NEWSCOM
GOVERNMENT & POLICY
been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.” AVANDIA WAS approved by FDA in 1999.
The once-blockbuster drug saw its sales plummet in 2007, after publication of a paper by Steven E. Nissen, a cardiologist with the Cleveland Clinic, that showed Avandia increases the risk of heart disease. FDA was first warned about the heart risks of Avandia four years ago by one of CAUTION Concerns its own scientists, who eventually left the about the safety of agency after being reprimanded for suggestAvandia prompted an FDA ing that a warning be placed on the drug, advisory panel to recommend that stronger warnings and according to the Union of Concerned Scienrestrictions be placed on the drug. tists, an advocacy group. “It is time for the agency to give its own scientists the respect they deserve when they raise red flags about the drugs they’re evaluating,” stressed Francesca Grifo, director of scientific integrity at the Union of Concerned Scientists. “We have a new Administration in office, and in spite of efforts by FDA leadership, it is still business as usual at the agency.” Grassley noted that he intends to keep CONTROVERSY OVER HIDDEN RISKS of diabetes drug pushing FDA to reform its drug safety prompts calls for government action office. “What’s happened with this drug further makes the case about the need to strengthen the office within the FDA that AN ADVISORY PANEL of the Food & Drug e-mails from executives of GSK discussmonitors drug safety after a drug is on the Administration voted on July 14 to keep ing whether to publish studies that found market,” he said. the controversial diabetes drug Avandia problems with Avandia. In one e-mail Rep. Rosa L. DeLauro (D-Conn.), (rosiglitazone) on the market, despite evidated July 20, 2001, an executive wrote: chairwoman of the House of Representadence linking the drug to an increased risk “We would hope that these do not see the tives Appropriations Subcommittee on of heart disease. The panel did, however, light of day.” The committee provided FDA Agriculture, which has jurisdiction over recommend tightening warning labels and with several other FDA’s budget, is also restricting sales of the drug. e-mails, all of which closely monitoring S CH3 FDA Commissioner Margaret A. Hamsuggested that the the Avandia controO N NH burg will now have to decide what action to company tried to hide versy. In response to O O take. The agency is under pressure to move studies that pointed the advisory panel’s N swiftly from members of Congress and to an increased risk vote, she urged FDA HO2C CO2H advocacy groups, who claim that Glaxoof heart disease with to remove the drug Avandia SmithKline (GSK), the maker of Avandia, Avandia compared from the market. hid data relevant to the safety of the drug. with its rival drug, “I understand Congress is also looking closely at this case Actos (pioglitazone), made by Takeda that there may be a lack of consensus on to determine whether FDA’s office of drug Pharmaceuticals. the effects of this drug at the FDA. But safety is in need of reform. GSK responded to the finance committhe result of the advisory committee vote The Senate Finance Committee, in partee’s investigation, saying the e-mails were is gravely disappointing and raises seriticular, has been investigating the safety of taken out of context from product liability ous questions as to whether the science Avandia since 2007. In a report released in litigation. The drugmaker is facing thouwas presented in an unbiased manner to February, the committee found that GSK sands of lawsuits alleging that it failed to the committee members,” DeLauro said promoted the drug despite studies suggestalert consumers to risks of heart failure and in a statement. “Given the compelling ing serious health risks. Committee Chairother injuries related to taking Avandia. evidence revealed in the weeks leading man Max S. Baucus (D-Mont.) and ranking “The Senate Finance Committee has up to this advisory committee meeting, it member Charles E. Grassley (R-Iowa) sent released a small subset of the 14 million is incomprehensible that 20 committee more details of that investigation to FDA pages of documents provided to plaintiffs’ members still voted to keep Avandia on on July 12. counsel in the product liability litigation,” the market. I intend to ask FDA some seriThe finance committee uncovered the company said in a statement. “GSK has ous questions.”—BRITT ERICKSON
FDA PANEL VOTES IN FAVOR OF AVANDIA
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JULY 26, 2010
