Diabetes pill raises red flag with FDA critics
By Lindsey Tanner, Associated Press Writer
Tuesday, October 21, 2005
CHICAGO A new diabetes pill that was headed for government approval has been linked to deaths, heart attacks and strokes, a medical journal reported Thursday in an analysis it said was rushed online to head off a Vioxx-like fiasco.
The study by leading heart researchers found twice as many deaths and cardiovascular problems in diabetic adults taking the drug Pargluva as those on dummy pills or a competing drug.
Developed by Bristol-Myers Squibb and Merck & Co., the drug, known generically as muraglitazar, was endorsed by a Food and Drug Administration panel last month. It is a treatment for Type 2 diabetes, the most common form of the condition and one that occurs most often in people who are overweight.
The Journal of the American Medical Association said it posted the analysis on its Web site Thursday ahead of next month's publication date because of public safety concerns. The study was by Cleveland Clinic doctors who reviewed data the FDA made public before the panel vote.
If the analysis is correct, the drug could have meant a "public health catastrophe" given that 18 million Americans have diabetes, said Dr. Steven Nissen, who worked on the analysis with Dr. Eric Topol and a clinic statistician.
"This is the Vioxx that isn't going to happen," Nissen said, referring to the popular painkiller Merck removed from the market last year after it was linked with serious heart problems.
Critics including Nissen have accused the FDA of lax drug surveillance because of Vioxx and other recent safety issues.