Trump suggests government scientists withhold plasma therapy for political reasons

© Evan Vucci / AP Photo
President Donald Trump speaks at the White House on Wednesday,

President Donald Trump on Wednesday accused government scientists of slowing down a safe but unproven anti-coronavirus therapy, convalescent plasma, for political reasons.

“There are a lot of people out there who don’t want to rush things. They want to do it after November 3, ”he said during a press briefing at the White House.

Trump and other senior administration officials have publicly urged Covid-19 survivors in recent weeks to donate blood, which contains antibody-rich plasma, to help treat the sick.

But the FDA decided at the last minute not to allow emergency use of plasma after top scientists at the National Institutes of Health argued that the data on the treatment’s effectiveness was still thin, reported Wednesday. the New York Times. While the NIH has no role in approving therapies, The Times wrote that NIH Director Francis Collins and National Institute of Allergy and Infectious Diseases Director Anthony Fauci alarmed the lack of definitive evidence.

More than 60,000 people in the United States have received plasma as part of a “compassionate use” program run by the Mayo Clinic, and clinical trials are underway. But there are still no results of randomized controlled studies, which are considered the benchmark in medical research.

Michael Caputo, HHS deputy secretary for public affairs, told POLITICO: “The NIH has no role in approving an EUA and the named person” – H. Clifford Lane, clinical director of the National Institute of Allergy and Infectious Diseases, in the New History of the York Times – “did not attend important meetings on the subject.”

The FDA declined to comment on the matter. “By policy, we are not in a position to say whether or not we will take action regarding the emergency use authorization for convalescent plasma and render a decision in due time,” said Anand Shah, deputy. FDA Commissioner for Medical and Scientific Affairs.

He added that the plasma is available through multiple routes, including clinical trials, an expanded national access program and a request for a single patient to use it in an emergency.

The NIH referred the questions to NIAID, which did not respond to requests for comment. An NIH source told POLITICO that concerns about the lack of definitive data loomed after the president appeared to be hanging on to plasma during recent press briefings.

Plasma therapy involves giving sick patients blood plasma from volunteers who have recovered from the virus. Plasma contains antibodies that could help fight infection.

The treatment has been used for over a century against diseases ranging from diphtheria to Ebola with mixed success. But while the risk of using plasma is low, there is no definitive evidence that it helps patients with coronavirus. Large randomized controlled clinical trials are underway, but could take months to produce results.

“I have heard fantastic things about convalescent plasma,” Trump told reporters. “And people are dying. And we should get it approved if it’s good, and I hear it’s good.

An expanded access program to provide plasma to patients outside of clinical trials will continue “while planning is underway to smoothly transition to the emergency use authorization for convalescent plasma,” said a Mayo Clinic spokesperson.

This summer, the FDA withdrew an emergency use authorization for hydroxychloroquine – another drug touted by the president as a cure for coronavirus – after randomized trials showed no benefit in treating sick patients or prevent disease. The FDA had given the green light to inexpensive drugs for emergency treatment of Covid-19 after two limited studies, prompting criticism from health experts who accused the agency of giving in to political pressure.

The plasma episode raises new questions about the FDA’s willingness to lower its standards for Covid-19 therapies and vaccines, said Rachel Sachs, assistant professor of law at Washington University in St. Louis who studies drug regulation.

“We saw [FDA Commissioner Stephen] Hahn will participate in a public relations campaign to assure and convince the American public that any vaccine will be safe and effective and at least one of the reasons the agency felt the need to embark on this campaign is political interference. She said. “This situation raises the possibility that the agency is seeking approval for a product that does not meet its rigorous standards for safety and efficacy.”