quarta-feira, 6 de junho de 2007

Avandia, o Legislativo americano assume uma posição.

Estou ainda sem possibilidade de avaliar os textos do NEJM publicados ontem, mas estou publicando abaixo, o despacho da Reuters.
Lawmakers to grill Glaxo, FDA on diabetes drug By Lisa Richwine and Susan Heavey WASHINGTON (Reuters) - U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia. A furor erupted last month when a Cleveland Clinic analysis linked Avandia to a 43 percent higher chance of having a heart attack. The Food and Drug Administration and Glaxo say other data provided conflicting evidence. Glaxo has said it gave regulators information in August 2006 that estimated a 30 percent higher heart-attack risk with Avandia. Some critics question why neither the FDA nor Glaxo alerted patients sooner. "The American people deserve to know why eight years after FDA approved Avandia, it's still unclear whether the drug is harmful or helpful," Rep. Henry Waxman, a California Democrat and chairman of the House Oversight and Government Reform Committee, said in a statement. Millions of patients take Avandia, known generically as rosiglitazone, and sales topped $3 billion last year. But analysts this week said prescriptions have fallen 16 percent since the Cleveland Clinic report as doctors switch patients to Takeda Pharmaceutical Co. Ltd.'s rival drug Actos. Glaxo released early findings on Tuesday from an ongoing company-funded study that was unable to show a link to heart attacks. It also defended itself and reassured patients in full-page advertisements in at least a dozen U.S. newspapers. "Patients and physicians should find these data reassuring," said a statement by Moncef Slaoui, London-based Glaxo's research and development chairman. Still, several experts said the new evidence still suggests a greater risk of heart attack. Waxman's panel is set to question Slaoui, FDA Commissioner Andrew von Eschenbach; cardiologist Steve Nissen, who wrote the Cleveland Clinic analysis, and others. CRITICISM OF FDA Concerns over Avandia have sparked an outcry from members of Congress who have blasted the FDA in recent years as being slow to respond to problems with other medicines, including Merck & Co Inc.'s withdrawn arthritis drug Vioxx. The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are seeking to use the Avandia case to push for tougher safeguards. Waxman said the House hearing would focus on whether the FDA is properly safeguarding the public and whether changes in the agency's authority, resources or leadership might be needed. The FDA is finishing its own Avandia analysis to better assess the heart risk but has not said when it will be completed. FDA officials have defended their actions, saying they had to weigh warning the public against concerns that diabetic patients could stop taking their medication altogether. "I believe we did it right with regard to Avandia," von Eschenbach told reporters last week. The agency has scheduled a July 30 public meeting to discuss the

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