Marty Makary, Often Wrong as Pandemic Critic, Is Poised To Lead the FDA He Railed Against

Panelists at a covid conference last fall were asked to voice their regrets — policies they had supported during the pandemic but had come to see as misguided. Covid contact tracing, one said. Closing schools, another said. Vaccine mandates, a third said.

When Marty Makary’s turn came, the Johns Hopkins University surgeon said, “I can’t think of anything,” adding, “The entire covid policy of three to four years felt like a horror movie I was forced to watch.”

It was a characteristic response for Makary, President Donald Trump’s nominee to lead the Food and Drug Administration, who looks set to be confirmed after a Senate committee hearing on Thursday. A decorated doctor and a brash critic of many of his medical colleagues, Makary drew Trump’s attention during the pandemic with frequent appearances on Fox News shows such as “Tucker Carlson Tonight,” in which he excoriated public health officials over their handling of covid.

Many former FDA officials and scientists with knowledge of the agency are optimistic about Makary — to a degree.

“He’s a world-class surgeon, and he has health policy expertise,” said Jennifer Nuzzo, a Brown University professor of epidemiology and former colleague of Makary’s at Johns Hopkins. “If you have pancreatic cancer, he’s the person you want to operate on you. The university is probably losing a lot of money to not have him doing that work.”

His critics say he at times exaggerated the harms of the covid vaccine and undersold the dangers of the virus, contributing to a pandemic narrative that led many Americans to shun the shots and other practices intended to curb transmission and reduce hospitalizations and deaths.

Should he take the reins at the FDA, transitioning from gadfly to the head of an agency that regulates a fifth of the U.S. economy, Makary would have to engage in the thorny challenges of governing.

“Makary spent the pandemic raving against the medical establishment as if he were an outsider, which he wasn’t,” said Jonathan Howard, a New York City neurologist and the author of “We Want Them Infected,” a book that criticizes Makary and other academics who opposed government policies. “Now he really is the establishment. Everything that happens is going to be his responsibility.”

At his confirmation hearing, Makary sounded a lower-key tone, extolling the FDA’s professional staff and promising to apply good science and common sense in the service of attacking chronic disease in the U.S., including by studying food additives and chemicals that could be contributing to poor health.

“We need more humility in the medical establishment. You have to be willing to evolve your position as new data comes in,” he testified. What makes a great doctor “is not how much you know; it’s your humility and your willingness to learn, as you go, from patients.”

Colleagues have applauded Makary’s skill and intelligence as a surgeon and medical policy thinker. He contributed to a 2009 surgery checklist believed to have prevented thousands of mistakes and infections in operating rooms. He wrote a widely cited 2016 paper claiming that medical errors were the third-leading cause of death in the United States, although some researchers said the assertion was overblown. He’s also founded or been a director for companies and said in the hearing that a surgical technique he invented eventually could help cure diabetes.

Humility, however, has not been Makary’s most obvious trait.

During the pandemic, he took to op-eds and conservative media with controversial positions on public health policy. Some proved astute, while others look less prescient in hindsight.

In December 2020, Makary defied established scientific knowledge and said that vaccination of 20% of the population would be enough to create “herd immunity.” In a February 2021 Wall Street Journal piece, he predicted that covid would virtually disappear by April because so many people would have become immune through infection or vaccination. The U.S. death toll from covid stood at 560,000 that April, with an additional 650,000 deaths to come. In June 2021, he said he had been unable to find evidence of a single covid death of a previously healthy child. By then there were many reports of such deaths, although children were much less likely than older people to suffer severe disease.

In February 2023, Makary testified in Congress that the lab-leak theory of covid’s origin was a “no brainer,” a surprisingly unequivocal statement for a scientist discussing a scientifically unresolved issue.

Some public health officials felt Makary gratuitously attacked authorities working in difficult circumstances.

“He went from being a pretty reasonable person to saying a lot of things that were over the top and unnecessary,” said Ashish Jha, dean of the Brown University School of Public Health, who was the White House covid-19 response coordinator under President Joe Biden.

And while almost everyone involved in fighting covid has admitted to getting things wrong during the pandemic, Jha said, “I never had any sense from Marty that he did.”

Makary did not respond to requests for comment.

Makary accused Biden administration officials of ignoring emerging evidence that previous infection with covid could be as or more effective against future infection than vaccination. While he was probably right, Nuzzo said, his statements seemed to encourage people to get infected.

“It’s reasonable to say that vaccine mandates weren’t the right approach,” she said. “But you can also understand that people were trying to blindly stumble our way out of the situation, and some people thought vaccine mandates would be expedient.”

At Johns Hopkins, for example, Nuzzo opposed a booster mandate for the campus in 2022 but understood the final decision to require it. School authorities were intent on bringing students back to campus and worried that outbreaks would force them to shut down again, she said.

“You can argue that seat belt laws are bad because they impinge on civil rights,” Howard said. “But a better thing to do would be to urge people to wear seat belts.”

Makary’s statements had “no grace,” he said. “These were people dealing with an overwhelming virus, and he constantly accused them of lying.”

Several public health officials were particularly upset by the way Makary cast aspersions on the Centers for Disease Control and Prevention’s vaccine safety program. In a Jan. 16, 2023, appearance on Tucker Carlson’s Fox News show, Makary said the CDC had “tried to quickly downplay” evidence of an increased risk of stroke in Medicare beneficiaries who got a covid booster. In fact, the CDC had detected a potential signal for additional strokes in one database, and in the interest of transparency it released that information, Nuzzo said. Further investigation found that there was no actual risk.

During Thursday’s hearing, Makary’s pandemic views were mostly left unexplored, but Democratic and Republican senators repeatedly probed for his views on the abortion drug mifepristone, which became easier to use without direct medical supervision because of a 2021 FDA ruling. Many Republicans want to reverse the FDA ruling; Democrats say there are reams of evidence that support the drug’s safety when taken by a woman at home.

Makary tried to satisfy both parties. He told Sen. Maggie Hassan (D-N.H.) he would be led by science and had no preconceived ideas about mifepristone’s safety. Questioned by Republican Bill Cassidy, chair of the Health, Education, Labor and Pensions Committee and an abortion foe, he said he would examine ongoing data on the drug from the FDA’s risk evaluation system, which gathers reports from the field.

The abortion pill question exemplifies the kind of dilemmas Makary will face at the FDA, Jha said.

“He’s going to have to decide whether he listens to the scientists in his administration, or his boss, who often disagrees with science,” he said. “He’s a smart, thoughtful guy and my hope is he’ll find his way through.”

“The two most important organs for the FDA commissioner are the brain and the spine,” said former FDA deputy commissioner Joshua Sharfstein. “The spine because there’s attempted influence coming from many directions, not just political but also commercial and from multiple advocacy communities. It’s very important to stand up for the agency’s success.”

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