TIME TO REPLACE, NOT REFORM FDA
Attorney Jonathan Emord
Author of "The Rise of Tyranny"
July 15, 2010
In my book The Rise of Tyranny, I reveal many instances in which drug industry executives have been complicit with FDA political appointees in causing unsafe drugs to enter the market over the objections of FDA medical reviewers. The political angst now expressed over just one of the drugs I wrote about, GlaxoSmithKline’s Avandia, is dreadfully late—coming a decade after FDA Medical Reviewer Robert I. Misbin first sounded the alarm within FDA on the link between that Type 2 diabetes drug and heart problems. Had Misbin been credited instead of discredited by FDA management, the drug never would have entered the market or, if it did, it would have been accompanied by extreme warnings.
The story of FDA’s approval of Avandia over the objection of agency medical reviewers (and FDA defense of the drug for over a decade) reveal precisely why FDA cannot be counted upon to protect the American public. In an April 2, 1999 internal memo Misbin explained to his superiors his concerns “about deleterious long term effects on the heart” from the drug. His criticisms were rejected. On May 25, 1999, FDA approved the drug for marketing without referencing the heart risks. Dr. Misbin later stated that “[o]ne of [his] superiors said something to [him] that [he] never [forgot], that we have to maintain good relations with the drug companies because they are our customers.” In February 2006, another FDA Medical reviewer, Dr. Rosemary Johann-Liang, strenuously urged that FDA require GlaxoSmithKline to put a black box warning on the drug, alerting people to its effect of increasing the risk of heart attack. Dr. Johann-Liang’s supervisor told her that FDA management was “upset with [her] recommendation” and “decided to act like [her] review never happened.”
California Congresswoman Diane E. Watson used the drug for her diabetes. She developed a heart murmur which she attributed to Avandia in a congressional hearing. On the advice of her physician, she stopped taking the drug. Seven years after the drug entered the market, caving to pressure brought on in no small measure by the efforts of FDA Office of Drug Safety Associate Director David Graham, FDA ordered a black box warning in Avandia labeling, but kept the drug on the market. In July of 2007, an FDA advisory panel voted 20-3 that Avandia increases cardiac ischemic risk in type 2 diabetics but voted in favor of keeping the drug on the market despite the extraordinary risk. In short, the economic interests of the drug industry won out over sound medical judgment.
There are many treatments for Type 2 diabetes that do not entail a 43% increased risk of heart attack (New England Journal of Medicine, May 2007, Meta-Analysis by Drs. Stephen Nissen and Kathy Wolski), yet FDA has until recently been a dogged defender of this drug seemingly unaffected by severe medical, scientific, political, and public criticism. If there was any doubt that the drug industry exercises undue influence over FDA, the case of Avandia (and over a dozen unsafe drugs now on the market) should have eliminated that doubt.
The solution to this problem lies not in “reforming” FDA. FDA is inherently corrupt. The solution lies in replacing FDA review altogether. In The Rise of Tyranny I offer an alternative. The approach I advocate involves creation of a new statute that would vest authority for drug reviews outside government, in independent University testing centers. Each center would have to qualify by establishing that the academics who would man it are free of any present or past association with drug companies. New drug applications would be filed with the Department of Justice. DOJ would remove all identifying information from the applications so that the drug company sponsor would not be visible to the university reviewers.
The DOJ would then randomly (and in secret) assign each new drug application to a university testing site for evaluation. Actual clinical testing to determine safety and efficacy would occur in secret with the identities of the reviewers known only to DOJ and with severe penalties for disclosures either from the drug industry or from the reviewers. The university would then publicly issue an evaluation. The evaluation would determine whether the drug was safe and efficacious under a system that would focus on a comparative assessment of risks and benefits, focusing primarily on whether the drug agent would eliminate disease symptoms or cure disease without placing patients in mortal peril.
The final evaluation, together with the University’s recommended physician and patient labeling, would then be published in the Federal Register and adopted automatically as the position of the United States. The drug company, if displeased with the result, could then challenge it in federal court to determine whether the testing was inadequate in some particular; in which case a court could order a new blinded evaluation.
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In this way, FDA, a captive of the drug industry, would be removed from the equation and science would reign over politics once and for all. Under the present system, FDA political managers know that if they play their cards right (and approve drug applications even in the face of serious safety questions), they may enjoy lucrative post-government employment. Were it not for comparable corruption in Congress, the system could be replaced now. Sadly, until we vote all of the rascals out, we are likely to see the business of industry protection continue at FDA at the expense of human life.
� 2010 Jonathan W. Emord - All Rights Reserved