Union of Concerned Scientists: Scientists, Public Health Advocates and Consumer Groups Demand Impartial FDA Review of Commonly Used Diabetes Drug
FOR IMMEDIATE RELEASE
MAY 25, 2007
CONTACT: Union of Concerned Scientists
Lisa Nurnberger (202) 331-6959 or (443) 668-9219 (cell); or
Meghan Crosby (202) 331-6943 or (937) 219-7107 (cell)
Scientists, Public Health Advocates and Consumer Groups Demand Impartial FDA Review of Commonly Used Diabetes Drug
Recent Study Finds Avandia Increases Risk of Heart Attack, Death
WASHINGTON - MAY 25 - 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"The Avandia controversy raises once again the memory of Vioxx, which was approved by the FDA and then withdrawn from the market after tens of thousands of people died," said Francesca Grifo, director of the Scientific Integrity Program at the Union of Concerned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 making 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. The letter is attached below.
The Union of Concerned Scientists is the leading science-based nonprofit organization working for a healthy environment and a safer world. Founded in 1969, UCS is headquartered in Cambridge, Massachusetts, and has offices in Berkeley, California, and Washington, D.C. For more information, go to www.ucsusa.org.
May 24, 2007
Dr. Andrew C. von Eschenbach
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20856
Dear Dr. von Eschenbach,
The American public is once again dismayed to discover that the Food and Drug Administration (FDA) has approved a drug whose risks may vastly outweigh its benefits. A study released Monday, May 21 in the New England Journal of Medicine indicates that Avandia may significantly increase the risk of heart attacks. Since diabetics are already at high risk of cardiovascular events as a result of their disease, the possibility of a drug-related increased risk of heart attack calls into question the wisdom of the continued use of this drug, as well as the basis on which it was approved.
In light of this study, and faltering public faith in the integrity of the FDA drug approval process, we write to urge you to ensure that the composition of any advisory committee that is being convened to review the safety of Avandia be free of any conflict of interest. At the minimum, no member of this committee should have had any financial ties to GlaxoSmithKline, Avandia's maker, for the past 36 months.
No law currently mandates that the FDA use only non-conflicted scientists on its advisory committees. But history teaches us that when scientists have conflicts of interest, the well being of the public may be compromised. Last December, a company-funded study of Avandia showed no increased heart attack risk when comparing rosiglitazone (Avandia) to metformin, a commonly prescribed generic drug widely used for glycemic control. Every author of that study either worked for or had financial ties to GlaxoSmithKline.
In February 2005, ten of the 32 scientists on the advisory committee that considered the safety of Cox-2 inhibitors, including Vioxx, had ties to the drug companies that made the products. The scientists voted to permit the companies to continue marketing the drugs, even though Vioxx had already been withdrawn from the market and had been implicated in tens of thousands of deaths.
By staffing the Avandia advisory committee with scientists from diverse specialties who are non-conflicted, you will send a message that the FDA cares about avoiding conflicts of interest and evaluating drugs on the basis of unbiased scientific findings.
The Avandia panel is just a first step in restoring public confidence. We urge you to take all steps necessary, including an expanded outreach to Schools of Public Health, to ensure that all future FDA advisory committees include only non-conflicted voting members, and to drastically curb the use of waivers to permit members with conflicts to participate on these committees.
Very truly yours,
Health Care Advocate
Mark P. Cohen
Food and Drug Safety Director
Government Accountability Project
Director, Integrity in Science
Center for Science in the Public Interest
Francesca T. Grifo, Ph.D.
Scientific Integrity Program Director
Union of Concerned Scientists
Arthur Aaron Levin, MPH
Center for Medical Consumers
National Women's Health Network
Diana Zuckerman, Ph.D.
National Research Center for Women & Families
vSteven Galson, M.D., M.Ph.
Director, Center for Drug Evaluation and Research
Robert Meyer, M.D.
Director, Office of Drug Evaluation II