Where Is The FDA?

MedPage Today recently published a four part series describing the results of a remarkable investigation in conjunction with the Milwaukee Journal Sentinel. It is the story of very expensive cancer drugs that have been released on the market with no evidence of efficacy or proof of safety.  This is explained as being the result of desperate cancer patients and organizations advocating quick FDA approval of any drug that might hold hope. 54 such drugs were examined. The average charge for these medications is $10,000/month but as high as $40,000/month. That $40,000 drug has been shown to extend life by 4 months. 40 of the drugs were approved without showing any evidence that they prolonged life or improve the quality of life. Looking at 26 of those approved between 2004 and 2011 only three were found to increase survival. This was by 10 months and  8 weeks and the third improved the 3 year survival rate from 61% to 70%.  Not very impressive.

What is the approval process? Instead of requiring proof of efficacy as measured by improved quality and quantity of life the FDA approves cancer drugs based on surrogate markers, supposedly showing that the drug is able to cause shrinkage or slowing of progression of a cancer. The FDA then gives the drug company many years to come up with better studies of safety and efficacy. The companies stall on this but they continue to collect exorbitant charges. Side effects, including drug caused deaths, are ignored. As Richard Deyo says “Maybe you live a month longer with a new drug but you are having horrible symptoms or horrible quality of life in the meantime”

What are the forces that create this perversion of research and approval? Yes, societal pressure is one of them. But we must not forget that cancer drugs are a $28 billion industry (in 2013). This is a strong motivation for an industry that has a history of distorting and profiteering from tainted research and marketing.  Add to that the fact that half of the FDA drug evaluation budget is paid for by the very pharmaceutical companies it is supposed to monitor.  Ironically, the FDA is now judging its own performance by using surrogate criteria, i.e., the number and speed of drug approvals. It certainly shouldn’t take $800 million to rubber stamp a bunch of applications. They should be able to do that before lunch. Maybe, just maybe, we need to replace the FDA with a true watchdog agency that has strong scientific integrity and maximum immunity from conflicts of interest, and political micromanagement. Also read  http://wp.me/p4MwV3-3a

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