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

Heading: Wyeth's Reaction to Estrogen Replacement Therapy Being Linked to Endometrial Cancer

Text: In 1975, the FDA's Obstetrics and Gynecology Advisory Committee concluded that there was a link between endometrial cancer and estrogen replacement therapy drugs such as Premarin. The Committee held public hearings, the evidence presented at which suggested a 7.6% increased risk for endometrial cancer among women taking estrogen replacement drugs. This risk decreased to 5.6% for exposure of less than five years and increased to 13.9% for exposure greater than seven years. Following the hearings, the FDA notified Wyeth that Premarin's label would have to be changed to warn consumers of the risk of endometrial cancer In response to these hearings and other reports of an endometrial cancer link, Wyeth penned a Dear Doctor letter in December 1975. The letter declared that it would be simplistic indeed to attribute an apparent increase in the diagnosis of endometrial carcinoma, solely to estrogen therapy. The letter went on to state that Wyeth is vitally concerned about the ultimate resolution of conflicting evidence in this area and suggested that using the drug as described in the package's labeling would minimize any potential risk and allow for continued use. Wyeth's letter in[c]ensed the FDA at all levels, including the Commissioner. Within weeks, FDA officials met with Wyeth executives to discuss the FDA's position that the letter misrepresented the available scientific data. The FDA's Director of Bureau of Drugs stated that he expected Wyeth to provide a sound medical and scientific response to the new information, but instead Wyeth misrepresented scientific findings. Wyeth failed to propose studies to confront the questions that the new data raised and failed to refute or confirm the studies that were then available. The FDA deemed Wyeth's letter a borderline violation of the Food, Drug, and Cosmetic Act and issued a Drug Information Bulletin to stat[e] objectively the findings linking estrogens in endometrial cancer. Shortly thereafter, the FDA required a boxed warning [2] of the endometrial cancer risk with every Premarin prescription.