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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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Barbara McClintock

5 AIDS Cure Act’’.

6 SEC. 2. ESTABLISHMENT OF BARBARA MCCLINTOCK

7 PROJECT FOR CURING AIDS.

8 (a) IN GENERAL.—The Secretary of Health and

9 Human Services shall in accordance with this Act estab10 lish a project for the purpose of developing a cure for ac11 quired immune deficiency syndrome (in this Act referred

12 to as ‘‘AIDS’’). The program may not be administered by
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1 any officer or employee of the National Institutes of

2 Health. Subject to the preceding sentence, the Secretary

3 shall designate an official of the Department of Health

4 and Human Services to be the head of such project, and

5 shall carry out this Act acting through such official.

6 (b) DEFINITION.—For purposes of this Act, the term

7 ‘‘cure’’, with respect to AIDS, means any and all ap8 proaches which will ensure a well-functioning immune sys9 tem and a normal life span with a reasonable quality of

10 life.

11 (c) CERTAIN REQUIREMENTS.—The Secretary, in

12 carrying out the project under subsection (a), shall ensure

13 that the following requirements are met:

14 (1) The project shall pursue any and all basic

15 science investigations, based on diverse theories and

16 schools of thought which elucidate the pathogenesis

17 of AIDS.

18 (2) The project shall identify, based on this

19 work, all promising curatives and to oversee their

20 timely and adequate testing through the extraor21 dinary powers detailed in section 5.
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1 SEC. 3. EFFICIENT AND COOPERATIVE MANAGEMENT OF

2 PROJECT.

3 (a) IN GENERAL.—The Secretary, in carrying out the

4 project under section 2, shall ensure that the following re5 quirements are met:

6 (1) The project shall establish one central loca7 tion for its work. All primary research staff shall

8 work at that location; contributing researchers lo9 cated around the world shall interact via video tele10 conferencing, an international computer network,

11 and regularly scheduled face-to-face meetings.

12 (2) The National Institute of Health’s existing

13 AIDS research programs shall be maintained. All

14 National Institute of Health basic science research

15 supplementary to that done by the Project shall be

16 performed cooperatively with the project.

17 (3)(A) All primary research staff and adminis18 trators shall be financially compensated only by the

19 project and may not have conflicts of interests with

20 private organizations (including but not limited to

21 universities, pharmaceutical companies, and private

22 research organizations).

23 (B) All primary research staff and administra24 tors shall be required to suspend their relationship

25 with any private organizations for the duration of

26 their association with the project. Policy council
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1 members shall be required to suspend their relation2 ship with for-profit organizations which represent a

3 conflict of interest.

4 (C) These requirements shall include full-time,

5 part-time, or consultant positions with a private or6 ganization or other government agencies, and the

7 suspension would include employment, consulting or

8 board membership fees, and stock or business own9 ership.

10 (4) The project shall be funded by public, not

11 private monies. Appropriations for the project shall

12 not be diverted from other health care or human

13 service programs.

14 (5) The project shall, in addition to basic re15 search investigations, operate an on-site clinic to

16 conduct small scale research trials with human par17 ticipants in such trials are crucial for testing

18 hypotheses related to its basic research.

19 (b) GOVERNING COUNCIL.—

20 (1) IN GENERAL.—The project under section 2

21 shall be governed by, not merely advised by, a coun22 cil composed of scientists and clinicians representing

23 divergent approaches, and people with AIDS and

24 HIV, and their advocates, from all affected commu25 nities. This council shall set policy and oversee re-
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1 search priorities, ethical standards, conflict of inter2 est rules and hiring of researchers.

3 (2) CERTAIN AUTHORITIES.—The Secretary

4 shall ensure that the following requirements are met

5 with respect to the council under paragraph (1):

6 (A) The council shall be composed of sci7 entists representing divergent approaches, clini8 cians with both research and community-based

9 experience and people with AIDS and HIV and

10 their advocates.

11 (B) The council shall have at least 21

12 members in order to adequately represent di13 verse communities, opinions and disciplines.

14 People with AIDS and HIV from diverse com15 munities shall be in the majority to ensure that

16 the project staff are ultimately accountable to

17 people directly affected by the course and out18 come of the research. Council members shall

19 step down and be replaced by new members on

20 a regular basis.

21 (C) The Council shall set policy for and

22 oversee research priorities. It shall develop

23 guidelines for and oversee the hiring of primary

24 research staff, ensuring both high quality (sci25 entific credentials and experience) and a diver-
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1 sity of disciplines and perspectives. Have pur2 sued specific AIDS theories shall not be a nec3 essary prerequisite for hiring. The Council shall

4 have the power to create new research positions

5 when necessary and to remove scientists from

6 their positions after due process and appro7 priate review of their work.

8 (D) The Council shall be charged with

9 evaluating the work of the project, as well as

10 the pace of the research, to insure that it

11 matches the urgency of the epidemic. Initially,

12 and throughout the life of the project, the

13 Council, in cooperation with the primary re14 search staff, shall solicit and evaluate all new

15 theories developed outside the Project. It shall

16 direct the Project scientists to evaluate and re17 spond to deserving proposals and to devise new

18 research plans where desirable.

19 (E) The council shall adopt strict, detained

20 codes governing medical ethics and conflicts of

21 interest and shall monitor compliance with

22 these codes. Project scientists shall report di23 rectly to the council about the progress of their

24 work in a manner to be determined by the
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1 council. The council shall report directly to the

2 President about the progress of the project.

3 (F) Council meetings, including those at

4 which all decisions are made, shall be public

5 and shall be held at least quarterly, with time

6 allotted for public comment. In addition, the

7 Council shall hold an annual public hearing on

8 its priorities and progress. A complete report of

9 the project’s goals and accomplishments shall

10 be updated by the Council, submitted to the

11 President and released to the public at least

12 once quarterly. The Council shall evaluate its

13 structure and process at least once per year and

14 make changes which allow it to function more

15 effectively.

16 (c) COORDINATING COUNCIL.—The Secretary shall

17 ensure that a coordinating committee is established for the

18 project under section 2, in accordance with the following:

19 (1) The community of scientists selected for the

20 project shall elect three of their members to serve as

21 the coordinating committee for the project, and de22 termine whether these positions should be perma23 nent or rotating.

24 (2) The coordinating committee shall be respon25 sible for facilitating communication among the dif-
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1 ferent scientists working on the project, for evaluat2 ing the progress of its work, and for convening the

3 entire staff on some regular schedule (or when nec4 essary) to evaluate the progress of the project as a

5 whole, reevaluate its direction, and to consider newly

6 developed theories emanating from both within and

7 outside the project.

8 (3) The coordinating committee shall also be re9 sponsible for keeping the policy council informed of

10 the progress of the project’s work, at times and in

11 a manner to be determined by the policy council.

12 The coordinating committee shall also make deci13 sions regarding the hiring of research associates,

14 technical staff, purchases of equipment and other

15 day-to-day needs.

16 (4) The first task of the coordinating committee

17 shall be to facilitate an intensive preliminary review,

18 lasting no more than three months, of all existing

19 pathogenesis hypotheses, as well as other relevant

20 information about AIDS pathogenesis. At the end of

21 this review, the primary research staff shall collec22 tively develop plans for evaluating and testing each

23 of the viable hypotheses, including timelines for eval24 uating the progress of this work.
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1 SEC. 4. OPEN AND PRODUCTIVE RESEARCH PATHS.

2 The Secretary, in carrying out the project under sec3 tion 2, shall ensure that the following requirements are

4 met:

5 (1)(A) Equal consideration shall be given to

6 conventional and other medical approaches and sci7 entific theories, and researchers representing diver8 gent approaches shall be on the primary research

9 staff well as be contributing researchers.

10 (B) The project shall aggressively pursue re11 search into all areas of AIDS pathogenesis. The two

12 broad categories of theories to be researched by the

13 project are—

14 (i) understudied virological/immunological

15 theories about how immune system damage oc16 curs; and

17 (ii) theories about co-factors which may

18 precede, activate or even substitute for HIV in

19 the process of immune system damage leading

20 to AIDS.

21 (C) Further work shall be done on the potential

22 role of recreational drugs (including alcohol) in pro23 gression. Nutritional research must also be included

24 in the Project. Several chemical and heavy-metal

25 toxins (including cigarette smoke) must be explored.

26 Psychoneuroimmunology and its connections between
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1 psychological stress, lack of social support, and im2 mune compromise, shall be studied.

3 (D) Examination shall be given to the full spec4 trum of pathogenesis theories, from those maintain5 ing that HIV is the sole and sufficient cause to

6 those considering HIV a primary cause together

7 with co-factors to those believing that HIV does not

8 necessarily play a causative role.

9 (E) A diversity of theories should be developed

10 and tested through both laboratory experiments and

11 epidemiological research, including careful examina12 tion of existing medical records of people with HIV

13 and AIDS.

14 (F) Researchers shall research epidemiological

15 and blood studies of long-term survivors from di16 verse populations to attempt to isolate the factors

17 that have sustained them. Subjective evidence, in18 cluding asking people with AIDS and HIV and their

19 care providers what factors they think may be play20 ing a role, and how the factors may have interacted,

21 shall be collected to supplement, and help to syn22 thesize quantifiable data.

23 (G) Consideration shall be given to the

24 hypotheses and results obtained in other countries,

25 and the best and brightest researchers from other
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1 countries shall be aggressively pursued by the

2 project. This may include agreements by another

3 country to reassign particular researchers to the

4 project for an indefinite commitment. The project’s

5 progress shall not await the conclusion of such inter6 national agreements.

7 (2) The project’s study of AIDS pathogenesis

8 and manifestations must focus on all populations of

9 people with AIDS and HIV. Equal consideration

10 shall be given to the differences between these popu11 lations as to their similarities or ‘‘norms’’. This in12 cludes women, children, gay men, lesbians, people of

13 color (of various affected national-cultural groups),

14 injection drug users, hemophiliacs and people with

15 inadequate medical care and/or nutrition.

16 (3) Basic science investigations and therapeutic

17 results shall be geared to people at every point on

18 the spectrum of AIDS and HIV—from the sickest to

19 the healthiest. Saving people considered ‘‘near

20 death’’ must be considered as important as early

21 intervention.

22 (4) Information generated by the Project shall

23 be made freely available to researchers, health care

24 providers, people with AIDS and HIV and their ad-
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1 vocates as soon as it is available, without being in2 hibited by professional publication practices.

3 (5) Curatives ultimately released due primarily

4 to project research shall not result in financial gain

5 to any private organization, and shall be made avail6 able to all affected people regardless of ability to

7 pay.

8 SEC. 5. EXTRAORDINARY POWERS.

9 In carrying out the project under section 2, the Sec10 retary shall have extraordinary powers to carry out the

11 following:

12 (1)(A) Direct the utilization of any and all ex13 isting United States Government funded research

14 entities and their facilities to clinically test promis15 ing cures developed on the basis of its research and

16 to direct the manner in which such research shall

17 proceed, including staffing, participants, location,

18 and timing. Such research shall be funded by the

19 project.

20 (B) The project shall design its own protocols

21 and work with these existing clinical trial programs

22 to develop research designs and methods appropriate

23 to the project’s goals, assuring that data gathered

24 by the NIH would accurately reflect the use of these

25 compounds in all populations and stages of illness.
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1 (C) The project shall provide funding for these

2 clinical trials of its own compounds. In areas of con3 flict, the project shall have the power to implement

4 its goals.

5 (2) Exercise the right of eminent domain to

6 carry out the following:

7 (A) Obtain from public and private organi8 zations, with just compensation, samples of all

9 potential curatives and all data regarding their

10 development (including safety and efficacy

11 data) as well as other information, materials, or

12 products deemed crucial to the Project.

13 (B) Implement clinical testing for potential

14 curatives owned by private companies, whether

15 under development or not, unless said compa16 nies adhere to an approved time frame and are

17 forthcoming with their data as such work pro18 ceeds.

19 (C) Use existing pharmaceutical company

20 facilities (with just compensation) for the pro21 duction of promising curatives to be utilized in

22 project research and, if effective, to produce

23 such curatives in sufficient amounts to be dis24 seminated to all people needing them.
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1 (D) If a drug company is found to be im2 peding or halting the development of a promis3 ing compound, the project shall first attempt to

4 work with the company to develop the needed

5 timetable for research and trials. A company

6 lacking the resources to develop a compound

7 shall have the option of selling the compound to

8 the project for a just compensation, or allowing

9 portions of its development to be undertaken by

10 the project.

11 (E) If, however, a company refuses to co12 operate with the project by not releasing needed

13 data, or by withholding samples of requested

14 compounds, the project is authorized to use

15 powers of eminent domain to procure samples

16 and data. The project shall have the power to

17 obtain the patents of such compounds if, after

18 reasonable attempts at cooperation, it finds that

19 a company will not develop a promising

20 compound in an accelerated fashion. After noti21 fication by the project that this power will be

22 used, a company shall have 30 days in which to

23 develop, for the project’s approval, a plan for

24 accelerated development of the compound to

25 avoid losing its patent.
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1 SEC. 6. PLANNING FUNDS.

2 Funds shall be allocated immediately to be used for

3 planning of the project under section 2 (including creating

4 facilities, selection of staff, funding, structure, and sched5 ules), so that the project can begin functioning as soon

6 as is possible.

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