AIDS and the FDA: An Ethical Case for Limiting Patient Access to New Medical Therapies

The acquired immunodeficiency syndrome (AIDS) epidemic has challenged deeply held notions on a number of issues ranging from sex education to the conduct of clinical trials. More particularly, AIDS and the human immunodeficiency virus (HIV) have focused attention on the way this nation regulates the manufacture and sale of drugs. The Food and Drug Administration (FDA) has come under increasing pressure to quicken the approval process for new medications. Exasperation with seemingly overzealous regulators who hamper the availability of promising therapies, however, are not new. For example, in the late 1970s, cancer patients and their advocates argued for changes in FDA regulations that would make “unap-proved” drugs more available. Unlike previous periods during which the FDA came under increased public scrutiny, though, AIDS and HIV have resulted in a prolonged attack on the premises that serve as the ethical foundation justifying the existence of the FDA. Moreover, those individuals and groups lobbying for major modifications in the drug approval process base part of their case not only on concerns over public policy but also on an analysis of the ethical principles involved in this debate. Mathilde Krim, who was a vocal advocate for making azidothymidine (AZT) available as soon as some evidence indicated its potential efficacy, believes that: “In the case of AIDS, it’s immoral to give people nothing at all when there is something that could do them good.”¹ Martin Delaney, a codirector of Project Inform, an AIDS activist organization, asks: “Is it ethical for the needs of the regulatory process to outweigh the needs of the patient?”² Furthermore, during the last several years, a number of underground drug markets have flourished. At the PWA Health Group in San Francisco, one can obtain many unapproved AIDS remedies, ranging from lipids to dextran sulfate.³ This year, PWA Health Group expects to sell over $1.25 million worth of drugs. The existence of these “buyers’ clubs” has helped to undermine the FDA’s ability to conduct its mission.