Soon after President Trump spiked a fever, shares of Regeneron, a pharmaceutical company he has previously invested in, also shot up—along with interest in the company’s experimental Covid-19 treatment. The president, his doctor announced within hours of the public learning that Trump had tested positive for SARS-CoV-2, had received the company’s monoclonal antibodies cocktail, which has not been fully tested in humans yet. (His doctor initially incorrectly called the treatment a “polyclonal antibody cocktail,” but it’s actually a dose of two monoclonal antibodies—highly effective antibodies manufactured in a lab to target the virus.) Trump has several ties to the company: He previously owned stock in both Regeneron and Gilead (the maker of the antiviral remdesivir that Trump is also taking), and Regeneron’s founder and CEO, Leonard S. Schleifer, belongs to Trump’s golf club in Westchester County, New York.
The announcement worried experts, and not just because of the potential side effects of taking untested treatments. No matter the outcome of Trump’s illness, using an experimental treatment with such a high-profile official could make it impossible to know whether and how the treatment actually works. That’s particularly troubling in the case of cloned antibodies, which researchers had been particularly enthusiastic about testing, given their potential.
Yet Regeneron’s trial in human participants is nowhere near the end—in fact, it’s still enrolling people, Dr. Ellie Murray, an assistant professor of epidemiology at Boston University School of Public Health, told me. “Having this be so much in the public eye could be really damaging for the trial.” If Trump improves after taking Regeneron’s treatment, people may be less likely to enroll in the trial for fear of getting the placebo, she said.
Dr. Angela Rasmussen, a virologist at Columbia University, agreed. “If Trump gets better, people may think that Regeneron’s drug works, especially if the president attributes his recovery to that medication,” she told me in an email. So far, the president has indeed trumpeted the easiness of his Covid-19 recovery, even if experts, including his own doctor, caution it’s too early to celebrate.
If Trump experiences side effects or takes a turn for the worse—as may yet happen—people might avoid enrolling in the trial because they believe the treatment won’t work or could even be harmful. While monoclonal antibodies are usually safe in general, “like all drugs, they can have adverse effects, including serious ones. They can produce infusion reactions and may be associated with everything from mild fever or rashes to anaphylactic shock,” Rasmussen said. “Either way, if fewer people are willing to enroll in a randomized controlled trial, it will make determining efficacy very difficult.” These circumstances are “unprecedented,” she said.
If beliefs around monoclonal antibodies start circulating based on how Trump seems to be faring or based on his own assertions about the treatments he’s receiving, Murray said, it might affect all clinical trials for monoclonal antibody treatments, not just Regeneron’s. And if these treatments are approved for widespread compassionate use or authorized for emergency use, researchers might never learn in a randomized controlled trial what the best dose is, or whether it treats mild or severe illness better, or the best time to take it. That could have major consequences for treating and preventing the virus—especially among high-risk populations, in whom a vaccine may not work as well.
Monoclonal antibodies could prove useful in certain circumstances, especially when it comes to protecting those at high risk of contracting and dying from the virus. Several pharmaceutical companies have rushed to develop monoclonal antibody treatments for the coronavirus. But none have been approved for use, with several undergoing phase 3 clinical trials to see how well they work. Last week, Regeneron announced in a press release that its cocktail of two monoclonal antibodies seems to reduce viral load and improve symptoms in patients with mild Covid-19 who did not need to be hospitalized. It’s not clear, however, if this treatment would help Trump, who was hospitalized.
That also complicates the argument for compassionate use of the treatment with Trump, Murray pointed out. “Compassionate use usually means that a person is really quite severely ill, that there are no other treatments available to try, and that, in the absence of treatment, the person has a high risk of death,” Murray said. Either Trump is sicker than his doctors are letting on, or he’s receiving the medication outside of the usual recommendations. “It’s kind of shocking for researchers to hear that the president was given compassionate use of a drug.” Neither Murray nor Rasmussen has heard of a case where a president has publicly taken an experimental drug or qualified for compassionate use.
Murray hopes that with careful communication to would-be participants, the trials will continue uninterrupted and no decisions on compassionate use or emergency use authorizations are made before the data from clinical trials is in. “I assume that Regeneron would still attempt to do its trial and hopefully, with some good public communication, it could recover from any potential damage that Trump’s use of it might have caused,” Murray said. It’s unlikely companies like Regeneron would suffer financially from an early rollout of their treatments, but the knowledge gained from thorough clinical trials is invaluable for understanding the best circumstances for administering monoclonal antibodies. Knowing which patients benefit the most from the treatments, and in what stage of the illness, can be critical for a medication’s success.
By touting an unproven treatment, whether directly (as he did with hydroxychloroquine for months) or indirectly (by receiving the preliminary treatment soon after announcing his diagnosis), Trump also leaves room for pharmaceutical companies to dominate the narrative when it comes to safe, effective Covid-19 medications. It’s not the first time the administration has prioritized businesses over safety regulations. Yesterday, the White House blocked new rules from the U.S. Food and Drug Administration for evaluating SARS-CoV-2 vaccines. The FDA released the new guidelines anyway, but as an appendix.
Trump says his health is rapidly improving and that he’s never felt better. He’s even suggested that Americans shouldn’t be afraid of Covid-19 or “let it dominate your life.” Trump also falsely implied that the flu is deadlier than Covid-19, in a post that Facebook deleted and Twitter hid on the grounds that it was spreading medical misinformation.
If the president has genuinely benefited from the treatments, of course, that’s good both for his own health and, presumably, for Regeneron stock, which will get a dose of positive press. But given that the virus is frequently fatal, may have long-term effects, and isn’t going away anytime soon, experts hope Trump’s improvements don’t come at the expense of the many vulnerable lives still hanging in the balance.