A US Senate investigation concludes, along with some FDA officials, that Avandia (rosiglitazone) should no longer be on the market, according to a front page story in the New York Times by Gardiner Harris.
In reports obtained by Harris, FDA officials David Graham and Kate Gelperin conclude that “rosiglitazone should be removed from the market.” Harris says the report, along with others, “are part of a fierce debate within the agency over what to do about Avandia.” The Times also reports that Janet Woodcock, the director of FDA’s drug center, has “ordered officials to assemble another advisory committee… to reconsider whether the drug should be sold.”
FDA Commissioner Margaret Hamburg told Harris that she will “await the recommendations of the advisory committee” and that she is reviewing the Senate inquiry.
The Senate investigation, from Max Baucus and Charles Grassley, will be officially released on Monday. The report criticizes Avandia’s manufacturer, GlaxoSmithKline, for its attempts to “intimidate independent physicians” and for efforts to “minimize or misrepresent ” the cardiovascular risk of rosiglitazone.
In response to the growing controversy over the drug, and at the request of the FDA, GSK initiated the 16,000 patient TIDE trial. According to the description of TIDE on ClinicalTrials.Gov, TIDE is designed “to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.”
In response, however, the FDA’s Graham and Gelperin say that TIDE is “unethical and exploitative,” Harris writes, since “patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit.” One of the FDA reports conldues that ““although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”
Senators Baucus and Grassley sent a letter to FDA’s Hamburg asking “what steps the FDA has taken to protect patients in the TIDE trial.”
Previous CardioBrief coverage on rosiglitazone: