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How Was Prozac Ever Approved?


The Doctor that pushed for the FDA to approve Prozac would go to jail if he did the same thing in 2000. The Truth Exposed here.
The following information has been gathered through the Freedom Of Information Act

A little background before we begin. . .

Prozac was allowed on the US market 12-29-1987. What happened shortly before and after 12-29-1987 regarding Prozac, Lilly and the FDA is where The Hidden Truth comes out. 

We do not use undisclosed sources. The information disclosed is all a Public Record, it has just been obscured from the public by the interested parties mentioned in this article.

The Beginning 

David Dunner of the University of Washington begins receiving money that will total over $1.4 million dollars from Lilly for his research and seminars.

Dunner was part of the FDA's Psychopharmacologic Drugs Advisory Committee that is responsible for reviewing new drug applications brought before the FDA. These members are asked if they might have any conflict of interest with each Pharmaceutical Manufacture presenting new drugs before The Committee. Dunner responded to this question by stating "no pending commitments at the present time". The FDA accepted his answer as truthful. 

Dunner had already been paid by Lilly for conducting a clinical trial on 100 people. Prozac was the drug used in his clinical trials.

Dunner had already given 5 seminars sponsored by Lilly (Prozac Manufacture) before this date. He failed to bring this to the committees attention. The seminars were regarding "depressive disorders." Dunner also failed to disclose that he had two additional seminars already booked for him by Lilly that would take place after Prozac was approved. 

Dunner appeared in Pittsburgh 1 day after Prozac was approved conducting a seminar on Prozac, while being paid by Lilly.

Dunner received another Lilly grant 5 days after Prozac was approved to conduct a new study on the effects of Prozac on sleep patterns.

Lilly conducted test on Prozac and found the drug not to be significantly more effective than the placebo, an FDA statistician suggested to Lilly that the test results be evaluated differently causing the results to come out more favorable for Prozac.

Guidelines constructed by Lilly for the clinical trials excluded the reporting of "adverse experiences caused by depression". The FDA admits this skewed the results.

Medical Doctor for the FDA Richard Kapit gives this review of Prozac "Prozac may exacerbate certain depressive symptoms and signs. Certain clinical risks of mild to moderate severity did appear to be associated with the use of Prozac, as determined by review of the safety data in the New Drug Application submission. These potential risks include intensification of the vegetative signs and symptoms of depression. It is suggested that labeling be developed which advises physicians about the possible exacerbation of the vegetative manifestations of depressive illness. If the drug is marketed, post-marketing studies should be required to assess more precisely the severity of these potential risks."

The FDA safety review discovered that Lilly failed to report information about psychotic episodes during Prozac's testing. The FDA did nothing to reprimand Lilly for omitting this data.

Two months before Prozac was approved for the market there had already been 27 deaths from controlled clinical trials. 15 were from suicides, 6 by overdose, 4 by gunshot and 2 by drowning. All were confirmed to be directly related to taking Prozac. An additional 12 deaths were reported but, could not be directly related to Prozac.

Shortly before a hearing on Prozac in August 1991 an FDA executive Paul Leber noted his concern about "the large number of reports of all kinds on Prozac (more than 15,000)". Paul Leber pressured personnel in charge of the agency's adverse reporting system to discount the large number of reports of adverse reactions to Prozac as "of Limited value".

By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths. The Commissioner of the FDA, David Kessler states "Although the FDA receives many adverse event reports, these probably represent only a fraction of the serious adverse events encountered by providers. Only about one percent of the serious events are reported to the FDA, according to one study".

Let us look at the math regarding the above statement. 28,600 reported adverse reactions - equates to 2,860,000 adverse reactions if Commissioner David Kessler's study is correct.

The following "Ethical Conduct Description" comes a little to late to stop David Dunner. What he did  is now a Criminal Offense.

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