White House again presses FDA to OK ‘game changer’ drug
WASHINGTON — White House trade adviser Peter Navarro is leading a Trump administration effort to demand the Food and Drug Administration reverse course and grant a second emergency authorization for the antimalarial drug hydroxychloroquine to treat COVID-19, the disease caused by the coronavirus.
Navarro, armed with a controversial new study that he says shows the drug’s effectiveness, is being cheered on by President Donald Trump, who has long touted the drug as a “game changer” and even used himself as a possible preventive measure. Trump praised the study on Twitter earlier this week, urging the FDA to “Act Now.”
Scientists have widely criticized the new study, by Detroit’s Henry Ford Health System, as flawed. In addition, just weeks ago the FDA revoked its emergency authorization for hydroxychloroquine after major studies found the medication wasn’t effective for COVID-19.
Navarro says there are 60 million doses of hydroxychloroquine in the Strategic National Stockpile that can’t be distributed unless the FDA issues an emergency authorization. He said the FDA should take action “within days, not weeks or months” so he could send the shipments.
Trump has told aides that he sees the Detroit study as “vindication”
of his position and wants the drug sent to hospitals across the country, in the words of another senior administration official who spoke on the condition of anonymity to discuss internal deliberations.
Navarro said if the Detroit data is backed up by subsequent studies, “there is blood on the media’s hands” for sowing doubts about the drug.
The FDA initially gave emergency use authorization to hydroxychloroquine in March based on scant evidence. The agency in April issued a safety warning about potential cardiac problems before withdrawing its approval last month.
The Henry Ford 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 noted the drug posed no safety problems.
Henry Ford officials said the results were different from other studies that didn’t show effects from the drug because they treated patients soon after they were hospitalized and used different dosages. The health system declined to make the authors available and the FDA said it would not comment.
But the study has been sharply criticized by scientists. 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 hydroxycloroquine 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 to 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.
“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.”
Doctors can still prescribe the drug for COVID-19 because it is approved for other illnesses. But Navarro said that the FDA’s safety warning and withdrawal of the emergency authorization had effectively killed demand.
Any decision about reauthorizing hydroxychloroquine will be made by FDA career scientists, said an administration official who spoke on the condition of anonymity.