Big Pharma Banks on Doctors’ Ignorance for Antidepressant Profits

     Dr. Eric Turner of the Oregon Health and Science University demonstrates in his June, 2026, article in JAMA Psychiatry the ignorant beliefs by both the public and physicians about FDA approval of a drug. Per surveyed American adults, fifty percent believe that the FDA only approves extremely effective drugs. Far worse, seventy percent of the physicians surveyed believed that a clinical trial must show statistical and clinical significance for the FDA to approve a drug.

     That is not true.

     Further, seventy-three percent of surveyed physicians also believed that FDA-approved drugs must be as effective as other drugs the FDA has already approved for the same condition. Forty percent believed, as well, that an FDA approved drug is forty percent more effective than these already FDA approved drugs.

     That is also not true.

     In fact, FDA approval of a drug does not mean clinically significant trial results that show the drug is equal to or better than any existing drugs. In fact, FDA approval of a drug does not even mean that it is effective overall.

     Dr. Turner cites Exxua (gepirone), an antidepressant approved by the FDA in 2023 and released to the public in 2025, as one horrifying example of what could be called FDA negligence – or corruption — in its approval of this antidepressant.   

     Go, Big Pharma influence.

     Initially, thirteen trials of gepirone were presented by pharmaceutical companies Fabre-Kramer and Organon to the FDA, but only two of those trials showed a positive result. The FDA denied approval due to the methodology of the studies and the fact that so many showed negative results. Organon resubmitted the drug for approval in 2001 and it was rejected then for lack of evidence for its efficacy.

     The FDA then rejected a third appeal from Organon for approval in 2003 because the new data that had been added by them was not convincing of efficacy and because the presentation of that new data appeared to have been manipulated. The FDA again denied approval in 2007 after yet one more Fabre-Kramer submission.

     These appeals by the Big Pharma company continued through 2015, when the FDA again denied approval by a nine to four vote by its advisors.

     However, in 2017 Dr. John Jenkins, Director of the FDA Office for New Drugs, approved one more appeal for the drug by its manufacturer and he argued in favor of approving gepirone, even though any positive trial results for it were not statistically significant and even though Fabre-Kramer had removed more than half of the failed studies from their last submission.

     Jenkins retired from the FDA the next year and he was immediately hired to serve on the Corbus Pharmaceuticals Board of Directors. Janet Woodcock took over for him at the FDA and she agreed with him about gepirone. The drug was released as Exxua in 2025 and cost users $1788.00 per month. It made Fabre-Kramer $46 million in 2026.

     Prescribing doctors and the public had believed in the FDA.

     Go, Big Pharma.

     Thanks to Mad in America contributor Peter Simon for brining this travesty to light.