REZULIN: Clinical Trial Officials Faulted for Oversight
Physicians in charge of a 1998 clinical trial testing the diabetes drug Rezulin failed to follow required monitoring procedures for a woman who died after taking the experimental pill, the Los Angeles Times reports. According to an e-mail sent by Dr. Robert Misbin to his FDA superiors Friday, trial participant Audrey Jones was not retested promptly after blood tests first revealed signs of liver damage after taking Rezulin. Misbin was the FDA official responsible for evaluating Rezulin's safety. Misbin wrote, "According to the protocol, [Jones], who went on to die following a liver transplant, should have had her (liver-function test) repeated within two weeks after the first elevation. In fact, it took five weeks to recheck her values. By that time her liver had been irrevocably damaged." The discovery comes at a time when FDA officials are meeting to decide whether to take Rezulin off the market. Since its release in 1997, the diabetes drug has been linked to 89 reports of liver damage, including 61 deaths. Dr. James Gavin, a member of the safety monitoring board for the clinical trial at NIH, said that the situation provided a "sobering kind of epiphany" of the dangers of the medication (Willman, 3/21).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.