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Dr. Stephen Hahn, the embattled head of the Food and Drug Administration, offered a guarantee Monday: Any vaccine for public use will be approved “on the basis of science and data.”
“We will not make that decision on the basis of politics,” he said in a interview with CBS Evening News. “It is a promise.”
Hahn’s promise comes after a series of recent public errors involving the FDA and the Centers for Disease Control and Prevention, the two federal agencies that are critical to the U.S. coronavirus response, which they have damaged their reputations at a time when they are most needed. according to seven prominent doctors and scientists who spoke to NBC News. They claim that recent events are clear signs of political interference by the White House and have weakened their confidence in the leadership of the agencies.
“It’s a huge scandal,” said Carl Bergstrom, a biologist at the University of Washington, who has become an outspoken critic of the US response to the pandemic and has written extensively about misleading health information. “What appears at the moment is that there is a White House that modifies the public health councils to improve the possibilities of election to the detriment of the lives of the Americans.”
In an interview published Sunday in the Financial Times, Hahn said the FDA could accelerate a coronavirus vaccine by issuing an emergency use authorization before the end of Phase 3 clinical trials. Comments were met with outcry from the public health experts, which led him to clarify in the CBS interview that a vaccine will not be politicized.
Before that, Hahn misrepresented the data on convalescent plasma, leading him to subsequently apologize for overstating the potential benefits of the treatment. Subsequently, he also ousted the agency’s chief spokesperson over the fiasco, according to The New York Times.
The CDC sparked its own crisis when it inexplicably changed its guidance on testing for COVID-19 in a way that went against the best available scientific evidence, according to Bergstrom. The updated recommendations, posted on the agency’s website Aug. 24, suggested that people exposed to the coronavirus “do not necessarily need a test” unless they have symptoms, are older, or have existing medical needs that make them especially vulnerable to the virus. virus.
But it is known that infected people can be contagious before they experience symptoms, and people can also transmit the virus even if they remain asymptomatic.
Later, CDC Director Dr. Robert Redfield backtracked and issued a statement saying that “all close contacts of confirmed or probable COVID-19 patients” may consider getting tested.
Loren Lipworth, an epidemiologist at Vanderbilt University Medical Center in Nashville, Tennessee, said recent developments are concerning because they undermine the CDC’s mission.
“As epidemiologists, CDC has always been the people we turn to for guidance and data,” he said.
Bergstrom said that anything that compromises clear public health messages could be very harmful, especially as scientists learn new things about the virus and its effects on humans as a pandemic evolves. About eight months after the worst pandemic in more than a century, research has shown that avoiding the coronavirus relies on three pillars that work together: extensive testing, social distancing, and wearing a mask.
“If you don’t trust the agencies that are telling you to do this, then you don’t have your key weapons to fight a pandemic,” he said.
With the FDA commissioner’s mistake, Lipworth said it is particularly important that the person who heads the agency responsible for overseeing the development of potential coronavirus treatments and vaccines conveys the information correctly.
That situation has only heightened concerns that federal agencies are now politicized. The spokesperson who was fired from the FDA was previously a reporter for One America News Network, a far-right media outlet that has been a strong supporter of President Donald Trump.
Beyond the obvious dangers of mischaracterizing data on a potential treatment, Lipworth said, it is still too early to know whether convalescent plasma is, in fact, beneficial to patients. While the therapy has been shown to be safe, clinical trials are underway, including at Vanderbilt University, to test its effectiveness.
“The evidence is certainly not conclusive whether or not Dr. Hahn reported it correctly,” he said. “But even if it had, we are still not at a point where we can say there is conclusive evidence of benefits.”
All physicians and public health experts who spoke to NBC News expressed concern that Hahn’s misrepresentation could tarnish the FDA’s reputation. Given that the agency is tasked with evaluating the safety and efficacy of vaccine candidates, this erosion of confidence could be especially problematic, according to Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa.
“It is a real concern, especially when we have people who do not trust the government and do not want vaccines and just believe that this virus is causing a problem,” he said.
Dr. Steven Goodman, professor of epidemiology and medicine at Stanford University, said recent incidents may cause people to question the motivations of federal agencies responding to public health emergencies.
“It reduces the confidence that they have no political influence,” he said. “Any statement the FDA makes that they should amend or qualify, or any indication that they are lowering their standards, makes future statements more suspect in the public eye.”
And while public health has been shaped by politics throughout history, recent events raise a different kind of red flag, according to Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine. in Atlanta, who works as an investigator. for Moderna’s coronavirus vaccine clinical trials.
“Politics has always played a role in public health, think of HIV, for example, but it should not be partisan,” del Rio said. “It should never favor one party over another.”
The missteps add frustration to scientists and public health experts who are already operating in an environment that is politically charged and riddled with misinformation.
“It’s worried me before, but this makes him angry,” Goodman said.
Dr. David Dowdy, associate professor of infectious disease epidemiology at the Johns Hopkins Bloomberg School of Public Health, called the recent events a “tremendous blow” to the credibility of the CDC and the FDA, but added that he hopes the damage is not permanent.
“In the long run, I hope this is not something that clouds them too much,” he said, “as long as we have a political situation where science is no longer a political problem.”
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