FDA Chief Apologizes for COVID Treatment Claim

TUESDAY, August 25, 2020 (HealthDay News) – As the World Health Organization warned on Monday that using plasma from COVID-19 survivors to treat other patients is still experimental therapy, US scientists have disputed a key statistic cited by US officials as grounds for urgent treatment approval.

In announcing the approval on Sunday, President Donald Trump and two of his top health officials spoke of the same staggering statistic – that treatment had reduced deaths by 35%, the New York Times reported.

Food and Drug Administration commissioner Dr Stephen Hahn went so far as to say that 35 out of 100 COVID-19 patients “would have been saved thanks to the administration of plasma.”

But many scientists, including a researcher in the Mayo Clinic study from which the statistic was allegedly taken, said on Monday that they could not determine where the number was coming from and that Hahn appeared to overestimate the benefits of the treatment. , the Time reported.

“Do I know where the 35 percent comes from?” said Dr Arturo Casadevall, one of the lead authors of the May Clinic study from Johns Hopkins University in Baltimore. “No.”

Actual data from the Mayo Clinic study shows that among a group of more than 35,000 patients, when plasma was given within three days of diagnosis, the death rate was around 22%, compared to 27% when it was administered for four days or more. after diagnosis, the Time reported.

But Hahn seemed to have instead confused the absolute risk and the relative risk in a small subset of patients in the study, the Washington post reported.

“I am absolutely in disbelief,” said Peter Lurie, a former senior FDA official and now president of the Center for Science in the Public Interest. Publish.

On Monday evening, Hahn admitted in a tweet that he misspoke during Sunday’s press briefing on the results of the plasma study.

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

What is the actual medical benefit? Eric Topol, director of the Scripps Research Translational Institute, said on Twitter Monday that data collected on plasma use in COVID-19 patients indicates that 3 in 100 people would be saved within seven days of treatment and 5 to 30 days and no 35..

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