Monday, January 19, 2009

How Accurate is Research on Antidepressants?

Former FDA Commissioner Goddard expressing his concerns over research dishonesty at a Pharmaceutical Manufacturers association meeting in 1966 stated this about the current research thirty-five years ago. "I have been shocked at the materials that come in. In addition to the problem of quality, there is the problem of dishonesty in the investigation of new drug usage. I will admit there are gray areas, but the conscious withholding of unfavorable animal clinical data is not a gray matter. The deliberate choice of clinical investigators known to be more concerned about industry friendships than in developing good data is not a gray matter. The planting in journals of articles that begin to commercialize what is still an investigational new drug is not a gray matter area. These actions run counter to the law and the efforts governing drug industry".

Goddard's immediate successor at the FDA, Dr Ley, spoke before the US Senate hearings of a spot check that showed up the case of an assistant professor of medicine who had reputedly tested 24 drugs for 9 different companies. "Patients who died while on clinical trials were not reported to the sponsor", an audit revealed. "Dead people were listed as subjects of testing. People reported as subjects of testing were not in the hospital at the time of tests. Patient consent forms bore dates indicating the subjects signed them after the subjects died" (US Senate report ).
Between 1977 and 1980 the FDA have discovered 62 doctors who had submitted manipulated or downright falsified clinical data. A study conducted by the FDA has revealed that one in five doctors investigated, who carry out field research of new drugs, had invented the data they sent to the drug companies, and pocketed the fees.
The system still remains corrupt. In fact in 1995, 150 top FDA officials held significant amounts of stock in the pharmaceutical companies they were supposed to be regulating. Drugs like Prozac have both helped and hurt people, yet while praise for them is abundant the other side of the story is often kept quiet. No fewer than 150,000 preparations are now in use. About 15,000 new mixtures and dosages hit the market each year. Approximately 12,000 human test subjects die yearly from drug testing, and many to of those deaths go unreported.

"The clinical trials system has now become a multibillion-dollar industry, with hundreds of testing and drug companies working with thousands of private doctors who mine their patient lists for test subjects". So the question for current research on antidepressants is how accurate is the research?

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