Not trusting the FDA, Black doctors’ group creates panel to vet Covid-19 vaccines
As trust in federal health agencies has withered over the last few months, a group of Black physicians has been working on an antidote: creating their own expert task force to independently vet regulators' decisions about Covid-19 drugs and vaccines as well as government recommendations for curbing the pandemic.
Organized by the National Medical Association — founded in 1895 as an answer to racist professional societies excluding Black doctors — the committee is meant to safeguard against any unscientific guidance from the Centers for Disease Control and Prevention and the Food and Drug Administration.
"It's necessary to provide a trusted messenger of vetted information to the African American community," said Leon McDougle, a family physician and president of the NMA. "There is a concern that some of the recent decisions by the Food and Drug Administration have been unduly influenced by politicians."
Just one of the examples he gave was the agency's go-ahead to use hydroxychloroquine against Covid-19 even though there was no reliable evidence that it worked, and some indication that it could cause heart damage. The FDA later back-tracked and revoked the authorization.
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McDougle frames the new task force as a way to address the suspicion that has sprouted up around Covid-19 vaccines. Some worry that, in being developed at "warp speed," the shots might not be safe or properly tested before they're approved, and the anxiety is only heightened for those who've been alienated by the medical system. That's part of the reason that certain patients of color are especially wary of taking part in the clinical trials — and those concerns may well persist even if adequate studies are done and a vaccine hits the market.
"I think this will help to increase uptake in the African American community, if members of our task force give it the green light," McDougle said. But he emphasized that their stamp of approval would come only if data show that the vaccine is, in fact, effective and safe.
They'll also be evaluating how well the clinical trial participants represent the demographic breakdown of the American population, as well as the fairness of the federal plans to distribute a vaccine — both of which are especially important given the disproportionate impact that the pandemic has had on Black, Latino, and Native American communities.
"There is a need for this task force. We need a trusted organization to take the lead on this effort," said emergency physician Uché Blackstock, the founder and CEO of the consulting firm Advancing Health Equity, who is not a member of the NMA. "What we've seen in terms of political interference in the FDA and CDC has really undermined what little trust the Black community had."
While the NMA may not be a household name for the lay public, Blackstock added, "because they are an organization of Black physicians led by Black physicians, what they ultimately say and recommend will have significant influence on whether people take the vaccine or not."
(McDougle didn't know how many members the NMA currently has, and the executive director did not respond to repeated requests for comment.)
The task force's leaders are still figuring out exactly how it will work. When asked what would happen if the FDA authorizes the use of a product without releasing the full data to support it — as was the case with the antiviral drug remdesivir in May — McDougle said that because some of the members are also involved with federal committees, he hopes that they would have access to those statistics, and that there wouldn't be much of a lag between a governmental decision and the NMA's review.
To scholars who study vaccine acceptance, the task force has the potential to either increase immunization rates or deepen mistrust. Under normal circumstances, Saad Omer, director of the Yale Institute for Global Health, would prefer that everyone simply look to the FDA and the CDC's Advisory Committee on Immunization Practices. "As a public health professional, the more the mainstream process is followed, the better," he said.
But he knows these aren't normal circumstances. He pointed out that there is a precedent: Other professional societies representing some medical specialties have their own committees, but their recommendations tend to harmonize with the CDC's. Of the NMA task force, he said, "I wish they didn't have to, but if they have to, I can understand why they're doing it."
The idea came from Rodney Hood, an internal medicine doctor in San Diego. Even before the Trump administration, he knew his patients didn't have much faith in government. They trusted him, their doctor, and he was their source of evidence-based advice. But as he saw agencies making decisions that seemed more motivated by politics than by data, he realized his own faith in the official vetting process was shaken.
That put him in a strange position when his patients asked about the vaccines being developed to prevent Covid-19 and when the researchers testing them asked for his help recruiting Black volunteers.
"It's kind of a Catch-22," he said. He's long been an advocate for the inclusion of communities of color in clinical trials, but he also feels that the agencies overseeing the work are "tainted."
"A lot of us are on a 'wait-and-see,' trying to get some feeling that the FDA, the CDC, and whoever else is going to approve these vaccines is going to do so based on the science, and not rush it out," he said.
The sentiment wasn't just true for physicians. Francine Maxwell, president of the San Diego branch of the NAACP, said that politicians' promises of an effective vaccine by the election has only made her community more suspicious. "They don't trust the science behind it, because they feel everyone is doing it to make 45 happy," she said, referring to President Trump.
The response she's hearing from many is to take a step back. "They're not going to partake when the vaccine comes. They're going to wait an additional year. They're going to watch and do their own study and see how the data points pan out," she said.
As a past president of the NMA, Hood knew that the organization had in its ranks the kind of expertise that could deeply analyze clinical trial data — and so, in August, he helped introduced a resolution to form this task force. "There were no objections," McDougle said.
Hood, who is on the task force alongside some epidemiologists and infectious disease specialists, is also hoping to look at the vaccine trial protocols more closely, and if he feels comfortable with one of them, will volunteer to participate himself.
Whether or not their assessment is the same as regulators', said Khadijah Lang, a family physician in Los Angeles and another member of the task force, "we will tell our patients what our scientific findings are with full disclosure and full transparency, explaining how we came to our conclusions."
That's good news to Sandra Crouse Quinn, professor and chair of the University of Maryland's family science department. "We need sunshine everywhere, we need the pharmaceutical companies to share their data, we need the NMA and any other independent body and the FDA itself to shine the light and, whatever their decision, to say what their rationale is," she said.
Still, she's worried about the acceptance of a Covid-19 vaccine generally — and what might happen if the NMA's task force's conclusion differs from federal agencies'. "How do we explain that so that it doesn't torpedo the credibility of any vaccine?" she asked.
Both McDougle and Hood answered that question with a kind of careful optimism. As Hood put it, "Hopefully, it will be the same as what the FDA and CDC are saying."