Avandia Critic Calls Glaxo-Funded StudyJul 14, 2010 | Parker Waichman LLP
GlaxoSmithKline got a drubbing yesterday, during the first day of a Food & Drug Administration (FDA) advisory panel meeting on Avandia’s safety. The recommendations ultimately made by the panel could help determine whether Avandia is allowed to remain on the market.
According to CNN, a Glaxo-funded study called RECORD was highly criticized by Dr. David Graham, an FDA researcher. “You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief,” he said of RECORD.
RECORD, which was released in 2009, did not find increased heart risks, as other Avandia studies have. It was touted by Glaxo as evidence of the drug’s safety.
Graham said the RECORD study would have been dismissed as “garbage” if it had been used to seek the drug’s original approval.
Graham’s own recently-released Avandia study of 227,500 Medicare patients found that those who took the controversial diabetes drug were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.
Graham is only the latest Avandia critic to tear into RECORD. Last week, a memo in a 756-page briefing document posted to the FDA Web site characterized RECORD as “inadequately designed and conducted to provide any reassurance about the CV (cardiovasular safety) of rosiglitazone.” The memo further states that the RECORD results “confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks.
According to a New York Times report, the FDA review of RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.
Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.
Last week, Dr. Stephen Nissan, who conducted that study, released a follow-up to it. The update looked at 56 clinical studies involving 35,500 patients, including RECORD, and found an increased heart attack risk of 28 percent. Without RECORD, the risk of heart attacks rose to 39 percent, according to study.
That update is also among the evidence being considered by the FDA advisory panel. Dr. Nissan, who was also present at the meeting, criticized Glaxo for failing to run any adequate trials of its safety.
“We have a drug that has been on the market for 11 years. The company had every opportunity to do large-outcome trials, adequately powered and properly run, to answer this question. They didn’t do it,” Nissan said.
Today, the advisory panel could vote to recommend that Avandia be removed from the market. While the FDA isn’t required to follow advisory panel recommendations, it usually does so.