Opinion ID: 1381810
Heading Depth: 3
Heading Rank: 1

Heading: Upjohn's Reaction to Hormone Replacement Therapy Being Linked to Breast Cancer

Text: As early as 1963, Upjohn was aware that Provera might exacerbate existing breast cancer. [8] In 1970, Upjohn withdrew Provest, an oral contraceptive containing estrogen and progestin, after a study showed that progestin caused mammary nodules in beagle dogs. Recognizing that Provest's withdrawal might alarm doctors prescribing combination hormone therapy drugs, Upjohn issued a Dear Doctor letter that assured that there was no reason to predict human extrapolation of this finding, but that there was also no way of disproving it. The letter distinguished Provest, a contraceptive used for a prolonged period of time for which there were adequate replacements, from Provera, a therapeutic agent[] for specific gynecological disorders. The letter concluded that Provera's benefits outweighed the possible risks and that continued use poses no unwise risk in this regard to you or your patients. In 1990, Upjohn hired the Degge Group to gather and review all available scientific data concerning the risk of breast cancer with hormone replacement therapy involving progestin. The goal was to determine what was known and what areas needed further research. The Degge Group found that the evidence was inconclusive, and it identified and recommended areas for further research. The Degge Group published the results of its research in 1992, in Fertility and Sterility, an obstetrics and gynecology medical journal. Upjohn, however, did not conduct follow up studies or research. By 1992, Upjohn still did not know the extent of the risk of breast cancer with progestin use as part of hormone replacement therapy. Between 1982 and 1994, Upjohn conducted thirty-four studies to prove that Provera protected the endometrium. The studies were monitored for breast cancer, but they were not designed to be large enough or long enough in duration to be capable of evaluating the breast cancer risk. Until 1995, there remained a prevailing view that progestin's addition to estrogen replacement therapy might reduce the incidence of breast cancer in much the same way that it reduced the risk of endometrial cancer. In 1995, however, a publication by Dr. Colditz examined available data from 1978 through 1992 and concluded that there was no benefit. In fact, the study found a slightly higher risk with the addition of progestin. Dr. Colditz observed a significant elevation in the risk of breast cancer among women using conjugated estrogen alone, a relative risk of 1.32; for estrogen and progestin, the relative risk was 1.41; and for progestin alone, the relative risk was 2.24.