BioCentury
ARTICLE | Strategy

The fallout from fat drugs

September 22, 1997 7:00 AM UTC

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...