| May 25, 2007 |  |
Scientists, public health advocates and consumer groups demand impartial FDA review of commonly used diabetes drug
Study finds Avandia increases risk of heart attack, death
WASHINGTON (May 25, 2007) - A coalition of scientific, public health and consumer organizations today issued a letter urging the Food and Drug Administration (FDA) to exclude scientists with financial ties to GlaxoSmithKline from a panel reviewing the safety of the pharmaceutical giant's popular type 2 diabetes drug, Avandia.
Earlier this week the FDA announced it would form the advisory panel in response to a New England Journal of Medicine article that found Avandia increases the risk of heart attacks by 43 percent and the risk of heart death by 64 percent.
"The Avandia controversy raises once again the memory of Vioxx, which was approved by the FDA and then withdrawn from the market after tens of thousands of people died," said Francesca Grifo, director of the Scientific Integrity Program at the Union of Concerned Scientists, a coalition member. "The FDA must demonstrate that it is serious about drug safety and make sure its outside experts are impartial."
The FDA also issued a public safety alert this week advising users of the drug to consult with their doctors about potential cardiovascular risks. The FDA disclosed it had known about the Avandia's potential risk since August 2006.
There is currently no law requiring the FDA to appoint members with no conflicts of interest to its scientific advisory panels. On May 9, the Senate defeated an amendment to an FDA reform bill that would have restricted the agency's use of experts with financial ties to drug makers.
Joining the Union of Concerned Scientists on the letter, which was delivered today to FDA Commissioner Andrew von Eschenbach, were the Center for Medical Consumers, Center for Science in the Public Interest, Consumers Union, Government Accountability Project, National Research Center for Women & Families, National Women's Health Network, U.S. PIRG and WoodyMatters. To view the letter, click here.
The Union of Concerned Scientists puts rigorous, independent science to work to solve our planet's most pressing problems. Joining with citizens across the country, we combine technical analysis and effective advocacy to create innovative, practical solutions for a healthy, safe, and sustainable future.
