Trump Touts Drug That FDA Says Isn’t Yet Approved for Virus

(Bloomberg) --

The Food and Drug Administration has been told by President Donald Trump to see if it can expand the use of a decades-old malaria drug as an experimental treatment for coronavirus patients.

The drug, chloroquine, hasn’t yet been approved for treatment of Covid-19, the disease caused by the new coronavirus. While it’s been available for decades for malaria, it’s not clear whether it will work against the new illness. A March 10 review of existing research found there’s little solid proof one way or the other.

During an at-times-confusing White House press conference, Trump said that chloroquine was approved for use and that he wanted to “remove every barrier” to test more drugs against Covid-19 and “allow many more Americans to access drugs that have shown really good promise.”

“Normally the FDA would take a long time to approve something like that, and it’s -- it was approved very, very quickly and it’s now approved by prescription,” Trump said.

An FDA spokesperson said the drug hadn’t been approved for use in Covid-19 patients. However, U.S. doctors are legally able to prescribe a drug for any illness or condition they think is medically appropriate.

More than a dozen generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz unit, manufacture chloroquine, also called hydroxychloroquine. It comes with few major known side effects, is relatively inexpensive and is widely used around the world. It’s also been touted by Tesla Inc. Chief Executive Officer Elon Musk as a potential treatment, and China has been testing it as well.

Mylan said in a statement Thursday it would immediately ramp up manufacturing of hydroxychloroquine pills at its West Virgina facility to meet expected high demand if the medication is shown to be effective against the disease. The generic-drug giant expects to be able to supply the drug by mid-April, ultimately providing 50 million tablets to potentially treat more than 1.5 million patients.

Other drugmakers are also developing experimental treatments and vaccines for Covid-19, with results from a Gilead Sciences Inc. drug, remdesivir, expected next month.

Gilead shares closed down 1.1% at $78.55 in New York, after earlier rising as much as 8.2%.

Press Conference

Trump has called for rules to be relaxed and government authority to be expanded to respond to the coronavirus outbreak, which has resulted in more than 200,000 confirmed cases and at least 9,000 deaths around the globe. Cities have been locked down and economies brutalized as governments try to prevent the spread.

At Thursday’s press conference, Trump and FDA Commissioner Stephen Hahn appeared to differ substantially about the status of the drugs being tested.

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.

Shortly thereafter, Hahn said that use of the drug would be in a controlled trial to find out whether or not it works, and if so, what dose would be safe and effective.

“We want to do that in a setting of a clinical trial,” Hahn said.

There was similar confusion over Gilead’s drug, which Trump said was “essentially approved.”

Hahn said afterward that remdesivir is “going through the normal process” and isn’t yet available to patients.

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, may have tilted that balance.

Drug Pipeline

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 its development efforts for a drug to treat the virus are ahead of schedule and it could start testing in humans this summer. Several vaccines are also in development.

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.

A small percentage of people die from infection by the coronavirus, and the vast majority get better on their own as their immune system battles the pathogen. That can make it more challenging to determine whether experimental drugs are effective.

©2020 Bloomberg L.P.