4 hours Ago By Todd Karpovich, Dan Belson
Maryland scholars on Monday alternately described President-elect Donald Trump’s pick to lead the U.S. Food and Drug Administration — , a Johns Hopkins researcher, surgeon and author — as a “courageous leader” and a “reasonable choice,” who nevertheless espouses some “worrisome” views.
Makary, who did not respond to requests for comment, currently serves as head of Islet Transplant Surgery at Hopkins. He also works as a public policy researcher and is the author of two New York Times-bestselling books entitled “Unaccountable” and “The Price We Pay,” which cover topics related to transparency and high costs in American health care. He previously made headlines after opposing some pandemic lockdown measures and COVID-19 vaccine mandates.
He also publicly criticized the FDA for what he saw as a slow rollout of coronavirus therapies, done to hamper Trump’s first presidency. His selection to run the FDA was announced over the weekend. Jerome Adams, the Maryland-born physician who during Trump’s first term, said in and emailed statement that while he had reservations about Makary’s “ability to oversee and navigate such a big agency given what seems like a lack of experience running large organizations,” overall, Makary “is a reasonable choice, and perhaps the least controversial of the new administration’s health picks so far.
” Baltimore-born pediatrician Dr. Paul Offit, a vaccine advocate known for co-inventing a vaccine that immunizes against rotavirus infection, said Makary has been a “brilliant surgeon” at Hopkins and that he agreed with some of Makary’s opinions on where coronavirus response measures went wrong. But there have also been times when Makary has “said some things that are worrisome” about COVID-19 vaccines, said Offit, a professor of pediatrics at Children’s Hospital of Philadelphia, who also directs the institution’s Vaccine Education Center.
What bothers Offit “the most” about Trump’s pick to lead the FDA is Makary’s willingness to side with Robert F. Kennedy Jr., the environmental lawyer turned anti-vaccine organizer who is Trump’s choice to lead the Department of Health and Human Services.
Offit described Kennedy as a “wild-eyed conspiracy theorist.” Kennedy, who ran for president in 2024, has been highly critical of U.S.
health officials for decades. In addition to railing against processed foods, fluoridated water and the pharmaceutical industry, Kennedy regularly pushes the debunked notion that vaccines cause autism. Kennedy endorsed Trump after dropping out of the race, and the two have collaborated on a campaign to “Make America Healthy Again,” or “MAHA.
” Makary, a regular Fox News commentator, days before being selected by Trump and said Kennedy was not “scary” and that “people should not dissect what [Kennedy] said 30 years ago and listen to what he’s saying now,” telling Fox News Sunday host Shannon Bream that Kennedy is “not anti-vax.” He Offit said Makary was “whitewashing” Kennedy’s statements about vaccines, noting Kennedy “remains a virulent anti-vaccine activist.” Ge Bai, a professor of accounting at Johns Hopkins Carey Business School, contends Makary is a respected leader who can guide the FDA into a new, more productive direction.
“Dr. Makary is an excellent choice to lead the FDA, an agency that will play a central role in the Trump administration’s MAHA movement,” said Bai, who is also a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. “Although health care was not a major focus during the presidential campaign, it’s likely to become a key issue in the midterm and 2028 elections.
” “The FDA needs a highly competent, decisive, and courageous leader who can break away from conventional wisdom and deliver outcomes for Americans quickly and effectively,” Bai said. Bai said she is confident that Makary is the best choice to lead the FDA. “Dr.
Makary has a stellar record as a surgeon, scholar, bestselling author, commentator, policy expert and public intellectual,” Bai said. “He has demonstrated his ability to think independently, challenge the status quo, and communicate effectively. These qualities make him an outstanding choice and increase the likelihood of his success as the FDA commissioner.
” In a statement announcing the nomination, Trump said Makary “will restore the FDA to the gold standard of scientific research” and “cut the bureaucratic red tape” at the agency to ensure Americans receive the medical cures and treatments they deserve. Makary’s nomination will require confirmation by the newly Republican-led Senate to take effect. Brian Abrahams, senior analyst for biotechnology and head of global health care research for RBC Capital Markets, wrote in a recent report forwarded to The Baltimore Sun that Makary has positioned himself as a “critic viewing the nation’s healthcare system as broken, and based on his writings he is focused on uncovering additional flaws in the system or among medical conventions that need to be fixed or challenged.
” Abrahams pointed out that Makary alleges that COVID-19 vaccines ignored the benefits of natural immunity. Makary also contends that health agencies should focus on the root cause of disease and on understanding why rates of diseases are increasing, rather than additional therapeutics, according to Abrahams. “We believe this is somewhat of a misleading distortion, as this is likely at least in part from improved screening for diseases such as cancer, mental health disorders, and genetic illnesses — innovative treatments for which have helped meaningfully increase the overall U.
S. expectancy over the past 50 years,” Abrahams wrote in the report. Ultimately, the analysts at RBC said Makary would not necessarily be as focused on pharmaceutical innovation as the current leaders in the FDA; could be particularly unfavorable for antibiotic, vaccine, obesity and chronic disease companies; and might not be overly impactful for companies developing drugs for rare or genetic diseases, or agents that holistically improve health.
“Though his nomination is not certain, we sense that if made FDA head, Dr. Makary could make the Agency more suspicious of, rather than collaborative with, drugmakers ..
. vs. the current FDA, which has leaned toward approving drugs that show activity with acceptable safety and leaving individualized benefit/risk discussions up to physicians and patients,” Abrahams wrote.
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