Trump’s aggressive stance on virus treatments raises concerns about putting politics ahead of security

Beating the virus and reopening the country have long been at the heart of Trump’s efforts for a second term. A Trump campaign document outlining Trump’s second term agenda makes eradication of Covid-19 one of his top priorities. The bullets in the document include: “Develop a vaccine by the end of 2020” and “Return to normal in 2021”.

“And frankly, in terms of quality, if you look at what we do and what we offer, the pharmaceutical companies are offering vaccines that have already seen results – it’s going to be very, very soon – in the third stage of trials.” Trump told a crowd of Republican delegates as he opened his convention in Charlotte on Monday.

The day before, Trump alleged, without evidence, that a ‘deep state’ within the FDA was deliberately delaying coronavirus vaccine trials, putting pressure on Dr Stephen Hahn, the man he had chosen to lead. the agency.

This is the latest example of a president who has previously touted unproven treatments for the coronavirus politicizing science around a disease that has already killed more than 176,000 Americans.

Trump has clashed with science advisers before and didn’t hesitate to call them when they disagree over the dire state of the pandemic, frequently infuriating his anger at Fauci, and criticizing the warnings of the Dr Deborah Birx and American Centers for Director of Disease Control and Prevention, Dr Robert Redfield, among others.

And while Trump has occasionally argued with his medical experts, the White House has given non-medical experts broad authority to talk about medical developments. White House trade adviser Peter Navarro, who is not a doctor and has no medical training but a doctorate in economics, told reporters on Monday that convalescent plasma “is one of the most common therapies. sure you can imagine “and suggested the timing of the EUA’s announcement was” late “. An EUA is not the same as an approval, but allows for greater distribution of treatment.

“The chances of it hurting you are close to zero, the chances of it helping you are close to 100%,” he said, noting that the FDA suggests it could lead to a 35% reduction in mortality. .

He added: “Convalescent plasma is like attacking Bambi, it has been shown to be safe and effective.”

But the 35% figure, from a Mayo Clinic study that has not yet been peer reviewed, does not actually show a 35% reduction in deaths among those treated. compared to those untreated, but among those treated earlier and at higher doses than those treated later and at lower doses. There is as yet no data from randomized clinical trials using convalescent plasma to treat Covid-19. Some of these trials are ongoing.

Navarro pushed back on questions about the timing of the announcement around the Republican convention, calling himself “an integral part” of the strategic national stockpile and vaccine and therapy development teams, despite the lack of medical training.

Pressed again by CNN’s Joe Johns on new information or data that led to the emergency use authorization, he said he was “unaware of the decisions and the data. I haven’t watched this. “

A prominent vaccine expert told CNN’s Wolf Blitzer on Sunday that the White House may have bullied the FDA into allowing emergency use of blood plasma.

“I think what’s going on here is you are witnessing bullying, at least at the highest level of the FDA, and I’m sure there are people in the FDA right now who are the workers over there who are as upset as I. am, “said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia.

The administration also raised the idea of ​​speeding up vaccine delivery through an EUA before the end of phase three trials, sources said. On July 30, during broader negotiations over coronavirus relief legislation in the office of House Speaker Nancy Pelosi, Senate Minority Leader Chuck Schumer asked White House officials in the room how things were going in the vaccination effort, according to two sources close to the meeting.

It was at this point that White House Chief of Staff Mark Meadows and Treasury Secretary Steve Mnuchin reviewed the different stages of vaccine development and then suggested that the effort to ‘AstraZeneca could be ready by September. As the conversation continued, White House officials raised the possibility of emergency use authorization before the end of phase three trials.

At that point, Pelosi interrupted to tell Mnuchin and Meadows that there shouldn’t be a corner cut during the vaccine development process.

The Financial Times first reported details of the July meeting.

Michael Caputo, deputy secretary for public affairs at the Department of Health and Human Services, denied Sunday that there had been any efforts to speed up vaccine development for political purposes.

“This is not true, don’t believe it. Talking about a surprise October vaccine plot is a grim resistance fantasy designed to undermine the president’s response to the coronavirus. And nobody, but nobody, among regulators career of the FDA that I know of, will never stand quietly for political pressure, ”Caputo said.

Meadows on Monday morning also dismissed concerns that there was political pressure to speed up a vaccine rollout, reiterating that the administration’s “Operation Warp Speed” will protectively produce large amounts of the drug. vaccines in phase three trials.

“Yeah, that doesn’t happen. I can tell you that we go through a standard clinical process like any other drug would happen and what we speed up is the non-testing side,” he said. he says. praise the manufacturing capacity and the idea that the vaccines will be ready for distribution “if indeed they prove to be effective for the American people”.

Trump has a habit of pushing unproven – and potentially dangerous – treatments for a virus that has crippled the economy on which he based much of the re-election speech.