Testing Safety Before the Drug Is Marketed

The media often treat the pronouncements of scientists and the results of scientific research with an aura of naive and undue respect. Scientific endeavors are conducted by ordinary human beings, many of whom come burdened with heavy biases and overwhelming financial interests. Especially in the field of human sciences, where complexity is made infinite by the interaction between human nature and society, bias easily runs rampant. Nearly all the research conducted in the area of psychiatric drugs is funded, designed, and conducted by drug companies or their close associates and allies, eliminating any hope of obtaining unbiased results. 

In reality, proving safety in clinical trials for FDA drug approval is an even more flawed process than proving efficacy. Often, serious and even fatal reactions will not be detected in the studies used for drug approval. 

In the past, the FDA (1995) itself has been vocal about the limits of premarketing testing and about the importance of the supposedly less scientific postmarketing spontaneous reporting system (SRS) in which 

When a drug goes to market, we know everything about its safety. Wrong. 

The FDA s June 1995 publication A MedWatch Continuing Education Article replicated the poster and made the following points in a section called Limitations of Premarketing Clinical Trials  

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