Cover Story

Escaping Responsibility

      A popular tactic employed by drug makers in lawsuits concerning their products is to escape responsibility for adverse effects by pointing to the fact that the FDA approved the drug — and so, the reasoning goes, it must be safe. The FDA, however, is a partner in this marriage, as evidenced by its actions.

      Due to an extended public relations effort by major drug makers, most Americans believe that the drug approval process is rigorous and complex, involving studies of thousands of people over a period of many years. Yet Freedom found that the scientific studies required for FDA approval generally last only about five to six weeks and involve a few hundred people at most.

      With many drugs, it is anticipated — and hoped — the consumer will take the substance for a lifetime. Thus the short term of these FDA studies would entirely miss such ghastly side effects as tardive dyskinesia and tardive dystonia3. In people suffering from these permanent conditions, the muscles of the face and body contort and spasm involuntarily, drawing the face into scowls and grimaces and often forcing the body into bizarre contortions.

      A “side effect” such as sudden death could also easily escape detection in a short-term study, but even with a frequency of only one half of one percent, such a drug could kill 5,000 of the first million people that take it.


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