Trump’s aggressive stance on virus treatments raises concerns about security policy

Hitting the virus and reopening the country has long been central to Trump’s pressure for a second term. A document from the Trump campaign outlining Trump’s second agenda makes the destruction of Covid-19 one of his top priorities. The document’s highlights include, “Developing a Fax by the End of 2020” and “Returning to Normal in 2021.”

“And honestly, in terms of quality, if you look at what we do and what we come up with, drug companies come out with faxes that I’ve already seen some results – it’s going to be very, very soon – in stage three. trials, “Trump told an audience of Republican delegates as he began his convention in Charlotte on Monday.

The day before, Trump had, without proof, claimed that a “deep state” in the FDA was deliberately delaying coronavirus vaccine testing, and pressured Dr. Stephen Hahn, the man he had chosen to stand at the bureau.

It is the latest example of a president who has previously unproven treatments for the coronavirus that police science is about a disease that has already killed more than 176,000 Americans.

Trump has previously clashed with scientific advisers and is not ashamed to call them out if they do not agree on the plight of the pandemic, he often traps his ire on Fauci, as well as criticizes warnings from Drs. Deborah Birx and U.S. Centers for Disease Control and Prevention, Dr. Robert Redfield, among others.

And although Trump has occasionally sparred with his medical experts, the White House has given broad authority to non-medical experts to talk about medical developments. White House adviser Peter Navarro, who is not a medical doctor and has no medical training, but a Ph.D. in economics, reporter told Monday that convalescent plasma “is one of the safest therapies you can think of” and suggested the timing for the EUA announcement was “late.” An EUA is not the same as an approval, but allows for a greater distribution of treatment.

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

He added, “Convalescent plasma, which is like going to Bambi, it has been proven safe and effective.”

But the figure of 35%, from a Mayo Clinic study that has not yet been peer reviewed, shows, in fact, no reduction of 35% in death in those treated versus those not treated, but below those treated earlier and in higher doses than those treated later and at lower doses. There are not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

Navarro shrugged off questions about the timing of the announcement around the Republican convention, calling himself an “integral part” of the strategic national advance and vaccine and therapeutic development teams, despite having no medical background.

Re-impressed by CNN’s Joe Johns about what new information or new data leads to authorization for emergency use, he said he “was not private about what the decisions were and what the data was. I have not seen that. “

A leading vaccine expert told CNN’s Wolf Blitzer on Sunday that the White House may have harassed the FDA for giving permission for emergency use of blood plasma.

“I think what’s happening here is that you see 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 who are over there. are about this as I am, “said Dr. Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.

The administration also came up with the idea of ​​tracking the distribution of faxes through an EUA quickly before phase three trials were completed, sources said. On July 30, during broader negotiations on coronavirus relaunch legislation in House Speaker Nancy Pelosi’s office, Senate Minority Leader Chuck Schumer asked White House officials how things were going about the fax attempt, according to two sources familiar with the meeting.

It was at this point that White House Chief of Staff Mark Meadows and Treasury Secretary Steve Mnuchin went through the various pieces of fax development, and then suggested that AstraZeneca’s effort could be ready by September. As the conversation progressed, White House officials raised the possibility of an emergency use authorization before three-three trials were completed.

At that point, Pelosi paused to tell Mnuchin and Meadows that there should be no corners during the fax development process.

The Financial Times first reported the details of the July meeting.

Michael Caputo, the assistant secretary of public affairs at the Department of Health and Human Services, denied on Sunday that there was any attempt to track the development of faxes for political purposes.

“This is not true, do not believe it. Speaking of a plot of a surprise vaccine for October, a lurid Resistance fantasy designed to undermine the president’s Coronavirus response. And not one, but none, during the FDA’s career. -regulators I know will ever stand still for political pressure, “Caputo said.

Meadows on Monday morning also dismissed concerns that there is political pressure to track down a fax machine, reiterating that the administration’s ‘Operation Warp Speed’ will protect large numbers of faxes in phase three trials.

“Yes that does not happen. I can tell you, we are going through a standard clinical process like any other medicine would happen, and then what we are accelerating is the non-testing side of it,” he said, continuing to tout production capacity and the idea that the faxes are ready to be distributed “if they actually prove effective for the American people.”

Trump has a history of driving unproven – and potentially dangerous – treatments for a virus that has raped the economy where he has pitched a lot of repeat pitch.