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103D CONGRESS

2D SESSION H. R. 4370

To establish the AIDS Cure Project.

IN THE HOUSE OF REPRESENTATIVES

MAY 10, 1994

Mr. NADLER (for himself, Mr. DELLUMS, Ms. VELA ́ZQUEZ, Mr. OWENS, and

Mr. MILLER of California) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To establish the AIDS Cure Project.

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 ‘‘AIDS Cure Act’’.

5 SEC. 2. ESTABLISHMENT OF PROJECT TO CURE AIDS.

6 (a) IN GENERAL.—The President shall in accordance

7 with this Act direct the Secretary of Health and Human

8 Services to establish a project for the purpose of develop9 ing a cure for acquired immune deficiency syndrome (in

10 this Act referred to as ‘‘AIDS’’). The program may not

11 be administered by any officer or employee of the National
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1 Institutes of Health. Subject to the preceding sentence,

2 the Governing Council shall designate an individual to

3 serve as a liaison between the Governing Council of the

4 project (established under section 4(a)), the Secretary,

5 and the President.

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 Governing

12 Council, in carrying out the project under subsection (a),

13 shall ensure that the following requirements are met:

14 (1) The project shall pursue comprehensive

15 basic science investigations, based on diverse theo16 ries and schools of thought which elucidate the

17 pathogenesis of AIDS.

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

19 work, all promising curatives and oversee their time20 ly and adequate testing through the extraordinary

21 powers detailed in section 5.

22 SEC. 3. OPEN AND PRODUCTIVE RESEARCH PATHS.

23 The Governing Council, in carrying out the project

24 under section 2, shall ensure that the following require25 ments are met:
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1 (1)(A) Thorough consideration shall be given to

2 both conventional and other medical approaches and

3 scientific theories, and researchers representing di4 vergent approaches shall be on the primary research

5 staff as well as be contributing researchers.

6 (B) The project shall aggressively pursue re7 search into all areas of AIDS pathogenesis, includ8 ing but not limited to—

9 (i) virological/immunological theories about

10 how immune system damage occurs, including

11 understudied approaches; and

12 (ii) theories about co-factors which may

13 precede, activate or even substitute for HIV in

14 the process of immune system damage leading

15 to AIDS.

16 (C) Examination shall be given to the full spec17 trum of pathogenesis theories, from those maintain18 ing that HIV is the sole and sufficient cause to

19 those considering HIV a primary cause together

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

21 necessarily play a causative role.

22 (D) Further work shall be done on the potential

23 role of recreational drugs and environmental toxins

24 in progression. The role of nutrition, exercise, and

25 adequate primary health care must also be re-
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1 searched in the project. Psychoneuroimmunology

2 and the connections between psychological stress and

3 immune compromise shall also be studied.

4 (E) A diversity of theories should be developed

5 and tested through both laboratory experiments and

6 epidemiological research, including careful examina7 tion of cases of people with HIV and AIDS and

8 interviews with people with HIV and AIDS and their

9 care providers including but not limited to primary

10 care clinicians, gynecologists, nutritionists, alter11 native or holistic practitioners, and mental health

12 workers.

13 (F) All research funded in this Act shall be con14 ducted in conformity with the ethics and privacy of

15 current medical research.

16 (G) Researchers shall study epidemiological and

17 blood studies of long-term survivors from diverse

18 populations to attempt to isolate the factors that

19 have sustained them.

20 (H) Consideration shall be given to the

21 hypotheses and results obtained in other countries.

22 Researchers from other countries shall be invited to

23 participate in the project. This may include agree24 ments with another country to reassign particular

25 researchers to the project for an indefinite commit-
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1 ment. The project’s progress shall not await the con2 clusion of such international agreements.

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

4 and manifestations must focus on all populations of

5 people with AIDS and HIV. Equal consideration

6 shall be given to the differences between these popu7 lations as to their similarities or norms. This in8 cludes, but is not limited to people of all age groups

9 (including children and seniors), gender, sexual ori10 entation, women (regardless of reproductive health

11 status), gay men, lesbians, people of color (of var12 ious affected national-cultural groups), injection

13 drug users, prison inmates, people with hemophilia

14 and people with inadequate medical care or nutrition

15 (or both), and persons with disabilities and chronic

16 conditions related to AIDS.

17 (3) Basic science investigations and therapeutic

18 results shall be geared to people at every point on

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

20 the healthiest. Saving people considered near death

21 must be considered as important as early interven22 tion.

23 (4) Information generated by the project shall

24 be made freely available worldwide to researchers,

25 health care providers, people with AIDS and HIV
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1 and their advocates as soon as it is available, with2 out being inhibited by professional publication prac3 tices. Funds shall be available as needed for the dis4 semination and translation of project materials.

5 (5) Curatives and therapies ultimately released

6 due primarily to project research shall not result in

7 financial gain to any private organization, and shall

8 be made available to all affected people worldwide

9 regardless of ability to pay. The project shall be re10 sponsible for establishing a mechanism for inter11 national funding and distribution of any such

12 curatives.

13 SEC. 4. EFFICIENT AND COOPERATIVE MANAGEMENT OF

14 PROJECT.

15 (a) GOVERNING COUNCIL.—

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

17 shall be governed by, not merely advised by, a coun18 cil composed of scientists and clinicians representing

19 divergent approaches, and people with AIDS and

20 HIV, and their advocates, from all affected commu21 nities. This council shall set policy and oversee re22 search priorities, ethical standards, conflict of inter23 est rules and hiring of researchers, and administra24 tors.
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1 (2) CERTAIN AUTHORITIES.—The Secretary

2 shall ensure that the following requirements are met

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

4 (A) The council shall be composed of sci5 entists representing divergent approaches, clini6 cians with both research and community-based

7 experience and people with AIDS and HIV and

8 their advocates.

9 (B) The council shall have at least 21

10 members in order to adequately represent di11 verse communities, opinions and disciplines.

12 People with AIDS and HIV from diverse com13 munities shall be in the majority to ensure that

14 the project staff are ultimately accountable to

15 people directly affected by the course and out16 come of the research. Council members shall

17 step down and be replaced by new members on

18 a regular basis.

19 (C) The Council shall set policy for and

20 oversee research priorities. It shall develop

21 guidelines for and oversee the hiring of primary

22 research staff, ensuring both high quality (sci23 entific credentials and experience) and a diver24 sity of disciplines and perspectives (including

25 alternative’’ or holistic approaches). Having
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1 pursued specific AIDS theories shall not be a

2 necessary prerequisite for hiring. The Council

3 shall have the power to create new research po4 sitions when necessary and to remove scientists

5 from their positions after due process and ap6 propriate review of their work.

7 (D) The Council shall be charged with

8 evaluating the work of the project, as well as

9 the pace of the research, to ensure that it

10 matches the urgency of the epidemic. Initially,

11 and throughout the life of the project, the

12 Council, in cooperation with the primary re13 search staff, shall solicit and evaluate theories

14 developed outside the project. It shall direct the

15 project scientists to evaluate and respond to de16 serving proposals and to devise new research

17 plans where desirable.

18 (E) The Council shall adopt strict, detailed

19 codes governing medical ethics and conflicts of

20 interest and shall monitor compliance with

21 these codes. Project scientists shall report di22 rectly to the council about the progress of their

23 work in a manner to be determined by the

24 council. The Council shall report to the Presi-
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1 dent through the liaison about the progress of

2 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 (G) Members of the Governing Council will

17 not be paid employees of the project. However,

18 the Governing Council will be provided with an

19 operating budget, including but not limited to,

20 the following purposes: Support staff; creation

21 and dissemination of reports and other mate22 rials; funds for transportation and other per

23 diem expenses; and funds for convening public

24 meetings.
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1 (b) REQUIREMENTS.—The Governing Council, in car2 rying out the project under section 2, shall ensure that

3 the following requirements are met:

4 (1) The project shall establish a primary loca5 tion for its work, in an area with a high incidence

6 of AIDS. All primary research staff shall work at

7 that location; contributing researchers located

8 around the world shall interact via video teleconfer9 encing, an international computer network, and reg10 ularly scheduled face-to-face meetings.

11 (2) The National Institutes of Health’s existing

12 AIDS research programs shall be maintained. All

13 National Institutes of Health basic science research

14 supplementary to that done by the project shall be

15 performed cooperatively with the project in coordina16 tion with the Office of AIDS Research.

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 or public organizations (including but not

21 limited to universities, pharmaceutical companies,

22 and private research organizations).

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

25 with any private or public organizations for the du-
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1 ration of their association with the project. These re2 quirements shall include full-time, part-time, or con3 sultant positions with a private or public organiza4 tion or other government agencies, and the suspen5 sion would include employment, consulting or board

6 membership fees, and stock or business ownership.

7 (C) The Governing Council members shall be

8 required to suspend their relationship with for-profit

9 organizations which represent a conflict of interest.

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 research, health

13 care, or human 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 if such trials are crucial for testing

18 hypotheses related to its basic research.

19 (c) COORDINATING COMMITTEE.—The Governing

20 Council shall ensure that a coordinating committee is es21 tablished for the project under section 2, in accordance

22 with the following:

23 (1) The community of scientists selected for the

24 project shall elect three of their members to serve as

25 the coordinating committee for the project, and de-
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1 termine whether these positions should be perma2 nent or rotating.

3 (2) The coordinating committee shall be respon4 sible for facilitating communication among the dif5 ferent scientists working on the project, for evaluat6 ing the progress of its work, and for convening the

7 entire staff on a regular schedule (or when nec8 essary) to evaluate the progress of the project as a

9 whole, identify gaps in research, reevaluate the

10 project’s direction, and to consider newly developed

11 theories emanating from both within and outside the

12 project.

13 (3) The coordinating committee shall also be re14 sponsible for keeping the Governing Council in15 formed of the progress of the project’s work, at

16 times and in a manner to be determined by the Gov17 erning Council. The coordinating committee shall

18 also make decisions regarding the hiring of research

19 associates, technical staff, purchases of equipment

20 and other day-to-day needs.

21 (4) The first task of the coordinating committee

22 shall be to facilitate a preliminary review of all exist23 ing pathogenesis hypotheses, as well as other rel24 evant information about AIDS pathogenesis. At the

25 end of this review, which shall last no longer than
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1 3 months, the primary research staff shall collec2 tively develop plans for evaluating and testing each

3 of the viable hypotheses, including timelines for eval4 uating the progress of this work, and submit these

5 plans to the Governing Council for review and com6 ments.

7 (d) SELECTION OF GOVERNING COUNCIL.—

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

9 Human Services (HHS) shall convene a national

10 AIDS congress to make recommendations to the

11 President for selecting the Governing Council. The

12 AIDS congress will meet only once, and for the sole

13 purpose of nominating the initial Governing Council.

14 The Secretary of HHS shall solicit nominations from

15 a wide variety of sources, including, but not limited

16 to, each of the following: AIDS activist groups;

17 health care providers; AIDS advocacy organizations;

18 AIDS service organizations; community-based AIDS

19 research organization; biomedical researchers and

20 nonmainstream (including alternative or holistic)

21 medical organizations; and health care planning

22 agencies, who shall send their nominations for the

23 Governing Council to the AIDS congress. The AIDS

24 congress will make recommendations to the Presi25 dent for the Governing Council. The President shall
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1 select the Governing Council based on the rec2 ommendations of the AIDS congress. The AIDS

3 congress will consist of 2 representatives chosen by

4 each of the HIV health services planning councils

5 under section 2602(b) of the Public Health Service

6 Act, chosen in a forum that is open to the public by

7 each of the HIV planning councils. The President

8 shall widely publicize the request for nominations.

9 (2) DATE CERTAIN FOR SELECTION.—In keep10 ing with the emergency nature of this project, the

11 nomination and selection process must be completed

12 within 3 months of the enactment of this Act.

13 SEC. 5. EXTRAORDINARY POWERS.

14 In carrying out the project under section 2, the Gov15 erning Council shall have extraordinary powers to carry

16 out the following:

17 (1)(A) Utilize, in cooperation with the agencies,

18 any and all existing United States Government fund19 ed research entities nationwide (including but not

20 limited to the AIDS Clinical Trial Group (ACTG),

21 the Community Program for Clinical Research on

22 AIDS (CPCRA)), and their facilities to clinically

23 test promising cures developed on the basis of its re24 search and to direct the manner in which such re25 search shall proceed, including staffing, participants,
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1 location, and timing. Such research shall be funded

2 by the project.

3 (B) The project shall design its own protocols

4 and work with these existing clinical trial programs

5 to develop research designs and methods appropriate

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

7 by the NIH would accurately reflect the use of these

8 compounds in all populations and stages of illness.

9 (C) The project shall provide funding for these

10 clinical trials of its own compounds. In areas of con11 flict, the project shall have the power to implement

12 its goals.

13 (2) Exercise the right of eminent domain to

14 carry out the following:

15 (A)(i) Obtain from public and private orga16 nizations, with just compensation, samples of

17 all potential curatives and all data (excluding

18 medical records) regarding their development

19 (including safety and efficacy data) as well as

20 other information, materials, or products

21 deemed crucial to the project, but protect the

22 privacy of research subjects and the researcher

23 over which the project will be exercising the

24 right of eminent domain. The project shall use
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1 its power of eminent domain only after reason2 able attempts at cooperation have failed.

3 (ii) To use eminent domain power, the

4 project must determine and identify whether

5 this research is essential information to the

6 project’s research and that it is unavailable

7 other than through eminent domain.

8 (iii) Once obtaining through eminent do9 main the research of an outside researcher, the

10 project shall make all efforts to preserve appro11 priate recognition of the scientist’s work. The

12 project shall also afford any researcher, whose

13 work is acquired through eminent domain, an

14 opportunity to participate in the project with

15 just compensation.

16 (B) If a drug company is found to be im17 peding or halting the development of a promis18 ing compound, the project shall first attempt to

19 work with the company to develop the needed

20 timetable for research and trials. A company

21 lacking the resources to develop a compound

22 shall have the option of selling the patent to the

23 project for just compensation, or allowing por24 tions of its development to be undertaken by

25 the project.
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1 (C) If, however, a company refuses to co2 operate with the project by not releasing needed

3 data, or by withholding samples of requested

4 compounds, whether under development or not,

5 the project is authorized to use powers of emi6 nent domain to procure samples and data. The

7 project shall have the power to obtain the pat8 ents of such compounds if, after reasonable at9 tempts at cooperation, it finds that a company

10 will not develop a promising compound accord11 ing to an approved timeframe by the coordinat12 ing committee. After notification by the project

13 that this power will be used, a company shall

14 have 30 days in which to develop, for the

15 project’s approval, a plan for accelerated devel16 opment of the compound to avoid losing exclu17 sive rights to the patent. Unless said companies

18 adhere to an approved timeframe and are forth19 coming with their data as such work proceeds,

20 then the project can implement clinical testing

21 for potential curatives by private companies.

22 (D) Use existing pharmaceutical company

23 facilities (with just compensation) for the pro24 duction of promising curatives to be utilized in

25 project research and, if effective, to produce
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1 such curatives in sufficient amounts to be dis2 seminated to all people needing them.

3 SEC. 6. PLANNING FUNDS.

4 Funds shall be allocated immediately to be used for

5 planning of the project under section 2 (including creating

6 facilities, selection of staff, funding, structure, and sched7 ules), so that the project can begin functioning as soon

8 as is possible.

9 SEC. 7. REAUTHORIZATION OF PROJECT.

10 After 5 years of operation, the Congress shall have

11 the power to reauthorize the project under section 2.

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