High Profit Kiddie Prozac Doesn’t Work. Maybe Never Did.

     Dr. Martin Ploderl, psychotherapist and member of Austria’s national suicide prevention program, publicized the results of a 2021 Cochrane study on Mad in America this week which showed that pediatric Prozac was no better than a placebo in reducing depression symptoms. These findings contradict the results of two earlier studies in 2016 and 2020 which have been used to show that Prozac was the most effective antidepressant for
children.

     The new Cochrane review demonstrated there was only half the efficiency claimed for Prozac by the earlier two studies. Additionally, the quality of the evidence found by the Cochrane review was rated “moderate,” whereas the two earlier studies evidence had been rated “low certainty.”

     Many of the earlier Prozac trials were conducted before the mandatory registration and reporting act was legislated in 2000. Prior to that, trial results did not have to be reported. One 2008 review of these earlier antidepressant trials showed that nearly all failed trials were unpublished in those earlier days. Eli Lilly’s first pediatric Prozac trial from 1986, for instance, was negative and so they could keep it from being published.

     Other factors contributing to the low efficiency for Prozac which Ploderl and his research colleagues found included “novelty bias,” manipulation of drop out rates for placebo and drug subjects, and many earlier trials that had been conducted with bias by the manufacturers themselves.

     Prozac has been artificially promoted as being the go-to kiddie antidepressant and has remained so despite there being no actual statistically significant evidence that it is any more effective than a placebo.

     In fact, this recent Cochrane review concluded that “most newer antidepressants may be associated with small and unimportant reductions in depression symptoms compared with placebo, which raises the question of whether they should be used at all.”

     Meanwhile, Eli Lilly was making a ton of money from their kiddie Prozac, which was being prescribed off-label through the 1990s. Prior to its patent expiration in 2001, Eli Lilly was pulling in over $2.5 billion annually for Prozac and the drug had a windfall $21 billion of overall cumulative revenue.

     Then, under the FDA Modernization Act – no collusion between the FDA and Big Pharma, of course — Eli Lilly was allowed in 2001 to conduct more of its own clinical trials on children and adolescents in exchange for a six month pediatric exclusivity extension on its Prozac patent. That yielded Lilly an estimated $500 million in additional revenue for a drug that may never have worked.

     For Eli Lilly, though, that’s just about enough profit to justify the black box warning on Prozac for its increased risk for suicidal thoughts and behavior in children, adolescents, and young adults under the age of twenty-four.