President Donald Trump on Wednesday accused government scientists of slow walking of a safe but unproven coronavirus therapy, recovery time plasma, for political reasons.
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President Donald Trump addressed the White House on Wednesday,
‘You have a lot of people there who do not want to rush things. They want to do it after November 3, “he said in a press release from the White House.
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Trump and other top administration officials have publicly urged Covid-19 survivors in recent weeks to donate their blood, which contains antibody-rich plasma, to treat the sick.
But the FDA decided at the last minute to refrain from authorizing emergency use of plasma after top scientists at the National Institutes of Health claimed that data on the effectiveness of the treatment were 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 are raising alarms about the lack of definitive evidence.
More than 60,000 people in the U.S. have received plasma under a “compassionate use” program conducted by the Mayo Clinic, and clinical trials are ongoing. But there are still no results from randomized, controlled trials, which are considered the gold standard in medical research.
Michael Caputo, Assistant Secretary to HHS for Public Affairs, told POLITICO, “NIH Has No Role in Approving an EUA and the Affiliated Person” – H. Clifford Lane, Clinical Director at the National Institute of Allergy and Infectious Diseases, in The New York Times’ New Story – “Didn’t Attend Important Meetings on the Subject.”
The FDA declined to comment on the matter. “Per policy, we can not comment on whether or not we will take action regarding authorization for emergency use for recovery time plasma and we will make a decision at the appropriate time,” said Anand Shah, FDA Deputy Medical and Scientific Commissioner.
He added that plasma is available through multiple pathways, including clinical trials, a nationally expanded access program and one-patient requests 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 were brewing after the president appeared to be placing on plasma in recent press releases.
Plasma treatment involves sick patients donating blood plasma from volunteers who have recovered from the virus. The plasma contains antibodies that can help fight the infection.
The treatment has been used for over a century against diseases from diptheria to Ebola with mixed success. However, although the risk of using plasma is low, there is no definitive evidence that it helps coronavirus patients. Large, randomized, controlled clinical trials are underway, but it may take months to produce results.
“I’ve heard fantastic things about plasma recovery,” Trump told reporters. ‘And people are dying. And we have to approve it if it’s good, and I hear it’s good. ”
An extensive access program to provide plasma to patients outside of clinical trials will continue “while planning is underway to transition smoothly to Authorization for Emergency Use of Plasma Recovery,” a Mayo Clinic spokesman said.
The FDA withdrew an emergency use authorization for hydroxychloroquine this summer – another medication that was cured by the president as a coronavirus – after randomized trials show no benefit in treating sick patients or preventing disease. The FDA had greenlighted the cheap drugs for emergency Covid-19 treatment after two limited studies, prompting 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. Louis studying drug regulation.
‘We’ve seen [FDA Commissioner Stephen] “Hahn is on a public relations campaign that seeks to reassure the American public and convince them that any fax will be safe and effective, and at least one reason the agency felt the need to engage in this campaign is political interference.” sei se. “This situation raises the possibility that the agency may try to approve a product that does not meet its strict safety and efficiency standards.”
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