FDA: Surrendering to Trump’s pressure
The Food and Drug Administration “just had the worst day in its history,” said Michael Hiltzik in the Los Angeles Times. On Monday, FDA Commissioner Stephen Hahn announced the agency was granting emergency approval of treating Covid-19 with convalescent plasma—a treatment scientists say has not been proved effective. The announcement followed strong pressure from President Trump, who last weekend issued a tweet attacking “the deep state, or whoever, over at the FDA” for delaying treatment and vaccine approvals so as to hurt him politically. White House health adviser Anthony Fauci and other top government doctors reportedly urged the FDA not to green-light the unproven therapy. But Hahn was “beaten into political sycophancy” and reduced to echoing Trump’s wild claims that plasma treatments lower mortality by 35 percent—a tenfold exaggeration of questionable data that left “medical experts aghast.” Hahn later admitted his numbers were wrong, but “severe” damage had already been inflicted on the agency’s credibility.
The therapy in question has been used for more than a century to fight various diseases, said Amy Dockser Marcus in The Wall Street Journal. It involves taking blood plasma from recovered patients—which holds Covid-19 antibodies—and infusing it into sick patients’ blood. An analysis of 71,000 patients who received the treatment at the Mayo Clinic suggests it had some effectiveness in cutting mortality among those who got it within days of being diagnosed. But to trumpet this slim evidence as a game changer “is the very definition of cherry-picking,” said physician Jeremy Samuel Faust in WashingtonPost.com. What’s sorely needed before doctors start administering potentially plasma therapy—which can cause dangerous immune reactions—are large randomized trials in which it is measured against a placebo treatment. Without such gold-standard trials, “there’s no solid proof” it works.
Trump has “made that impossible,” said Arthur Caplan in StatNews.com. Now that he’s strongarmed the FDA into approving the treatment, and called it a cure, “no trials will get funded or enrolled.” Sick patients will clamor for convalescent plasma, and doctors will fight over limited supplies without knowing “if it works, for whom, and how best to use it.” This sends up a red flag for the fall. If Trump “needs an October surprise to salvage his political future,” who doubts he’d try to rush through an unproven vaccine?