WASHINGTON (BLOOMBERG) - The head of the United States Food and Drug Administration (FDA) walked back his claim that an experimental therapy had provided a dramatic benefit to Covid-19 patients, a rare reversal for an agency that has prided itself on rock-solid science and public trust.. Read more at straitstimes.com.
WASHINGTON - The head of the United States Food and Drug Administration walked back his claim that an experimental therapy had provided a dramatic benefit to Covid-19 patients, a rare reversal for an agency that has prided itself on rock-solid science and public trust.
"That was not the way that I would have worded it," said one of the doctors who led the blood plasma study, Dr Arturo Casadevall, chairman of the department of molecular microbiology and immunology at the Johns Hopkins School of Public Health."I hope they will issue a clarification," he said earlier on Monday.
Dr Robert Califf, the FDA commissioner under former president Barack Obama, said that he thought Dr Hahn had misspoken."It would be good for Steve to publish a correction," Dr Califf said on Twitter earlier on Monday. "Based on the data we have today, it's very likely that plasma is reducing mortality," Dr Casadevall said."The one thing we are missing is a randomised controlled trial", the gold-standard test that will tell researchers and regulators if blood plasma is a breakthrough, an incremental help or something in between, he said.
The FDA analysis was pulled from a subset of data in the trial - typically a no-no for credible studies. And despite a day of criticism online from doctors and researchers, Dr Hahn's correction was not enough for some.
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