President Donald Trump speaks during a media briefing in the James Brady Briefing Room of the White House, Sunday, Aug. 23, 2020, in Washington.(AP Photo/Alex Brandon)
Reporter: Questions about the political pressure FDA was under
03:15 - Source: CNN
CNN  — 

As President Donald Trump races to reassure Americans that good news is on the way before the November election, there are concerns that efforts to fast-track coronavirus therapeutics and a vaccine are putting politics before health and safety.

Trump is set to lay out his vision for four more years amid a global pandemic and staggering unemployment at the Republican National Convention starting Monday – and key to that vision will be overcoming the spread of coronavirus.

But the White House’s convention eve announcement about the Food and Drug Administration’s emergency use authorization for convalescent plasma is again prompting questions from medical experts about the safety and efficacy of any solutions Trump pushes.

Several top health officials had previously been skeptical there was enough data to justify emergency plasma authorization.

Among those skeptics: Dr. Francis Collins, head of the National Institutes of Health; Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and the nation’s premiere infectious disease expert; and Dr. H. Clifford Lane, who works under Fauci at the NIH, according to a knowledgeable source.

Beating the virus and reopening the country have long been central to Trump’s push for a second term. A document from the Trump campaign outlining Trump’s second term agenda makes eradicating Covid-19 one of its top priorities. The document’s bullet points 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’re doing and what we’re coming up with, drug companies are coming out with vaccines that are I’ve seen some results already – it’s going to be very, very soon – in stage three trials,” Trump told a crowd of Republican delegates as he kicked off his convention in Charlotte on Monday.

At his Sunday news conference announcing the convalescent plasma news, Trump said he believed “political reasons” had slowed down FDA’s approval of the therapeutic treatment, but that he “broke the logjam” last week. Those remarks amounted to tacit confirmation that he applied pressure on the agency ahead of its announcement.

The day before, Trump had alleged, without evidence, that a “deep state” within the FDA was deliberately delaying coronavirus vaccine trials, pressuring Dr. Stephen Hahn, the man he had picked to head the agency.

It’s the latest example of a President who has previously touted unproven treatments for coronavirus politicizing the science around a disease that has already killed more than 176,000 Americans.

Trump has butted heads with scientific advisers before and hasn’t been shy about calling them out when they disagree about the dire state of the pandemic, frequently training his ire at Fauci, as well as criticizing warnings from Dr. Deborah Birx and US Centers for Disease Control and Prevention Director Dr. Robert Redfield, among others.

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

“The odds of it hurting you are close to zero, the odds 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, that’s like going after Bambi, it’s proven safe and effective.”

But the 35% figure, from a Mayo Clinic study that has not yet been peer reviewed, does not, in fact, show a 35% reduction in deaths in those treated versus those not treated, but among those treated earlier and at higher doses than those treated later and at lower doses. There is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

Navarro pushed back on questions about the announcement’s timing around the Republican convention, calling himself an “integral part” of the strategic national stockpile and vaccine and therapeutic development teams, despite having no medical background.

Pressed again by CNN’s Joe Johns on what new information or new data led to the emergency use authorization, he said he was “not privy to what the decisions were and what the data was. I haven’t looked at that.”

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

“I think what’s happening here is you’re seeing bullying, at least at the highest level of the FDA, and I’m sure that there are people at the FDA right now who are the workers there that are as upset about this as I am,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

The administration has also raised the idea of fast-tracking the distribution of vaccines via an EUA before phase three trials were completed, sources say. On July 30, during broader negotiations over the coronavirus relief legislation inside House Speaker Nancy Pelosi’s office, Senate Minority Leader Chuck Schumer asked the White House officials in the room how things were going on the vaccine effort, according to two sources familiar with the meeting.

It was at that point that White House chief of staff Mark Meadows and Treasury Secretary Steve Mnuchin walked through the various pieces of vaccine development, and then suggested that the AstraZeneca effort could be ready by September. As the conversation continued, the White House officials raised the possibility of an emergency use authorization before phase three trials were completed.

At that point, Pelosi interrupted to tell Mnuchin and Meadows there should be no cutting of corners during the vaccine development process.

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

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

“This is not true, don’t believe it. Talk of an October surprise vaccine plot is a lurid Resistance fantasy designed to undermine the President’s Coronavirus response. And nobody, but nobody, among the career FDA regulators I know will ever stand quietly for political pressure,” Caputo said.

Meadows on Monday morning also dismissed concerns that there’s political pressure to fast-track a vaccine, reiterating that the administration’s “Operation Warp Speed” will protectively produce large quantities of vaccines in phase three trials.

“Yeah that’s not happening. I can tell you, we’re going through a standard clinical process like any other drug would happen and then what we’re speeding up is the non-testing side of it,” he said, going on to tout manufacturing capacity and the idea that the vaccines will be ready to distribute “if indeed they prove efficacy for the American people.”

Trump has a history of pushing unproven — and potentially dangerous — treatments for a virus that has crippled the economy on which he was basing much of reelection pitch.

One study of the antimalarial drug hydroxychloroquine, which he has said he has taken himself as a prophylaxis, showed it helped patients better survive in the hospital, but other studies have found no benefit, and some have seen patients with cardiac side effects.

He’s also dangerously suggested ingesting disinfectant could possibly be used to treat people who have the virus, as well as sunlight as a treatment alternative.

Kevin Liptak, Jake Tapper and Jim Acosta contributed to this story.