https://www.politico.com/news/2020/08/23/plasma-treatment-coronavirus-fda-trump-400390
Outside experts and former officials have accused FDA of caving to White House pressure
during the pandemic — most notably in its decision to authorize
emergency use of hydroxychloroquine for treating Covid-19 infection
despite limited evidence. The agency later pulled the authorization
after randomized clinical trials found it provided no benefit, but Trump
as recently as this weekend complained about the agency's reversal.
Hahn,
a longtime cancer doctor, declined to contradict the president's claims
about plasma being "very effective" on the press briefing stage Sunday
night. "If you are one of those 35 out of 100 people who these data
suggest survive as a result of it, this is pretty significant," he said.
The
data from the expanded access program is not a randomized controlled
clinical trial, making it difficult for scientists to eliminate other
factors in patients' recovery. Two randomized trials cited in the FDA's
emergency use authorization, in China and the Netherlands, were both
halted.
The
Chinese trial could not enroll enough patients. The Dutch trial ended
after sponsors found "no difference in mortality, hospital stay or
day-15 disease severity."
But other outside experts — including at least four former FDA chiefs — have urged the agency to hold off an emergency authorization until there is clear data that plasma works.
"Let's get the trials done & if
the results are life saving, let's make it standard of care, thus
benefiting hundreds of thousands to millions," former FDA Commissioner Robert Califf tweeted this week. "If not we can avoid the huge expense & effort & keep looking for best treatments."
