First, a bit of background. Makary, the current FDA commissioner, is a surgeon and was a professor of health policy at the Johns Hopkins School of Public Health. He initially voiced support for stay-at-home orders during the pandemic but later changed his mind. In February 2021, he incorrectly predicted that the US would “have herd immunity by April.” He has also been very critical of the FDA, writing in 2021 that its then leadership acted like “a crusty librarian” and that drug approvals were “erratic.”
Prasad, an oncologist, hematologist, and health researcher, was named director of the FDA’s Center for Biologics Evaluation and Research last month. He has long been a proponent of rigorous evidence-based medicine. When I interviewed him back in 2019, he told me that cancer drugs are often approved on the basis of weak evidence, and that they can end up being ineffective or even harmful. He has written a book arguing that drug regulators need to raise the bar of evidence for drug approvals. He was widely respected by his peers.
Things changed during the pandemic. Prasad made a series of contrarian comments; he claimed that the covid virus “was likely a lab leak” despite the fact that the vast majority of scientists believe that the virus jumped to humans from animals in a market. He railed against Anthony Fauci, and advised readers of his blog to “break all home Covid tests.” In 2023, he authored a post titled “Do not report Covid cases to schools & do not test yourself if you feel ill.” He has even drawn parallels between the US covid response and fascism in Nazi Germany. Suffice to say he’s lost the support of many of his fellow academics.
Makary and Prasad published their “priorities for a new FDA” in the Journal of the American Medical Association on Tuesday. (Funnily enough, JAMA is one of the journals that their boss, Robert F. Kennedy Jr., described as “corrupt” just a couple of weeks ago—one that he said he’d ban government scientists from publishing in. Lol.)
Let’s go through a few of the points the pair make in their piece. They open by declaring that the US medical system has been “a 50 year failure.” It’s true that the US spends a lot more on health care than other wealthy countries do, and yet has a lower life expectancy. And around 25 million Americans don’t have health insurance.
“In some ways, it is absolutely a failure,” says Christopher Robertson, a professor of health law at Boston University. “On the other hand, it’s the envy of the world [because] it’s very good at delivering high-end care.” Either way, the reasons for failures in health care are not really the scope of the FDA, which has a focus on ensuring the safety and efficacy of food and medicines.