US FDA emergency approval for blood plasma therapy on hold
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Last week, just as the US Food and Drug Administration was preparing to issue an emergency authorisation for blood plasma as a Covid-19 treatment, a group of top health officials, including Anthony Fauci, intervened, arguing that emerging data on the treatment was too weak, according to two senior officials.

Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic.

They thought the study’s data to date was not strong enough to warrant an emergency approval.

Statisticians at the F.D.A. are now examining the Mayo data to better understand what factors other than the treatment might have influenced patient responses, such as higher-quality care in the hospital, Dr. Lane said.

A research team also published preliminary results from a plasma trial last week. Their study of hospitalized Covid-19 patients in the American Journal of Pathology reported that a group of 136 patients who received the treatment were more likely to be alive four weeks later compared with 251 patients who did not receive it.

That study found a statistically significant benefit only when patients were treated within three days of admission and when the plasma contained a high concentration of antibodies.

But an emergency authorization could have the unintended effect of making it harder for rigorous clinical trials to definitively show whether plasma works. "If the F.D.A. does grant the emergency authorization, it could make it even harder to get answers", said Dr Ortigoza of N.Y.U.

Source: https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html
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