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Group linked to Scientologists loses Prozac bid

Title: Group linked to Scientologists loses Prozac bid
Date: Friday, 2 August 1991
Publisher: Wall Street Journal
Main source: link (45 KiB)

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WASHINGTON —The Food and Drug Administration on Thursday rejected a request by a group affiliated with the Church of Scientology that it ban the anti-depressant drug Prozac on grounds that it makes people suicidal and violent.

The FDA released a letter to the Citizens Commission on Human Rights saying that it had found no evidence for these claims or for the commission's additional claims that Prozac is addictive and causes movement disorders.

The agency said it had reviewed the evidence provided by the group, along with data supplied by the drug's manufacturer, Eli Lilly & Co. of Indianapolis.

The group's petition cited cases of depressed patients being treated with Prozac who committed or attempted suicide.

The FDA said the data provided no way of determining the relative roles of the drug and the depression in causing the suicidal behavior. "Depression itself is highly associated with suicide," the agency said.

It said clinical trials did not show any greater rate of suicide attempts among depressed patients on Prozac than among those being given placebos or treated with other anti-depressants.

Eli Lilly called the action a reaffirmation of the safety and effectiveness of the drug. It said the Citizens Commission on Human Rights was a Scientology front group engaged in "a dangerous deception."

The FDA said the drug's labels already note that violent behaviors have been reported among a small number of patients and that, in clinical trials, hostile behavior was observed at rates ranging from 1 in 100 to 1 in 1,000.

The commission said Prozac had been linked to murders, but the FDA said the small number of cases and the lack of detailed information made it impossible to draw conclusions from the data.

The group asked for the ban last October.