FDA endorses masking placebos as proven drugs as a get-rich-quick scheme
Numbers Rule Your World 2013-04-22
That's not really what the FDA said but based on the shameful actions unearthed by ProPublica and reported by Scientific American here, one would think one can get away with this scam.
Three years ago, the FDA busted a Houston lab (based on a whistleblower report) that fabricated loads of research studies that were used by the FDA to approve about 100 drugs. Eighty-percent of those drugs were generic drugs that the lab supposedly proved as (bio)equivalent to the brand-name counterparts.
Three years later, the FDA has only reviewed new research on 21 of those drugs. The agency has refused to provide any information about the names of the drugs that have been fraudulently approved, nor provided any information about how they were reevaluating these drugs. The excuse is "confidential commercial information".
To date, the FDA has not pulled any of the drugs from the market. (Some are off the market because the pharma pulled them.) Even pharmacists do not know that those drugs are under a cloud of suspicion and continue to sell them. Some drugs still carry labels that reference the discredited studies. Some peer-reviewed articles continue to be available with no reference to the controversy (not too surprising).
The FDA claimed that so far, no harm has been reported from any of the suspicious drugs.
This leads me to my scam: if I create an injection of saline and market it as equivalent to a cancer-treating drug, I will do no harm; in fact, I may even do some good based on the placebo effect. I will make loads of money based on the belief (mislabeling) that my drug can treat cancer. The FDA seems to be saying I can do this so long as my "drug" does no harm.
The article makes no mention that anyone is being prosecuted for the fraud. The lab director does not appear to be in legal trouble. The pharmaceuticals who made a lot of money selling these drugs are portrayed as peripheral players. The chemists who faked data apparently have been fired. There is also no mention of whether the FDA personnel who approved the fraudulent research are being cited for professional negligence and failing their duty of care.
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The biggest revelation is in the last page of this long article. Former FDA agent was cited:
There are thousands of bioequivalence studies done every year, he pointed out, with each study generating thousands of pages of paper records. "Do you really think we're going to look at 100 percent of them? We're going to look at maybe 5 percent if we're lucky," he said. "Sometimes 1 percent."
So, he's saying that most drugs are approved without any oversight.
This makes me angry, and it should make you angry, too.