Creating Waves of Awareness
Comment by Debby Bruck on July 23, 2009 at 9:24pm
Comment by Debby Bruck on February 24, 2010 at 12:07am
Comment by Debby Bruck on February 24, 2010 at 12:11am Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports, The New York Times writes. Moreover, if every diabetic taking Avandia were given Actos instead, about 500 heart attacks and 300 cases of heart failure would be avoided each month. The pill was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be yanked (Graham said this in 2007 - look).
Some FDA officials want Avandia withdrawn because they believe a safer alternative exists, the Times adds, noting others insist studies offer contradictory info and Avandia should remain an option. GlaxoSmithKline, which makes the pill, says it studied Avandia extensively and “scientific evidence simply does not establish that Avandia increases” risk of heart attacks. The debate, which began with a meta-analysis in The New England Journal of Medicine (see here and here) is intensifying thanks to disagreement over a new clinical trial (see the FDA report on the trial here) and a Senate probe concluding Glaxo should have warned of risks earlier (press release).
READ THE 342-PAGE SENATE REPORT RIGHT HERE
In a December 2009 internal memo, FDA official Janet Woodcock, wrote “there are multiple conflicting opinions” about Avandia within the agency (see here), and she ordered an advisory committee, expected to meet this summer, to reconsider whether the drug should be sold. FDA commish Margaret Hamburg tells the Times she’ll wait for the committee recommendations but is reviewing the Senate findings, which are expected to be released on Monday. The investigation criticizes Glaxo for failing to warn patients years ago that Avandia was potentially deadly.
“Instead, GSK executives attempted to intimidate independent physicians (see here), 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,” according to the report from Max Baucus, a Montana Democrat, and Chuck Grassley, an Iowa Republican, which the Times obtained.
Graham and Gelperin argued in separate internal reports that a new Glaxo study called TIDE is “unethical and exploitative” because patients given Avandia face greater risks than those given Actos, with no promise of added benefit. The trial may include patients who had heart attacks or chest pains even though foreign drug regulators warned against Avandia’s use by such patients. “The safety of the study itself cannot be assured and is not acceptable,” one report concludes.
The internal reports, which were dated October 2008 and not made public until now, were later overruled by other FDA officials, and Glaxo is currently enrolling patients in the TIDE trial, which isn’t expected to be completed until 2020, although the company is hoping to report some results to the FDA by 2014. But by 2012, the Times notes, the Avandia patent expires.
Grassley said the internal agency battle shows the FDA needs to be reorganized to give more power to safety officials over their counterparts who approve drugs and deal more directly with industry. “It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Grassley tells the Times. “The Avandia case may be the most alarming example of the problem with this setup.”
Glaxo issued a statement saying the report “draws conclusions on the safety of Avandia
(rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. In addition, the report cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia, and communicate those findings to regulators, physicians and patients.” Here is thecomplete statement.
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