitment to deal
with that population. I think there is also a need to recognize
that not only is there a need to deal with that population
because of their intravenous drug abuse, but the risk that they
bear, the risk that they bear to the children that ultimately
will be born as a result of their collaterals, a result of the
risks to the heterosexual population that they represent, but
there is also, I think, an absolute opportunity for education and
counseling these individuals through methadone treatment centers
that probably allows us the most easy access to those individuals
that have otherwise been difficult to access within the
community. Our best guess is that as many as 50 percent of those
ho are currently IV drug abusers would take advantage, if it were
made available under the right circumstances, of methadone
treatment.

The issues also relate to the regulatory process which
extend to methadone treatment centers. I believe that we should
reevaluate at the present time the requirements for methadone
treatment centers to ensure that we take every effort to bring
them in for whatever level of treatment we can provide, even if
it isn't the full spectrum of services that are currently
required in our methadone treatment centers to assure that we
have the opportunity to educate and counsel these individuals.
That requires changes with respect to substance abuse. It
requires changes with respect to limitations of the FDA in terms
of methadone allocation. But it is -- it seems to me that in
terms of the potentials that we face with respect to this
population that we have opportunities that need to be exercised,
and we do need to take some major actions with respect to that
population.

MR. CREEDON: Does your paper spell this problem out
with the FDA? Does it specifically do that?

DR. AXELROD: No, it does not. It does not.

MR. CREEDON: If you could give us more information on
that, that could be helpful.

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DR. AXELROD: Yes, I would be happy to.

DR. PRIMM: Dr. Axelrod, the other thing that I would
like you to elaborate on, if you would, is the expansion of
primary care, primary medical care, in methadone maintenance
treatment centers and in drug treatment programs in general,
because it's there generally where the intravenous drug user
comes in contact with any officialdom in the health- giving
community, for example, and we don't have the kind of funds to do
that, yet we are heavily, as you know, monitored and regulated by
the Division of Substance Abuse Services and, of course, the Food
and Drug Administration. We do need increased dollars in order
to expand the program to do the kinds of counseling that you
suggest.

DR. AXELROD: Dr. Primm, I agree with you absolutely,
and I think that we are saying the same thing.

DR. PRIMM: Yes.

DR. AXELROD: -There needs to be changes with respect to
the regulatory process to facilitate the activities of the
methadone treatment centers to become a major player with respect
to education and counseling, and I am prepared to advocate and
have advocated major changes that would allow for the role that
you have identified for the methadone treatment centers. I think
it is absolutely critical that we utilize those centers to
provide the kind of information and primary care that they can
provide.

DR. PRIMM: My point was, in order to be specific, so
you would know, is that it would be highlighted in front of the
Commission, so that I don't sound like a broken record myself
when I talk to my fellow Commissioners and to the public. I know
you have, and this way it's now officially on the record that
it's strongly endorsed, and so has Dr. Curran today, and I'm
highly appreciative of that also.

DR. AXELROD: Thank you. The epidemiologic information
currently being obtained in New York State, as you know, is
coming from a variety of different areas. We have it from
alternate sites which have existed -- blood banks, the military
screening program -- to the point that at the present time we
have screened roughly two million individuals, or there have been
two million blood tests in New York State, and we have roughly
10,000 positives which have occurred as a result of that
extensive testing. The most extensive testing that we have been
engaged in is one which we have just initiated and have just
completed the evaluation of some 5000 samples, and that is the
evaluation of every newborn within the State of New York, and we
expect to do some 260,000 individuals who are born in New York

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State to give us a seroprevalence, at least within the
childbearing community within New York State. Lest you think
that is going to be a panacea, you should recognize that these
are going to have to be evaluated with respect to a number of
other features, such as fertility, abortion rates, and I could go
on and identify some of the other factors that are going to have
to be taken into account in evaluating even this 100 percent
sample in terms of determining the level of seropositivity among
childbearing women in New York State.

We hope to have certainly some definitive information
by the end of the first quarter of this year that will give us
for the first time at least an opportunity to evaluate the future
potential for children who will be born in New York State with
AIDS, who are likely to be seropositive, and perhaps a better
indication of the extent to which it has entered the heterosexual
community within New York State as a result of this extensive
testing procedure.

MR. CREEDON: Is this that each mother would be tested?
Is that what you're saying?

DR. AXELROD: Every mother is currently being tested.
The process that we have initiated is related to the newborn
screening sample, which is required within New York State. Every
infant is tested for PKU and a number of other congenital
diseases. Once that is completed, all identifiers are removed
from the sample, and we are doing testing for not just HTLV-III
or the AIDS virus, but we are also doing testing for some of the
other viruses that have been related to determine their
prevalence within the general population.

MR. CREEDON: Does that include HTLV-I?
DR. AXELROD: Yes, it includes HTLV-I.

DR. SERVAAS: Dr. Axelrod, when you test, then the
mother goes ahead to nurse her baby, she's not told that she's
positive?

DR. AXELROD: We don't know who the mother is.

DR. SERVAAS: You don't. Do you test in the prenatal
clinics?

DR. AXELROD: We recommend it; we don't mandate it. We
recommend all our prenatal clinics -- we have, in fact,
identified -- we have sent information to every obstetrician in
New York State, recommending that he raise this issue with every
prospective mother. Our family planning clinics are aware of it,
and we are doing screening directly in some cases in family
planning clinics and other prenatal clinics that are operated by

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the counties as well as by the state. But in this situation, we
have no way of identifying who the mother is, because it is done
on a totally anonymous basis, and I think it's important to
distinguish information which is being gathered for epidemiologic
purposes on a blind study, such as Dr. Curran identified, and our
urging the mothers to go to the clinics and to be tested or
urging doctors to have potential mothers tested by virtue of one
of our anonymous testing sites that exist throughout the state.
There's a very major distinction which Dr. Curran made before,
and I think he made it very eloquently, so I don't need to say it
again.

MR. CREEDON: I didn't know whether there was a
difference of opinion between the two of you on this issue. Is
there?

DR. AXELROD: No.
MR. CREEDON: Because from --

DR. CURRAN: I think New York State is really in many
ways a model program for some of the family surveys. We're
working closely together.

MR. CREEDON: I mean, from a policy standpoint, one
could argue that if you're going to go to the trouble of testing,
you really ought to find out, you know, who has the virus and
tell then.

DR. AXELROD: That raises a whole new series of
questions, and I think in terms of our ability to have a 100
percent sample, which is what we set out to achieve, and not bias
the sample, to seek consent, which we would have to do under
those circumstances, would change the value of the information
that we otherwise would obtain. The value of this information is
that it is not selective, except for those characteristics which
I've already indicated to you that are going to have to be
evaluated before we draw any conclusions. But at least in terms
of the population, it is not additionally biased by a
self-selective process in terms of who provides consent and who
does not. And I would be reluctant to test samples with
identifiers. I certainly would not be permitted to do so without
the consent of the individual.

DR. CURRAN: I can give you an example of how that
works. You take a state like Georgia, where we have, I
mentioned, one hospital where 1 percent of the pregnant women are
positive. Obviously the thing to do there is to go into the
hospital and start some programs for care and prevention and
things like that. But let's say, you say, well, we know that
that's true in one hospital. How many other hospitals are there
in the State of Georgia that might have similar rates or even

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rates that are 1 in 1000, and how many don't have any at all? It
is almost impossible to go around to every hospital where babies
are delivered in the State of Georgia and start these kinds of
programs, because just getting them going would be an enormous
task. PKU testing, however, is done on a state basis in every
state by mandate, and little pieces of filter paper are shipped
into a state laboratory in one place. There's a little bit of
extra blood in all of these filter papers. So all you have to do
-- and you have age,:race, and sex, without name, and your
hospital number -- all you have to do is blind those, and you'll
know immediately what it is in every pregnant woman in the state.
Then you know where to go to start your prevention programs. I
think that's the idea that you can focus your prevention efforts
based upon.

DR. AXELROD: Precisely.

DR. CURRAN: I don't know if they understood what the
PKU filter paper thing is. It isn't a question of going to the
woman. It's a question of going to some room where all this
stuff is kept and testing it all, you know. But you have to
blind it. If you don't blind it, then it's, I think, unethical.

DR. AXELROD: There's another advantage in terms of the
way in which this is being done, and that, of course, is that
it's being done all in one laboratory, that there is no problem
of interlaboratory comparison, that all of these things are being
done in one location and is engaged in some fairly extensive
proficiency testing to assure, at least, that there is a
similarity with respect to the procedures that are followed, and
you do not deal with the multiplicity of problems that ultimately
you have to deal with when this is extended to a wide number of
laboratories. As I mentioned to you earlier, we currently have
reported a total of about 12,500 AIDS cases. We are currently
seeing about 300 per month, and that has remained relatively
stable over the last six, eight months. Since January of '86, in
fact, case counts have been averaging about 300 month, but there
has not been a major change. I would caution that you not pay
very much attention to the reports subsequent to January '87
because of the lag that has already been referred to in Dr.
Curran's comments in terms of the reporting. But we certainly
seem not to be proceeding at an accelerated pace, and if
anything, there appears to have been reached, at least, a plateau
with respect to the numbers of new cases being reported in New
York State. The next chart that you have is one which I think

MR. CREEDON: Is there any change in the nature of
homosexual versus the number of IV drug abusers?

DR. AXELROD: Yes. The number of IV drug abusers is
representing an increasingly higher proportion of those

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individuals, as is the number of children who are being reported.
Although that is a very low number, there is an increasing number
of children who are being reported. The next chart which I've
provided to you is an indication of the fact that the number of
deaths is continuing to increase and is --

MR. CREEDON: Which chart is this, David?

DR. AXELROD: It's "AIDS Deaths in New York State,
1983-1987, Monthly Resident Deaths," which should be part of your
package. The point, of course, is simply not the chart, but the
fact is that we are experiencing, as you would expect, given the
large infected population, the large number of AIDS case that
exist, both diagnosed and characterized and those perhaps not
characterized, the number of deaths that is occurring is
continuing to rise in a linear fashion, so that we can expect at
the same time as we appear to be decreasing the number of cases
being reported, the number of new cases being reported, there is
a major increase in the number of deaths. The concern, of
course, is that there will be a panic with respect to a large
number of deaths that is occurring, that will not fully
acknowledge the effectiveness of the public health initiatives
that are underway, and the fact that the number of new cases, in
fact, may be decreasing. So that while the number of deaths is
very frightening to all of us, it is, I think, a recognition of
the fact that we do have a large infected pool.

As of November 1986, 57 percent of the reported AIDS
cases in New York State have died. The mean survival time for
AIDS diagnosed cases in New York State is roughly 8.7 months.
Risk factors for AIDS you already know about. 13 percent of the
homosexual/bisexual men are expected to live four years, compared
to 7 percent of the IV drug abusers or individuals who are both
homosexual/bisexual and IV drug abusers. The number of
hospitalized AIDS patients in New York State with PCP,
pneumocystis carinii pneumonia, has grown from 690 in 1983 to
4202 in 1986 or a sixfold increase. Interestingly enough, at the
same time, the number of hospitalized patients with Kaposi's
sarcoma increased twofold between 1983 and 1985, but in 1986, the
number actually declined. And while the absolute numbers may not
be entirely correct, we do believe that there has been a decline
in the number of Kaposi's sarcoma associated with the homosexual
population. That is consistent with other reports that suggest
that the relationship of anal receptive intercourse in the
homosexual population has decreased and along with it the number
of cases of Kaposi's sarcoma that are being seen.

So we view this as an indication, at least, if the
reports that have been provided, including a recent one in the
New England Journal of Medicine, are indicative of changes in
behavior, then certainly the data that we have with respect to
Kaposi's is consistent with the changes that we have observed.

124

 
 

MR. CREEDON: And again, David, these changes in
behavior presumably occurred back --

DR. AXELROD: Earlier.
MR. CREEDON: Four years ago or something like that.

DR. AXELROD: Well, we don't know how long ago. I
don't think anyone knows precisely the point of contact and all
of the cofactors involved with the development of Kaposi's
sarcoma. But the answer, yes, is that there have been behavioral
changes undoubtedly that have affected the number of cases of
Kaposi's that are currently being seen and the changes in the
number of cases that are being diagnosed. There is a series of
charts, and there is one in which there is a warning clearly
evident by virtue of showing you what the change is with respect
to the reporting at any given year because of the lag that
occurs, which is approximately one year. So my caution is that
you not take the 1986 data at this point as being definitive.
There undoubtedly will be additional cases reported. You already
have heard something about the tuberculosis case rates, and as
Dr. Curran has indicated, it will be in the MMWR this week, and
there's no point in my discussing it. Obviously it is a problem
for us.

The next chart which you have -- I believe you have it
-- is the pediatric AIDS cases, which shows an increase. This is
a plot at six-month intervals of the number of cases being
diagnosed, and what it does is, I think, confirm what you
otherwise would have concluded with respect to the increasing
number of intravenous drug abusers within the reported AIDS
population. I have also provided you with information with
respect to the number of AIDS cases, hospital discharges,
hospital days, and deaths since 1983. The numbers, I think, are
rather interesting with respect to several factors, and that is
that the number of deaths is now beginning to exceed the number
of cases. The number of hospital discharges is continuing to go
up linearly, as is the number of hospital days, although the
average length of stay has declined substantially with respect to
hospitalization. The AIDS cases, hospital discharges, and deaths
are represented in the chart which you also have, and I'm going
to try to move through this quickly, but I think you can see that
while we have certainly reached a plateau perhaps with respect to
the number of new cases being reported, we have no such plateau
with respect to the resource needs of the population that already
exists. We have an extensive system in New York State, a data
system that allows us to monitor some trends in inpatient care
for AIDS, and what you can see is that the primary care mix of
AIDS patients has changed since 1983. In 1983, about 40 percent

125

 

 
 

 

of AIDS patients were on Medicaid. By 1986, the fraction of AIDS
patients on Medicaid has increased nearly 50 percent. The Blue
Cross share decreased from 34 percent to 26 percent from 1983 to

1986.

I think the point of all this is that we are seeing a
situation in which the combination of Medicaid and medically
indigent account for some 70 percent of the total number of AIDS
being treated in hospitals in New York State. That represents an
enormous burden, a financial burden to the state, and again cries
for a greater participation of the federal government in the
problems of financing this enormous cost of hospitalization. We
certainly have been successful in reducing the number of days for
each hospitalization, but if you will look at the information
with respect to expected payer, it is very, very clear that the
Blue Cross share continues to go down; the self-pay, the
medically indigent continues to go up, and Medicaid also will
continue to go up.

It also makes it very clear that there is a need for
the federal government to recognize, as we have suggested that
they should, that the states require some direct assistance with
respect to the financing of those individuals who are currently
without any source of payer. We have suggested that Medicare
consider this population to be similar to that population with
advanced stage renal disease and be eligible for immediate
Medicare services with, I think, a change in the nature of the
way in which services can be provided in terms of an increased
availability of other non-hospital services. I believe that
there can be major changes with respect to the way in which
treatment is carried out, and while our primary responsibility is
not a reduction in costs, I believe there can be some additional
reductions in costs associated with a greater flexibility in
terms of federal participation in the care of these individual
patients. You have also before you a chart which identifies a
change in the percentage of beds in New York City that represents
beds occupied by AIDS patients. For these charts, we have used a
definition which is different from the CDC definition. We've
used a definition of HIV with illness as being the mechanism for
identifying resource needs. So when you look at these
hospitalizations, they represent not the AIDS definition itself,
but a rather broader definition which we feel is more relevant to
the kinds of projections that we --

MR. CREEDON: I think that makes more sense in terms of
trying to evaluate what our expenses are, rather than classifying
as AIDS or ARC or some other.

DR. AXELROD: We have no ARC classification. We have
AIDS and HIV with illness as a mechanism for identifying resource
needs. There have been a variety of projections as to what the
number of cases will be in New York State, and I have given you a

126

 
 

 

chart with a range of potential cases. We expect that the total
by 1991 will be roughly 50,000 with approximately 20,000 of those
still alive in 1991. We have by risk group provided you with
information in terms of what we feel are the rates of increase in
each of the populations, based upon extrapolation from existing
information, as well as the data that we have available through
December 31st of 1986 in terms of the extrapolation. Those
represent our efforts to provide a range, given all of the
different estimates that have been made, the different models
that have been suggested, the difficulty in using any of those
models, because of the problems that we have with the kinds of
subpopulations that Dr. Curran referred to earlier. Those
represent, I think, some of the major problems that we have. I
think they're a summary of the kinds of information in New York
State. But I again would urge that the Commission consider the
various problems that we have with respect to the coordination of
the epidemiology, the nature of the questions being asked, the
priority of the questions and how they relate to our basic public
health mission, the allocation of dollars, the coordination of
the research that is currently taking place, the relationship to
other public health disorders such as TB, venereal disease, how
they interact with the problems of AIDS, the effectiveness of our
prevention and education programs, the relationship to the drug
programs, and our ability to address the collaterals and spouses
of those IV drug abusers who are -- remain a major current
source, the need for the federal participation and the expansion
of service availability.

For example, the hospice regulations are totally at
variance with the experience of all of us in terms of the needs
care of the AIDS-afflicted population. At the present time,
hospice is available under Medicare for those who spend 80
percent outside of the hospital and 20 percent in the hospital.

I think it is probably the reverse with respect to AIDS patients,
so that effectively they are precluded from participating ina
hospice under existing regulations. Manpower is becoming an
increasingly critical element. There is a need to make all of
those involved in the delivery of health care services aware of
the kinds of preventive activities that they can engage in to
prevent their own risk. But there is also a need for manpower
training development to deal with the special problems of those
who are afflicted with AIDS, and clearly the federal government
needs to deal more effectively with the cost burdens that are
being borne by the states. And finally, I would be remiss if I
didn't identify the problems that result from a fragmented policy
with respect to addressing the discrimination that takes place
with respect to those who are afflicted with AIDS. The AIDS
population is a population that is already largely discriminated
against because of race, and without the kinds of protection that
can be provided on a federal level, we have a fragmented system
in terms of further protecting that population from all kinds of
prejudice that exists within our society.

127

 

 
 

 

Members of the Commission, I am confident that you
represent a social conscience for government and will provide
the thrust that will enable us to have a more responsible social
role, all of us, in dealing with the multiplicity of problems
that all of us are confronted with. The data are all
secondary. The responsibility is one of our society, and I think
we have the opportunity to demonstrate the compassion and the
concerns that I believe the society has identified in dealing
with disasters and catastrophes that we have had to deal with in
the past. If this is indeed the number one public health
problem that we face, then clearly there is much more that we can
do. There is much more that we should do. And the kind of
commitment that we have made as a government is far less than we
should have made, if, indeed, we are to conquer the problems, if
we are to deal effectively with the problems that confront us.

Thank you very much.

MR. CREEDON: Thank you very much. Questions? Dr.
Walsh?

DR. WALSH: David, certainly you have had to face this
problem to a greater degree than anyone else, being in your
position in New York State, and I've had the opportunity to talk
with you many times and hear you many times. I'm very impressed
with your experience and your ideas. Just one comment before my
question so that you won't misunderstand any preoccupation on the
testing business from the Commission. To add to what John
Creedon has said, part of the reason we are interested in getting
a handle on as accurate projections as we can is for the very
reasons you brought up, not only the care aspect, but if you're
looking for federal funding for assistance in the training of
counselors, improvements in education and the like, it just helps
us to know the enormity of the problem to a greater degree than
we are getting now from a mixture of reports. I just wanted you
to know that. We are not looking at testing as an end in itself.

DR. AXELROD: I didn't mean to be pejorative in my
comments. What I think I was voicing was a sense of frustration
with respect to focus on the test; because from my perspective,
in some ways it doesn't matter whether or not the patient who
comes in is negative or positive. What it does is provide the
opportunity for education and counseling, and that, it seems to
me, has to be the thrust of our program to expand the intravenous
drug abuse activities.

DR. WALSH: The next question I have, one of the two
questions I have which pertains to the testing, is blind or
anonymous testing unfortunately doesn't enable you to carry out
the counseling, and I wondered, for example, when you have the
increase in, say, syphilis in New York State, in the sexually
transmitted disease centers, do you blind test for the HIV virus
now?

128

 

 
 

DR. AXELROD: We are doing it in selected clinics, yes.

DR. WALSH: In selected clinics?
DR. AXELROD: Yes.

DR. WALSH: But are you -- they're true blind? You're
not able to identify?

DR. AXELROD: No, but I think that in some of these
areas, what it does in terms of the location of the clinic, it
allows us to focus our activities through bringing in mobile
vans, for example, and to provide for on-street education of
individuals, which is also what we intend to do with some of the
information that we get from the seroprevalence study of all
women who have delivered children. This affords us an
opportunity by geographic location to target for special
attention those areas that have sero- prevalence rates that we
think are going to cause us some additional problems. It
provides for the kind of focus that Mr. Creedon was, I think,
attempting to address in his questions.

DR. WALSH: This increase indicates, at least to me,
that our education programs, for better or for worse, are not
getting through on prevention. But let me ask you this, and this
is a massive question, and you may have to perhaps submit this
later; whatever the Chairman prefers. As the Chairman alluded in
his report to fragmentation, you have alluded to fragmentation.

I must say that most of the people involved, like Jim and the

others, all are aware that there is a degree of fragmentation

taking place. If you were in the position of being the czar in
Washington, what would you do to correct that situation?

DR. AXELROD: As you indicated, that's not a question I
think that I can answer in several sentences, but I think that
there is a mandate for a single coordinating body which can make
recommendations and allocate resources more effectively than is
taking place at the present time. I think that there is a need
for participation of a number of different agencies, some of
which are within Health and Human Services but some of which are
outside of Health and Human Services, like the Department of
Education, that have a very major role to play in terms of our
addressing this epidemic. I would be delighted to indicate to
you some ways in which I think this can take place. I'm not sure
I would want to define it with an off-the-cuff response, because
I think it is the key question at the present time.

DR. WALSH: I think it would be helpful because, you
know, I have a horror, frankly, of Manhattan Project thoughts;
but, on the other hand, this seems to be something that's been
suggested by others, but I think it would be helpful since in the

129

 

 
 

 

 

i

State of New York you have been through the mill on this to a
greater degree than anyone I know, certainly. I think we would
benefit a great deal, Mr. Chairman, by having Dr. Axelrod really
submit to us after due thought his thoughts on what we could
recommend or what may be considered to get better coordination
than we are getting, because there are people in authority here
in Washington who feel they do have proper coordinating bodies
and so on, and if they do have and they're not working, perhaps
you can suggest why and suggest what could be done to improve
them. We will make this a blind paper if you like.

DR. AXELROD: Well, I would do it with great caution
because of an experience that was related to me by the late
Baniford Bush who, in the course of identifying the enormous
impact that a single individual can have, identified himself as
the single person responsible for the Sputnik lag by virtue of
the information he gave to the President telling him that he need
not worry about the future of rocketry and that it was not going
anywhere. He related that to me as the potential dangers of a
single person or entity being responsible for those things, but I
would be happy to try and frame it with that as the question.

MR. CREEDON: Clearly, you know one of the issues we
will be addressing, although not today and not at these hearings,
is the question of what part of the financial burden should rest
with the federal government, the state government, the local
governments, Medicare, Medicaid and whatever. This is part of
the issue, but right now we're trying to get a handle on the
scope of the problem. Mr. Chairman?

ADMIRAL WATKINS: I guess we will close this out. We
want to have questions for both of you, but we need to get on to
the next two witnesses. If you can both stay throughout that,
the Chairman would like to press on with the next witnesses. We
do have lots of questions for you, and then I want to lay some
ground rules on follow-on questions to you individually that we
would like to exchange in writing. But in closing out on what
Dr. Walsh has said, Dr. Axelrod, we are going to have one open
hearing late in the cycle before we have to make our final report
to the President. Clearly by that time, we will also have been
through the mill a lot more, and we will have a greater grasp on
the scope of this whole set of issues. I think at that time
we'll be better prepared to discuss the issue of what follow-on
institutional process has to be recommended to allow this
president to pass the baton to the next president in a much more
orderly way than he might have if we leave the fragmentation
unattended to. So we don't know what that is. The AMA has made
a recommendation along these lines. It's not all that well
defined. The National Academy's Institute of Medicine has also
made the same kind of recommendation. You're now talking about
it.

 

 

 
 

We believe there's something there. We don't know what
it is. But we certainly are open to that kind of presentation,
and it would be helpful to receive your input with the idea it
may help us frame a follow-on hearing. I believe it's in May or
certainly late in the cycle when we have an open window, where
this issue will have to come up from selected witnesses who have
really given some thought to what we're really talking about.
We certainly don't want an overwhelming bureaucracy. We want to
do a lot of coordinating. We want to facilitate advice to both
executive and legislative branches. We want to see that kind of
antifragmentation regime as limited in bureaucracy and staff as
necessary, but also we'd like to see it there and to be able to
carry some national stature baton for the leadership in the
country until such time as we feel the institutional process has
built itself up and can get control of this. So it's an
important issue. It's a little off our prevalence issue, but
since it was raised here and since obviously you have some very
strong feelings about it, it would be helpful to us to get that
input from you so we can maybe frame our thoughts a little better
for what we will now agree to as a necessary hearing on that
particular set of issues.

DR. AXELROD: I'd be pleased to do that.

MR. CREEDON: Our next witness is Dr. Alexander
Langmuir, Chilmark, Massachusetts. Dr. Langmuir was at one point
the chief epidemiologist of CDC. Welcome.

PRESENTATION BY DR. ALEXANDER LANGMUIR

DR. LANGMUIR: Thank you, Mr. Chairman and
Commissioners. I deeply appreciate the honor of being invited
from really active retirement in Martha's Vineyard to testify
along with my colleagues. They are now very much on the firing
line in this very serious epidemic crisis. I once was there,
too. In fact, I had my full measure of this at CDC for 21 years,
and these men have my very warm sympathy and very best wishes. I
have issued for you beforehand two documents which are merely
supportive, and my testimony was distributed this morning. The
charts on the back of my testimony are the same as the charts on
the back of the paper I issued before. My long-held view which
is now becoming widely known to at least some is that the
projections of the incidence of AIDS, basically the Coolfont
projections which Dr. Curran has shown, are rather too high. I
presume this is the reason I've been invited here to testify and
am most happy to do so.

The active practice of epidemiology has been my
professional career for 50 years, and during this time I have
become increasingly intrigued with epidemic theory which I
learned at Hopkins as an MPA student, and I've applied it
essentially constantly in my very active career. Epidemic theory

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is the effort to divine the laws, the underlying biological
forces that control epidemics and then to express them
mathematically. Dr. Curran mentioned three expressions in one of
his presentations. This is basically epidemic theory. Now,
progress in this has been very distressingly slow. The problems,
the factors, the forces, the infinite varieties of subpopulations
have to be included, and then you add to this a variable and long
incubation period. The mathematics becomes impossible even with
the aid of the most modern computers.

But there are some factors. It's not totally
empirical. In fact, I have no use at all for purely empirical
curve fitting. I don't think there's any place for that. You
can fit almost anything to a curve. You need a biological basis
of some kind to start with and then see if your curve comes
anywhere near meeting those fundamental conditions. I'd like to
explain. Back in 1840, a very great epidemiologist, William
Farr, who set up the vital statistics program for Great Britain
that set the pattern for the world, observed early in his career
that, in watching a smallpox epidemic and sort of playing with it
mathematically, that there seemed to be an orderly arrangement.
The ratios of one month to the next fell into an orderly pattern.
Almost 100 years later, Dr. Brownley showed that this really was
the statistical normal curve, the Delsean curve which is the
basis of classical statistics. Dr. Brownley, very enthusiastic
about Farr, proceeded to say this is Farr's law, which says
nothing but that epidemics rise and fall in a cocked hat normal
curve and a Delsean curve fits it pretty well. But this is what
I mean by Farr's law, and I invoked it only in the most broad
terms. Obviously they're not strictly a normal curve, but this
does describe a very large number of epidemics. It's a sort of a
traditional biological epidemiological inference involved there.

Then later in a cattle plague epidemic, Farr, who was a
temerarious fellow, proceeded to write a letter to Parliament and
charge that the fears expressed in Parliament that this rising
epidemic of cattle plague was going to ruin the economy of
London. He proceeded that the curve was, indeed, rising up into
50,000 attacks in the cattle and cows of the area around London
but that the rate of increase was falling off. It was veering
off. He then proceeded to do the extraordinary thing of
predicting that it was going to turn over and crest in the next
month and decline. Dr. Frost, whose successors taught me at
Hopkins, said this was the most courageous epidemic prediction a
public official had ever given. Now I am known also now as one
of the more temerarious predictors. I try to predict every time
I get a chance. I've been right some of the time, and I've been
wrong on very many occasions. I persist in this trait for
several reasons. First of all, it's exciting and fun to do so,
and what's important than to not have fun in your job. To be on
the cutting edge of a new epidemic problem and sometimes a step
or two over is a place that I have enjoyed being all my life.

132

 

 
 

 

Now, more seriously, to make reasonably responsible
predictions demands at least the beginning of an understanding of
this underlying theory of the disease. When predictions are
fulfilled, you gain great confidence, and you then proceed to
elaborate your theory more accurately. When your predictions
are wrong, you look at why. You re-examine your premises and
Start over again. I first indulged in my obsession of
predicting on AIDS in October of 1985 when I was drafted by Dr.
Fred Robbins, president of the Institute of Medicine, to open a
discussion on the epidemiology of AIDS during that October 1985
meeting devoted entirely to that subject. Jim Curran was there
and commented on my remarks. Fred Robbins said be provocative,
so I started off by quoting William Farr on the cattle plague. I
then went on to challenge the prevalent and still now widely held
view that AIDS is going to increase continually, even
logarithmically. We heard today more than I've heard ever before
of the fact that some, at least among the homosexuals, it is
leveling out.

I stated categorically on the basis of my own broad
professional judgment that no biological system, whatever it may
be, can increase logarithmically and geometrically for long. It
just is not biologically a tenable idea, although in 1985 this
was a widelyheld belief. I argued that among the four
principles of transmission categories, none of them had the basic
ingredients of further logarithmic increase. I then went on to
what I say hazard a forecast -- prediction would be too strong a
word at that time -- that the epidemic would crest in the
midsummer of 1986. That was a year and a half ago. This caused
not a ripple of interest in the reading. Jim Curran made a few
polite remarks, and the panel went on and discussed everything
else except my contribution. Perhaps this is just as well. The
forecast clearly missed. The incidence continued to increase; to
some, continuing alarmingly, but to me, I looked at it and said
it's dampening off further, it is steadily progressing, the
doubt ing time is increasing. So I was not too discouraged, even
though I was wrong in the exact dates.

Now, with my colleague, Dennis Bregman, with whom I
have worked for a number of years on GBS and other problems,
influenza, we submitted a brief manuscript to the CDC to focus
this issue. We proposed a publication in the Morbidity-
Mortality Weekly Report which has done some of this, not often.
Being the editor and really the founder of the modern report, I
took some pride in making a submission to it, even though the
submission was respectfully declined. Again, we predicted
peaking this month, December of 1987, and, again, it looks a
little bit better, but we were basically considered wrong. Our
reassessment of our failures led to what we think are rather
clear explanations. We are not discouraged. In the first time,
I had grossly underestimated the incubation period. I thought it
was two or three years perhaps. Now almost everyone is aware

133

 

 
 

 

that this incubation period is not only long but quite variable.
I believe it falls into a log normal curve, that it runs from one
year to 25 years or a lifetime. That makes it very difficult for
theoreticians to put it into an equation, but it clearly fits
everything that I'm aware of the data. This is a disease where
we're seeing the effects now of that big activity back in the
early 1980s. In that error, I must say I had very ample company.

The second failure, the one where I predicted it would
crest this month, was very clearly an artifact of reporting. I
was in Martha's Vineyard and getting the weekly reports and
studying them carefully, but I was not as alert to the lag
between the time a case is seen and diagnosed and the time that
report gets to Atlanta. In the late fall of '86 and January and
most of February of '87, there was the dearth in reporting
several thousand cases. This gave a false and encouraging feel
that the epidemic was curving over more and peaking. Well,
Dennis Bregman and I have persisted again, and I would like to go
now to.the Table 1 in the data we present. Table 1 shows the
classic data from CDC. It comes directly from those official
reports, and essentially everyone is broadly familiar with it.
Sometimes it's reported and presented arithmetically, as Jim did
in that rising curve with the Coolfont predictions. I believe
it's sounder to present this on a logarithmic scale. If we may
go to Figure 1, the four disease categories are shown there on a
log scale. That's not terribly esoteric. Every time you look at
a stock report in the New York Times, it compares the Dow Jones
average with the Standard & Poor. This is charted on a log
scale. It is the way you show relative changes where you
compare what it's doing and how one curve is varying in
proportion to the other as compared to absolute numbers.
Notice that the homosexual curve arises steeply and then veers
off; the drug abuser curve also and the transfusion and the
hemophiliac curves also.

To me, those curves are amazingly congruent. They all
arise and veer off in parallel. I did not expect this. I
expected the transfusion hemophiliacs to be lagged behind. I
expected a variety of differences. These are really quite
different populations. They are all moving together. To me,
broadly speaking as an epidemiologist, some primary major force
is affecting these curves, and it's the same broad force. I
think that is a logical conclusion. What is that force? It's
not any single one. It's a composite, what we call in
mathematics a vector resultant of many, many forces applying.
Basically, to me, it was a whale of an epidemic of this disease
spreading in the early '80s, and we're still dominantly
influenced by that fact. Now, then, to get a curve fitted to
this which any student using William Farr as a role model
couldn't resist, I've taken the homosexual/bisexual cases and the
intravenous drug cases, added them together along with that
category where they can't tell the difference. This makes 90

134

 

 

 
 

 

percent of the total cases, and that proportion remains a
constant.

I've added them together on an annual basis, and there
we have in '82 881 cases, building up to 25, and I then take a
simple arithmetic test. What is the percent increase from one
year to the next, the first ratio, take off one, and you have
186 percent, then 106 percent, then a 75 percent increase. This
is the same thing. The curves are veering off, and I won't get
into the mathematics of this, but, simply, if you take a ratio, a
second ratio, you get a measure, what is called a deceleration,
and that's surprisingly constant. It permits us to draw a normal
curve which is in the last figure. This is my prediction or, I
say, my projection, not a prediction, of the course of the AIDS
epidemic in homosexuals and IV drug abusers, 90 percent of the
total problem. This looks different because this is now on an
arithmetic scale. But looking at the logarithmic scale, this is
veering off, and I predict it will peak in July of 1988 and then
decline. The area under that curve by 1995 will only be about
130,000 cases. I have no brief for the accuracy of that
estimate. The important thing is that I believe it's going to
crest next year within six months and start down. I believe it
won't go down symmetrically. I think there are many, many forces
which I can't go into that will tend to make it trail off longer.
But I believe we have seen the resultant of this force in the
early '80s, and it's going to wear off slowly, and we're going to
go to a low and declining endemic level through the rest of this
century. I appreciate the opportunity of presenting my rather
maverick views.

MR. CREEDON: Thank you very much, Dr. Langmuir.

MS. GEBBIE: In making your predictions, Dr. Langmuir,
to what extent have you taken into account the data on the number
of infected people already known? If we take even the most
conservative estimate that we heard earlier today of 350,000
already infected people, the total I get out of your chart is
about 82,000. That is a fairly low number of cases out of the
number already infected. Did you take that number into account
or --

DR. LANGMUIR: This is totally the AIDS reports
corrected as accurately as possible for reporting. These are
date of diagnosis correctives. These are October data and
limited to 1986. There was a nine month period to catch up and
we found that was not enough, we increased the figures by another
5 percent by each category exactly. I think the data are okay.
This is what William Farr did. I think it is rather neat and
simple. It is a projection on a totally different basis. It is
a projection that has some biological precedence and therefore, I
believe it should be considered. I believe it is more valid than
an empirical projection that has no biological basis.

135

 

 
 

 

MS. GEBBIE: In trying to consider it, and I think we
should consider all possible projections that are put in front of
us, where one looks remarkably different from the others, if we
are to go with it, it seems to me we have to be able to explain
what the differences are. Perhaps one of the things you could
provide us as subsequent material is how you would account for
what appears to be a much lower rate of illness in infected
people using your model than in any other --

DR. LANGMUIR: I don't believe that is necessarily
true. I believe the infected figures. I think the estimates
ranging from say 500,000 to 1.5 million are quite within the
range. We don't know what proportion of the infected people are
going to develop AIDS. Almost certainly in any biological system
except guillotining in the French Revolution, it doesn't take 100
percent. Whether it is 50 percent or on the average say 25
percent, whether the co-factors in the homosexual population of
AIDS, hepatitis, herpes, are going to make that proportion
higher, I don't know. I have no knowledge or basis of
interpreting what proportion of infected people will come down
with AIDS.

MS. GEBBIE: Your curves would seem to take a much
lower view than anybody else's.

DR. LANGMUIR: Not necessarily, a lower proportion of
them, yes. I don't know what that figure is. We saw the
estimated curves. I suspect this will be different with
hemophiliacs and blood transfusions than with homosexuals. It
will vary with homosexuals in different areas. That is a great
figure and I agree we need to know. More important in the
projection, we need to have a better measure of what this
incubation period is. I've been wrong twice. If the incubation
period averages six years which spreads out to 12 years, maybe
one year to seven years and tail out to 25 years, this is
crucial. I believe that where you get this will be the
transfusion data. The transfusion data ought to be nearly
perfect for this. I am urging CDC to follow every transfusion
case just as fast as possible, be very up to date with it. Very
shortly, if it is going to turn over, the transfusion data will
show this turnover most accurately and soonest.

MS. GEBBIE: I don't think I asked my question plain
enough. I will write it out and ask for an answer. I do want to
see that. Thank you.

DR. LANGMUIR: On the infections, I have no way of
judging what proportion of the infections will come down with
AIDS. Therefore, it doesn't come into this projection.

MR. CREEDON: I think that is your answer.

136

 

 
 

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DR. LANGMUIR: I tried to answer.

MS. GEBBIE: From my point of view, that makes it hard
to use this because we have infected people out there. If we
don't have some grasp of how many of them are going to become ill

DR. LANGMUIR: These are the numbers of AIDS cases I
project. These are the ones you have to plan medical care for
and each state is going to have its own curve and so on. If this
curve has any applicability, as I believe it does, it should be
very helpful to each area to make this curve for their own region
and get at least a quick first order approximation of what their
problem will be. I think it is very useful or could be.

MS. GEBBIE: I am having trouble seeing it in the
context of the other data which I have, but I appreciate your
efforts to help me understand it.

MR. CREEDON: Any other questions of Dr. Langmuir?

DR. LEE: I would love to hear Dr. Curran's comments on
Dr. Langmuir's.

DR. LANGMUIR: It is not the first time he has seen it.

DR. CURRAN: It won't be the first time Alex has heard
my comments either. Well, I think Alex and Dennis, as many of
the other people involved in mathematical epidemiologic models,
have called our attention to the key variables to look for. I
think I would agree with Alex, Dr. Langmuir, in saying that since
we are not seeing an exponential increase in AIDS, which we have
never really seen beyond mid-1982, that is it is not strictly
exponential, doubling every "x" number of months, then that is
telling us something about both the natural history of infection
as well as the number of people who are becoming infected. Where
we differ is in the use of the logistic model. The logistic
model makes the assumption, the biologic assumption of
saturation of infection and disease and it should fit, I believe,
the hemophilia group, where the cohort of hemophiliacs in the
United States can be essentially assumed to be saturated and no
longer to become infected.

It is somewhat confusing whether the curve would
exactly fit because the curve then is measuring past infection
and future natural history. I think the truth is somewhere
between a logistic curve, which assumes saturation, and an
exponential curve, and the three curves that we submitted, the
damped exponential, is the one which comes with 1 million to 1.5
million most closely, the damped exponential assumes continuing
susceptibles entering the population. The reason I say that
curve would fit the biologic plausibility better is that

137

 

 
 

 

logistic models have not fit well those infections which are most
like in my view HIV infection, that is infections like hepatitis

B, gonorrhea, syphilis, infections that are sexually transmitted,
which tend to result in epidemic curves which peak and then level
off.

I think we would agree that this is not going to go up
forever. I think it is going to peak. I don't know -- I am
concerned about predicting peaking in mid-1988 because I believe
that is premature. I think it will peak but instead of going
down all the way, it will level off a couple of steps below the
peak. The question we all have is how far below the peak. I
believe that is very much up to what happens in society in terms
of the numbers of new susceptibles entering the population, the
efficacy of education programs, et cetera. There has not been a
sexually transmitted disease that I know of that has obeyed
Farr's law, so to speak.

DR. WALSH: Alex, do you make that same projection
effective for outside the United States, where the disease is
primarily heterosexual?

DR. LANGMUIR: One, I challenge that statement. I
don't believe African AIDS is primarily heterosexual. There is
so much blood and so many needles and ulcers, I don't think we
know how AIDS is spread in Africa.

DR. WALSH: I can only quote the Africans. They
believe it is heterosexual. WHO has accepted it as heterosexual
there. I just wondered --

DR. LANGMUIR: I have no thought of applying this
outside of the U.S.A.

DR. WALSH: You are very correct on the blood business
and there is very little progress being made there on controlling
blood supply. I didn't think you did but I wanted to be sure.

DR. LANGMUIR: I would say I don't think there is
heterosexual spread of any consequence in this country. I think
we are seeing a homosexual and IV drug problem dominantly from
1980 to 1982 or 1983. Since then it has fallen off by behavioral
changes in homosexuals, somewhat less for the IV drug users.

That is why I predict this curve is going to go down, go down
steadily, not necessarily symmetrically, but down to a
progressively lower level for the rest of our life and that of
most of our children.

DR. PRIMM: Dr. Langmuir, what we are seeing in
intravenous drug using programs, sexual behavior among IV drug
users, is a tendency for under 35 year old IV drug using males to
have as a sexual partner a female who is of course heterosexual

138

 

 
 

and not an IV drug user, and another sexual partner, female, who
is an IV drug user and usually is infected with the virus or is
HIV antibody positive. In your explanation, how do you account
for this not being a great window of spread, and we are seeing
more and more of these cases coming up every day. I am seeing
them on a personal basis, the heterosexual population that has
nothing to do with IV drug abusers, women who are not IV drug
users but who happen to be dating an in the closet IV drug user
or in the closet bisexual male, particularly among blacks and
hispanics. How do you explain that with Farr's phenomenon?

DR. LANGMUIR: Simply by the parallel of those curves.
If these factors were of consequence, I'm sure they are there
anecdotally and so on, and my friend, Dr. Henderson at Hopkins,
jumps all over me with this projection, because he sees the cases
infected in the OB Clinic at Hopkins. I say, look at the
congruity of those curves, look at the stability of how the cpDc
classifies heterosexual cases, half of them from foreign born,
other Third World countries, and half contacts of high risk
groups. If this was a factor of consequence, these groups should
be increasing in proportion to the total. It has stayed a
constant 7 percent, less than 7 percent, steadily without any
change. It cannot be an epidemiological factor of consequence.
It is a secondary, minor force.

DR. PRIMM: What about the underreporting that Dr.
Redfield talked about with the population that is volunteering
for the Army and that really boils down to an underreporting of
the numbers that are really out there, because we know that about
55 percent of high school, blacks in high school and Hispanics in
high school, drop out before the 10th grade, so they don't have a
high school diploma and 67 percent of that group use drugs, more
than those who stay in high school. What about that population,
do you think it is small?

DR. LANGMUIR: I am dealing with the national reports
from the states, local cities, to cDC. This has been what I have
done all my life, relied on this system, morbidity/mortality
reports, then developed into an organ of great precision to
primarily the state health officers and everyone else interested.
I believe, certainly in the homosexual group, responsible group,
concerned deeply, the reporting is probably improving rather than
being under. Admitting the problem, everybody is familiar with
it, the clinics are there, the reporting mechanism should be up
to high gear. We believe in San Francisco, it is very good.

The IV drug problem is more difficult but they are
coming in under care also. I think there is a little reluctance
on the part of the reporters, the doctors, to report these. The
hemophiliacs, again, over time, the doctors have been most
reluctant to be responsible for giving a death certificate to
somebody. Over time, they are familiar with this, they are aware

139

 

 
 

 

of how responsible it is. I believe the lag and the reluctance
to report is going down. I think the reporting, although there
may be lags in getting to cpc, is basically improving over time,
because there is more recognition of the seriousness of the
problem. I am thinking in the broad macro picture, the total
nation. I look for evidence of heterosexual spread outside of
the context. I have pounded CDC and Jim Curran and his
colleagues. I do not see the data over time of what is called
the not identified risk, the number must be so small, well under
l percent, or it would have been recognized and talked about.

MR. CREEDON: Maybe we can move onto our last witness,
who is Dr. Michael Osterholm of the Minnesota Department of
Health. Dr. Osterholm?

PRESENTATION BY DR. MICHAEL T. OSTERHOLM

DR. OSTERHOIM: Mr. Chairman and members of the
Presidential Commission, I too want to thank you for the
opportunity to address the Commission today, to share with you a
perspective on the Acquired Immune Deficiency Syndrome problem in
the heartland -- that area in the middle of the United States not
often thought of in the national AIDS picture. Although there
are many regions in this country where the AIDS epidemic has yet
to be experienced in the ways that we have come to know it in
many of our East and West coast cities, my public health
colleagues and I in Minnesota, and other Midwestern states,
believe it is just a matter of time before we begin to document
an increased -- if not similar -- incidence of HIV-related
morbidity and mortality in the heartland.

This may seem a bit premature, considering that the
incidence of AIDS in Minnesota to date is only 69 cases for one
million population, ranking us 25th nationally. It is a figure
that is more than ten-fold lower than that documented in the
state of New York, and seven-fold lower than that found in
California. However, many residents in Minnesota -- as do
residents of other states in the heartland -- continue to deny
that AIDS will ever be a real problem. This denial sets the
state for a very serious AIDS problem into the 1990s. For the
purpose of describing the AIDS problem in Minnesota, I would like
to provide you with an overview of our state's population.
Minnesota has a population of approximately 4.2 million people,
with half of the population residing in the Twin Cities
metropolitan area. Although not easily quantified, a
substantial number of persons at increased risk for HIV infection
are estimated to reside in Minnesota. An estimated 100,000
homosexual or bisexual men live in the state, with a majority
thought to be in the Twin Cities metropolitan area. This
estimate is subjectively supported by demographic variables used
by the CDC to measure the disease impact of AIDS. In the
discussion I would be happy to elaborate on how those estimates

140

 

 
 

 

were arrived at. But more importantly, we estimate that less
than five percent of these men are Gay identified. Rather, the
majority of these men live in a world of denial of their own
sexuality that makes it very difficult, if not impossible, to
penetrate so as to bring home the perceived risk of HIV
infection.

These types of problems are different than those often
seen in more widely open Gay communities of the East and West
Coast. The number of chronic intravenous drug abusers residing
in Minnesota -- again, primarily in the Twin Cities metropolitan
area -- is estimated by our Minnesota Department of Human
Services Chemical Dependency Program to be between 1.5 and 2,000
persons, a number substantially less than that probably in one
area of New York City. The number of persons who use
intravenous drugs recreationally has not been well quantified,
but it may be many times that number. Personally we have worked
up a number of large outbreaks of viral hepatitis type B
associated with IV needle use in recreational drug users. Three
to four hundred persons with hemophilia in Minnesota are
estimated to have received blood products potentially
contaminated with HIV.

Based upon these estimates of the at-risk, population,
and the seroprevalence data collected by us and others within our
state, we estimate that at least 20,000 Minnesota residents are
currently infected with HIV. We believe many will ultimately
know some form of HIV-related disease. As of December 7, 1987,
289 cases of AIDS, with 163 deaths, have been reported to our
Department. However, the total number of cases represents a 43
percent increase in cases since July 1 of 1987. Of the 287
cases, 251 -- or 87 percent = - have resided in the Twin Cities
metropolitan area at the time of diagnosis. This is changing,
however; and, in fact, there was a 75 percent increase in case
numbers in rural Minnesota between July 1 and that of December 7.
Most Minnesota cases have occurred in homosexual or bisexual men.
As of December 9, 1987, 239 == or 83 percent -- of our AIDS have
resulted among Gay or bisexual men. Nine <= or three percent --
have occurred in intravenous drug abusers; and 17 -- or 6 percent
-- have occurred in Gay or bisexual men with a concurrent history
of IV drug use. The remaining 22 adult or adolescent AIDS cases
have occurred in persons with hemophilia, as a result of
transfusion, as a result of heterosexual contact; and, in four
cases, transmission categories remain undetermined at this time
as investigations continue.

To date, only two cases of pediatric AIDS have been
reported in Minnesota. One occurred following a blood
transfusion, the other one remains unidentified, as we are
continuing to work that case up. The racial distribution of
Minnesota AIDS cases is as follows: White, not Hispanic: 88
percent; Black, not Hispanic: nine percent; Hispanic: three

141

 

 
 

PO

percent; Other: one percent. A disproportionate number of AIDS
cases have occurred among people of color in Minnesota. Blacks
have accounted for nine percent of our AIDS cases, yet only
comprise 1.3 percent of our state's population. In addition,
Hispanics account for three percent of AIDS cases, and comprise
only .8 percent of our state's population. Unfortunately, many
of us in public health may take some comfort in recognizing that
many of the observations to date regarding the increased risk of
AIDS among our communities of color come from places like New
York City, and Newark, New Jersey, and thus hold only limited
implications for the remainder of the country. We, in the
heartland, must remember that early in the HIV epidemic many
practitioners in clinical medicine and public health believe that
AIDS in Gay men would be an important problem only in New York
City, San Francisco, and several other metropolitan areas in the
East and West coasts.

Today the heartland is repeating that early experience
of those coastal metropolitan communities with regard to AIDS and
Gay men. We believe that the metropolitan areas of the heartland
will also repeat many of the experiences with AIDS in communities
of color. What does all this mean for the heartland and AIDS of
the future? It is difficult to impress upon residents of the
heartland the long term importance of AIDS upon their health.

For example, in Minnesota only 162 residents have died from AIDS
through 1987, while in 1986 572 residents died on our highways in
that single year. This will change, and it will change
dramatically. In a recent publication from our Department, we
projected the morbidity and mortality from AIDS in our state
through the year 1990. While these projections were made in
1985, they remain accurate within several percent of the

original projections as of today. By the end of 1990, we predict
that there will be between 1,300 and 1,900 AIDS cases among
Minnesota residents. Also by that time, the person years of
potential life loss for AIDS will exceed for all the causes of
years of potential life lost for single, never-married men ages
25 to 44 in our state.

 

In addition, it will be the number two cause of years
of potential life lost among all men 25 to 64 years of age, only
falling slightly behind that due to heart disease. By 1991, AIDS
will even be the number one cause of years of potential life lost
in this latter group. Unfortunately, we in public health have
concluded that there have been only limited changes in risk
behavior in our state at this time. In part, this is due to the
lack of perceived risk related to HIV infection. I think many of
the situations we have heard today relative to major behavior
changes have occurred in areas where the high incidence of AIDS
makes the problem much more visible than in an area such as ours..
For example, although we too in Minnesota have documented a
significant decrease in the incidence of syphilis in Gay men in
our state, we have been unable to document any change in the

142

 
 

 

incidence of acute clinical viral hepatitis type B among Gay or
bisexual men in our state, from January 1982 through June 1987.
As you know, the risk behaviors responsible for the transmission
of hepatitis B are similar to those responsible for the
transmission of HIV. In addition, we estimate at this time that
the incidence of intravenous drug abuse in our state is at an all
time high.

It is apparent that AIDS will have a dramatic,
nationwide impact on all aspects of society. In some areas, the
impact is obvious now. For other areas, like the Heartland, it
will not begin to realize a dramatic impact until 1990 or later.
It is critical that this Commission and all other federal and
state and local agencies involved with the AIDS epidemic realize
that we have yet to appreciate the likely or potential impact of
AIDS in many areas of our country. We urgently need to expand
our current efforts in bringing about behavior changes in these
areas. We still have a chance in these areas to have significant
impact on those who are currently at risk. We recognize that
programs aimed at behavior change and, in some settings, major
social change, require extensive economic and human resources.

However, the added burden and cost of life lost in our
society as a result of high AIDS incidence rates in metropolitan
areas nationwide -- and, to a lesser degree, in our rural areas
-~ should be taken into account when examining the cost of
programs which impact on HIV transmission. Allocating resources
now for such programs may prevent a much greater cost in the
future. Public health officials are the first to acknowledge
that behavioral and social change will not be easily realized.
Therefore, we must also consider the more limited, traditional
public health strategies and disease prevention and control. We
must also begin to focus on the issues related to behavior
formulation, rather than emphasizing behavior change. These
issues should be raised in our younger age groups, where the
developing behavior patterns can be influenced, rather than
attempting to devote all of our resources to behavior change
among adults and older adolescents.

Finally, I have come to more fully appreciate the
impact of AIDS when I realize that my nine year old daughter and
my six year old son will grow up into a world of AIDS.
Unfortunately, this will occur regardless of whether they live in
New York or California, or if they live in Minnesota or Iowa.
AIDS in the heartland will take a serious toll. Maybe not now,
but eventually. It is critical that we not forget that area
which has been considered to date as often the flyover land for
AIDS. Thank you.

MR. CREEDON: Do we have some questions? Yes, Cory?

143

 

 
 

 

DR. SERVAAS: Could you clarify something; we talked
about it earlier, and it has to do with prevalence. That is the
testing of the blood donors in Minnesota. You had in excess of
250,000 low-risk, and no positives. Could you explain that?

DR. OSTERHOILM: We have a somewhat unique situation in
Minnesota, with a very close working relationship between our
state health departments and the two blood banks which are
responsible for testing all the residents within the state.
Within the context of that, we do all the follow-up through the
state health department and any HIV positive, in this case
talking about a reactive EIA positive Western Blot donor. As of
last month we had tested a total of 520,000 different donations, -
which is approximately 320,000 different donors. It was raised
this morning that a number of them are repeat donors. To date we
have identified 15 positive individuals, of which we have
followed up all 15; 14 of the 15 had acknowledged high risk
behavior; one did not. We have completed culturing 13 of these
individuals which included the one individual who did not
acknowledge risk factor; 13 of 13 are virus positive.

The other two are undergoing culture procedures right
now. We have every reason to believe, because both are high risk
-- and one actually has clinical diseases -- they will both be
positive. So, in our state, in a very low risk setting with two
very, very outstanding laboratories, we did not find a single
positive in 520,000 tests. Excuse me, false positives in 520,000
tests with 320,000 different individuals. We are continuing to
monitor that.

MR. CREEDON: Any other questions?

MS. PULLEN: Does your state require reporting of HIV
positive individuals, or just of cases?

DR. OSTERHOLM: We do require reporting by all health
care officials for anyone who is HIV antibody positive, as
defined by a positive Western Blot or other confirmatory tests.

MS. PULLEN: What do you do with that information?

DR. OSTERHOIM: Several things. First of all, we do --
as has been indicated by the Centers for Disease Control -- try
to define how we can, in the best ways possible, the demographic
aspects of that information. We have initiated a number of
surveys within our states so as to attempt to define that part of
the iceberg underneath the water line. But also, in addition, in
terms of risk reduction information, we do have a very active
contact notification program which we then do follow-up with
these individual patients when reported. We now have more than

144

 
 

 

we can handle. We have had over 600 individuals who are HIV
positive reported to us in the last several months, so that we
are a bit overwhelmed, and we do have a priority system for that.

In terms of unsuspecting contacts, et cetera, in terms
of following that up. So we have made every attempt, either
through our own agency or through local groups which we support,
in terms of risk reduction programs to provide that. I think one
of the things that I would like to emphasize relative to that is
that we are very aware of -- and I am sure that this is not
anything new to anyone in the audience -- that unfortunately we
have had a certain fixation in this country upon testing an
individual, providing them with an hour of counseling, and
appreciating that we will be able to change one of the most
intimate behaviors in our lives with that testing and one hour of
counseling. I think that we are initiating a number of programs
to look at long-term behavior change support programs that will
allow that individual to continue to receive that kind of
behavior change support necessary.

MS. PULLEN: Have you been able to identify any
seropositives through the contact notification program?

DR. OSTERHOLM: Yes, we have.

MS. PULLEN: Have you experienced any difficulties with
confidentiality in that program?

DR. OSTERHOLM: We have not experienced any problems
with confidentiality; but, in terms of the overall progran,
Minnesota probably has the tightest single piece of legislation
in the country on a statewide basis, in terms of confidentiality.
It is a result of efforts years ago to appreciate the importance
of confidentiality, whether the record happens to be associated
with mumps, measles, rubella, or HIV. We have very strong
protections, including penalties for release. But, more
importantly, our records are not even discoverable in a court of
law by law. So that should we be provided with a subpoena, we do
not have to surrender those records.

MS. PULLEN: Would you provide a copy of that statute
to us please?

DR. OSTERHOLM: Sure, I would be very happy to.
MS. PULLEN: Thank you.

MR. CREEDON: Have you had much of a public outcry
about this program?

DR. OSTERHOIM: I would say yes and no. I don't know
how to answer that, in the sense that I think that unfortunately

145

 

 
 

far too often there have been certain what I would call fringe
elements who have received a great deal of publicity, and who
have received a great deal of attention, who hardly represent the
mainstream of the infected individuals involved. Yet it seems

as if there is a lot of outcry. I had the dubious distinction,
for the first time in my career last fall, of having someone call
for my resignation.

It happened by two different people on the same day,
totally by accident. One was a Lyndon LaRouche Congressional
candidate from southwestern Minnesota, and the other was a well
known, outspoken Gay activist from the Twin Cities. One because
I was turning the state over to Gay men, and the other one
because, in fact, I had been bought over by the Gay lobby. I
think that when you try to appraise that type of outcry, you then
begin to put yourself somewhere in the appropriate perspective of
where public health has to be and should be. In terms of the
mainstream, no. In fact, I think there has been tremendous
support from within various groups within the state.

DR. WALSH: Did I understand you to say that you
contact tracing?

DR. OSTERHOLM: We do contact notification, yes. We
have several forms of it.

DR. WALSH: Have you had any resistance from the
contacts when you traced them?

DR. OSTERHOLM: Are you talking about the individuals
whose names have been provided?

DR. WALSH: Yes.

DR. OSTERHOLM: Actually I can say that I know of none
specifically. I think, again, that most of the times when one is
working with partner referral contact notification, (a) it works
in those areas where the seroprevalence is still quite low. I
think in a place like Minnesota that is one particular option.
(b) It is a method to bring home that personal vulnerability far
in advance of the deaths, or at least the visible sign of AIDS,
which is in many cases, I think, a major motivating factor in
some of our larger cities of the East and West coast. And (c) I
think the point is that the contact notification is only as good
as the voluntary nature upon which people will, in fact, identify
contacts or can identify contacts. The first thing one does is,
in fact, attempt to help the individual do the contact
notification themselves. That is always the best, if it can be
done and is done. In some cases, that is not elected to be done.
We actually have a program that we have developed and which we
call Partner Outreach Service, where we actually will help
individuals through several sessions to develop the skills to do

 

146

 

 

 
 

their own contact notification. Then we have our own separate
notifiers that will do the same thing. But I think on the whole
no, we have not really experienced any of the kinds of --

DR. WALSH: That bears out the same experience that
Colorado has had. They have had virtually no resistance on
contact tracing.

DR. OSTERHOLM: I think I should emphasize again that
this is a very labor intensive effort, not one that I think
should be taken lightly, but it can only be a small piece of a
very large prevention program, because of the number of people
you can reach. But I think clearly for unsuspecting contacts it
can be a major effort.

MR. CREEDON: Terry?

DR. CRENSHAW: I think you made just a critical point
that I would like you to elaborate on, and that I think is not
very well appreciated. That is that in counseling and testing,
just as with sex, often once is not enough. One hour of
information when a patient learns of their positive status, when
anxiety levels are so high, does not necessarily sink in and
induce behavior change. Could you elaborate a bit on your
programs of reinforcement, and how you are finding that to be
effective?

DR. OSTERHOLM: First of all, let me point out that, in
fact, some of the most significant changes from a population
base standpoint of sexual behavior in Minnesota have occurred
among Gay-identified men. I want to make that point up front,
because I think these are the individuals who come to grips not
only with their sexuality, but with the AIDS problem. The larger
problem that we have in Minnesota -- and I think is
characteristic of much of this country -- and should not, and is
often unfortunately characterized by the experiences of places
like New York City and San Francisco, is appreciate that the vast
majority of men who have sex with men are not Gay-identified.
This probably came home best to us a year and a half ago, and we
had a male prostitute who came forward who is infected with HIV;
and, based on signs and symptoms, had been infected for at least
several years.

In the previous four years he had had sex with over
1,000 different Twin Cities men from the affluent suburbs of the
southwestern part of the Twin Cities. In most of the cases, he
had to crawl over the children's toys to get in the front door
back into the bedroom. And, on a number of occasions, had to
crawl out the back window as the wife came home early
unexpectedly. We did a lot of follow-up in those settings.

147

 

 
 

 

Unfortunately, the idea of human sexuality -- we often
talk about the Kinsey scale, and I am not one to lecture to you
about human sexuality; but I think we in public health in
Minnesota fully appreciated that from that zero to six, whether
you are heterosexual or homosexual. There are a lot of people
out there that might be one number in terms of what they do
romantically, one number in what they do emotionally, and one
number what they do physically. Our biggest problem, then, in
attempting to deal with HIV is attempting to get people to come
to the realization of their own human sexuality. They are in
such denial with it that it makes it much more difficult for us
to even begin to deal with AIDS. That is in stark contrast to
that area where people are Gay-identified, they are openly part
of a Gay "community." It makes it much easier to deal with HIV.
That's why, in Minnesota, that combined with the relative absence
of acute frank AIDS cases yet makes this idea of one hour kind of
support -- it is like telling the drunk driver one time on the
highway as he is driving home, You shouldn't do this, even though
he is a chronic drinker, and expect that you have just solved his
chronic drinking and driving problem.

, DR. CRENSHAW: Do you have any follow-up on your more
frequent counseling approaches and impact upon behavior?

DR. OSTERHOLM: I think one of the real difficult
aspects of this epidemic is, in attempting to plan "research
strategies" concurrently with intervention, as we so have devised
it, it is very difficult. Some of you may be aware in Minnesota
-- where some of the finest work in the country has been at the
University of Minnesota on non-smoking and youth, and that whole
area of behavior -- we are working with that group to begin to
define and further characterize how can one actually begin to
look at behavior change in human sexuality. I would go back and
reemphasize, though, I think from our experience with all other
"preventable high risk behaviors" that formulation is a heck of a
lot better than change.

DR. CRENSHAW: That is another exceedingly good point
that you raised, because I think people nix the advice of the
kind that you give to someone once they are already either
sexually active or active in substance abuse. Once they are not
yet sexually active, or active in drug abuse, and how you can
influence that behavior. Thank you.

MR. CREEDON: Cory?

DR. SERVAAS: Could you tell us how you would approach
getting other laboratories in the country up to speed? And you
mentioned that Iowa City has a good lab also. But if Minnesota
can do it, and Iowa can do it, how could we get uniformity in the
country, do you think?

 

 
 

DR. OSTERHOLM: Well, first of all, let me just
indicate for the record, I'm an epidemiologist and not a
laboratorian, so that I don't speak out of turn. I think that
one of the things that I've been very careful about emphasizing
is that the data I've just provided to you from Minnesota
relative to our blood bank testing -- and I might add that these
two laboratories, in fact, also do all of our high-risk testing,
and we have actually taken 400 specimens of which we had
approximately 100 positives and blindly provided them to the two
laboratories independently, and they had 100 percent agreement on
400 specimens, so it's not even a function of just they were
lucky at their labs. I mean, action and proficiency, they're
very good. But I think it's developing that kind of expertise.
I think Dr. Francis made an excellent point this morning. Others
have commented that where you do have proficiency interest and
you do have the kind of laboratory expertise, this test in the
hands of those kinds of laboratories, I think it's true: the
clerical errors exceed the errors that come from the laboratory
tests themselves. I might add that even in our own state, we
have even developed the expertise not only in testing
HIV-infected individuals for antibody, but also in culture. In
work that was done at the University of Minnesota by Dr. Hank
Balfour and colleagues, we've just completed 56 asymptomatic
individuals with hemophilia who are Western Blot positive, and
virus was cultured from 56 of 56.

I think the techniques in the laboratory have improved
significantly over the last two years, such that to do it, I
would say working in conjunction with the cDc through their
proficiency testing program, and I would have to say that the
laboratorians on a whole, I think, are doing a lot themselves. I
think the problems have come in, when I've seen it come in, are
some fly-by-night companies that have no interest in necessarily
legitimizing the proficiency issue have come onboard, and maybe
that's an area that needs to be addressed. But I think there are
many qualified laboratories out there now that could do the kinds
of testing that we're talking about.

MR. CREEDON: We can open the questions, I think, to
the entire panel now. You may have skipped asking a question
before when we were moving on. Yes?

MS. GEBBIE: Actually I have the same set of questions
for Dr. Axelrod and Dr. Osterholm. We heard this morning a good
deal about the present estimates and calculations of incidence
and prevalence in this country, and it's very clear that we're
working from limited data, from special populations, and kind of
interpolating various places. It's not complete. A key
question, I think, for this panel on a national basis, which each
of you must have answered on a state basis, is whether the kind
of information we have now, even though it's a range estimate
rather than a specific number of infected and so on, whether

149

 

 
 

 

that's adequate to make the kind of policy projections and policy
recommendations we're going to be making, or whether it is not,
and if it is not, can each of you identify the specific kinds of
studies that you think would be most critical to do to start
filling those data holes?

DR. AXELROD: Well, I would first say that I don't
think the data that we have represent the kind of information
that I think is adequate to allow us to address the public health
needs. As I indicated earlier, epidemiology is the tool of all
of us who are involved in public health, and the tool that we
have is a very blunt one right now in terms of our ability to
deal with the kinds of special resource needs that have to be
allocated within the community. I don't think that we are able
to establish the kind of hierarchy that we need to establish with
respect to public health initiatives with the information that we
have.

What are the kinds of things that can be done? Well, I
think that the CDC effort and our own with respect to testing a
very large segment of the population to determine the
seroprevalence among both high-risk and no-known-risk populations
is very, very critical. I think it's also important that we do
some analyses of cases, of individuals who have various kinds of
infections as part of the linear study of what is happening to
populations within certain ages who are being hospitalized for
infections that would not normally require hospitalization, so
that we can begin to get some better idea of the progress of the
disease and perhaps more information with respect to those cases
by virtue of this kind of evaluation of what the outcome is going
to be.

As Dr. Langmuir correctly pointed out, we don't know
whether the case mortality rate is going to be 50 percent or 60
percent or 30 percent or whatever it is. But we do know that
there appears to be a great deal of variation, and we don't know
whether that variation relates to cofactors which we can define
by virtue of the kind of studies that I think can be undertaken.
So I think that there is a great deal of need for additional
epidemiologic studies to sharpen our ability to allocate the
scarce resources that we have, whether it be in prevention,
education, counseling, or the direct provision of health care
services.

DR. OSTERHOLM: I would agree largely with those
comments. I would add, however, that if we're talking about
behavior change, then we do need more information relative to how
and where do we target that. But if we're talking about
behavior formulation, we don't. We don't need to be told anymore
that our youth are going to grow up into a world of AIDS, and
that that those problems which are affecting our adults today
will be the problems that will affect our youth tomorrow. We

150

 

 
 

don't need to be told anymore that it's much easier to formulate
behavior than it is to change behavior. And yet I see a real
absence in this country of any concerted effort for real youth
education relative to HIV prevention in a way that I think will
provide us the kinds of benefits tomorrow and next year. I think
far too often we've been preoccupied with this epidemic, and
appropriately so because of the size of it, the next six months,
the next year, or the next two years, and we need to start
looking at a generation. I think even you as a group have heard
already the likelihood of a vaccine. If even a vaccine is
available, what would be the likely outcome in terms of the
number of infected individuals.

I would like to say one thing. I think that we do now
realize, I think, that if we look at the risk behaviors out
there, we're at an all time high in this country for hepatitis B.
We've already heard information on heterosexual transmission of
various sexually transmitted diseases. I can tell you in
Minnesota and many other areas like us, that there still is a
relative absence of belief in the AIDS epidemic. I keep getting
challenged on this whole issue, because it just hasn't hit yet.
And it's like the person who can't see the tornado in the middle
of the night on the plains out there and doesn't believe it's
coming until after it just went by their house, and when it
finally came in the middle of the night, they believe it was out
there. I think that's where we have the problem. In fact, there
are some programs we can begin to deal with. I would say that
the CDC family of studies approach, which I find, I think, a very
positive approach, I know in our own state, as an adjunct to what
we're already doing, will help us to further refine where the
infection is and where we need to target what resources.

DR. AXELROD: I think I would just make one other
comment which I have not, because I suspect most of you are aware
of it, and that is that New York State has a mandated AIDS
curriculum currently that begins in kindergarten and runs
throughout the entire curriculum, so that although there has been
a great deal of controversy about certain sections of it, there
has been the acceptance of a need for an AIDS curriculum which
will be in place and mandated by the Regents.

MR. CREEDON: Dr. Curran?

DR. CURRAN: As long as everybody is getting in their
wish list for data, in thinking down the road, I think that -- I
really agree with Mike that behavior formulation would be the
answer. I think that there's not been a lot of research in the
last few centuries, decades, years on how -- what formulates
promiscuous sexual behavior and intravenous drug abuse, and I
think that we know that it shouldn't be formulated, but the
Characteristics that lead to it are pretty complex socially and
psychologically, and I think that probably there's a need for

151

 

 
 

 

quite a bit more research in those areas. They have not been
areas that a lot of people have jumped into. All of the sex
research societies are relatively new, and you can count the
number of books recently on why people are heroin abusers, you
know, relative to the importance of the problem.

MR. CREEDON: What is your reaction, Dr. Curran, to
some of Dr. Axelrod's more recent statements, as well as his
earlier statements, about a lot more needs to be done in order to
get a handle on it? I mean, do you think -- I guess in part it's
the same question that Ms. Gebbie asked, you know. In other
words, are there additional studies that are not <-- that have not
been done or are not being planned or contemplated that we should
be thinking about over and above the ones that have already been
planned?

DR. CURRAN: Well, I agree with just about everything
that Dr. Axelrod said. I'd have trouble repeating it.
[Laughter.] But I've always agreed with just about everything
he's said. [(Laughter. ]

MR. CREEDON: Well, we have it on the record here.
DR. AXELROD: I'll write that down.

MS. GEBBIE: He didn't make that in the future tense,
though. |

[Laughter. ]

DR. CURRAN: I don't know what "federal coordination"
means, but I think a Manhattan Project would probably be based in
Albany.

(Laughter. ]

Or in Manhattan, one of the two. I think that we, as a
society, don't understand heroin abuse, homosexuality, and sexual
promiscuity very well. I've always been amazed at how much -- I
used to work in STDs before AIDS. I was always amazed -- as I've
become middle-aged, I understand it better, but I was always
amazed at how many people could get STDs each year and how few
middle-aged people ever had one.

(Laughter. ]

And I think sexuality is a phase we all pass through,
and we don't know how we got there, and we can't remember how we
left it. I mean, --

MR. CREEDON: Are you speaking for yourself here?

152

 

 
 

 

(Laughter. ] | SO ~-

ee DR. CURRAN: I mean, I'm in part serious. It's amazing
how we can watch the TV shows every day and see all the blatant
sexuality thrown at us without ever dealing with it on an
interpersonal basis. Almost none of us, I'm sure none of you
panel members have really talked about your own sexual lives with
each other, and yet all you do, you know, probably 60 hours a
week is work on this problem. But as individuals, we don't do
that. Maybe Dr. Crenshaw, who works in this all the time, is
more open. But I mean seriously, as a society, we don't provide
much guidance for our children. I have trouble -- I have kids
about the same age as Mike's, and it's awfully tough. It's tough
for parents. I mean, if we say it's the parents' job to give
kids sex education, how do they do that? How do we do that? How
do we tell them to do that? I mean, what is this process of
behavior formulation, that I agree. with Mike is important, you
know?

DR. CRENSHAW: Jim, I want to underscore here that we
don't know what we don't know, most of us. Everybody, if they've
had sex once or twice, feels that they have a perspective on the
world of human sexuality and are completely oblivious to the true
spectrum of activity that is occurring. And what I'll add there,
when you're talking about multiple partners or promiscuity, it's
talked about as though there is a non-promiscuous person and a
promiscuous person, and indeed what you're more likely to find
are episodes in a person's life, not just in their teenage phase,
but in between marriages perhaps or during periods of being
single, when they may go through very aggressive or even
compulsive sexual activity, and then spend the majority of their
life, once they get trapped into or find a relationship, where
they are not being as sexually active with as many partners. So
there are many, many different phases in addition to the Kinsey
spectrum that you mentioned of sexual orientation in our society.

DR. CURRAN: I think Mr. Creedon and Dr. Walsh may
remember. I referred to that as serial monogamy.

MR. CREEDON: I remember it very well. You said serial
monogamy with some occasional deviation; was that what it was?

DR. CURRAN: Yes, that's what it was, something like
that.

DR. WALSH: I think one thing you have to keep in mind
with your children, in my case my grandchildren, if you wait
until they're 15, it's too late. You're invading their privacy.
You've got to get them earlier, if you're going to talk to them
at all about sexual behavior. You've got to get them before
that.

 

 

 
 

 

DR. OSTERHOILM: But I think that one of the points that
I would really like to emphasize here, and it's been driven home
to me as someone who is really out in the trenches. Several
years ago, I was in a community giving a lecture on AIDS, and a
gentleman who is a well recognized individual in the comnunity
was on the same program with me, and I basically made the spiel
that I just made just now about the need for behavior
formulation, and he very appropriately got up as part of the
parent group and emphasized that, in fact, that was important,
but that it really should be at home, and it should start at
home, and the schools really didn't have business being involved
with it.

And in fact, I might add, it was at the same meeting
that when I talked about sex education, I had an individual stand
up and said that he had 20 years ago completed schooling on how
to weld, and now he welds; and so he didn't think we should be
teaching sex education in school if we're really going to deal
with the AIDS epidemic. But in fact, I think that what happened
here was very, very instructive to me, because this individual,
after saying this, had talked about in his own family. He and
his wife had just spent the last 25 years raising their kids ina
way that they were very proud of, and that they all had healthy
sexualities, et cetera, et cetera. Seven months later, this
individual's son, who is married and had three children, was
diagnosed with AIDS in another state and was an unknown bisexual
to his father and his mother and to his wife. I think the whole
point is, I appreciate this more and more as somebody who has
some academic friends in the area of fish and wildlife biology,
that in fact we know more about the sex lives on a population
basis of white-tailed deer and ruffed grouse than we do about
human beings, and we're trying very hard to change human behavior
relative to this whole issue of human behavior.

And so I'd have to say, to get back to behavior
formulation, it's very critical that some of the research not be
just done in seroprevalence surveys. We can do seroprevalence
surveys until we're blue in the face, but the ultimate point is
changing behavior. And I am not one to ascribe to the fact that
if you tell someone they're at risk, that means you change
behavior. We've got to get to the very basic level of behavior
formulation and behavior change. And social scientists in this
country have been grossly underfunded. I'm not a social
scientist, so I'm not putting a plug in for my own area. We
don't know.

MR. CREEDON: Well, you know, one of our primary
motives is survival, and I guess if people think that their
survival is threatened, they'll change their behavior maybe.
Yes, Dr. SerVaas?

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; DR. SERVAAS: We know what Dr: ‘Axelrod has done with
pregnant women's blood and serum and Dr. Curran. But in
Minnesota, do you have very much good help for the pregnant
women who are HIV positive, and what do you do in Planned
Parenthood?

DR. OSTERHOIM: Well, I think at this point, we have
tried very hard in our family planning facilities and in prenatal
care to emphasize the need for risk screening and so forth. I
think that one of the problems we have is that, as one of the
individuals you will hear from tomorrow, Dr. Landesman, found in
a recent study in New York, half of the individuals, who were HIV
infected at the time presenting with delivery, had no identified
risk factor other than that they were a member of the community
of color, and they'd had multiple male partners throughout their
life. We have tried to emphasize more of that. We are
beginning to look in Minnesota as part of the family of surveys
and other statewide activities what Dr. Axelrod described earlier
in doing testing of all newborns to try to better target that
program. We are, you know, looking at that as an approach.

DR. SERVAAS: Then do you let them know, so they won't
nurse their babies, or do they just go on and nurse their babies?

DR. OSTERHOLM: Well, at this point, if we know, we
Clearly believe they have a right to know and should know.

DR. SERVAAS: And so you do tell them?

DR. OSTERHOILM: When we have anyone who is HIV
positive, we will. Now we haven't done any blinded studies that
way, SO we would not be in a position. On the other hand, we
have missed a lot of HIV-infected individuals, I'm sure, as
we're starting now to see a number of HIV infected children, not
yet AIDS cases. We only have two pediatric AIDS cases, and I
know of many, many children we're currently following who are HIV
infected, who will be AIDS cases within the next several, you
know, years probably.

MR. CREEDON: Our time is about up, so I'd like to turn
the chair back to Admiral Watkins. I would like to just ask Dr.
Langmuir before I do that, you keep us informed of your --
however often you make these projections, that you let us know
when it starts down. That would be very helpful.

DR. LANGMUIR: I will be watching what comes from CDC.

MR. CREEDON: Thank you.

ADMIRAL WATKINS: Dr. Curran, in your family of surveys
that you posed in your latest -- in the CDC report to the
Domestic Policy Council, you talked about sentinel surveillance

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in 30 of the standard metropolitan statistical areas, and you
talked to us about how vast a survey that was, and it seems to me
in discussing that, you opened the door to the possible rejection
by certain people who will be tagged in that survey that may not
come forward. And the question is in my own mind, then, it's
fine to lay out this concept of survey, but who else is getting
involved to lay the groundwork and prepare the way for the Lord
on this one? It seems to me that an effort can be made to
optimize that 30 SMSAs to make them as productive as possible by
an education and leadership program that is a precursor and walks
us up to it to the point where the nation knows it's going on,
knows who's leading it, encourages the participation, so that
when we get that sample, it becomes a useful sample in a
seroprevalence database and is not just another verification that
we're at 1.5 million, because we really can't trust it anyway.
You see, we had so many people not come forward that we're not
really sure what we have.

It just seems to me that we don't need to accept that.
Now you also talked about, and perhaps you were interested in
some antidiscrimination things. Dr. Osterholm says they have the
tightest thing going in Minnesota, and it's not a problem there.
Capitol Hill says it's a big problem. There's fractionation in
the states. We don't have the proper groundwork laid. We should
have federal laws. Dr. Bowen says, no, we shouldn't. We should
take it easy, let the states do their thing. Two years ago,
there was only 40 pages on AIDS and what states were doing.
Today there's three volumes on AIDS, what the states are doing.

This is still a very confusing area, and it seems to me
that if we're going to make some recommendations to the President
on seroprevalence, and you're moving out with a plan that perhaps
has already been bought by the Domestic Policy Council as the way
to go -- I haven't seen that support, but I assume it's going to
come -- and that really we have to wait for two years to get the
ultimate survey, but actually this 30 SMSAs starting May of '88
could well suffice as a much more accurate baseline data from
which we could make projections -- then it would seem to me we'd
optimize that and make it a new kernel of credibility in this
database and have a less vacillating sort of approach to it.
Could you fill us in on how you would better do that? What
recommendation might you make to make this a much more accurate
-- let's say the optimum would be that everyone would come
forward, because you could prove the anonymity; you could prove
that what you were doing was legitimate; you've laid the
groundwork to encourage people in the high-risk areas to come
forward -- so can you give us a little idea of what you might do
there?

DR. CURRAN: Sure. I think first of all, you're right
about the Domestic Policy Council and the President. The report
was submitted to the Domestic Policy Council on the day of your

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press conference, and Attorney General Meese endorsed it
enthusiastically, as he had in previous meetings, the issue of
the family of surveys. We were assured that the resources would
be available to do that. In anticipation of those resources, we
detailed 125 CDC employees who weren't working on AIDS to assist
state and local health departments in those 30 areas to prepare
and plan and a budget request, which they are doing, which is due
Monday, to actually begin these surveys in those 30 metropolitan
areas. The issue of leadership is again like the epidemic; it's
a multiple one. There's the national leadership, the federal
leadership. There's the state and local leadership. And then
there's leadership not only for the surveys themselves, but for
the prevention and control programs which are going on next to
then.

I think there's again some -- it's very difficult to
Separate the prevention and control activities from the
surveillance activities which target those control activities and
evaluate them at the same time. For example, you can do a
blinded testing program in a VD clinic, which is offering
voluntary testing and counseling at the same time. You may have
half of the patients in the clinic undergo voluntary testing and
counseling and half don't. What you want to know is, what's the
level of infection in that clinic. So being tested blindly, for
example, doesn't preclude you from getting tested voluntarily and
getting counseled. The same person might get tested twice, but
for a different purpose. Do you see what I mean? So what you
want is leadership at the local level and at the federal level
for the prevention and control activities and for the
surveillance activities.

Now in the FY '88 budget, federal budget, there's quite
an expansion of testing and counseling efforts, as well as
community education efforts, which will provide funds to state
and local governments. It can be argued whether they're enough,
whether they're the right focus, but there's quite an expansion
over the '87 budget. We don't have an FY '88 budget yet. This
is one of the longest, I think, times. You know this from your
years in government -- you've never had a budget on October lst.
December 10th is a little later than normal. But we presume that
the '88 budget will be some combination of what Congress wants,
what the President has requested, and it will be -- whatever it
is, it will be a big increase over '87, and a lot of that big
increase will be for testing and counseling. That money will go
to the states close to the same time as the survey money. The
money will not be focused in those 30 SMSAs, but it is weighted
toward where the problems are, and this is an urban disease to a
large extent. So a lot more of the money will be available in
those areas where the surveys are and where the disease is.

ADMIRAL WATKINS: But don't you agree it would be -- as
part of the strategy, to start building the educational program

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for the nation as a whole of what these 30 SMSAs are, what the
intention is, so that there's some basic knowledge. The people
that will read your report, the technical people, all understand
it; but the American people are not going to get into that
report in that kind of depth, and it just seems to me that
national leadership, state leadership, and local leadership
should be integrated in some way to optimize the outcome of that
very incredible survey. It just seems to me, I don't see that
coming out of any entity.

DR. CURRAN: Well, I think I would agree with you.
You're talking about coordinated leadership.

ADMIRAL WATKINS: Something like that.

DR. CURRAN: If you will. Something that would say,
this is what the prevention program is. This is what the
surveillance program is. This is what the education program is.
It's fully supported, and it's nationally coordinated at the
national level and the state level and the local level.

ADMIRAL WATKINS: And whatever obstacles there are,
they'll be removed. If Minnesota has no obstacles because of
laws, other states might. And it seems to me that's something
that the state legislature, were they to hear that kind of
strategy, may work on very hard in this forthcoming legislative
cycle that may pull the states more together on the kinds of
things that they feel may be necessary.

DR. CURRAN: Well, I can't speak for the health care
part. The cdc is involved in prevention programs and only
partially involved in prevention programs in the IV drug use
area. But I can say that we're in close contact with the state
health officers and the state epidemiologists, and it would be
very easy for us -- we already are getting constant readings from
them about what type of leadership and coordination they want
from the federal government.

ADMIRAL WATKINS: Dr. Axelrod, a couple of things came
up. We heard here that in New York, for example, there may be a
three to six month wait in some of the drug treatment centers
before people can even be admitted because of a shortage. You
talked about the fact that a 1,000 to 10,000 treatment slot
increase in New York was going to take place. Is that enough to
get the waiting lines down to something that is reasonable or is
that still so inadequate that it is like a little drop in the
ocean?

DR. AXELROD: I think it will get the waiting list down
but there will be a new waiting list that will develop. As I
indicated, there are currently 40,000 slots. Our estimates are
there are 250,000 IV drug abusers.

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MR. CREEDON: What is a "slot?"

DR. AXELROD: A position for someone to fill who is in
need of service or willing to accept service. There are roughly
50 percent of the 250,000 that probably could be induced to
participate in the methadone maintenance program of one form or
another. Even increasing it to 50,000 or 60,000, it still leaves
a large potential unmet need that could be addressed by expanding
both the number of sites, the number of available slots for
methadone maintenance, but also to change the nature of the slots
to bring the methadone to the places where the individuals are,
whether it is some of the shelters we have for the homeless. The
idea is to move the methadone maintenance to where the
individuals are, not alone to require those who are the drug
abusers to come to the centers. I think that we require a
rather new view of the way in which we are going to provide those
services and to address the needs of the individuals rather than
address the needs of the providers.

ADMIRAL WATKINS: I take it that when you mentioned
this was one area where the federal government needed to focus
and it is certainly one of the major areas that we are going to
be addressing next week in our hearing, trying to get some feel
for what the Federal role would be. Let's take it in the State
of New York vis-a-vis availability of drug treatment centers.

DR. AXELROD: Absolutely, Mr. Chairman. I think we
have all recognized the fact that our efforts, no matter how
bold, to interdict the flow of availability of intravenous drugs
into this country have not met with overwhelming success. Having
failed and it may be a modified failure, having failed in terms
of total interdiction, we as a government have an obligation for
that failure to address those who have been affected and who are
part of our drug abusing population. I don't feel we as a nation
have effectively addressed the large number of intravenous drug
abusers that exist in our country. I think we have an obligation
that in fact is a failed obligation.

ADMIRAL WATKINS: You also implied that the federal
government needs to get into the business of fixing the
discrimination issue. Why can't New York State solve its
discriminatory practices either in law or by attitudinal change,
educational programs, much as Minnesota has done?

DR. AXELROD: I didn't suggest we couldn't. I think
the issue that you raise is one of leadership and where this
nation as this nation stands with respect to discrimination, how
we aS a government, and I speak of the federal government, want
to deal with the problems of discrimination and confidentiality.
I think it can be done in such a way as to make it uniform and
make it a clear issue with respect to where this government, this
federal government stands. We can do it in New York State. We

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will. That's not the issue. The issue is where is the
leadership. Where is the determination, that this is not going
to be tolerated by this state or by this nation, what is more
important, the state or the nation. I think that each state
represents a small fragment. We can get into a long discussion
of Jeffersonian or Hamiltonian views of government, but that gets
us nowhere. The issue is leadership and you have identified it,
and the leadership should come by a national commitment to the
elimination of discrimination.

ADMIRAL WATKINS: Is it possible from your point of
view as the Centers for Disease Control moves down this
seroprevalence survey nationally and their stepping stone
technique, to use that as the opportunity to provide that
leadership? Does that enhance the work of their survey and the
value of it?

DR. AXELROD: I think absolutely. The worth of their
survey is clear to all of us in public health. I think you are
quite correct in suggesting that there needs to be a greater
public recognition of that worth and how it relates to our
efforts to deal with the problem. I think it takes a clear
statement by the federal government, not necessarily the CDC, by
the Domestic Policy Council or someone else at that level of
coordination of governmental activities. We were successful in
New York State by virtue of the Governor placing this issue right
up front and saying this is what we are going to do, this is
absolutely critical to our ability to address the issue as a
state, and we were going to do this. I can assure you it wasn't
all roses. At the same time, we did educate a lot of people
about what we were doing, why we were doing it and how the
information was going to be used.

ADMIRAL WATKINS: Dr. Curran, with that statement from
Dr. Axelrod, it seems to me that it would be very valuable for
this Commission to have you review your own survey plans that you
have and give us some thoughts, come back and talk to us perhaps
as a body or talk to me individually, and tell me what your
people think, in your connections with the state and local health
officers and the others who are going to have to work this
problem in the survey, and tell me what you think the obstacles
are to your getting the very best data. The goal is highest
value for your survey. If I were to have the best of all worlds,
I would knock down these obstacles as we move down this survey
path to optimize it. If you will give us those obstacles, maybe
we can pick those up one by one and we can get some consensus to
knock them over and make this a very effective survey for you.
Does that sound like it is doable?

DR. CURRAN: Yes, sir.

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es ADMIRAL WATKINS: Let's get-all the obstacles out in
the open.. What would make you very happy, if you could walk into
a situation where everybody is going to stick out their arm and
bleed?

. DR. CURRAN: Get rid of discrimination, provide medical

ADMIRAL WATKINS: That is good but let's get very
specific. What do you mean by that? Do we have manpower
shortage problems? Is that the issue? Are there bureaucratic
hurdles we have to get over? What kind of resources are you
really talking about? I think we have to get very specific now.
This is something we might be able to recommend to the President
in time to assist you. I would like to have the other
Commissioners just nod whether they agree that this is an useful
thing for the Commissioners to have from Dr. Curran.

DR. WALSH: I think it is useful. I wonder where he
will be working next month if he does it.

(Laughter. }
' ADMIRAL WATKINS: He's courageous.
DR. WALSH: Part of the obstacles he has to remove --

ADMIRAL WATKINS: He made some comments today that were
very open and refreshing.

DR. WALSH: If you will give us the recommendations, I
think they would be invaluable and we will ascribe anonymity and
confidentiality.

DR. LANGMUIR: As a general epidemiologist, not
involved at all in the survey issue, I have been listening, and
there is one crucial point in the random family sample survey,
namely, this is very expensive. Somebody has to go and knock on
randomly selected doors, be very persuasive, even with all these
obstacles broken down, and then take a blood specimen, get it
separated, ship it to the lab. I have heard that the price of
that is somewhere from $500 to say $1,000 per specimen. That
seems low to me. You have to get an organization to do it,
travel. If you do a telephone survey, but this is getting that
specimen. The term they brought up is a national health survey
of 35,000. That is a sizeable number. We admit that seens
small. Let's say it is done for 100,000. $1,000 per specimen.
You are getting into tight sums of money.

When you are finished, what do you have? You have one
figure from a random sample, much like the unemployment rates,
for that particular time of the survey which was done over a

161

 
 

 

period of some months. It tells me as an epidemiologist almost
nothing. It may be one percent; half of one percent; some
figure. It really makes no difference if it is four tenths or
six tenths. The numbers of positives, if it is 1 per 1,000 to
start with, there will only be 100 positives in 100,000 samples.
To be meaningful, we have to repeat this say every three months
or every month like the unemployment survey. If we could do
that, we could get the trend. That would be of some value. It
still wouldn't tell us where the problem is. The 30 city
standard metropolitan area gives us immense amounts of
information, crude though they be, variable though they be, they
are very useful locally and brought together through CDC into a
coordinated regular report, would give us trends and tell us what
is really going on. I am much in favor of the 30 area study. I
don't see the utility of a random study.

ADMIRAL WATKINS: Dr. Axelrod, would you just give me a
feel for the Minnesota experience and its relevance to New York?
Let me say New York City in particular.

DR. AXELROD: The Minnesota experience with respect to
contact tracing specifically?

ADMIRAL WATKINS: With respect to their experience.
They have obviously a different culture in the society there for
a variety of different reasons. It was mentioned on the two
coasts, we have more out of the closet willingness to come
forward. In other words, how do we extrapolate from the State of
Minnesota and the Twin Cities to New York and New York City in
particular?

DR. AXELROD: I don't think you can extrapolate to the
major metropolitan area, the focus of the epidemic, certainly for
the IV drug problem in New York, which is Battery Park and
extends into parts of New Jersey. If one does the focus, that is
where you would find it. The population in New York City is
very, very different than that in Minnesota. On the other hand,
there are areas in New York State, up state in particular, in
which there are similarities to the kinds of things that have
been described in Minnesota. Some of the experiences there may
be relevant to the kinds of recommendations that would fall from
the discussions we have had about Minnesota, but I think in terms
of the relationship of the major metropolitan area, the New
Jersey/New York City area that is most affected and represents
some 90 percent of the cases of AIDS at the present time and 90
percent of the cases of seroprevalence, I'm not sure there is a
direct relationship.

There are some areas, some general areas, which are
important. Those, I think, relate to the counseling issue, the
continuity of counseling, which we certainly agree with; the
formulation of behavior, which we certainly would agree with, as

162

 

 
 

 

part of the rationale for some of the activities that we have
undertaken. The school curriculum which we have developed as
part of that aspect of the formulation of behavior patterns that
will prevent children during the course of their development from
becoming part of the IV drug community or part of the tragedy
that is AIDS at the present time. Those elements, I think, are
relevant, not just to Minnesota or New York, but to the entire
country. I think in terms of the different populations, the
populations in fact in New York City and the metropolitan areas
of New Jersey, are very different from those that are being
observed in Minnesota.

ADMIRAL WATKINS: That closes our meeting for today.
What I wanted to make sure of is that we keep the lines of
communication open with this Commission. None of the
Commissioners are satisfied that we have had enough of an
opportunity to ask all the questions we would like to ask of you
today. We have a full staff now and our intention is to prepare
questions much as prepared in other hearings on the Hill and the
like, where we ask you if you would please come back to us and
answer certain questions that we were unable to ask and that we
feel are very germane, particularly in this set of hearings on
incidence and prevalence. We will be putting those together. We
will ask the Commissioners to get their questions prepared and
submitted to us in the office within the next week, before the
next hearings next week on drug abuse. You must have your
questions. If you are not satisfied by those prepared by staff
that are in your briefing book, I would like to have the
additional questions that we can follow up on. I can guarantee
we will move expeditiously to the individual panelists, to all
the panels, or whoever you feel is appropriate to answer the
questions you ask, and we would hope the panelists would be
willing to participate with us on answering those as
expeditiously as you can, within a couple of weeks. Would that
be an acceptable arrangement?

DR. AXELROD: Absolutely. I would suggest, Mr.
Chairman, also with respect to your May meeting, we will have
seroprevalence studies of effectively 100 percent of all newborn
infants in the State of New York over a six month period by the
time of that meeting, which I think might be very informative to
you. We will have it broken down by major geographic areas, as
long as it doesn't potentiate the identification of individuals.

ADMIRAL WATKINS: I want to thank you very much for
spending the time to be with us today. It has been very
important to the Commission. We appreciate the personal effort,
the time and the willingness to spend these hours with us.

MR. CREEDON: Thank you.

(Whereupon, at 5:10 p.m., the meeting was adjourned. ]

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