“The SSRIs are pretty terrible drugs and patients aren’t too happy taking them. But doctors choose to ignore how bad these pills are,” writes Prof. Peter C. Gøtzsche, MD in Chapter 3 Depression of his excellent book Deadly Psychiatry and Organised Denial.
“When the first best-selling SSRI, fluoxetine [Prozac], appeared in the late 1980s, there was no doubt about it. Senior management in Eli Lilly wanted to shelve it after having considered to market it for eating disorders, but Lilly was in serious financial trouble and had to make it a success,” Prof. Gøtzsche continues.
“Initially, the FDA was sceptical and noted serious flaws in Lilly’s trials.
“An FDA officer wrote in 1984 that patients who didn’t do well after two weeks had their code broken, and if they were on placebo, they were switched to fluoxeine.
“In this way, six weeks of fluoxetine was compared to two weeks on placebo, which is a hopelessly flawed comparison and, with the blinding broken, more bias was introduced.
“It also turned out that 25% of the patients had taken an additional drug, and when the FDA in 1985 removed patients on other drugs from Lilly’s trials, there was no significant effect of fluoxetine.
“By adding benzodiazepines, Lilly broke the rules for its trials but didn’t inform the FDA, and when the FDA later learned about it, the agency permitted it and thereby broke its own rules.
“The public and the doctors were never informed about this ruse.
“The FDA went to extremes to make it look like fluoxetine worked.
“Perhaps the fact that Lilly is an American company played a role.
“Fluoxetine was approved when Bush senior was president and he had been a member of the board of directors of Lilly.
“Vice President Dan Quayle was from Indiana where Lilly’s headquarters are, and he had former Lilly personnel on his own staff and sat on an FDA oversight committee.
“The German drug regulator found fluoxetine ‘totally unsuitable for the treatment of depression,’ and furthermore noted that according to the patients’ self-ratings there was little or no response, in contrast to doctors’ ratings.”
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