How Was Prozac Ever Approved By The FDA?

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Thu, 13 Jan 2005 20:10:58 -0800 (PST)

[sSRI-Research] How Was Prozac Ever Approved By The FDA?

 

 

 

http://www.prozactruth.com/fdalilly.htm

 

 

How Was Prozac Ever Approved?

 

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

 

1982

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.

 

1985

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.

 

1985

Guidelines constructed by Lilly for the clinical trials excluded

the reporting of " adverse experiences caused by depression " . The FDA

admits this skewed the results.

 

1986

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.

 

1987

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.

 

1991

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 " .

 

1992

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.