Drug Testing by FDA in Crisis

Friday, April 10, 2009

Things are so bad with the Food and Drug Administration’s clinical trial system for approving new drugs that the country is “virtually defenseless” from preventing another Vioxx scandal. This finding, and many others regarding dangerous conflicts of interest in the FDA process, are reported in a new study by the Government Accountability Project (GAP). The report says the FDA has suffered from a lack of funding since 1992, while the pharmaceutical industry has grown into a money-making machine earning $40 billion in profits in 2006 for the top 10 companies. With fewer dollars to properly test new drugs, the FDA has been forced to “heavily rely on fees it receives from the very industry it is supposed to regulate,” which gives drug companies considerable leverage in getting federal regulators to rush drug approvals at the sacrifice of product safety, according to GAP.

 
And then there are the myriad conflicts of interest. GAP cites a 2003 study that revealed approximately two-thirds of academic medical centers hold equity interests in companies that sponsor research at these institutions. In addition, there are for-profit research organizations that conduct clinical trials on behalf of pharmaceutical companies. Marcia Angell, former editor of the New England Journal of Medicine and a senior lecturer at the Harvard Medical School, told GAP that all clinical trials should be administered by the National Institutes of Health: “It is self-evidently absurd to look to investor-owned companies for unbiased evaluations of their own products. Yet many academic investigators and their institutions pretend otherwise, and it is convenient and profitable for them to do so.”
-Noel Brinkerhoff
 

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