A New Illness
The study that gained FDA approval of the tranquilizer Xanax is an example. In 1980, psychiatrists invented a new illness called panic disorder, and listed it in the APAs bible, the Diagnostic and Statistical Manual.
To ensure the FDA would approve Xanax for treatment of panic disorder, its manufacturer, Upjohn, hired a psychiatrist, Gerald Klerman, to organize and promote the studies required by the agency.
As the man responsible for the earlier but seriously flawed NIMH studies that duped the health care industry and public into believing that neuroleptic2 drugs were safe and effective, Klerman came well qualified for the job.
Undoubtedly his contacts from his days as NIMH director from 1971 to 1975 and his supervision of the National Institute of Drug Abuse and the Alcohol, Drug Abuse and Mental Health Administration from 1977 to 1980 were added benefits.
Advertisements promoting the Xanax study stated evaluations were made at weeks one, two, three, four and eight of the study. The conclusion that Xanax was safe and effective, however, was based on the findings of week four.
Small print at the bottom explained that week four was considered the end of the study because of the high rate of placebo dropouts. This in itself is highly unusual and a red herring as dropouts occur far more frequently from side effects of the drug being tested than from the non-results of a placebo or from the mild side effects that may arise from another drug administered.
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