Fluoxetine (Prozac) from Eli Lilly was the first SSRI approved for depression in children and adolescents. But it doesn’t work and it increases the risk of suicide and violence. After having reviewed Lilly’s unpublished clinical study reports, which we got from a drug agency, psychiatrist David Healy and I concluded that fluoxetine is both unsafe and ineffective.
As we describe in our review, which can be downloaded here, essential information was missing; there were unexplained numerical inconsistencies; new outcomes appeared that were not prespecified in the trial protocol (the Texas sharpshooter fraud); rating scales and analyses were changed; the trial protocols were violated in other ways; and the efficacy outcomes were biased by differential dropouts and missing data.
The publications of the trials were seriously misleading and – with ten people who lost a child or spouse to suicide as a consequence of being prescribed a depression drug for a non-psychiatric condition – I called for retraction of the fraudulent trial reports, but to no avail.
Fluoxetine is a horrible drug that should never have been approved. But Lilly was in financial trouble and turned their drug, which they had wanted to shelve, into a blockbuster.
Lilly’s frauds are second to none. See more in my freely available book, Is psychiatry a crime against humanity?