[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3310 Introduced in House (IH)]

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 Representatives 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 establish a project for the purpose of 
developing a cure for acquired 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 approaches which will ensure a well-
functioning immune system 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 extraordinary 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 requirements are met:
            (1) The project shall establish one central location for 
        its work. All primary research staff shall work at that 
        location; contributing researchers located around the world 
        shall interact via video teleconferencing, 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 administrators 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 administrators 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 relationship 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 organization or other 
        government agencies, and the suspension would include 
        employment, consulting or board membership fees, and stock or 
        business ownership.
            (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 research 
        investigations, operate an on-site clinic to conduct small 
        scale research trials with human participants 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 council composed of 
        scientists and clinicians representing divergent approaches, 
        and people with AIDS and HIV, and their advocates, from all 
        affected communities. This council shall set policy and oversee 
        research priorities, ethical standards, conflict of interest 
        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 scientists 
                representing divergent approaches, clinicians 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 diverse communities, 
                opinions and disciplines. People with AIDS and HIV from 
                diverse communities shall be in the majority to ensure 
                that the project staff are ultimately accountable to 
                people directly affected by the course and outcome 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 (scientific credentials and 
                experience) and a diversity of disciplines and 
                perspectives. Have pursued specific AIDS theories shall 
                not be a necessary 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 appropriate 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 
                research staff, shall solicit and evaluate all new 
                theories developed outside the Project. It shall direct 
                the Project scientists to evaluate and respond 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 directly 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 determine whether these 
        positions should be permanent or rotating.
            (2) The coordinating committee shall be responsible for 
        facilitating communication among the different scientists 
        working on the project, for evaluating the progress of its 
        work, and for convening the entire staff on some regular 
        schedule (or when necessary) 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 responsible 
        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 
        decisions 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 
        collectively develop plans for evaluating and testing each of 
        the viable hypotheses, including timelines for evaluating the 
        progress of this work.

SEC. 4. OPEN AND PRODUCTIVE RESEARCH PATHS.

    The Secretary, in carrying out the project under section 2, shall 
ensure that the following requirements are met:
            (1)(A) Equal consideration shall be given to conventional 
        and other medical approaches and scientific theories, and 
        researchers representing divergent approaches shall be on the 
        primary research staff well as be contributing researchers.
            (B) The project shall aggressively pursue research 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 occurs; 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 progression. 
        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 immune compromise, shall be studied.
            (D) Examination shall be given to the full spectrum of 
        pathogenesis theories, from those maintaining 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 examination of existing medical 
        records of people with HIV and AIDS.
            (F) Researchers shall research epidemiological and blood 
        studies of long-term survivors from diverse populations to 
        attempt to isolate the factors that have sustained them. 
        Subjective evidence, including asking people with AIDS and HIV 
        and their care providers what factors they think may be playing 
        a role, and how the factors may have interacted, shall be 
        collected to supplement, and help to synthesize 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 international 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 populations as to their similarities 
        or ``norms''. This includes 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 advocates as soon as it is 
        available, without being inhibited 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 available to all affected 
        people regardless of ability to pay.

SEC. 5. EXTRAORDINARY POWERS.

    In carrying out the project under section 2, the Secretary shall 
have extraordinary powers to carry out the following:
            (1)(A) Direct the utilization of any and all existing 
        United States Government funded research entities and their 
        facilities to clinically test promising 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 conflict, 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 organizations, 
                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 companies adhere to an 
                approved time frame and are forthcoming with their data 
                as such work proceeds.
                    (C) Use existing pharmaceutical company facilities 
                (with just compensation) for the production of 
                promising curatives to be utilized in project research 
                and, if effective, to produce such curatives in 
                sufficient amounts to be disseminated to all people 
                needing them.
                    (D) If a drug company is found to be impeding or 
                halting the development of a promising 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 cooperate 
                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 notification 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 schedules), so that the project can 
begin functioning as soon as is possible.

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