April, 1994 — Study 329 trials begin

Sept 28, 1994 — Trial: Joyce Fentress et al vs Eli Lilly commences in Louisville, Kentucky. Joseph Wesbecker was depressed, and his physician puts him on Prozac a second time in August, 1989, although he has a history of bad reaction to the drug. After two weeks in which his behaviour is increasingly bizarre and erratic, he goes to the print shop where he works, armed with an AK47, and wounds 12 people, kills 8 (including Kenneth Fentress), then turns the gun on himself. The evidence against the drug is solid so the defence uses a strategy of discrediting Wesbecker.

Oct 24, 1994 — Testimony: An expert witness on the proper conduct of randomized control trials (RCT) to test medication for approval, Dr Nancy Lord, testifies in Fentress about the trials conducted in the 1980's to support Lilly's FDA application to approve Prozac. She notes that "The data was flawed for a number of reasons"(See transcript pages 47 - 50):

• "They (Lilly) permitted the use of… psychotropic concomitant medications" "taking fluoxetine all by itself has never been studied", (they allowed trial subjects to be given benzodiazepines, to reduce the side effects of Prozac by treating them);
• "They broke the blind." (The investigators did things likely to reveal who was taking Prozac in the trials and cherry picked subjects for the next phase);
• "They did not code adverse experiences correctly." (Adverse events were not reported to the FDA as required, or were reported as something less serious;
• "They never really did Phase 3; they did a large Phase 2. They did the same protocol over and over." (Phase III trials are required for FDA approval; they test the drug on a population that matches real life as closely as possible);
• "They didn't use adequate samples" (size not large enough to determine significance);
• "It looked like they did everything possible to kind of tone down the problems with the drug rather than give them a rigorous, systematic and comprehensive evaluation;"
• "At one point in 1984, Eli Lilly received word from the British authorities that they were not going to approve this drug because of their concern with suicidality and agitation …and Lilly then went over there and looked at the data again and pulled out cases that they didn't think were suicide (but) how are they to know? The investigator thought it was a suicide attempt. They said, well, they don't think it is.". (In other words, the drug company overrode the investigator and tampered with the data).

  Back in 1984 Eli Lilly is manipulating data to prove efficacy and safety that is not real. Because they are first out of the gate, the Prozac data escapes the same scrutiny to which subsequently introduced SSRIs are subjected.

1994 — Italy's Giovanna Fava, editor-in-chief of the journal Psychotherapy and Psychosomatics, writes that "long-term use of antidepressant drugs may increase, in some cases, the biochemical vulnerability to depression, and worsen its long-term outcomes and symptomatic expression. Since then, Fava has periodically revisited this issue, and he recently published an updated review of the literature in Progress in Neuro-Psychopharmacology and Biological Psychiatry.""Here is a sampling of what he found in the research literature:

• After six months of antidepressant treatment, the drugs "generally fail to protect" against a return of depressive symptoms. (In other words, maintenance treatment is ineffective, compared to placebo.)
• Two-thirds of patients maintained on antidepressants suffer from "residual symptoms", with "anxiety, insomnia, fatigue, cognitive impairment, and irritability the most commonly reported."
• As patients are switched from one antidepressant to another or to a polypharmacy regimen, their illness may be propelled "into a refractory phase, characterized by low remission, high relapse and high intolerance."
• Antidepressants increase the risk of a "switch" into mania, and thus into bipolar illness. Antidepressants also increase the risk that bipolar patients will become rapid cyclers, and that bipolar patients will develop a syndrome dubbed Chronic Irritable Dysphoria."