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FDA Advisory Committee Votes to Keep Rosiglitazone on the Market

Posted: Sunday, July 25, 2010

Thirty-three members of the US Food and Drug Administration (FDA) cast 20 votes for various label options that would allow GlaxoSmithKline's rosiglitazone (Avandia) to stay on the market despite concerns over associated heart risks, while 12 members voted to recommend that the FDA withdraw the drug.

The fate of rosiglitazone (Avandia) appears to be decided for now after an advisory panel voted 20-12 to recommend that the FDA allow the controversial diabetes drug to stay on the market, but with stricter label warnings. Last weeks' vote marks the second time an FDA advisory panel has essentially endorsed rosiglitazone. In 2007, a panel voted that while the drug appears to carry a higher risk of cardiovascular events, it should continued to be marketed.

The FDA does not have to follow the advice of its advisory committees, but it often does.

Of the 20 panel members who voted that rosiglitazone should stay on the market, only three voted that there be no changes in the product labeling: 17 voted to recommend that GlaxoSmithKline be allowed to continue marketing the drug -- but with several caveats.

For instance, seven panelists said the company should be required to revise its current label to include contraindications for certain patient populations -- although they didn't clarify which patients might fall into the high-risk subgroup. They also favored adding a warning to the label to recommend rosiglitazone's use only in patients who have already tried another antidiabetic agent.

The 12 panelists who voted that the the drug be yanked from the market argued that there isn't a need for rosiglitazone when patients can take pioglitazone (Actos), which works as well as rosiglitazone but hasn't been found to present excess ischemic events.

The panel spent hours poring over several interpretations of GlaxoSmithKline's controversial RECORD trial, which the company has leaned on as one of its main defenses on the cardiovascular safety of rosiglitazone.

Despite the overall positive vote for rosiglitazone, there weren't many good things said about RECORD over the two-day meeting.

Another trial that came under fire during the meeting -- but was ultimately exonerated -- was the TIDE trial, which is an ongoing head-to-head outcomes trial comparing rosiglitazone with pioglitazone. The FDA ordered GlaxoSmithKline to conduct the trial after its 2007 advisory committee hearing.

An FDA reviewer called it "unethical and exploitative" to enroll patients in a trial that was created to detect harm. He also said the informed consent form for the trial obscures the risks of rosiglitazone while focusing too heavily on a more innocuous portion of the study -- a piece designed to detect vitamin D's effect on cancer.

Despite that scathing assessment, the panel voted 19 to 11, with one member abstaining (and one ducking out early), to keep TIDE open, arguing that if rosiglitazone stays on the market, then a head-to-head trial is necessary in order to keep an eye on potential safety signals. Several members favored retooling the trial's consent form.

The director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock, MD, said the agency would make a decision "as soon as possible."

At the start of the two-day hearing, the Senate Finance Committee -- which has been investigating rosiglitazone for several years -- announced that GlaxoSmithKline hid negative trial results on rosiglitazone more than a decade ago.

Rosiglitazone was approved by the FDA in 1999 to treat Type 2 diabetes. But "as far back as 2000, internal e-mails show that GSK executives sought to downplay scientific findings, which raised questions about the safety [of the drug]," wrote the Finance Committee, citing an internal memo about a trial comparing rosiglitazone with pioglitazone (Actos) that found rosiglitazone presented a "worse lipid profile" than its competitor.

In another e-mail, sent on July 20, 2001, a GlaxoSmithKline executive, discussing the negative data, wrote, "We would hope that these do not see the light of day."

The company had projected that if the poor study results went public, GlaxoSmithKline stood to lose $600 million from 2002 to 2004, according to a document obtained by The New York Times.

According to a press release from GlaxoSmithKline, the material released by the Senate Finance Committee represents just "a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation. They include drafts and other documents taken out of context, which therefore are incomplete and misleading."

Source:, FDA press release, July 2010

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