“Deep State” Charges Shake FDA Trust

Is the FDA to be trusted?

Solving the biggest healthcare crisis of our time so the world of orthopedics and patient care can get back to normal will require trust. Any therapies and vaccinations developed by healthcare scientists to treat COVID-19 will only work if providers and patients trust and use them.

The keeper of that trust is the Food and Drug Administration (FDA).

“Deep State” at the FDA

In the early hours of Saturday, August 22, 2020, the ultimate boss of the FDA, the president of the United States, tweeted, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed and saving lives!” He then added “@SteveFDA,” Steve Hahn, M.D., the Commissioner of the FDA.

Earlier that week, the president suggested the delay by the FDA in an emergency measure supporting blood plasma was a political one. National Institutes of Health (NIH) Director Francis Collins expressed his opposition to granting emergency use status, saying the evidence was too weak. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, believed the plasma treatment met the low bar for emergency use.

According to the Washington Post, the president became increasingly annoyed by the disagreement among the scientists, setting up his tweet to pressure the FDA.

“I hear great things about it, that’s all I can tell you. It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after November 3rd,” said the president during a news conference.

Hahn “Shocked and Upset”

Hahn, a Washington political newcomer, was “shocked and upset” by the president’s comments, according to published reports and immediately called his White House contacts to find out why his boss’ boss was angry. In those calls he said the agency was on the verge of granting emergency use of the plasma treatment.

By the end of Saturday, the White House press secretary tweeted that the president was going to announce, “a major therapeutic breakthrough on the China Virus.”

FDA Says 35%…but NO Published Evidence?

The next day, Commissioner Hahn rushed back from a family home in Colorado to join the president and the secretary of Health and Human Services to announcing an EUA (emergency use authorization) for a use of blood plasma from patients who have recovered from COVID-19. All three said, according to research, the treatment “would save the lives of 35 in 100 coronavirus patients.”

Great news. The problem was that it wasn’t accurate. Even some of the authors of the study said, “Huh?”

“I don’t know where the 35% number comes from,” says Arturo Casadevall of Johns Hopkins University’s Bloomberg School of Public Health, the last author of the study, which has been posted as a preprint but has yet to be peer reviewed.

Eric Topol, M.D., founder and director of the Scripps Research Translational Institute, tweeted that it was “outrageous” to claim a 35% improved survival from that study. “There’s no evidence to support any survival benefit. 2 days ago, FDA’s website stated there was no evidence for an EUA,” he wrote. And Rachel Sachs, an associate professor of law at Washington University in St. Louis, wrote that given the political pressure on the FDA, issuing the EUA without publishing the evidence and without a supporting randomized trial “risks further damage to public trust in the agency.”

“The FDA was once again bullied into doing something that initially it wasn’t going to do,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Unnamed sources within the FDA told the Washington Post that employees of the agency felt “demoralized” that the commissioner had allowed the agency to become a prop in the presidential race. They wondered how the agency would have any credibility on an upcoming vaccine decision “if it bungled something much simpler?”

Hahn’s Contrition

By late Monday night, in a series of tweets, Hahn said the criticism he received about his blood plasma statement was “entirely justified,” and he sought to “reassure the American public” that the FDA “will remain data driven.”

Hahn didn’t clear his apology with HHS leadership and further aggravated a reportedly, contentious relationship with his boss, Alex Azar, the HHS secretary. The two had previously disagreed over HHS overruling the FDA and blocking the agency from regulating laboratory-developed tests.

Jerome Avorn, M.D., a professor of medicine at Harvard, told the Washington Post he’s been following health regulatory decisions for decades, but had “never seen this amount of arm-twisting to force agencies like the FDA and CDC [Centers for Disease Control and Prevention] to make decisions based on political pressure, rather than the best science.”

White House Denounces “False Narrative”

A White House spokesperson denied the charges, saying “this false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is dangerous to the American public.”

“You saw convalescent plasma. You saw remdesivir. You’ll soon see vaccines pouring out years ahead of what they would have been under a ‘more traditional’ administration, where they would have taken years to come up with this stuff,” said the president.

The White House chief of staff, Mark Meadows, said the president “had to make sure that they felt the heat,” during an interview on ABC’s “This Week.”

“If they don’t see the light, they need to feel the heat because the American people are suffering. This president knows it, and he’s going to put it on wherever—the FDA or NIH or anybody else—to make sure that we deliver on behalf of the American people,” Meadows said.

Past FDA Commissioners Damage Control

But the administration’s first FDA commissioner, Scott Gottlieb, M.D., said the president’s charges are unfounded.

“I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients,” Gottlieb said on CBS’ “Face the Nation.”

An Obama appointed FDA Commissioner, Robert Califf, M.D., chimed in, tweeting that, “One of Commissioner’s jobs is to protect this critical independence of judgement of the Center Directors and their staffs. It is naive to believe that politics aren’t part of the picture —both Dems and Reps.”

“The way the public part [of the plasma announcement] was handled will erode precious public confidence,” Gottlieb said on Twitter. “You earn public confidence in small drops and you loose [sic] it in buckets.”

He added, “Plasma is probably incrementally helpful to Covid patients and meets criteria for an EUA.” He added, “We need to keep FDA decisions with FDA. The FDA professional staff supported this. It’s their decision.”

Restoring Trust

So, we come back to public trust and the development of a vaccine.

The administration is reportedly developing a public relations campaign to convince the public that scientists are in charge of developing vaccines and therapies and that anything approved by the government will be safe and effective. One senior administration official asked the Washington Post, “How can we get people to trust a vaccine if the president is saying the deep state is behind it?”

The agency has issued dozens of EUAs during the course of the coronavirus pandemic—mostly for diagnostic tests. But also, for some drugs and has been forced to revoke the EUA. For instance, the agency revoked an EUA for the malaria drug hydroxychloroquine, which was touted by the president as a treatment for COVID-19 but found in studies to be ineffective and possibly harmful.

Hahn has penned op-eds in the Washington Post and the Journal of the American Medical Association promising he would listen to an outside panel of experts and would not authorize any vaccine unless it was safe and effective.

We asked Glenn Stiegman, one our favorite device consultants and former device leader at the FDA’s Center for Health and Radiologic Devices (CDRH), if this controversy was eroding trust of his clients seeking FDA approvals and clearances?

He said he didn’t see this particular issue, “while being remarkable and crazy, having an impact on our clients, since approving another total disc replacement or stent doesn’t necessarily have global ramifications. The offices across CDRH dealing with devices do indeed use science to make decisions, not political ‘persuasion.’ We do count on FDA consistency and transparency, which sometimes we struggle to see, but more often than not, there is a precedent, policy, and regulations to guide them.”

AMA Concern

On August 26, the American Medical Association (AMA) was alarmed enough to issue a statement to “strongly” urge the FDA ensure transparency in COVID-19 vaccine development to promote confidence among physicians and the public.

The association said it is committed to fighting medical misinformation. “However, physicians need to feel confident in the safety and efficacy of the COVID-19 vaccine candidates. To help physicians promote vaccine confidence among their patients and the general public, we must start now to provide information, education, and transparency around the FDA’s process for authorization or licensure, as well as the standards by which FDA will review vaccine candidates and the clinical endpoints which the FDA hopes to achieve.”

Does the Public Trust the FDA?

Arthur Caplan is director of the division of medical ethics at the NYU Grossman School of Medicine. He wrote, “It’s people worrying they’re going too fast, saying, ‘I don’t trust Trump, I don’t trust this whole process.’ There is a huge number of people that are just not going to accept whatever FDA says as adequate. The administration has shown itself time and time again to push its political agenda and steamroll the science.”

There are no polls yet to gauge public trust after recent events, but in a 2015 poll from the Pew Research Center, only 19% of Americans reported that they trusted the federal government always or most of the time. However, when it came to the FDA and the CDC, 51% and 71% of the U.S. population reported that they view those agencies favorably, respectively.

This past March, Pew asked a cross-section of Americans in a survey whether they had seen misinformation about the COVID-19 outbreak. Those who get their political news from social media were the most likely group to say they had seen at least some misinformation. More than half (57%) said this in March, versus 49% or fewer among the groups turning to other platforms. When this question was asked again in April, increases occurred across all media news groups.

Hahn and his team have their work cut out for them. They have put their careers on the line, threatening to resign if any vaccines are approved over their objections.

The agency has tentatively scheduled an October 22 meeting of its outside advisory committee to consider a potential vaccine.