8.19.20 -Government health leaders (including Dr Fauci) urged caution regarding plasma treatment

[iluvtennis]

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

F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold

Government health leaders including Dr. Francis S. Collins and Dr. Anthony S. Fauci urged caution last week, citing weak data from the country’s largest plasma study.

Aug. 19, 2020

WASHINGTON — Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.

But clinical trials have not proved whether plasma can help people fighting the coronavirus.

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.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.

The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has given infusions to more than 66,000 Covid-19 patients thanks to financing from the federal government.

An F.D.A. spokeswoman declined to comment, but Mr. Trump reacted angrily, suggesting the decision was politically motivated.

“You have a lot of people over there who don’t want to rush things because they want to do it after November 3,” he said referring to Election Day, as he proclaimed without evidence that convalescent plasma helped “way over 50 percent” of Covid-19 patients infused with it.

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The press conference today is just trump manipluating the FDA head to go around the scientists and doctors to give authoriztion to proceed with the plasma studies. I so DESPISE trump - he needs to listen to the scientists/doctors.

[JI7]

1. Anyone know how long it will be before Fauci can talk again ?