FDA opens two-day hearing to examine safety of diabetes drug Avandia

The Fiscal Times: "There will be more at stake than just one drug's future when the Food and Drug Administration opens a two-day hearing Tuesday on the safety of the diabetes drug Avandia. The 30-member panel of outside experts will also be rendering judgment on research methods that are frequently used to compare effectiveness and are slated to become a pillar of the nation's drug safety monitoring system. If the panel or the FDA leadership proves reluctant to rely on those methods, it could set back efforts to hold down health care costs and develop safer drugs." GlaxoSmithKline's Avandia "has been under a cloud since 2007" when two Cleveland Clinic researchers published "a pooled analysis of more than 40 clinical trials that showed that compared to other drugs, Avandia raised the risk of heart attacks among already cardiovascular-compromised diabetes patients. But the drug stayed on market after an FDA panel gave it a green light despite agreeing with the negative findings. The agency added a warning to the drug's label, but said the heart risks were inconclusive" (Goozner, 7/13).

The New York Times: "In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda. … Avandia's success was crucial to SmithKline … But the study's results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart. But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law." A company spokeswoman said the results of its study were not turned over "because they 'did not contribute any significant new information.' The company said that Avandia was safe" (Harris, 7/12).

The Wall Street Journal: "A former Food and Drug Administration official said the maker of diabetes drug Avandia withheld from regulators information suggesting the drug posed an increased risk for serious heart problems, according to people familiar with her statements. … The statements by the ex-FDA official, made in a deposition for lawsuits filed against Glaxo, are included in a letter received Monday by the agency from Sen. Charles Grassley (R., Iowa), the top Republican on the Senate Finance Committee, which has been investigating Glaxo and Avandia. His letter, co-signed by committee chairman Sen. Max Baucus (D., Mont.), includes additional information detailing internal company records about Avandia, according to people familiar with the letter."

Rhyne said the letter has been "intentionally taken out of context" and the documents "identified by plaintiffs counsel involved in the product liability litigation...are a small subset of the 14 million pages of documents that have been provided in the litigation by GSK. The documents do not offer any new clinically relevant scientific information and do not provide the full extent of GSK's studies and the evaluation of Avandia" (Mundy, 7/13).

Reuters: Patients who have filed suit against the drugmaker have argued that the sealed files in that suit should be open to the FDA for its deliberations. "It is unclear what the court-sealed documents contain, but it raises questions about whether the FDA will be acting on Avandia without the benefit of all available information. … A court-appointed master is considering the request to lift the documents' confidentiality, but it is unclear when that decision will be made and how it would impact the drug's fate" (Heavey, 7/12).