Trump Touts Malaria Drug That FDA Says Isn’t Approved for Virus
The Food and Drug Administration has been told by President Donald Trump to see if it can expand the use of an experimental malaria drug, chloroquine, to treat patients in the middle of the U.S. coronavirus outbreak.
At a press conference at the White House Thursday, Trump and the head of the FDA gave apparently conflicting comments about the availability of the drug. Trump said chloroquine had been approved and could be given to patients by doctors with a prescription.
“It’s been around for a long time, so we know that if things don’t go as planned it’s not going to kill anybody,” Trump said.
Minutes later, FDA Commissioner Stephen Hahn, said that use of the drug would be in a clinical trial to find out whether or not it works, and if so, what dose would safe and effective.
“Again, we want to do that in a setting of a clinical trial,” Hahn said, following up on Trump’s remarks at the press conference. Doctors in the U.S. are allowed to prescribe drugs for uses that haven’t been approved by the FDA, in what’s called off-label use.
An FDA spokesperson said the drug had not been approved for use in Covid-19 patients.
Trump also said that an experimental drug fromGilead Sciences Inc., remdesivir, is also “essentially approved.” Trump didn’t elaborate on what that meant. Hahn said afterward that the FDA has a responsibility to make sure drugs are safe, and work, even as it loosens regulation.
Hahn said that issues like dosing would matter, given that the disease are different.
The FDA has increasingly stepped back from its regulatory role in the middle of the crisis, announcing that it would let states regulate tests to diagnose the virus in order to speed their rollout. It has also said it is temporarily halting inspections of drug plants in the U.S. and abroad.
The agency’s standard for drugs is to look at the risk posed by side effects compared with how effective treatments are. But the growing number of coronavirus cases in the U.S., and the lack of any proven therapy or vaccine, appears to have tilted that balance.
Gilead’s remdesivir was originally developed for use against the Ebola virus. The drugmaker is expected to report early results of tests of the experimental medicine in April.
Regeneron Pharmaceuticals Inc. said Tuesday itsdevelopment efforts for a drug to treat the virus are ahead of schedule and it could start testing in humans this summer. Another therapy, the malaria drug chloroquine, is being studied against Covid-19, and China has included it in treatment recommendations.
Even those in Trump’s inner circle have cautioned against equating early research on drugs with proof that they work.
Deborah Birx, a member of the president’s coronavirus task force, said during Wednesday’s White House briefing that Trump had asked for a briefing on potential treatments for the virus. Birx said that even evidence a drug works in animals doesn’t mean it will work in people.
“Of course, there’s always anecdotal reports, and we’re trying to figure out how many anecdotal reports equal real scientific breakthroughs,” Birx said.
While a small percentage of people die from infection by the coronavirus, the vast majority get better on their own as their immune system attempts to battle the pathogen. That can make it more challenging to determine whether experimental drugs are effective.
Source: Read Full Article