The FDA has recently come under scrutiny for its approval of various psychiatric drugs between 2013 and 2024 when there was little positive evidence for their value, and when the FDA’s advisory committees had actually voted against their approval.

     These unwarranted approvals suggest hidden conflicts of interest for the advisory board members voting their approval for these psychiatric drugs.

     For example, in 2016 the antipsychotic drug  pimavanserin demonstrated only one favorable trial out of the four the FDA reviewed. The FDA medical reviewers deemed the drug “not approvable,” but their decision was overturned by the FDA after the advisory board voted to approve it.

     In 2023 the  antidepressant gepirone, which had been rejected for approval twice earlier, was approved despite only two of the twelve trials the FDA reviewed having positive outcomes.

     The antidepressant Spravato was approved by the FDA despite only one of its three trials showing it worked any better than a placebo. Six more  effectiveness trials were conducted, and in only one of them did Spravato beat the placebos.

     The FDA does have a system in place to identify potential conflicts of  interest between voting advisory board members and their financial holdings. These “medical experts” must reveal their financial holdings before voting on a drug, and if they either have investments in that firm or have been financially employed or rewarded by it, they are disqualified from the vote. The FDA does a have a waiver for special circumstances to allow members to vote even if they have financial connections to a pharmaceutical firm.

     There is a loophole in all of this, though.

     The financial rewards that are received from the pharmaceutical company by the voting member now occur in the future, not in the present or past. Hence, no apparent conflict of interest at the time of the vote.

     Of one hundred and seven physician-advisers that the publication Science examined in 2018 who  voted on the approval committees, forty received more than $10,000 in earnings or research support from the makers of the drugs that the panels had voted to approve.

     Twenty-six of those members were rewarded more than $100,000 from the Big Pharma firms, and six of those approval board physicians were compensated more than $1 million by the drug manufacturers afterward.
  
     Only forty-one of them – just 38 percent — received no compensation whatsoever.

     The sixteen top-earning advisory board members received more than $300,000 each from the $24 million plus in personal payments or research support from the  pharmaceutical industry. More importantly, 93% of that money came from the makers of drugs (or from their competitors) that those advisers had previously reviewed.These FDA advisory board members therefore look squeaky clean in the past and in the present. No conflicts of interest there.

     But in the future?

     That’s when they become the criminals.