GlaxoSmithKline has released a 30-page “white paper”, defending itself from charges that it downplayed Avandia’s potential heart risks. The white paper followed release of a Senate Finance Committee report that was highly critical of both Glaxo and the U.S. Food & Drug Administration (FDA) for their handling of Avandia.
According to the Senate report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said.
The Senate report also claimed that Glaxo tried to undermine criticism of the drug: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report says.
The Senate Finance Committee report was the result of a two-year investigation, and drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials, as well as interviews with Glaxo and FDA officials and anonymous whistleblowers.
Glaxo says the Senate report “mischaracterizes and distorts” the company’s record. In its white paper, the company calls the suggestion that it downplayed Avandia’s heart risks “fundamentally flawed and contradicted by the record of extensive, ongoing interactions between GSK and the FDA.” According to the Associated Press, the company says it voluntarily submitted data on Avandia’s heart effects in 2005, and has steadily updated the government since then. It also faulted the Senate report for omitting several studies that appear to show Avandia is safe.
One of those studies, the Glaxo-funded RECORD trial, followed patients for five years and found no difference in heart-related hospitalization or death between those taking Avandia versus other treatments. However, the Senate report charged that Glaxo was aware since at least 2004 that RECORD was statistically inadequate, or “underpowered.”
Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta- analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the Food & Drug Administration (FDA’s) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.
Earlier this week, the FDA said it would conduct another safety review of Avandia, and it plans to convene an advisory panel in July to address its potential heart attack risks.