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DUKE UNIVERSITY MEDICAL CENTER

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Department of Pediatrics
Division of Infectious Diseases

August 31, 1990

Dr. June Osborne

Dean, School of Public Health
University of Michigan

109 Observatory Street

Ann Arbor, Michigan 48109

Dear June,

The Third Report of the National Commission on Acquired
Immune Deficiency Syndrome was sent to me on August 20, 1990. It
is a comprehensive summary of a great deal of testimony presented
to the commission. Our first hand experience in North Carolina
substantiates the rural spread of this infection. In fact, that
is one of the issues which interests us and we plan to
investigate the mechanism of such spread.

The portion of the report which concerns me and prompts this
letter relates to HIV Research and Drug Development. The
personal opinion expressed in this letter is not at the request
or instigation of any of the ACTU associated committees, groups,
or leadership. It may be possible to dismiss my comments as
biased on the basis of my role as an investigator in the ACTU.
However, as one who is dedicated both to the care of HIV infected
persons and to clinical trials. I must speak on behalf of our
infected patients because the report may jeopardize their care.

The very strong criticism that there is a lhack:.of
information from the ACTU can be responded to with ample
documentation of scientific accomplishments. The trial
demonstrating the efficacy of AZT in asymptomatic patients was
conducted through the ACTU. The ACTU also demonstrated the
efficacy of AZT at all stages of a disease at a dose level which
was half of that indicated at the time of initial approval of the
drug. These two accomplishments alone are important to the
hundreds of thousands of people with infection. The ACTU has
done all the work in children with AZT resulting in approval of
the drug. It is unnecessary to reiterate the entire list of
accomplishments but I enclose a document dated May 16 with a
cover letter by Dr. Fauci.

Box 2951 ¢ Durham, North Carolina 27710 © Telephone (919) 684-6610, 684-3570

 
The allegations of under-representation of people of color,
women and children imply that this occurs through exclusion of
these persons from protocols. This is not correct but rather is
related to problems with the health care system in the United
States. Some of the behaviors which place persons at risk for
HIV infection define persons who have not had access to our
existing health care system. This requires expenditure of funds
to provide health services for these people. It is not easy to
consider enrolling drug users if facilities for support systems
including assistance in rehabilitation are unavailable. In order
to obtain data from the clinical trials persons must be able to
comply with the taking of medications and attendance in clinics.
The commission has merely identified the disproportionately high
representation in health care and in clinical trials of those
persons with health insurance and education. The problem is the
delivery of health care in this country and it is reflected in
access*‘to clanical trials. “This if: net the fault of the .AcTU
Clinical Trial system.

As you know, I have been an advocate for every aspect of
care for children with HIV infection. It needs to be stated
clearly that children are 1-2% of the total population with AIDS
and therefore would be "under-represented" in clinical trials if
absolute numbers are used for comparison. For the past four years
the ACTU has worked very hard to conduct pediatric clinical
trials. The number of ACTUs has expanded, the units supported by
NICHD have been included, and the National Hemophiliac Foundation
which cares for children has been incorporated into the trial
system. Access of children to clinical triais has greatiy
improved and the design and implementation of trials is
excellent. All trials have accrued patients at anticipated
rates. The protocols are carefully coordinated to assure that
the most important questions are asked first and that the patient
population (a precious resource) is accessible to provide the
answers in a timely fashion. I would suggest that the commission
avail themselves of the research agenda, the priorities, and
learn the means by which such decision making occurs. I am
concerned that all the progress we've made could be destroyed by

the commission's report. The withdrawal of funding would end the
clinical trials.

An important issue is the allegation or perception of
contiict:-of interes® frow.investigatore:. Many of the
investigators have multiple conflict of interest statements on
record for various committees on which we serve. This allegation
was made in person to the members of the executive committee
within the last several months. I believe the allegation is
totally unfounded. The ACTU is organizing formal conflict of
interest statements so that even the perception of such conflict
of interest can be avoided. Each one of us who has served on any
Federal Advisory Committee or in the Institute of Medicine has
multiple such documents on file. These are available for review.
Responding to such allegations does take time away from

investigative responsibilities and requires additional paper
work.

 
A review of the AIDS publications and the preceding
dissemination of information from the ACTU should serve to
respond to the criticism of delays in the publication of clinical
trial information. It is of primary importance to produce
accurate scientific data. It is also important to disseminate
information rapidly. It would be instructive for the commission
to review a time line of one of the studies, the announcement of
the data, and the publication dates. There are already in
existence avenues to disseminate information prior to publication
and the commission report does not refer to these existing
mechanisms.

In summary I am disappointed that despite the many
valid points made by the commission's report it seems to me that
many allegations have not been critically reviewed prior to their
publication in this report. I would encourage you and the
commission to discuss these allegations with the AIDS Clinical
Trial Unit. There are data to consider in addition to expressed
opinions. You could certainly attend the meetings or discuss the
issues with the leadership.

I hope that you will accept these comments as a personal
response to the commission's report. I would be happy if they
were shared with the other members of the commission. I feel
strongly that the statements in the commission's report
concerning the ACTU are inaccurate, incomplete and lack
substantive documentation. The report could harm the clinical
trials effort.

With warm personal regards.

Sincerely,

Cily/
Catherine\M. Wilfert, M.D.

Professor of Pediatrics
and Microbiology

CMW: jb

Enclosure