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FDA Grants Emergency Authorization to Use Plasma Treatment for Coronavirus

FDA Grants Emergency Authorization to Use Plasma Treatment for Coronavirus
The Food and Drug Administration granted an emergency use authorization for blood plasma from patients who have recovered from COVID-19 as treatment for the disease. The move comes a day after Trump accused the FDA of slowing the development of vaccines and treatments for the coronavirus in order to hurt his chances in the November election. Trump announced the emergency authorization in a news conference Sunday in which he called it a “breakthrough.” But health experts warn that while the treatment has shown promise more study is needed before it is heralded as a game changer in the fight against the virus. Although the treatment has already been used in tens of thousands of patients, the authorization makes it easier for some to obtain it.

“The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” the FDA said in a news release. “The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.” The FDA news release included some glowing praise for Trump by Health and Human Services Secretary Alex Azar: “The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19.”

Everyone pretty much agrees that convalescent plasma could provide some benefit to patients fighting COVID-19 but many scientists and physicians have also warned the evidence is far from conclusive. Former FDA commissioner Scott Gottlieb said on CBS’ Face the Nation that while the use of plasma is “probably weakly beneficial” some officials wanted to “see more rigorous data” before the decision to authorize it was made. Gottlieb also emphasized that more than 70,000 people have already gotten the treatment, so “it’s widely available right now, patients are getting it.” But he did recognize that the emergency authorization would likely make it easier for some people to obtain the treatment.

The authorization had been on hold as top health officials, including Anthony Fauci, cautioned that the data was too weak to warrant the approval, the New York Times reported earlier this week. The skeptical officials pointed to data from the Mayo Clinic and said it was not strong enough. The debate over the use of plasma shows how the White House is pressuring agencies to test and approve treatments for the coronavirus. Mark Meadows, the White House chief of staff, said earlier Sunday that “the announcement that’s coming today should have been made several weeks ago.” Trump has publicly advocated for lots of unproven treatments during the coronavirus pandemic. Most famously, Trump touted the use of malaria drugs hydroxychloroquine and chloroquine and the FDA granted emergency authorization to use the drugs to treat COVID-19.

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