FDA chief apologizes for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. Scientists and medical experts were critical when President Trump announced the FDA had authorized emergency use of the treatment.
Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observation.
The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways -- and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.
Lurie said Hahn’s performance at the press conference undermined his credibility, particularly among FDA staff.On Monday, House Speaker Nancy Pelosi, a Democrat, called Hahn a “disappointment” and said House committees were looking into FDA actions. At Sunday’s briefing Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Trump wants FDA to ‘feel the heat,’ chief of staff saysThe president’s claim that the FDA is delaying clinical trials for the coronavirus vaccine for political reasons is his way of making some at the agency “feel the heat” and push forward, White House Chief of Staff Mark Meadows said
Read more »
FDA chief issues mea culpa for his plasma treatment claimsFDA Commissioner Stephen Hahn issued a mea culpa late yesterday, conceding that he had overstated the benefits of convalescent plasma as a treatment of coronavirus at a press conference last weekend with President Trump
Read more »
FDA chief walks back comments on effectiveness of coronavirus plasma treatmentThe FDA's decision to issue emergency use for the treatment came a day after President Donald Trump accused the agency of delaying enrollment in clinical trials for Covid-19 vaccines or therapeutics.
Read more »
Trump and FDA announce new method to treat hospitalized COVID-19 patientsThe president said the new, expedited method of treatment has led to a reduced mortality rate by 35 percent in coronavirus patients.
Read more »
US FDA announces emergency authorization for convalescent plasma to treat Covid-19The US FDA announced emergency use authorization for convalescent plasma to treat coronavirus, a decision President Trump called 'truly historic.'
Read more »
Coronavirus updates: FDA may OK blood plasma treatments; CDC drops 14-day quarantine guideline; Trump accuses FDA of slowing vaccine testingPresident Donald Trump claims the FDA is trying to slow testing of COVID-19 vaccines until after the November election. Latest news.
Read more »