Martin A. Makary, MD, a surgeon and public policy researcher at Johns Hopkins University who has taken public positions at odds with public health leaders on vaccination schedules and measures promulgated to limit the spread of COVID-19, has been named by President-Elect Donald Trump as his nominee for commissioner of the FDA.
“FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator,” Trump stated. “The agency needs Dr. Marty Makary, a highly respected Johns Hopkins surgical oncologist and health policy expert to course-correct and refocus the agency.”
Makary would report to the Secretary of Health and Human Services (HHS)—a position to which Trump has said he will appoint Robert F. Kennedy Jr., who has targeted the FDA for drastic changes on a host of biopharma and broader healthcare concerns.
Speaking November 18 on “The Brian Kilmeade Show,” a radio talk show hosted by a co-host of the Fox News Channel morning show “Fox & Friends” and syndicated through Fox News Radio, Makary said he was less worried about Kennedy’s nomination than what he called the medical establishment that Kennedy has also long criticized.
“I’m worried about all the medical leaders who misled us in so many ways. That’s what should be raising deep concerns, not RFK Jr., who’s now talking about the root causes of our chronic disease epidemic,” Makary asserted. “He’s actually talking about the health of the population. Up until this point, politicians have only talked about different ways to finance the broken healthcare system. Now he’s actually talking about how to fix it by addressing health.”
Asked if everyone needed to receive vaccines, Makary replied: “Look, vaccines save lives. And I know Bobby Kennedy believes that. Now whether or not you follow the rigid recommendations that are out there now, or say, for example, you use the Japanese schedule or one of the accepted schedules in Europe, like the U.K. schedule, where they may not give the hepatitis B vaccine on the day of birth.”
“Sometimes, questions are good”
According to the website of the U.K. government, as of September 1, doses of the hepatitis B vaccine are routinely administered to babies at 8 weeks, 12 weeks, and 16 weeks. However, the U.K. directs that babies born to mothers infected with hepatitis B receive the vaccine “at birth, 4 weeks, and 12 months old.”
“Hepatitis B is a sexually transmitted infection, and you get it from IV drug use. Do you need it on the day of birth? If somebody wants to make a personal decision to modify that and postpone it till later in childhood, we live in a free country, and so I think sometimes, questions are good,” Makary asserted.
“This is the same establishment that lost so much trust over the last four years, and that’s why we’re seeing less compliance,” Makary contended. “It’s not because of Bobby Kennedy. It’s because of vaccine mandates and cloth masks on toddlers and shutting schools down, and ‘opioids are not addictive.’ For 20 years we heard that. And the food pyramid. That’s all dogma from the government. That’s why people are skeptical. Not because of Bobby Kennedy.”
As commissioner, Makary would run an agency that now has more than 18,000 employees, and which decides on applications for some 50 new drugs and biologic products each year. The FDA is now led by commissioner Robert M. Califf, MD, who was appointed by President Joe Biden to return to the position he first held during the administration of Barack Obama; Califf left office the day Trump was sworn in to his first term.
Makary is the chief of islet transplant surgery at Johns Hopkins, and the author of two New York Times bestselling books—Unaccountable (2012), which faulted doctors and hospitals for high costs and a lack of transparency; and The Price We Pay (2019), an examination of issues he contended were responsible for the nation’s sky-high medical care costs.
A visiting professor at over 25 medical schools, Makary has received the Nobility in Science Award from the National Pancreas Foundation, has published over 250 peer-reviewed scientific articles, and has served on several editorial boards.
“Repeal COVID-19 vaccine mandates”
Among COVID-19 pandemic public health measures Makary has criticized are mandatory masking of children and mandatory vaccinations of young adults. In a paper published in 2022 in Journal of Medical Ethics, he and a research team took issue with the mandates of numerous universities forcing students to receive third-dose booster shots, contending the mandates:
- Were not based on updated stratified risk-benefit assessments for adults ages 18–29.
- May result in “a net harm” to healthy young adults
- Introduced harms that were not outweighed by public health benefits “given modest and transient effectiveness of vaccines against transmission,” and for which young adults were not reliably compensated.
The boosters “may result in wider social harms,” Makary and colleagues asserted.
“Policymakers should repeal COVID-19 vaccine mandates for young adults immediately and ensure pathways to compensation to those who have suffered negative consequences from these policies. Regulatory agencies should facilitate independent scientific analysis through open access to participant-level clinical trial data to allow risk-stratified and age-stratified risk-benefit analyses of any new vaccines prior to issuing recommendations,” Makary and colleagues added. “This is needed to begin what will be a long process of rebuilding trust in public health.”
While Kennedy has emerged in recent years as a sharp critic of the COVID-19 vaccines, and has been quoted as calling it “criminal medical malpractice to give a child one of these,” he insisted on NPR the day after Election Day: “Of course, we’re not going to take vaccines away from anybody,” adding: “We are going to make sure that Americans have good information about vaccines and vaccine safety.”
However, Kennedy has called for overhauling the FDA’s oversight of food, contending that the agency needed to reduce the prevalence of ultra-processed foods in order to reduce the burden of chronic disease: “In some categories, there are entire departments, like the nutrition departments at FDA, that have to go, that are not doing their job. They’re not protecting our kids,” he told NBC.
In addition to Makary, Trump also named Dave Weldon, MD, a physician and former Republican Congressman from Florida, as his nominee for director of the U.S. Centers for Disease Control and Prevention (CDC).
