Scarcely two weeks after the Senate overwhelmingly passed legislation touted as a major fix of FDA's failing go to assure drug safety, The New England Journal of Medicine published an analysis linking the diabetes drug Avandia to a 40% increase in the risk of heart attack. This finding is especially troubling because general public with diabetes are already at illustrious risk of cardiovascular problems. A million diabetics are estimated to be current Avandia users in the U.S.
The review of safekeeping data from dozens of trials be conducted by Cleveland Clinic cardiologist Steven Nissen, MD, and biostatistician Kathy Wolski, MPH. In 2005, another Nissen-led study concluded that an about-to-be-approved diabetes drug, Pargluva, had a lofty risk of cardiovascular problems, a finding that convinced the FDA not to grant approval. Avandia and Pargluva are both member of a class of diabetes drugs known as PPAR. Another drug surrounded by the class, Rezulin, was withdrawn contained by 2000 because of its liver toxicity; while a fourth, Actos, remains a best-seller.
Subsequent revelations have raise even more questions more or less the FDA's ability to assure drug safekeeping. According to The New York Times, John B. Buse, MD, Chief of Endocrinology at the University of North Carolina and President-elect of the American Diabetes Association, wrote to the FDA seven years ago warning of Avandia-associated heart problems. And almost a year ago, Glaxo, initiator of Avandia, informed the FDA that its own internal analysis suggested cardiac risks associated with the drug.
But the FDA have said that the evidence of safety problems is inconclusive and that in that is no cause for regulatory feat. Not so with the FDA's European counterpart. The European Medicines Agency, which apparently have a lower threshold for action, put out strong warning about cardiovascular risk put a bet on in September 2006. And the director of the FDA division responsible for post-market sanctuary recently told member of Congress that his staff's recommendation of a black box stipulation for the drug's label be overruled by senior management.
So, will the lately passed Senate bill fix the FDA's poor record within assuring drug safety? In an editorial commenting on the Avandia review, drug sanctuary experts Bruce M. Psaty, MD, and Curt D. Furberg, MD, concluded, "While the Senate bill has heaps strengths ... none of its provisions would necessarily have identified the cardiovascular risks of rofecoxib [Vioxx] or rosiglitazone [Avandia] contained by a timely fashion." I agree and suggest that any hope for shrewd changes at FDA very soon rests with several proposed bills self discussed in the House of Representatives. And, I believe, the Avandia experience identify the most critical reforms that must be fragment of any legislation if it's to make a difference.
First, nearby must be complete transparency of all trial notes and FDA access to insurance industry (including Medicare) databases so the agency can determine how drugs are being used and what outcomes they are generate. The public's health can single benefit from having honourable minds like those of Nissen and Wolski analyzing facts and reaching their own conclusions. Second, unlike FDA's handling of Avandia, the public should always be without hesitation alerted to any signals of toxicity.
Most important, Congress must mandate creation of an independent FDA drug sanctuary office, one specifically all give or take a few public protection. A dedicated safekeeping office would potential have be watching more vigilantly for signs of problems with PPAR diabetes drugs given their poor sanctuary record.
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