The recent press conference announcing an FDA Emergency Use Authorization (EUA) for COVID-19 convalescent plasma seems like something we — a physician who has cared for dozens of hospitalized COVID-19 patients and an infectious disease epidemiologist — should cheer. Instead, we were shocked and saddened to see another government institution brought low. This time, it was the FDA and its commissioner, Dr. Stephen Hahn, whose names and reputations were sullied and whose actions seemingly endanger the public health.
Although the investigation upon which the FDA based this decision to grant a EUA tried to show there was a benefit to convalescent plasma, the study design makes it hard to draw firm conclusions about the treatment’s effectiveness. Others have reported on the commissioner’s since corrected false claim that the data showed convalescent plasma astonishingly reduced absolute mortality by 35 percent when in reality, the results were a far less impressive 35 percent relative reduction in mortality among a small subset of patients.
It is hard to believe an accomplished physician-scientist, let alone the head of the FDA, could honestly make such a fundamental statistical mistake, especially when it so clearly advanced the agenda of his boss. Rather than thoughtfully offering up a potential incremental advance to sick patients, this whole announcement seems like it was more about making convalescent plasma into a breakthrough that the president could tout during the Republic National Convention.
Why do we care if the FDA commissioner used a little hype in the service of hope? Why are we making a fuss about what might turn out to be a useful COVID-19 therapeutic?
First, adequately testing treatments is essential, and this decision needlessly hampers that effort. Properly designed and conducted clinical trials are how we understand whether a therapy will help or hurt our patients, and how it should be used in practice if it turns out to be safe and efficacious. With convalescent plasma, we are early in the process.
We have yet to see very positive results from well-done randomized clinical trials, and most public health scientists and clinical experts are not, however, convinced that it works. With an unsubstantiated public perception that this is a definitively proven life-saving therapy, patients will be even less likely to enroll in the studies we need to figure out the answer.
What’s frustrating is that the federal government has made this mistake of letting uninformed politicians write the prescriptions before. Earlier this year, the FDA issued a EUA for hydroxychloroquine, based in large part on the fierce boosterism of the president and his trade advisor, Peter Navarro. When the data came out, they showed hydroxychloroquine was ineffective with serious side effects, and the FDA revoked the EUA. These emergency authorizations are a useful tool, but only if they are informed by evidence and clinical needs, not driven by the political whims of the White House.
Even more importantly, the hydroxychloroquine and convalescent plasma episodes sow doubts about the integrity of the FDA, a world-class regulatory agency with a long and storied history of protecting the American public from unsafe and ineffective drugs. When the process of approving therapies is so tainted, how can patients be sure any of the treatments they take are safe and effective?
An FDA that is beholden primarily to political rather than public health concerns could also cause harm with an untested vaccine. Just a few weeks ago, Russia’s President Vladimir Putin formally approved a COVID-19 vaccine. Of course, this vaccine had not yet been adequately tested, but this did not stop Putin from releasing it to the Russian people, so he looks like a hero. After the convalescent plasma debacle, it becomes increasingly possible that the FDA will enable President Trump to follow Putin and announce a EUA for an incompletely tested vaccine as an “October surprise” just before the election.
If Dr. Hahn surrenders to the president on another product that is not yet ready for prime time, he would be doing irreparable damage. He would impede further COVID-19 vaccine research while also needlessly exposing tens of millions of healthy Americans to an untested and potentially unsafe and ineffective product. Such a step would also further undermine public confidence in safe vaccines at a time when we also desperately need people to get flu shots and prevent measles outbreaks.
Dr. Hahn’s actions at the FDA should concern us all. Amid a pandemic, we do not need political pandering by the agency. We need it to expedite access to promising new agents without compromising their clinical study and the health of the population.
Zahir Kanjee M.D., MPH, is a hospitalist physician at Beth Israel Deaconess Medical Center and assistant professor of Medicine at Harvard Medical School. Gregg Gonsalves, Ph.D., is an assistant professor of Epidemiology of Microbial Disease at the Yale School of Public Health, Associate Adjunct Professor of Law at Yale Law School, and a 2018 MacArthur Fellow.