- The following information has been gathered through the
Freedom Of Information Act
- 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.
- 1982 - 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
- 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 on his clinical
- 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 Pittsburg 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.