President 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.
Michael Caputo, assistant secretary of HHS for public affairs, told POLITICO, “NIH has no role in approving an EUA and the person quoted” — H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, in the New York Times story — “did not attend key meetings on the topic.”
The FDA declined to comment on the matter. “Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma and will render a decision at the appropriate time,” said Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs.
He added that plasma is available through multiple pathways including clinical trials, a national expanded access program and single-patient request to use it in an emergency.
NIH referred questions to NIAID, which did not respond to requests for comment. An NIH source told POLITICO that concerns about the lack of definitive data had been brewing after the president appeared to latch onto plasma in recent press briefings.
Plasma treatment involves giving sick patients blood plasma from volunteers who have recovered from the virus. The plasma contains antibodies that could help fight off the infection.
The treatment has been used for more than a century against diseases from diptheria to Ebola with mixed success. But while the risk of using plasma is low, there is no definitive evidence it helps coronavirus patients. Large, randomized, controlled clinical trials are underway but could take months to produce results.
“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.”
An expanded-access program to provide plasma to patients outside clinical trials will continue “while planning is under way to transition smoothly to Emergency Use Authorization of convalescent plasma,” a Mayo Clinic spokesman said.
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.”