/Coronavirus missteps from CDC and FDA worry health experts

Coronavirus missteps from CDC and FDA worry health experts

Dr. Stephen Hahn, the embattled head of the Food and Drug Administration, offered an assurance 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 an interview with CBS Evening News. “That’s a promise.”

Hahn’s pledge comes after a series of recent public missteps involving the FDA and the Centers for Disease Control and Prevention — the two federal agencies that are critical to the U.S. coronavirus response — that have damaged their reputations at a time when they are needed the most, according to seven prominent doctors and scientists who spoke to NBC News. They say that the recent events are clear signs of political interference from the White House and have shaken their trust and confidence in the leadership of the agencies.

“It’s an enormous scandal,” said Carl Bergstrom, a biologist at the University of Washington, who has become an outspoken critic of the U.S. pandemic response and has written extensively about misleading health information. “What it looks like at this point is you have a White House altering public health advice to improve election chances to the detriment of American lives.”

In an interview published Sunday in the Financial Times, Hahn said the FDA could fast-track a coronavirus vaccine by issuing emergency use authorization before the end of Phase 3 clinical trials. The comments were met with outcry from public health experts, prompting him to clarify in the CBS interview that a vaccine will not be politicized.

Before that, Hahn misrepresented data about convalescent plasma, leading him to subsequently apologize for overstating the potential treatment’s benefits. He also subsequently 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 COVID-19 testing in a way that ran contrary to 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 exhibit symptoms, are older or have existing medical needs that make them especially vulnerable to the virus.

But it’s been known that infected individuals can be contagious before they experience symptoms, and people can also spread the virus even if they remain asymptomatic.

CDC Director Dr. Robert Redfield later 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 the recent developments are troubling because they undercut the CDC’s mission.

“As epidemiologists, the CDC has always been who we turn to for guidance and for the data,” she said.

Bergstrom said that anything that compromises clear public health messaging could be very damaging, especially because scientists do learn new things about the virus and its effects on humans as a pandemic evolves. Roughly eight months into the worst pandemic in more than a century, research has shown that staving off the coronavirus relies on three pillars that work in concert with one another: testing widely, 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 against a pandemic,” he said.

With the FDA commissioner’s blunder, Lipworth said it’s particularly important for the person leading the agency responsible for overseeing the development of potential coronavirus treatments and vaccines to convey information correctly.

That situation has only furthered concerns that the federal agencies are now politicized. The spokesperson who was let go from the FDA was previously a reporter for One America News Network, a far-right media outlet that has been a staunch supporter of President Donald Trump.

Beyond the obvious dangers of mischaracterizing data on a potential treatment, Lipworth said, it’s still too early to know if convalescent plasma is, in fact, beneficial for patients. While the therapy has been shown to be safe, clinical trials are ongoing — including at Vanderbilt University — to test its effectiveness.

“The evidence is certainly not conclusive whether or not Dr. Hahn communicated it correctly,” she said. “But even if he had, we’re still not at a point where we can say there’s conclusive evidence of the benefits.”

All of the doctors and public health experts who spoke to NBC News expressed concern that Hahn’s misrepresentation could tarnish the FDA’s reputation. As the agency tasked with evaluating the safety and effectiveness of vaccine candidates, this erosion of trust could be especially problematic, according to Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa.

“It’s a real worry, especially when we have people who don’t trust the government and don’t want vaccines and barely believe that this virus is causing a problem,” he said.

Dr. Steven Goodman, a professor of epidemiology and medicine at Stanford University, said the recent incidents may cause people to question the motivations of the federal agencies that respond to public health emergencies.

“It reduces confidence that they are without political influence,” he said. “Any statement that the FDA makes that they have to amend or qualify, or any hint that they are lowering their standards, makes future statements more suspect in the eyes of the public.”

And while public health has been shaped by politics throughout history, the recent events raise a different sort of red flag, according to Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine in Atlanta, who is serving as an investigator for Moderna’s coronavirus vaccine clinical trials.

“Politics has always played a role in public health — think about 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 a politically charged environment rife with misinformation.

“I’ve been concerned before, but this elevates it to angry,” Goodman said.

Dr. David Dowdy, an 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 isn’t permanent.

“Long term, I hope that this is not something that will tarnish them too greatly,” he said, “if and when we have a political situation where science is not a political issue anymore.”

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