World

Study critical of new diabetes pill S. Ariz. tops in nation for diabetes

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, such as evidence linking some antidepressants with a greater risk of suicidal thoughts in youngsters. The FDA appeared to be heading down the same road with Pargluva despite that criticism, said Dr. Catherine DeAngelis, JAMA's editor in chief. "It is beyond me why individuals who are supposed to be overseeing the safety of the public would take a chance when it's not necessary," DeAngelis said. In a statement, the FDA said it appreciates "the need for careful assessment of risk versus benefit for all drugs, particularly those indicated for long-term, preventive therapy." "The FDA has made significant investments of resources and expertise in developing fundamentally better methods for identifying and monitoring cardiovascular safety issues with all drugs." Bristol-Myers Squibb and Merck issued a written statement Thursday that said Pargluva "was extensively studied and all available data were reported to the FDA." Pargluva would be the first diabetes drug on the market designed to lower blood sugar, reduce fatty triglycerides and increase levels of "good" cholesterol, Nissen said.