Freedman B; International Conference on AIDS.
Int Conf AIDS. 1989 Jun 4-9; 5: 950 (abstract no. W.F.O.5).
McGill University and the Jewish General Hospital, Montreal, Canada
Prominent proposals for changes in the drug approval process (e.g., the US FDA's treatment IND exemption) with respect to the treatment of HIV disease rely upon or entail the view that it is unethical and/or scientifically unnecessary to conduct controlled trials (the control arm using a placebo or a current therapy). Early understandings of the ethics of controlled trials presumed that each arm must be in a state of theoretical equipoise vis-a-vis each alternative arm, a state only satisfied when the evidence favouring any treatment arm was exactly as weighty of that favouring each alternative. A contrasting normative approach, clinical equipoise, has been developed by the author as a formal method of analyzing this ethical issue. Equipoise within the clinical community depends upon the known elements of the therapeutic index of the novel treatment in question (including etiologic rationale, functional/clinical effects, undesired side-effects, and exogenous factors relative to compliance, availability, mode of administration, and cost). As applied to AIDS drugs in particular, it is argued that control arms, though not necessarily placebos, should commonly be maintained, and that proposals presuming the contrary should be rejected.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Clinical Trials as Topic
- HIV Seropositivity
- Placebos
- prevention & control
- therapy
Other ID:
UI: 102180980
From Meeting Abstracts