Editor’s note: After this story was posted, the White House announced that President Trump was treated with an experimental Regeneron antibody treatment.
President Trump may be just another of the 7 million Americans infected with Covid-19. But he is also the most powerful person in the world — which means that more than any other patient, he could use extraordinary measures to treat the virus with unapproved therapies.
Will he? Should he?
From the start of his administration, Trump has argued that patients suffering from potentially deadly diseases should have earlier access to experimental drugs. In May, Trump veered outside the bounds of normal medical practice by taking hydroxychloroquine in hopes the malaria drug would prevent Covid-19 infection, based not on solid scientific evidence but on letters sent to him by supporters who told him the drug worked to ward off the virus.
There is also a difficult reality: The few drugs that have been proven to have an effect on Covid-19 are not for patients who are just starting to show symptoms, but for those who need to be hospitalized.
“When the president calls, it’s hard to say no, but it’s also important to stay within the process. Just as the president is not above the law, he is not above any type of regulatory oversight and protection when it comes to experimental medicines,” said Peter Pitts, former associate commissioner of the Food and Drug Administration and president of the Center for Medicine in the Public Interest.
Still, experts told STAT that at least one drug, remdesivir, made by Gilead Sciences and granted an emergency use authorization by the FDA, is a likely candidate to offer the president, based on medical practice.
Scott Gottlieb, who served as the commissioner of the FDA earlier in Trump’s term, said he thinks it would be “reasonable to consider” giving him remdesivir.
“If the reports are true that the president is symptomatic, I think it would be reasonable to consider giving him remdesivir, given that we have good information about that drug’s profile, and this is the president of the United States, so we want to lean forward on getting him the best possible care,” Gottlieb said.
Gottlieb acknowledged that remdesivir, technically, is cleared only for patients who are in the hospital, so this would be “off-label,” but he said that its safety profile is well-understood and it’s “reasonable” to believe that it could help patients earlier in their illness.
What if Trump’s medical team wants to go further? Another option would be the experimental monoclonal antibodies being developed by Eli Lilly and Regeneron, which are considered among the more promising experimental therapies. Both companies have said they plan to discuss the possibility of an emergency use authorization with the FDA. But many experts see these as too early to give in this situation.
Eli Lilly said Sept. 16 that some doses of its monoclonal antibody seemed to speed the reduction of levels of the virus in patients’ Covid tests, and might be helping prevent hospitalization. On Sept. 29, Regeneron said that its monoclonal antibody cocktail also lowered virus levels, especially in patients who were not producing their own natural antibodies. But large-scale tests of the drugs are ongoing, and many experts have said it is too early to grant them emergency use authorization.
“I think the antibody drugs are too early along in their development to consider them at this point,” Gottlieb said, “especially since there are drugs like remdesivir where we have much more information about its application in this setting.”
Other drugs that have been proven to have a benefit in treating the coronavirus — including steroids, which have had the most dramatic effect, and baricitinib, an Eli Lilly arthritis drug — would be used only much further along in the disease.
Dexamethasone, a widely available steroid, has proved to improve the odds of survival for patients hospitalized with Covid-19. But there are no data to support using the drug for patients with mild, early-stage disease like Trump, said Nahid Bhadelia, an infectious disease physician and medical director of the Special Pathogens Unit at the Boston University School of Medicine. And it may do more harm than good.
“You don’t want to give it to a patient too early,” Bhadelia said. “It’s a blunt instrument, so it may suppress a good immune response as well as a bad one.”
If Trump’s medical team did want to push for a drug that was more experimental and was not on the market, they could likely do so through a single-patient investigational new drug application, or IND. In the case of a president, the FDA might grant such an application in a matter of hours, and it is likely that a manufacturer would make a drug available.
But the effort to get access could also become political. “They could contact the company and work on ‘right-to-try’ access,” Pitts said, referring to legislation that permits patients easier access to experimental medicines. “The president talks a lot about right to try, so maybe this is an opportunity to see how that works on the executive level.”
It’s not simply a question of whether the president should have access to medicines that are not approved for other people, though. It’s a question of whether taking an unproven treatment is wise. Doctor’s call this “the therapeutic misconception” — the idea that a patient should have a treatment, even when sometimes it is better to do nothing.
“There are a host of unproven therapies for Covid-19 that are recommended by various clinicians and researchers,” said Robert Califf, who served as the FDA commissioner during the final years of the Obama administration.
“It’s important to remember that the vast majority of drugs that enter testing have unexpected toxicity or turn out to be ineffective or have higher risk than benefit,” said Califf, who is now the head of clinical policy and strategy for Verily and Google Health. “In addition, any of the proposed therapies that are not being developed under FDA oversight are modern snake oils.” Even medicines that work for some people can be detrimental for other patients. The antibodies, he said, “are not definitively beneficial,” especially if someone is producing antibodies against their disease.
There are other ways that the decision of how to treat the president could become political. Members of the administration, including economic adviser Peter Navarro, have continued to push for the benefit of hydroxychloroquine in treating Covid-19. President Trump called convalescent plasma, a treatment made from the blood of recovered patients, a “very historic breakthrough in our fight against the China virus” when it received a controversial emergency use authorization in August. But studies showed its benefits were underwhelming. In addition, supplies of the plasma are limited, and it’s recommended mainly for hospitalized patients.
It’s possible that the president could want access to either, or to a cocktail of hydroxychloroquine, the antibiotic azithromycin, and the mineral zinc, which has been much talked about on the internet despite limited evidence of efficacy and side effects including diarrhea and potential heart risks.
In May, explaining his daily regimen of hydroxychloroquine plus zinc, Trump told reporters during a meeting in the White House State Dining Room: “I’ve taken it for a week and a half now and I’m still here. What do you have to lose?”
Throughout the coronavirus pandemic, the president has, through his comments, made many decisions political. The question is whether that will happen with his own treatment decisions.
Damian Garde contributed to this story.