UNITED IN ANGER: A HISTORY OF ACT UP STUDY GUIDE

UNIT 4: THE POLITICS OF HIV/AIDS MEDICINE

Unit Summary
Unit 4 examines the politics of HIV/AIDS medicine.  One of the lasting lessons from ACT UP was that medical research and scientific inquiry can be deeply political, biased, and unfair rather than neutral, as it is often made to seem.  In order to fight HIV/AIDS, ACT UP discovered that it was necessary to fight the prejudices of homophobia, sexism, and racism that operated within systems of medical authority.  Just as importantly, ACT UP helped change the role of the “patient” into that of the expert, resulting in new research protocols and ethical standards for medical treatment.  

The objectives of Unit 4 are:

  • To become familiar with several government agencies that provide health services, including the FDA (Food and Drug Administration) and the NIH (National Institutes of Health) and their relationships to the private, profit-based, pharmaceutical industry

  • To understand why these government and corporate entities were not addressing the scientific needs of people with AIDS

  • To articulate ACT UP’s various critiques of the HIV/AIDS scientific community

  • To understand the research agenda set by ACT UP

 *Note: Unit 4 explores the interventions made by ACT UP into scientific and medical communities.  An important yet complex topic, this unit proceeds slowly, provides in-depth commentary, and invites a more sustained turn to the ACT UP oral histories that help to narrate the film.

Making Connections: The FDA and the NIH
The previous unit introduced you to the Centers for Disease Control and Prevention (CDC) and its role in the AIDS epidemic.  Unit 4 will reference two other Federal agencies that are responsible for protecting the public health in the U.S.: the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).  Some of ACT UP’s greatest achievements involved improving, sometimes dramatically, the ways these institutions function for the public good.  Before discussing the ways ACT UP intervened within these bureaucracies to save and extend lives, review the following descriptions of the FDA and the NIH, both of which impact your health.

The FDA 
(For a complete list of FDA functions, see here.)

The FDA is responsible for protecting the public health in many ways, some of which directly affect people with HIV/AIDS.  Of utmost importance to ACT UP were the following FDA control mechanisms, as described in the ACT UP FDA Action Handbook:

 By law, the FDA must approve all drugs sold on the open market as safeand effective. It must also approve all experimental drug trials as reasonably safe, in relation to the possible benefits of research and risks of the trial, to subjects participating in them. And the FDA can raid a health food store or buyers’ club for making unsubstantiated medical claims for food substances, and can block imports of foreign drugs, or interstate transportation of unapproved substances.

The FDA regulates the entire process of testing experimental drugs in humans, following the drug through the various phases of testing and examining the data submitted by the trial sponsor after the completion of trials to determine if the drug meets the standards legislated by Congress….

 
The NIH
(For a complete list of NIH responsibilities, see here.)

The NIH, as the primary Federal agency responsible for biomedical and health-related research, in large part has the power to determine the AIDS research agenda in the U.S.  ACT UP targeted the NIH as the body that established research and funding priorities (such as deciding which drugs and therapies to invest time and resources in) and, crucially, controlled how research on HIV/AIDS was conducted (including how AIDS “clinical trials,” or health-related research studies in human beings, were carried out, who could participate in and potentially benefit from them, and who could determine protocols and procedures for the trials).  Most of the AIDS research within the NIH occurs under the office of NIAID, the National Institute of Allergy and Infectious Diseases, as AIDS is caused by an infectious agent, HIV (Human Immunodeficiency Virus).

Key Terms
accelerated approval
AIDS Clinical Trial Group (ACTG)
AIDS Treatment Registry (ATR)
AZT
Centers for Disease Control and Prevention (CDC)
clinical trials
combination therapy
Community Constituency Group (CCG)
drugs into bodies
expanded access/parallel track
Food and Drug Administration (FDA)
insider/outsider Strategy
Men who have sex with Men (MSM)
monontherapy
National Institutes of Health (NIH)
Person with AIDS (PWA)
protease inhibitor
Treatment and Data Committee