Lilly Removed Data on Depression & Abnormal Thoughts as Frequent Adverse Reactions:Clinical Trials

Peter R. Breggin, M.D. was the expert witness for the plaintiffs in the Joseph Wesbecker trial [while on Prozac, Wesbecker killed 8 people and seriously wounded 12 people at the Standard Gravure plant in Louisville, KY in 1989], As the expert witness, Dr. Breggin was allowed ‘discovery’, which meant that he was permitted to search through Eli Lilly’s data on their clinical trials of Prozac.
 
Paul Smith of Dallas, Texas was the attorney for the plaintiffs.  He had agreed to “fix” the trial in Lilly’s favor before the trial began [pages 250 to 257 of “Medication Madness” by Peter R. Breggin, M.D.]
 
Page 252 of the book “Medication Madness” by Peter R. Breggin, M.D. reads: “Before I got on the stand, attorney Paul Smith had told me in a shouting match not to dare bring up one particular smoking gun.  From my Freedom of Information Act inquiries to the FDA, I had found that initial drafts of the Prozac label had listed “depression” and “abnormal thoughts” as two of the three most commonly reported adverse reactions to the drug.  In these drafts, the company in effect admitted that it own principal investigators – the scientists conducting the clinical trials- were reporting that their patients frequently became more depressed on Prozac. Combined with an increase in “abnormal thoughts” this indicated that the drug was making many people worse and even potentially dangerous.  I then discovered that shortly before the label was made official, “abnormal thoughts” was dropped from the list of the top three adverse effects and replaced with the more innocuous “abnormal dreams.”  Then, on the last day before the label was officially approved, an FDA official scratched out “depression” from its prominent place in the label.  Depression as a serious adverse effect of Prozac went from being “frequent” to being nonexistent.  The company, in combination with the FDA, had expurgated some of the most damning information from the label shortly before its publication.  Attorney Paul Smith outright refused to let me testify about this.

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