The Wall Street Journal investigates study 3014, a clinical trial of Sanofi-Aventis' antibiotic Ketek. The principal investigator for the trial is in jail for fabricating data and another trial investigator was on probation during the trial and later lost his medical license after being arrested for hiding cocaine in his underwear. The FDA had asked for the study to look at potential liver damage. While the agency later discounted the trial results, it did approve Ketek in 2004 based on its approval and track record in Europe. Now, though, instances of liver failure have been documented among patients taking Ketek, and Sanofi-Aventis denies that it has hid evidence linking the drug to potentially deadly side effects.
- read the article from The Wall Street Journal (sub. req.)