Is ‘it can’t hurt’ the rationale for giving Trump unproven Covid-19 treatments?

Like all Americans infected with SARS-CoV-2, the virus that causes Covid-19, President Trump deserves the best medical care. As he has now been discharged from Walter Reed National Military Medical Center, we wish him a fast and full recovery.

But what does “the best medical care” mean? For many diseases, and especially new ones with emerging evidence, what is best is often unclear. As doctors and as students of medical history, we believe that the best care involves safe therapies known to be effective.

Using this definition, there are reasons to be concerned for the president.

It is always hazardous to comment on the care another doctor or team of doctors is providing their patient. This is especially true when the patient is the president of the United States. So we begin by acknowledging that what we know about the president’s condition is based solely on what the White House or his doctors have publicly shared. It is entirely possible that his doctors are reacting to realities about which we are unaware. We hope the information we have is accurate, as the American people deserve to be hearing the truth.

Assuming the public reports are true, many of the treatments the president has received have been far from standard. Hospitalizing an obese, 74-year-old man with Covid-19 and low oxygen levels is completely reasonable. The treatments he has received, however, are not those that other patients with his clinical situation would have gotten.

Even before the president tweeted out testing positive for Covid-19 on Friday morning, he had received a combination of two monoclonal antibodies developed by the drug maker Regeneron. Soon after arriving at Walter Reed, he was given the antiviral remdesivir, as well as zinc and vitamin D. He later received a dose of dexamethasone, a steroid.

We will put aside zinc and vitamin D. These are two generally harmless medications, though admittedly there is no evidence from well-done clinical trials supporting their use.

Regeneron’s antibody drug is being developed for treating patients with Covid-19. It is presently being tested in clinical trials and is available to patients only under the FDA’s expanded access program, in which patients with “an immediately life-threatening condition or serious disease” can gain access to an investigational drug. The rub is that there is no convincing proof this drug helps — which is why it is being tested.

For patients who are critically ill, taking an investigational drug can be reasonable. But for someone whose chances of recovery are greater than his chances of death, as is the case for the president, it is not common to gamble with a new product whose harms may well exceed its benefits.

Remdesivir is available through an FDA emergency use authorization. This antiviral appears to be safe but only marginally beneficial. When used in patients with Covid-19 who are severely ill, such as those with pneumonia from the infection, it might slightly improve time to recovery in those who will recover but it does not decrease the likelihood of dying or needing mechanical ventilation. When used for patients with milder disease, there is a very tiny improvement in recovery.

Dexamethasone has been a bright spot in treating Covid-19. It is the one medication that has been shown to improve the chance of survival. This benefit, however, is restricted to patients already on supplemental oxygen or those needing mechanical ventilation, and only for those treated more than a week after symptoms begin. These facts suggest that dexamethasone does not work in the early phase of Covid-19, when the virus is replicating, but in the later phase, when a runaway immune reaction against the virus, what’s called a cytokine storm, may be harmful.

We wonder what to make of the president’s treatment. One possibility is that the American public was misled and the president was much sicker than we were told. Another more likely possibility is that, because of who he is, the president is being treated with medications that are either not available to the public or not indicated for his condition.

This isn’t surprising, but neither is it right or beneficial. VIPs like the president are often treated differently, frequently to their detriment. We have both witnessed wealthy patients receiving screening tests that they do not need that result in procedures to evaluate ambiguous results of those screening tests. Sometimes harm ensues.

The first problem with the president receiving unproven care is that there is a real chance that the cocktail of medications he is getting will do harm. In fact, in a key study of dexamethasone, patients treated with the steroid who did not require oxygen were apparently harmed. And, what happens when you mix an unproven antibody cocktail, remdesivir, dexamethasone, and wash it down with zinc and vitamin D? We have no idea, but it is naïve to think the answer is, “It can’t hurt.”

Second, the president’s care may seem unfair. Many will be embittered seeing him receiving therapy that would not be offered to the more than 7 million Americans who have been or are currently infected with Covid-19. Although the president is unlikely to benefit from this care, it may cause his constituents to further lose faith in the equity of the U.S. health care system.

Third, the president’s care sets a bad example. Just as he squandered the opportunity to wear a mask and lead by example, treating a president with unproven drugs is a missed opportunity. Medicine advances through clinical trials by which we discover if one therapy is superior to another. These trials require patients to enroll and be randomized to a treatment group or a control group. Randomized clinical trials benefit us all and are the safest way to receive experimental drugs.

Thomas Chalmers, the famous medical researcher, once wrote, “One only has to review the graveyard of discarded therapies to discover how many patients have benefitted by being randomized to a control group.” Without randomized trials, and patients enrolling in them, we never know if a therapy is safe and/or effective.

We hope that President Trump is truly on the road to recovery, and that his recovery is rapid and complete. If he does recover, we won’t know if it was because of all the treatments he received or in spite of them. It is easy to think that we should throw out the playbook of medicine when treating VIPs, the wealthy, or presidents, but the truth is we do not do them any favors and we send the wrong message to the public when we do.

Adam Cifu is an internal medicine physician and professor of medicine at the University of Chicago. Vinay Prasad is a hematologist-oncologist and associate professor of medicine at the University of California, San Francisco. They are the authors of “Ending Medical Reversal” (Johns Hopkins University Press, 2019).