Monday, February 22, 2010
Update on the story re diabetes drug Avandia
As I reported during the weekend, according to a Senate report, some FDA officials have been calling for a recall of the diabetes drug Avandia since at least 2007. AboutLawsuits.com is reporting today (here) that the report also accuses GlaxoSmithKline, the manufacture of the drug, of intimidating doctors and failing to adequately warn patients about the risk of a heart attack from side effects of Avandia and that about 500 heart attacks and 300 cases of heart failure may be avoided each month if Avandia were recalled. The Senate report is available here. Meanwhile, GlaxoSmithKline has issued a strongly worded rejection of the US Senate Finance Committee report (available here). Glaxo complained the report drew inconsistent conclusions, cherry picked information from documents and mischaracterized “efforts to research Avandia and communicate those findings to regulators, physicians and patients.” Glaxo also claims that it has consistently shared data with regulators around the world and updated safety information as new data became available. However, as reported today in Pharmalot (here), there is evidence that the FDA has in the past chastised the drugmaker for failing to report multiple postmarketing studies involving Avandia as required by law. Pharmalot's article includes at least one link to an FDA letter that supports this conclusion.