The FDA needs a public health visionary
This month marks the one-year anniversary of the Food and Drug Administration approving hydroxychloroquine to treat COVID-19. Needless to say, the agency will not be commemorating its endorsement of a totally ineffective drug, whose approval was withdrawn in June.
With President Joe Biden still contemplating his choice for FDA commissioner, it’s worth recalling that fiasco. Its chief lesson? The FDA needs a leader who will champion public health, not cheerlead for faster cures.
It may seem churlish to raise the hydroxychloroquine episode so soon after the FDA granted three emergency use authorizations for preventive vaccines, a triumph not just for medical science but the disciplined deployment of regulatory science. Yet we must never forget that it took a herculean effort to ensure the agency did not cave into political pressure by prematurely granting those approvals, a move that would have destroyed the agency’s reputation.
Before the election, when company pronouncements suggested a successful vaccine was imminent, a group of top scientists secretly met with outgoing FDA Commissioner Steven Hahn at his request. One of them, Eric Topol of the Scripps Research Translational Institute, had publicly called for his resignation, citing not just hydroxychloroquine but the rushed approval of convalescent plasma to treat COVID-19.
The group, led by Michael Osterholm of the University of Minnesota, a leading epidemiologist, insisted Hahn maintain the agency’s traditional approach to evaluating new products when reviewing the vaccine makers’ applications. That included a rigorous review of the companies’ data by agency scientists presented at a public meeting of its outside vaccine advisory committee. Nothing less than public trust in the agency was at stake.
Their entreaties emboldened Hahn to resist White House pressure to approve the vaccines before the election. That, in turn, gave the FDA’s in-house scientists adequate time to present a persuasive case for why the vaccines’ benefits outweighed their risks. Vaccine hesitancy, the biggest roadblock to bringing the pandemic to an early end, would have been much worse now had that not happened.
Rebuilding trust
Restoring faith in the agency will take more than simply changing who sits in the Oval Office. Indeed, Biden, whose son Beau died of brain cancer, has been a major champion of more rapid drug development. When vice president, he led the call for a “cancer moonshot” and pushed hard for passage of the 21st Century Cures Act, whose entire purpose was speeding up drug development reviews and making it easier to get approvals.
Everyone wants better treatments for cancer and other diseases, of course. But recent experience suggests most of the new therapies emerging from the drug industry’s labs make only marginal improvements in life expectancy and health, even though their prices have escalated wildly.
Where do gains come from?
In fact, most of the gains in life expectancy in recent years, especially in cancer care, have come from public health campaigns to reduce smoking and air pollution, improve diets, and conduct early detection screening. In the treatment arena, better use of existing therapies, based on analyzing electronic health records for their real-world outcomes, is a surer path to longer lives than placing all of one’s bets on the success of new treatments.
Under a farsighted commissioner, the FDA could lead the charge on those fronts. He or she could also lead the way in combating the major public health challenges facing the American people, which are the immediate causes of declining life expectancy. That difficult list includes racial and class disparities in health treatment and outcomes, the obesity and opioid epidemics, the mental health crisis and food safety.
The anti-smoking crusade and youth vaping deserve renewed attention. The new FDA leader also could expedite the use of electronic databases to modernize the drug and medical device adverse event reporting systems, which still rely on voluntary reporting.
Nothing in that broader agenda threatens the search for better drugs and devices. But if Biden picks an FDA chief seen as putting product development first, it will send a signal that his administration will continue the recent past’s shortchanging of public health.