'Without evidence': Once again, FDA expands use of COVID-19 treatment without research to back it up

The U.S. Food and Drug Administration late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although no published research supports such widespread use.

The approval allows doctors freedom to prescribe the antiviral earlier. But it comes less than a week after the agency approved use of convalescent plasma without published scientific support, fueling concerns the agency is yielding to political pressure.

"It seems to be a pattern of approval without science, without data, without evidence," said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, California and a national expert on the use of data in medical research.

In May, the FDA allowed remdesivir to be used for hospitalized adults who need oxygen, but not those sick enough to require ventilation. A government study published that month in the New England Journal of Medicine found those patients recovered faster than those who hadn't gotten the drug, though there was no evidence that it saved lives.

Earlier this month, the Journal of the American Medical Association published a study of less severely ill hospitalized adults, showing that five days of treatment with remdesivir was better than standard care, though "the difference was of uncertain clinical importance."

No other studies have been published supporting more widespread use of remdesivir. Yet the FDA said the data is now compelling enough to expand its use to all hospitalized patients, including children.

"The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus," FDA Commissioner Dr. Stephen M. Hahn said in a prepared statement announcing the agency had granted an emergency use authorization for remdesivir.

The FDA uses that process to approve products that, based on scientific evidence, it is “reasonable to believe … may be effective.” An emergency use authorization can be issued only during an emergency, such as the COVID-19 pandemic, when there are no adequate, approved and available alternatives.

Topol said he was appalled by the expanded approval of the drug. "There are no data to support wide use of remdesivir," he said. "This is extraordinary."

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What to know about antiviral drug remdesivir and COVID-19

The FDA announced the expanded use of remdesivir at 5:20 p.m. ET on Friday, citing the studies published in May and August.

In a statement, Dr. Merdad Parsey, chief medical officer of the Foster City, California-based Gilead Sciences Inc., said the company was pleased with the FDA's decision to expand use of the drug, which he referred to by its trade name.

“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease," he wrote.

Will expanded use of remdesivir help patients?

Dr. Francisco Marty, an infectious disease doctor and researcher at Brigham & Women's Hospital and Harvard Medical School, said the expanded emergency use will help him get the drug to patients who are less sick but who he thinks are likely to benefit from the antiviral.

Marty, who has helped conduct some of the remdesivir trials, said he treats cancer and transplant patients who are high risk for complications, and he'd like to get them on the drug as quickly as he can. Before the expansion, he had to wait until they got sicker.

"I fight with Gilead as much as many people, and try to push them," he said. "But for me, it's what's best for the patient. How can we help the most people?"

Dr. Nuala Meyer, a critical care physician and scientist at the Perelman School of Medicine and the Hospital of the University of Pennsylvania, said she doesn't think the FDA's decision will change treatment for most of her patients.

Patients at PennMed are given remdesivir only if they have pneumonia requiring supplemental oxygen. That would have accounted for more than half of the patients during Philadelphia's surge in April and May, Meyer said, but fewer today.

Most of her current patients, she said, are in the hospital for about 48 hours, so it wouldn't make sense to put them on remdesivir, an intraveneous therapy with a five-day course. "I'm not aware of a whole lot of data in hospitalized patients who don't require oxygen," she said.

Meyer is concerned that the expanded use may make it harder to get the drug for patients who need it. "We would certainly prioritize patients in whom it is shown to have a benefit."

She said she was surprised by the FDA's approval of remdesivir for all hospitalized patients. "We always expect the FDA to base decisions on data and we do get concerned when we see decision-making that we can't find the data to support," she said.

Dr. Stephen Hahn is the new commissioner of the Food and Drug Administation.

FDA under fire for coronavirus response

Hahn, a radiation oncologist and former chief medical executive of the MD Anderson Cancer Center in Houston, has been FDA commissioner only since December, but this is the fourth time he has run afoul of the scientific community for his agency's actions to combat the coronavirus.

In March, the FDA allowed makers of COVID-19 antibody tests to sell their products as long as they registered with the FDA. The agency tightened those restrictions about six weeks later, but it has been criticized for standing in the way of other testing that could identify more people while they are contagious with COVID-19.

In May, the FDA issued an emergency use authorization for a drug called hydroxychloroquine, which was strongly promoted by President Donald Trump. There was little data supporting the approval, and the FDA reversed its decision in June after mounting evidence suggested the drug did more harm than good.

Sunday, Hahn and the president announced the FDA would issue emergency approval for convalescent plasma, in which blood products from recovered patients are administered to those whose immune systems haven't built up enough antibodies to fight off the virus.

Trump described it as "a powerful therapy," and the authorization as "a very historic breakthrough."

But there is no data supporting the agency's position that plasma is effective for treating COVID-19 patients.

Hahn claimed at Sunday's news conference that convalescent plasma reduced fatalities by 35%, but the study actually found a benefit only for patients who received plasma early, were under 80 and were not on ventilators.

He later apologized on Twitter for his claim. Friday he appeared to have fired his new spokeswoman in response to the incident.

The scientific community was horrified by the authorization of plasma and its characterization by Hahn and the president.

Between that and Friday's announcement for remdesivir, Topol said the agency's emergency approval process appears "farcical."

For decades the FDA has set the world's standard for drug approvals. Although it has been criticized before for yielding to political pressure, those who follow the agency said they have never seen such consistent politicization.

Topol and others said they are particularly concerned about the FDA because the public needs to have faith in the agency that will approve any COVID-19 vaccine.

Topol said he fears it may be too late to preserve the FDA's credibility. "For the public that's paying attention, it's already been sacrificed," he said.

Without widespread acceptance of vaccines, Topol added, there will be no way to end the COVID-19 pandemic, which has already killed nearly 182,000 Americans and sickened nearly 6 million more. "We need that to be widely adopted to get pre-COVID life reestablished."

Contributing: Elizabeth Weise

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: FDA ignores science in expanding remdesivir to treat COVID-19