HydroxychloroquineTouting Criticized Study, White House Presses FDA to Authorize Hydroxychloroquine — Again
In March, the FDA, on scant evidence, initially gave emergency use authorization to hydroxychloroquine. The agency in April issued a safety warning about potential cardiac problems before withdrawing its approval last month. The reason for the FDA authorization withdrawal was the results of several large-scale, randomized, double-blind trials, all of which showed that not only does hydroxychloroquine offer no benefits to COVID-19-infetced patients, but that it substantially increases the risk of serious heart problems and heart-related deaths. Laurie McGinley and Josh Dawsey write in the Washington Post that earlier this month, a Henry Ford Health System study found death rates were 50 percent lower among the patients treated with hydroxychloroquine, the authors said. They also said the drug posed no safety problems. The study has been criticized by scientists, but the White House and Trump supporters in the media have urged the FDA to reauthorize hydroxychloroquine for emergency use.
White House trade adviser Peter Navarro, and Trump supporters like Rudy Giuliani and Fox News Laura Ingraham, have been demanding that the FDA reverse course and grant a second emergency authorization for the antimalarial drug hydroxychloroquine to treat COVID-19. Laurie McGinley and Josh Dawsey write in the Washington Post that in March, the FDA, on scant evidence, initially gave emergency use authorization to hydroxychloroquine. The agency in April issued a safety warning about potential cardiac problems before withdrawing its approval last month.
The reason for the FDA authorization withdrawal was the results of several large-scale, randomized, double-blind trials, all of which showed that not only does hydroxychloroquine offer no benefits to COVID-19-infetced patients, but that it substantially increases the risk of serious heart problems and heart-related deaths.
Earlier this month, a Henry Ford Health System study, which involved more than 2,400 patients hospitalized between March and May, found death rates were 50 percent lower among the patients treated with hydroxychloroquine, the authors said. They also said the drug posed no safety problems.
The Henry Ford study is the reason for the calls by Navarro, Giuliani, and Ingraham for the FDA again to grant emergency authorization to hydroxychloroquine use in COVID-19 patients.
McGinley and Dawsey write:
But the Henry Ford study has been sharply criticized by scientists who said it shouldn’t be used to change policy. It was an observational study, considered much less rigorous than a randomized trial, in which patients are randomly assigned to receive a treatment or not. And its results fly in the face of three major randomized trials that have found hydroxychloroquine is not effective in treating or preventing COVID-19.
Critics also noted that twice as many of the Henry Ford patients who received hydroxychloroquine also got a steroid — which has been shown to benefit COVID-19 patients — compared with those who didn’t get hydroxychloroquine. That made it hard to know which drug benefited the patients, they said. The authors made statistical adjustments to account for that, but other scientists said the methodology wasn’t clear and that it is very hard to correct studies in that way.
“You want to look at the totality of the data,” said Eric Topol, director of the Scripps Research Translational Institute. “The totality is overwhelmingly in the opposite direction. You have to conclude with the Henry Ford study is an outlier and there’s some kind of confounder that is skewing the data and not representing the truth.”
Many scientists who spoke with McGinley and Dawsey said they doubted the FDA would move to reauthorize hydroxychloroquine based on the Detroit study, because of the damage such a reversal would inflict on the agency’s credibility.
“When future coronavirus vaccines come up for FDA approval, the public should have full confidence that the FDA will make the correct decision to protect the public health by ensuring that vaccines are safe and effective,” David Boulware, an infectious-disease specialist at the University of Minnesota Medical School who conducted one of the major clinical trials on hydroxychloroquine, told McGinley and Dawsey.
