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The NIH panel rejects the FDA's claims about the advantages of coronavirus plasma therapy

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

Lindsey Wasson | Reuters

A panel of experts convened by the National Institutes of Health said Tuesday there was "insufficient data" to support convalescent plasma work against the coronavirus and rejected claims made by President Donald Trump and the head of the Food and Drug Administration .

The panel said it had reviewed the available data on treatment and found nothing from "well-controlled, adequately performing randomized clinical trials demonstrating the effectiveness and safety of convalescent plasma" for the treatment of Covid-19. It was also said "there was no difference in 7-day survival" for patients, which is what FDA Commissioner Dr. Stephen Hahn disagreed, who said the treatment resulted in a 35% improvement in survival.

"There isn't enough data to recommend either for or against the use of convalescent plasma to treat COVID-19," the panel said in a statement. "Convalescent plasma should not be considered the standard for treating patients with COVID-19."

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

The FDA granted emergency treatment approval on Aug. 23, which would allow U.S. healthcare providers to use the plasma to treat suspected or confirmed infections in hospitalized patients.

Results from a study by the Mayo Clinic, which the FDA cited in its approval of the plasma treatment, show that patients below the age of 80 who did not receive a ventilator and who received plasma with high antibody levels within three days of being diagnosed did better than patients who received plasma with a low level of antibodies. One weakness of the Mayo study was that it did not include a controlled group of patients who received a placebo.

The FDA's decision to approve emergency use came a day after Trump accused the FDA of delaying entry into clinical trials for Covid-19 vaccines or therapeutics. Trump's criticism and the FDA's actions led some scientists to say the emergency deployment was politically motivated, especially since it was announced on the eve of the National Convention of Republicans.

Under heavy criticism, Hahn later went back to his comments on the benefits of convalescent plasma, saying he could have explained the data about its effectiveness better.

"I have been criticized for comments I made on Sunday evening about the benefits of convalescent plasma. The criticism is entirely justified," Hahn tweeted on August 24th. "What I should have said better is that the data shows a relative risk reduction that is not absolute." Risk reduction. "

He also said he does not bow to pressure from Trump. "The decision was made by FDA scientists based on data submitted a few weeks ago," Hahn tweeted.

"We looked at the Mayo Clinic data," he said during a CBS interview on Aug. 25. "The Mayo Clinic identified a group of patients. Certain patients who appeared to benefit most, that the antibodies were of most benefit to them. Us." asked for additional validation data confirming this, which meant that patients with high antibody levels were compared to patients with low antibody levels. "

The FDA has issued emergency clearance for several coronavirus tests and some drugs. In May, the agency approved antiviral remdesivir so that hospitals and doctors can use the drug on hospitalized Covid-19 patients. Hydroxychloroquine was also granted emergency approval, but the FDA later removed the name once the agency determined that the anti-malarial drug is unlikely to be effective.

The NIH panel announced Tuesday that it will continue to evaluate new clinical data on the use of convalescent plasma from Covid-19. It said that "well-controlled, sufficiently powerful randomized trials are needed to determine whether convalescent plasma is effective and safe."

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