June 28,2010

Grassley, DeLauro comment on JAMA reports re. diabetes drug Avandia



TO:      Reporters and Editors

FR:      Jill Kozeny for Senator Grassley, 202-224-1308

                Kaelan Richards for Representative DeLauro, 202-225-3661

RE:      JAMA reports on Avandia

DA:     Monday, June 28, 2010

Below are statements from Senator Chuck Grassley and Representative Rosa DeLauro about reports published today by the Journal of the American Medical Association, JAMA, regarding the diabetes drug Avandia. 

“The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July.  Patients and taxpayers need and deserve a clear response and rationale from the Food and Drug Administration about the safety and efficacy of this drug," Grassley said.

“Coupled with the previous findings, these new studies appear to confirm that Avandia is dangerous and should be pulled from the market.  The evidence now seems to be overwhelming that taking Avandia significantly increases a patients’ risk of a heart attack, even when compared to a similar prescription drug.  This information will make it even more difficult for the FDA to justify keeping this dangerous drug on the market,” DeLauro said.

In February, Grassley and Chairman Max Baucus released a Finance Committee report and expressed concern about the FDA’s actions to protect patients amid substantial controversies surrounding Avandia, which was approved for market in the United States in 1999.  The committee report explores when the Avandia manufacturer became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.  Baucus and Grassley directed the report over concerns that Avandia and other high-profile drugs such as Vioxx put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies downplaying or under-exploring potential safety risks.  In 2007, Congress enacted legislation giving the FDA some new tools to better protect patients from harm caused by drugs that are brought to market without sufficient safety oversight or consumer warnings. However, the legislation did not fix a fundamental problem at the FDA, which is the imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place.  Grassley’s amendment to strengthen the independence of the post-market surveillance office was defeated during debate over the larger FDA bill that year.

In April, DeLauro chaired a hearing to examine the issues surrounding the safety of Avandia subsequent to the studies that found an increased risk of cardiovascular death in patients taking the drug.  The information revealed during this hearing, and in the Senate Finance Committee staff report, was very troubling.  After a study published in the New England Journal of Medicine found that Avandia may cause heart attacks, the manufacturer reportedly launched a public relations campaign to undermine the legitimate concerns that were outlined in the study.  According to additional reports, the manufacturer also attempted to intimidate physicians who expressed concern about Avandia’s safety and/or sought to suppress their comments.  The hearing highlighted the fundamental problem at the FDA, referenced above, in that an imbalance exists within FDA between the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE).  This structure is biased by design because those who initially approve drugs also decide how they are regulated for safety in post-marketing.