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."
One of the things I learned from the President's convening of the players in this latest gambit to stem covid is that conceptually the plasma therapy is linked to the vaccines being developed.
ReplyDeleteThe plasma contains antibodies that are introduced directly into a patient's system. The vaccine spurs someone's body to make antibodies.
When are antibodies introduced into the system most effective? Before a person gets infected, or right after they get infected from covid.
The idea is that someone who contracts covid will be given plasma with antibodies. Now, if this fails to help people, then it is a flag. It is an indication that it is possible vaccines may be ineffective also. In fact, it is an indication, apparently, that someone who had covid may be at risk to get it again.
So this plasma program is critical towards developing an understanding of whether covid is something that can bve counteracted at all.
The President did with this plasma project what he did with his campaign and he did with his business: he brought together people from various professions and created a team that worked like a military machine to coordinate and plan and implement his will.
This is not something lost on the liberal media. The best the President's detractors can point to are voices who say there are no guarantees with this plasma.
But this is something the President's team freely admits. We're on a war footing, and usual protocols are being put aside. The winning battles of America's finest moments in armed conflicts came with high desth tolls, many that in retrospect were preventable. But in war, that's how it is. The generals learn to plow forward and put aside the losses for the sake of achieving the greater good of total victory.
Caution has its place in peacetime, but a slice of wild abandon in the elixir is what is required during the heat and fog of encountering an invisible and uncertain viral enemy.
Many, like myself, are just passive observers of this process, or at best volunteers who sign up to serve as test subjects for the plasma and vaccine therapies. We are living through extraordinary times. This is one of President Trump's finest moments. He may not get re-elected, but he made medical history by his leadership guiding us to this point. Ultimately, historians will focus on his coronavirus virus as the true test of his Presidency, and whether or not the liberal press realizes it, this is what greatness is.