PRESIDENTIAL COMMISSION ON THE
HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC |

HEARING ON DISCRIMINATION, ETHICS, AND TESTING

The Hearing was held at the
Vanderbilt University Stadium Club
25th Avenue and Kensington Street

Nashville, Tennessee

Friday, March 18, 1988

COMMISSION MEMBERS PRESENT:

ADMIRAL JAMES D. WATKINS (Ret.), CHAIRMAN
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.

BENY J. PRIMM, M.D.

PENNY PULLEN, M.D.

CORY SERVAAS, M.D.

POLLY L. GAULT, EXECUTIVE DIRECTOR

COMMISSION MEMBERS NOT ATTENDING:

 

JOHN CARDINAL O'CONNOR

WILLIAM B. WALSH, M.D.

 

 
 

 

I-N-D-E-X

PAGE
OPENING REMARKS
Admiral Watkins, Chairman 310

PANEL ONE
USES OF TESTING
William Schaffner, M.D., Professor and Chairman 311
Preventive Medicine, Chief of Infectious Diseases
Vanderbilt University

Renslow Sherer, M.D., Acting Director . 314
AIDS Service, Cook County Hospital

Joseph Mercola, D.O., Chairman 317
AIDS Committee, Humana Hospital

Arthur Di Salvo, M.D., Chief 319
Bureau of Laboratories, South Carolina Department
of Health and Environmental Control

Clark Heath, M.D., Chief 321
Bureau of Preventive Health Services

South Carolina Department Of health and

Environmental Control

PANEL TWO
EFFECTS OF TESTING
Gerry Sandler, M.D., 344
Associate Vice President for Medical Services
National Headquarters, American Red Cross

Donald Burke, M.D., COL., M.C., Chief 345
Department of Virus Diseases
Walter Reed Army Institute of Research

Paul Cleary, Ph.D. 347
Division of Aging, Harvard University Medical School

Stephen Morin, Ph.D. 350
Chair of the Psychology an AIDS Task Force
American Psychology Association

William Lawson, M.D., Ph.D. 353
American Psychiatric Association
Department o Psychiatry, Vanderbilt Medical Center

 

 
 

 

I-N-D-E~X (continued)

PANEL THREE

CONFIDENTIALITY: MEDICAL RECORDS/REPORTING

Rita Finnegan, RRA, Executive Director
American Medical Record Association

Charles H. Wallas, M.D., Member
Board of Directors, American Association of
Blood Banks

Harry A. Woodman, Vice President
New York Life Insurance Company

Fredia S. Wadley, M.D., M.S.H.P.A.
Director of Health for Metropolitan
Nashville Davidson County

Willard Cates, Jr., M.D., Director
Division of Sexually Transmitted Diseases
Center for Prevention Services

Centers for Disease Control

PANEL FOUR

LEGAL ASPECTS OF TESTING

Honorable Kenneth W. Starr
U.S. Court of Appeals for the
District of Columbia

Deborah Jones Merritt, Assistant Professor of Law
University of Illinois, College of Law

David Randolph Smith, Assistant Professor of Law
vanderbilt University School of Law

ADJOURNMENT

APPENDIX

Submitted Testimonies

PAGE

381

384

386

388

390

411

413

415

451

 

 
 

 

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

MS. GAULT: Ladies and Gentlemen, Members of the
President's Commission, my name is Polly Gault. I ama
designated federal official here and in that capacity it is
my privilege to turn this over to the Chairman.

CHAIRMAN WATKINS: Good morning.

Our first panel today consists of Dr. William
Schaffner, Dr. Renslow Sherer, Dr. Joseph Mercola, Dr. Arthur
DiSalvo and Dr. Clark Heath.

Over the last two days we have heard from a variety of
witnesses about the complex discrimination and medical ethics
issues raised by the HIV infection. Well, finding solutions to
the concerns raised in those areas will not be easy. The
testimony presented at these hearings has prepared the
Commission to address sensitive issues of discrimination and
ethics related to HIV infection, with a clear understanding of
those concerns.

Today, we are going to focus on another area that
presents us with difficult but important questions; testing for
evidence of HIV infection. We will begin by examining how the
available tests are currently used, meaning what factors do
physicians and others consider in ordering or recommending the
test and in communicating the test results back to the tested
individual.

We will then examine the issues related to the
confidentiality of HIV test results and current procedures for
safeguarding that information.

Finally, we will examine the many legal issues that
testing for HIV gives rise to, including informed consent and
the constitutional issues presented by mandatory testing.

Before we hear from our first panelist, Mrs. Gebbie
has asked for an opportunity to say something briefly.

Mrs. Gebbie.
MRS. GEBBIE: Thank you.

Just very briefly, I think all the Commissioners are
aware that no matter what we talk about we almost always come
back to testing. As I listen to what is talked about here and
in the community, I am fascinated by the jump from the technical
questions about the test to questions about various specific
issues and individuals, without attention to all the

intermediate steps, such as the decision-making an individual

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physician makes to decide to order the test for a patient or the
decision-making made in a community about use of the test.

So, I am really looking forward to today and hope that
we can get a much better grasp of those intermediate steps and
the various things that are evaluated by practitioners and
others in the process of utilizing the test, to see it as a
process with many more steps than we may have been considering
earlier. I think it will help us to have a background for any
recommendations we might choose to make about applications for
the test in any kind of a population setting.

Thank you.

CHAIRMAN WATKINS: Thank you.

Dr. Schaffner.

DR. SCHAFFNER Yes. Good morning, everyone.

The subject, as you have just heard, is serologic
testing for HIV infection continues to provoke intense debate
among informed and knowledgeable persons interested in providing
the best medical care for individuals, as well as optimal
strategies for interrupting the transmission of the virus and
protecting the public health.

I believe these controversies can be resolved and I
believe it is a myth that there is a conflict between civil
liberties and the best personal and public health practices, but
-- but -- there are certain preconditions that must be met
before the tensions regarding serologic testing can be resolved.
These would include, just very quickly, we need much more
increased education, much more education regarding human
immunodeficiency virus out in the population, so they understand
the issues, particularly in regarding treatment issues.

Confidentiality must be iron clad. Non-discrimination
must be assured and health departments must have increased
resources in order to carry out their tasks of partner
notification, contact testing and counseling.

Absent any of the above, I think tension will remain
because of the all too human skepticism of those at risk, their
suspicion of government and authority. However, if they are in
place, we can concentrate on designing strategies, including a
variety of methods, each suited to specific questions to which
we need answers and to local circumstances.

Clearly, we need an assessment to the extent that the
virus has spread in the entire U.S. population and you have all

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heard about the CDC studies, which will start to provide us |
information in that regard.

I think we need to continue to emphasize voluntary
testing with consent in a setting of confidentiality or even
anonymity. That ought to be continued and enhanced.

We have started some experiments in our country on the
use of mandatory testing. Emphasis: experiments, such as
premarital testing in several states. We do not need to repeat
this experiment in 50 states. What we need to do now is pause

and critically examine the current experience. And, frankly,
what I hear is that we will not.

To my knowledge, not a single state that has mandated
premarital testing has concurrently provided the resources to
evaluate the effects of the program. We won’t be able to learn
nearly as much from these experiments, and we ought to consider
them experiments, as we ought to.

Now, on the basis of yesterday’s testimony, some of

it, I should like quickly to add one more example to reinforce
the theme that we need data critically analyzed to advance the
quality of the debate. The issue is the protection of health
care personnel, particularly in hospitals. You heard among
other things yesterday the argument for making such testing
mandatory for at least certain classes of patients, who are
going to be admitted for evasive procedures.

As the person at the Vanderbilt Hospital, who is
responsible for infection control, now in my 20th year in that
position, I am vitally interested in this question.

Several quick points.

First, the track record to date of conventional
infection control practices is superb. The risk to health care
personnel, which is never zero and never will be, is elevated
above people selling shoes. We accept that. Our task is to keep
that elevated risk absolutely as low as possible.

Two, recently we have introduced universal cautions
designed to further enhance safety of hospital personnel.

Three, I agree completely -- I agree completely --
that the concept of universal precautions is not entirely
suitable to the operating room. So, I consider the current
debate valid. How then to resolve the issue? First, let’s
recognize that there are higher risk areas in this country than
others. What may be appropriate in San Francisco may not be
appropriate in Dubuque or, for that matter, in Nashville.

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And it is my theme, ladies and gentlemen, we need
data. What proportion of patients coming to a hospital for
surgery in any given area are infected? How many false
positives would result from testing and what are the
consequences of that? What proportion of patients, particularly
those who have been in motor vehicle accidents or other traumatic
Situations, had to go to operation so quickly that under the best
of circumstances testing results could not be available?

What proportion of patients have had their surgery
delayed because tests were not drawn, simply forgotten, results
delayed or results confusing to interpret what are the causes?
What proportion of patients decline testing? Will patients go
elsewhere for care?

We don’t have the answers for any of these questions.
So, the question is amenable to study and we ought to find out
the answer.

We tried to study this question in Nashville about a
year ago. We could not find a single agency, foundation or
other funding source, which would sponsor such an investigation.
This is a matter of intense interest to health care workers
throughout the country and I think ideally somewhere between five
and ten hospitals around the country ought to do studies that are
Similar to those that I have outlined.

At that point with the data in hand we could then join
with the various surgical colleges, the surgical societies with
infectious disease physicians and public health authorities and
produce guidelines for the surgical profession. Incidentally,
it is notable that the surgical societies have been thunderously
Silent on this issue to date, now five or six years since the
start of the outbreak. They have my sympathy.

They have no data, just as we don’t, and their own
membership is quite divided and intensely so on the issues.

Data are what is necessary.

One last comment. The tension in serologic testing is
tied irrevocably to research in drugs, effective, early in the
@isease. I will say it again. This whole tension in serologic
testing is tied to the progress of research in finding drugs
that are effective early in the therapy of the disease. If we
had such a drug, the tension in testing would disappear. People
would come. You couldn’t beat them away with a stick, that want
to be tested because they would have the advantages of therapy.

Push my recommendation, ladies and gentlemen. Push

drug research. It is going faster than it was, but it could
faster yet.

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Ladies and gentlemen of the Commission, I applaud your
efforts. I, and, indeed, the nation are grateful to you. I
think our country has the capacity to curtail this epidemic and
your work will provide a solia foundation, which will enable us
to go forward with greater resolve and with greater success. I
am at your disposal should I be able to help you any further.

Thank you very much.

CHAIRMAN WATKINS: Thank you, Dr. Schaffner.
Dr. Sherer.

DR. SHERER: Thank you, Admiral Watkins.

It is clear that the first principle of public health
that we have to adhere to with AIDS, as with all public health
problems, is that of engaging the public trust and the public
confidence. That bears centrally on the issue of testing, HIV
antibody testing and public policy.

It is clear as well that you all are very familiar
with two AIDS epidemics. The first is the real problem that we
face, which you are trying to address yourselves to; the second
is the epidemic of fear. I think the best, most terrible
example one can think of the latter in our country is the fate
of the Ray family in Arcadia, Florida, in which a decent
American family with three children, who carry the HIV virus,
were in sequence turned away from their school, driven from
their church, their home was burned and they were eventually
driven from their town.

That is simply illustrative of the power of the fear
of AIDS. Any public policy related to HIV antibody testing
simply must consider that and try to counter it at every

opportunity with the available scientific data on the
transmission of this disease.

We have heard that high quality epidemiologic data is
essential. We have much in hand. We have much work to do in
order to improve on that data. The collection of that
information is essentially a matter of research and should not
be confused with the issue of public policy related to HIV
antibody testing. We need aggressive research in a variety of
segments and the recent CDC’s MMWR on the spread of the
infection in our country clearly indicates those areas where
such data is necessary. That is a matter of epidemiologic
research that should not be confused with public policy.

Education, through individual counseling directed
towards behavior change, is the tool that we have at hand with
which to control and to limit the spread of this disease.

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Counseling, therefore, is the major cost that is being borne and
that must be borne in order for us to be able to come to grips
with the spread of HIV.

In that regard, testing is, at its best, from a public
health perspective, an adjunct to that education. It must be
understood in that regard. It can assist us in changing
individuals’ behaviors, but it can’t go beyond the outcome of
that counseling itself. It does not lend anything more than the
counseling itself and if we are given a choice between the two, I
would and I think most would choose the counseling.

Ciearly, as well, we have to insist on linking
counseling, the individual consent, and participation in the
process with the testing process at every opportunity. I have
authored an article entitled "HIV Antibody Testing and Physician
Use of the Test, Consent, Counseling, Confidentiality and Caution
with every Test." If we can’t guarantee absolute
confidentiality for individual test results, we run two terrible
risks: first, the risk that we may impair the data collect,
which we all agree is so critical.

Secondly, we may also indirectly lead to or promote
the spread of this virus because of discouraging individuals who
need this testing the most from coming forward. Many other
individuals have stated these positions more eloquently than
myself, including the National Institute of Medicine and the
American Academy of Science. I recommend their positions to
you.

We have had in my own state, I think, two examples of
legislative initiatives related to testing that are the best
examples of public policy errors. I can only agree with Dr.
Schaffner, that we should observe the results of these two
endeavors in Louisiana and Illinois and not move forward with
premarital screening at this point.

The numbers, I think, are very instructive in Illinois
in 1988. We estimate 200,000 people will be married in Illinois.
Of those, we estimate that we will identify one to 200 people who
carry the virus at enormous cost to individual taxpayers and an
equal number, 1 to 200, of indeterminate outcomes of tests. I
think the issue has been well-studied, thoroughly studied, ina
publication by Dr. Cleary, who will present in a later panel this
morning.

We will only identify 1/10th of 1 percent of all those
individuals who carry the virus. We estimate in Illinois that
50,000 people may carry the virus, and yet we are going to use
this test to screen 200,000 people, of whom only 100 will carry
the virus. This makes no public health sense. We are using
this precious resource of counseling and testing in exactly the

315

 

 
 

 

wrong population and with considerable morbidity, i.e.,
psychological morbidity, for those individuals undergoing that
process.

Furthermore, in our state no one has provided this
test free of charge. This policy has the effect of discouraging
poor people from faithful monogamy, from getting married. The
results in January in Cook County were that 40 percent reductions
were observed in the number of people applying for marriages and
there were increases across all the state lines in Wisconsin and
in Iowa.

Most importantly, it does not make good public health
sense to engage in premarital screening. We need to urgently
make testing and counseling available to the 50,000 people we
estimate may carry this virus, to the two to three hundred
thousand people who are most at risk, i.e., homosexually active
men, intravenous drug users and their sexual partners.

Another example of a policy error that passed in
Illinois, but fortunately was vetoed by the Governor, was the
screening of all hospital admissions. Hospital admissions
primarily are children less than five and adults over the age of
50. In both groups, the prevalence of this virus is extremely
low. The cost of such an endeavor would be extraordinary and the
yield would be extremely low.

The practical problems inherent in testing in a low
incidence population are well-described. I refer you again to
the articles by Paulker and others. The number of false
positive initial screening tests with ELISAs and the number of |

either false positive or indeterminate Western Blots is |
significant in this population.

This test needs to be used with caution. In every
instance it should be associated with consent, with counseling
by someone trained in order to give specific recommendations on
how to prevent the spread of this virus, including abstinence
and faithful monogamy. However, all of you will recognize that
those are two practices with high failure rates.

Failing those two, we need to be specific and explicit
about safe sex and safer sex and clearly include the use of the
condom in those recommendations.

I agree with the comments that have been made about no
mandatory use of the test and I think others have spoken very
eloquently to that.

The two most important things that I think this
Commission could accomplish, would be to establish a national
AIDS education policy, federally supported, federally

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coordinated. I think it is a tragedy to be discussing this in
1988, when we knew what needed to be done in 1983.

Secondly, I would say that you have before you an
opportunity to make the beginnings of planning for what we know
will occur in terms of the deli ery of patient care services,

At Cook County Hospital, we have 20 people in the hospital right
now, over 300 in our clinics monthly. our experience has just
begun.

We urgently need planning dnd cooperation of an
unprecedented kind between loc4l authorities, city, county and
state authorities, the Federal Government and the private sector
in order to accommodate what is a growing crisis in patient care
services. (

I thank you very muth for your attention and for the
opportunity to address you this morning.

CHAIRMAN WATKINS: THank you.

\

Dr. Mercola. \

DR. MERCOLA: There have been three recent studies
published, two in JAMA and one in the New England Journal of
Medicine, which review most of the commonly cited objections to
compulsory screening programs. It Seems, that consistently the
major objection to screening in each of these analyses revolves
around the false positive rate or the Specificity of the test.

Each of these authors feel that local laboratories
would not be able to achieve the very high standards of
performance that lab screening blood donors and military
recruits have already obtained. There is great concern that
large numbers will be falsely identified as carrying the AIDS
virus.

This viewpoint, however, fails to consider several
important items. If a false positive is found, this result is
not obtained in a vacuum. This result is interpreted in light
of a person’s personal risk factors and if there is a question
as to the accuracy of the test, experts can be consulted for
additional diagnostic verification. So, rather than a
confirmatory test, there is a confirmatory process.

Even more importantly, however, these tests that most
analysts used in their evaluation of screening are for the most
part the early first generation ELISA systems. However,
refinements with these systems have greatly increased the
accuracy of the test. Additionally, newer, second generation
systems, using recombinant DNA technology, are currently under
review for licensing by the FDA.

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<<

Both of these tests, the newer, first generation test
and the second generation test offer specificities in the ranges
of 99.98 percent or about 10 to 20 false positives out of every
100,000 people screened. If these tests are combined with even
more accurate second generation Western Blot confirmatory tests,
it seems possible to eventually reduce overall the false positive
rate to well below one in a million in a widespread screening
program; certainly acceptable levels.

The studies that document this new technology and some
of these statistics can be found'in my written testimony.

As you know, Illinois has been one of the first states
to implement compulsory marriage AIDS screening. It would be
helpful to share my experience as a private physician in this
community as a result of this legislation being passed.

There is widespread agreement that education is the
most effective weapon we have in the battle against AIDS.
Perhaps some of the most beneficial effects of this AIDS
legislation in Illinois has been the pressure it has put on
primary care physicians to learn more about AIDS and the testing
process.

In the community where I practice, this pressuring
motivation has been more effective in reducing physicians’
general inertia to AIDS education than any continuing medical
education program. This factor should not be diminished.
Informed physicians can serve as a potent force in educating the
community about the dangers and appropriate precautions for
AIDS.

 

One major item always mentioned in any screening
program is the cost. The costs are generally based upon prices
in effect prior to initiation of the screen. It appears that
once screening is begun, there are very potent free market
pressures to reduce the price of the test. Prior to initiation
of the compulsory marriage screen in Illinois, a typical charge
for the ELISA screen was $50.00 to the patient.

Shortly after legislation was enacted, several
companies introduced lower rates, forcing the general prices for
the screen down. Life Source is a company which screens the
blood for northern Illinois and they have recently offered
screens to physicians for the price of $8.00.

In summary, it appears that the false positive testing
rates have been a major objection to more widespread screening.
With the application of the current recombinant DNA technology
to the ELISA screens and a refinement of the first generation
ELISA systems, these arguments are becoming progressively

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invalid. Many people believe that one of government’s few
legitimate functions is to protect and defend its citizens.
This is certainly true for foreign invaders and it would be
difficult not to classify the AIDS virus as anything but an
invader of the most pernicious type. I would encourage the
Commission to recommend more widespread compulsory testing at
this time.

Aside from giving us valuable information about the
epidemiology of the disease, it would serve as part of an
effective strategy to protect and defend the citizens of this
country.

Thank you.
CHAIRMAN WATKINS: Thank you, Dr. Mercola.
Dr. DiSalvo.

DR. DiSALVO: Admiral Watkins and Members of the
Commission, I have some prepared remarks but unfortunately my
luggage and I didn’t get to Nashville at the same time. I will
submit them if we ever get united.

I represent the Association of State and Territorial
Public Health Laboratory Directors (ASTPHLD). There is a State
Public Health Laboratory Director in every state.

The test is used for many purposes as you have heard:
screening the blood supply; employment, such as in the State
Department, the Department of Defense, Job Corps. They are used
as diagnostic tests to differentiate AIDS and ‘the AIDS-related
complex or the lymphadenopathies. They are uséd for studying
epidemiology. In the public health setting, there are two
primary uses of this test: (1) to serve for alternate site
testing, where counseling is provided. This diverts those in
high risk groups from going to blood banks to get their testing
performed and (2) to perform surveillance.

4

In the public health setting, there are several types
of clinics which are high risk, such as venereal disease,
tuberculosis clinics, jails and prisons, childbearing women and
drug abuse clinics.

We feel that the testing procedure for HIV infection
is excellent when it is used as a protocol, a combination of
tests; that is, not just simply the screening test but followed
up with confirmatory or supplemental testing if the screen is
reactive. Many of the State Public Health Laboratories were
performing these tests, before the test was licensed.

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Beginning with the licensing of the test in March of
1985, until the end of last year, December 31st, 1987, we have
examined over half a million specimens. We found over 37,000
positives, which is a positivity rate of 7.5 percent. In 1985
and 1986 the states as a whole, as well as in South Carolina,
which is a low incidence state were finding 20 percent of the
specimens screened were positive and now, as more and more.
people are being screened, the positivity rate is dropping.

In recognition of these early problems which we have
seen from a laboratory point of view, the ASTPHLD has held
consensus conferences. We had the first in May 1986, one in
March 1987, and the third one was last week, March 1988. The
problem we addressed is to set up a uniform testing protocol, so
results can be compared no matter where the test is done and so
the results are accurate and free of false positive and false
negative testing.

We have organized a uniform reporting system. We have
worked on developing an algorithm of testing procedures; that is,
screening is first performed with an EIA test. Then if it is
positive, the screening test is repeated and then proceed to the
other components of the supplemental testing.

We have discussed quality control. We do not think
there is sufficient quality control for the diagnostic
laboratories and this must be organized at the national level.
We have requested the Public Health System to do this. We need
proficiency testing samples to be sent to the laboratories as
well as a panel of blood sera of known quantity and
jdentification to which all state laboratories would be

comparing in our daily use as the standards.

One essential item we would like to address is the
matter of FDA approval. All laboratory test reagents go through
an approval process with the FDA. These are processed as medical
devices through the Pure Food and Drug Amendment. However, HIV
testing reagents do not go through this protocol. Since they
were originally developed for screening drug donors, they are
approved as biologics under the Public Health Service Act. This
is a much more rigorous process and has more delays. You have
heard other members of the panel mention new tests, recombinant
DNA tests, and these have been evaluated. There is a very good
evaluation by Colonel Burke, who is a speaker later on this
morning, and they are excellent but they are not available to
state laboratories yet.

The process must be expedited to get these approved
faster and we believe if they are done as medical devices, this
will enhance that process and expedite it. And we also think
there should be some regulation of all laboratories performing
HIV testing.

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We also believe we need direct funding to the public
health laboratories. There are many expenditures besides actual
patient testing which we try to do which are not covered. We
are active in test development and test evaluation. Each time we
change test procedures, we have to compare the new procedure to
the old. It is quite an expensive process in changing new
procedures and new reagents. All states are bound by certain
purchasing requirements. The state laboratories cannot buy the
reagents that we think are the best. We have to go through
expensive evaluation procedures before purchase of new reagents.

We believe we should be able to provide these tests
free of charge to local physicians, which we cannot do at this
time. We also believe in extra work-up of patients, who have no
known risk. These patients require more than the ordinary
work-up and also for health care workers. When I am involved
with testing a health care worker who has been inadvertently
exposed to body fluids from a patient with AIDS, we do
additional laboratory studies on that patient, trying to allay
their fears or come up with an earlier acknowledgment of whether
or not they have infection.

Surveillance programs, which have also been mentioned,
require data. We don’t have all the data. We need funding to
do more seroprevalence studies, so the results will be more
meaningful.

And, finally, State Public Health Laboratories are
reference labs. There are many blood banks which will only
perform screening tests. All they are interested in is
screening, and, if it is positive, discarding the blood. But we
still have to be concerned with the donor (patient) at the other
end. The blood banks send those samples to the state public
health laboratories for more extensive testing, i.e. the
confirmatory testing or the supplemental testing. We think we
should have funding for that.

Thank you very much.

CHAIRMAN WATKINS: Thank you, Dr. DiSalvo.

Dr. Heath.

DR. HEATH: Thank you, Mr. Chairman.

HIV testing is obviously a most important tool for
AIDS prevention. By detecting early asymptomatic infection, it
lets us focus now more on early spread of virus and less on late

illness and that obviously is a very basic concept for
prevention.

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In prevention work, the test serves two quite
different purposes. One is to test individuals. By identifying
individual cases of infection, we can attack the epidemic by
counseling affected persons and by helping them to change risk

behaviors, to receive early medical care and to trace their sex
and drug use contacts.

The second purpose is quite different. It is to test
populations. This lets us know where the virus is spreading at
present, which population groups are the most affected and which
are least. Without that kind of knowledge, we are really
hard-pressed to design appropriate prevention programs or to
assign our prevention resources properly.

In the case of individual testing programs, it is
important, I think, that several conditions be met for the
testing to be used properly. The most important, obviously, as
has been mentioned, is that patient confidentiality be assured
to the extent that that is possible. This calls for security of
records, for continuous training of health caregivers and for
adequate legal safeguards.

The other conditions that need to be addressed in
individual patient testing concern counseling, both before and
after testing, referral appropriately for medical care and
follow-up and finally assistance in tracing contacts. These
several aspects of testing I have drawn schematically in the
figure, which is attached at the back of my written testimony.

Ideally, in my view, whenever the test is performed on
an individual case, each of these services needs to be available
and used appropriately in that case. It is not just a matter of
doing the test and reporting a result.

I would agree with my colleagues here that mandatory
testing at present is entirely unwarranted and
counterproductive, except in the special\situation of testing
blood donors. Our ultimate prevention goal, I think, is to help
people achieve behavior change and behavior change, as we all
know, is an intensely voluntary matter. Mandatory testing seems
to swim against the current.

I would also think, though, that routine testing,
which is not the same as mandatory testing, in high risk
settings, such as STD and tuberculosis clinics, does seem to be
appropriate if you have reason to think that the level of HIV
infection is high enough, 1 percent or more, and provided that
you do make pretest information available, pretest counseling to *
the people in the clinic and that options for informed refusal of
the test are available to the patient.

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In the case of population testing, confidentiality is
not an issue since no personal identifiers are used. There have
been active debates about this, but I think that confidentiality
problems are clearly not applicable. Instead, the central issues
that must not be forgotten are adequacy of sample Size,
completeness and accuracy of data collection and capacity to
analyze findings properly. Those are not to be thought of
lightly.

Incomplete or inadequate testing surveys, which are
easy to do, can be highly misleading and so these matters really
deserve our close attention.

In my written testimony I have suggested a half a
dozen specific recommendations based on these ideas, which I
will not reiterate at this point.

Thanks.
CHAIRMAN WATKINS: Thank you, Dr. Heath.

We will commence our questions this morning from Dr.
Lilly.

DR. LILLY: Pass.
CHAIRMAN WATKINS: Dr. Crenshaw.

DR. CRENSHAW: In regard to the testing of hospital
patients, is there anyone on this panel who feels that HIV
testing and the knowledge of positive status for the physician
doesn’t improve the quality of care that patient will get, the
quality of medical treatment?

DR. SHERER: I will speak to that. I don’t think
anyone has directly spoken to that. My answer as a practitioner
would be yes, there are many instances where I would want that
information to inform my care. The issue of testing all people
admitted to hospitals, I think, was addressed by -- and was
really resolved, is resolved, by the application of universal
precautions for infection control --

DR. CRENSHAW: Excuse me. I am heading in a really
different direction. What I am trying to point out is something
has been overlooked. I know that if a patient came in with
diabetes and I was asked to take charge of the medical care but
wasn’t allowed to know whether the patient was a diabetic, all of
the garden variety infections and diseases that a diabetic is
exposed to should be more treated more aggressively, more
enthusiastically, closer monitoring in health care; things that
would be considered trivial ina healthy patient without diabetes
can be exceeding serious, number one.

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Number two, using this same analogy, although it is
not perfect, to deal with patients who have a HIV positive
status, I know that I as a physician, if I were in the wards in
clinical medicine, would treat a patient whom I knew was HIV
positive -- I would watch them much more closely. I would treat
them more aggressively and I think most physicians would, number
one.

Number two, I think that something that has been very
misleading to the general public and that I think all of you can
change, because it hasn’t been emphasized enough. I heard the
comment that because there is no cure, people aren’t going to run
for testing.

Why don’t you start telling people that there are all
sorts of cures for the diseases that kill people who are HIV
positive? Not all of then, but there are treatments and cures
for Pneumocystis and for a whole variety of other things that if
someone gets in there early enough and knows the warning signs
because the doctor has competently informed them and the doctor
knows that they are infected, a great deal of improvement to the
quality of care and the prompt treatment of infectious
opportunistic diseases can be made.

/

I would like to hear any objections to that if I am

not stating the case accurately.

DR. SHERER: I think you have heard support for that
position. Clearly, we need to make voluntary testing as widely
available as possible on the basis of identified risk. That
clearly will assist and inform an individual physician’s ability
to provide care in the future. I don’t think there is any
impediment to that that exists at the present time in the
context of consent from the individual and counseling for its
public health value, as well as. for its medical value.

I didn’t hear any disagreement with that.

DR. CRENSHAW: I would like to hear the rest of your
reactions.

DR. SCHAFFNER Perhaps I can get into this, Dr.
Crenshaw.

I think it is important that we not overstate the
case, that we be quite precise. I have never been declined
permission to do a test when I thought’ it was clinically
indicated. So, I think the concept of treating the diabetic
without knowing his blood sugar is spurious. That is a
circumstance, which does not come up. I think if a physician
has a relationship with a patient and will sit down -- one of my

324

 

 
 

 

quips to the students is "Consent is never informed unless the
physician is sitting." You have _to-sit down and talk with the
patient. You will obtain consent. You ought to be able to
persuade your patient. |
DR. CRENSHAW: I haven’t made myself clear.
Obviously, no diabetic has refused. I am saying that in HIV
there are those who want treatment that do not want the doctor
to know. That has been discussed *-

DR. SCHAFFNER That is a rare phenomenon. I think if
the patient is ill, and that is what we are talking about in
this circumstance -- if the patient jis ill and the physician
will take the time and is empathetic and interested in the
patient, that informed consent will be attained. It will be
forthcoming. P

Second, you then address the question of whether every
patient need be tested in order that health care personnel can
take appropriate precautions. That also is an overstatement.
The use of universal precautions with every patient, I think,
will provide that assurance.

DR. CRENSHAW: All I am trying to get at -- I mean
these are all important issues but I am trying to get at the
specific issue of can’t we inform patients, prospective patients
-- a lot has been said, you know, there is no cure and there is
no reason to know -- can’t we generally inform and would you
support informing them that there are lots of treatments that can
keep them alive for a longer period of time if they -- I mean, I
think the opposite message is getting across than we really could
be giving to encourage people, depending on -- and want to be
tested.

DR. SCHAFFNER Oh, I think we have been enthusiastic
about encouraging voluntary testing and continue to be so. I
think that is the cornerstone of our approach.

DR. CRENSHAW: Dr. Mercola.

DR. MERCOLA: I would just like to comment on Dr.
Schaffner’s reference to the likelihood that there will be a
greater likelihood that more people would be inclined to test
themselves if, in fact, an early cure were known.

The Commission probably is aware of some studies
currently in progress, which are using low dose AZT as a
treatment for people in the early stages of infection and there
is a great likelihood that this, in fact, may be an effective
therapy. So, I think at this point in time, we do have
something to offer patients who have an infection. And as the
results of these studies are made aware, we could already have

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EE

-- the leg work or the ground work could have already been
accomplished so that these people are identified and they can
avail themselves of treatment.

DR. CRENSHAW: The other thing I would like your
comment on, perhaps, Dr. DiSalvo, is that I have gone in to
anonymous testing centers to be tested several times over the
years and each time I have gone in, there has been enthusiastic
attempts to talk me out of getting tested. I have gone in
anonymously, too, so they didn’t know who I was.

I think that is reflected in what we see in the |
statistics, that of the people who come in, depending on where
you are, a varying percentage of people actually proceed to get
the blood test. Most people, once they get in the car to drive
down and inconvenience themselves to get their blood drawn,
generally have their minds very well made up.

So, I would like you comments on -- I know that in
some areas it has done very well because I have talked to people
who are discouraging those from getting tested. I think the
compelling question that turns a lot of people off, that would
have turned me off if I weren’t so determined is if you are
infected, have you thought of the consequences and do you think
you can cope. And I said no, I don’t think so. I am not sure
how I would, but I would find a way.

 

I would think that would be true for any normal human
being, that they wouldn’t think this would be an easy thing to
cope with. But would you comment on the discrepancy between the
people who come in and want to be tested and the people who walk
out the doors without getting their blood drawn and what is
precipitating that?

If we are doing effective pretest counseling, it seems
to me the opposite would be the case. Would you perhaps comment
on it, tell us how we can improve that situation?

DR. DiSALVO: I am the State Laboratory Director in
South Carolina, so I don’t deal with that but Dr. Heath is
responsible for that. I think he could answer much better than
I could.

DR. CRENSHAW: Great.

DR. HEATH: You also have to realize that in South
Carolina we don’t do anonymous testing, so we don’t have
anonymous test sites. But I agree strongly, the people who come
in, self-referred, for testing have screwed up their courage and
thought it through a good deal, so talking them out of it is not
something that our staff puts a lot of time into.

326

 

 

 
 

 

It is a different situation when you talk about
starting a program that may involve routine testing in a clinic
population where you think there are a lot of folks who are
infected and this will be a good use of the test in terms of
finding new infections and preventing further spread.

I think about this in a public health way more than a
Clinical care way. So, I think the use of the test medically is
very valuable for people who are a symptomatic or
presymptomatic. Such a use of the test is going to become more
and more important as time goes on and as we find that using
some of these immunosupportive drugs will help slow down virus
multiplication and the progression of immune suppression before a
person gets sick.

So, I think knowing a person’s positivity status
before they get ill is very medically important and it is
basically a medical test, just to come back to this other point.
In all of that, I probably lost your question.

DR. CRENSHAW: No, no, you did fine. Thank you.

In relation to your public health knowledge, you know
a snapshot of what is happening in the various testing centers
in the nation, how do you account for that discrepancy, which
can be very wide? That concerns me. I am not sure we are doing
our jobs when a significant percentage of people who screw up
their courage and walk through the doors walk away without
getting tested.

I think we can improve that situation. I just don’t
know how.

DR. SCHAFFNER I think it is a matter of reeducating
people in those testing centers. Remember when the testing
centers were first established? The concept was that counseling
was important. It wasn’t important to know whether you were
positive or negative and we went through that phase very, very
quickly when we discovered that patients wanted to know.

Actually, I think there is another barrier. Even in
those states, such as ours, where once you get through the door,
you will be tested and counseled, the waiting list to get in is
still too long. I finally screwed up my courage, made the phone
call, come back in two weeks for your appointment. I think we
need much more resources in that regard.

DR. CRENSHAW: I agree with you. MThank you.

DR. DiSALVO: May I make one comment on that? \

327

 

 

 
 

 

I don’t think it.is so much getting up your courage
and going in the door. I think what you have to consider,
particularly in our state, which is mostly rural and small
towns, you have to go to the county health department and that
alone is a stigma. People know why you are there. That is one
of the reasons why the State Laboratories would like to be
directly funded, so that we could provide this testing service
to the private physicians so anybody, like yourself, who screws’
up the courage, can go to their own physician in private and
have that test done in private, not with everybody seeing them
walking into the county health department.

DR. CRENSHAW: I think that is a very valuable point.

CHAIRMAN WATKINS: We are going to shift out of
sequence a bit now. Dr. Conway-Welch has to leave for about an
hour, so we will shift to her next.

DR. CONWAY-WELCH: Thank you, Mr. Chairman.

I would like to get your best advice on an issue which
is obvious to all of us and we certainly hear a lot of
constructive information on it. We started out with the issue
of mandatory testing of all patients admitted to hospitals or a
special group of patients admitted to hospitals. If we dealt
with that from a public health issue alone, I think that it
would be very clear in terms of the issues and recommendations.

Unfortunately, imbedded in that issue are political,
social, religious and economic issues as well. I wonder if you
could clarify again the recommendations that you all would
think, in terms of should there be mandatory testing of all
hospital admissions and/or groups of hospital admissions. Could
you all comment on that issue again?

DR. SCHAFFNER I think a global recommendation from
the Commission for a national practice is premature. We don’t
have enough information. Clearly, you ought to have five --
anywhere from five to ten hospitals in this country study this
question so we will have the data so that a recommendation can
be made a year from now.

DR. SHERER: I would just agree that blinded
seroprevalence studies, which have already been done, need to be
continued. We do need to know seroprevalence in that group and
have that information at hand.

As public policy, I think the consensus of the public
health community on this issue is clearly against --
unequivocally, that it is poor public health policy, that the
cost would.be astronomical, that the disruption of the normal
conduct of hospital activities would be extraordinary, that it

328

 

 
 

 

is unfounded for infection control because of the application of
universal precautions. I don’t think it should have a serious
hearing here, other than gathering data for research purposes and
that can be done through blinded seroprevalence studies.

DR. CONWAY-WELCH: Dr. Day, yesterday, commented on
the fact that universal precautions were not useful, as far as
she was concerned; one of the reasons being that she ran out of
supplies that she needed in order to institute some of the most
basic precautions in surgery and that is probably a valid point,
but her rejection of universal precautions as being a solution
was of concern because certainly that is one solution that the
health profession has put forward in order to protect health care
workers the seropositivity of their patients.

Could you comment on that dilemma?

DR. SCHAFFNER I understand the argument but I think
the conclusion is austere. It is austere because I think that
there is a whole category of health professional servants, who
feel the intensity of exposure greater than an internist, for
example, and who feel that the application of universal
precautions is not yet entirely applicable inside the operating
theater, exactly as Dr. Day and her colleagues are exposed.

On the other hand, there has yet to be a surgeon who
has acquired infection. The true risk, I suspect, is going to
be very, very low. I don’t think that the quality of this
debate will be enhanced, will be advanced one iota until the
situation is carefully studied.

We ought to regard the question as a valid one. We
ought to empathize with the deeply-held concerns of at least a
large proportion of surgeons, and since this is an eminently
studiable issue, we ought to provide the information.

DR. SHERER: I would also add, I think that in my
opinion the internist or the surgeon, who bases his or her
behavior in patient interactions on the basis of a test is
making a serious infection control error. That certainly is one
of the reasons for the principle of universal precautions, the
obvious point being that false negatives are found early after
the infection for six weeks to six months or more and also later
in the stages in infection for persons with AIDS. In most of
those cases, it is recognized that infection is present.

But that clearly is a solution that universal
precautions provides. I would hate to think that we would
embark on public policy in this regard simply for lack of
supplies, the first point, which you began with. We clearly
need to make these supplies and take these precautions and
implement them nationwide in hospitals and accept that cost.

329

 

 
 

 

 

DR. MERCOLA: . I would like to comment on Dr.

_$chaffner’s point that at this point there are no surgeons who
are infected with the virus that we know of. Another factor to
consider is that many surgeons are not testing themselves, so
they may have acquired infection and just be unaware at this
point.

Another consideration would be many hospitals, at
least in my area in Illinois, if an employee of the hospital is
accidentally punctured with a needle, they are screened
routinely for hepatitis, but they are not being screened for
AIDS.

DR. SCHAFFNER Well, they ought to be.
CHAIRMAN WATKINS: Dr. SerVaas.
DR. SerVAAS: This question is to Dr. Mercola.

We are all proud of our leader, Admiral Watkins,
because he zeroed in on pushing the FDA and funding the FDA to
get the drugs to help the patients immediately and get rid of
the bottleneck, because we know there is a bottleneck and the
drugs are just there.

In your opinion, isn’t it equally important now that
we are into the testing phase here to push the FDA to review the
AIDS antibody tests that are there and the antigen tests to
hurry it along so that we can get our false negatives out of the
way and that we can get on with voluntary testing? If we could
put to rest the problem of false positives, then we could say to
all Americans, you know, it is not expensive to get tested. If
we could -- what would you think -- since you are in private
‘industry more or less. Humana Hospital isn’t a government thing
and you can act more quickly in many instances probably than
government bodies. ,

If we got the word out that for $3.00 you can be
tested -- and that is what the Red Cross takes for the test, and
that includes the screening test, which we know gives some false
positives, but which all doctors that I know would never tell a
patient that they are positive after the screening,
that -- and the Red Cross also includes the confirmatory Western
Blot.

Now, we already have pretty much laid to rest, as I
understand it -- and I would like your feeling about it -- the
false positives on the -- false positive problem with the
confirmatory Western Blot done at good labs and, of course, if
it is done ina poor lab, we worry about it still and that is
the other thing that I would like you to talk about and that is

330

 

 
 

 

don’t you think that we should set up an organization in the FDA
or do you think -- probably the FDA -- to get medical device --
call this a medical device and have the labs certified, who are
going to be doing the confirmatory Western Blots because we know
if they are done properly, then only the mixing up of the tubes
can give you a real false positive, where a patient would be told
that.

Doctors should all be trained never to tell a patient

until they do have the confirmatory test. Would you agree that
it is dangerous at this point, Dr. Mercola, for us to confuse
the public with information about false positive tests not being
-- as being a problem and there is some literature that is out
that would refute Dr. Burke, for instance, who says it is one out

of -~ way back it was one out of 135,000 and Dr. Brooks Jackson,
who got none out of 580,000, no false positives.

There is literature that shows that a man who
predicted that we would have a large number of false positives
if we tested that many people in the State of Minnesota -- I am
talking a long time to get to the point and I would like you to
comment about the urgency of getting the FDA to certify the labs
that are going to be doing the confirmatory tests so that we can
lie to rest in the view that the public has -- if we lie that to
rest and if we said it is free -- anyone who wants the test can
have it free, knowing that it costs $3.00 and because there
wouldn’t be so many confirmatory tests, it wouldn’t really cost
that much and we could lie to rest all this rhetoric about it is
so expensive.

Now, we know why it is expensive. It is expensive
because we need all of this pretest counseling that in many
instances is telling people, you know, should you or should you
not be testing but we are talking about the American citizens
who want to be tested.

And then I have a question for Dr. Sherer.

DR. MERCOLA: It is a very complex question or set of
questions.

Let me just first respond by saying I would firmly
agree with Dr. DiSalvo’s position, that in fact strong
recommendations of encouragement should be made to have the FDA
consider repositioning the AIDS into -- I forget the specific
terminology, but I am sure it is in his written testimony.

The issue of false negative is really almost laid to
rest. Most of the tests currently available and licensed by the
FDA are nearly a hundred percent sensitive. They will pick up
nearly every single person infected so that clearly the major

331

 

 
 

 

issue is the area of the false positives or the specificities of
the test.

The first generations currently licensed by FDA have
been improving the technology to the point where, as I mentioned
earlier, there are nearly 20 false positives on the initial first
generation ELISA screens out of a hundred thousand.

DR. SerVAAS: But we all know about the false
positives on the ELISA, but no doctor is going to give that out.

DR. MERCOLA: No, I realize that but those 20 false
positives need to be subsequently reconfirmed with the Western
Blot.

DR. SerVAAS: Exactly.

DR. MERCOLA: Currently, the Western Blot is very
labor intensive and very costly.

DR. SerVAAS: That would average out, though, because
the Red Cross averages out at $3.00 each --

DR. MERCOLA: No, I realize that if you are going to
just do the test. Just let me continue and that is the
recombinant DNA technology is also being applied to the Western
Blot system, which will also dramatically improve the ease of
the test and the cost of the test. So, the whole cost factor
can be seriously reevaluated in the future, as these tests are
licensed by the FDA, but there certainly needs to be a caution.

The first generation tests are good as they are

presently evaluated. There may be some factors that we are
unaware of, such as E coli contaminants, changing of the virus,
which may impact on our ability to effectively screen for this
disease in the future. So, they should seriously evaluate it,
but it is my understanding that in Europe the first generation
screening systems are not even being used. It is exclusively
second generation systems.

So, I would encourage the Commission to make that
recommendation.

DR. SerVAAS: And these tests, to your knowledge, are
now being held up for approval by the FDA?

DR. MERCOLA: Yes. They are currently under review.
There are two companies at this point -- one, I understand, is
Abbott and there is one other company -- it is in my written
testimony -- that currently have submitted data to the FDA for
approval of their test.

332

 

 
 

 

DR. SerVAAS: So, it is crucial for our Commission to
fund the FDA to get those reviews through, so we can be as
current as Europe in our first generation test.

DR. MERCOLA: But certainly to seriously evaluate it
because we wouldn’t want to have a test on the market that was
inferior in any way long term that would be counterproductive.

Another issue, too, is that there are seven companies
that currently license the ELISA screens. Within that range,
some are more accurate than others. When you start screening
large populations that can be a serious factor. As opposed to
us having 20 false positives per hundred thousand, you might
have a hundred or two hundred and then other factors come into
consideration.

DR. SerVAAS: At the FDA, it is our understanding that
there is also a test that will do both HTLV-1 for cancer-causing
sexually transmitted virus and the HIV simultaneously. This test
also could be reviewed if we could put some emphasis on funding
because of the FDA lack of funds to get the reviewers to do these
tests, to review these tests. Is that, in your opinion, one
of the urgent problems for the conditions you address?

DR. MERCOLA: I would agree with that. As I said
earlier, the major objection that most serious investigators
have to more widespread application of screening seems to be
this issue of the false positive rate and with these new systems
that the technology is available, if we can implement them, that
component of the argument to more widespread screening would be
eliminated or should be eliminated.

DR. SerVAAS8: Thank you.
CHAIRMAN WATKINS: We have to move along.

Dr. Primm, before we start here, I have to remind all
the Commissioners, we must terminate this panel at 10:30. We
have a very tight schedule today. We have to be out of this
building at 4 o’clock this afternoon. So, I would like to
restrict our questions to one. I would like you to think about
focusing it to one of the panelists and unless one of the other
panelists feels that they‘ have got a serious problem with
perhaps another panelist’s. answer and he wants more information,
I would like to move along.

If we can do that, I think we can get more out of the
pressed time we have.

So, with that, Dr. Primn.

333

 

 
 

 

DR. PRIMM: At the Harlem Hospital Center where a
number of people, who are seropositive, come into these drug
units. And at San Francisco General Hospital -- Dr. Schaffner,
I think you were here when Dr. Day spoke yesterday and she
talked about the number of people who come into the hospital
emergency room, where she is the chief orthopedic, I guess,
trauma person there and a number of them are positive.

She also talked about the lack of equipment available.
Dr. Sherer, you are at Cook County Hospital, another hospital
that I am very familiar with, that I know that equipment is not
always available; yet, we talked very much about the infection
precaution procedures being implemented.

Suppose they don’t have the kind of things to carry
out the infection precaution procedures that you have indicated.
What do you recommend for surgeons who -- orthopedic surgeons,
surgeons who deal with gunshot wounds and so forth and so on in
these major city hospitals, where it is unrealistic to think that
all the time they have things available because you know they
don’t and I know that they don’t, and I don’t know about you, Dr.
Schaffner, you are here at Vanderbilt, but in the major cities.
where public hospitals are, we don’t have them available.

Wouldn’t it be of some help then to surgeons and
others to know the seropositivity status of individuals, who
might be coming into that institution for surgery. A lot of the
people -- they can’t get consent because the people are
unconscious. What would you recommend then?

I think these are important factors to be considered
before we blatantly talk about Utopia being present in all of
our institutions, which is not the case.

DR. SHERER: It is certainly true that Cook County
Hospital is often short of critically-needed supplies. I can’t
recall the time, however, when rubber gloves, masks or goggles
were among those. They are widely available for the procedures
that might put individuals at risk in the trauma unit and in
vascular surgery and labor and delivery.

I think it is really important to underscore this
discussion with just the data that is at hand on health care
workers, who appear to have acquired the infection asa result
of their occupations. There are 12 at my last count reported
worldwide and the studies that have looked at the rate of
infection among health care workers find it to be zero or
extremely low. That should just be the context in which we have
this consideration because really every effort has to be made to
implement the universal precautions that I support. We are doing
this at County Hospital. I believe the other hospitals that have

334

 

 
 

 

the highest burden of patients are taking the same steps and we
simply need to maximize those efforts.

I repeat, and I would like to comment on a couple of

points that were made earlier -- Dr. SerVaas, I think you have
stated an ideal that we all aspire to. I hope that physicians
now know how to use this test and don’t inform patients. I have
personal experience with many such instances and not just people
being informed that they have a positive test, but that they have
AIDS on the basis of a positive test, which, of course, is an
incorrect representation of the test results.

I also don’t think that it is true to say that we have
licked the problem of false negatives. We do have an antigen
assay that appears to be useful, but we have not instituted wide
application of that assay in any sense. False negatives still
are a serious concern.

DR. SerVAAS: I didn’t say that. I thought -- I said
we have licked the problem of false positives when we use
qualified labs. We all admit there is a great need to do more
to prevent false negatives.

DR. SHERER: That is true. It was Dr. Mercola, who
said that, and I disagree with the statement. That is something
that we will be with and I want to also support the comments on
the critical need for FDA standardization of Western Blot
techniques and of the laboratories that perform then.

Indeterminate Western Blot studies are still a
considerable problem in many laboratories in Illinois, as well
as nationwide and that does represent a continuing problem. I
don’t believe that we will have a technologic fix in the sense
that I am hearing here that will settle all the issues of
testing and their problems, particularly in mass screening use.

CHAIRMAN WATKINS: Dr. Walsh.

DR. WALSH: I seem to have come in today where I left
yesterday and that is confused.

I hear from this panel several things, generally in
opposition to increasing the amount of testing, even whether you
do conditional testing or routine testing on hospital admissions
and so on. And then I hear repeatedly that you don’t have enough
data to make certain conclusions on the extent of the disease,
the incidence of the disease, the prevalence of the disease and
this all affects medical practice and what we are going to do and
it just -- I am beginning to be concerned because we had
adifficulty in this interim report answering the questions on
incidence of prevalence.

335

 

 
 

 

For those of you who have read it, we had difficulty
and based on what you all have said this morning, I just wonder
whether it is going to be premature for us to make any :
recommendation by June the 24th.

The CDC is just starting some routine testing in a
body of hospitals. If they follow the usual pattern, something
that they start now, they may report on by November or December
and they clutch it to their chest like it is top secret and you
can’t get a hold of it until it is properly evaluated.

Other things that bother me are the blank conclusion
that people lose jobs, homes and insurance. Some of you that
said that their insurance -- that they lose their insurance if
there is a false positive and so on and, yet, 75 percent of the
people are all covered by group insurance and they don’t lose
their insurance.

We have the insurance problem of some 37 million
people, who are totally uninsured and if they fall into that
category, of course, they are in trouble, but so are 37 million
other people in trouble if they have heart failure in that
group.

My question, therefore, is really -~ the word
"mandatory" raises a flag with everyone. I have brought up
before a fact that was suggested by the AIDS group in Hawaii of
getting away from that term and using the term "conditional
testing" as a way of gaining access to more data. In other
words, what is wrong, if just for data collection, we do routine
testing on hospital admissions? What is wrong if in premarital
testing with the people who are to be married, are willing to pay
for it themselves -- it is no cost to the taxpayer -- if they pay
for it themselves, it gives us another batch of data that is
spread across not necessarily high risk groups, but the data that
would give us information as to just where we should be going
with this disease and I don’t see how we are going to get data
collection without broader collection, preserving
confidentiality, preserving anti-discrimination and all that
business, but it seems to me that I keep hearing from witnesses
that we don’t want to do routine testing, but we don’t have
enough data to tell us what to do. Now, how do you get the data
if you don’t want more testing to get a better idea of what we
are dealing with?

Do we have a million and a half seropositives or do we
have three million or do we have 800,000? Statements were made
by some of you that such and such a publication has given us
assurance of that. That is baloney because I know of five other
publications that will disagree and as long as they are sound
scientific disagreement, I don’t think we should accept any

336

 

 
 

 

publication with the data that we have at hand as being
authoritative enough to make a conclusion.

So, that is why I am confused. I don’t understand the
resistance to more routine testing or conditional testing, if
you will, and then the complaint that we don’t have enough data.
We have complaints even from members of our Commission that the
CDC is too slow, that they don’t do this and they don’t do that
and I have that complaint also, but how are we going to get the
data?

DR. SCHAFFNER I think the goal is worthy, Dr. Walsh,
and I think that if we realize that we will not have a perfect
answer but we will have pieces of answers and we do, indeed,
have parts of those answers now, I think we can proceed.

Recall that the nationwide information from first time
blood donors is available; recall also that we have information
on military recruits. We are now in process nationally under
CDC sponsorship of doing a whole series of anonymous testing
studies, which are going to provide us a whole lot more insight
into the kind of answer that you were looking for. How widely
prevalent is infections of this virus, knowing it is an
imperfect result.

I think in part what you are hearing is that we are
also provincial, as well as interested nationally. We would
like to know what is happening down our street and it is
difficult for each of us to do the kind of mini anonymous
testing survey that we would like because I think resources are
limited.

The further application of routine but voluntary
testing in such settings as sexually transmitted disease
centers, tuberculosis clinics, et cetera, et cetera, I think is
going to provide us a lot more information.

DR. WALSH: Because we hear that on the amount of
routine testing that has been done hasn’t justified the results
-- I think if you get only five out of 200,000 or whatever it is
or 50,000, it does justify because it tells us that perhaps we
should be more optimistic about the degree of seroprevalence
than we are. Maybe we don’t have a million and a half and that
gives us some information.

You know, if we are going to do a test -- you and I
practice the same kind of medicine, supposing we did away with
all those screening lab tests that come in. How many of those
really tell us anything worth -- and, yet, we do them on every
patient and if we were to make the positive findings we get
from, say, a seropositive patient on everybody who comes into
the collective hospitals, we would abandon that test, too. We

337

 

 
 

 

wouldn’t want to do that because we pick up one knowledgeable
test it helps out.

This is a disease that causes death for the next
decade at least and that is the thing that is giving me
confusion. I don’t understand.

CHAIRMAN WATKINS: We have time just for one answer
and then we are going to have move on.

DR. DiSALVO: I firmly support routine testing in
certain groups in which it is epidemiologically indicated. I
don’t -- I agree that it is not epidemiologically indicated in
premarital testing or as a routine hospital admission for all
admissions. It should be done selectively and certainly, as
mentioned before, our TB clinics and -- tuberculosis clinics, I
think it definitely should be done.

CHAIRMAN WATKINS: Ms. Pullen.

MS. PULLEN: I wanted to ask Dr. Sherer about his
position on AIDS counseling for newlyweds and how to protect
them and potential babies that could be conceived, but since
time is limited, I would like to ask Dr. Mercola some things
about written informed consent and the practicalities of that in
the child care setting because I think this is a more important
issue to get at than how persons view premarital counseling.

In Illinois, we have a law that says that no person
may perform or order to be performed an HIV test without written
informed consent of the person upon whom it is to be performed.
Could you comment on, one, the consent form that is the standard
form that is being used and its usefulness as a counseling and
then its effect; two, the blanket policy of written informed
consent in all cases and what the effect of that is and
specifically the problems, perhaps, that are caused for health
care workers and others in the line of duty, who will become
exposed to potentially virus carrying body fluids and must weight
for six weeks to six months until their own antibodies either do
or do not appear to determine whether that exposure was to virus
or just to blood?

DR. MERCOLA: I have a copy here of the consent form
that Humana Hospital currently uses and, as you can see, it is
quite long. This is the minimum that could be put together and
still meet the full compliance of the law as currently passed in
Illinois.

There was a great concern for maintaining the
confidentiality and making certain that the person was fully
aware of some of the potential complications of false positive
tests. As a result of that, the form is, from my experience and

338

 

 
 

many other physicians, tends to be quite confusing and impairs a
really effective counseling effort. At this point in time, I
have not had any patients of mine who -- where this form has
impaired them from actually proceeding with a test, but it has
actually been relatively counterproductive in basically providing
the intent of the law, which was to inform the person.

So, there is certainly room at this point for
improving the form and making it simpler to expedite consent.
Now, there certainly is the other practical issue of obtaining
informed consent in a hospital setting for the situations which
you described. Obviously, that is an issue and, in fact -- I am
not quite certain of the details of the law as it is
constructed, but I believe there is a provision, which allows
for testing of individuals if, in fact, a health care worker is
accidentally punctured.

MS. PULLEN: Not that I am aware of in Illinois, not
yet.

DR. MERCOLA: Okay. Then I was confusing that. So,
that certainly is an obvious problem with the Illinois law as it
is currently constructed because there is no way that that
particular, potentially-infected health care worker would know
what their -- more accurately, what their risk of infection
would be from a needle puncture.

So, it is a serious problem and I think some strong
effort needs to be made to revise the law that has been passed
in Illinois and is certainly being considered for approval in
other states at this time.

CHAIRMAN WATKINS: We have two Illinois panelists
today so you have two questions, if you would like to ask
another one.

MS. PULLEN: Thank you, Admiral Watkins.

Dr. Sherer, a year ago you stated at a public health
issues forum at Sangamon State University, which was that
instead of doing premarital, what should happen is that
applicants should be advised and counseled universally to always
use condoms in their marital relationship. Do you still hold to
that view?

DR. SHERER: I don’t recall exactly that. We did
provide an alternative to this law, which I think is proving
itself to be a poor public health policy. That alternative
would be to make a basic AIDS pamphlet, educational material
available in the clerk’s office, have a couple sit down and
review that and have there be additional numbers there for
further counseling, if necessary, and for testing, to testing

339

 

 
 

EE

and counseling centers and to have that be a requisite for
individuals seeking marriage licenses.

Your earlier point about what about infants, which I
know is one of the, I think, the intents and we all share, I
think, great concerns for the problems of AIDS and infants.
Eighty percent of those infants, as you know, are born out of
wedlock. The clear vector of the infection in infants, in
minority populations in our country, in AIDS in women, is
substance abuse. And if we are serious about addressing that
problem, we will take steps to make more treatment slots
available for the 80,000 estimated drug users in Illinois, of
whom only 8,000 are able to get to any kind of therapy at any
time.

I would commend the Commission for the preliminary
points it has already made on the problem of substance abuse.
That clearly is where we should focus our attention if we are
serious about addressing that. That would be a cost effective,
a viable alternative to what has been widely acknowledged as, I
think, poor public health policy.

MS. PULLEN: On the point of substance abuse, I agree
with you, but would you please answer my question, whether you
still believe counseling marriage license applicants to
consistently use condoms in their marital relationship is the
answer?

 

DR. SHERER: I certainly subscribe to the Public
Health Service recommendation of faithful monogamy as a viable
alternative to the HIV epidemic and to the threat in a couple,
but it is clear that marriage doesn’t necessarily provide any
protection. In an era where recommendations to heterosexuals
are, if they have had multiple partners, particularly if they
have potentially had partners with other risk factors, yes, then
I think that safe sex using condoms is a reasonable alternative
for those individuals.

Certainly another alternative would be for them to
seek that counseling, seek the testing and, if negative, then,
of course, then protection is not necessary, but, yes, I think
that that is a reasonable alternative for any heterosexually
active individual in 1988.

DR. SerVAAS: No babies? I have 11 grandchildren.

DR. SHERER: Dr. SerVaas, I think if people are
considering pregnancy and childbirth, any woman is considering
that, then clearly counseling and testing is appropriate and
establishment that there is lack of infection before proceeding
with pregnancy is the appropriate steps that should be taken.

340

 

 

 
 

TY

I don’t think there is any likelihood that our
recommendations from the Public Health Service for the
prevention of AIDS is going to threaten the ongoing American
family.

CHAIRMAN WATKINS: We have only five minutes. I would
like to restrict the remaining questions to questions only
directed to the panelists, one or more, and then if the
panelists would be willing, we would like to receive the answers
to those questions and then perhaps there will be some
additional we will come up with that the Chairman of the
Commission will send to you individually and ask you further
questions.

Dr. Lee, do you have --

DR. LEE: I will yield my time on this illustrious
panel.

CHAIRMAN WATKINS: Mrs. Gebbie.
MRS. GEBBIE: I won’t.

I must admit, I don’t share Dr. Walsh’s confusion. I
think we have heard consistently from almost every witness we
have had that they see a need for more testing in conjunction
with counseling and properly planned programs and I have heard
that over and over again. So, he and I may need to talk.

 

My question is directed to Dr. Schaffner. You have
suggested that we should collectively construe the State of
Illinois or the State of Louisiana as a national experiment on
the question of how well and how effectively premarital testing
programs work, but nobody else should rush into it until we
evaluate those.

If we construed it that way, if that is what we
decided to see it as, what ought we have funded or constructed
around that law that would allow us to evaluate it and at what
time interval ought we set that up so that we could decide, you
know, hey, it was really brilliant and we should follow it or,
no, it has some flaws and we should do something else in the
rest of the country?

DR. SCHAFFNER Well, I think we should have done a
number of things. One is that just an assessment of number of
marriages and analysis of where any changes in rates of marriage
are taking place, to find those couples more precisely
demographically. I think we can do concurrent evaluations in
the surrounding states where it was clearly anticipated people
would go in order to avoid getting the test or just perhaps

341

 

 

 
 

 

avoid paying for it, and look at Illinois or Louisiana
residents, who are marrying out of state.

I think there is room for a series of interviews from
a sample of people who have married out of state and married in
state to see what kind of attitudes about it. Those kinds of
things, I think, would help us a great deal.

MRS. GEBBIE: At what intervals should we --

DR. SCHAFFNER I haven’t designed the study, but I
would think you would have a lot of information after the first
six months.

MRS. GEBBIE: My written follow-up to all witnesses
would be for some further elaboration on that evaluation model.
What we should do to critique this kind of decision and help us
apply it elsewhere.

CHAIRMAN WATKINS: Mr. DeVos.

MR. DeVOS: The fact of the matter is I guess we are
really not interested in testing. What we are interested in is
treating patients properly and preventing the spread of this
disease and our whole shift is on the technical aspects of
testing, which is how we help do those things.

Therefore, I am always interested in costs and this
panel knows that. We also know in this disease, the progression
of it is a multiplier effect. So, I guess we are going to need
more data as to whether it is economically valid to prevent other
people from getting it, which will lead to 400 or a thousand or
whatever, and the cost of doing that as opposed to testing a
whole lot of people.

That takes some real work ahead when we start studying
the real cost of taking care of those people who get it, to say
nothing about the human suffering that is involved. So,
testing, maybe you- can confirm for me, is it 99 percent reliable
and is it and can it be done for under $10.00?

DR. DiSALVO: I would like to respond to that.

Yes, it can be done for under $10.00, including
confirmatory testing, and it is one of the best tests we have in
medical laboratory practice. Sensitivity and specificity are
greater than 99 percent. If we get 90 percent in many of our
tests, we are elated, particularly in syphilis serology and
fungal serology. Over 99 percent -- it is a tremendously good,
accurate test.

342

 

 
 

 

MR. DeVOS: That is all I want to know because I hear
this smoke screen all the time against testing, that it is not
reliable and it costs too much and I thank you.

DR. MERCOLA: It is 99.999 -~

MR. DevOS: I understand that but I hear all the other
confusion on costing all the time with numbers being thrown
around and non-reliability and I think that is important to get
on the record very quickly.

CHAIRMAN WATKINS: I would like to, in closing the
panel out, Dr. Schaffner, Dr. Sherer and Dr. Mercola, if you
would, please, to send me a letter and review the bidding in
your area on hospital accreditation in the area of
administration of confidentiality of health information and tell
me if it is put to rigorous examination in that accreditation
process, if there should be changes made in the accreditation of
hospitals, to look into it, not only in the confidentiality, but
the casual revelation of any information needs to be sampled and
looked at very hard to build the credibility so that those
individuals coming in and receiving the counseling and the advice
would have a very good feeling that there is a tough system, a
tough regimen in the country, and raise the awareness within the
hospital administration area, that this is an important area and
could we put additional emphasis on that.

So, one, I would like to know what you think you have
today and could it be strengthened by us making a recommendation
on the accreditation process in the area of confidentiality and
in the area of broach of that confidentiality, of how you would
-- maybe Dr. DiSalvo would do the same thing for me -- how the
breach of that confidentiality would be treated in the
accreditation process review? How would they look at that? How
is it handled? How aggressive is it? How willing to cooperate
is the hospital?

Let me know if you think that is a valid point that we
can make comments on.

We thank this panel very much for coming here. We are
going to have to move on to the next one. I am very sorry.

The next panel is on the effects of Testing and Dr.
Jerry Sandler, Associate Vice President for Blood Services,
National Headquarters, American Red Cross; Dr. Paul Cleary,
Division on Aging, Harvard University Medical School; Dr. Steve
Morin, American Psychology Association, Chair, Psychology and
AIDS Task Force; Dr. William Lawson, American Psychiatric
Association, Department of Psychiatry, Vanderbilt Medical Center
and Colonel Donald Burke, Chief, Department of Virus Diseases,
Walter Reed Army Institute of Research.

343

 

 
 

 

Thank you very much for coming today. =
Dr. Sandler.

DR. SANDLER: Admiral Watkins and Commissioners, thank
you for your invitation to testify today.

I would like to just highlight some of the points that
are in my written testimony, which is available to all of you.
I am a professor of medicine and I am responsible for the Red
Cross’s 56 regional laboratories, which conduct 37 million
laboratory tests for infectious disease each year.

During the past three years these laboratories
conducted 18 million ELISA tests and an additional 36,000
Western Blot tests for HIV antibodies. That is, we do one-half
million tests each and every month.

In addition Red Cross regional blood centers have
notified more than 2,000 persons who denied risk behavior for
HIV infection when they donated blood, but their blood test
subsequently tested positive for HIV antibodies by ELISA and
Western Blot.

Based on that experience, I would like to make some
comments.

First, with reference to large scale laboratory
testing in low risk populations, as you have just heard, it is
very doable and it can be done reliably. When we test 10,000
people in a low risk population, namely a blood donor
population, we come up with 1 indeterminate test result and that
indetermination I would like to explain to you by analogy to a
pregnancy test. If you test the woman very early in pregnancy,
you may get an equivocal answer. You just wait a little bit
longer and repeat the test, nature takes its course.

The same is true of an HIV infection. If you will
give the laboratory two tubes of blood from a person with an
indeterminate, one taken early on and a second some weeks later,

they can tell you that the first one was an equivocal result and
the second one is either positive or negative.

I hear the argument about testing low risk populations
is not feasible because of large numbers of false positive tests
that would result. On the contrary, a well-run laboratory, using
FDA-licensed ELISAs and Western Blots, supplemented occasionally
by recombinant ELISAs, can distinguish positive tests from
negative tests. Such testing can be done if that is to be the
goal of public policy.

344

 

 
 

 

For the record, may I interject a couple of comments
about Dr. SerVaas’ quote of the Red Cross $3.00 figure for HIV
testing. I think it is extremely important that we understand
that that is the cost for bottles, that is, a reagents only cost
figure. That is not the cost per test for a full scale testing
progran.

Secondly, I would like to relate some general
information on the subject of donor notification.

Recently, I reviewed 900 reports by Red Cross
physicians, who conducted donor notifications. Only 50 percent
of current blood donors with positive tests for HIV antibodies
admitted risk behavior, compared to more than 90 percent one
year and two years ago. But second, in-depth interviews,
conducted by trained interviewers revealed that more than 90
percent of these same donors were identified to have risk
behavior.

People simply aren’t talking openly about risk
behavior as they did, probably because of increased concerns
about confidentiality. Our observation that 50 percent of blood
donors with positive HIV antibody tests presently do not openly
admit to risk behavior is, therefore, the result of an
unwillingness to talk to blood center personnel about it, rather
than a discovery of new, unrecognized routes for HIV infection.

We estimate that 5 to 10 percent of donors being
notified today are genuinely surprised by their positive test
results. Most of these, but not all of these, persons are
single women, who admit to sexual relationships with men, who
they know are or suspect to, be IV drug users or bisexuals.

All persons being notified of positive tests need
immediate and ongoing counseling. The subjects for counseling
are straightforward. They are public health, (how not to infect
others the way you got infected), medical, (what is the meaning
of the test), and psychological.

Thank you. I would be pleased to answer any
questions.

CHAIRMAN WATKINS: Thank you, Dr. Sandler.

In interest of Dr. Burke having to leave, we will go
next with Dr. Burke.

DR. BURKE: Thank you.

I am the Chief of the Department of Virus Diseases at
Walter Reed. I am personally responsible for the design and
conduct of screening in the U.S. Army. I also assist the other

345

 

 
 

<<

military services in their screening programs and have done so
for two years.

I wish to address a number of the common
misconceptions and concerns about HIV screening programs. My
comments derive from experience and not from theory.

The first concern is that false positive test results
are common. That may be true in some public laboratories or in
some private sector laboratories, where quality control is
feeble. In our own program, the false positive rate is 1 out of
every 135,000 individuals tested. We have measured that number
and we know it to be true.

Second, the cost effectiveness of HIV screening is
questioned. We do our testing under a contractual relationship
and pay $4.00 per person tested. This includes transport of
specimens, testing of specimens and reporting of results. It
costs us about $300.00 in the New York, San Francisco and
Washington areas for every case detected; that is, for every
HIV-infected individual detected laboratory testing costs are
approximately $300.00.

Third, some hold that the logistics of establishing
HIV screening programs are insurmountable. Mr. Taft, the Deputy
Secretary of Defense, directed on 30 August 1985, that we would
begin testing of all applicants for military service. Within six
weeks we had a fully functioning program in place that was
testing 60,000 people per month.

 

The fourth concern is that suicides are commonplace
when wide scale testing is implemented. Thus far, among
applicants for military service, there have been 1.8 million
individuals tested; 3,000 have been found to be HIV infected.
To date, we are unaware of anyone who has committed suicide in
direct response to being told of the diagnosis of HIV infection.

Fifthly, some contend that the requirement for pretest
counseling renders testing programs too expensive. In our
civilian applicant testing program, pretest counseling consists
of distribution of a one-page fact sheet. We reserve
individualized, one-on-one counseling for post-test counseling
to persons who have tested seropositive. The cost of pretest
counseling is nil.

Sixth, it is often said that because there is no cure
for HIV, testing is useless. HIV-infected persons can be
directly benefited by knowledge of their infected status.
First, they can be assured of a prompt diagnosis and effective
therapy of opportunistic infections. Second, HIV-infected
persons, who know their infected status, may be able to slow
progression to AIDS by careful attention to diet, physical

346

 

 

 
 

 

fitness and avoidance of other infectious diseases. Third,
HIV-infected persons can avoid the guilt and pain of having
unwittingly transmitted a potentially fatal infection to their
lover or spouse.

Concern number seven is that wide scale screening for
HIV will "drive the epidemic underground." This is commonly
said. To date, a grand total of only 75,000 HIV-infected
persons have been diagnosed as HIV-infected through alternative
test site programs. This represents about 5 percent of all of
the HIV-infected persons in America today. Restated, 95 percent
of HIV-infected Americans remain totally unaware of the fact that
they can transmit a fatal communicable disease to their sexual
partners. As a direct consequence of a national failure to
encourage wide scale routine testing, the epidemic is already
underground.

In closing, I reject the passive and fatalistic
attitude, championed by some, that effective routine HIV testing
is beyond the capability of the U.S. public health machinery.

The means are in hand today to establish an accurate diagnosis in
each and every case of HIV. We as a society must abandon the
strategy of ignorance. We can no longer systematically deny the
rights and benefits of painful but critically important knowledge
to the 1 1/2 million Americans who carry a fatal infectious
disease. :

We must set as a clear goal, wide and free
availability of high quality HIV testing.

Thank you.
CHAIRMAN WATKINS: Dr. Cleary.

DR. CLEARY: Yes. My name is Paul Cleary and for the
past several years, I have been conducting research on the
notification of seropositive blood donors at the New York Blood
Center. I am concerned about maximizing the positive impact of
those blood test results.

When biomedical tests are evaluated, technical
performance is usually the prime consideration. Indeed, much of
. the debate concerning the appropriate use of tests for HIV
antibodies focus on the error rate of those tests. Many people
do not realize how many HIV tests results will be incorrect,
especially in low prevalence populations.

However, I would like to disagree with Dr. Mercola,
when he said the several papers that have analyzed testing
programs hinge on the number of false positives. I think Mr.
DeVos slightly overstates it when he says it is a smoke screen

347

 

 

 
 

 

but I would agree with him that in many cases this emphasis is a
detraction from some of the more important issues.

I would like to argue today for the importance of
considering a broader array of consequences of HIV testing
before implementing testing programs. Furthermore, I will
propose that testing should not be conducted without careful
analysis of the potential impact on the persons being tested and
that any testing should be conducted by persons who have
received substantial training in the interpretation of test
results, in providing support to seropositive individuals, and
in promoting behavior change.

We recently analyzed the effectiveness of a
hypothetical national compulsory premarital screening program.
This example highlights, I think, some of the issues in
compulsory screening. In our analysis approximately 1,200
infected individuals, who had not already transmitted the virus
to their partner, would be detected each year. Many of those
persons might alter their behavior to prevent or reduce the
spread of the virus to others, but this is the best result
achievable in a program that would screen more than three and a
half million people.

As many as 380 people with false positive results
would be told incorrectly that they were almost certainly
infected and many of these people probably would experience
severe psychosocial morbidity. More than a hundred infected
individuals would be told that they were probably not infected
and this false reassurance could increase high risk behaviors.

There would be other less important but logistical
difficulties in implementing a mass testing and notification
program in a premarital setting. It currently takes up to about
four weeks for some testing sites to complete a series of EIA and
Western Blot tests on a sample. It would be necessary to develop
protocols about what information, if any, should be given to
patients, who are EIA positive, pending Western Blot results.
Also, if test results were needed prior to marriage, the test
sequence would have to be initiated about a month ahead.

The financial and opportunity costs of a national
screening program would be enormous, probably exceeding a
hundred million dollars annually. Such an expenditure might be
justified if the program could sufficiently reduce the spread of
HIV and if other, more cost effective efforts were already being
taken. Considering that there are probably between one and one
and a half million infected individuals in the United States and
that a hundred million dollars represent more than the Federal
Government spent on AIDS education in 1987, a compulsory
premarital screening program does not appear to be a sensible
allocation of resources.

348

 

 

 

 
 

 

Let me emphasize again here that I don’t think false
positives are the issue. The issues, as Dr. Sherer emphasized,
is that education is a critical component of screening programs.

Another potential negative impact of mandatory
screening programs is that they may discourage people from
seeking information or contacting health authorities. Again, as
Dr. Sherer indicated, and the press has reported in Illinois,
where mandatory premarital screening has been instituted, many
persons are leaving the state to be married or are avoiding
marriage altogether. Thus, testing programs that are compulsory
may alienate the very persons they are intended to help.

The difficulty of promoting behavior change among
seropositive individuals cannot be overemphasized. HIV
infection is feared and stigmatized and it is extremely
difficult for infected individuals to tell others, such as
sexual partners and physicians, about their infection.

Furthermore, the behaviors that put others at risk,
intravenous drug use and sexual behavior, are notoriously
difficult to change. \

Let me emphasize that HIV screening is something I am
strongly in favor of and it can be an extremely effective public
health tool. HIV antibody tests are almost indispensable \for
making the blood supply in the United States as safe as possible.

The screening of donated blood, however, is so
effective primarily because it is easy to discard infected blood
and thus definitely prevent the transmission of HIV. In order
for a screening program to be effective, I think there are
several conditions that must be met. |
One, the program must reach a large number of persons
who are at high risk of HIV infection. !
The testing program should not alienate individuals
who are at high risk.

A series of tests must be used under carefully
controlled conditions.

And, finally, and most importantly, there must be a
way of maximizing the positive impact of the test and minimizing
the negative impact. It is important to remember that simply
identifying an individual as infected does not necessarily have
any positive impact. It is necessary to promote difficult
behavior changes for a testing program to have any positive
effect whatsoever.

349

 

 
 

 

"t

In order to maximize the likelihood of these
conditions being met, I make the following recommendations.

As Dr. DiSalvo recommended, a task force should be
developed to coordinate and monitor standards for HIV screening
test protocols and these standards should be enforced
nationally. One problem that has caused a great deal of
confusion is the lack of uniform standards for certain tests,
such as the Western Blot. Epidemiologic, clinical and public
health activities would be facilitated if only standardized,

licensed tests were used.

I agree strongly with Dr. Burke that we can do much
better than we have been doing.

More rigorous procedures should be established for
monitoring the performance of laboratories performing tests.
Monitoring programs such as those conducted by the American
College of Pathologists have been extremely useful in this
regard.

Three, programs should be developed to train health
professionals concerning the advisability of testing for
different types of persons, the interpretation of test results
and the meaning of HIV infection. These programs should train
physicians, nurses and other health professionals in such topics
as the epidemiology of HIV infection and the natural history of
HIV infection. . —

Four, programs should be developed to train health
professionals concerning how to provide support to and encourage
behavior change among seropositive individuals.

In order to maximize the impact of testing programs,
they should in almost all cases be voluntary and anonymous. If
it is not possible to ensure anonymity, rigorous procedures
should be established to ensure confidentiality.

The importance of developing training programs for
medical and paramedical professionals cannot be overemphasized.

Believe it or not, I think everyone in this room is in
agreement. We all share a common goal of reducing the spread of
HIV infection. Since the virus can only be spread, for all
practical purposes, by a limited number of behaviors, it is
critical that we focus extra effort on developing strategies for
modifying those behaviors among all individuals and especially
among HIV-infected individuals.

Thank you for your attention.
CHAIRMAN WATKINS: Dr. Morin.

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DR. MORIN: Thank you.

Mr. Chairman and Members, thank you for the
opportunity to present the views of the American Psychological
Association. My name is Steve Morin. I am the President of the
California State Psychological Association. I am also an
Assistant Clinical Professor of Medicine and Senior Investigator
at the Center for AIDS Prevention Studies at the University of
California, San Francisco.

I am the chair of the American Psychological
Association’s Task Force on Psychology and AIDS.

A little over a year ago, I was invited to Atlanta to
address the CDC on testing issues. I was one of the few
behavioral scientists that were involved in initial planning on
the testing issues. It became clear in the course in the
deliberations in Atlanta that there was considerable confusion
about and not much definition to the tern "counseling" as it was
being used in discussions of a prevention campaign.

Following that conference, APA attempted to pull
together some definitions of what would constitute "counseling"
and "education." From this effort evolved a position paper,
which I have submitted for your consideration. It is sponsored
by the Coalition for AIDS Prevention and Education, which is a
group of 24 national professional associations, who have signed
on to this position statement.

What the position paper attempts to do is define what
is meant by "counseling" and how counseling can be effective as
part of a prevention campaign.

Dr. Cleary has spoken about the need for behavior
change as part of a prevention campaign. Our efforts have been
to focus on what will facilitate the kind of behavior change that
would, in fact, result in stopping the spread of HIV infection.

You have my written testimony which you can read. I
do want to go over some of the recommendations.

We believe that testing as part of an AIDS prevention
campaign should be voluntary rather than Mandatory. This is
because AIDS, by and large, is a behaviorally transmitted
disease. We are talking about voluntary behaviors. In order to
change and facilitate the change of voluntary behaviors, one
needs to have the cooperation of the person with whom you are
working.

We also believe that testing programs should be
anonymous, whenever possible, and in the absence of this, that

351

 

 
 

 

they should be confidential with prohibitions against |
inappropriate disclosure. This comes as part of a desire to
remove the barriers that are currently present, that prevent
some people from seeking counseling and testing.

We also believe that testing should be part of a
counseling program rather than vice-versa. In other words, we
would like to see routine counseling available. We have
targeted certain places where it makes the most sense to start
with federally-funded programs. These would be family planning
clinics, prenatal care clinics, sexually transmitted diseases
clinics and substance abuse treatment centers. Here you will
find, in all probability, the greatest number of people who are
potentially infected.

What we are suggesting is that routine counseling be
available. If in the pretest counseling, testing seems to be
advisable, based on the history that is obtained, then the
testing would go forward and post-test counseling would then be
made available.

We believe that as part of the pretest counseling, it
is important for individuals to be informed about the legal
ramifications of HIV testing, including local and state laws

about disclosure, confidentiality and non-discrimination.

Pretest counseling should involve prevention
education. We make a differentiation between "education" and
"counseling." Education is giving people information, i.e.
factual information about how the virus is transmitted.
Counseling involves making an individualized assessment of that
jndividual’s risk and attempting to give specific
recommendations, tailored to that individual, about avoiding
future transmission of the virus.

It would also involve informed consent, so that it
would be clear that all people understood the implications,
including the psychological implications, of a possible positive
test results.

Post-test counseling should include further education
about preventing infection and assistance for the seropositives
in managing the potential psychological and social consequences
of infection.

Follow-up mental health treatment should also be made
available where an assessment indicates that the individual’s
commitment to behavior change is unclear or where severe
psychological distress is evident. Our surveys indicate that of
those tested through alternative test sites, approximately 7
percent would make use of follow-up counseling if it were made

352

 

 
 

 

available. Currently such services are not funded through
alternative test sites.

We believe that an effective program that targets
specific federally-funded programs would cost about $400 million
for an initial start-up. It would be somewhat less expensive if
it were continued.

We further believe that one of the ignored issues in
the whole epidemic has been the mental health implications of
the AIDS epidemic. A number of people, not only people with
AIDS and ARCs, but particularly seropositives are known to be
considerably more anxious and depressed than people who test
negative.

We believe that there needs to be emphasis on mental
health treatment for these people and for significant others of
these people, as well as health care providers. We are
recommending a $25 million appropriation directed through the
National Institute of Mental Health to states in order to
facilitate AIDS mental health treatment across the country.

We also believe that in order for these programs to be
effective, you need, in essence, an army of counselors; people
who are well-trained, not only about AIDS, but are also well-
trained in how to work with people to facilitate behavior
change. This is going to require a major allocation of funds
and resources to train these people to be effective.

We also think that these programs need to be routinely
evaluated so that they can be improved as they go forward.

Again, thank you for the opportunity to present these
views.

CHAIRMAN WATKINS: Thank you, Dr. Morin.
Dr. Lawson.

DR. LAWSON: Mr. Chairman,, Members of the Commission,
I am pleased that you invited me to speak to you. I am William
Lawson. I am Assistant Professor of Psychiatry at the
vanderbilt University School of Medicine. I am also the Chief
Medical Officer for the Department of Mental Health and Mental
Retardation for the State of Tennessee and I am pleased to
represent the American Psychiatric Association, a medical
specialty society representing over 34,000 physicians
nationwide, to discuss with you the multi-faceted issue of HIV
antibody testing.

I am going to just pretty much agree with what some of
the other members, particularly Dr. Morin, has already

353

 

 
 

 

recommended and the American Psychiatric Association supports,
affirms the idea that all psychiatric patients who are to be
treated based on their clinical conditions and that neither
serological status nor HIV infection should impede the delivery
of appropriate medical-psychiatric treatment.

Further, we support the idea consistent with our own
guidelines that HIV serological testing should not be performed
solely for the purpose of routine screening or staff awareness.
As physicians, our association supports the position of the
American Medical Association that testing for an antibody to the
AIDS virus, when used in conjunction with appropriate counseling
-- and Dr. Morin has already, I think, addressed that important
issue -- can serve the important public health purpose of
providing impetus for behavior change that minimizes the risk of
AIDS virus.

We would emphasize that testing conducted along, in
the absence of appropriate supportive counseling and without
strictly adhering to confidentiality of test results is
insufficient and there is some evidence that this could also be
counterproductive. :

we further feel that the types of behavioral changes
needed to reduce the transmission of HIV infection is further
supported by knowledge about AIDS and targeted education
programs and we feel that those are the most effective tools in
the arsenal of public health strategies aimed at motivating
behavioral change.

Some of the questions that have come up include: Will
knowledge of test results affect behavior change or stimulate
undesirable reactions in the infected? Will a negative status
lead to responsible behavior or engender a false sense of
security? These kinds of studies are currently underway, but
unfortunately this knowledge is limited because there hasn’/t
been any other HIV-like infections existing in the past.

However, we can offer some guidance in terms of how to
counsel and treat the individual under many of the pre and
post-test scenarios. We cannot predict the outcome of knowledge
of test results for individuals.

When we look at the literature, it is pretty mixed...
The only thing that can be said for certain at this point is
that knowledge of test results is clearly associated with this
host of symptoms, ranging from depression, suicide and stress
and to some, denial, and this is an important symptom because
denial of the person who tested HIV positive, of course, can
jeopardize others.

354

 

 
 

 

Current research is suggesting that learning one’s
Serological test results can have either beneficial or adverse
effects. We urge the Commission to recommend in subsequent
reports the need for additional research to clearly identify the
psychiatric ramifications of serological HIV testing and to
define appropriate criteria for its use.

Education of different populations continues to be an
important endeavor at ADAMHA. An innovative targeted approach
to reach high risk groups, such as HIV drug users and to reach
out to minority communities must continue to be evaluated.

More important than testing, we feel, is to expand
outreach programs, especially since infection by IV drug users
offer the most significant method of infection of low risk
populations. Outreach programs directed to this population must
be expanded.

Some have made the argument that testing shouldn’t be
at all and part of that argument stems from the observation that
the psychological impact, as well as some of the documented
social consequences of testing can be significant, including such
matters as job loss, as well as the failure to be able to get
appropriate referrals of people who are going from essential
institutional settings into more deinstitutionalized settings.

On the other hand, we recognize that testing for
medical diagnosis and management is critical. Clearly, this
issue needs to be addressed concomitantly with the issue of the
effectiveness of this information on social change. It is also
essential that testing is done, whether the results are positive
or negative, that pre and post-test counseling be done tailored
to the needs of the patients.

As Dr. Morin has suggested, we found instances
unfortunately in which the pre and post-test counseling was not
useful but was meaningless to the patient. So, it’ must be
directed to the specific patient populations that we are working
with.

Statutes which mandate reporting of positive test
results with clear patient advisers, we feel, may be keeping
large numbers of infected and uninfected persons away from
testing altogether. Mandatory reporting, especially in the
absence of nondiscrimination guarantees, undermine the success
of a voluntary testing program.

The goal of the testing program is to reach
individuals at high risk of contracting AIDS. Most are already
in minority groups fearful of government and are much less
likely to come forward to be tested if there is a chance that
their names will be reported. our primary objective is to get

355

 

 
 

 

people tested, educated and into treatment when necessary.
Mandatory reporting of those in need, we feel, will drive them
underground and away from the held that they need.

The APA makes it clear that patients must be confident
that issues discussed with their physicians are private and will
not be divulged. We feel that a breach of confidentiality is
only a last resort and is to be utilized only after scrupulous
attention has been given to all other alternatives.

In situations where the patient HIV status is
documented positive, our guidelines encourage the physician to
work with and advise the patient to either terminate the
behavior that places other persons at risk of infection or to
notify individuals, who may be at continuing risk of exposure.
This policy permits the physician to notify a third party
believed to be at risk for infection only if the patient has
clearly refused to change behavior or notify those at risk.

As I am sure that you know, the issue of testing is in
reality several important sub-issues, which cannot be examined
in a vacuum. The members of the American Psychiatric
Association stand ready to assist the members of this
Commission, as well as others, in the development of public
policy responsive to individual safeguards and societal
concerns.

CHAIRMAN WATKINS: Thank you, Dr. Lawson.
Our first questioner will be Mr. DeVos.

MR. DevVOS: Like some of you, I get fascinated with
this need for more testing and more data. In the corporate
world we have a new product. That is the same thing all my
research people always tell me. Well, we can’t go yet, we need
more data. And if I listened to them forever, I would never get
anything done.

It is sort of like going to the President now with a
recommendation that we can’t give you a recommendation because
we don’t have enough data. So, I have a very simple question
today and I think, Dr. Burke, you have helped us greatly by
getting rid of some of the confusion and misconceptions, but
maybe just -- we have two men in the psychological field here.
What is the one thing we can do -- we have all these various
problems with testing and fear and all the rest of it -- what is
the one thing we could recommend to the President of the United
States that he could do to get people who are at risk to come in
for a test?

DR. BURKE: We may get some divergent views on this
but I think we may actually come to a common ground. I believe

356 -

 

 

 
 

that antidiscrimination is the key to having an effective
program of testing, test-linked counseling. That is public
health through testing.

MR. DevOS: You see assurance in that one --

DR. BURKE: Yes, and I think there are a couple of
ways to achieve that. One of them is through passage of
forceful new legislation, but another one is to enforce existing
legislation with high visibility. I believe that we could
recommend to the President and to the Surgeon General of the
Public Health Service that when there are blatant instances of
unfair discrimination, like the case of the Florida boys, that
they should speak out very clearly. They should teach the
nation that the infection with HIV is really an unfortunate
situation.

We need that leadership. We need it in legislation
and we need it in the public relations so that the public in the
United States understands fully the implications of the disease
for those unfortunate people who are infected.

MR. DevOS: If I come out with a new product and I
want to get it sold, I have to have a slogan, a message that
reaches people who are potential for this deal. And I am
looking for that one message to deliver to these people so that
instead of all this arguing about voluntary and all this, we
forget that argument -- so that they will want to get tested so
badly, just like they want to buy my product so badly, they will
stand in line to do that.

 

\

DR. MORIN: Let me try to reshape your question here.

Having been involved for the last three years in
marketing the test in San Francisco, we have done extensive |
advertising. We have even done a market research survey of why \
people will be tested and why they won’t be tested.

The arguments that bring people to testing include
first -- now, there may be something of medical benefit from
knowing one’s antibody status. Second, people are very
concerned about the possibility of infecting others. And third,
people who have not had much risk behavior and do have a certain
level of anxiety hope to have some relief of that anxiety. Those
are the major reasons that are found in marketing research on the
test.

However, I beg to differ because I don’t think we are
trying to sell the test. What we are trying to sell is behavior
change and what we are trying to do is prevent the spread of the
virus. You can get behavior change without the test.

357

 

 

 
 

In San Francisco, we have set up a number of projects
where people come in and talk about their need to change
behavior and they do it. Group support is important for
behavior change. We have a seroconversion rate that is close to
zero among gay men in San Francisco. That is remarkable. This
kind of behavior change has been facilitated through voluntary
programs. It is now the group expectation and the community
expectation that people do not do those things that spread the
virus. That has to be our national way of thinking, that we do
not spread this virus and we are going to do whatever we need to
do to make sure that doesn’t happen.

MR. DevVOS: I am a positive guy, who believes most
people are well-intentioned and honorable and that is why I
think if you appeal to some of that, we are going to get some
place.

DR. SANDLER: I wonder if I might make a comment on
that and that would be, I think you have to get on with it and
that is the way to move with it. It was June 1985, only a few
months after the antibody test had been licensed, the Red Cross
decided at that point -- now, that is an awfully long time ago
-- that we were going to start notifying people with positive
tests and we did it and we have been doing it since.

Now, a lot of people today are still wringing their
hands but we have been notifying people who came into blood
centers -- and remember, we have just the opposite situation.
We have a person who has signed on a dotted line saying I have
no risk behavior. Now, since June of 1985, we have been going
to those people and saying the lab test is sufficiently reliable
for us to come to you and tell you you may not do any blood
again. You are potentially infectious. You must get
counseling. The sky has not caved in.

DR. LAWSON: Let me just also address that point. I
want to agree with the other panelists that the issue really --
and I think if there is one message, it is really not to base
the program on information about test results because I think
the literature is pretty clear that it may or may not cause the
desirable behavior that we want.

I think the positive message, as the San Francisco
experience has described quite well, is that using education
programs targeted, we can produce change. Unfortunately, as
most of the studies that look at the impact of drug abuse
programs have demonstrated, minority groups are differentially
not involved. I think that if the President is going to get one
message, we have to target to those groups, who have not been
reached before and we will have to push the idea that it is
possible to change people’s behavior with the appropriate
educational programs, but it is very unclear as to whether

358

 

 

 
 

CO

knowledge of test results is going to bring about the kind of
desirable behavioral change that we would like to see.

MR. DevVOS: Dr. Morin, would you be kind enough to
send that report to the Commission to the attention of the
Admiral, so that we could have that data in our file and then
for this report?

DR. MORIN: Yes.

MR. DevOS: Thank you.

CHAIRMAN WATKINS: Mrs. Gebbie.

MRS. GEBBIE: I think Dr. Cleary has a comment.

DR. CLEARY: I would just like to second the opinion
that I think that we do have the data. We can proceed; we
should proceed. Obviously, at the New York Blood Center we test
every unit of blood. We obviously advise people. We think we
have been very successful. I think you can make a tremendous
impact.

What we want to do is minimize shooting ourselves in
the foot, if you will. We want to contact people and we want to
have screening as inclusive as possible. I think to do so we
need to recognize that one, the things that prevent people from
coming in are fear of disclosure and, two, once they do have a
positive test result, we want to maximize behavior change.

 

In the Blood Center, we have been told by persons --
and this makes us shudder -- that they have actually donated
blood to have their blood tested because our program has such a
good reputation. I don’t think that is the way to proceed. I
think the way to proceed is to establish a high priority for
quality counseling, quality support throughout the country. I
think we have enough models to do that today.

CHAIRMAN WATKINS: Mrs. Gebbie.

MRS. GEBBIE: The longer we go on, I guess the harder
it is to just ask a question without some comment.

I remain impressed and feel the need to reemphasize
that when we are certain that all witnesses are answering the
same question, there is a remarkable degree of cohesion in the
answers. Our problem, particularly around this particular piece
of the debate, is that we often don’t ask sufficiently clear
questions, so we get three different answers because people
interpreted the question somewhat differently.

359

 

 

 
 

 

The focus on behavior change, to me, is critically
important because I want some people that are currently negative
to change their behavior, too, so that we don’t feed into the
epidemic and I get concerned if we narrow it.

Given that there is that remarkable degree of cohesion
when we really stick to looking at each question very precisely,
but also given that because of the confusion in this debate, we
have got some policies already made or some people already dug in
onto viewpoints, based on early experiences -- I guess I am
‘harking back to some testimony we have heard on developing
community policies and such ~- how do we construct the debate
from here on out so that we can take that degree of cohesion and
really clear views on moving ahead and make it happen?

I think having a slogan or clear, positive thing will
be helpful but it is still going to have to be translated into
actual programs or something. Is that doable at a single
national level or ought we move toward a recommendation that
allows that cohesion to be acted out at a local level or ata
state level or at a regional level or at a subgroup level that
somehow cuts across geographic boundaries but is targeted around
drug users or some other subgroup?

I think we really need some discussion from as many of
you as can comment on how we make that next move.

DR. CLEARY: I think we should do both. I think we
should move immediately at a national level to disseminate
information. I think it is appalling that we have materials
available that have not been distributed. I think it is
striking that European nations with much, much lower levels of
prevalence, have been much more aggressive in disseminating
information about this disease.

The country is very knowledgeable about AIDS, about
routes of transmission. It is less knowledgeable about things
such as casual transmission and so on. I think that is
counterproductive and feeds into the epidemic. So, I think that
is one recommendation you could make.

I also think that we know that such type of programs
are destined to failure unless there is more localized, more
subgroup specific and more tailored types of interventions, both
among populations in general and among persons who are
seropositive. So, I think it has to be nationally coordinated,
it is not a local problem. There has to be a national response
immediately; however, that will not suffice. I think there also
has to be detailed levels of programs, both at state and local
levels, to address the specific issues in different communities.

360

 

 
 

 

DR. MORIN: I agree. I think where we are finding a
lot of common ground is the agreement of facilitating behavior
change, both among positives and negatives, is the only way we
are going to stop the spread of the virus. There is general
agreement on that. How you do it and who does it, have become
major policy problems.

Theoretically, the Centers for Disease Control should
be facilitating the national program on preventing the spread of
the virus. You will find that they have very few staff with
expertise in the behavioral sciences. They offer virtually no
technical assistance to the states and local programs on how
best facilitate behavior change.

All of these programs are going to have to be
organized and run at a local small unit level because that is
the only way you are ever going to reach people on a one to one
basis and facilitate the kind of change we are talking about.
This is how best to facilitate these prevention programs.

There has been a general lack of leadership from the
cbc in facilitating targeted, local prevention programs.

DR. LAWSON: I just want to add to that two other
points and that is I agree with your points, but I would add
another dimension and that is the communication change.
Obviously, if we provide information at a local level, we run
into a very interesting phenomena and that is that the usual
mechanisms that we would have that would work very well for the
majority of the community may not reach the black and Hispanic
populations and it is not because of some overt effort of
discrimination. It is because the usual mechanisms have not
been designed in the past that have been meaningful to reach
those populations. What we need to do is to look at and
recognize that there may be different methods of communications,
perhaps through the churches, perhaps through an informal
network, in which we need to address those concerns.

Another way it is looked at is also in terms of
modality. It is interesting that there has been very little
discussion in terms of the chronically mentally ill and, yet, we
well recognize that these folks make up a disproportionate
number of the homeless. Why is that? I suspect it is because
we have compartmentalized the homeless, the mentally ill in one
dimension and AIDS in another dimension and yet we see them as a
potential and major vector because of the fact that they are
frequently victimized and also because this is a population of
folks who are very, very likely to end up homeless, perhaps
because of the presence of HIV infection and not having access
to the usual kind of support facilities in the comnunity.

361

 

 
 

 

DR. BURKE: I think another perspective on it is that
we are finally coming to the realization that we need to address
the problem of AIDS and HIV primarily as a medical problem. It
is in the best interest of our society and it is in the best
interest of the individual to know fully about his own medical
condition. If there are obstacles to achieving this goal, they
must be overcome. One of the obstacles is the discrimination.
Another is the problem of false positive testing, but we are
moving beyond that now.

The issues are how can we get everybody in the United
States, who is infected with this virus, to know that they are
infected and how can we do that with the least unfavorable
impact to the individual. If we can take those steps, then we
have a very realistic chance of beating the epidemic. And I
think that is largely what our panelists are saying here today
is that the medical goal, the medical diagnosis, the medical
approach to the epidemic is achievable, and it is achievable
now.

CHAIRMAN WATKINS: Dr. Burke, let me have a quick
follow-up on that because it is an extremely important point you
are raising.

The Centers for Disease Control have recommended and
the Medicine Policy Council of the White House has approved the
so-called family surveys. These include the 30 SMSA. They also
include going out for bid for three pilot cities, in which
actually seroprevalence data are going to be obtained. If you
were responsible for preparing the three pilot cities properly
to -- with the idea, with the objective of a hundred percent
volunteerism because we can prove our ability to the extent
reasonably practical on anonymity, confidentiality, prevention
from discrimination in those cities, would you not then build a
strategy along the line you recommended as a precursor to
conducting that, to ensure that the value of the seroprevalence
data in the three pilot cities were optimized or would you just
let it happen?

In other words, you are all telling us that certain
precursors have to take place to get the seroprevalence data to
be valuable. So, would you give me your strategy then -- let’s
say you are in charge and let’s say Nashville was a selected
site and it was one of the 30 SMSAs, which it probably is not,
but let’s say that you were responsible to build that strategy
so when the testing was actually done by the health officials in
this area to obtain the data, you would feel comfortable that
people would be willing to come forward and participate because
it is not only in their best interest but also in the interest of
public health, what strategy would you build then, starting at
the national down to other levels?

362

 

 
 

What are the things that go through your check-off
list?

DR. BURKE: That is quite a tall order, sir.

CHAIRMAN WATKINS: But that is the order that is at
hand and we are getting all around it, but we have to deal with
it and we have had the rhetoric and the generalities. Now,
let’s get specific. What is the strategy that you want us to
recommend, to pass to CDC to say you must -- because I have
asked this to the director of the Centers for Disease Control
and he agrees that something like that ought to be done ahead of
time, so that we don’t just let it happen with technical people
doing it, without all the other psychosocial interest at hand, in
place properly.

DR. BURKE: There are two separate approaches to
screening. One of them is to develop data. If that is your
primary interest, then it is essential to get a very
representative and unbiased sample of the population. And,
frankly, I think that in the current psychological milieu of the
United States, that is close to impossible on a voluntary basis
because of the two or three years of background that we have had.
Maybe five or ten years from now, once the psychology has changed
in the United States, that it may be possible to get 100 percent
voluntary participation in an HIV screening progran.

The second use of testing is as a medical device for
the individual. There it is up to the individual physician to
provide the test to the individual, to make sure that they
understand the effects of that virus on themselves and their
loved ones. So, what I am saying is that I don’t think it is
possible to have the perfect model in place within the next year
and expect a hundred percent of Americans to come forward for
testing. I think that is just too fast a time scale to expect
realistically.

The purpose of the family of surveys is to develop
data. It is not designed to have a direct impact on disease
transmission. It is primarily a surveillance tool, rather than
an intervention tool.

CHAIRMAN WATKINS: I understand, but if you are going
after even good data, would you not want to have some kind of an
objective to achieve a percentage of participation on the
statistically valid information so that it is useful or would
you hold off -- would you recommend holding off until you did
that because otherwise it could be counterproductive.

DR. BURKE: Once you have made that recognition that
there are two possible uses of testing; one, surveillance and
second, interventive, then you can proceed to conduct your

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surveillance and say, okay, how can we get an unbiased, good
representative sample of the population. There are a couple of
places to do that and I think, by and large, the CDC’s approach
is reasonable; that is, to go to hospital admissions and do
identifier-unlinked studies; to go to women who are delivering
babies and to determine what the prevalences are there.

I think to try to go out into the population right now
and expect a hundred percent cooperation is just unrealistic. We
are going to have to use the best data available, which is
people who come routinely into contact with the medical
profession.

CHAIRMAN WATKINS: All right. Have you recommended
then that there are not be a three pilot city seroprevalence,
blood-letting effort because you don’t think it is a proper to
go to get the right data, that we are not going to get the right
data unless we lay the proper groundwork? ©

DR. BURKE: Well, it is a question, again, of how you
go about obtaining those samples.

CHAIRMAN WATKINS: I am not talking about the 30
SMSAs. I am talking about the three major pilot cities, in
which seroprevalence data is going to be obtained in a random
basis to get the right demographic information that is necessary
to determine seroprevalence in those three cities and perhaps
related to the 30 SMSA data in those three cities.

DR. BURKE: I think at this point the data may come
out of that may be very difficult to interpret, sir.

CHAIRMAN WATKINS: Well, are you recommending that it
be deferred until such time as we are ready to run it properly
in order to get the right data or is it still valuable data no
matter who participates?

DR. BURKE: Tough question, sir. I think that it
probably will be valuable data in that it will reveal infection
in some individuals who no one expected to be positive. That
it may not give a cut of the actual distribution of infections
in that community, but I think that the value that may come out
of that is that we may be surprised in a survey of that nature.

So, I would go ahead with it, sir.
CHAIRMAN WATKINS: Thank you.
Dr. Lee.

DR. LEE: I will yield to the distinguished
Commissioner on my left.

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MS. PULLEN: This is the first time I have been on Dr.
Lee’s left.

[Laughter. }

I would like to point out that in terms of the
audience, I am to Dr. Lee’s right.

Dr. Burke, would you please comment on whether you
believe that universal HIV screening of patients at Walter Reed
Army Hospital either is having or will have an effect on the
delivery of health care in that facility and what effect?

DR. BURKE: We conducted a blinded survey at our
hospital, about a year and a half ago to determine how
frequently patients were being admitted to our hospital, that
were totally unsuspected of being HIV positive. As you are
aware, we have a very aggressive HIV testing program in the
military and for someone to slip through our nets, that is
remain undetected through clinical suspicion through our
screening programs, we thought would be unusual.

Nonetheless, we did find that about one out of every
200 admissions to the hospital was a patient with an unsuspected
HIV infection. That information was in turn provided through the
channels in the Department of Defense to help make decisions
about whether or not military hospital admissions should be
routinely tested. The Army policy, which has just gone into
effect just within the last month or so, is that hospital
admissions, all hospital admissions, should be routinely
screened. This policy hasn’t been implemented yet, so I can’t
tell you whether or not the routine screening has had a favorable
or unfavorable impact.

Let me add parenthetically that the blinded type of
survey that we did in our hospital, that is to take the blood
samples that were being sent for other routine tests, remove the
patient identifiers from the blood tube, and test, is something
every hospital in the United States could do today very simply
and at very low cost.

When I am told that the resources aren’t available to
determine the prevalence of HIV in a given hospital, I frankly
don’t believe it. It means that people don’t want to do it.
There are ways that each jurisdiction can develop this type of
prevalence information and make the decision hospital by
hospital. Is it worth it? If a hospital in Des Moines finds
that there are no persons who are infected, then they might
decide not to implement routine admission testing. If a
hospital in New Jersey found in a blinded study that 1 to 5
percent of their admissions were patients with unsuspected HIV

365

 

 
 

 

infections, then they might want to seriously consider routine
admission testing.

CHAIRMAN WATKINS: Dr. Walsh.

DR. WALSH: Well, for the first time in a couple of
days, I am finally encouraged and unconfused because
particularly of the testimony of this panel and particularly
with what Dr. Sandler and yourself have said about your
experience. When you stop to think that between you, you have
25 million tests or tests that have been done, you haven’t
chased anybody underground. You haven’t had anybody commit
suicide and I think that the stress that maybe where we have
gone off is we get in the use of the generic term of "public
health" and then you get into basically a political
organization, which is an organization of public health
officials, and that is where a lot of the civil liberty
arguments arise and we lose sight -- and I think your use of the
term "medical knowledge" is perhaps better, the medical approach
to this is better and it might give us a key of how to go because
the data that you two have presented, to my mind, is an
invaluable sample.

It also is an invaluable demonstration that the people
whom you have diagnosed are for the most part grateful and for
the most part do go to counseling and get counseling, which is
an essential cornerstone of what many of the civil liberty
arguments have been about.

I just feel that the waters have been so muddied by
some of the other testimony that we have heard, that I feel like
I have just had a wonderful cold shower hearing this panel and I
think you have given us a much better sense of direction because
you have recognized concerns; you have recognized, you know, the
confidentiality and discrimination, but you have demonstrated
that you are thinking ahead for this country. And as you pointed
out, Dr. Morin, the behavioral change, once you have the
knowledge, is very important, but the knowledge of the disease is
an important aspect of the receptivity because I still maintain
that most people want to live as long as they can and they are
not going to run away from a test. And I heartily endorse a
modification, perhaps, of the education programs as they are now
constituted.

Dr. Cleary pointed out, you know, that CDC is sitting

on some stuff and so on, but I am not one who believes sending
out 20 million pieces of literature to a lot of houses is going
to accomplish a thing, but I think if the kind of education that
you are talking about -- and I think that is what Dr. Cleary is
getting at -- is so important that if you educated people, as Dr.
Crenshaw tried to get out earlier, as to the value of why this
test is being done, what is the positive side of testing, how are

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-~- you know, this is good for your country; it is good for your
health; it is good for everything that we are doing and it is the
only way to contain the epidemic. I think we could put away so
much of the fear and I really don’t have any questions because I
am just sitting here thoroughly delighted.

CHAIRMAN WATKINS: Dr. SerVaas.

DR. SerVAAS: Jerry Sandler, you fired the first blast
when you said that I called this a $3.00 test at the Red Cross
and I want to tell you that if you are paying $3.00 for your
little bottle and then just the test, then you should buy them
from us because we are paying $1.21 and we buy a lot fewer than
you do and I can tell you that you had better get next to your
purchasing agent because I really --

CHAIRMAN WATKINS: That may be a conflict of interest,
Dr. SerVaas.

DR. SerVAAS: But, Dr. Sandler, there must be some
misunderstanding because in the interest of testing and knowing
what it costs, I researched this before I came for this testing
period and I was told that the Army now pays a little less than
$4.00. So, I didn’t believe the Army necessarily, so I called
Damon Laboratories from whom they buy their tests, with whom
they contract. Isn’t that right? And I talked extensively with
Damon Laboratories over a period of several months.

They assured me that they charge the Army $4.00 and
that includes the Western Blot on the positives. Now, they said
the Red Cross gets by for less than $4.00. In fact, they said
the Red Cross, it costs them only $3.00 because the Red Cross has
so few Western Blots to do. They have only ELISAs and ELISAs are
very cheap. They said we do 8,000 every night, 8,000 ELISA
tests. That is the screening test, as you all know. And they
don’t really have to send out too many for the confirmatory test,
which costs us at Mayo Clinic $23.00. We don’t send out a lot
either but a lot more than you do per capita.

Now, at the blood banks you aren’t going to send many
Western Blot tests out, of course, because you don’t get that
many coming in with their positive blood. So, if you are really
paying $3.00 for your little kit, then you really are paying too
much because Damon Laboratories feel -- and before you get to
answer, I have a question for you and it isn’t this -- Damon also
said and there are other laboratories besides this commercial
lab, that they send 40 knowns out to the -- they receive 40
knowns from the Army every -- with every batch every month and if
they get them wrong, if they get any of those known tests wrong,
then they don’t get paid or they have to do them over.

367

 

 
 

 

Now, this is their way of certifying the Damon
Laboratories or whatever other commercial laboratory they use.
Damon said they could do our tests in the Middle West for $5.00,
including everything. That includes your little bottle. That
includes the Western Blot, if necessary, and they would like a
little more experience to see how many Western Blots they would
need to do.

Now, the reason that I wanted to make that clear is
we -- I feel so very strongly about testing because we have
always -- my entire professional career has been in prevention.
So that we do mammography and all the other things, spirometry
and early detection of disease. So, I have nothing in my career
except testing in my effort to prevent the spread
of -- it would be the easiest, most logical thing for us to
be concerned about and that is why I have researched it.

Now, I have the feeling that we are sitting here
dragging our feet, Jerry Sandler, in exactly the same way we
drug our feet when we knew how many kids were dying or going to
die from hemophilia and we just said, oh, we must test a little
longer; we must study this a little longer before we defer the
blood. And I just have one question that I want to ask you when
I get through, but I want to tell you that the history shows that
we first knew that the hemophiliac -- the first hemophiliac
patient had Pneumocystis pneumonia very early months, late
December or early 1982. Now, when we knew that there were those
at the Hemophilia Foundation who were very concerned and many
people knew that because they pooled the blood, so many people
would be getting AIDS from the blood for their Factor 8.

Now, we knew that in ’82 and the stress from the
people who were so -- getting more than their share of heartburn
because they couldn’t convince the CDC. They couldn’t convince
the Red Cross. They couldn’t convince the AABB, the blood
bankers. They couldn’t. They tried. And do you know that all
through ’82 and through -- when in ’83 did we start deferring
high risk blood, do you -- well, I will ask you that later.

I can tell you that it was not until Don Francis said
as far as I am concerned the assembled leaders of the blood
banking industry are about to take a course of action that could
be best termed negligent homicide. This was a year before we
started deferring the blood that is the reason we are looking
with great compassion at the sad fact that 9,000 more -- upwards
of 9,000 kids, boys and girls, but mostly boys, are now AIDS
positive and are going to be suffering from AIDS. This is two
years, almost two years, but the blood bank -- and I think, Dr.
Cleary, you mentioned the New York Blood Bank. In the words of
the New York Blood Bank in 1983 were there are at most three
cases of AIDS from blood donations and the evidence in two of
these is very soft. And there are only a handful of cases among

368

 

 
 

 

hemophiliacs. This is the then president of the New York Blood
Center. These are non-profits.

And do you know that it was the for-profits, who first
deferred high risk blood and when we first started deferring
blood from the special interest groups, we said we won’t defer
blood from those who are not promiscuous, just those who are
completely promiscuous about their sex life, but the story is a
sad commentary and it is blood on the hands of the foot draggers
and the people who said let’s sit back and wait until all the
facts are in; we really don’t have many cases, but all of these
poor kids were getting their Factor 8 infused into their arms by
their mothers during this time.

Now, my question to you, Jerry Sandler, since you
picked on me and said I wasn’t right about my facts, my question
to you is, the Red Cross, is it true that the for-profit Alpha
Therapeutic Corporation or whatever, were the first and that the
Red Cross and the other non-profit blood banks came in quite a
lot later as far as deferring any high risk -- as deferring the
high risk blood and what defense do you have for the slowness
with which our public health people and our people at the CDC and
our people at the blood banks, the non-profit blood banks, at
their reluctance to begin deferring blood when it was very
apparent that that blood was going to kill a lot of people? When
did you start deferring blood compared to the for-profits?

DR. SANDLER: Hi. Dr. SerVaas --
DR. LEE: Could you clarify the question, please?

DR. SerVAAS: Because we are doing this all over
again. We are sitting here dragging our feet.

DR. SANDLER: I have taken some notes, Dr. Lee.

CHAIRMAN WATKINS: There is a strong letter that

follows, Dr. Sandler.
t

DR. SANDLER: Dr. SerVaas, I can assure you that there
was no intent on my part to do, other than trying for the
record, correct a factual reference to the cost. It certainly
wasn’t a blast. My wife can tell you what a blast is from me
when I really mean it. =: |

With regard to the facts about the cost, we purchase
18 million test kits from one particular manufacturer, Abbott
Laboratories. I can assure you that no one in the world buys
the individual Abbott ELISA test cheaper than the American Red
Cross. The cost of the bottle is well less than $1.00, the
actual bottle. But we have to buy a lot of bottles for
proficiency, for the protocol. We do not use the free Western

369

 

 
 

 

Blot service available to all users of Abbott Laboratory’s test..
We go to DuPont Laboratories and pay over $30.00 per test in
order to get an FDA-licensed Western Blot.

So, the cost of the bottle -- that was just a way of
saying "reagents only." The cost for the Red Cross to do the
test varies by community. In some communities we have only two
positive tests per 100,000 people. In some other communities we
have more than 50 positives in the United States and outside the
United States, outside the continental United States, where we
test also, we have extraordinarily high numbers. So --

DR. SerVAAS: Jerry, I explained that all in my
question. I have only one question for you.

DR. SANDLER: Oh, okay. Sorry.

DR. SerVAAS: And that is we know that it varies
according to how many Western Blots you do. Of course, it does,
but my question is about the blood because I am so concerned that
we are sitting here, we are looking for more ways to slow down
the thing that Don Burke could do for us. I think that voluntary
testing -- I wouldn’t be so strong about this except I can tell
you that people line up to be tested voluntarily and we have
never had a breach of confidence and we have never had a case of _
discrimination on the people we have notified and we have never
notified anyone without a doctor doing it when they are positive
without counseling and I can’t tolerate our sitting here as a
responsible group with this health care crisis raging and we are
still looking for more statistics, but, Jerry, I want to know --
I want to show that history is repeating itself.

So, I want you to tell us how long did you wait to
defer blood after we knew that these hemophiliac kids had died
or had AIDS? How long did we wait? From 1982, when Francis
pounded on the table and the CDC and everyone tried to get them
to start deferring high risk, how long did we dawdle?

DR. SANDLER: On the subject of dawdling, the
definitive, scientifically-responsible act that could have been
taken was to begin implementing testing. The chairman of Abbott
Laboratories was given the first FDA license at 10:00 in the
morning on March 2nd, 1985, which permitted -us to take
definitive action. Ten minutes after the chairman of the board
of Abbott Laboratories got the license, I met with him in the
Federal Building at 300 Constitution Avenue and made an oral
agreement and that night we started to test. Now, that --

DR. SerVAAS: Jerry, that is not my question at all
because Shadle(?) at the CDC says the test is fine but if we
just spent more time doing a better job of deferring bad donors,
we would have a lot fewer slips at the blood bank.

370

 

 
 

 

Now, my question is -- we are talking about deferring
blood so that the hemophiliac kids, who were already getting
infected, we didn’t defer the blood. That is the biggest thing
we could do, the biggest thing at that point. We didn’t have an
FDA-approved test. But we could defer the blood, which we did do
before we started testing, a good while before, but not for about
a year and a half.

DR. SANDLER: Dr. SerVaas, let me explain --
DR. SerVAAS8: Two years, what was it?

DR. SANDLER: You are quite right. You are absolutely
right. Individual people -- and you have named at least two of
them, who are employed by the CDC, did make those statements and
the American Red Cross turned to the CDC and asked what is the
position of the CDC. Now, in the same way that you as a member
of this Commission have said several things, what you have said
is not, necessarily, the position of this Commission, nor was
what Don Francis said the position of the CDC. We respond to cpc
recommendations. We do not, necessarily, respond to opinions of
individual employees when these opinions are not reflected by
their organizational policies or recommendations.

DR. SerVAAS: All right. There were bomb threats --
the National Hemophiliac Association had bomb threats on their
office when it was even talked about deferring the blood because
it was against the civil rights of the people who were supposed
to be able to give blood and not stigmatize them at a time when
their rights were just then being brought forward.

Now, these are high risk people and the population
sided in but, Jerry, it is blood on our hands and you know it is
and if we do the same thing again that we did for the
hemophiliacs, then we can spend a lot of time with individual
cases and tragic cases, but there are so many of them, and they
went on so long unnecessarily, that I feel right now -- in
Indiana we lost two mothers because they didn’t know that their
spouses, their husbands were -- one was a bisexual and the other
one was a former drug addict -- we lost two mothers and one baby
and another sister who now has it.

Now, that is just people that I know about and I think
it is blood on our hands that we don’t let people know that they
are AIDS positive and I think that Dr. Cleary or any other
doctor who confuses the cost with a lot of expensive pretest
counseling for people who have had blood transfusions or were
former drug addicts and now are not, pretest counseling can draw
the costs far up and his article in JAMA was described in a most
unflattering manner by the AMA yesterday to me, as being not very
responsible, but the word was "insipid."

371

 

 
 

Now, that was someone who came here from the AMA and I
have to agree that the battle lines are forming, Dr. Sandler,
and, Jerry, I don’t think that we want to do the same thing in
foot dragging that we did and let the for-profits in this case
start deferring blood before the non-profits and that includes
AABB and the Red Cross.

My question to you is how can you explain just that
one thing. Why you waited so long and why when responsible
people could show you that those people were getting infected,
why did we not take action?

DR. SANDLER: I guess when you are paying people to
give blood, you can’t trust them as much. So, you probably have
to take action a little bit differently when you are paying
people to tell the truth, as opposed to people volunteering.

If we want to spend our time, Admiral Watkins, on this
subject, we can. I think some of us are going to try to catch
an airplane.

CHAIRMAN WATKINS: I think we really need to move
along. If there are any other comments --

DR. Se€rvVAAS: Well, there is just one. There was a
commercial reason. They were selling to the hemophiliacs and
they were threatening their own customers by giving them the
blood and then their doing it really forced the for-profits to
start doing it, to defer that blood. It is a tragic tale.

CHAIRMAN WATKINS: Dr. Crenshaw.
DR. CRENSHAW: Thank you.

Dr. Burke, from conversation that I recall in the
past, you said one thing to me that I thought was pretty
compelling in response to the question the Admiral asked, what
could we do to get. the American public to really respond ina
way to make these kind of studies meaningful.

What you said to me is that if the President got on
the air waves and really made a plea saying we need your held,
this is really important to our national health, et cetera, and
not just saying this is something that, you know, would be nice
if you did, but really made a plea and asked for all Americans
to be responsible and to come forward and to really help on this
issue of these three cities or however it were done, that that in
and of itself, if it were done well and if it were done and
marketed widely, which it would be if he preempted channels,
could turn the whole thing around.

372

 

 

 
 

 

Do you still believe that and am I quoting you
accurately?

DR. BURKE: Thank you, Dr. Crenshaw.

I appear here today as a representative of the
Department of Defense and it is not my position to advise
directly the President of the United States.

DR. CRENSHAW: I am sorry. A little procedure and
protocol there.

DR. BURKE: However, we did have this conversation;

I believe that a high level of leadership in the Federal
Government would be very helpful in the national effort. If the
President were to do this, I would personally be delighted.

Let me add that that is my personal opinion, that the
national effort requires this type of additional emphasis to
ensure full public participation. With that caveat aside, yes, I
still hold to that position.

DR. CRENSHAW: Thank you. The other thing I would
appreciate your comment on is if hypothetically -- and I want to
just deal with this hypothetically -- when the antibody tests
became available, if the recommendations made by Walter Reed Army
Hospital on reclassifying the disease to stages of HIV positive
and if the same way that AIDS is being dealt with, the whole
infection were -- beginning in ’85 -- how far ahead would we be?
What advantages would that have provided? And somewhat in line
with Cory’s comments, Dr. SerVaas’ comments, are we foot dragging
and how much longer can we endure this with the void of knowledge
it leaves us with?

DR. BURKE: I have fairly strong views on this point.
I think the time has come to recognize that the term AIDS itself
and the whole concept of AIDS is an anachronism. We know that
the etiology of this disease is the human immunodeficiency virus.
This Commission is named the Commission on the Human
Immunodeficiency Virus and, yet, the Centers for Disease Control
continues to report on a weekly basis only the AIDS cases.

Because we don’t have in place on a national level any
mechanisms for surveillance for HIV in the community, we have no
idea about what is happening to the real epidemic. The real
epidemic is the virus infection as it occurs today. AIDS cases
in 1988 are HIV infections that occurred in 1978; that is, the
data we are amassing today on AIDS is a decade old. As an
epidemiologist, I cannot make rational decisions and I cannot
make allocation of resources based on data which is a decade old.

So, I think it is important to change the focus away
from AIDS. The only way to do that is to be more aggressive

373

 

 
 

 

about diagnosing HIV infections wherever and whenever they
occur. Once you have diagnosed an individual, it is a straight-
forward matter, using certain staging systems like the Walter
Reed staging system or others, to determine which patients are
early stage HIV infections and which others are late stage
infections.

But I think we would we would be much further ahead
today in our understanding and in our approach to this disease
if from the beginning, when the blood tests were available, that
we aggressively applied those as widely as available. They are
good tests. This is a medical condition requiring diagnosis.
Those diagnoses should be reported on a regular basis. We should
deal with this disease as if we would any other.

DR. CRENSHAW: Thank you.

And then, Dr. Morin, I wanted to publicly compliment
you on the leadership you have shown in San Francisco, where you
have encouraged widespread testing in the gay community, where by
contrast to your sister city on the East, that is not yet the
program that is being taught from within the gay community.
Would you elaborate on that a little bit.

DR. MORIN: Well, first of all, it is not widespread
testing. We are recommending people come in for counseling --

DR. CRENSHAW: Well, test-linked counseling, but I
mean I have heard you speak much more strongly about encouraging
gay men in San Francisco to be tested, as long as it is done with
counseling and I think that it reflects very important leadership
there that I would like to see get a little more contagious.

DR. MORIN: We believe there are certain advantages
for gay men being tested and particularly those who are
positive, to monitor their health status, and to attempt to find
ways of medically intervening early in HIV infections, so that
one can ward off the deterioration of the immune system by early
intervention. That has proven to be a very successful argument
with gay men, particularly those who fear they might be infected.

Let me comment just briefly, however, because I think
some of the comments here need to be clarified. The voluntary
programs coupled with counseling work remarkably well in terms
of facilitating behavior change. The only data we have to date
on whether you get behavior change or not in the mandatory
testing program really comes from the military. The follow-up’
data on people who were traced in Colorado, reported by the
Colorado Health Department, indicates virtually no behavior
change.

374

 

 

 
 

 

Behavior change has to do with the quality of the exit
counseling. It seems to me foolish to go forward in identifying
all of these people who are infected and then proceed to do
nothing in terms of facilitating behavior change with such
people.

DR. CRENSHAW: I think we would all agree with you on
that point.

DR. MORIN: And talk about foot dragging -- let me
talk a bit about foot dragging in the prevention effort. Since
July of last year, legislation that would supply the funds to do
the counseling at sexually transmitted disease clinics and
substance abuse clinics, as well as prenatal care and family
planning clinics, has been stalled in Congress.

Right now, if you go into a sexually transmitted
disease clinic in the United States, no one talks to you about
HIV infection. I think that is foot dragging. I think it is
irresponsible. Why is that legislation stalled? It is stalled
because certain members of Congress have become fixated on
testing everyone in the country and have become completely
irrational about it. Others completely oppose nondiscrimination
provisions, which are also included as an incentive to testing in
that bill.

So, you have two big barriers to actually doing
effective prevention education and counseling in this country
--these two issues.

DR. CRENSHAW: Well, I would emphasize that, speaking
for myself and I hope eventually for the panel, I think testing
is as important for negatives, to ensure that status, as
positives and I will certainly do everything I can to bring that
along.

My last quickie, because I don’t want to absorb too
much time, is for Dr. Sandler. I was pleased to hear that and
to have been aware that the blood banks are notifying. What is
the lag time? It used to be 45 or 65 days before you were
allowed by certain state laws in some areas to tell someone who
donated blood that they were positive.

I don’t want you to go into all the reasons that that
is there because I think those are fairly well-discussed, but
what is the lag time now? Do you notify them within the week,
immediately or are you waiting for two or three months?

DR. SANDLER: I wish there were a quick answer to
that. Each one of our 56 regions operates within a state that
has its own laws and there are an enormous variety of programs
in each one and there is just really no general statement.

375

 

 

 
 

 

I can make this general statement. We are not He,
notifying promptly. I think that is one thing I could certainly
say, but there are delays that are necessary for a variety of
reasons. There is no two notification programs that are alike in
the Red Cross with regard to notification. The process is highly
individualized.

DR. CRENSHAW: So, you can’t make a general statement,
but within a week or two --

DR. SANDLER: It is not as soon aS a week or two under
any -- it requires considerably longer than that.

DR. CRENSHAW: What could we do to help because you
are saying not soon enough and I agree with. I think we ought
to get that knowledge back to people as quickly as reasonably
possible. How can we help to facilitate that?

DR. SANDLER: The limiting factor on that is the
absence of alternatives for some people to get a quick test
back. Let me explain. If we became known as the place that in
town were you can get a test result back in writing in a week,
we will become the place for high risk individuals to get tested
in every community. We would like to have our answers come back
sooner, but if we were the best test and the quickest test in
town, the safety of the blood supply would be threatened.

What can you do? If there were multiple,
confidential, anonymous, places for anyone with risk behavior to
be tested, then there would be no concern on our part to get an
answer really back fast, but we are holding back in certain
communities so we are not the best show in town.

DR. CRENSHAW: Thank you.
CHAIRMAN WATKINS: Dr. Lilly.

DR. LILLY: I am going to pretend that I am Rich DeVos
for a minute and ask a cost question. We have actually had a
good bit of discussing of cost but basically we haven’t been
talking about cost effectiveness. I took some figures from page
2 of Dr. Cleary’s presentation about having to do with testing of
candidates for marriage license applicants, where
he suggested that there might be approximately 3 1/2 million
people, I think, tested per year and then taking various figures
as to how much that test might cost, I first took Colonel Burke’s
estimate of $4.00 and then more recently I took Dr. ServVaas’
estimate of $5.00 and then calculating that procedure might

identify 1,200 positives in any given year, to see just how much
it had cost to identify that positive and depending on the

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figures you took, it came between 40 and 90 thousand dollars per
identified individual.

Now, given the fact that we all seem to be in
agreement that just doing the test is not the point,
but -- not just identifying people who are positive is not
the point, but that of changing behavior is the point, I am
wondering if anyone thinks that we might do better with that 40
to 90 thousand dollars by another approach, such as education?

It is addressed to whoever has an opinion on the
subject.

DR. CLEARY: I was quoted and have an opinion, so I
will respond. I think in many senses cost is a red herring. I
think if we had a test that had an efficacious impact, almost
all of us would spend very large amounts of money to implement
the test. It can be done relatively cheaply.

Let me come back to the quote from Damon Laboratories.
I phoned Damon Laboratories to see how much they would cost and
they gave me a quote, which was substantially higher. I don’t
remember the exact cost right now. My second question to Damon
Laboratories was does that include counseling? And they said
yes it does. We will send you a pamphlet if you have a positive
result.

I am not sure that those of you who have not worked
with seropositive individuals understand how enormously
difficult it is to change behavior, how carefully you have to
work with them to tell partners, to Change their behavior. It
is an enormous task.

And the direct answer to your question is yes, I think
we could spend those monies more effectively by encouraging
counseling, encouraging testing, but above all things, focusing
on the behavior. We have to change behavior if we are to stop
this epidemic. And I agree there has been foot dragging and I
will tell you where there has been foot dragging.

We do testing at the New York Blood Center. We have
tested and screened and notified 1 1/2 million blood samples,
okay, but there is still reluctance among many people and there
is a lack of funds to do the appropriate counseling. We have a
federal grant and it is a demonstration grant. We are doing a
study on counseling. There are no direct services monies to do
that kind -- the cost and the false positives and the technical
issues are a red herring. We need to get out there and stop
foot dragging, but to change the behavior and I think Dr. Burke
could address this himself, but I have heard -- you know, the
fact that you are identifying those new persons in the hospital

377

 

 
 

 

jndicate that something in the screening program is not
efficacious.

We have to change the behavior, stop the spread.
Identification is fine but stopping the spread, keep in mind, is
the ultimate issue here.

DR. LILLY: I would concur as I stated yesterday, as a
matter of fact, to someone else who made that point. I have
always felt that the best reason for deciding to impose a policy
with respect to testing or anything else is to ask one’s self
will this measure be effective in halting transmission of the
virus.

DR. BURKE: I would like to respond to that also.

I think that some of the numbers used in the original
article by Dr. Cleary and his colleagues were probably
substantial underestimates of the actual prevalences. Those
were largely based on blood donors, who are extremely
prescreened ahead of time. So, those costs of $40,000.00 per
case are probably well off of the actual figure. I think the
cost figures that I presented earlier are probably much truer.
So, I think the cost/benefit that is given in the Cleary paper
is somewhat off.

I do agree, however, that the purpose of HIV testing
programs in the civilian community is not simply to identify
individuals who are positive but to allow targeted use of
counseling resources on those individuals. I actually prefer
the term of "targeted counseling" or “test-linked counseling" as
the reason for doing the testing. It is not just to test per se.

Then, once you have found somebody who is positive, it
makes sense to spend a substantial amount of money on those
individuals, who are positive, to ensure that they do deal with
their disease, that they don’t deny, that they don’t transmit
the infection to other individuals. It would be wise for this
Commission to recommend that there be made available a
substantial amount of funding for counseling services for
individuals who are detected as positive in screening programs.

I think this is a point on which the panelists here
would all agree: if effective mechanisms .for counseling of
positive persons were in place, then widespread testing could
have a very favorable impact on the epidemic. Fair enough?

DR. LILLY: What kind of counseling -- post-test

counseling do positives receive, who are applying for entrance
into the Armed Services?

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DR. BURKE: There are two levels of testing that we do
in the military. one is applicants for military service. The
other one is people who are on active duty. For persons on
active duty, we have full responsibility for their medical care.
Persons that are found to be HIV positive become involved in
extensive long term relationships with chaplains, psychologists,
psychiatrists, other social support services. The situation is
different for individuals who are picked up through the screening
of applicants to military service, for whom we do not
historically have the responsibility for their medical care. For
example, if a person has a heart murmur, we do not provide
medical care for his heart murnur.

But what we do for HIV positive persons which we do
not do for any other disease, is we bring that person in. He is
told in person by a physician of the diagnosis and then he is
given a list of all of the resources available in his community
for people that are HIV infected. So, we do go that extra mile
to make sure that counseling is available, and that individual
knows where to get it.

CHAIRMAN WATKINS: We have to make it short, Dr.
SerVaas.

DR. SerVAAS: Okay. Just one thing about that, Dr.
Cleary, about the marriage, the couples, the getting married --
you don’t want to tell them to use a condon. You don’t need to
counsel them to -- they are getting married possibly to start a
family so that you want them to be free to practice sex the way
-- you don’t have to change their behavior. What do you have to
change their behavior for unless they are positive? And that
goes with what Dr. Burke says. We really want to protect the
women and men who might be unknowingly, unwittingly marrying
Someone who is positive and that, I think, no one should deny us
from being able to do in a very inexpensive, confidential,
voluntary way.

DR. LILLY: JI didn’t understand the point, Dr.
SerVaas. What are you disagreeing with?

DR. ServVAAS: Why do we need counseling to muddy the
waters? We need a lot of counseling when they are positive but
our hands are tied constantly in some states because we need
personal post-test and pretest counseling for blood recipients,
seven year olds. A kid doesn’t have to change his sexual
behavior at seven year old to be told he is negative, but you
need negative counseling, too, in some states and this is absurd
and it costs millions in legal fees for a lot of people who are
trying to help. It is really absurd to have some rules about
pretest and post-test guidelines where you are trying to help the
blood donors, the blood recipients, the blood transfusion

379

 

 
 

 

recipients in states where they make it very difficult to do
voluntary testing.

CHAIRMAN WATKINS: Let’s let the panelist answer now,
Dr. SerVaas, and we have to close it out.

Dr. Cleary.

DR. CLEARY: We are talking about a national
prevention program. The best national prevention program is not
to look under the lamp because the light is there. Premarital
populations are low prevalence and it is a snapshot. It is a one
point in time snapshot. We do want to counsel negative persons
so that they will not subsequently transmit or receive the virus.
We do want to counsel persons who are positive so they will not
spread the virus. The point is we want to go where we are going
to have the most impact, using the programs that have the most
impact. We want to be inclusive and we know that anonymity and
confidentiality promotes inclusiveness and we want to be
effective and we know that a major emphasis on behavioral change
increases effectiveness.

CHAIRMAN WATKINS: Any disagreement on the panel on
that?

I would like to thank you very much. This is an
extremely informative panel. We would like to keep our dialogue
with each of you open between now and the time the Commission
terminates on the 24th of June and I can assure you there will be
additional questions we would like to have as prompt response to
as possible.

Thank you very much and we will recess for about ten
minutes and then we will be back here to start the next panel

promptly at 12:15. Bring your lunch, Commissioners.
(Whereupon, at 12:05 p-m., the meeting was recessed,

to reconvene at 12:15 p.m., the same afternoon, Friday,
March 18, 1988.).

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AFTERNOON SESSION

CHAIRMAN WATKINS: Panel 3 concerns confidentiality of
medical records and reporting, and we have with us today, Ms.
Rita Finnegan, Executive Director, American Medical Record
Association, Chicago, Illinois; Dr. Charles Wallas, Member Board
of Directors, American Association of Blood Banks, Arlington,
Virginia; Mr. Harry A Woodman, Vice President of New York Life
Insurance Company, New York; Dr. Fredia Wadley isn’t present in
the room, but we hope that she will join us shortly and Dr.
Willard Cates, Jr., Director, Division of Sexually Transmitted
Diseases, Center for Prevention Services, Centers for Disease
Control, Atlanta, Georgia. Welcome, Dr. Wadley, and we will
proceed now with testimony from Ms. Finnegan.

MS. FINNEGAN:: Good afternoon, Mr. Chairman. My name
is Rita Finnegan, Executive Director for the American Medical
Record Association. AMRA is a professional association with
29,000 members who are responsible for assuring the accuracy and
confidentiality of patient information in a variety of health
Care settings. AMRA welcomes this opportunity to share its views
with the Presidential Commission as it strives to address a range
of very complex and controversial issues. The HIV epidemic is a
human tragedy of unknown proportions. Extensive and intensive
research needs to be done to find appropriate answers to many
questions about the HIV. In order for that research to be
effective, there must be a solid and valid baseline of data.
Herein lies a major problen. Accuracy of information needed for
this baseline is dependent to a large extent upon accuracy of
information provided by those being tested and treated for AIDS.
The assessment of where we are as a nation in response to the HIV
epidemic is fraught with error because persons who may be willing
to come forward and be tested and thus, be counted, as well as
those who are already suffering from diseases caused by HIV
infections do not have the assurance that their personal right to
privacy will be protected. AMRA members are strongly committed
to putting into action the principles spelled out in our
guidelines for handling health data on individuals tested or
treated for the HIV virus. \

Copies of this document were\ earlier provided to the
Commission, and there are additional copies at the desk in this
room. All efforts to protect patient confidentiality in any
type of health care setting are only as effective as the persons
who are responsible for maintaining that protection. A concrete
example of the effect of a breach of confidentiality is offered
for consideration. The January 8, 1988, Journal of the American
Medical Association reports the case of a young man whose life
was ruined by the inappropriate disclosure of a positive HIV
antibody test. The man had been diagnosed 6 months earlier as
having AIDS, was following safe sex guidelines and refrained from

381

 

 
 

<<<

donating blood or semen. Without his consent, a physician
ordered an HIV antibody test and sent the results to the local
health department. The man’s employer was notified, and he was
fired. The townspeople found out about it, and he was socially
ostracized. His landlord asked him to move. He lost both his
health and life insurance. Ten days after that test was taken,
‘this man’s life was ruined. Caregivers especially need to be
aware of the critical need for strict confidentiality safeguards
for this kind of information. The adverse psychological and
economic effects of disclosing test results have been documented
in many such reports, often resulting in suicide attempts or
major depressive illnesses. Given the appreciation that any
system will only be as strong as those responsible for
maintaining that information, I urge the Commission to consider
several options as it develops recommendations to give to the
Congress. First, AMRA believes the public needs a better
appreciation of how health information is protected in all cases,
not just information related to AIDS. Not only must our
profession be vigilant about this matter, but the entire health
care community, as well, including the health insurance industry.
Secondly, we believe that many in Congress and some
representatives of the Administration make an assumption about
confidentiality laws that is not particularly valid. Not all 50
states have adequate laws to protect the confidentiality of
medical records.

 

There are some states which have very limited
guarantees of patient confidentiality protection. Until
recently, Montana was one of those states. However, last year
Montana became the first state to adopt the uniform health care
information act. The uniform act was drafted in 1985, by the
Uniform Conference of Commissioners on State Laws, endorsed by
AMRA that same year and approved by the American Bar Association
in 1986.

In spite of dedicated effort on the part of the
national law commission and AMRA, the Uniform Act has thus far
been introduced to the legislatures of only nine states. To
date, Montana is the only state that has passed this law. Our
reason for focusing on the uniform act is because we believe it
provides the best legislative language to guarantee
confidentiality protection for individuals while at the same
time defining disclosure policies for those who have a
legitimate need for the information contained in the medical
record.

The need for uniformity and confidentiality protection
has been stressed repeatedly by such key figures in health care
as Secretary Bowen, Senator Kennedy, Senator Quayle and
Congressman Waxman. AMRA believes that if such uniform laws
were adopted throughout the country, we would have a firm legal

382

 

 

 
 

OT

basis for guaranteeing protection of an individual’s right to
privacy.

We, also, believe that prodding from the Federal
Government would speed adoption of this state law. A precedent
for such action was established with the withholding of highway
funds until certain state statutes were adopted. By adopting
this uniform law throughout the country, AMRA’s specific
confidentiality principles could be more easily applied to
achieve that fine balance between the protection of patient
rights and the public need to know. AMRA’s policy on handling
HIV information concurs with the policy statements recently
issued by the American Hospital Association. AMRA and AHA agree
that when patients are HIV positive and have been diagnosed as
having AIDS this information should be a part of the record so
that providers of care can render proper treatment and take
necessary precautions. Such records should be maintained with
the health records of other patients in physically secure areas
under the control of the medical record manager. Health care
facilities need to have strict policies that indicate action to
be taken if a staff member inappropriately discloses sensitive
medical information which represents another reason why states
need to have uniform confidentiality statutes with penalties for
violation of the law. These sanctions could then be used as the
basis for adopting uniform health care facility policies.

Additionally every health care facility must educate
all employees to the importance of confidentiality and outline
the consequences of violations. In this educational programming
the special sensitivity that must be accorded information about
individuals who are infected with the HIV virus must be
discussed, as well as the adverse consequences that could occur
if information is erroneously released.

 

AMRA believes special protective measures must be
taken in health care facilities offering screening programs to
detect the presence of antibodies to the HIV virus. Such
programs may identify individuals who display no active signs of
infection. AMRA firmly believes that anonymous testing is
possible and should be voluntary. AMRA recommends that
voluntary testing records be retained only for the length of
time required by law on a manual basis, then shredded. We
recommend manual files because present computer systems do not
have adequate controls to restrict access to the sensitive
information only to those who need to know.

It should be noted that when apparent breaches of
confidentiality occur, the cause is often the patient. Patients
and their families often communicate the fact of their test or
illness to another person, never expecting the information to be
redisclosed. Often the name of the health care facility is
included in the conversation. So, when the information becomes

383

 

 

 
 

EE

i

known, it appears that the facility breached confidentiality,
when in fact, it was the patient’s own doing. A major Chicago
health care facility averaging over 400 HIV tests per month for
the past few years has never been accused of a breach of
confidentiality.

Until the general public has an educated and informed
sense that their rights to privacy and non-discrimination are
being protected in the health care environment, the true picture
of HIV prevalence is not likely to become a reality.

I commend the Commission for its intensive work and
the credibility it has established in such a brief period. I
\ thank you for the opportunity of testifying here today on behalf
\ of the American Medical Record Association.

CHAIRMAN WATKINS: Dr. Wallas?

DR. WALLAS: Mr. Chairman and members of the
Commission, my name is Charles H. Wallas. I represent the
American Association of Blood Banks on whose Board of Directors
I serve.

I am Director of the Blood Bank and Transfusion
Service and an associate professor of pathology at Vanderbilt
University Medical Center. I am certified by the American Board
of Internal Medicine and the American Board of Pathology in blood
banking and clinical pathology. I am honored to be here today to
address the important issue of confidentiality as it pertains to
HIV-related information in blood banking and transfusion
medicine.

 

The American Association of Blood Banks brings
particular expertise to these hearings. The organization is the
professional medical association for those individuals and
institutions engaged in blood banking and transfusion medicine.
It sets standards for and inspects and accredits blood banks
and transfusion services. AABB member facilities numbering 2400
collect nearly half of the nation’s blood supply and transfuse
over 80 percent of all the blood collected in the United States.
The 8000 physicians, scientists, technologists, administrators
and nurses who are individual members of the American Association
of Blood Banks work to advance transfusion medicine as a science.

Throughout its 41-year history the American
Association of Blood Banks has been dedicated to maintaining an
adequate blood supply and making it as safe as possible for the
American people. Experience has demonstrated that this goal is
best achieved through a volunteer blood donor system.

In the prepared statement which was submitted for the
record of this hearing, I outlined some of the procedures

384

 

 

 
 

 

utilized in blood banks and transfusion services to protect the
privacy of medical records and to guard against unauthorized
disclosure of privileged information about the volunteer blood
donor. Exposing donor identities to discovery would discourage
most donors from donating. The American Association of Blood
Banks therefore believes that confidentiality is essential for
maintaining an adequate blood supply that is as safe as
possible.

The American Association of Blood Banks also believes
that the confidentiality of medical records outside the blood
center is crucial to controlling the spread of AIDS. AIDS,
AIDS-related complex and HIV seropositivity are stigmatizing
conditions. The potential for unwarranted disclosure of
personal information or HIV antibody status is a disincentive to
voluntary testing. More importantly, lack of confidentiality
undercuts the efforts of the public health community. To achieve
the public health goals of detecting, controlling and preventing
the spread of AIDS, it is important to identify and obtain the
cooperation of infected individuals. This can be accomplished by
providing alternate test sites, other than a blood center, where
individuals can go for confidential evaluation and testing and by
ensuring that their medical records and diagnostic information
will be kept confidential.

The American Association of Blood Banks recommends
that the Commission consider federal statutory protections for
personal identities and records related to HIV counseling and
testing. The protections we recommend are no more than those
provided under the standard doctor-patient privilege. However,
the American Association of Blood Banks believes that protective
legislation is necessary because state courts are beginning to
make exceptions and draw distinctions to the general rule against
non-disclosure in the blood donor context. For example, during
the last week of February, the US Supreme Court declined to
review the appeal of a Texas Appellate Court decision requiring a
hospital to turn over to plaintiff’s attorneys the names and
addresses of blood donors whose blood had been used in the care
of a deceased infant. This decision is contrary to a 1987
decision rendered by the Supreme Court of Florida. Cases with
similar confidentiality issues are currently pending in
California and Colorado. Decisions, such as in the Texas case
will have ser‘ous effects on the outcome of these cases and
ultimately on both volunteer blood donors and high-risk
individuals seeking testing and counseling.

To strike a balance between the need for
confidentiality and the duty to protect the public health, the
American Association of Blood Banks, also, recommends that the
Commission allow for certain exceptions to any confidentiality
protections. Permissible exceptions could allow a treating
physician or other appropriate party to notify certain

385

 

 
 

 

individuals and institutions of a person’s test results. Such
parties might include blood, organ, semen and breast milk banks,
spouses or other known sexual contacts, state health officers, if
required by state law or court order and health care workers who
might be exposed to infection as defined by the Centers for
Disease Control.

Given these differing legal interpretations and the
explosion of AIDS-related legislation at the state and local
levels, the American Association of Blood Banks would, also,
urge the Commission to recommend that the US Food and Drug
Administration preempt state and local regulation of blood donor
suitability criteria, product labeling requirements and the
conduct and interpretation of testing including HIV testing.

This is necessary to ensure nationwide uniformity and the ability
to share blood supplies across state lines to meet emergencies or
shortages.

In summary, the American Association of blood banks is
making four specific recommendations for your consideration.
One, in order not to deter blood donation, protect the
confidentiality of blood donor records.

No. 2, in order to encourage those potentially at risk
for AIDS to be tested and counseled, protect the confidentiality
of records generally, thereby controlling or preventing the
spread of AIDS.

No. 3, to protect the public health, allow for certain
exceptions to confidentiality protections in order to notify
parties, such as blood cénters, spouses and health care workers
of a person’s positive test results. .

No. 4, to ensure that blood can be shipped across
state lines, allow the US Food and Drug Administration to
preempt state regulations regarding blood donor criteria and
blood testing and labeling.

On behalf of the American Association of Blood Banks,
I thank the Commission for the opportunity to testify. I
commend you for your efforts and wish you every success. Thank
you.

CHAIRMAN WATKINS: Thank you. Mr. Woodman?

MR. WOODMAN: Good afternoon. I appreciate this
opportunity to present information on protection of
confidentiality by life and health insurers. I am chief
underwriter for New York Life Insurance Company and am past
president of a national organization of professional
underwriters. I am also the immediate past board chairman of
MIB, an information exchange to prevent insurance losses due to

386

 

 

 
 

|

fraud or omission and am chairperson of the Society of
Actuaries’ Committee to monitor the spread of AIDS.

Before discussing confidentiality of HIV-related
information, I would like to emphasize the critical importance
to life and health insurance companies of testing for HIV
antibodies.

The risk among persons who are seropositive is much
greater than that for virtually all other uninsurables. For
example, the mortality risk is five to 10 times greater than the
risk among most persons who are uninsurable because of recent
malignancies or coronaries. Moreover, many of these
seropositive persons who were not previously interested in
insurance are now likely to apply because of their
seropositivity, often for maximum benefits.

Blood testing, which includes the established three
test protocol for AIDS antibodies, is solely based on the amount
of coverage applied for or because of medical indications.
Before blood is drawn, we obtain the written consent from the
proposed insured to perform tests, including those for HIV
antibodies. It has always been our concern that sensitive
information should not be conveyed to an employer or agent or be
improperly accessed through MIB. Section 13 of the NAIC’s
(National Association of Insurance Commissioners) Model Act on
Insurance Information and Privacy,, which has been adopted in 13
states and is applied uniformly by most companies in all states,
prohibits the disclosure of personal or privileged information to
any person who does not have a need to know.

T

I will describe the steps taken by New York Life to
keep information about test results from agents, as well as
company personnel. To the best of our knowledge, preservation
of confidentiality is approached with the same degree of
dedication by the overwhelming majority of life and health
insurance companies. If a blood test is HIV seropositive or
indeterminate, the lab sends the test results directly to our
chief medical director. These results are not transmitted by
the lab through the normal route and hence are not handled by
our regular underwriting staff. After receiving these test
results, our chief medical director sends a letter by registered
mail to the proposed insured suggesting consultation with a
physician. No‘disclosure is given to any other person. The
application is declined, and the reason given is "current
medical findings." A non-specific abnormal blood test code is
reported to MIB. The phrase "current medical findings" is used
to describe all examined test findings that require declination.
Using this non-specific nomenclature to cover a variety of
reasons for declination prevents the agent and field office
personnel from deducing the specific reason. Information
pertaining to seropositive or indeterminate test results and to

 

387

 

 

 
 

 

other declinations for blood or urine findings is maintained in a
special confidential file. It is never attached to the
application file.

I also wish to comment on actions which MIB has taken.
MIB has a distinguished history of maintaining confidentiality
through strict security measures. On several occasions, MIB has
voluntarily supplemented its procedures in response to privacy
concerns. Last year the specific code for an HIV seropositive
test result was voluntarily withdrawn, and results are now
included in a non-specific code under which a number of other
test results are reported. Through the efforts of our national
organizations, the American Council of Life Insurance and the
Health Insurance Association of America, as well as state
organizations, individual companies are well aware of the special
need for the absolute confidentiality of information relating to
AIDS. If breaches occur, we feel that they can be handled by
present state regulatory mechanisms. We expect that if needed
changes regarding confidentiality are recommended by the NAIC,
they will be quickly adopted by most companies in all states as
has been done previously with NAIC proposed legislation.

Finally, there is every reason to believe that
insurance companies will continue to act on their own to
maintain their excellent record of confidentiality. After all
this is only sound business practice, since the price of
carelessness has always been the loss of consumer confidence.
With the advent of AIDS, companies have even more reason to
care. Thank you very much.

CHAIRMAN WATKINS: Thank you, Mr. Woodman.
Dr. Wadley?

DR. WADLEY: Mr. Chairman, members of the Commission,
Commissioner James E. Word of the Tennessee Department of Health
and Environment could not be here today, but he asked that I
bring you these comments. Human immunodeficiency virus antibody
testing at our counseling and testing sites within the Tennessee
Department of Health and Environment for the most part are done
on an anonymous basis except at the Metropolitan Davidson County
Health Department here in Nashville where we do confidential
testing. However, at Metro, verification of identity is not
required, and obviously fictitious names are sometimes given, and
I might add accepted. We estimate from one-third to one-half of
those names are false. Blood samples are sent to the state lab
without a name but a number. Only one person in our department
has access to those names and numbers, and this information is
kept in a locked file.

Test results are not released to anyone other than the
individual tested. So far, there have been no known breaches of
confidentiality. Across the state, however, at other health

388

 

 

 
 

 

departments we are beginning to offer a choice of anonymous or
confidential testing. It has been necessary to have
confidential testing because often individuals come to our
health department for other services (tuberculosis, prenatal,
sexually-transmitted disease, family planning), and give their
name. Later it is determined that an HIV test is appropriate
and that individual accepts testing after counseling.

At the Metropolitan Health Department here in
Nashville, we, also, have an HIV Plus Program which offers an
initial health evaluation to those individuals found to be
seropositive. The medical records of these individuals contain
the HIV antibody test results, but this practice is explained to
them before they enter this program. Records are kept in the
program area in a locked file, and there have been no known
breaches of confidentiality. At this time before the Tennessee
General Assembly is a bill to strengthen our confidentiality
statute relating to sexually-transmitted diseases. This was felt
to be indicated, not only by the Department of Health and
Environment but, also, by the Tennessee AIDS Advisory Committee.
This bill defines AIDS as a sexually-transmitted disease and
specifically outlines the conditions under which information
concerning a sexually-transmitted disease can be released.

There is, also, a bill before our General Assembly to
require mandatory reporting of HIV antibody positive
individuals. Although many members of the Tennessee AIDS
Advisory ‘Committee could recognize some advantage to reporting
the group voted not to endorse this bill because at this time in
Tennessee, it is felt that confidentiality statutes are not
strong enough, and antidiscrimination measures should be taken
' first to protect for employment, housing, school attendance,
etc.

\

Even with improvements in these areas, there was a
concern among some members of the Committee that future
legislation might allow the reported names to be given to blood
banks, correctional facilities, schoolis, insurance companies and
so on.

Other considerations relative to mandatory reporting
which should be considered are: developing a reporting system
that is very sensitive to confidentiality; convincing private
physicians to report; deciding if laboratories are to report and
what constitutes a positive test; and determining what is to be
done with the reported names. There are some advantages that
could result. For example, we could collect better
epidemiologic data to monitor the disease. Secondly, we could
provide education and counseling to those diagnosed in the
private health sector. Then last, but not least, we could
provide partner notification. One important consideration is
how to convince those with high-risk behavior that

389

 

 

 
 

 

confidentiality will be kept so that they will continue to seek
testing.

I recognize that even with improved confidentiality
laws there is always a possibility of a breach, and, therefore,
some type of discrimination. In public health in Tennessee our
record with confidentiality has been excellent. Commissioner
Word and I would have to support mandatory reporting of HIV
seropositives after reasonable efforts have been implemented to
decrease the risk of confidentiality breaches and discrimination
because of the advantages in disease control that reporting could
provide.

Until this has occurred, Commissioner Word is
supporting anonymous reporting of HIV seropositives as a means
of having better data to study the extent of the infection in
Tennessee. Thank you.

CHAIRMAN WATKINS: Thank you. Dr. Cates?

DR. CATES: Thank you, Admiral Watkins, members of the
Commission. I appreciate the opportunity to share my views and
the views of CDC concerning the confidentiality of information
collected during counseling and testing for antibody to HIV.

Let me begin by thanking my colleague Russ Havlak who
was primarily responsible for accumulating the aggregate data
that you have in the written testimony before you.

I wish to state in the strongest possible terms that
confidentiality along with a companion concern of
antidiscrimination is a pivotal factor in determining whether we
will succeed in preventing the spread of HIV in this country. At
present, CDC has 59 cooperative agreements to carry out AIDS
prevention programs. As shown in Attachment A of my written
testimony, about one-third of these areas perform all HIV testing
within their prevention programs in ways that maintain the
anonymity of each patient, namely, no names are provided. In the
remaining two-thirds, antibody testing is confidential, namely,
personal identifiers are collected with the assurance that this
information will be secure from any release that is not
authorized by the patient.

Of the 40 areas which offer confidential testing, over
half, also, offer anonymous testing for patients who preferred
this way of determining their HIV antibody status. Where
testing is anonymous, confidentiality issues do not arise. When
testing is confidential, the issue is whether health departments
can back up their assurances that personally identified
AIDS-related information can be secured from releases to which
the patient does not consent.

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Every state has a statute protecting the
confidentiality of STD records. Most were enacted in the years
between 1930 and 1960, and generally are firm but non-specific.
Unfortunately, most of these STD statutes do not shield records
from release through litigation. Nevertheless, overall during
the 40-year record of performance by the nation’s health
departments concerning STD confidentiality is outstanding. Even
without legislative protection to support them in many cases,
health officials have often heroically avoided releases of
information that could have harmed individuals, as well
influenced community trust in their disease control programs.

Turning to Attachment B of the written handout, you
will find a summary of the current status of AIDS and STD
confidentiality statutes plus reporting provisions throughout
the country. Regarding confidentiality, only 13 areas
specifically shield AIDS-related records from subpoena.
However, this is more areas than currently have extended this
protection to other STD documents. Regarding reporting, 49
areas have made AIDS reportable by classifying it either as a
communicable or a reportable disease. |

|

The problem is that few states have ever enacted
statutes to protect the records of non-STD communicable diseases
from release because they were usually not sensitive and rarely
in demand or the subject of litigation. AIDS obviously has
changed the situation. Appendix B, also shows that 12 states
currently require HIV infection to be reported. Only four of
these, Colorado, Minnesota, Texas and Wisconsin have
confidentiality laws covering AIDS which protect against release
through litigation. Making HIV reportable without stringent
confidentiality protections is potentially dangerous. While the
reporting of HIV infection is a valuable public health tool
(which can support both surveillance and prevention efforts), the
absence of stringent confidentiality protections could present
risks that would undermine the benefits of being able to directly
contact the HIV positive person.

In the future, testing will be more widely available
in settings where maintaining strict confidentiality will be
more difficult. For example, confidentiality in hospitals is
much more difficult to maintain than in health departments where
records are used for limited purposes and access to them can be
restricted and rigidly controlled. Therefore,
antidiscrimination provisions are an absolute necessity. While
the release without consent of personally identifiable
AIDS-related information may not be totally avoidable, we
certainly can enact and enforce measures that would discourage
unwarranted discrimination against people with HIV infection and
provide redress when they are victimized by such acts.

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DHHS feels that confidentiality around AIDS and HIV
infection is best strengthened through state legislation.
Therefore, we believe that the Commission should endorse a
federal leadership role by recommending the development of model
legislation on confidentiality for presentation to states. Since
the confidentiality on sensitive health records is an area of
particular concern to CDC, and especially to us in the STD arena,
we have watched the developments in this legislation arena with
interest for a number of years. Our Attachment C provides a
prototype state AIDS and STD confidentiality statute.

To prevent the spread of HIV, swift and decisive
enforcement of antidiscrimination laws is as important as having
such provisions in the first place. In reviewing the
alternatives, we believe this responsibility would be most
efficiently discharged at the local level through state
legislation and city or county ordinance, rather than through
new or broadened federal statutes in this area. Therefore, DHHS
feels the Commission should endorse some model legislation for
presentation to the states on antidiscrimination covering all
fields relevant to AIDS patients, housing, education,
employment, insurance and medical care. To ensure prompt
adoption of this model legislation, we believe it should be
supported again, with the strongest technical assistance and
backing possible from the federal level.

Thank you again, Mr. Chairman, members of the
Commission for the opportunity to share our views on this
important matter. I hope these remarks are of help to you.

CHAIRMAN WATKINS: Thank you, Dr. Cates. We will
commence our questioning with Dr. Primn.

DR. PRIMM: Ms. Finnegan, you have had considerable
experience over the years managing hospital records and patient
records.

Yesterday we had a number of individuals report to us
that there was a need to have information available on the
seropositive or seronegative status of people in hospitals.
These witnesses testified that over seventy people may come in
contact with a patient’s chart, and that information is
sometimes divulged. I asked one of the witnesses yesterday what
would be one way of protecting that information? Perhaps you may
have some suggestions yourself for the Commission regarding
protecting sensitive medical data in hospitals and health care
settings.

MS. FINNEGAN:: You have identified a very real
problem in health care institutions, and our association has
studied it a great deal. We believe that the first priority is
patient care, taking care of the individual who is infected.

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Therefore, we recommend that the information on the patient’s
condition, lab tests, etc., should be included in the patient’s
medical record. It has been our experience that when you
designate by special seals or you identify with special
warnings, etc., that there is information somewhere else about a
patient instead of in the medical record, that you draw more
attention to the problem than if you include the information in
the patient’s medical record. We do, however, believe that
every health care institution must have an extremely good
education program on confidentiality in order to ensure that all
employees from housekeeping up through the medical staff are well
educated in the provisions regarding the privacy rights of that
patient.

DR. PRIMM: Have you had any experience with use of
computers to transfer this information? One of the speakers
yesterday suggested that use of special codes to enter the
computer in order to get out certain information might be a way
of safeguarding against confidentiality breaches. I know this
is an almost impossible question to answer, but since you have
such a plethora of experience in this area, I thought maybe you
could give us some insight. What about computers?

MS. FINNEGAN:: Actually our association believes that
it is more dangerous to include the information in computerized
systems at the present time than it is to maintain it manually,
because the security provisions that most health care
institutions have adopted with regard to computers are not
satisfactory. People have passwords and things like that, but
it is not at all uncommon for one physician to allow another one
to use the password for someone to look over your shoulder while
you are putting the password in. We just do not feel that
computer security is what it should be. I think the number of
hackers that have gotten into important computer systems in this
country indicates their vulnerability. Therefore with the
present state of the art, and we know that could change tomorrow,
we feel that for many institutions their records should be
maintained manually. There may be a small number of institutions
that feel they have an adequate computer security system, but as
we have looked at institutions, their computer security for
medical records is not what we believe it should be.

DR. PRIMM: Thank you.

CHAIRMAN WATKINS: Dr. Lilly?

DR. LILLY: I just have a couple of questions. A
point of information, Mr. Woodman. At one point you said that
your codes do not allow disclosure of information to people who

do not have a need to know. I was wondering, how do you define
a need to know?

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MR. WOODMAN: Only somebody who is involved in the
underwriting process has a need to know. Beyond that, we keep
sensitive information out of the hands of the regular
underwriters to the maximum extent we can, and we keep
information out of the regular underwriting files and put them
in special confidential files.

DR. LILLY: Okay, so that would be a strictly in-house
need to know?

MR. WOODMAN: Yes, any individual’s records would be
protected. I mentioned that the MIB does not contain any
specific code for HIV seropositivity, only a generalized code
which includes a number of other abnormal blood test results,
and that MIB confidentially is quite highly protected.

DR. LILLY: We have had a great deal of discussion in
these and other hearings about confidentiality. I think this
may be the first time that I recall that the subject of breach
of confidentiality by court order has come up.

I am wondering to what extent the information that the
insurance industry might collect in this manner is subject to
that type of breach of confidentiality that you might have to
supply it by court order.

MR. WOODMAN: The action of our company, and I suspect
most companies, and I know the action of MIB would be to notify
the party involved that we have received a court order to allow
them to take any appropriate action on their part and possibly
restrain the court from getting that information.

DR. LILLY: How long do you store that information?

MR. WOODMAN: We store confidential information for
a period of 7 years. Confidential underwriting information is
not stored that length of time.

DR. LILLY: Dr. Cates, you referred to the fact that
you, you being the government, has expressed a distaste for
federal legislation banning discrimination and mandating
confidentiality. I find myself very unclear as to the reasons
for that. What you do recommend is, or at least, you personally
recommend is that the government devise model legislation. With
respect to such model legislation, do you have any idea as to the
extent to which a federal recommendation of state adoption of
model legislation has ever proved successful in the past?

DR. CATES: STD model legislation, developed at the
federal level, eventually helped the enactment of state
legislation to protect records. Again, the position of the
Department is that this is a state-based responsibility and that

394

 

 
 

 

we will work very closely with each of the states to provide them
with model legislation and will use our federal "persuasive"
powers to get that enacted.

DR. LILLY: At one point racial discrimination was,
also, considered to be a state responsibility, but the Federal
Government at some point changed its mind. Do you think that
that might happen with respect to AIDS-related discrimination?

DR. CATES: It is certainly possible that the Federal
Government will change its mind.

CHAIRMAN WATKINS: Mr. DeVos?
MR. Devos: I pass.
CHAIRMAN WATKINS: Dr. Conway-Welch?

DR. CONWAY-WELCH: A point of clarification, Dr.
Wallas, I believe that you said that you recommended that the
Commission consider federal statutory protections for the
confidentiality of personal identities and records related to
HIV counseling and testing with certain exceptions. One of
those exceptions was to permit notification of test results by
the treating physician or other appropriate party to certain
individuals and institutions, and one of those was blood,
organs, semen and breast milk. That is the official position of
the association. Is that correct?

DR. WALLAS: Yes, it is the official position of the
association that you maintain clearly a delicate balance between
protecting the right of the patient who is being tested and those
in the health care system who have a need to know, and I think a
donor center clearly is such an area. It would be terribly
important for a blood center to know if an individual infected
with AIDS had donated unknowingly so that we could notify
recipients of that donation.

DR. CONWAY-WELCH: I am trying to see mechanically how
that works. That is done after the person donates blood that
there would be history taken that would indicate that he had --

DR. WALLAS: Currently what is being done is different
from that. I can expand on that, if that would be useful. What
is being done currently falls under the generic term of look back
in which any time a donor comes in who previously tested HIV
negative and now tests confirmed positive for HIV, they track
back through the donor records and notify hospitals about
previous donations so that we can see about notifying and
testing the recipients of those units to potentially prevent
these individuals from transmitting to others. There has, also,
been a general recommendation that all patients be tested who

395

 

 
 

 

received large quantities of blood from 1977 to 1985, when
testing was instituted, particularly in areas where they could
have received blood from potentially high-risk donors.

Those are in place generally in terms of lookback and .
locally in terms of the other program that I mentioned, but we
are not currently reporting in the other direction. We do not
yet have blood donation information from those who have HIV
infection.

DR. CONWAY-WELCH: Is that contrary to Dr. Wadley’s
comments? I think perhaps I may have misheard. Did you say
something to the contrary, that current recommendations from
your perspective would be that it would not be appropriate to
notify or to include exceptions? I am not sure if I am making
myself clear. I don’t think I am. I thought I heard a
difference in opinion between you and Dr. Wallas, and I was
trying to clarify that, but I think perhaps I did not. Thank
you.

CHAIRMAN WATKINS: Mrs. Gebbie?

MRS. GEBBIE: In exploring this whole issue of records
and confidentiality laws, Dr. Cates, one of the things that just
occurred in recent revision of our laws in Oregon was abandoning
the old distinction between sexually-transmitted diseases and
other reportable conditions. Since that is not always clear
immediately upon a condition becoming important to public health,
we extended that same broad protection that you outlined here to
any condition of public health importance that becomes
reportable. Has CDC looked at that or are you really convinced
that narrowing this only to STD records is the way to go? I
would appreciate some comment.

DR. CATES: I don’t know CDC’s position on this. My
personal view is exactly as you described. The whole arena of
public health has become much more complex and more subject to
litigation. Thus, the extension of statutory protection for
confidentiality to the range of communicable, or even
reportable, diseases would provide a better umbrella than just
STD. It has been vital to STD because of the partner
notification process that we heard discussed back on March 1.

MRS. GEBBIE: Thank you. May I sneak in two questions
here if I am real fast? Mr. Woodman, a number of us have only
peripheral knowledge of the MIB, and in fact, most of what I
know about it is what I hear from people terrified of any of
their information ending up in it because it is viewed as
something almost worse than a black hole of Calcutta, something
like a sieve out of which all sorts of data can fall.

396

 

 
 

 

You have described the fact that things are stored
under fairly broad codes so that it is not HIV specific, but it
is simply some odd blood test which certainly provides some
comfort, I think, were there to be a leak. The other thing that
I am not clear on is what controls there are on the quality of
the data going in. That is, I would have less concern about some
information on me going into something like that, if I were
certain that it wasn’t just somebody looked at one test result
Sideways and said, "Oh, my gosh," and ticked it off on a form and
sent it off. Rather, that there are some quality controls to
make certain that it is really, accurate, and it has gone through
rigorous criteria on the way. In addition to whatever comment
you would like to make, I think it would be helpful for us to see
the written policies governing that filing and release of data
from that bureau.

MR. WOODMAN: Regarding the quality of the
information, it is up to the reporting company as to what is
reported. The MIB has no direct control over the quality of
information. However, the MIB does require that the reporting
company do self-audits and report those self-audits to MIB,
verifying that the code was correct and the information
underlying the code was correct. The MIB also does its own
audits, with visits to each company at least once every 3 years.
Randomly-selected records are reviewed to obtain the same
assurances that the information is correct and the code is
correct. Even if an incorrect code were reported to MIB, it
still would not do a great deal of harm to the individual
because a company cannot act solely based on MIB information. It
can use MIB information only as an alert.to make its own
independent investigation, and it must take action solely on the
basis of that investigation. So, if an incorrect code were in
MIB, it would not harm the person other than to perhaps delay the
processing of an application. There is a procedure for
correcting that information, if it is determined that it is
incorrect.

MRS. GEBBIE: And you are reasonably certain that your
member companies follow that process of not acting solely on the
basis of that information?

MR. WOODMAN: Yes, the results of MIB’s own audits
have been excellent in that respect. That is not to say that it
could not happen. Nothing is perfect, but I feel that it is
just about as good as it could possibly be.

MRS. GEBBIE: Thank you. I would appreciate receiving
the written backup on that. My last question is for Dr. Wallas.
You spoke of the preemption of state laws regarding blood banks,
the requirements for donors and requirements for documentation
and so on. It was unclear to me whether you wanted that
preemption because some states aren’t meeting a minimum standard

397

 

 
 

 

and are therefore putting people at risk or because some states
are demanding an excessive standard and therefore causing
everybody else problems or just because it is plain confusing to
have 50 state standards, and you would rather tidy it up and have
one.

DR. WALLAS: I don’t think we are talking about the
safety issue as much as we are about the ability to meet
individual variations and state requirements which could
potentially prevent blood being shipped across state lines from
Tennessee to Kentucky. For example, if Kentucky required
certain labeling requirements that Tennessee did not require, it
would be impossible to ship the blood across the line because it
would not meet Kentucky’s laws.

So, primarily the issue is one of compatibility from
state to state so that we do not tie up the ability to share
resources around the country because shortages are frequent, and
there are often areas that have blood that could ship to other
areas if we did not have restrictions that would prevent that.

MRS. GEBBIE: There are a lot of areas where we don’t
happen to have a federal law, but among the states there is a
cooperation that sorts out that kind of thing. Is this a
hypothetical problem or are there real examples of incompatible
state laws that are preventing the use of blood across state
lines?

DR. WALLAS: This is at the moment, I believe,
somewhat hypothetical, but there are increasing numbers of
legislative initiatives in terms of labeling requirements that
could potentially impair the ability to ship. I cannot cite you
specific examples, however. We could provide that information to
you, if you would find that useful.

MRS. GEBBIE: I would find that very much useful.
Thank you.

CHAIRMAN WATKINS: Dr. Lee?

DR. LEE: First of all, Dr. Cates, it is a pleasure to
see you here again. You are clearly in a good humor whenever we
see you, and this cheers us up, and I am happy to see you. My
first question is to you. We had a prior witness who made a
very obvious statement, and I don’t know why this isn’t the
case. Why doesn’t CDC report on HIV infection; why do they keep
reporting on AIDS?

DR. CATES: Yes, I was in the audience when that
statement was made. CDC is in the process of collecting what we
feel is the most accurately available information (through the
family of surveys) on the current level of HIV infection.

398

 

 
 

Moreover, the December 18, 1987, MMWR supplement (the report to
the Domestic Policy Council) provides the best available summary
data regarding HIV infection. CDC strongly supports Dr. Burke’s
call for the focus on HIV infection, not AIDS.

DR. LEE: Thank you. Let us get into this
confidentiality and the law business a little bit, Dr. Wallas.
In my experience which is very extensive, being as old as I an,
the law always gets what it wants.

Let us look at how the law gets what it wants. We are
subject to the sunshine laws. So, is everybody else. We have
just heard the gentleman from the insurance company make the
statement which Frank Lilly picked up on that his information is
available, quotes, to anyone who does have a need to know, end
quotes.

Now, Since an insurance company is in the business of
underwriting insurance, I assume that anyone and everyone in an
insurance company can find out that information. Furthermore,
insurance companies are notably not eleemosynary institutions.
To the best of my knowledge, if you were turned down for any
reason for any policy, this is public knowledge and is spread to
every other insurance company in the world, as far as I know.
Now, if this gentleman from the insurance company wants to tell
me this is not the case, he can do so. I would not believe hin.

Now, what are we going to do about the fact that
confidentiality is a complete myth? I mean let us look at what
happens if you are in Rich DeVos’ company, say. You put
somebody in your personnel department and somebody has to
process the insurance forms. Insurance is a huge hole. Somebody
has to process the insurance forms. You would not have to see
AIDS. All you have to see is Kaposi’s sarcoma, Monilia,
pneumocystis, funny lymphocyte counts, and away we go. Now, that
is transmitted to this MIB. It is transferred to anyone and
everyone in the insurance company. It is transferred to the
personnel director at the company where the person works. The
personnel director reports to the president of the company, and
forget about it. Who are you fooling? I mean we are not 25
years old. So, why do we talk about this? How can you in the
insurance industry come to us and talk about confidentiality?

But I know what you are going to say. What I want to know is
what Dr. Wallas says. What can we do about the lawyers? You
know, Shakespeare had some great comments about them. It wasn’t
damn the lawyers or drown the lawyers, but it was something close
to that. What are we going to do about this? Because you know
they are going to come. They are going to overturn this and that
and the other thing, and they are going to get into it.

399

 

 
 

 

DR. WALLAS: Relative to donor information |
specifically? What would you like me to address? I mean
dealing with the lawyers is --

DR. LEE: When you talk about confidentiality, I
mean do you see any hope, sir, in keeping them out of this
information?

DR. WALLAS: I think that it is discouraging, indeed,
that the Texas case occurred. I think that Florida stood fast
in terms of donor confidentiality records. I think it is
critical that we have some sort of national standard that
prevents that, and I am not sure exactly what that involves
because I am not a lawyer.

However, I think that it is critical if we are going
to continue having voluntary blood donors appearing at donor
centers to give altruistically. We are going to need to protect
the information they provide or we won’t have voluntary blood
donors. I don’t have a solution for you. However, I think it is
a critical issue, and I think it is one that needs to be
addressed by this Commission.

MR. WOODMAN: Mr. Chairman, may I at least rebut
Dr. Lee, even though he is not going to believe me?

DR. LEE: I want to believe you, but I have learned
not to.

CHAIRMAN WATKINS: The rest of us are objective and
have an open mind, Mr. Woodman, press along.

MR. WOODMAN: Thank you. First of all, we have to
make a distinction between underwriting and claims. In the
underwriting process the information can be maintained within a
small unit, and that is exactly what we do, particularly with
highly confidential information, such as HIV seropositivity, as
I previously described.

Claims information that is administered through a
personnel office, obviously would be protected with respect to
confidentiality only as carefully as the personnel office
handles it. In an insurance company the claims information is
handled much the same way as the underwriting information is
handled. But if an individual working for a manufacturing
concern or whatever does not have the confidentiality
maintained by that company’s office, it is not the fault of
the insurance company. Dr. Lee indicated that it becomes
general knowledge when a person is declined for insurance; that
is not true. An underwriter might discuss that with another
underwriter, but that is forbidden procedure. Because we are
not perfect, it can happen but I think with someone declined

400

 

 
 

 

because of seropositivity, that type of information which we
recognize as sensitive would not be exchanged.

Underwriting actions by an insurance company are not
reported to MIB. We only report coded information on a medical
impairment. So, I hope I have at least made some progress in
dispelling some of the concerns you have.

DR. LEE: No, you really haven’t, but that is all
right. I am saying that if you send in these helper suppressor
T cell ratios into the MIB, I mean the ballgame is, you know,
everyone knows about it.

MR. WOODMAN: It is a non-specific code.

DR. LEE: Who can get into the MIB? Any private
detective, I assume by making a phone call and stating that
he is XYZ and --

MR. WOODMAN: No. It is a user unfriendly system.
There has been no record of hackers ever getting in, and the
only persons who have access are authorized persons in an
insurance company who’ are MIB members and who have a need
to Know.

CHAIRMAN WATKINS: Mr. Woodman, a follow-up on that.
What could you tell Dr. Lee about your own internal audit
program within the MIB or other networks that are sampled to see
that your policy is actually carried out? This is one of the big
problems. We have great policies around. Very few people carry
them out right. So, the question is how do you police your own
system for need-to-know access? Have you done some sampling of
that? If so, how good is it? Are there any reports on it that
can demonstrate? You say that you have not had any breach of
confidentiality. Is that a matter of record of the proper
auditing agencies that are tasked to do that kind of thing within
the MIB or other insurance networks?

MR. WOODMAN: The MIB has never been accused of any
specific breach of confidentiality or had any legal actions
brought against them. Certain MIB information conceivably could
have been leaked by an underwriter but not by the MIB itself.

CHAIRMAN WATKINS: What would happen in that case
with the underwriter? Would he then follow the litigation under
state law? Is it highly disciplined within the system
so that everybody is irate within your organization network?

MR. WOODMAN: Yes. Underwriters have a professional
obligation, and they are also employees of a company. It
certainly would be highly unacceptable to the employer to have
an employee accused of breaching confidentiality.

401

 

 
 

 

CHAIRMAN WATKINS: You say.that the ‘number of those
cases are small or zero?

MR. WOODMAN: Or zero. I am not aware of any record
of any such cases. Each company conducts a self-audit, as I
mentioned. They are required to examine a number of cases each
year and assure the MIB, through an audit by someone other than
the underwriter who handled the case, that the information was
correctly reported. Also, as I said, a MIB representative
visits the company every 3 years and asks the company prior to
his visit to pull certain selected files with the highest
possibility of error because of the particular code involved.
These are then carefully reviewed by the MIB auditor.

CHAIRMAN WATKINS: Dr. Lee, did you have any further
questions?

DR. LEE: No, I will pass.
CHAIRMAN WATKINS: Dr. Walsh?

DR. WALSH: Would that we lived in a perfect world.
If we were as great automatons as some of us would like, I would
suppose that we wouldn’t even have HIV to worry about, but
nevertheless I am concerned a bit about one or two things.
Philosophically I have a natural reluctance to any new federal
legislation that will interpose itself between physician,
patient and the like. Most of the witnesses, while stressing
the necessity for confidentiality, and we all agree with it,
have indicated that the system by and large has worked very
well, as Dr. Cates has pointed out. It has really worked quite
well in the normal relationship and even our quizzical Dr. Lee
was going back 8000 years at one comment to talk about how
confidentiality has always been a part of our system in
medicine.

I would like to get your comments on whether you are
really interested.or want new federal legislation or perhaps
federal leadership exhibited by guidelines or parameters that
the states could follow. Secondly, be it law or guidelines, if
my philosophical reluctance is overcome, while I have heard much
about confidentiality, I have heard much about public health, I
have heard much about medical management; I have not heard any
comments on what should be the status if a patient who is
seropositive following counseling rejects behavior change.
Nobody seems to want to address this part of the epidemic. Does
the confidentiality law or guideline that you are talking about
protect society against this potential assassin if behavior
change is absolutely rejected by that individual following
counseling or counseling is rejected following the discovery of
seropositivity? Those are two of the questions. I don’t see

402

 

 
 

 

that we gain anything by beating the system to death or by asking
the insurance industry to take undue risks, by not having
conditional testing. if people who are seropositive want to
suddenly by one-half million dollars worth of insurance and so
on, and impose, therefore, a penalty on all other policy holders
who in the long run have to pay for that loss. This is why I am
fearful. I don’t know of any federal law that will cover
everything. I hate the thought of a federal law because it will
create a new career for lawyers because there is no federal law
passed that a lawyer won’t contest. So, I am concerned as to the
difference between law and guidelines, common decency in
recognition of confidentiality and the like. So, I welcome the
comments

of any of you on those three questions.

MS. FINNEGAN:: Our association believes, along
with the American Bar Association and the National Health
Commissioners that state legislation would be the best approach
on this particular matter, and Secretary Bowen recently wrote to
the governors of all of the states to urge consideration of that
legislation at the state level. So, we share your concern about
federal legislation. We would prefer to see legislation at the
state level with reference to the confidentiality of medical
records.

DR. WALLAS: I come back to the problem with the blood
donor and restate my concern that we have Florida which has
upheld confidentiality of donor records and Texas which has
bolted from that position, and so, we face now the potential for
variability in the protection of the donor. It is my feeling
that if we go on with states allowing lawyers to get into donor
records that we will destroy the volunteer blood donor system.
So it is my feeling that we need to move above the state in this
particular issue and guarantee the confidentiality.
Unfortunately, the Supreme Court of the United States refused to
hear the Texas case. It would have been very helpful if they had
not done that. So, I don’t have an answer for how to deal with
it, but I think if we allow the states to set their own rules in
this particular issue, we will create havoc with the donor
supply, and so, I think we need to rise above that level somehow
and perhaps have some uniform approach that applies to all
states.

DR. WALSH: Is no one going to comment on my question
about what to do with the behavioral change that is rejected?

DR. WADLEY: I will take it. First of all, I would
like to say that I agree that when you talk about
confidentiality and what we have done with the system in the
past, I think we have done darn well.

DR. WALSH: Darn well, that is right.

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DR. WADLEY: In fact, sometimes I am almost insulted
when they talk about how bad it is because I think we have got
an excellent record, and when STD records have been subpoenaed
by a judge I have gone in with a plain manilla envelope, talked
them into it that they didn’t need it, and that was long before
AIDS ever came on the scene. Secondly, as far as what I am
relating to in public health, there are already model guidelines
for CDC, model guidelines by TMA, and if states want to do it,
they can, and states that are wanting to do it are doing it, like
Tennessee right now.

The issue of knowingly exposing has become very
bothersome for public health officials, and sometimes I think
they would like to put their heads in the sand and hope that it
goes away. The problem many times is first of all, there is no
system of documenting when you come in for anonymous testing.
There has been an occasion in Tennessee of where a patient states
that he is not going to change his behavior. This is very rare,
and this happened to be an individual that had many other mental
health problems. We were able to intervene and get that
individual off the street. But that bothers us tremendously
because for the most part we have very little way of knowing
unless it is the rare situation where they tell us, "I am going
back out on the street, and I don’t care what you say," but that
is bothersome to us.

DR. WALSH: As I say, again, we find that is
relatively rare. I agree with you. It is relatively rare,
but again, nobody seems to want to address it. I just feel that
if we are looking for federal guidelines or state laws, this has
to be addressed, even if it is only 2 percent, if we are going to
contain this disease. We have got to address it.

How about you, Dr. Cates? You must have some thoughts
on it? Again, as an individual, and I realize you cannot speak
for CDC. ;

DR. CATES: Fortunately, these situations are rare
events, probably much less than the 2 percent you cite. In
those circumstances where it occurs, we favor a graduated
approach in terms of offering individuals increasing incentives
to change behaviors before you start imposing penalties to
restrict behaviors. We call this the “least restrictive
alternative" approach.

CHAIRMAN WATKINS: Mrs. Gebbie, follow-up?
MRS. GEBBIE: Just to comment on that, I think the

reason people haven’t talked about it is that we have not asked
these panels to address that question. In fact, there have been

404

 

 

 
 

 

a number of conferences and meetings among public health
officials on that issue. There are guidelines developed, and

I know that it would be possible to assemble quickly a panel

of people who have varying views on that and some ideas about
guidelines. So, I guess I get a little nervous when we say that
nobody has talked about it when it is partly because we haven’t
put that question to panels of witnesses.

DR. WALSH: I disagree with you, Kris, with all due
respect, because, we have had witness after witness ask for
federal legislation, this kind of legislation and that kind of
legislation. We have seen witnesses attacked by the panel in
one way or another for alleged violations of confidentiality,
and yet, I feel that indeed, if you are going to talk about
federal legislation guidelines or state legislation, that is an
important part of it. I don’t think it should be relegated to a
special session where we can sit up here and look down and say,
"We have got a bunch of right wing kooks out there now who are
going to talk about driving people with a whip to the state
because they won’t take behavior change."

MRS. GEBBIE: I think you are misrepresenting that
view. I think the issue of control of persons who are not
following up appropriately with counseling is neither
contradictory to confidentiality nor an essential part of it. It
is a separate debate piece of this epidemic, and I just
get real nervous when we start jumbling subjects together.

DR. WALSH: I disagree with you.
CHAIRMAN WATKINS: Dr. SerVaas?

DR. SerVAAS: I just had a quick question for Dr.
Wallas. Are the blood banks finding it more difficult to get
donors now? Have you had a big dropoff in the number of people
who are giving blood?

DR. WALLAS: I can speak for the Red Cross situation
in this community. The number of donors has been dropping
gradually over the last 3 years. They are finding themselves
increasingly having to try to import blood from other centers to
try to meet community needs. The only reason that we haven’t had
a major crisis as a result of the falling number of donations is
that fortunately physicians have begun to be more circumspect
about the use of blood and that has probably been a spinoff of
the increasing public concern and physician concern about
potential transmissible diseases from transfusion, but it is
clear that we are seeing increasing difficulty recruiting
donors. We still have a problem with donors incorrectly
thinking that they can acquire HIV infection by being a blood
donor, and we have a major public relations issue around all of
that.

405

 

 

 
 

 

DR. ServVAAS: Has the fact that hospitals do
autologous blood or clean the blood and reuse the blood during
surgery, or directed donation, that is sometimes used I
understand in New York with the C sections, affected the number
of people donating blood? Obviously you wouldn’t be giving
blood if you were going to go donate blood for surgery coming
up. Does that have anything to do with the dropoff?

DR. WALLAS: That is difficult to assess. It is very
hard to know whether directed donor programs have fragmented the
blood supply which is clearly a concern. I don’t think there are
any good data one way or the other about that issue.

In terms of whether people are not donating because
they are waiting to donate for themselves, also, I don’t believe
there are any good data, but I firmly believe that we have a need
to encourage our patients and counsel with our patients to donate
blood for themselves in anticipation of surgery and a recent
article from San Francisco General Hospital suggests that perhaps
10 percent of blood needs could be supported by autologous
transfusions. So, I think that is clearly a goal to shoot for.

DR. ServVAAS: Have suits against the blood banks been
a major problem? I believe that Irwin Bank had some problems.

DR. WALLAS: Most states currently view blood as a
service and not as a sale, and therefore, by: and large blood
centers have not had successful suits against them relative to
transmission of disease.

DR. SerVAAS: But are there a large number of suits
being defended?

DR. WALLAS: I think there are, but I cannot give you
a number, and if you would like that information, I think that
the American Association of Blood Banks could provide that. I
think that is an ongoing problem. Would you be interested in
that information?

DR. ServVAAS: Yes.

CHAIRMAN WATKINS: Dr. Crenshaw?

DR. CRENSHAW: I will defer to Dr. Lilly.

CHAIRMAN WATKINS: Dr. Lilly?

DR. LILLY: I thought I had already had a turn.

CHAIRMAN WATKINS: All right. Dr. Lee has another
question.

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DR. LEE: Ms. Finnegan, you know, as Mr. Woodman well
knows, it takes an unskilled amateur approximately 30 seconds of
looking at a chart to tell whether that person is HIV positive.
The clues are ridden through there. Now, if I were running an
insurance company, I wouldn’t care whether anybody put HIV
positive in there. I would look for about 15 other little things
and tell my people to find out what the story is and put a big
black star on that guy’s application.

What is your organization doing about that, because
any lawyer can get any chart, as I know, as we all know? Is
there anything you can do about that?

M8. FINNEGAN:: The major thing that we can do is to
make sure that the patient has provided an informed consent, and
by that I mean --

DR. LEE: Informed consent for what?

MS. FINNEGAN:: For the release of the medical
information to the insurance company.

DR. LEE: I think a lawyer can get that chart no
matter what. They can subpoena the chart. Lawyers aren’t
worried about informed consents or anything like that. There is
no consent form that anyone can sign that a lawyer cannot crack.

MS. FINNEGAN:: A lawyer will have to have a case
filed in order to issue a subpoena. It is true that if someone
is determined to get information, they can get it, but there are
many things that we can do to prevent information transfer in the
majority of cases, and that includes having informed consent of
the patient and counseling the patient so that the patient
understands what he is signing. We find today that large numbers
of patients are paying their own bills rather than have
information sent to their insurance companies.

DR. LEE: I love it. I believe it.

MRS. GEBBIE: A follow-up on your firm position that
this confidentiality issue should be handled at the state level.
We have got about 10 years of experience with one very specific
federal confidentiality law, that governing records dealing with
drug and alcohol. Is your message today that such law was a
mistake? Why isn’t that confidentiality legislation providing a
handy model for this particular set of records we are talking
about now?

MS. FINNEGAN:: All right, the federal legislation on
drug and alcohol records is one of the ones that has made
lawyers rich, as we have discussed earlier. It has recently

407

 

 
been revised, and no one can interpret it in many instances.
There were problems with it the first time, even its
applicability. Some attorneys said it applied to any hospital
that took Medicare money. Others said that you had to run a
special program for the treatment of alcohol and drug abuse
patients, and now, supposedly the law has been revised so that
it only applies to special programs, but then the other day an
attorney told me, "That was kind of true, but the interpretation
that was being given to it was that it still applied to any
hospital that had a patient with that kind of diagnosis."

We believe that the consent form required for release
of alcohol and drug abuse records is the same type of consent
form that should be used for release of information on patients
having HIV testing because that is a more stringent type of
consent form than is customarily used for release of information
in many other settings.

DR. WALSH: The main reason federal legislation always
worries me is you have got 535 members of Congress. All you
have to do is live in Washington, D.C., and go down and sit when
they are marking up legislation or watch them mark it up. It
represents a viewpoint of every lobbyist or every constituent of
200 million people that get in before that law comes out. It
takes the entire American Bar Association to interpret the law
once it is written, and that is what frightens me about getting
federal laws on this. It just doesn’t make any sense and never
will.

CHAIRMAN WATKINS: Are there any other questions
before I close out the panel? Dr. Crenshaw?

DR. CRENSHAW: Just a brief one. Asa psychotherapist
with also, a medical practice pertaining to sexual medicine, I
have struggled a lot with insurance companies. I have found that
one’ of the techniques used by insurance companies to avoid
payment of claims, long before AIDS, was to request the detailed
records before they would pay a claim. It may not be appreciated
that this is another way of accessing records because I think
most insurance companies are streetwise enough to know that
people don’t want their sexual information circulated anywhere.
So, this is just a point I might bring up, that it might not
occur to most people. They might not think about it. Also, with
respect to mental health diagnoses, I spent a 13-year battle
fighting and protecting my charts from subpoena, and if I were
not so stubborn, which I am and willing to take some risks at
certain times, attorneys can penetrate the mental health and the
alcohol diagnoses, if they are determined.

If anyone wants to comment on either of these issues,
I am open, but I wanted to include these anecdotes.

408

 
 

 

CHAIRMAN WATKINS: I would like to focus on something
other than the law right now. We have a large number of
professional organizations who deal with health care in the
nation. Irrespective of what the laws are in the states,
it seems there is a professional ethic that could be
restrengthened in the minds of the American people. Maybe it is
time to take a hard look at what we are doing within the health
care delivery system to protect against breaches of
confidentiality, and set an example for the nation. With the
confusion on confidentiality, is now not the time to convene a
high-level national leadership interchange between the American
Medical Association, American Nurses Association, American Bar
Association, American Hospital Association, American Medical
Record Association, U.S. Department of Health and Human
Services, CDC, state territorial health officers and so forth to
address this issue very specifically? Don’t try to get it
broader than that. Try to say, "What can we do to reassure
people with respect to confidentiality? That through the
professional ethics that we have in our organizations, we are
going to do our darndest to convince you that we can handle it.
That we are not going to tolerate violation of our professional
ethics" You can do that, irrespective of law. I realize it
doesn’t have the power that perhaps some tough legal backup does,
but it would send a very strong signal. It might even influence
state legislation or model state legislation to back you up. I
would like to have some comments from each of you on something
along that line. Ms. Finnegan?

MS. FINNEGAN:: I would agree with your comments that
there is much that can be done within existing codes of ethics
and from an administrative point of view. For example, we
believe that every health care institution should orient their
employees to confidentiality immediately and require them to
Sign a statement indicating that if they breach confidentiality
they are subject to immediate termination. I think if you start
out immediately upon hiring employees orienting them to the fact
that your standards at that institution require them to handle
all information whether it be coded or non-coded information very
carefully, then you create a climate that can carry the
institution’s policies a long way. It is a very major effort,
and I certainly would support the idea of a conference. I think
there is much more that could be done in the educational programs
for medical students and other health professional students to
carry forward the doctrine of confidentiality.

CHAIRMAN WATKINS: Dr. Wallas?

DR. WALLAS: If I understand your suggestion, it is
akin to a consensus conference in which a group of leadership
organizations would get together to set standards and, also,
to indicate to the nation that there is a broad-based concern
about confidentiality.

409

 

 
 

 

 

CHAIRMAN WATKINS: Not so much concern, I would rather
look at it the other way, as a very positive thing to reaffirm
where we stand in modern technology, to reaffirm where we stand
as a uniform body of professionals that we don’t perhaps need a
lot of laws around. We are stronger than that. Our belief is
in confidentiality after 8000 years according to Dr. Lee, and so
it seems to me the --

DR. LEE: I did not say that it was 8000 years.

CHAIRMAN WATKINS: Oh, with particular emphasis,
because it is such a volatile issue. It seems that what we are
trying to do is calm fears and take advantage of historical and
ethical perspectives on this and strengthen them. The
conference that was just held by the AMA was enthusiastically
participated in at all levels on the education of health care
providers across the board. Now, we are talking about taking on
the most contentious and volatile issue. It is probably the
primary obstacle to the kind of health-driven steps that you
would like to take to deal with the virus through a more open
and willing testing procedure. It seems to me that it is time to
address this. Ms. Finnegan, I would like to take your idea and
run it nationally. We must recognize that this is still an issue
in the minds of those who are willing or not willing to come
forward, and at least it would be a start to push ideas into the
system and make confidentiality a matter of sprofessional ethics. -
At least you would set some standards, and it would be very
difficult then within professional organizations to accept those
who violate those standards irrespective of law. Recognizing,
perhaps in cases such as Mowery here, that it would be nice to be
able to do something in terms of litigation.

DR. WALLAS: I think that is an excellent idea. I
cannot speak for the AABB, but I suspect that they would be
fully supportive of that approach and would participate.

CHAIRMAN WATKINS: Dr. Cates, do you have any views?

DR. CATES: First, under Mrs. Gebbie’s guidance,
the state public health officials have gotten together to
discuss confidentiality as a key issue on several occasions.
I certainly would support a reaffirmation of basic
confidentiality principles and perhaps even a broadening of
principles for all communicable diseases. Second, as
Dr. Wadley aptly described, even in the absence of model
laws, the STD control arena will continue its heritage of
protecting confidentiality at occasional personal risk to
those who take strong stands.

CHAIRMAN WATKINS: I am also dealing with the
perception of the American people on the issue. After all, I

410

 

 
 

 

know you all do a good job in your organizations. That is not
the issue. The issue now is can we convince others of your
credibility to do a good job. When we have cases come up that
Clearly are in violation of what we all think are ethical
practices, we all get upset. So, from the presentations that
have come before this Commission, it is evident that there is
enough of that going on to raise the question of whether by just
coming together in itself we have addressed this in such

a way as to make an impact on the nation as I think this
Commission is doing. It seems to me the aggregate view on

this issue, the fact that there seems to be a great deal of
consensus among the people who have come before this Commission
could well help allay some of the fears.

DR. CATE8: I agree. To build on the collection of
organizations you are suggesting, and to support an idea that
Dr. Burke had earlier, if you as a Commission could rally the
weight of the presidential image behind this principle, we would
form a unified country peer pressure for concern about what
confidentiality and antidiscrimination really mean.

CHAIRMAN WATKINS: Thank you very much for coming
before the Commission today. We appreciate the time you have
all taken. It has been helpful to the Commission, and we will
proceed now with the next panel.

Panel number four, the legal aspects of testing. We
have three panelists, the Honorable Kenneth W. Starr, United
States Court of Appeal for the District of Columbia Circuit;
Deborah Merritt, Assistant Professor of Law, University of
Illinois College of Law: David Randolph Smith, Assistant
Professor of Law, Vanderbilt University School of Law. Welcome
to the Commission, and we will commence with a statement by
Judge Starr.

JUDGE STARR: Thank you, Mr. Chairman. It is a
Pleasure to appear before the Commission as it goes about its
important task. At the outset, I am well advised to share with
the Commission a caveat that as a sitting judge, it would be
inappropriate for me to set forth opinions or views on the
specific legal issues raised by the testing question. My task,
of necessity, will be limited to describing the state of the law.
I therefore come before you only to describe and not to opine and
emphatically not to advocate.

With that, permit me in the few minutes allotted to me
to share a few brief thoughts about the state of the law that is
more fully developed in my paper. The first and most fundamental
point is that testing does indeed trigger constitutional issues
when the testing is administered by or required by the
government. Testing by private employers, in contrast, does not
implicate the higher law of the Constitution, unless, again, it

411

 

 
 

 

is required by the government for the product of governmental
action.

The principal constitutional question would be whether
a mandatory testing program violated the fourth amendment to the
United States Constitution. That basic safeguard states with
majestic simplicity that the right of the people to be secure in
their persons, houses, papers and effects against unreasonable
searches and seizures shall not be violated. The language of
the amendment is general. The words therefore call out for
interpretation and that is where the judiciary comes in. As the
great Chief Justice John Marshall put it, it is emphatically the
province of the judicial department to say what the law is. The
issue before us in the law is obviously new. The consequences of
the tragedy are therefore only beginning in earnest to find their
way into the courthouses across the land.

Thus it is that the principal reported case to date on
the legality of a mandatory HIV testing program is, in fact,
limited. That case, decided just 11 months ago, upheld a program
of mandatory testing instituted by the United States State
Department to expand its existing employee medical fitness
program for foreign service employees seeking to qualify or to
remain qualified for service abroad.

But there is a more substantial body of law in the
arena of mandatory drug testing programs. Although the issues
raised are obviously different, we can nonetheless expect helpful
guidance in the near future from the Supreme Court which has very
recently agreed to hear a case coming out of the Fifth Circuit
Court of Appeals in New Orleans, upholding a mandatory drug
testing program for certain Customs Service employees.

In looking then more generally to fourth amendment
jurisprudence, what we see in the judicial literature is a
careful focusing of the judicial eye on the core value of the
fourth amendment, reasonableness. Is the governmental intrusion
under all the circumstances reasonable? In making this obviously
judgmental evaluation, the courts have looked to the nature of
the government interest at stake, and then balanced that interest
against the expectation of privacy that society is prepared to
recognize as reasonable on the part of the individual. This, I
hasten to add, is a societal recognition. It is the values of
the community that is the question and not the individualized
perhaps idiosyncratic views of a judge or a single court.

In this regard, the courts over the years have tended
to be generous in upholding governmental intrusions aimed at
promoting public health and safety, as opposed to intrusions
carried out in the enforcement of the law. This is aptly
illustrated by a Supreme Court decision at the turn of this

412

 

 

 
 

a

century upholding, against constitution challenge, a mandatory
inoculation program.

The final point I would share in these opening comments
is that the courts tend to look in these kinds of cases very
keenly at the safeguards that surround a particular intrusion by
the government. Is the intrusion as narrowly tailored as
possible? Is it as limited as reasonably possible? Are
interests in confidentiality taken into account? Are standards
imposed to guard against wide ranging discretion on the part of
officials vested with governmental power?

In closing, I would say, Mr. Chairman, that the courts
have shown a special interest in whether the program under
scrutiny has evidenced careful, deliberate, considered judgment
of one or more of the political branches of government, as
opposed to a less deliberative and perhaps less carefully crafted
program, without the safeguards of the democratic process. This
is, at bottom, a requirement of reasoned decisionmaking that is
sensitive to the individual interests at stake. That is the
path toward the higher ground of our Constitution. Thank you.

CHAIRMAN WATKINS: Thank you, Judge Starr. Ms.
Merritt? .

MS. MERRITT: Good afternoon. I am delighted to appear
here before the President’s Commission on the HIV Epidemic.
Compulsory HIV testing of individuals obviously raises difficult
constitutional and public policy concerns. As {I have indicated
in my written testimony, the most serious constitutional issues
arise under the fourth amendment. Other possible constitutional
Claims, such as claims based on a right of privacy or on the due
process clause, are largely subsumed by a fourth amendment
analysis.

 

The fourth amendment represents a wise decision on the
part of our ancestors that in a free society, more information is
not always a good thing. It would be useful in any society to
know which individuals are harboring contraband or carrying on
criminal activities in their homes. If the police could search
dwelling places and individuals at will, without warrants or
probable cause, we might in fact have less crime in our society.
In the same way, if we could test the entire population
continuously for HIV antibodies, we might reduce somewhat
transmission of the AIDS virus. ‘

The fourth amendment, however, reminds us that health
and safety are not the only important values in a free\society.
Health and safety are important, but those values must ‘be
balanced against the interest of individuals in maintaining their
privacy and integrity against governmental intrusion. For these

\

413

 

 

 
 

 

reasons, the fourth amendment limits somewhat the circumstances
under which the government may conduct searches of its citizens.

The fourth amendment, of course, does not forbid all
searches. Privacy, like public health, is not a value that
should override everything else. Hence, the fourth amendment
prohibits only unreasonable searches. I have suggested in my
written testimony that the courts might look at a dozen different
factors to determine whether a particular testing program is
reasonable. I cannot address specific programs in this brief
introductory testimony but I wish to make the following three
points.

First, all mandatory HIV testing programs will be
subject to substantial scrutiny under the fourth amendment. HIV
blood tests gather intimate medical information about an
individual through a procedure that penetrates, however briefly,
the individual’s bodily integrity. The negative consequences of a
positive test result are potentially enormous for the subject.
The individual who tests positive for HIV antibodies must face
the possibility of death from a dreaded disease; the disruption
of his or her intimate relationships; the potential loss of jobs,
friendships, and health insurance; and the possibility of social
harassment.

Some of the individuals who bear these burdens
moreover, will be individuals who will not have posed any threat
to public health. They either will be the victims of false
positive test results or individuals who, regardless of their
infection, would not have engaged in any activities threatening
the risk of infection to others. For all of these reasons, the
courts will weigh the necessity of any mandatory testing program
with great care.

Second, in order to pass muster under the fourth
amendment, any testing program must treat test subjects in a
dignified and humane manner, must rely upon accurate testing
methods, must eliminate the possibility of arbitrary discretion
in choosing test subjects, and must maintain test results in a
confidential manner. Without these minimum safeguards, it is
unlikely that any mandatory testing program would satisfy the
fourth amendment.

. Finally, beyond these minimum safeguards, mandatory
testing programs are most likely to survive fourth amendment
scrutiny if they further a concrete and substantial governmental
interest, if they enjoy a high level of effectiveness, and if
they constitute the least intrusive means of achieving the
government’s purpose. Testing programs aimed at low risk
populations or programs that gather information about HIV status
without using that information for a well articulated purpose are
less likely to satisfy the fourth amendment. I would be happy to

414

 

 
 

 

answer your questions about specific testing programs during our
general discussion period. Thank you.

CHAIRMAN WATKINS: Thank you, Ms. Merritt) Mr. Smith?

MR. SMITH: Mr. Chairman and members of the Commission,
I am delighted to appear on this panel of lawyers, and I guess I
would like to respond, just for a moment, just to the first point
about Shakespeare’s criticism of lawyers. The absolute --
\

DR. LEE: Did he say something good?

\

CHAIRMAN WATKINS: We love you as an American. \

MR. SMITH: He said, the first thing we do, let us kill
all the lawyers. That was Henry IV, the second part of Henry IV,
however, the words were spoken by Dick the Butcher, and he was a
member of Jack Cades’ rebellion who sought to overthrow and
institute an anarchistic system so Shakespeare, read in context,
and I will produce these remarks as a supplementary filing, that
the first thing that is necessary for the rise of anarchy in the
individual rights is to kill all the lawyers.

The only other thing I would like to Say on that regard
is what de Tocqueville observed which is that there is hardly a
question of importance that comes before the American public that
does not involve a legal question. Lawyers, unfortunately, are
in everything. So let us just talk a little bit about some of
these questions from the lawyer’s perspective.

The mandatory testing question I think is obviously
critical. I would like to address it, though, from the police
powers standpoint. As I have said in what I submitted to you,
for public health, individual rights may be sacrificed if it is a
legitimate exercise of the police powers, if there is a
reasonable and legitimate public health risk. TI think that is
the real difficulty here and what you can do that will be so
important is to say what is necessary for the public’ health and
to critically examine on a cost benefit analysis basis whether
testing all hospitalized patients, all persons in drug abuse
clinics or all applicants for marriage licenses really is
necessary when you, from the standpoint of how will that really
affect the spread of the disease and what are the negative trade
offs in terms of disadvantages from the public health standpoint.

The courts are going to be very interested in what the
CDC has to say about this type of testing and what is startling
to me is how much of the testimony, at least what has appeared in
the papers, Dr. Day, etc., is really in conflict with what the
recommended guidelines are for the prevention of HIV
transmission, for example, in the hospitalized setting. I think
that is a specific area in which widespread screening has not

415

 

 
 

 

 

been called for by the CDC and there is a case for mandatory
screening for certain procedures that can be made, but that needs
to be articulated and made clear. .

The other point I want to make about mandatory testing
is you do not solve all of your legal problems. What you
generate are test results. What do you do when you get all of
these test results? Well, you may get false positives which
creates potential liability for negligence and negligent
infliction of emotional distress and all sorts of things that are
generated by false positives, particularly if you are not relying
upon established protocols. If you simply do ELISA testing and
you do not follow up with the Western Blot Testing you are going
to have false positives and that may create liability.

The more importantly, then you get into this
confidentiality problem which I think is central here, and that
is, how are you going to keep this information confidential? You
have generated all of this information about positive test
status, positive test results and then you have a problem of
public disclosure of private facts, invasion of privacy,
defamation liability, medical malpractice liability if persons do
not treat persons who are seropositive.

Then you also raise the question of tort liability for
duty to warn. Now I know that someone is positive. Can I be
sued if I do not tell their lover or spouse or foreseeable
victims? Contact tracing, yes, there certainly have to be, there
are questions that are going to arise and I think that
confidentiality is not absolute and that one has to depart from
confidentiality if a person waives it, to the insurance company.
Certainly, it is waived with respect to those who are treating
the patient and that waiver of confidentiality may be necessary
under the Tarasoff decision to warn foreseeable victims so
mandatory testing is going to generate a great deal of questions,
legal problems. Even after you have solved the initial problem
of its constitutionality there is a potential tort liability once
you have all of these positive test results, and what are you
going to do with them?

With respect to voluntary testing, I think the major
concern here from the tort standpoint is informed consent. Most
of the recommendations of the hospital, American Hospital
Association and the Centers for Disease Control and the American
Medical Association call for informed consent. I realize that
the Texas Communicable Disease Statute has department from that.
I think informed consent as a part of counselling is quite vital
and I think that should be a recommendation of the Commission
where voluntary testing is appropriate.

On duty to warn, the American Medical Association has
called for specific statutes saying when do we warn, how do we

416

 

 
 

 

insulate liability. I do not think that is a good idea. I think
it is too difficult a topic and we should leave that to the
courts to be developed similarly as it has been done with respect
to duty to warn with psychotherapists and psychiatric patients
who pose a danger. With respect to non-compliant patients and
quarantinings, I do not think we need statutes there. I think
that there are going to be cases, compelling cases where persons
are unable to control their behavior and pose risks. I think
existing law provides the means to handle those cases and if you
throw this into the legislature, I am very afraid, I am very
afraid what would happen. But I think that is something that
needs to be talked about.

Finally, there is the question of civil rights, and I
think that goes hand in hand with confidentiality. If you say
there are going to be exceptions to confidentiality and we are
going to admit some cases where status should be revealed, then
you ought to do something to prevent people from losing their
Jobs and being denied housing. Whether that is at the state
level under handicapped discrimination, that needs to be
addressed but I leave it to you to set the agenda on the
questions. Thank you.

CHAIRMAN WATKINS: Thank you, Mr. Smith. Dr. SerVaas?

DR. SerVAAS: I guess my question is to Ms. Merritt but
it could be to Mr. Smith or Judge Starr. Do you know anything
about laws, state laws or federal laws, any kind of guidelines
that say post-test negative counseling will be done in person
and, if so, how is it different from the blood banks where there
is not pre-test counseling? Do they notify people by mail or not
at all if they are negative? We heard that on the positives,
they do that with the physician and post-test counsel the
positives.

MS. MERRITT: I do not know of any statute in any state
so far that requires anybody doing counselling to do it in one
form or another. Obviously the state statutes are just
beginning in this area. On blood banks, I did not hear the prior
testimony and I do not know other than my personal experience
which had to end seven months ago when I became pregnant and was
no longer eligible to give blood.

In terms of the type of counselling that one should

talk about, blood banks, I think, first of all, present a very
different sort of issue when talking about mandatory testing than
most of the other types of statutes that we talked about here

The individual interest is relatively slight and the government
interest is extremely strong. In that context, for example, I
See no problem with doing only one test rather than a repeat test
if your only purpose is to throw out the blood. If your purpose

417

 

 
 

 

is to then notify the individual about the test result, you may
want to do more testing. .

In terms of the type of counseling, though, which was
your question with these different areas, aside from the blood
banks, whenever you are doing counseling, usually your purpose
is to identify the people who are infected and to stop them from
infecting others. In the blood bank context, it is a more narrow
purpose of simply throwing out that batch of blood and not
engaging in other sorts of public health counseling. Outside of
blood banks, without the counseling, testing is likely to be
ineffective. Testing in itself really does not really do much
from a public health point of view unless you talk to the person
who is positive and explain to them what the implications are for
the future. That is why I say that the counseling has to be
closely bound up with the testing.

Now, in terms of the negative results, in many of the
contexts in which one would think about doing mandatory testing,
it makes sense to counsel even when a negative result is received
because those people are at high risk. The testing, for example,
may be done in a drug abuse program. The testing may be done in
a sexually transmitted disease program and that sort of clinic.
These are people who may be at risk and who, when they go back
out into the community, will be at risk again so that from the
public health standpoint, maybe the counseling is important
there, too.

If one starts testing broad populations, for example,
the blood bank, the blood donor population, negative counseling
probably can be replaced by simply public education because then
we are simply dealing with a broad segment of the public. We
want to reach everybody not just those who are interested in
giving blood.

DR. SerVAAS: Thank you.
CHAIRMAN WATKINS: Dr. Crenshaw?

DR. CRENSHAW: Mr. Smith, I agreed with all of your
comments. I thought they were very cogent with the exception of
two and that I want to clarify because I was so busy chuckling at
your earlier remarks I may have missed a few points. I thought l
heard you say that with voluntary testing the legal ramification
was informed consent. You applied the legal problems of perhaps
reporting a false positive result due to an ELISA alone, the duty
to warn issues and all sorts of other issues to mandatory testing
only. It is my opinion they apply to both equally well and we
struggled with all those problems already today.

MR. SMITH: Yes, I would agree. I probably should have
made that clearer. What I meant to say is that with mandatory

418

 

 
 

 

testing, you still have this panoply of legal issues. Once you
get positive test result with or without informed consent, you
still have all of these other legal issues, but you have the
additional problem of did you get --

DR. CRENSHAW: The informed consent.

MR. SMITH: --the informed consent which can lead to
another problem, just the victim’s finding out about the test
result when he or she perhaps did not want to, whether that is
actionable as a negligent infliction of emotional distress and
then if they lose their job, was that caused by the test that was
does without informed consent. I think there is one case where
Someone was tested without informed consent, probably through an
insurance reporting, it was found out they lost their job and
they sued under the lack of informed consent there so you do have
all those issues apply.

DR. CRENSHAW: Plus the issue of those. Okay, I think
that is important because we do try to sometimes put our heads in
the sand about the touchy issues that you mentioned and we are
forced to face them no matter which direction we head, and I
think it is important that that is really clear.

You mentioned, and I will qualify it by in the best of
all possible worlds that when it came to duty to warn and issues
like Tarasoff and so forth, that the court should decide this.
Abstractly I agree with you, but you and I both know how long
the courts take to get around to doing this, and I wonder if you
do not think it-is practical that all of the organizations like
the AMA and the APA, that are qualified to exercise opinions
really need to be giving some guidance to their memberships in
the interim. I assume it could be several years and the loss of
a lot of lives if we just flounder.

MR. SMITH: I was responding to recommendation 16 of
the report of the Council on Ethical and Judicial Affairs of the
House of Delegates of the American Medical Association December 6
through 9, 1987, in which they Say specific statutes must be
drafted while protecting to the greatest extent possible the
confidentiality of patient information to provide a method for
warning unsuspected sexual partners protecting physicians from
liability for failure to warn, establishing clear standards for
when a physician should inform, provide clear guidelines for
public health authorities. This really assumes that there can be
bright lines, and the problem is what should be done with respect
to a warning and what is a reasonable warning and when it is
reasonable to notify just depends on a lot of things, and there
are guidelines and doctors differ and there is ethical difference
about when and how and who should do this.

419

 

 
 

 

We can debate that but I do not think you will ever
cover all the issues. -.Foster parents, do they have a right to
know that an AIDS foster child is coming into their family. I
think probably so. You are going to miss some things inevitably
and as Melville said, all men are enveloped in whale lines. We
cannot really draw this line. I think it is wonderful to have
policy statements but a statute I am afraid will either err on
the side of too much disclosure or err on the side of insulating
too little disclosure and I think it is perhaps better to keep it
the way the Tarasoff case is and just say, look, if somebody
wants to sue you and say you were unreasonable, let them prove it
to a jury and get all the facts out and put the burden on them to
show you were unreasonable, but have this statutory thing debated
in all of our legislatures, it just troubles me.

DR. CRENSHAW: Well, we are mixing apples and oranges
here. I am not talking about legislatures, I am talking about
professional organizations.

MR. SMITH: I would favor that.

DR. CRENSHAW: Yes, I hear what you are saying but in
all of the guidelines whether it has to do with common practices
and diseases, none of our policies cover even a substantial
portion of the cases and there is judgment there. The only
reason I am tangling with you at all on this point is that if we
left it to the legal profession to set these things, what is the
fastest they could do it?

MR. SMITH: Well, --

MS. MERRITT: In 50 years?

MR. SMITH: The law moves slowly. —

DR. CRENSHAW: Yes, I rest my case.

MR. SMITH: But I think you, the Commission should
promulgate recommendations for the duty to warn and the duty to
contact tracing as an exception to confidentiality. I think that
would be very appropriate.

DR. CRENSHAW: Thank you. I repeat, I rest my case.

CHAIRMAN WATKINS: Dr. Lilly?

DR. LILLY: JI am concerned about the fact that I know a
fair number of people, some of them are high risk individuals who
have, after consideration, decided not to be tested for HIV
antibodies. I must say that all of them that I am aware of,
having taken that decision decided to behave as if they were
infected. On the other hand, I agree very strongly that people

420

 

 
 

 

should be encouraged voluntarily to be tested but given your
extremely pessimistic view about the confidentiality that one can
expect from testing, what do I do? What do we do?

MR. SMITH: I think the person does have the right not
to be tested. However, there is a risk. I mean, they still
could be sued, I suppose, for negligently transmitting the
disease if they had the symptoms of the disease and had reason to
know they had the disease and they sexually passed it on or
passed it on through drugs. They could still have tort liability
even if they had never had actually had an affirmative test
because they would have reason to know they were infected. But I
think the point is that people have legitimate fear of not having
their antibody status known because of what is going to happen if
it is found out because the realities are latency and everything
else. So that is a legitimate fear and I do not think that that
is elicit but once voluntary testing and contact tracing, I think
you have to make an analogy to the foreseeability that people
will remain active.

When Roy Cohen, they released the medical records of
Roy Cohen from the National Institutes of Health in Harpers
Magazine, and there are statement in his record saying that he
did not wish to remain, he did not wish to follow a course of
sexual abstinence and he was telling his position. In the Rock
Hudson case, physicians were sued there because they knew that
Mr. Hudson was being sexually active so if you posit those facts
where you know people are going to remain sexually active and
endanger people, this is troublesome and you have to ‘deal with
what is an appropriate response. If that deters people from
becoming tested, that may argue, unfortunately, for broader
mandatory testing which will be, sort of, I am not really in
favor of that so the educational mission, the ethical
encouragement to get people to know and act responsibly and
protect them so that they will not be fearful of coming forward
and being tested, that is really the hope I think..

DR. LILLY: What legal consequences of anonymous
testing might follow in that sense? [Is anonymous testing really
anonymous? Is it unbreachable in any sense?

MR. SMITH: Well, yes. When you get tested here in
Nashville at the public health authorities, and it is positive,
you come in, at that point, they find out who you are I suppose
and they ask about sexual contacts and they anonymously go and
try to contact them so that is preserved but, and generally the
public health people, unlike doctors, do not have duties to go
out necessarily and warn people that they have a patient
relationship with, but I think that contact tracing, the public
health authorities have done it for other sexually transmitted
diseases, and I think the new grants that CDC require and that

421

 

 
 

 

you participate in that approach so I think it is a reality for .
sexually transmitted AIDS. o

MS. MERRITT: If I could speak to your question, too,
even though it was addressed just to one. I think there is
really a threefold answer to your question. One is to maintain
the availability of anonymous testing and even in that context,
when one does contact tracing, contact tracing itself can be
confidential because the contacts do not have to be told who it
was that exposed them. Some people will have had only one
sexual contact and will guess, but others will not. Secondly, to
have laws on confidentiality and to make those laws as clear as
possible, I think I probably would differ with my colleague, Mr.
smith, in saying that a law on the duty to warn would be a good
idea. The courts have been engaged in a lot of controversy over
Tarasoff and it might be a good idea for the legislature to try
and strike out a line at least. It will have to be interpreted
by the courts later, but give people reassurance about what is
protected and what is not.

And thirdly, of course, anti-discrimination laws
because a lot of the things that people who are infected fear are
things they should not have to fear at all, being thrown out of
their apartments, being harassed at work, that sort of thing. If
we can give them that assurance, perhaps people will continue to
come forward. Maybe that would reassure some of the people you
know.

CHAIRMAN WATKINS: Dr. Conway-Welch?

DR. CONWAY-WELCH: I would like any of the members of
the panel to share some of their thoughts on an issue that
bothers me. We talk about testing. We frequently link that with
counselling, and there seems to be a big assumption that we have
an enormous quantity of counsellors out there who are well
educated and able to leap into the breach. All we have to do is
find the money to pay them and we will have solved the
testing/counselling problem, at least to some degree. Obviously,
we know that that is not true. My personal concern comes from
the fact that I know, for example, that nurses in their
education, depending on the type of education they receive, have
a variety of backgrounds in counselling techniques or may have
none, depending on some of the curricula issues. I am wondering
what legal issues there are that need to be considered with
regard to counseling.

I might add that in the curricula of many medical
schools, there is not a major focus on counselling skills and yet
people assume that the physician would be a prime person to
become involved in that effort. We certainly are in the midst of
a nursing shortage. They are another logical type of person who
would counsel, but we are short already of nurses. Could you

422

 

 
 

 

comment on legal issues surrounding the qualifications of
counsellors and what problems are out there that we need to know
about?

MS. MERRITT: I agree that it is a tremendous problem,
and I would think that one of the most concrete recommendations
this Commission could make would be to allocate the resources to
training more counselors. I Suppose when I think of counselors
in connection with mandatory testing programs, I think of people
who are perhaps social workers, perhaps nurses, who are
specifically trained for that purpose. It is another issue about
the government liability for poor counseling, and that- is also a
difficult one. I do not see the legal issues there being nearly
as important as simply the social, public policy, and economic
issues that we have simply got to make up our minds to \allocate
those resources. Governments are protected, to a large: extent,
by sovereign immunity, from suit by people who are dissatisfied
with what the government has done. One would have to look state
by state at the type of waiver the government has made of
sovereign immunity and I am not an expert on that at all, but
generally liability for negligence might not be a problem in
that context. It would depend on the states, I suppose. \I am
speaking out of my depth. \

DR. CONWAY-WELCH: So it is really a state issue. MSs
MERRITT: Yes, and then obviously the Federal Government,“if the
Federal Government got involved in counselling, then the
sovereign immunity question would be on the federal level.

MR. SMITH: I was going to say that there is a
potential negligence tort action if, you can imagine the patient
is told over the phone by the-doctor, he is calling you up, you
tested positive, come by my office, suicide. That is a case that
might be brought. So there is negligent counselling. The
question of who does it, I think the American Hospital
Association came out in November and recommended’ the physician do
it and sort of said that community agencies might interrupt the
continuity of a patient’s care and may be perceived as less
personal in counselling provided by the patient’s physician. I
think it sort of goes hand in hand with informed consent.
Whoever is getting the informed consent for assuming voluntary
testing for a moment, if you had voluntary testing and you have
informed consent, informed consent and then post-test counselling
are really, should be considered related.

The question of, now that assumes that this is being
done in a hospitalized setting. Outside of that setting, if a
person goes in and is tested in some other way, I think there are
some legal questions there. Again, negligence que tions, and the
people who do sexually transmitted diseases and inform people
about the status there need to probably think about the more

423

 

 
 

 

severe implications of positive test result, but it isa real
problem. oT SO

DR. CONWAY-WELCH: Are there not enough protections in
place already for inappropriate counseling or to protect
patients from the results of improper counseling. Is that
already handled through other areas of liability and malpractice?

MS. MERRITT: It would be handled through the
malpractice, the common law tort area, and the standard that
would apply would be simply the professional standard of the
counsellors, just as with the doctor the standard is: Did this
fall within the standard of reasonable care of a reasonable
doctor. Malpractice is judged by the standards of the profession
itself. So actually those standards are already there which I
suppose in a sense means one does not create more legal problems
by training more counselors. In fact, if there are legal
problems, they may be most acute if one is not providing
adequate counseling at the beginning.

DR. CONWAY-WELCH: With all deference to my medical
colleagues with whom I work very closely, the fact that we have a
shortage of nurses and a supposed glut of physicians may indicate
additional opportunities for folks. But I disagree with the
American Hospital Association singling out a profession that my
background does not have, the background in counseling that other
professions do, and I am not necessarily saying even nursing
does, but other professions do have more of a background in
counselling. I think that is a troublesome area. I am hearing
you say that from a liability point of view, a patient protection
point of view that is covered by current legal statutes, etc.,
and that there may be a person power issue but it is not a legal
issue.

MR. SMITH: Just on finances, some hospitals have
officers or staff positions that are specifically involved with
informed consent. This is all they do is go around and, Case
Western was one of the first to put this in. Whoever that person
is, the in-house counsellor who is getting informed consent would
probably be the person who would have the facility to do this
sort of thing in the hospitalized setting, and that I think you
are right, physicians do not necessarily like informed consent so
they would not like to sit down and talk about all these things
either if anyone does.

DR. CONWAY-WELCH: Dr. Schafner says the definition of
informed consent is if a physicians sits down in the room with a
patient.

MR. SMITH: Yes.

CHAIRMAN WATKINS: Mrs. Gebbie?

424

 

 
 

 

MRS. GEBBIE: I think it would be helpful if we could
hear a little more discussion between at least Ms. Merritt and
Mr. Smith, but Judge Starr may have some comments as well on this
issue of whether it is better to let something be defined by
virtue of court cases or by having a statute first. I suspect
their views depend in part on where we are. I get very
impatient waiting for 48 court cases to sort things out and find
it much tidier to work with the legislature to get a sense of
something to begin with. Obviously, you disagree with that.
Could you talk about that a little more?

MR. SMITH: Well, it is, the attention and balancing
between civil liberties and public health are so fraught with
political, I mean, we have a bill in Tennessee to test food
handlers. All food handlers must be tested. That has a lot of
political sway in Tennessee I suppose, and that is what happens
when the bill gets into the legislature is that there are, now,
the courts are not immune to this sort of politics. I do not
mean to suggest for a moment that the courts are better to solve
this problem but the duty to warn might be argued by some as an
immunity statute where physicians do not want to have any
liability for failing to warn and therefore want to insulated
themselves for liability and a statute could achieve the
immunizing effect.

So if the goal is to immunize people from liability
then a statute, a federal statute is the best way because a
federal statute can override state constitutional objections.
This is something that I am sure Judge Starr can talk about but
under the supremacy clause if you say physicians cannot be sued
for state tort law claims involving da-dum-te-dum-de-dum-te-dun,
then you have a strong argument for displacing state tort law
remedies at the federal level, and if you want an immunity
protection statute, a federal remedy is probably better.

What I sort of said as a way of resolving the balance
between public health and civil liberties and what should you do
to really solve that tension, there I think the courts may be
better, and I was referring specifically to these duty to warn
problems and the non-compliant patient problems. I think if you
put those bills through states or for the federal legislature,
you will not be happy with what comes out in the end. You may
be, but it is interest group politics on both sides, and maybe
the courts are a little bit less susceptible maybe.

MS. MERRITT: I think a lot of these are subjects that
are good for legislative treatment. On the duty to warn in
particular, I reacted on that before because the Tarasoff
decision, which I am sure you have heard about in other
contexts, has remained tremendously controversial. It is always
subject to attack. Courts in different states have followed it

425

 

 
 

 

to different extents, and courts in many states have not even
addressed the issue so we do not know what the rulings would be
in those states. We are not completely free of legislative
activity in the AIDS area. In states like California, for
example, we have very strict confidentiality statutes so that
doctors in that sort of state are really caught in a hard place.
Are they bound by the statute, or are they bound by the Tarasoff
decision? Theoretically the statute would overrule, to the
extent that it is inconsistent, a judicial decision but I can
understand doctors feeling uneasy about what their potential
liability would be in states like that.

Also, while I agree with Mr. Smith that the
legislatures sometimes make mistakes, I feel there are good
things that come out of legislatures too. My home state of
Illinois has taken a lot of grief in some quarters for being one
of the first states to require premarital testing, and passing
some other statutes, but we have some very good statutes on AIDS
in Illinois. We have statutes that have allocated more funds to
treating drug abuse. We have a very good confidentiality
statute. We have a statute that requires mandatory testing only
based on reasonable suspicion with a warrant. There are a lot
of good statutes there, and that is only the first attempt by one
state. Others may do better as they find these things so I
certainly would not rule the legislature out of these areas.

JUDGE STARR: If I could share my parochial perspective
from the judiciary, my sense is that in a wide variety of areas,
the courts look with great interest to what, in fact, the
legislative branch has done, and accords enormous respect to what
the legislative branch has done. In a way, this boils down to
how we want to govern ourselves. While the courts feel quite
comfortable in carrying on in the great traditions, the centuries
old tradition of leaving the common law, when there is, in fact,
an identifiable public issue that raises a wide variety of public
policy considerations and as to which reasonable people can
differ, it seems to me that that kind of question in a democratic
society lends itself more to a democratic solution through the
legislative process with all of the difficulties and pitfalls of
that process.

I would simply say that when the legislative process
does, in fact, operate resulting in a law, the courts have shown
the most enormous deference to the will of the legislature if you
will, in the most sensitive areas of our constitutional life.
One of my favorite examples is from the first amendment area in
the Pentagon papers case. There the Supreme Court paid
particular attention to the history in the Congress of the United
States of the espionage laws and whether, in fact, Congress had
seen fit to vest the Executive with authority to go in and seek a
pre-publication han on a newspaper. I realize that is far
removed from the concerns of this Commission.

426

 

 
 

 

I cited by way of example that even as foundational as
the first amendment is to a democratic society, the Supreme Court
has been most anxious to look to Congress to see what Congress
has, in fact, done. Courts frankly feel, speaking rather
generally, a bit ill equipped to engage in the broad kind of
balancing process that legislatures go about. I recall the
observations made by now-Judge Bryer who served as an aide to
Senator Kennedy for a number of years and was the principal staff
architect for a number of very important pieces of legislation.
He was a professor at the Harvard Law School and an immensely
able man. He said that when he became a judge, he discovered one
very basic difference in his professional life was he could not
pick up the telephone and call someone who knew the answer. You
had to rely entirely on the institutional, the very formal
process of litigation.

How conducive that is to resolving broad social
problems is a matter ultimately of judgment of the individual,
but courts by and large feel keenly the institutional limitations
of our roles.

MRS. GEBBIE: Thank you. That is very helpful. Maybe
I think so because it comes closer to where I think I was
deciding.

My other question goes back to this issue of mandatory
testing because I think that remains a troublesome issue for lots
of us. I tend in a lot of arena to look at things as a see if
you try something and if that does not work, you try something a
little harder or a little firmer or a little more restrictive,
that is, in a sequence of steps rather than jumping into the most
extreme example. To a fair number of people, mandatory testing
sounds extreme and sounds like something that is apt to be tested
in the courts if it goes into place in any broad way. In those
court tests of mandatory testing then that might happen, would
one of the considerations be whether less restrictive or
voluntary kinds of programs had been tried first and found
wanting to protect the public’s health or would the evaluation be
based on some other things? I think that was alluded to ina
couple of your testimonies but I would really appreciate some
further discussion of that.

MS. MERRITT: I think absolutely that would be a very
important criterion. In all of the drug testing cases, which are
the most analogous ones we have right now, the question of less
intrusive means or least restrictive manner has been an important
criterion in the courts. For example, in the drug testing cases,
the courts have often asked if there is some other way the
employer could tell whether or not people were taking drugs. Can
you just look at the people and figure that out or is testing

427

 

 
 

 

really the best way? I think absolutely that would be one of the
major issues in evaluating constitutionality of AIDS testing.

JUDGE STARR: I would simply add that without
expressing an opinion but just in looking at the opinions that
have come out to date, in the drug testing area, as Professor
Merritt knows, it would be difficult to exaggerate the importance
that the courts thus far have placed on the totality of the
situation. It is very much, if you will, an holistic analysis.
It is a very non-mechanical analysis. I think it would be a
mistake to elevate any single factor in the equation and place
the spotlight of importance predominantly on that factor, but it
certainly is true that the courts are vitally interested in
whether there are efficacious alternative means that would, in
fact, warrant a lesser intrusion.

On the other hand, the courts would, it seems to me by
reading the cases, be quite sensitive to a governmental statement
to the effect that this is, in fact, a very efficient, effective
way of achieving an important governmental interest and we have
taken individual liberty interests fully into account ina
variety of ways, even if there might be, in theory, a less
restrictive or less intrusive, I should say, way of going about
the process.

MRS. GEBBIE: That is helpful. Thank you.
CHAIRMAN WATKINS: Dr. Lee?

DR. LEE: Mr. Chairman, dealing with three witnesses
like this lends an atmosphere of danger to our proceedings. It
is like being in the Roman amphitheater with three lions, you
know, the slightest wrong move and it is curtains.

First, a note. You made a terrifically interesting
point which I have been dwelling on, and that is that, of course,
Shakespeare never said anything. It is one of his characters
that said these things. That is a mistake I will never make
again, but from my point of view, it almost seems like we are
getting anarchy with the lawyers. De Tocqueville said that we
were going to disintegrate from within. One of the things that
we have seen in this Commission is that drug abuse may make us
disintegrate from within, and a breakdown in our system of
justice will clearly make us disintegrate from within.

I have two major questions which I hope all three of
you will address. First of all, fourth amendment issues seem to
always revolve around reasonableness or unreasonableness. There
are other vague limitations that crop up when you are talking
about the fourth amendment like this business about a clear and
present danger. Is there any way that you see this at an
approach to the AIDS problem? Can you balance the clear and

428

 

 

 
 

 

present danger against the fourth amendment? How do you see
that? Or is it just, who can?

MR. SMITH: Holistically.

DR. LEE: It is impossible? You see, that is one of
the things that we have to face, though.

MS. MERRITT: No, I am not sure it is impossible. It
is, of course, difficult because these are difficult issues.
Maybe it is easier to talk about specific programs. We have been
talking very generally about the fourth amendment and mandatory
testing and it is hard if one does not focus on a particular
program. Take, for example, a proposal to screen all prisoners
for infection with the AIDS antibody. I would feel ‘fairly
confident in saying that, if the program has the sorts of
safeguards I described before, that is, we use the standard
medical protocol for testing -- the ELISA test, followed up by a
confirmatory test -- if we have some provisions for
confidentiality which will be very important in the prison
context because it is very hard to keep things secret in prison,
if we are not picking prisoners in an arbitrary manner, I suspect
that the courts would uphold the constitutionality of screening
prisoners.

There is a very strong deference to prisons. In the
case of drug testing, the courts have shown that deference.
There are special concerns about security and about safety in the
prisons. The state has a special interest in protecting
prisoners from being infected by others.

The only real question that I think courts would raise
in the prison context when one is talking about testing is what
do you plan to do with the results since obviously simply testing
the prisoners does not solve the problem. The state must show
exactly what it plans to do with the results. That is, does it
plan to have the prisoners then put into prisons that will have
more or less equal facilities? Does it plan to counsel those
prisoners who are infected? Does it plan to give them condoms?
What is the state’s plan?

If that sort of question can be answered, I would think
that kind of program, if you look at all the factors that you
talked about, and I agree very much with Judge Starr that it is a
very holistic approach, the courts look at a dozen or more
different factors, it would be quite likely to survive review.

Other types of programs might be less likely to survive
review. For example, a mandatory program testing all pregnant
women for the AIDS virus. There, some of the factors tend to
point the other way. We have a very intimate aspect of life
protected specially by court decisions, the right to bear

429

 

 
 

 

children; we have a low risk population where if we are talking
about all pregnant women in the country, we will have very few
who are really true positives. All the problems remain of a
higher number of false positives. In addition, we have a
tremendously pressing question of what do we do with the results.
Surely, once the woman is pregnant, the state is not going to say
now you must have an abortion. I cannot, for policy or
constitutional reasons, imagine any legislature saying that so
then the question is what do we do? Well, we can counsel the
woman, but, of course, we could offer that counseling without
having the mandatory test either, and this might be a case in
which the courts would look at the less restrictive means, the
fact that pregnant women as a whole tend to do what their doctors
ask them to do, and if we left this matter to the doctors and
their patients, we probably would get as much testing.

So that is an example of how the factors might be used
without knowing for sure how a court would turn out. But if you
take all of these different factors and try to apply them in a
particular context, it does become easier than talking in
general, reasonableness terms.

DR. LEE: Judge Starr, does a fatal widespread epidemic
illness represent a clear and present danger, and does that
override the fourth amendment?

JUDGE STARR: I will respectfully decline to opine
specifically but let me share some general thoughts on that. For
one thing, I must say that the notion of clear and present danger
is a very familiar one to the bench and the bar and to the public
generally. We associate it with first amendment analysis. That
is to say, in light of the basic protections in a democratic
society envisioned by the first amendment, before there can be a
prohibition, substantial curtailment of speech, there must, in
fact, be a clear and present danger. That has not been the test
in the fourth amendment area as to whether a governmental
intrusion is justifiable or not. It is not the law, at this
stage at least, that government must establish a clear and
present danger in order for it to take a particular, intrusive
sort of action that would constitute a fourth amendment event.

In fact, the fourth amendment itself, in the part that I did not
read, articulates this legal standard of probable cause which, in
the law enforcement setting, every police officer on the beat is
familiar with. That police officer, he or she, must have
probable cause to take a particular kind of action and the like.
So there is a less daunting standard than a clear and present
danger.

But it might be helpful at getting at this if I shared
with you very briefly a couple of examples from the courts in
this closely analogous, albeit different area of drug testing.
In one, the testing program was upheld, in the other, the

430

 

 
 

 

program was struck down. Why the difference? Although they did
come out of different courts why the difference? In looking at
those cases, one principal difference that emerges is that the
system that was upheld by the Fifth Circuit in New Orleans was a
very carefully crafted, albeit mandatory, testing program. There
was a clear establishment of the government’s interest. Here is
why we are interested in having these test results. Here is why
we need these test results, this being the Customs Service’s
involvement in drug enforcement. That was the basis of the
Agency’s interest there.

There were also safeguards in place so as to minimize
the intrusion. And my colleagues have rightly said these
testing programs obviously do involve intrusions. They are
fourth amendment events, but there were, in fact, safeguards in
place in that program so as to minimize the extent of the
intrusion, the personal embarrassment and the like. It was
carefully crafted.

The program in contrast that was struck down was not
the result of a careful administrative process. It was a good
idea that the police chief of a particular community had, and was
executed in a rather intrusive and indeed rather heavy handed
manner. There was no involvement by the political process which,
again, the courts, and I am sounding again a slightly different
chord than Professor Smith, there was no indication that the
political branches, the legislative branch or the executive
branch at a policy making level, had in fact sanctioned this
activity, the head of the department and the like at a meaningful
level. No action by the state legislature, no action by a city
council. It was simply done.

Now, I do not want to suggest that action at the
highest levels of the political branches is necessary to
withstand fourth amendment scrutiny but I do want to emphasize
that it is very helpful in this entire equation that courts will,
in fact, look to.

MR. SMITH: If I could just, I think the fourth
amendment question is going to be favorable to allowing testing
as long as it is a reasonable exercise of police powers to
prevent public health epidemic which goes to the point of ~looking
very carefully at the medical public health risk and if it is a
reasonable or potential risk, I think the courts are going to
show a lot of deference.

The point that I wanted to come back to was this
business of statutes or court cases, the kind of careful,
multi-factorial, holistic balancing that applies to fourth
amendment really ought to apply to most of these questions. When
you get a statute on the books, then you have to engage in this
search for legislation intent, sort of a Hemanutic,

431

 

 
 

 

will-of- the-wisp, what did the legislature think even though they
may not have thought about it.

For example, in AIDS, in California, the Barlow case, a
demonstrator in a gay rights parade bit a policeman, was
arrested, said he had AIDS, and the court tried to order his test
result, or his being tested. The court was handcuffed because
the California legislature passed a statute saying you could not
disclose test results. Well, in Tennessee, we did not have a
statute and the court ordered the prisoner tested so the statute
can be both a shield or a sword and in a way, the court can
handle the case and balance the equities if there is a statute
and then we do have to look to what our political representatives
wanted to do, even though they may not have thought about the
question before them. But on this question, I think that
hospitalized testing for all patients between 15 and 65 has a
good chance of withstanding the constitutional scrutiny. The
testing of people with marriage licenses has a good chance of
withstanding constitutional scrutiny, depending upon the medical
health risk, and I think that is a very tough question about
whether we should have such laws because those are close issues,
but I think the courts probably will sustain those if I had to
bet.

DR. LEE: Could I get into one other area? We heard
testimony the other day about the Supreme Court decision on
whether contagiousness is a part of 504, and we have this problem
with the Department of Justice and the Executive and Legislative
branches which do not seem to like that Supreme Court decision
and there is machinery to question it. Is the Supreme Court
decision the law of the land? What happens in your system when
somebody does not pay any attention to it?

_ MR. SMITH: That is a good question for the Judge, but
I just want to add one thing. The Supreme Court in the Arline
case decided the question of contagiousness under Section 504 in
a tuberculosis case, and wrote a footnote, as you are aware,
saying we are not deciding AIDS or HIV for the reason that
different facts may call for different results. The logic of the
opinion would suggest, most commentators, and, in fact, was
applied, I believe, by the ninth circuit in the Chalk case that
persons with AIDS are handicapped because they are disabled and a
person with AIDS should fall within Section 504 and most states
have interpreted their handicapped statutes along that line.

The question is whether HIV positive status, mere
infectivity constitutes a disability or a handicap or an
impairment within the meaning of the statute. That is a legal
loophole, a lawyers’ argument which somebody who does not want to
extend civil rights protection to HIV positive persons can seize
upon, whether the United States Supreme Court will determine that
HIV positive status is a handicap gets into lots of questions

432

 

 
 

 

about perceptions and being perceived as handicapped and
reasonable minds can differ, but I do not think it is fair to say
that the Supreme Court’s decision in Arline decides the issue of
contagiousness as a handicap in all settings because of this
difference between actual impairment now versus future
impairment.

JUDGE STARR: To respond to the specific question, when
the Supreme Court renders an interpretation of a statute, then
that is indeed the law of the land. Congress can change it, we
see the movement with respect to the Grove City decision which
was not a constitutional decision but rather the Supreme Court,
as authoritative interpreter of the law, and in this instance,
the statute, so what the court said in Arline is what this
statute means. If, in fact, the executive branch is unenamored
of that interpretation, if the Congress of the United States
finds it not to its liking, then Congress can quickly take or it
may take some time, take corrective action. I can cite a
personal experience in that respect. I authored an opinion for
my court, interpreting one aspect of a statute and it had quite a
major consequence on a major business transaction, and it took
the United States Congress 27 days to overrule my decision, not
to say that I was wrong but simply to overrule to change the law.
So until such time as Congress sees fit to act differently, if
you will, in the rehabilitation act in Section 504, then Arline
is the law of the land, but with the possible gap as to which
there will, I am sure, be further litigation.

MS. MERRITT: The most important fact about Arline is
that it does not decide any of the really important issues
because Section 504 does not mandate treating handicapped
individuals exactly like nonhandicapped individuals. It says
that otherwise qualified handicapped individuals must be treated
like nonhandicapped ones, and I think the Supreme Court remanded
to the lower courts to develop standards on what we mean by
otherwise qualified in the context of a communicable disease.
But I suspect very strongly that a teacher, for example, with an
active case of tuberculosis that could be communicated to
children in the classroom, would not be considered otherwise
qualified for the job. So I do not think there should really be
too much problem with saying that people who have diseases,
whether communicable or not, are handicapped and are covered by
the statute. That does not really get to the important
question, which is whether they are otherwise qualified. That
is where the courts would take into account the public health
risks.

MR. SMITH: The Supreme Court, though, did adopt the
American Medical Association’s recommendation on how to determine
what constituted otherwise qualified and with respect to a
disease and since AIDS is not an airborne disease, presumably
someone in employment who was HIV positive in an office setting

433

 

 
 

 

 

would be otherwise qualified to work so if the law does apply to-
an HIV positive persons, it pretty much would extend its
protection, but that is sort of a question that the Court did not
want to address.

DR. LEE: Thank you very much.
CHAIRMAN WATKINS: Ms. Pullen.
MS. PULLEN: No questions.

CHAIRMAN WATKINS: Dr. Walsh?

DR. WALSH: Yes. I ama great believer in the last

shall be best, and if I heard you all correctly, I am kind of
pleased that the three of you are legal specialists and you are
cautioning us against rushing headlong into recommending new,
federal statutes and so on which is very close to my own heart
because, for many reasons, not only philosophical but because I
do not think we know enough yet about this disease and where it
is going.

In the definition of mandatory testing, which is a
problem for this Commission, I mentioned earlier that a term used
in Hawaii of conditional testing be put on the horizon. Would
there be a difference in the legal interpretation if say as part
of your contractual obligation to buy insurance, you have to
take an HIV test if you want to buy more than $50,000 worth or
$100,000 worth? In other words, would that be considered
mandatory testing or would that come more under contract law or
contract law interpretation? That is one question. Want to
answer that first?

MS. MERRITT: I think the question really is does it
raise constitutional issues. If it is done solely by private
parties, there are no constitutional issues at all whether you
call it mandatory or conditional. The only time you would get a
constitutional issue, either a fourth amendment issue or another
constitutional issue, in the scenario you are talking about is if
the state passed a law saying all insurance companies should
test. If the insurance company does it, there is no
constitutional issue.

DR. WALSH: Now, along the same line, what will be the
fate of the people in the District of Columbia who cannot buy
life insurance because the District of Columbia Council chose to
pass a law emotionally really because anyone that was HIV
positive could not buy life insurance without a test, even though
those who wanted to buy life insurance were willing to take a
test so they could purchase it. The result has been to drive all
the life insurance companies out of the District of Columbia.
Will that law last if somebody chooses to bring a suit?

434

 

 
 

 

MR. SMITH: Well, that law, that was the other side of
it. That law was challenged constitutionally as a violation of
the insurance company’s due process rights. Now, once again, the
courts did what Judge Starr has suggested and gave wide sway of
deference to our publicly elected authorities with the result
that there is no life insurance available in the District of
Columbia. It is not altogether certain that every state, if a
state constitutional challenge were brought as opposed to a
federal court constitutional challenge, it is not certain that
every state would say that is constitutional. But for the most
part, it probably would be constitutional.

DR. WALSH: And that is not an unfair infringement of
the 95 percent of the people who do not have AIDS?

MR. SMITH: I would argue it is unconstitutional and it
does violate due process but I would probably apply a stricter
level of judicial scrutiny that the federal courts would. The
federal courts, when it comes to a due process review, are
extremely deferential with economic regulation. As long as the
legislature is not proven to be on drugs, they will sustain the
legislation. Under, well, we just happen to defer it to the
legislature. But if you start looking at, a state court, some
state courts, have sort of sailed out on their own, and applied a
more vigorous level of judicial scrutiny with respect to due
process claims including economic due process claims, listen, you
are destroying the insurance company’s right to make a living and
sell insurance in D. C. and you ought to show some reasonable or
Significant justification. The court did not get into it.

DR. WALSH: Would it have a better chance if someone
who is denied the opportunity to buy insurance filed the suit and
said it is not the insurance company he is worried about, it is
himself and his family.

MR. SMITH: It is a more appealing case, but the legal
principles --

DR. WALSH: Would be the same.
MR. SMITH: Are the same.

JUDGE STARR: I would just add, if I may, if you would
permit me, that the courts have, over the years, developed the
phrase rational basis. If there is a rational basis for the
statute, then the courts will not strike it down on due process,
substantive, if you will, due process grounds. The idea is that
the courts are not to be in the business of fashioning public
policy. That is for the legislature and even if the courts feel
profoundly that the legislation is unwise, if there is a rational
basis for it, it would be sustained.

435

 

 
 

 

 

DR. WALSH: Now, a second question, I have two or three
but they are all simple ones. One of you commented, I think it
was you, Ms. Merritt, that because of the threats of
discrimination and the like, that information related to HIV was
extremely significant and had some basis for maintaining
confidentiality to a very strict degree. Was this information,
in your opinion, more significant than information used to be in
the test for syphilis. I mean this had the same stigma before it
was treatable and the same superstitions. You know, people
thought you could shake hands and get syphilis and one thing or
another. Why is the statute different?

MS. MERRITT: It is not different. In fact, there are
very strict confidentiality statutes with respect to testing for
syphilis, and if the same sorts of statutes were adopted with
respect to AIDS, they would go a long way. That is how we
actually managed to combat syphilis in this country, I think, by
having a combination of public health efforts. There were
medical advances with a cure for syphilis, there was contact
tracing, and there were very strict confidentiality statutes.

In fact, the statute is so strict, there is a New York case, for
example, interpreting their statute where the person who,
herself, went into to be tested, wanted to have the test result
released publicly because she was involved in a law suit where
she was suing somebody who had raped her and she wanted to prove
he had given her syphilis. They refused to release the result
publicly, even at her own request, because the public policy is
so strong that in order to conquer syphilis we have to have this
confidentiality protection.

DR. WALSH: Yes, but if you had denied a marriage
license after having the test, the confidentiality is blown, is
it not?

MS. MERRITT: Not necessarily. The state does not
publish the fact that it has denied you a marriage license.

DR. WALSH: But one of the two of you know, and
families would know.

MS. MERRITT: Sure, and when speaking of
confidentiality, I do not think that any of us mean that
confidentiality would overrule, for example, a warning that a
doctor would give to a patient’s spouse if the patient had him
or herself refused to tell the spouse. We are not talking about
absolute confidentiality, but the sort of protections that
prevent employers or other people -- busybodies on the street --
from knowing.

436

 

 
 

 

DR. WALSH: Is the anonymous testing program being
carried out by CDC in 30 or 40 hospitals in any way in danger of
being accused of a violation of informed consent?

MS. MERRITT: I would not think so, although I do not
know much about the specifics of the program.

DR. WALSH: Well, they just picked 40 hospitals ana
they are doing anonymous testing of routine hospital patients.

MS. MERRITT: Oh, I am sorry. I see. I thought you
meant the alternative testing.

DR. WALSH: No, I wondered whether that, I personally
hope it is not threatened but I am just curious. When you talked
about informed consent, whether some patient could bring a suit
on that basis.

MS. MERRITT: Probably not because the samples are not
identified to the individual. As I understand it, the blood is
drawn for other reasons, and then we would just take a random
sample of the blood and we would remove all of the identifiers
and we do this solely for epidemiological --

DR. WALSH: Is there any obligation, though, on the
part of those that you find are seropositive? Is there
anyobligation on the part of the hospital to inform the patient
that indeed he has become seropositive?

MS. MERRITT: Well, by definition the hospital cannot
do that because in order to conduct this testing program without
running into informed consent problems, --

DR. WALSH: Oh, I mean, then would CDC be obligated to?

MS. MERRITT: You have to have destroyed all of the
identification so that there is no way.

DR. WALSH: Okay. Now, finally, my last question. You
were talking about the reasonable departure from the rules of
confidentiality if public health risk is involved. Could you
answer my question to which I have gotten no answer all day as to
what bearing would this have on the seropositive patient who
knowingly rejects behavioral change and continues to behave in a
promiscuous fashion? In other words, is that a reason to
digress from the rules of confidentiality without informed
consent?

M8. MERRITT: I would think that that would be a reason

to do something, whether it is to counsel the patient further, to
try and get that patient to change, or it is to contact a spouse

437

 

 
 

 

or another known identified person who is at risk. Or even in
the extreme cases, I think Professor Smith mentioned earlier,

we do have and have had in the past statutes dealing with
recalcitrant patients in the tuberculosis context and in other
contexts and if somebody continues to put the public health at
risk and will not modify their behavior, we can even isolate that
person. Now, in a lot of states right now, we do not have clear
legal standards with respect to AIDS, and that is why I suggested
it might be a good idea to think about those standards -- when
the doctor should have a duty to warn and that sort of thing. I
personally would not see any problem with that.

DR. WALSH: Do you have any comment on that?

MR. SMITH: I would agree that the first step is to .
encourage people to warn, etc., but if you have a non-compliant,
non-cooperative patient, then civil liberty issues seem to pale
with respect to the clear and present danger.

DR. WALSH: This may be one of the things that will end
up in court and the rules will then be made after the fact.

MR. SMITH: Well, there probably would be a proceeding
but that is probably how it should be handled because every case
is --

DR. WALSH: No, I am in sympathy with that. I hate new
laws if we can avoid then.

CHAIRMAN WATKINS: Dr. Crenshaw, you have a follow up
question?

DR. CRENSHAW: The San Diego case you referred to about
the police officer who was bitten? Just a point of interest, I
was involved in that case, and eventually there was an injunction
of ‘some means by which the person who bit the police officer had
to be tested against his will. However, it was against the law
for the public health department to tell the police officer what
the results were.

MR. SMITH: Okay, that is it. They could not release
the results because of the statute.

DR. CRENSHAW: Exactly. One point of curiosity,

following up on Dr. Walsh’s point. You mentioned earlier, Mr.
Smith, that if someone was infected, had spots, even if they had
not been tested and knew that they had reason to know that they
were ill and continued to have sexual partners, that would be
cause for concern. Somebody who has had a few sexual partners
who have become infected but someone who does not want to know
and who states that they do not want to know because they do not
want to confront all the changes to their life and the ethical

438

 

 
 

 

issues of continuing to have sex. Where does something like that
fall?

MR. SMITH: Well, it is once again this amorphous,
common, reasonable person of the common law. I suppose a person
could continue to engage in sexual activity even though there is
a possibility that they are positive without being held liable
under civil tort law for negligence. And there is another
problem with respect to, suppose they did infect somebody and
then the person who was infected sued the infected person, there
might be some defense of contributory negligence or assumption of
the risk in that you did not use the safe practices, etc., but
the answer it there is a moral and ethical obligation to be very
concerned and find out about your status if you have reason to
suspect you may be infected, and that might arise to a legal duty
to where you could be sued if it was reasonable to assume that
you might be infected.

There are, I do not think you can rely on the tort law
however to stem the epidemic. These tort suits that come up here
and there are going to do nothing to prevent the spread of AIDS.
You could pass a law saying you will be liable, all persons who
pass along AIDS through the use of intravenous needles can be
sued in tort or, you know, that is not going to stem the spread
of AIDS. I mean, it is a nice, moral slap on the hand, it is a
reaction, it is a good one, but it is not going to stop the
epidemic. You have got to do education and counselling and
research. Those are the things that are going to solve that.

CHAIRMAN WATKINS: Dr. SerVaas, do you have a follow up
question?

DR. ServVAAS: Yes. My question is to Ms. Merritt, and
it has to do with a statement you made about mandatory testing.
You were listing the kinds of mandatory testings that you thought
maybe could be or could not be conducted without legal
ramifications. While you were talking about the mandatory
testing of pregnant women, you said you thought that there would
not be any purpose because obviously she is already pregnant. I
agree with everything but I wonder whether you would want to tell
the man in your life so that he could take care of you and not
become infected with the AIDS virus if you had not already
infected him? Would that not be a reason?

I have another question. I am just curious to know of
how you feel about the mandatory marriage license testing and
whether there has been any kind of referendum or any kind of
surveys in Illinois to find out what the public in Illinois
thinks about it. The reason I want to tell you that is that we
did do a survey of 11,000 we questioned. The question we asked
was do you believe that all who apply for marriage licenses
should be tested for AIDS. The answer, of 11,000 people, 90

439

 

 
 

 

 

to

_percent said yes they did believe that. Seven percent said no
and three percent had no answer. - I am not telling you that I am
’ for any kind of mandatory testing which I have gone on record
always as being against but I want to know what you think. Do
you have any surveys or referendums in Illinois that tell you
what we the people think about testing for marriage license
applicants? ,
MS. MERRITT: Well, to go back to your first question
first, on the testing of pregnant women, it would be a reason to
test pregnant women to find out if they were infected so they
could tell their spouses, but it is not a reason that applies
particularly to pregnant women. That would seem to be a reason
to test everybody in the population and the question is whether
or not it is worth doing that, given the low rate of infection in
the population as a whole, the fact that you have to keep testing
every six months and those sorts of questions that I am sure you
have discussed before. In the pregnancy setting, that is a
rationale that applies to everyone.

I will say about pregnancy that I do think that in fact
doctors and patients are beginning to ‘test solely on a private
basis. I know that in my clinic, doctors have decided to test
all women. They can, of course, refuse to have the test.

To move on to your second question about premarital
testing, Representative Pullen is your expert on the Illinois
situation since she is a member of the Illinois legislature and
she could tell you much more accurately than I could what went on
in the legislature, and, in fact, about polls from Illinois. I
am sure that there are some, but I do not have any figures in my

own mind as to what people in Illinois think about the marriage
license testing.

DR. ServVAAS: I could not tell the way you explained it
how you felt about it.

MS. MERRITT: About how I felt?
DR. ServVAAS: That is really what I wanted to know.

MS. MERRITT: My feelings about premarital testing are
rather mixed. At first glance, it seems to be a relatively easy
step to take. After all, we already draw blood in most states
for syphilis. Why not test for AIDS as well? In addition, we do
have a risk of transmission in marriage. It is not like food
handlers and we do know that sex and also giving birth are ways
of transmitting AIDS.

The problems with the premarital testing, and I am sure
you may have heard some of these points before too, are first of
all, the questions that people still have about the rate of false

440

 

 
 

 

positives. I have heard, I have looked at the medical literature
and seen estimates ranging from one in every, and this is a
combined false positive rate if one uses both the ELISA test and
the Western Blot, the estimates for false positives range from
one in every 1,250 to one in every 100,000. There is a broad
range of values there. If you test 1.7 million people each year
who are getting marriage licenses, then you get false positives
ranging from 17 which is a relatively low number to 1,360 which
is a fairly high number.

You also have a greater number of people who are in the
ambiguous middle position who have a positive ELISA test. There
is also work that suggests that on the first ELISA, if you test
the premarital population, as many as 50 percent of the
positives may be false positives who then are ruled out by the
Western Blot. I sort of wonder what those people and their
potential spouses think about having had one’ positive test and
one negative test. So you have a serious problem in terms of the
kinds of psychological burdens you are imposing on people who may
be false positives or sort of halfway false positives who do not
know what they are doing. And as I am sure you have gotten from
the statisticians before, that is a greater problem when you test
low risk populations than when you test high risk ones. You have
not heard about that?

DR. SerVAAS: No.

MS. MERRITT: Well, the statistics, you can show it all
on a blackboard but if you test the high risk population, most of
the positive results will be true positives. As you test the
lower risk population, a greater proportion of the positive
results become false positives. I could work it out for you on a
blackboard but there is not one here. That happens to be the way
it works up so I think it is a troubling case for that reason.

DR. SerVAAS: I think it is troubling that we do need
to educate people never to take an ELISA result and we have been
given testimony from two different sources where 580,000 very low
risk people were tested and not one false positive. I think we
have pretty much debunked a lot of that fear of false positives
but it has not caught up with all of the experts.

MS. MERRITT: One final comment about the marriage

Situation is that there are other alternatives other than simply
going to mandatory testing. I think somebody asked before about
less) intrusive alternatives, and I know that there will be people
in the country who will feel it is another example of government
getting on their back if they are mandated to take a test. There
are some states now, I think California requires all marriage
applicants to read and complete themselves a questionnaire that
will reveal to them whether or not they are at high risk and then
counsels them both in writing on the questionnaire and orally

441

 

 
that if they feel in any way that they are at risk, they owe it
to themselves and their partners to have a test before getting
married. That sort of counseling, specific counseling which can
be done even in a somewhat written form perhaps with the
marriage license might be one step to try first before going to
the more intrusive measure of mandated testing.

CHAIRMAN WATKINS: Thank you, Ms. Merritt. Dr. Lee?

DR. LEE: Could you clarify one point? Dr. Walsh heard
something different than I heard and this is a relatively
important point for us so please clarify it. He said, are you
cautioning us against passing additional statutes?

DR. WALSH: Federal statutes.

DR. LEE: Federal statutes. And I thought I heard
Judge Starr say that he had the greatest respect for any
legislation and that it had a profound effect on how he conducted
his business. This is quite important for our report and so
forth. Could you clarify this?

JUDGE STARR: Well, I am not here to recommend
anything. I think if I understood Dr. Walsh’s question, he was
suggesting do not rush head long. What I tried to convey was
that the courts are keenly interested in the results of the
deliberative process. It is presumed, of course, that the
legislative process is a deliberative and careful process. The
courts are willing to presume that. My point was that if there
is, in fact, a statement in the form of law from the political
branches, or a considered judgment by the executive branch at a
significantly high level, then that judgment of the political
branches will garner the respect of the courts. It does not
necessarily mean it will eliminate constitutional concerns but it
certainly will weigh heavily in the balance as a sign of the
non-political branches’ respect for the political process.

DR. LEE: You see, we are caught in our final report as
to whether we will or will not recommend that the legislative
body look at certain items. The alternative is to let it pass,
disregard it.

DR. WALSH: That is not true.

DR. LEE: Well, what is the other alternative?

DR. WALSH: That is your conclusion, Burt, that is not
true.

DR. LEE: What is the alternative?

442

 
 

 

DR. WALSH: That is not true. The alternative is to
observe what has happened at state legislative efforts and make
efforts to determine what the success has been, what the
Challenges have been, what controls of successes have resulted,
before you rush head long into federal legislation. Federal
legislation is much more difficult to modify or remove once
passed, and has much greater implication I think. So I do think
there are alternatives. I just do not feel that as conscientious
as we have been in our hearings, that in nine months on a subject
this complex, we are yet in a position to recommend federal
limiting legislation or federal legislation of any kind. That is
all.

MR. SMITH: I think, if I may just offer one point, the
notion of state legislatures as being a laboratory in the
experimental process in working things through is one of the
major strains in the law for allowing state legislatures to
experiment and try to work things out before federal legislation.
They have been trying to pass federal product liability
legislation for years and it has been defeated. There are all
kinds of, and medical malpractice legislation at the federal
level, there are certain very significant advantages to federal
legislation that overrides and Supersedes contrary to state law
and is a supremacy clause point.

So, for example, if you really decide as strongly that
one or two particular things just had to be uniform and had to be
set and had to be moved on now, then federal legislation would be
appropriate. One of the issues is a question about employment
and housing and applying the handicapped laws specifically to
persons who have AIDS or HIV status, and federal legislation
there would, for example, after the Arline decision, Tennessee
amended its state statute to exclude from the coverage of
handicapped communicable diseases. They just said no. Under our
law, under our state employment discrimination law, a handicap,
the term communicable diseases is not a handicap and they
directly went against the Arline opinion so you are having a lot
of shaking out but the larger question of a statutory solution to
these problems is that when you get into state tort law and how
to handle these balancing problems, federal, it is different from
state, although statutes themselves have advantages. You have to
sort of ask if it is going to federal legislation or is it going
to be statutes at the state level and there is a little
difference there. But I might be in favor of certain things at
the federal level but on the whole, a lot of these things do not
need necessarily statutes.

DR. LEE: One of the things that repeatedly comes up
for us, though, is that this is not a state’ problem. It isa
national problem. AIDS walks. It is an international problem so
that just like your state liability stuff and state drug laws and
state discrimination laws, etc., etc., do have their limitations

443

 

 
 

 

and this many, many, many witnesses have, if there is one thing
that I have come away with, is why does your President not do
something, what does your government not do something. This is
the type of other side of the coin. I understand Dr. Walsh’s
opinion but the other side of the coin has been expressed here
vehemently.

MR. SMITH: Well, as Publius said, delay is hateful but
promotes wisdom.

CHAIRMAN WATKINS: I have asked the Executive Director
to clarify one point for the record because I am a little bit
confused on what was said.

MS. GAULT: On a number of issues, this Commission is
going to have to make recommendations about whether there should
be changes to state statutes or federal statutes and so it is
important that this panel’s relevant testimony not be
misrepresented. I would therefore like to go through the list
of these issues so that this panel’s positions are made clear.
If you do not feel comfortable responding right now, you may
respond in writing.

The first is federal laws on anti-discrimination
against those who are seropositive. The second is some type of
federal law on confidentiality or some type of federal law
encouraging states to do something in the area of
confidentiality. The third is a federal law affecting federal
funds for states which did or did not have contact tracing laws.
This is an issue that we will have to face at some point soon.
The fourth is some type of federal law, perhaps a withholding of
funds, which did or did not encourage states to enact criminal
statutes related to the transmission of HIV.

All of these are issues that we will have to either
take an affirmative position on or a negative position on and I
think it would be helpful for us to get your position in writing
on these particular issues.

JUDGE STARR: Well, I can be very brief and say again,
it is not my position or would not be appropriate for me to make
any recommendations of any kind.

MR. SMITH: I think that I would say that with respect
to the last, withholding funding from states that did not pass
criminal statutes. I think there you are talking about a carrot
and stick approach of federal incentive, using the spending power
to encourage state legislation on criminal statutes. I think
that the states are already moving in this direction and do not
need a lot of encouragement and that is a marginal benefit in
curing the epidemic.

444

 

 
 

 

With respect to contact tracing, I think that is pretty
much already in place in a number of ways, and if federal
legislation is necessary to encourage contact tracing, so be it,
but I question whether it is really necessary because I think
states for the most part, as I Say, under the CDC grants,
sexually transmitted disease grants, they have got to do it
anyway so you have got to decide whether it is really necessary.

On confidentiality, AIDS test results are confidential.
They are part of the chart, they are part of the file. They are
confidential. Whether you should have any special rules
regarding HIV status, I do not think so. I do not think you need
that. With respect to penalties for disclosure and an additional
federal remedy for invasion of privacy or something of that sort,
I think state laws are already there. If it is really found
wanting, and maybe a federal law there. The one area that you do
need some guidance on is this gap in Section 504 and gap in state
employment and housing laws where civil rights is a gap and there
are not state laws that are good in that area, and that would be
the one area where there might be a need so that one is worth
considering.

CHAIRMAN WATKINS: Would you put that, Mr. Smith, in
the context of the Mowery case in East Tennessee, the latter
statement you just made. Where would you see it going there?

MR. SMITH: A federal statute prohibiting
discrimination?

CHAIRMAN WATKINS: No. I am talking about the Dwayne
Mowery case here in Eastern Tennessee.

MR. SMITH: The student? \

\
CHAIRMAN WATKINS: Right. Where would you put that?
That is up to the state, as I understand, and this is one state
that does not seem to have --

MR. SMITH: Our laws are not particularly helpful
there, although I think under the education laws, you might have
been, well, I think the state medical records laws and breach of
confidentiality, if it could be proven that his\medical status
was released by school officials under the education law, you
might be able to state a Claim, but we would have\a problem under
our state laws there. I think you would, in order\to remedy and
protect that fellow, that young boy and others like him, you
would need to have a stricter state confidentiality law, a
specific cause of action which may or may not be needed at the
federal level. \

’

\
\

445

 

 
 

 

 

CHAIRMAN WATKINS: Do. you sense that there isa . .
proclivity in Tennessee to move in that direction as a result of
the lessons learned out of this case?

MR. SMITH: Yes, I think there is. But the Tennessee
state legislature, after the Arline case, the first thing they
did was say, well, the federal, the United States Supreme Court
says that communicable diseases fall within the definition of
handicapped. We say no, and it is debatable whether our amended
state employment discrimination statute would not apply to AIDS
put I think that a federal law that set up just as Section 504
reads, to apply that to HIV status would clarify the law, and
then secondly, if you had a specific statute, I think isn’t it
Representative Waxman has a statute.

CHAIRMAN WATKINS: ‘So you are recommending to the
Commission that perhaps there needs to be a clarification.

MR. SMITH: Yes, I do think there needs to be a
clarification on Section 504 and AIDS and HIV. That is number
one because the courts are divided on this, and there really is
some dissent on that legally and a recommendation would recognize
the need for that legislation and with respect to
confidentiality, if a doctor discloses confidential information
without a privilege, there would be liability under state tort
law, but a federal remedy I think would be very strong, effective
ana clear and would set a tone but I think number one, for the
Mowery case in Tennessee, you have to have discrimination.

DR. WALSH: Jim, may I ask a question please?

CHAIRMAN WATKINS: I would like to have Ms. Merritt
answer.

DR. WALSH: All right, when she is finished, I would
like to ask a question, too, of you I mean.

CHAIRMAN WATKINS: Ms. Merritt, would you answer?

MS. MERRITT: Sure. You are asking for my opinion as
to whether I think it would be a good idea to pass these laws,
not whether or not they are constitutional because I do not see
any particular constitutional problems.

MS. GAULT: Well, it had been represented that you were
opposed to any kind of federal laws.

MS. MERRITT: My feelings on the laws you suggest are,
on the last two you mentioned, the carrot and stick approach with
respect to criminal laws and contact tracing, I think I agree
with Professor Smith there that that is an area that has always
been very much a state domain, public health, contact tracing,

446

 

 
 

 

criminal laws for people who expose others knowingly to a
contagious disease. I think the states are also acting there,
either under their existing laws or with new ones, quite rapidly
to deal with that problem. I have just written a long article
about federalism and how important it is even today to maintain a
role for the states, and I think that is one area in which we can
safely leave the role to the states.

On the other two statutes, I do see more role for
federal involvement. Confidentiality, to begin with, I think is
perhaps one of the most important steps that anyone can take to
try to stem this epidemic because it is a way of encouraging
voluntary testing which in the end is probably the way we will
get most people to be tested. Even if we enacted mandatory
testing for everyone tomorrow, it would be a nightmare to put it
into effect and to really do it.

We are going to have to rely to some extent somewhere

on voluntary testing and confidentiality is the key to that, and
if we have some states that are moving in that direction but not
others, this is an area in which national uniformity could help a
lot. It is something that requires a lot of thought, how we are
going to draft that statute, and one would want to look at what
states have done and it is possible we are not even ready today,
we need to think about it for a few more months, but that is an
area for federal involvement.

Similarly, on discrimination, I think that might be an
area for federal involvement. It certainly has been in other
Civil rights areas, from discrimination against racial minorities
to the aged to women to people with handicaps. And again, that
would be a significant step towards controlling the epidemic
because of the effect it would have on people’s willingness to
come forward and be tested voluntarily and might fit in well with
that the states are doing in terms of contact tracing and other
sorts of public health protections. The question you will have
to face there is do you take the approach of Title VII which is
to have a federal anti-discrimination law that applies to almost
everyone except for small employers who are specifically excepted
or do you take the approach of the discrimination against the
handicapped, the Rehabilitation Act, which applies only to people
who receive federal funds, and is a much more limited kind of
statute. The reason that was done, I think, with the
Rehabilitation Act was a sense of caution. It was also done with
respect to school children because education is traditionally a
state domain and there was a sense of moving cautiously there.

It obviously, however, does not go very far in terms of
relieving the problem if the only anti-discrimination law on the
federal level applies only to those who receive federal funds. A
much stronger step would be to take the Title VII approach which
would apply to all employers with exceptions and in the AIDS case

\

447

 

 
 

 

 

perhaps there is not even a good reason for exceptions for
smaller employers. ~ .

CHAIRMAN WATKINS: Are you recommending that the latter
be something that we, the Commission, consider?

MS. MERRITT: I would recommend considering that.
Again, with discrimination laws, one would need to look at what
the states have done for suggestions. The states are marvelous
resources in this country -- Brandeis called them the marvelous
laboratories of research. There may be language in the state
tatutes that would be useful. It obviously deserves a lot of
thought, but those are the two areas in which federal
involvement would be acceptable.

CHAIRMAN WATKINS: Thank you. Dr. Walsh?

DR. WALSH: The question that I just wanted to raise,
you do understand, we do have to sometimes wash our dirty linen
in public because of the Sunshine Law, and I was not aware that
we were mandated to give opinions on the four suggested laws that
were suggested by Polly. I do not know where that came from in
the mandate, nor have I ever seen it in the mandate. I did not
mean to say that we should not consider in any way whether a
federal remedy on anything may be helpful or may be sought but I
think that even in those areas where Mrs. Merritt has indicated
we should consider legislation, she has made patently clear that
this is something that is going to take considerable time and
research. I am concerned as to whether this Commission has the
skill or the time to do such a thing and rather than do it badly,
my own inclination was to avoid it, that is all. And I do not
see anything in any mandate that we had that specified that we
had to have answers to the four points you raised.

CHAIRMAN WATKINS: Well, of course, we do have to make
recommendations to the President so that he may give advice to
his Cabinet members on legal matters relating to the HIV. This
js our charter. Whether we comment specifically with
recommendations or whether we provide enough information so that
advice can be given on legal matters is the issue.

DR. WALSH: That is all right. That is the only point
I am making here.

CHAIRMAN WATKINS: We are going to close out now. I

would like to have the final question with Ms. Merritt. You gave
us a very nice insight into one very specific testing program
involving prisons that you were postulating as a possible
scenario that would be legally unobjectionable. We have had
strong recommendations with respect to testing on entry into a
hospital or other similar environment for certain kinds of
medical treatment, either to protect those conducting very

448

 

 
 

 

intrusive operations or in the best interests of the patient in
terms of the health care that can be provided. Would you also
think that mandatory testing for HIV in specific non-emergency
cases where local medical, competent medical authority would
state is in the best interest of the patient or Clearly in the
best interest of the attending health care providers would be
legally unobjectionable? I want to get quite specific as you
wanted to be specific. Would you discuss that, from the same
context you did in the prison case?

MS. MERRITT: Sure. Let me just run through briefly
the constitutional factors, the arguments that one might make in
favor of such a program, mandating testing for hospital
patients. First of all, one already does much lab work in the
hospital so it is not perhaps an additional intrusion.

CHAIRMAN WATKINS: I am not asking you for all patients
necessarily.

MS. MERRITT: Right. But of some subset. There is
some possibility of transmission if we are talking about surgery
or other sorts of invasive procedures, and arguably there is some
diminished expectation of privacy which is a factor we have not
talked about here yet today but courts do take into account in
the hospital setting because the patient is voluntarily going
into the hospital. It is also a non-criminal setting which tends
to weigh in favor of constitutionality. We are not going to
punish the person if they are positive.

The arguments that would weigh against the
constitutionality, obviously we have all the heavy burdens that
we always have when we deal with mandatory testing of anyone.
Hospitalization for many people is not really a choice. It is an
emergency or it is something that needs to be done, not an
elective procedure. There may, in fact, be a high proportion of
false positives depending on the particular population we are
testing. If we are testing adults generally rather than simply
drug users or some group like that. There is a big question
about what steps exactly the hospital will take if the patient
tests positive. I do not imagine that we want to then tell the
hospital they have the right to refuse to treat the patient. I
assume we want to protect medical care for the patient so it is a
question then of what exactly, why the hospital is, how they are
going to use this information. It may be that as a practical
matter, doctors and nurses cannot treat all patients as if they
are infected and will take different steps with respect to
patients who are shown to be infected.

Those kinds of factors are what the courts would weigh
in deciding constitutionality. My suspicion is that the courts
would find it constitutional to mandate that. My question is
whether or not that is a law that is necessary because doctors

449

 

 
 

 

 

ti

have such a strong .bargaining position with respect to their
patients, this seems to me precisely an area in which hospitals
can be left to their own devices. "

CHAIRMAN WATKINS: Let me just add that the context
would be where there has been an inability to obtain that
permission from the patient. We were told in general that the
patient-doctor relationship is such that the individual will come
forward when it is found clearly in his or her best interest to
allow that test to take place. I am referring to the case where
that test was disallowed by the individual. Do you proceed with
the care? I think that came up in the San Francisco General case
from Dr. Lorraine Day. She would proceed with it, it was
difficult for me to see the difference between that and using the
proper protective procedures under all circumstances but

nevertheless, I am just trying to deal with that.

Also, considering possible downstream litigation,
suppose you provided an alternate procedure because you did not
get that permission and did not want to conduct the invasive
procedure that an orthopedic surgeon might have to go through
under certain circumstances? Would there then be liability on
the doctor for not providing the correct procedure? In other
words, I am just trying to explore a little more the legal
considerations related to mandatory HIV testing on entry into a
hospital.

MS. MERRITT: Well, again, it is a question of who is
mandating the testing. The point I was making a minute ago is
that I believe that probably if the government mandated the
testing.

CHAIRMAN WATKINS: No, the doctor I would think.

MS. MERRITT: Okay, that is what I was saying, is that
the government probably could do that but probably does not need
to. Hospitals could adopt their own internal rules that they
will not accept a patient who is not willing to be tested for
AIDS or aS a somewhat less restrictive alternative, the
hospitals could adopt a rule as my obstetrics clinic did, that
everyone will be tested if they agree to it, if somebody refuses
then they are assumed to be positive and are treated in that
manner. Doctors have, I think, a fairly high bargaining position
with respect to their patients. Despite all the talk about
patients’ rights, patients have to get into the hospital and will
tend to go along with whatever rules are there.

MR. SMITH: Mr. Chairman, may I respond to that just
briefly?

CHAIRMAN WATKINS: Yes.

450

 

 
 

 

MR. SMITH: I think there is a case, narrow category,
and you have picked a very narrow area where one can make a case
where universal precautions may not be so persuasive where a
specific surgical procedure involves, can be done a different way
more safely to those in the OR and consent would make a
difference in how you would do the procedure. The CDC guidelines
talk about that but they come out and say, get an informed
consent, this narrow area. The effort to expand that narrow area
to get around the universal precautions and to broaden testing of
all patients, all surgical patients, I think you have to sort of
raise an eyebrow at that, and ask, is the purpose really a
concern to do the surgery differently and better to serve the
patient or is the concern really to prevent infection and to not
treat the patient or to deliver or to refer or to avoid. The
comments of Dr. Day really are at odds with the statement that a
physician may not ethically refuse to treat a patient when an
epidemic prevails, a physician must continue his labors without
regard to the risk of his own health. There is a medical ethics
question about that little narrow area, but I think in certain
cases, narrow area of cases with respect to certain procedures,
it may be advisable to have a mandatory test done where it is
really necessary and efficient on the cost benefit. It is a very
Narrow area, and to sort of expand that to all surgical patients
and justify non-treatment is --

CHAIRMAN WATKINS: Well, I am certainly not proposing
that. I wish we had had the wisdom of you here, it was germane
to the discussion yesterday and I think it is important to
Clarify. Anyway, I do not want you all to leave with the feeling
that we do not think law abiding citizenry is a fundamental
underpinning of our society and if we had all the lawyers like
you three, then we would feel a lot better about the nation. So
let us leave it on that note, and we will close now. In closing
these hearings, I would like to thank all of our witnesses, not
only these but their predecessors for presenting the complex and
difficult issues of testing, ethics and discrimination clearly
and articulately over these past three days. They have been
extremely valuable hearings. You have raised enormously
important issues for our future response to the epidemic and
offered some options for humane solutions. The Commission will
maintain a continuing dialogue with all of our witnesses as we
would like with you to follow-up on questions that we were unable
to ask you today.

451

 

 
 

 

I would also like to thank my fellow commissioners here
for their patience and dedicated attention to these intensive
days of testimony. They have been some of the most intensive we
have held yet. So thank you very much, and thank you, Dr.
Conway-Welch, who is not with us right now. She and the members
of the Vanderbilt Stadium group here with security force and so
forth, have been very generous in allowing us to be at this very
special place for these hearings. With those comments, we will
adjourn the hearings. Thank you.

(WHEREUPON THE HEARINGS WERE ADJOURNED. )

452