Key Takeaways
- Expected FDA commissioner nominee Martin Makary has advocated for better aligning US medical practice with evidence, even when this breaks with the medical establishment.
- But some worry about times Makary has diverted from or misconstrued data to advance his positions, which could exacerbate public distrust in US health officials.
- Whether Makary would disagree with his potential boss, expected HHS Secretary nominee Robert F. Kennedy Jr., who has spread misinformation about health care, is unclear.
Martin Makary, President-elect Donald Trump’s pick to lead the US Food and Drug Administration, is a self-professed supporter of evidence-based medicine, which excited potential stakeholders, at least at first.
Makary wrote a book published this fall titled Blind Spots, which outlined several instances he argued the medical establishment failed patients by not following the data.
“Having spent many hours with top doctors sorting scientific evidence from opinion on some of today’s biggest health questions, I realize that much of what the public is told about health is medical dogma, an idea or practice given incontrovertible authority because someone decreed it to be true based on a gut feeling,” Makary wrote in the book’s preface.
Makary aims to push the health system in the opposite direction.
“When we use sound scientific studies to make recommendations, we shine and help a lot of people,” he argued later in the introduction.
Many in the FDA space are enthusiastic about the comments.
“Overall, he seems like a person who’s committed to using data to solve public health problems and in that sense, I’d like to be optimistic and I certainly believe FDA could have done a lot worse,” Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA, told the Pink Sheet.
Lurie said his organization will not oppose Makary’s nomination, unlike other Trump health nominees like Robert F. Kennedy Jr. for Health and Human Services secretary. But some are conflicted about how Makary might use the office and commitment to data to influence public health.
Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said Makary’s willingness to speak out, even when his positions disagree with the current status quo, is important.
However, Gellad is concerned that Makary has sometimes “used data incorrectly to support his positions.”
Gellad said the practice of “going further than the data suggested to make a point,” usually because of either political or personal preference, is particularly problematic when coming from someone saying their incorrect point is evidence-based.
“This is what got us into this mess about trust,” in US health leadership, Gellad said.
Taking Data Too Far
Gellad has raised concerns about the US health officials' COVID-19 communications under both political parties. He has highlighted situations where leaders projected more certainty about data than the evidence suggested or overgeneralized data to make things simpler, if not quite as accurate, for the public in an effort to promote particular actions, like getting COVID-19 booster shots.
Gellad praised Makary for highlighting the risks of myocarditis from the COVID-19 shots when he felt some federal officials were downplaying the adverse event.
“The problem was it started to go a little far,” Gellad said. Makary started to imply that “there was a big risk of myocarditis in children under the age of 12,” when the evidence was that the risk was largely confined to adolescent and young-adult males.
Makary started mispresenting evidence to oppose the vaccine overall and in younger people, Gellad said.
Another example was Makary’s 2016 British Medical Journal analysis that argued medical errors are the third-leading cause of death in the US, which has been subject to a wide range of criticism, including that it generalized data on older and sicker Americans to the entire hospitalized population.
Medical errors are a very real problem, but exaggerating the scope of the problem can cause harm, including scaring people away from beneficial medical care, McGill University’s Jonathan Jarry wrote of the medical errors analysis.
“We don’t want people who are put forward as an ideal candidate because they go with the data when they don’t,” Gellad said.
In recent years FDA commissioners appointed by presidents on both sides of the aisle often have used the analogy that the agency’s job is to “call the balls and strikes.” which deemphasizes the amount of judgement that can be required when the data is not as conclusive as would be ideal or science is evolving.
Some critics argue that being clear about when and how judgement impacts decisions is better, rather than trying to convey that a decision is a mathematical certainty.
“Everyone who has or had a leadership position at the FDA in recent years would say they believe in evidence-based medicine, but to some extent EBM is in the eye of the beholder,” said Diana Zuckerman, president of the National Center for Health Research. “That’s inevitable because some evidence is better than others, some evidence is more open to different interpretations than others, and there will always be decisions that need to be made on less-than-ideal evidence.”
“I think Marty Makary has shown that he has a strong focus on evidence, and that is important at the FDA because the agency has relied less on scientific evidence in recent years,” Zuckerman added. “I haven’t always agreed with Dr. Makary’s interpretation of the evidence. For example, I extrapolated from limited evidence regarding the effectiveness of masks during the pandemic and apparently came to a different conclusion than he did.”
Will Makary Fight Health Care Misinformation?
The FDA slowly seems to be learning from its COVID-19 communication mishaps and thinking more carefully about how to communicate uncertainty and nuance.
If confirmed, Makary in some ways seems positioned to easily continue current FDA Commissioner Robert Califf’s misinformation work, but like Califf, will face close scrutiny.
Makary also could be working under Kennedy, one of the country’s most notorious communicators of health misinformation, particularly anti-vaccine content.
Gellad said whether Makary’s willingness to disagree with the mainstream medical establishment will translate to a willingness to push back when Kennedy’s positions are not rooted in science is an open question.
“It’s one thing to go against the mainstream when it brings one attention and positive notoriety,” Gellad said. “It’s another thing when one’s boss is telling one to stop, right?”