Whos to Blame for Approving Bad Drugs?
March 13, 2001 (Washington) — When there is a major train wreck, the government often investigates the possible underlying causes. Now a newspaper report has sparked the question among some consumer watchdogs of whether the same investigative reaction should occur when prescription medications are withdrawn. According to the newspaper’s account, prescription drugmaker Warner-Lambert Co. assured the FDA that its type 2 diabetes drug Rezulin was safe prior to its approval in January 1997 — even though the company knew of at least 12 people who suffered life-threatening liver damage during clinical trials of the drug. Citing previously undisclosed company e-mails and memos, the paper reported that certain FDA officials also worked with Warner-Lambert executives to remove barriers at the agency to the drug’s approval. In fact, the paper reported, highly placed FDA officials went as far as to replace the originally assigned agency reviewer, who was adamantly against approving Rezulin. The
