Dr. Donnie Boy who fancies himself some sort of scientist or doctor, able to modify NOAA weather maps and overrule actual doctors announcing an emergency authorization from FDA (obviously a direct order from Donnie) regarding Convalescent Plasma use. NIH had asked FDA to delay allowing the use of Convalescent Plasma because the proof of its effectiveness is weak. In general the technology is pretty well known. However only the best, most well equipped hospitals can employ it safely. If the case for efficacy is weak, then the risks become an issue.
FDA has proven very "pliable" under Dr Hahn. We had evidence of that in their dealings regarding vaping. Now here it is again. I expect some dumbassed premature determination regarding vaccines from FDA around the election which would be laughable given the timing of Stage 3 trials and the timing of the election.
Safety is a major concern with vaccines because vaccines are given to large volumes of healthy people. Treatments are given to much smaller numbers of sick people. As such FDA can afford more risk with treatments than it can with vaccines.
Convalescent Plasma use sits somewhere in between vaccine and other treatment on the risk scale because it is more of a process than it is medicine.
Of course IDIOT Azar joined Dr Donald and Hahn at the briefing today.
This is weird. I mean really weird. I will let the experts present this story.
Before calling on the experts, here is a statement from Trump on Saturday. “
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
On the very next day. Fox News reports, "President Trump on Sunday granted an emergency authorization for the usage of convalescent plasma to treat coronavirus patients, dubbing it a “major breakthrough.'"
Speaking to reporters from the White House Sunday, Trump said the FDA has "issued an emergency use authorization... for a treatment known as convalescent plasma."
"I think there might have been a hold up, but
we broke the logjam over the last week to be honest," Trump said at a late afternoon news conference announcing the new authorization.
Really?? Then why the statement on Saturday?
Why isn't this medical breakthrough being announced by Trump? Medical breakthroughs are announced by medical experts. Is there something funny about this medical breakthrough?
Let's consult the medical experts.
The Tmes reports, "The Food and Drug Administration on Sunday authorized the emergency use of blood plasma from people who have recovered from coronavirus infections for the treatment of patients hospitalized with Covid-19.
"The decision, which was delayed after top federal scientists urged further study of the treatment, was praised by President Trump at a news conference in which he said plasma was “very effective,”
even though no rigorous clinical trials have proven that it works."
“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump said.
The Times continued with its report. "But the president’s endorsement notwithstanding, convalescent plasma,
however promising, has not been proven to work in randomized clinical trials, considered the best way of determining whether a treatment is effective.
"Although Mr., Trump said the new approval would “dramatically expand access” to the treatment,
convalescent plasma cannot be easily scaled up into millions of doses like manufactured drugs, because it is derived from blood donations."
Most important in all this is the statement made by Dr. Stephen M. Hahn.
On a call earlier in the day with reporters, the commissioner of the Food and Drug Administration, Dr. Stephen M. Hahn, said that information from studies conducted this year showed that the treatment was safe and had the potential to be helpful. However, he added that the agency would continue working with researchers studying the treatment and update the authorization as appropriate.
But enrollment in randomized trials — at least 10 such studies have begun in the United States — have faltered, collectively enrolling only a few hundred people.
Judge for yourself the validity of Trump's announcement. I would love to hear from his supporters, but I doubt that will happen. They don't talk about Trump very much.