In the April 19,2007 issue of NEJM,Dr. D.B. Ross a former FDA physician involved in the Ketek review process, presents what reminds me of a prosecutors closing argument critical of the FDA performance in the approval of Ketek and its response to a flawed drug trial and its slow response to increasing evidence of its liver toxicity.
He is critical of the way that the FDA handled the entire matter and seems to present a very fact oriented argument absent of emotional laden rhetoric. NEJM features his commentary and also present the "defense closing argument" penned by five current FDA physicians somewhat less prominently in the correspondence section. So the interested reader can study both sides of the issue "did the FDA do its job appropriately?"
For a more detailed and nuanced personal view the audio interview with Dr. Ross is available on the NEJM site . He opines that the culture of the FDA changed about ten years ago and now a "culture of approval" is found. A significant percentage of FDA operating funds derives from drug companies and the incentive arrow points in the direction of faster rather than slower approval.Dr. Ross presents instances where pressure from above serves to discourage criticism of trials and more rather than less scrutiny.
Part of the FDA mission ( or at least their mission statement as the two need not necessarily coincide completely) is to "speed innovations".Ross believes that the speed imperative and the driver of big pharma funding may at least be part of what seems to be a problem at this agency.
While the word speed may be instructive in this instance, in general I believe that Thomas Sowell's insight regarding institutions and organizations (any decision making unit) works best. Do not look at what an organization says it is doing, look instead to the incentives and constraints it faces and the feedback it can receive. There does seem to be an incentive to speed innovations (it may not just be mission statement verbiage) and there is a budgetary restraint and at least until recently( when senate committees have investigated) much of the feedback was from the drug companies.
We now have testimony from two long time FDA physicians (remember Dr.David Graham and the Vioxx saga) which have seriously damaged the reputation of the FDA and our belief that a drug is safe and effective because the FDA says it is. Still more concern is raised in another Perspective Commentary in the same issue of NEJM by Dr.Mirian Shuchman which discusses the approval process of the vagus-nerve simulation for treatment of depression.
