I

104TH CONGRESS

1ST SESSION H. R. 761

To establish the AIDS Cure Project.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 31, 1995

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

MILLER of California, Mr. ABERCROMBIE, Mr. Lewis of Georgia, Mr.

MCDERMOTT, Mr. TRAFICANT, Mr. PALLONE, Mr. ACKERMAN, Mr.

DEUTSCH, Mrs. MALONEY, Mr. YATES, and Mr. ENGEL) introduced the

following bill; which was referred to the Committee on 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
2

•HR 761 IH

1 be administered by any officer or employee of the National

2 Institutes of Health. Subject to the preceding sentence,

3 the Governing Council shall designate an individual to

4 serve as a liaison between the Governing Council of the

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

6 and the President.

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

8 ‘‘cure’’, with respect to AIDS, means any and all ap9 proaches which will ensure a well-functioning immune sys10 tem and a normal life span with a reasonable quality of

11 life.

12 (c) CERTAIN REQUIREMENTS.—The Governing

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

14 shall ensure that the following requirements are met:

15 (1) The project shall pursue comprehensive

16 basic science investigations, based on diverse theo17 ries and schools of thought which elucidate the

18 pathogenesis of AIDS.

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

20 work, all promising curatives and oversee their time21 ly and adequate testing through the extraordinary

22 powers detailed in section 5.
3

•HR 761 IH

1 SEC. 3. OPEN AND PRODUCTIVE RESEARCH PATHS.

2 The Governing Council, in carrying out the project

3 under section 2, shall ensure that the following require4 ments are met:

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

6 both conventional and other medical approaches and

7 scientific theories, and researchers representing di8 vergent approaches shall be on the primary research

9 staff as well as be contributing researchers.

10 (B) The project shall aggressively pursue re11 search into all areas of AIDS pathogenesis, includ12 ing but not limited to—

13 (i) virological/immunological theories about

14 how immune system damage occurs, including

15 understudied approaches; and

16 (ii) theories about co-factors which may

17 precede, activate or even substitute for HIV in

18 the process of immune system damage leading

19 to AIDS.

20 (C) Examination shall be given to the full spec21 trum of pathogenesis theories, from those maintain22 ing that HIV is the sole and sufficient cause to

23 those considering HIV a primary cause together

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

25 necessarily play a causative role.
4

•HR 761 IH

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

2 role of recreational drugs and environmental toxins

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

4 adequate primary health care must also be re5 searched in the project. Psychoneuroimmunology

6 and the connections between psychological stress and

7 immune compromise shall also be studied.

8 (E) A diversity of theories should be developed

9 and tested through both laboratory experiments and

10 epidemiological research, including careful examina11 tion of cases of people with HIV and AIDS and

12 interviews with people with HIV and AIDS and their

13 care providers including but not limited to primary

14 care clinicians, gynecologists, nutritionists, alter15 native or holistic practitioners, and mental health

16 workers.

17 (F) All research funded in this Act shall be con18 ducted in conformity with the ethics and privacy of

19 current medical research.

20 (G) Researchers shall study epidemiological and

21 blood studies of long-term survivors from diverse

22 populations to attempt to isolate the factors that

23 have sustained them.

24 (H) Consideration shall be given to the

25 hypotheses and results obtained in other countries.
5

•HR 761 IH

1 Researchers from other countries shall be invited to

2 participate in the project. This may include agree3 ments with another country to reassign particular

4 researchers to the project for an indefinite commit5 ment. The project’s progress shall not await the con6 clusion of such international 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, but is not limited to people of all age groups

13 (including children and seniors), gender, sexual ori14 entation, women (regardless of reproductive health

15 status), gay men, lesbians, people of color (of var16 ious affected national-cultural groups), injection

17 drug users, prison inmates, people with hemophilia

18 and people with inadequate medical care or nutrition

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

20 conditions related to AIDS.

21 (3) Basic science investigations and therapeutic

22 results shall be geared to people at every point on

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

24 the healthiest. Saving people considered near death
6

•HR 761 IH

1 must be considered as important as early interven2 tion.

3 (4) Information generated by the project shall

4 be made freely available worldwide to researchers,

5 health care providers, people with AIDS and HIV

6 and their advocates as soon as it is available, with7 out being inhibited by professional publication prac8 tices. Funds shall be available as needed for the dis9 semination and translation of project materials.

10 (5) Curatives and therapies ultimately released

11 due primarily to project research shall not result in

12 financial gain to any private organization, and shall

13 be made available to all affected people worldwide

14 regardless of ability to pay. The project shall be re15 sponsible for establishing a mechanism for inter16 national funding and distribution of any such

17 curatives.

18 SEC. 4. EFFICIENT AND COOPERATIVE MANAGEMENT OF

19 PROJECT.

20 (a) GOVERNING COUNCIL.—

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

22 shall be governed by, not merely advised by, a coun23 cil composed of scientists and clinicians representing

24 divergent approaches, and people with AIDS and

25 HIV, and their advocates, from all affected commu-
7

•HR 761 IH

1 nities. This council shall set policy and oversee re2 search priorities, ethical standards, conflict of inter3 est rules and hiring of researchers, and administra4 tors.

5 (2) CERTAIN AUTHORITIES.—The Secretary

6 shall ensure that the following requirements are met

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

8 (A) The council shall be composed of sci9 entists representing divergent approaches, clini10 cians with both research and community-based

11 experience and people with AIDS and HIV and

12 their advocates.

13 (B) The council shall have at least 21

14 members in order to adequately represent di15 verse communities, opinions and disciplines.

16 People with AIDS and HIV from diverse com17 munities shall be in the majority to ensure that

18 the project staff are ultimately accountable to

19 people directly affected by the course and out20 come of the research. Council members shall

21 step down and be replaced by new members on

22 a regular basis.

23 (C) The Council shall set policy for and

24 oversee research priorities. It shall develop

25 guidelines for and oversee the hiring of primary
8

•HR 761 IH

1 research staff, ensuring both high quality (sci2 entific credentials and experience) and a diver3 sity of disciplines and perspectives (including

4 alternative’’ or holistic approaches). Having

5 pursued specific AIDS theories shall not be a

6 necessary prerequisite for hiring. The Council

7 shall have the power to create new research po8 sitions when necessary and to remove scientists

9 from their positions after due process and ap10 propriate review of their work.

11 (D) The Council shall be charged with

12 evaluating the work of the project, as well as

13 the pace of the research, to ensure that it

14 matches the urgency of the epidemic. Initially,

15 and throughout the life of the project, the

16 Council, in cooperation with the primary re17 search staff, shall solicit and evaluate theories

18 developed outside the project. It shall direct the

19 project scientists to evaluate and respond to de20 serving proposals and to devise new research

21 plans where desirable.

22 (E) The Council shall adopt strict, detailed

23 codes governing medical ethics and conflicts of

24 interest and shall monitor compliance with

25 these codes. Project scientists shall report di-
9

•HR 761 IH

1 rectly to the council about the progress of their

2 work in a manner to be determined by the

3 council. The Council shall report to the Presi4 dent through the liaison about the progress of

5 the project.

6 (F) Council meetings, including those at

7 which all decisions are made, shall be public

8 and shall be held at least quarterly, with time

9 allotted for public comment. In addition, the

10 Council shall hold an annual public hearing on

11 its priorities and progress. A complete report of

12 the project’s goals and accomplishments shall

13 be updated by the Council, submitted to the

14 President and released to the public at least

15 once quarterly. The Council shall evaluate its

16 structure and process at least once per year and

17 make changes which allow it to function more

18 effectively.

19 (G) Members of the Governing Council will

20 not be paid employees of the project. However,

21 the Governing Council will be provided with an

22 operating budget, including but not limited to,

23 the following purposes: Support staff; creation

24 and dissemination of reports and other mate25 rials; funds for transportation and other per
10

•HR 761 IH

1 diem expenses; and funds for convening public

2 meetings.

3 (b) REQUIREMENTS.—The Governing Council, in car4 rying out the project under section 2, shall ensure that

5 the following requirements are met:

6 (1) The project shall establish a primary loca7 tion for its work, in an area with a high incidence

8 of AIDS. All primary research staff shall work at

9 that location; contributing researchers located

10 around the world shall interact via video teleconfer11 encing, an international computer network, and reg12 ularly scheduled face-to-face meetings.

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

14 AIDS research programs shall be maintained. All

15 National Institutes of Health basic science research

16 supplementary to that done by the project shall be

17 performed cooperatively with the project in coordina18 tion with the Office of AIDS Research.

19 (3)(A) All primary research staff and adminis20 trators shall be financially compensated only by the

21 project and may not have conflicts of interests with

22 private or public organizations (including but not

23 limited to universities, pharmaceutical companies,

24 and private research organizations).
11

•HR 761 IH

1 (B) All primary research staff and administra2 tors shall be required to suspend their relationship

3 with any private or public organizations for the du4 ration of their association with the project. These re5 quirements shall include full-time, part-time, or con6 sultant positions with a private or public organiza7 tion or other government agencies, and the suspen8 sion would include employment, consulting or board

9 membership fees, and stock or business ownership.

10 (C) The Governing Council members shall be

11 required to suspend their relationship with for-profit

12 organizations which represent a conflict of interest.

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

14 private monies. Appropriations for the project shall

15 not be diverted from other health research, health

16 care, or human service programs.

17 (5) The project shall, in addition to basic re18 search investigations, operate an on-site clinic to

19 conduct small scale research trials with human par20 ticipants if such trials are crucial for testing

21 hypotheses related to its basic research.

22 (c) COORDINATING COMMITTEE.—The Governing

23 Council shall ensure that a coordinating committee is es24 tablished for the project under section 2, in accordance

25 with the following:
12

•HR 761 IH

1 (1) The community of scientists selected for the

2 project shall elect three of their members to serve as

3 the coordinating committee for the project, and de4 termine whether these positions should be perma5 nent or rotating.

6 (2) The coordinating committee shall be respon7 sible for facilitating communication among the dif8 ferent scientists working on the project, for evaluat9 ing the progress of its work, and for convening the

10 entire staff on a regular schedule (or when nec11 essary) to evaluate the progress of the project as a

12 whole, identify gaps in research, reevaluate the

13 project’s direction, and to consider newly developed

14 theories emanating from both within and outside the

15 project.

16 (3) The coordinating committee shall also be re17 sponsible for keeping the Governing Council in18 formed of the progress of the project’s work, at

19 times and in a manner to be determined by the Gov20 erning Council. The coordinating committee shall

21 also make decisions regarding the hiring of research

22 associates, technical staff, purchases of equipment

23 and other day-to-day needs.

24 (4) The first task of the coordinating committee

25 shall be to facilitate a preliminary review of all exist-
13

•HR 761 IH

1 ing pathogenesis hypotheses, as well as other rel2 evant information about AIDS pathogenesis. At the

3 end of this review, which shall last no longer than

4 3 months, the primary research staff shall collec5 tively develop plans for evaluating and testing each

6 of the viable hypotheses, including timelines for eval7 uating the progress of this work, and submit these

8 plans to the Governing Council for review and com9 ments.

10 (d) SELECTION OF GOVERNING COUNCIL.—

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

12 Human Services (HHS) shall convene a national

13 AIDS congress to make recommendations to the

14 President for selecting the Governing Council. The

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

16 purpose of nominating the initial Governing Council.

17 The Secretary of HHS shall solicit nominations from

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

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

20 health care providers; AIDS advocacy organizations;

21 AIDS service organizations; community-based AIDS

22 research organization; biomedical researchers and

23 nonmainstream (including alternative or holistic)

24 medical organizations; and health care planning

25 agencies, who shall send their nominations for the
14

•HR 761 IH

1 Governing Council to the AIDS congress. The AIDS

2 congress will make recommendations to the Presi3 dent for the Governing Council. The President shall

4 select the Governing Council based on the rec5 ommendations of the AIDS congress. The AIDS

6 congress will consist of 2 representatives chosen by

7 each of the HIV health services planning councils

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

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

10 by each of the HIV planning councils. The President

11 shall widely publicize the request for nominations.

12 (2) DATE CERTAIN FOR SELECTION.—In keep13 ing with the emergency nature of this project, the

14 nomination and selection process must be completed

15 within 3 months of the enactment of this Act.

16 SEC. 5. EXTRAORDINARY POWERS.

17 In carrying out the project under section 2, the Gov18 erning Council shall have extraordinary powers to carry

19 out the following:

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

21 any and all existing United States Government fund22 ed research entities nationwide (including but not

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

24 the Community Program for Clinical Research on

25 AIDS (CPCRA)), and their facilities to clinically
15

•HR 761 IH

1 test promising cures developed on the basis of its re2 search and to direct the manner in which such re3 search shall proceed, including staffing, participants,

4 location, and timing. Such research shall be funded

5 by the project.

6 (B) The project shall design its own protocols

7 and work with these existing clinical trial programs

8 to develop research designs and methods appropriate

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

10 by the NIH would accurately reflect the use of these

11 compounds in all populations and stages of illness.

12 (C) The project shall provide funding for these

13 clinical trials of its own compounds. In areas of con14 flict, the project shall have the power to implement

15 its goals.

16 (2) Exercise the right of eminent domain to

17 carry out the following:

18 (A)(i) Obtain from public and private orga19 nizations, with just compensation, samples of

20 all potential curatives and all data (excluding

21 medical records) regarding their development

22 (including safety and efficacy data) as well as

23 other information, materials, or products

24 deemed crucial to the project, but protect the

25 privacy of research subjects and the researcher
16

•HR 761 IH

1 over which the project will be exercising the

2 right of eminent domain. The project shall use

3 its power of eminent domain only after reason4 able attempts at cooperation have failed.

5 (ii) To use eminent domain power, the

6 project must determine and identify whether

7 this research is essential information to the

8 project’s research and that it is unavailable

9 other than through eminent domain.

10 (iii) Once obtaining through eminent do11 main the research of an outside researcher, the

12 project shall make all efforts to preserve appro13 priate recognition of the scientist’s work. The

14 project shall also afford any researcher, whose

15 work is acquired through eminent domain, an

16 opportunity to participate in the project with

17 just compensation.

18 (B) If a drug company is found to be im19 peding or halting the development of a promis20 ing compound, the project shall first attempt to

21 work with the company to develop the needed

22 timetable for research and trials. A company

23 lacking the resources to develop a compound

24 shall have the option of selling the patent to the

25 project for just compensation, or allowing por-
17

•HR 761 IH

1 tions of its development to be undertaken by

2 the project.

3 (C) If, however, a company refuses to co4 operate with the project by not releasing needed

5 data, or by withholding samples of requested

6 compounds, whether under development or not,

7 the project is authorized to use powers of emi8 nent domain to procure samples and data. The

9 project shall have the power to obtain the pat10 ents of such compounds if, after reasonable at11 tempts at cooperation, it finds that a company

12 will not develop a promising compound accord13 ing to an approved timeframe by the coordinat14 ing committee. After notification by the project

15 that this power will be used, a company shall

16 have 30 days in which to develop, for the

17 project’s approval, a plan for accelerated devel18 opment of the compound to avoid losing exclu19 sive rights to the patent. Unless said companies

20 adhere to an approved timeframe and are forth21 coming with their data as such work proceeds,

22 then the project can implement clinical testing

23 for potential curatives by private companies.

24 (D) Use existing pharmaceutical company

25 facilities (with just compensation) for the pro-
18

•HR 761 IH

1 duction of promising curatives to be utilized in

2 project research and, if effective, to produce

3 such curatives in sufficient amounts to be dis4 seminated to all people needing them.

5 SEC. 6. PLANNING FUNDS.

6 Funds shall be allocated immediately to be used for

7 planning of the project under section 2 (including creating

8 facilities, selection of staff, funding, structure, and sched9 ules), so that the project can begin functioning as soon

10 as is possible.

11 SEC. 7. REAUTHORIZATION OF PROJECT.

12 After 5 years of operation, the Congress shall have

13 the power to reauthorize the project under section 2.

Æ

HR 761 IH——2