Cover Story

      Looking again at antidepressants, their quantities grow despite bountiful evidence of hazards which range from increasing risk of sexual dysfunction to suicide.

      A look beneath the surface reveals much more. Kessler solicited funds from the major pharmaceutical makers, persuading them that their drugs could be approved much more rapidly if they would pay the FDA to do so. Thus “user fees” came into being — payments to the FDA which enable it to hire staff who will then be able to expedite reviews, primarily reviews of the manufacturer’s application. In effect, the drug maker pays the salaries of the people who have the power to approve its drug.

      User fees amount to hundreds of millions of dollars and comprise a major portion of the FDA’s budget. It is hardly a mystery how FDA officials became so eager to follow the bidding of the drug companies.

      Generic drugs and medical devices have, to date, been excluded from the Kessler plan, with the result that their products have been handled far more slowly. In effect, the more money the FDA receives from the drug manufacturers, the more compliant it is to their wishes.

      It is because the FDA serves private interests, not the American people, that unsafe drugs cascade onto the market in vast quantities — and into the homes of the Don Simpsons and millions of others.


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