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The approval allows doctors to prescribe the antiviral sooner. But it comes less than a week after the agency approved the use of convalescent plasma without published scientific backing, fueling concerns that the agency is giving in to political pressure.
“It seems like a model of approval without science, without data, without evidence,” said Dr. Eric Topol, vice president of research at Scripps Research in La Jolla, Calif. And national expert on the use of data. in medical research.
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In May, the FDA cleared remdesivir for use in hospitalized adults who need oxygen, but not for those who are sick enough to require ventilation. A government study published that month in the New England Journal of Medicine found that these patients recovered faster than those who had not received the drug, although there is no evidence that this saved Lives.
Earlier this month, the Journal of the American Medical Association published a study of less seriously ill hospitalized adults, showing that five days of treatment with remdesivir was better than standard care, although “the difference has a difference. clinical significance uncertain ”.
No other study has been published supporting a more widespread use of remdesivir. Still, the FDA said the data is now compelling enough to expand its use to all hospital patients, including children.
“Data shows that this treatment has the potential to help even more hospital patients suffering the effects of this devastating virus,” FDA Commissioner Dr. Stephen M. Hahn said in a statement, announcing that the The agency had granted an emergency use authorization. for remdesivir.
The FDA uses this process to approve products that, based on scientific evidence, it is “reasonable to believe … can be effective.” An emergency use authorization can only be issued in an emergency, such as the COVID-19 pandemic, when there are no adequate, approved and available alternatives.
Topol said he was appalled at the drug’s expanded approval. “There are no data to support widespread use of remdesivir,” he said. ” It’s extraordinary. ”
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The FDA announced the expanded use of remdesivir at 5:20 p.m. ET on Friday, citing studies published in May and August.
In a statement, Dr Merdad Parsey, chief medical officer of Gilead Sciences Inc., based in Foster City, Calif., Said the company was happy with the FDA’s decision to expand the drug’s use, which he referred to by his trade name.
“As we learn more about COVID-19 and further establish the efficacy and safety profile of Veklury, we see the benefit of making the drug available to patients at early stages. disease, ”he wrote.
Will the expanded use of remdesivir help patients?
Dr Francisco Marty, an infectious disease physician and researcher at Brigham & Women’s Hospital and Harvard Medical School, said expanded emergency use would help him deliver the drug to patients who are less sick but who, according to him, are likely to benefit from the antiviral.
Marty, who helped run some of the remdesivir trials, said he was treating cancer and transplant patients who are at high risk of complications, and would like them to take the drug as soon as possible. Before the expansion, he had to wait until they were sicker.
“I fight Gilead as much as a lot of people and try to push them,” he said. “But for me, it’s best for the patient. How can we help the most people? ”
Dr Nuala Meyer, an intensive care physician and scientist at the Perelman School of Medicine and the University of Pennsylvania Hospital, said she doesn’t think the FDA decision will change the treatment of most his patients.
PennMed patients receive remdesivir only if they have pneumonia requiring supplemental oxygen. That would have represented more than half of patients during the Philadelphia outbreak in April and May, Meyer said, but less today.
Most of her current patients, she said, are in the hospital for around 48 hours, so it wouldn’t make sense to put them on remdesivir, an intravenous therapy with a five-day course. “I don’t know a lot of data on inpatients who don’t need oxygen,” she said.
Meyer is concerned that the expanded use may make it more difficult for patients who need it to obtain the drug. “We would definitely prioritize those patients who are shown to be of benefit. ”
She said she was surprised by the FDA approval of remdesivir for all hospital patients. “We always expect the FDA to base its decisions on data and we worry when we see decision making that we can’t find the data to support it,” she said.
FDA under fire for coronavirus response
Hahn, radiation oncologist and former medical director of the MD Anderson Cancer Center in Houston, has only been FDA commissioner since December, but this is the fourth time he has clashed with the scientific community over his agency’s actions. to fight against the coronavirus.
In March, the FDA allowed manufacturers 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 come under fire for opposing further testing that could identify more people while they are contagious with COVID-19.
In May, the FDA issued emergency use authorization for a drug called hydroxychloroquine, which was heavily promoted by President Donald Trump. There was little data to support the approval, and the FDA overturned its decision in June after growing evidence suggested the drug was doing more harm than good.
On Sunday, Hahn and the president announced that the FDA will issue emergency approval for convalescent plasma, in which blood products from recovered patients are given to those whose immune systems have not built enough antibodies to fight against the virus.
Trump described it as “powerful therapy” and the authorization as “a very historic breakthrough.”
But there is no data supporting the agency’s position that plasma is effective in treating patients with COVID-19.
Hahn claimed at Sunday’s press conference that convalescent plasma reduced deaths by 35%, but the study actually found a benefit only for patients who received plasma early, were under 80. years old and not on ventilators.
He then apologized on Twitter for his claim. On Friday, he appears to have fired his new spokesperson 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 looks “ludicrous.”
For decades, the FDA has set the global standard for drug approvals. Although he has previously been criticized for giving in to political pressure, those who follow the agency have said they have never seen such consistent politicization.
Topol and others have said they are particularly concerned about the FDA because the public must have confidence in the agency that will approve any COVID-19 vaccine.
Topol said he feared it was too late to preserve the credibility of the FDA. “For the attentive public, this has 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 this to be widely adopted to restore pre-COVID life. ”
Contribuer: Elizabeth Way
Contact Karen Weintraub at [email protected]
Patient health and 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 any editorial contribution.
This article originally appeared on USA TODAY: “Without Evidence”: Once Again, FDA Expands Use of COVID-19 Treatment Without Research to Support It
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