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.
