I Learned the Hard Way That a ‘Breakthrough’ Treatment Isn’t Innocuous
By: The Atlantic
Tags: Health, Plasma, Coronavirus, Politics, Covid 19

I Learned the Hard Way That a ‘Breakthrough’ Treatment Isn’t Innocuous

The FDA’s emergency authorization of plasma treatments for COVID-19 prioritizes politics over science

Photo: skaman306/Moment/Getty Images

By Craig Spencer

In 2014, I spent 19 days being treated for Ebola in a New York City hospital. I had contracted the virus while treating patients in Guinea, and as no definitive treatments existed at the time, I received convalescent plasma based on its historically therapeutic role. After receiving plasma, however, I struggled to breathe, and my condition deteriorated. Thankfully I recovered, but my story shows that convalescent plasma isn’t innocuous.

That experience, combined with my time as a physician fighting the coronavirus, leads me to find the FDA’s emergency authorization for plasma as a treatment for COVID-19 deeply alarming. The Trump administration’s declaration that convalescent plasma is a “major therapeutic breakthrough” marks this as just another example of politics getting ahead of science. Convalescent plasma may indeed have a beneficial role in treating COVID-19, but only further testing can determine whether it will work effectively for this disease. The FDA’s emergency authorization, however, may make that harder to do, and undermine the credibility of our public-health institutions in the process.

Developed more than a century ago, convalescent plasma — the transfusion of antibody-rich plasma from disease survivors into others suffering with the same disease — was one of medicine’s first real therapeutic breakthroughs. It dramatically improved treatment of diphtheria, measles, and other infectious illnesses. Though side effects, such as allergic reactions or the transfer of other blood-borne pathogens, do exist, they are relatively rare. That’s one reason convalescent plasma is often used to treat infectious diseases without cures, such as Ebola. Further testing in the Ebola outbreak, however, showed that transfusing plasma was not beneficial to patients. Although my case was an outlier and no adverse reactions were associated with its wider use, treatment with convalescent plasma did not significantly improve patients’ chances of survival.

After my recovery, I donated plasma as part of an FDA-approved investigation, and then returned to Guinea to work with an organization that was conducting trials in hopes of finding a cure for Ebola. The results of the trials weren’t what we wanted, but they’re what the science told us. This is why basing our treatment decisions on sound data, not political persuasion, is so important.

Sadly, Sunday’s decision to authorize the use of convalescent plasma for COVID-19 only continues the Trump’s administration’s gross politicization of potential treatments in this pandemic when lives are at stake. In April, the FDA granted the emergency authorization of the antimalarial hydroxychloroquine — a drug often touted by President Donald Trump — despite the absence of convincing evidence that it could effectively treat the disease. Indeed, in June, the FDA revoked its authorization, declaring that it was “unlikely to be effective.” By then, however, the drug had become a partisan flash point, and the FDA’s rushed action raised serious concerns about whether the agency was subject to political pressure in its decision making.

The reversal brought the ire of Trump, who questioned the FDA’s decision and urged the agency to “act now,” ostensibly to reauthorize the use of hydroxychloroquine. Just last week, Trump tweeted that the “deep state, or whoever, over at the FDA” is “hoping to delay” treatment decisions until after the election. The FDA had halted the emergency authorization for convalescent plasma after top federal health officials, including Francis Collins and Anthony Fauci, intervened. These officials rightly argued that the data supporting the transfusion of plasma were not robust enough to warrant emergency approval. But when the FDA reversed course Sunday, deeming the authorization “another achievement in [the] administration’s fight against [the] pandemic,” it became clear that public health is taking a back seat to politics, especially in the face of an upcoming election.

To add insult to injury, the Trump administration presented a twisted and rosy representation of the statistics from a recent non-peer-reviewed Mayo Clinic study to justify its decision. This study didn’t have a control group and wasn’t randomized — the gold standards for careful, credible research. Further, when FDA Commissioner Stephen M. Hahn boasted that 35 out of 100 people infected with COVID-19 “would have been saved because of the administration of plasma,” he either didn’t understand the data or purposefully misrepresented them to overemphasize the observed impact. Scientists and statisticians quickly pointed out the mistruth on social media. The bewildered authors of the Mayo Clinic study themselves struggled to explain where this claim originated, as the true impact based on even their imperfect study would be substantially lower. At one point, a former FDA commissioner suggested that Hahn should issue a correction. And late on Monday night, he did, admitting, “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

This confusing back-and-forth undermines ongoing trials to test whether convalescent plasma is indeed an effective treatment for COVID-19. Conducting these trials has already presented challenges, but not because convalescent plasma hasn’t been widely used to treat COVID-19. More than 100,000 people nationwide have already received it. The problem is that the majority of those received it through an expanded-access program, which was not part of a formal research study. By further expanding the use of convalescent plasma outside of clinical trials, the FDA’s action will paradoxically complicate the process of recruiting patients for those crucial studies, ultimately making it harder to understand for whom and at what point in their illness convalescent plasma may have a benefit.

Many scientists and health-care providers, myself included, suspect that once we have more data, convalescent plasma will ultimately prove somewhat beneficial. It will be another tool in our treatment toolkit, but is unlikely to be a “major therapeutic breakthrough” in how we treat COVID-19. Though the existing data may indeed justify the legal standard of the FDA’s emergency authorization, by rushing its approval, this administration has again shown that political priorities take precedence over public-health prerogatives and undermined scientific research. This will have a huge impact on the credibility of our long-trusted medical and public-health organizations such as the FDA and the Centers for Disease Control and Prevention. If people feel that the decisions around science or safety are being rushed for political points, the rollout of a vaccine could be undermined.

COVID-19 is not Ebola. But the science of research during disease outbreaks and the standards for approving treatments backed by science alone do not change with the virus in question. If Trump is truly committed to finding the right therapeutics for COVID-19, he needs to back off and let scientists and the agencies traditionally entrusted with this responsibility do their job, unimpeded by political posturing.