Live from FDA: Nissen speaks on Avandia
GAITHERSBURG, MD -- Today is the day--the hunger awaited combined congress of the FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to debate the cardiovascular risks of GlaxoSmithKline's () Avandia. And, as expected, the compartment was swollen for the shrink of the two-day meeting. FDA Commissioner Margaret Hamburg kicked things off with a impatient energy talk, urging the panel to "follow the science, wherever it leads, and the lay will dwindle into place." She was followed by the FDA and finance presentations, during which GSK tried to made the holder that Avandia helps come across an unmet need in patients with diabetes.
Furthermore, when old appropriately, Avandia has a uncontested risk-benefit profile and should remain a healing option, company representatives emphasized. Avandia critic Dr. Steve Nissen () of the Cleveland Clinic also appeared before the panel in a feisty mood. He incisive to the Avandia green light box from 1999, saying the increment in LDL cholesterol in these patients should have raised more concerns. The one attitude medical professionals don't want to do, he said, is augment LDL cholesterol in this perseverant population.
But in the expedition to replace Rezulin, which was raising hepatotoxicity concerns, the FDA approved Avandia, letting the "genie got out of the bottle"--and we've been fatiguing to get it back in ever since. Nissen also slammed the RECORD trial, which was funded by GSK and hypothetically showed the painkiller was safe, as being "unacceptable in quality," titling one slide: "Record - How not to Perform a Safety Study." The test is flawed, he emphasized, because there was "extraordinary unblinding," with GSK and Quintiles getting unrestricted availability to the curing codes. RECORD, which he calls plenary of flaws and essential biases, should not be employed to pull the panel's ruling that affects so many lives.
Furthermore, with an selection in the same class--Actos (pioglitazone)--with favorable crap on cardiovascular outcomes, "continued marketing of rosiglitazone cannot be medically or ethically justified," Nissen concluded. Regarding his New England Journal of Medicine article depreciatory of Avandia, Nissen said he knew it would be controversial, but the obvious had a perfect to distinguish about the protection concerns anent Avandia, and he doesn't bemoan what he did. Thomas Marciniak, a reviewer for the FDA center that approves experimental drugs, then took the stage. He was very frank, saying just as all Gaul is divided into three parts, the FDA is divided into three factions concerning Avandia--those in favor, those against, and himself, who just recently entered the debate.
He said a circus aerosphere has caused a moment of a distraction, and then got moral into his analysis. The open-label attributes of RECORD was problematic, he noted, adding that the crack was inadequately designed to victual any reassurance about the cardiovascular safe keeping of the drug. In fact, he bluntly stated he would have rejected the scan design. However, he does maintain that some bumf can be salvaged from RECORD, if one looks at the plain evidence rather than the GSK reports. The panel convergence comes with the news that in the fall of 1999, SmithKline Beecham to bargain out if Avandia was safer than Takeda's Actos.
GSK was delivered a significant muff when the study results showed Avandia no better than Actos, but the haunt also provided clear signs it carried greater cardio risks.
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