The Food and Drug Administration is no stranger to political interference. Special interests have played as much of a role as actual data in the approval of questionable cancer drugs and faulty medical devices for almost as long as the agency has existed.
Yet the latest breach of principle by the FDA feels far more perilous than earlier ones — in part because of the number of lives and livelihoods at stake, but also because it’s part and parcel of a systematic undermining of the nation’s premier scientific institutions.
On Sunday the agency granted an emergency authorization for the use of plasma from people with coronavirus antibodies to treat COVID-19 patients, absent substantial evidence that the treatment actually works or a definitive sense of who might benefit from it.
Last week, regulators appeared to be holding off on authorizing wider use of such “convalescent plasma,” owing to scientists’ concerns about that lack of evidence. But after President Donald Trump complained bitterly about that delay, the FDA decided to move forward.
In announcing the new decision, the president and his team have vastly overstated the promise of convalescent plasma, calling it a “major therapeutic breakthrough” and claiming that it has been proven to “reduce mortality from COVID by as much as 30 to 50 %,” without explaining that any such findings come with heavy caveats.
Dr. Stephen Hahn, the FDA’s commissioner, went so far as to suggest that the plasma therapy could save the lives of 35 out of every 100 coronavirus patients who took it. As STAT News reports, the number is much closer to three to five out of every 100, and even that lower estimate is questionable: The data came from an observational study, not a rigorous clinical trial.
Hahn could have made a more honest case for authorizing plasma therapy by simply pointing to the urgency of the moment and the apparent safety of the treatment. The administration could have helped resolve the questions around convalescent plasma by arranging for more rigorous clinical trials. That it instead chose egregious overselling of its benefit is unconscionable, especially as an election nears.
This is hardly the first time the Trump administration has sacrificed scientific integrity for the sake of political theater. The president pressed the FDA to grant a similar authorization to the malaria drugs chloroquine and hydroxychloroquine, despite ample warning from scientists that the drugs were not only unproven for the coronavirus but potentially dangerous. That authorization was revoked in June, after the drugs were linked to serious heart complications in more than 100 patients, including at least 25 who died.
The administration also stripped the agency of its ability to regulate lab-developed diagnostic tests, a move that may improve the supply of coronavirus diagnostics but will also wreak havoc on countless patients suffering from other serious conditions. Nearly from the start of the pandemic, the president has sidelined, muzzled and disempowered the Centers for Disease Control and Prevention, an agency with perhaps the highest concentration of infectious disease expertise in the world.
To the administration’s supporters — indeed, to anyone eager for coronavirus treatments — it may seem like a win to eliminate roadblocks that keep tests, treatments and vaccines from entering the marketplace. But skipping science now only costs more time, and potentially more lives, in the long run.
What if convalescent plasma doesn’t work? What if it does, but only on a specific subset of patients? What if it’s good for some patients but actually dangerous for others? Authorizing the therapy makes it all but impossible to answer those questions, because patients who can get it from their doctors are unlikely to sign up for a clinical trial.
Politicizing the regulatory process — tying the authorization and approval of treatments to political considerations — undermines the entire system. On Saturday, the president accused the FDA of deliberately thwarting the development of a coronavirus vaccine in an effort to imperil his reelection.
The agency’s latest moves show that it’s susceptible to such criticism. This makes it hard to trust that regulators will do their jobs to fully and publicly vet any prospective vaccines before allowing them on the market.
If widespread vaccination is the key to victory over a pandemic that has already cost more than 170,000 American lives, injecting politics into medical science is dangerous and potentially fatal.
