Bart Stupak (D-Mich.Thursday sent letters to the , the , Merck and Schering-Plough to request information about Vytorin, and Sen.Grassley (R-Iowa) on Thursday began a separate investigation into the medication.According to the Journal, the "lawmakers' interest is the latest sign that the flap over" Vytorin, as well as the safety concerns about Avandia, "is adding new fuel to a long-running debate" about the use of "surrogate markers" in the FDA approval process.Approved Vytorin and Avandia in large part based on evidence that they helped control cholesterol and blood sugar levels, respectively, with those measures "believed to reflect important clinical benefits" that "serve as proxy markers, or surrogates, for the drug's broader and more important effect on the body," the Journal reports.Use of surrogate markers helps reduce approval times for new medications because "studies can generally be shorter, smaller and cheaper," but the markers "can be misleading," according to the Journal.That, "in light of what's happened with Avandia and Vytorin, maybe the FDA needs to re-examine when it's appropriate to use surrogate endpoints.Added, "These two cases also highlight the importance of vigilant postmarketing surveillance and the need for more postmarketing studies to address important safety questions.That "people taking Vytorin are doing so because they believe it will reduce their risk of heart attack.Addition, he said, "It would make sense for FDA to require manufacturers to conduct an endpoint study to determine whether Vytorin just reduces cholesterol or if it also reduces heart attacks.Said that they would examine the use of surrogate markers in the agency approval process."shift by the FDA toward tougher scrutiny of new drugs could add hundreds of millions of dollars to the cost of developing a drug at a time when some big drug makers are struggling to replenish product pipelines," the Journal reports (Wilde Mathews/Winslow, Wall Street Journal, 1/25).Reprinted with kind permission from .Can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at .Kaiser Daily Health Policy Report is published for kaisernetwork.Free service of The Henry J.Family Foundation 2005 Advisory Boardpany and Kaiser Family Foundation.Rights reserved.HOW INTERESTING WAS THIS ARTICLE?Not Very.Read more Oxycodone and acetaminophen(oxycodone hydrochloride and acetaminophen) tablet [mallinckrodt inc.]
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