Over the past 16 months, there has been a revolving door of leaders within the Department of Health and Human Services. Dr. Marty Markary, who resigned as head of the Food and Drug Administration on Tuesday, is the latest to learn that it’s easier to criticize a system from the outside than to change it from the inside.
Scientists, public health professionals, physicians and members of the public all depend on the F.D.A. It ensures that our medications are safe and effective, that our food supply is not contaminated and that our medical devices actually work. For the F.D.A., as for every government agency, there is good and bad in its history. At times, it has been slow to adapt, limited in focus, opaque about its data and captive to a culture of caution.
Unfortunately, despite Dr. Makary’s credentials as a creative physician-scientist, the F.D.A. became less reliable and transparent under his tenure. Trust in the agency — among the public and among the scientists who make the work happen — has plummeted.
With Dr. Makary’s departure, the F.D.A. is leaderless. It’s not alone: The Centers for Disease Control and Prevention hasn’t had a permanent director in months (and the last one lasted only four weeks). There is no surgeon general. Over the past year and a half, many parts of the U.S. public health system have been dismantled. Staff have been fired, seemingly haphazardly; funding for core data systems, logistics and community partnerships has been cut; research funding is moving at a glacial pace; and longstanding guidelines have changed on a dime.
This week, as our country and the globe confront a hantavirus outbreak, the all-too-predictable effects of destruction without a plan have become clear. Who and what can be trusted to keep us safe?
It’s true that our public health institutions were largely designed for another time; they were not working as well as they could have. The Covid-19 pandemic revealed that they were unprepared for a global, fast-moving and complex health crisis and were too often disconnected from the communities they serve.
Big systems are extraordinarily hard to move, not because the people inside them are evil or complacent, but because institutions with decades of regulatory sediment, legal exposure, external influence and deeply entrenched professional cultures are designed, almost by default, to resist disruption.
But changing them is possible. And it is necessary.
Dr. Makary missed his opportunity for reform. Successful leadership requires understanding why the resistance to change is present. (Sometimes it’s a good thing: Systems that oversee drug safety should be predictable and deliberative.) It requires valuing historical knowledge while also being willing to challenge it. It means clarity of strategy, transparency in execution, coalition building through deep listening and a willingness to admit when you’re wrong.
Dr. Makary can boast some laudable wins from his time at the F.D.A., such as leveraging artificial intelligence to monitor clinical trials in real time, and important course corrections, like the long-overdue removal of a black box warning on hormone therapy.
But overall, we’ve witnessed the erosion of the agency’s prestige and capacity: inconsistent standards, showy headlines at the expense of serious priorities, and immense confusion about what scientific evidence does and does not say.
Under Dr. Makary’s leadership, the agency refused to review a new flu vaccine (and then reversed course); introduced a program meant to speed up the approval process for rare-disease medications, and then ran it in a way that opened it up to political interference; and shared unsubstantiated hunches (such as linking Tylenol to autism). Along the way, the United States lost countless high-quality staff of impeccable integrity, whose work kept us all safe from diseases and from unsafe food and medicines.
The consequences of these actions are not abstract. They are measured in lives affected: a person with Huntington’s disease who won’t be able to get a promising treatment because of regulatory delays; a family who lost trust in a vaccine their child needed; or a pregnant woman in an emergency department who actually needed Tylenol to reduce a fever, but didn’t get it out of unfounded fears that it could cause autism. This is, of course, on top of families already feeling abandoned by the health system and overwhelmed by medical bills.
Dr. Makary has reportedly resigned because he did not want to bow to political pressure to authorize the sale of flavored vapes. If this is true, it’s an admirable stand.
But it also comes too late. Dr. Makary’s tenure is just the latest in a cautionary tale about performative disruption, not because he challenged the F.D.A., but because he mistook provocation for the hard, unglamorous work of institutional change.
The opportunity now is to rebuild the institutions Americans rely on, with intentionality. That means appointing leaders at the F.D.A., C.D.C. and H.H.S. who have experience running complex organizations, who understand that public trust is rebuilt one transparent decision at a time, through genuine listening, and who are willing to do what’s right when the science demands it.
Americans’ lives depend on it. The decisions at the top determine whether people get safe and effective treatments faster than they do today; whether the food, drugs and devices in our homes are demonstrably safer; and most of all, whether we can trust what we’re being told.
