‘First in Man’: The Politics and Ethics of Women in Clinical Drug Trials

Abstract

Within the world of pharmacology, the male body has traditionally been taken as the biological norm. Coupled with this, concern about danger to the unborn foetus has meant that, until very recently, ‘women of childbearing potential’ were routinely excluded from most of the early phases of clinical drug testing. Consequently, most drugs tested during Phase I trials were initially carried out on healthy male volunteers. During subsequent phases when drugs were tested on patients, women remained largely under-represented. As a result, some drugs prescribed for women have later been discovered to be lacking in efficacy, and women are more likely to suffer adverse drug reactions than men. The exclusion of women during the early phases of clinical drug trials has now been lifted and drugs are currently being more widely tested on women. This paper examines the differing political and ethical positions adopted by the pharmaceutical industry, drug regulators, pharmacologists, women's groups and patient activists in relation to the exclusion and inclusion of women in clinical drug trials.