"Doctor, are you trying to kill me?": ambivalence about the patient package insert for estrogen.
In 1976, the U.S. Food and Drug Administration proposed new requirements for patient labeling for estrogens prescribed for menopausal and postmenopausal women. This paper explores the variety of responses to this proposal from women and their husbands, feminist and consumer activists, physicians, pharmacists, and pharmaceutical manufacturers, as represented in letters written to the FDA. The drug industry and the medical profession opposed patient labeling on the grounds of cost and a resentment of governmental intrusion. Feminists and consumer advocates were in favor of the idea, but the response from current estrogen users was mixed: most women wished to be better informed, but many expressed concern that estrogen would be removed from the market. This ambivalence suggests unresolved tensions regarding conceptions of female aging, the medical management of menopause and aging, informed consent in medicine, and governmental regulation of medical practice. The debate thus represents an important moment in the history of women's health care.
Watkins
Elizabeth Siegel
ES
D001291:Attitude of Health Personnel; D001294:Attitude to Health; D004345:Drug Industry / Q000266:history / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000266:history* / Q000331:legislation & jurisprudence; D004967:Estrogens / Q000009:adverse effects / Q000266:history*; D005260:Female; D049673:History, 20th Century; D006801:Humans; D008297:Male; D008593:Menopause / Q000187:drug effects; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history; D014933:Women's Rights / Q000266:history
D004967:Estrogens