NIH panel refutes FDA claims on benefits of plasma treatment for coronavirus

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Convalescent plasma from a recovered coronavirus disease (COVID-19) patient is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington, April 17, 2020.Lindsey Wasson | Reuters

A panel of experts convened by the National Institutes of Health said on Tuesday that there was “not enough data” to show that convalescent plasma works against the coronavirus, refuting claims by President Donald Trump and the chief of the Food and Drug Administration.The panel said it looked at the available treatment data and found nothing in “well-controlled and sufficiently powerful randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma” for the treatment of Covid-19. He also said “there was no difference in 7 day survival” for the patients, contradicting FDA Commissioner Dr Stephen Hahn, who said the treatment resulted in a 35% improvement. of survival.

“There is not enough data to recommend for or against the use of convalescent plasma for the treatment of COVID-19,” the panel said in a statement. “Convalescent plasma should not be considered standard therapy for the treatment of patients with COVID-19. “

There are no officially approved drugs or vaccines for the coronavirus. Plasma is taken from patients who have recovered from Covid-19 and have developed antibodies to the virus, and then infused into sick patients. It is one of the many therapies tested as a potential treatment.

The FDA granted emergency treatment clearance on August 23, allowing U.S. healthcare providers to use the plasma to treat suspected or confirmed infections in hospital patients.

The results of a Mayo Clinic study that the FDA cited in its approval for plasma treatment indicated that patients under the age of 80 who were not on a ventilator and were receiving plasma with high levels of antibodies in the three days after diagnosis behaved better than patients who received plasma with low antibody levels. One weakness of the Mayo study was that it did not include a controlled group of patients receiving a placebo.

The FDA’s decision to allow emergency use came a day after Trump accused the FDA of delaying recruitment into clinical trials for Covid-19 vaccines or therapies. Criticism of Trump and the FDA’s action led some scientists to say the emergency use was politically motivated, especially since it was announced on the eve of the Republican National Convention.

Hahn, under heavy criticism, later returned to comments he made about the benefits of convalescent plasma, saying he could have better explained the data on its effectiveness.

“I have been criticized for the remarks I made on Sunday night about the benefits of convalescent plasma. The criticism is fully justified, ”Hahn tweeted on August 24. “What I should have said better is that the data shows a reduction in relative risk and not an absolute reduction in risk. ”

He also said he was not giving in to pressure from Trump. “The decision was made by career scientists at the FDA based on data submitted a few weeks ago,” Hahn tweeted.

“We looked at the data from the Mayo Clinic,” he said in an interview with CBS on Aug. 25. “The Mayo Clinic identified a group of patients, some patients who looked the most like this, that the antibodies benefited them the most. We asked for additional validation data that has come in that supports this, meaning that we compare patients who have high concentrations of antibodies to those who have low concentrations of antibodies. ”

The FDA has issued emergency use authorization for several coronavirus tests and certain drugs. In May, the agency granted authorization for antiviral remdesivir, allowing hospitals and doctors to use the drug on Covid-19 hospital patients. Hydroxychloroquine also received emergency clearance, but the FDA subsequently withdrew the designation after the agency concluded that the malaria drug was unlikely to be effective.

The NIH panel said on Tuesday it would continue to assess emerging clinical data on the use of convalescent plasma from Covid-19. He said that “well-controlled and sufficiently powerful randomized trials are needed to determine whether convalescent plasma is effective and safe.”

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