How terrible to be a wealthy brat who has it all to go through your entire life thinking everyone has it in for you and hates you. I wonder why you would think everyone hates you? Did you do something to make them hate you? Hugs
resident Donald Trump on Wednesday accused government scientists of slow-walking a safe but unproven coronavirus therapy, convalescent plasma, for political reasons.
“You have lot of people over there that don’t want to rush things. They want to do it after November 3rd,” he said in a White House press briefing.
Trump and other top administration officials have in recent weeks publicly urged Covid-19 survivors to donate their blood, which contains antibody-rich plasma, to help treat the sick.
But the FDA decided at the last minute to hold off on authorizing emergency use of the plasma after top scientists at the National Institutes of Health argued that data on the treatment’s efficacy was still thin, the New York Times reported Wednesday. While NIH has no role in approving therapies, the Times wrote that NIH Director Francis Collins and National Institute of Allergy and Infectious Disease Director Anthony Fauci raised alarms about the lack of definitive evidence.
More than 60,000 people in the U.S. have received plasma under a “compassionate use” program run by the Mayo Clinic, and clinical trials are ongoing. But there are no results yet from randomized, controlled studies, which are considered the gold standard in medical research.
“I’ve heard fantastic things about convalescent plasma,” Trump told reporters. “And people are dying. And we should have it approved if it’s good, and I’m hearing it’s good.”
The FDA this summer retracted an emergency use authorization for hydroxychloroquine — another drug touted by the president as a coronavirus cure — after randomized trials showed no benefit treating sick patients or preventing illness. The FDA had greenlighted the inexpensive drugs for emergency Covid-19 treatment after two limited studies, sparking criticism from health experts who accused the agency of caving to political pressure.
The plasma episode raises fresh questions about the FDA’s willingness to lower its standards for Covid-19 therapies and vaccines, said Rachel Sachs, an assistant professor of law at Washington University in St. Louis who studies drug regulation.
“We’ve seen [FDA Commissioner Stephen] Hahn be on a public relations campaign attempting to assure and convince the U.S. public that any vaccine will be safe and effective and at least one reason the agency has felt this need to embark on this campaign, is political interference,” she said. “This situation raises the possibility that the agency may seek to approve a product that doesn’t meet its rigorous safety and efficacy standards.”
That last part is really important. Can we trust a rushed vaccine from this administration? Hugs