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103D CONGRESS
1ST SESSION
H. R. 3310
To establish the Barbara McClintock Project to Cure AIDS.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 19, 1993
Mr. NADLER introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To establish the Barbara McClintock Project to Cure AIDS.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Barbara McClintock
AIDS Cure Act’’.
SEC. 
2. 
ESTABLISHMENT 
OF 
BARBARA 
MCCLINTOCK
PROJECT FOR CURING AIDS.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall in accordance with this Act estab-
lish a project for the purpose of developing a cure for ac-
quired immune deficiency syndrome (in this Act referred
to as ‘‘AIDS’’). The program may not be administered by
any officer or employee of the National Institutes of
Health. Subject to the preceding sentence, the Secretary
shall designate an official of the Department of Health
and Human Services to be the head of such project, and
shall carry out this Act acting through such official.
(b) DEFINITION.—For purposes of this Act, the term
‘‘cure’’, with respect to AIDS, means any and all ap-
proaches which will ensure a well-functioning immune sys-
tem and a normal life span with a reasonable quality of
life.
(c) CERTAIN REQUIREMENTS.—The Secretary, in
carrying out the project under subsection (a), shall ensure
that the following requirements are met:
(1) The project shall pursue any and all basic
science investigations, based on diverse theories and
schools of thought which elucidate the pathogenesis
of AIDS.
(2) The project shall identify, based on this
work, all promising curatives and to oversee their
timely and adequate testing through the extraor-
dinary powers detailed in section 5.
SEC. 3. EFFICIENT AND COOPERATIVE MANAGEMENT OF
PROJECT.
(a) IN GENERAL.—The Secretary, in carrying out the
project under section 2, shall ensure that the following re-
quirements are met:
(1) The project shall establish one central loca-
tion for its work. All primary research staff shall
work at that location; contributing researchers lo-
cated around the world shall interact via video tele-
conferencing, an international computer network,
and regularly scheduled face-to-face meetings.
(2) The National Institute of Health’s existing
AIDS research programs shall be maintained. All
National Institute of Health basic science research
supplementary to that done by the Project shall be
performed cooperatively with the project.
(3)(A) All primary research staff and adminis-
trators shall be financially compensated only by the
project and may not have conflicts of interests with
private organizations (including but not limited to
universities, pharmaceutical companies, and private
research organizations).
(B) All primary research staff and administra-
tors shall be required to suspend their relationship
with any private organizations for the duration of
their association with the project. Policy council
members shall be required to suspend their relation-
ship with for-profit organizations which represent a
conflict of interest.
(C) These requirements shall include full-time,
part-time, or consultant positions with a private or-
ganization or other government agencies, and the
suspension would include employment, consulting or
board membership fees, and stock or business own-
ership.
(4) The project shall be funded by public, not
private monies. Appropriations for the project shall
not be diverted from other health care or human
service programs.
(5) The project shall, in addition to basic re-
search investigations, operate an on-site clinic to
conduct small scale research trials with human par-
ticipants in such trials are crucial for testing
hypotheses related to its basic research.
(b) GOVERNING COUNCIL.—
(1) IN GENERAL.—The project under section 2
shall be governed by, not merely advised by, a coun-
cil composed of scientists and clinicians representing
divergent approaches, and people with AIDS and
HIV, and their advocates, from all affected commu-
nities. This council shall set policy and oversee re-
search priorities, ethical standards, conflict of inter-
est rules and hiring of researchers.
(2) CERTAIN
AUTHORITIES.—The Secretary
shall ensure that the following requirements are met
with respect to the council under paragraph (1):
(A) The council shall be composed of sci-
entists representing divergent approaches, clini-
cians with both research and community-based
experience and people with AIDS and HIV and
their advocates.
(B) The council shall have at least 21
members in order to adequately represent di-
verse communities, opinions and disciplines.
People with AIDS and HIV from diverse com-
munities shall be in the majority to ensure that
the project staff are ultimately accountable to
people directly affected by the course and out-
come of the research. Council members shall
step down and be replaced by new members on
a regular basis.
(C) The Council shall set policy for and
oversee research priorities. It shall develop
guidelines for and oversee the hiring of primary
research staff, ensuring both high quality (sci-
entific credentials and experience) and a diver-
sity of disciplines and perspectives. Have pur-
sued specific AIDS theories shall not be a nec-
essary prerequisite for hiring. The Council shall
have the power to create new research positions
when necessary and to remove scientists from
their positions after due process and appro-
priate review of their work.
(D) The Council shall be charged with
evaluating the work of the project, as well as
the pace of the research, to insure that it
matches the urgency of the epidemic. Initially,
and throughout the life of the project, the
Council, in cooperation with the primary re-
search staff, shall solicit and evaluate all new
theories developed outside the Project. It shall
direct the Project scientists to evaluate and re-
spond to deserving proposals and to devise new
research plans where desirable.
(E) The council shall adopt strict, detained
codes governing medical ethics and conflicts of
interest and shall monitor compliance with
these codes. Project scientists shall report di-
rectly to the council about the progress of their
work in a manner to be determined by the
council. The council shall report directly to the
President about the progress of the project.
(F) Council meetings, including those at
which all decisions are made, shall be public
and shall be held at least quarterly, with time
allotted for public comment. In addition, the
Council shall hold an annual public hearing on
its priorities and progress. A complete report of
the project’s goals and accomplishments shall
be updated by the Council, submitted to the
President and released to the public at least
once quarterly. The Council shall evaluate its
structure and process at least once per year and
make changes which allow it to function more
effectively.
(c) COORDINATING COUNCIL.—The Secretary shall
ensure that a coordinating committee is established for the
project under section 2, in accordance with the following:
(1) The community of scientists selected for the
project shall elect three of their members to serve as
the coordinating committee for the project, and de-
termine whether these positions should be perma-
nent or rotating.
(2) The coordinating committee shall be respon-
sible for facilitating communication among the dif-
ferent scientists working on the project, for evaluat-
ing the progress of its work, and for convening the
entire staff on some regular schedule (or when nec-
essary) to evaluate the progress of the project as a
whole, reevaluate its direction, and to consider newly
developed theories emanating from both within and
outside the project.
(3) The coordinating committee shall also be re-
sponsible for keeping the policy council informed of
the progress of the project’s work, at times and in
a manner to be determined by the policy council.
The coordinating committee shall also make deci-
sions regarding the hiring of research associates,
technical staff, purchases of equipment and other
day-to-day needs.
(4) The first task of the coordinating committee
shall be to facilitate an intensive preliminary review,
lasting no more than three months, of all existing
pathogenesis hypotheses, as well as other relevant
information about AIDS pathogenesis. At the end of
this review, the primary research staff shall collec-
tively develop plans for evaluating and testing each
of the viable hypotheses, including timelines for eval-
uating the progress of this work.
SEC. 4. OPEN AND PRODUCTIVE RESEARCH PATHS.
The Secretary, in carrying out the project under sec-
tion 2, shall ensure that the following requirements are
met:
(1)(A) Equal consideration shall be given to
conventional and other medical approaches and sci-
entific theories, and researchers representing diver-
gent approaches shall be on the primary research
staff well as be contributing researchers.
(B) The project shall aggressively pursue re-
search into all areas of AIDS pathogenesis. The two
broad categories of theories to be researched by the
project are—
(i) understudied virological/immunological
theories about how immune system damage oc-
curs; and
(ii) theories about co-factors which may
precede, activate or even substitute for HIV in
the process of immune system damage leading
to AIDS.
(C) Further work shall be done on the potential
role of recreational drugs (including alcohol) in pro-
gression. Nutritional research must also be included
in the Project. Several chemical and heavy-metal
toxins (including cigarette smoke) must be explored.
Psychoneuroimmunology and its connections between
psychological stress, lack of social support, and im-
mune compromise, shall be studied.
(D) Examination shall be given to the full spec-
trum of pathogenesis theories, from those maintain-
ing that HIV is the sole and sufficient cause to
those considering HIV a primary cause together
with co-factors to those believing that HIV does not
necessarily play a causative role.
(E) A diversity of theories should be developed
and tested through both laboratory experiments and
epidemiological research, including careful examina-
tion of existing medical records of people with HIV
and AIDS.
(F) Researchers shall research epidemiological
and blood studies of long-term survivors from di-
verse populations to attempt to isolate the factors
that have sustained them. Subjective evidence, in-
cluding asking people with AIDS and HIV and their
care providers what factors they think may be play-
ing a role, and how the factors may have interacted,
shall be collected to supplement, and help to syn-
thesize quantifiable data.
(G) Consideration shall be given to the
hypotheses and results obtained in other countries,
and the best and brightest researchers from other
countries shall be aggressively pursued by the
project. This may include agreements by another
country to reassign particular researchers to the
project for an indefinite commitment. The project’s
progress shall not await the conclusion of such inter-
national agreements.
(2) The project’s study of AIDS pathogenesis
and manifestations must focus on all populations of
people with AIDS and HIV. Equal consideration
shall be given to the differences between these popu-
lations as to their similarities or ‘‘norms’’. This in-
cludes women, children, gay men, lesbians, people of
color (of various affected national-cultural groups),
injection drug users, hemophiliacs and people with
inadequate medical care and/or nutrition.
(3) Basic science investigations and therapeutic
results shall be geared to people at every point on
the spectrum of AIDS and HIV—from the sickest to
the healthiest. Saving people considered ‘‘near
death’’ must be considered as important as early
intervention.
(4) Information generated by the Project shall
be made freely available to researchers, health care
providers, people with AIDS and HIV and their ad-
vocates as soon as it is available, without being in-
hibited by professional publication practices.
(5) Curatives ultimately released due primarily
to project research shall not result in financial gain
to any private organization, and shall be made avail-
able to all affected people regardless of ability to
pay.
SEC. 5. EXTRAORDINARY POWERS.
In carrying out the project under section 2, the Sec-
retary shall have extraordinary powers to carry out the
following:
(1)(A) Direct the utilization of any and all ex-
isting United States Government funded research
entities and their facilities to clinically test promis-
ing cures developed on the basis of its research and
to direct the manner in which such research shall
proceed, including staffing, participants, location,
and timing. Such research shall be funded by the
project.
(B) The project shall design its own protocols
and work with these existing clinical trial programs
to develop research designs and methods appropriate
to the project’s goals, assuring that data gathered
by the NIH would accurately reflect the use of these
compounds in all populations and stages of illness.
(C) The project shall provide funding for these
clinical trials of its own compounds. In areas of con-
flict, the project shall have the power to implement
its goals.
(2) Exercise the right of eminent domain to
carry out the following:
(A) Obtain from public and private organi-
zations, with just compensation, samples of all
potential curatives and all data regarding their
development (including safety and efficacy
data) as well as other information, materials, or
products deemed crucial to the Project.
(B) Implement clinical testing for potential
curatives owned by private companies, whether
under development or not, unless said compa-
nies adhere to an approved time frame and are
forthcoming with their data as such work pro-
ceeds.
(C) Use existing pharmaceutical company
facilities (with just compensation) for the pro-
duction of promising curatives to be utilized in
project research and, if effective, to produce
such curatives in sufficient amounts to be dis-
seminated to all people needing them.
(D) If a drug company is found to be im-
peding or halting the development of a promis-
ing compound, the project shall first attempt to
work with the company to develop the needed
timetable for research and trials. A company
lacking the resources to develop a compound
shall have the option of selling the compound to
the project for a just compensation, or allowing
portions of its development to be undertaken by
the project.
(E) If, however, a company refuses to co-
operate with the project by not releasing needed
data, or by withholding samples of requested
compounds, the project is authorized to use
powers of eminent domain to procure samples
and data. The project shall have the power to
obtain the patents of such compounds if, after
reasonable attempts at cooperation, it finds that
a company will not develop a promising
compound in an accelerated fashion. After noti-
fication by the project that this power will be
used, a company shall have 30 days in which to
develop, for the project’s approval, a plan for
accelerated development of the compound to
avoid losing its patent.
SEC. 6. PLANNING FUNDS.
Funds shall be allocated immediately to be used for
planning of the project under section 2 (including creating
facilities, selection of staff, funding, structure, and sched-
ules), so that the project can begin functioning as soon
as is possible.
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