The Food and Drug Administration is withdrawing its approval of using restorative blood plasma for Covid-19 patients in an effort to counsel physicians who have dealt with a confusing amount of data on the effectiveness of the therapy.
The agency said late Thursday that the authorization, a subject of controversy since its initial issue in August last year, would be revised to restrict the use of plasma to hospital patients early in the course of the illness and hospital patients with a medical condition who have their ability to make antibodies. Patients should only receive plasma containing high levels of antibodies.
“The update is designed to help restore plasma to be best used by those who will benefit,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “It’s used a little more arbitrarily.”
Dr. Claudia Cohn, chief medical officer of AABB, an organization that represents transfusion medicine, said the group plans to make interim recommendations on restorative plasma later this month. “There are so many studies with different conclusions,” she said. “It’s not clean, it’s not black and white.”
Dr. Marks said the FDA came to its decision after reviewing the results of several recent studies. Some showed benefits from restorative plasma, the antibody-containing fluid taken from the blood of people recovered from Covid-19. Others showed no benefit.
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Two clinical trials of restorative plasma for hospital patients discontinued last month after researchers said there appeared to be no benefit. Three studies involving hospitalized patients recently reported some benefit to plasma, but only when administered to patients shortly after admission. Yet another study showed that elderly outpatients who received plasma shortly after showing symptoms were less likely to develop serious illness.
Arturo Casadevall, chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, called the FDA’s decision “a step forward.” He said, “For the first time, doctors in the US will be given advice on when to use it and how to use restorative plasma.
Dr. Casadevall is a co-founder of the Covid-19 Convalescent Plasma Project, which helped organize a nationwide comprehensive study of restorative plasma that began last April.
Despite the conflicting findings, there remains a demand for restorative plasma, in part because there are few effective treatments for Covid-19 and many people remain unvaccinated. Since the FDA issued the emergency permit last August, the blood industry has distributed an average of about 20,600 units of restorative plasma per week among hospitals across the country, according to the American Red Cross.
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The FDA’s earlier decision to allow restorative plasma for hospitalized Covid-19 patients was largely based on results from an agency-sponsored expanded access program, through which more than 72,000 patients received plasma. For a study published last month in the New England Journal of Medicine, researchers analyzed data from 3,000 of those patients and reported a clear survival benefit in hospitalized patients who received no mechanical ventilation and who received plasma with high levels of antibodies.
But many scientists were skeptical of that finding, saying that expanded access studies lack the scientific rigor of traditional studies because they don’t have a control group to compare any apparent effect.
Dr. Marks of the FDA said the approval of restorative plasma “could have been done much better. It had to do with the sense of urgency that everyone feels. I can’t blame anyone for a sense of urgency. “
Dr. Marks also said the data can be confusing. Each unit of recovering plasma is unique and reflects the immune response of the recovered patient who donated it. It took time to figure out the best way to measure the antibodies in a unit, he added.
The US is not the only government trying to establish reliable guidelines for the use of restorative plasma. In Argentina, a study in elderly outpatients published in the New England Journal of Medicine last month contributed to current recommendations there to treat elderly Covid-19 patients early in the course of their illness. “Plasma supplies are not endless, and public health officials invariably face tough decisions,” said co-author Dr. Fernando Polack from Fundación Infant in Buenos Aires. “All of these decisions require data-based guidelines and are the best way for physicians to feel comfortable with individual cases.”
Donors giving blood and plasma at a donation center in Brooklyn, NY
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Natalie Keyssar for The Wall Street Journal
Louis M. Katz, chief medical officer of the Mississippi Valley Regional Blood Center in Davenport, Iowa, which provides blood products to more than 120 hospitals, said the evidence supporting the use of restorative plasma in hospitalized patients is weak. “I think the data is there that it works early,” he said. “As you get sicker and sicker people, the thinner the evidence.”
In an editorial to the New England Journal of Medicine paper on the US Extended Access Study, Dr. Katz that restorative plasma should only be used in patients in early disease. The problem with that suggestion, he added later, is that FDA approval for emergency use still only applies to hospitalized patients, who tend to show up in the hospital if they have been ill for a long time.
Treating Covid-19 patients who are just starting to show symptoms poses its own challenges. “Logistically, it is very difficult to treat patients earlier,” said Dr. Katz. “It is difficult to transfuse a lot of plasma in outpatients.”
Dr. Marks said a large National Institutes of Health study is now underway to test recovering plasma in people with Covid-19 who are sick enough to come to the emergency room but not hospitalized just yet. as other randomized controlled trials. of plasma in outpatients. “As long as we don’t have that data, we’ll keep the license for hospitalized patients,” he said. “We will refine it if necessary. This is a scarce resource. “
Write to Amy Dockser Marcus at [email protected]
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