The fallout from fat drugs
Now that it has pulled Redux dexfenfluramine and Pondimin fenfluramine from the U.S. market, Wyeth-Ayerst Laboratories must brace for litigation. One protection that the pharma company could raise is a well-performed epidemiological study demonstrating no statistical link between taking the drugs and developing heart valve defects. But while such a study could bolster the company's position in court, product liability attorneys contacted by BioCentury suggest it does not offer a watertight defense.
The company's ability to conduct a definitive epidemiological study is already hampered by the drugs' removal from the market. The company cannot conduct a prospective trial of patients before and after they begin drug use. Instead, Wyeth-Ayerst will begin enrolling a study within two weeks that compares obese patients who took the drugs with those who never took them.
The company will enroll 400 who took Interneuron Pharmaceuticals Inc.'s Redux and 400 who took Fen-Phen and compare them to an age, weight and sex matched control group of 400 non-users. Echocardiograms will be taken to determine whether