One potential downside to being the President of the United States — too much care.
Presidents have always received VIP medicine, but “excessive care isn’t necessarily good quality care,” said Dr. J. Randall Curtis, a professor of pulmonary and critical care at the University of Washington School of Medicine in Seattle.
The concern is that having too much focus and too many people involved could result in over-treatment as President Donald Trump receives carefor COVID-19 at Walter Reed Military Medical Center.
At a news conference Saturday, officials said Trump’s medical team included three pulmonary critical care specialists, two infectious disease doctors, an anesthesiologist, an Army nurse, four Navy nurses, a clinical pharmacist and the director of the medical center’s executive medicine program. That’s in addition to the president’s physician, Navy Cmdr. Sean Conley.
Conley said Saturday he was using a “multi-prong” approach to treat Trump.
“He is receiving all of the standard of care and beyond for routine, international COVID protocols,” Conley said. “He’s the President. I didn’t want to hold anything back. If there was any possibility that it would add value to his care and expedite his return, I wanted to take it.”
Curtis acknowledged as president of the United States Trump and his medical team would want to have lots of input and options. Even so, other physicians noted overtreatment can be an easy trap to fall into with high-profile patients.
“It is common for people who hold positions of stature to get more aggressive care because there’s pressure to give someone everything imaginable. I would hope his physicians are being very deliberate in the treatment,” said Dr. Russell Buhr, a professor of pulmonary and critical care medicine at the University of California, Los Angeles.
That could explain why the president is receiving relatively aggressive treatment for someone whose physician described him as “doing very well” on Saturday.
“I don’t think we can speculate on the reasons behind the care,” said Buhr.
Once he was hospitalized, Trump’s doctors began him on a course of remdesivir, a prominent experimental drug in the fight against the coronavirus that some clinical trials have shown can shorten the duration of the illness.
A number of doctors and researchers reacted with dismay to the drugs and vitamins that President Trump had been given before his hospitalization. On Friday Conley released a list of medications the president was being given to fight COVID-19.
While one of the treatments – a pair of antibodies being developed to help fight the virus – is being explored in large clinical trials, the other drugs and vitamins have not been well researched, and there is no information about using them in combination, a handful of researchers said.
“It’s bad medicine and it’s a bad message,” said Dr. Vinay Prasad, a hematologist-oncologist at the University of California San Francisco, who studies health policy, clinical trials and medical decision-making.
Bad medicine because of the lack of proof, he said, and a bad message because it suggests important people don’t need to wait for the scientific process to unfold before getting access to unproven medicines.
Some medications will be safe and helpful, others will be unsafe and unhelpful or somewhere in between, and only rigorous clinical trials can reveal the difference, Prasad said.
“The best medicine is not to give drugs that have no proof,” he said.
According to Conley, Trump on Friday received an 8-gram dose of an antibody cocktail made by the pharmaceutical company Regeneron. He had also been taking vitamin D, zinc, the antacid Pepcid, melatonin, and aspirin, though it’s not clear whether Trump continued taking these after being hospitalized.
“It is interesting and a bit concerning that they are trying so many therapies that are both experimental and unproven,” said Dr. Alden Landry, an emergency medicine physician at Beth Israel Deaconess Medical Center in Boston. “This is not the typical treatment for patients especially at this (early) stage of the virus.”
All treatments carry risks, and any one of the therapies Trump is taking might be harmful alone or in combination with other therapies, the doctors said.
What Trump has not been given is hydroxychloroquine, the malaria drug he had touted with little evidence and took briefly himself this spring. Studies since then have shown the drug is ineffective against COVID-19 and can be dangerous.
Trump had asked about the drug, Conley said, but was not receiving it.
When people battle disease their immune system produces antibodies specific to that illness. With monoclonal antibodies, drug companies try to provide these same protective molecules to boost a patient’s immune response.
The treatment Trump received contained a combination of two monoclonal antibodies currently being tested against COVID-19. Because it is still considered experimental, it is not yet available to the general public outside of clinical trials.
Dr. James Crowe, Jr., who directs the Vanderbilt Vaccine Center in Nashville, Tennessee, said the downside of delivering more than one antibody is that it can dilute the power of the most potent one. The plus side is the virus is unlikely to escape when it is hit by two monoclonal antibodies at once, said Crowe, who is developing a different monoclonal antibody with drug giant AstraZeneca.
Regeneron recently released an analysis of its cocktail in 275 patients, showing it to be safe and to reduce a patient’s viral load,though there’s still no basis yet to conclude whether it is effective.
Dr. Rajesh Gandhi, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, said he has given a similar drug made by Eli Lilly and Co. to his patients, and is optimistic about the approach.
“We think antibodies are most likely to work if given early,” Gandhi said, which is probably why it was tried on the president so soon after his diagnosis. In many diseases, early treatment is more effective, he said, noting that “although the antibodies are promising, they are still experimental.”
Dr. Ilan Schwartz, an infectious disease expert at the University of Alberta in Canada, agreed that it was reasonable to try Trump on the antibody cocktail. “I think there’s enough data to support that it’s probably safe,” he said. “It’s certainly not ready for prime time, but in exceptional circumstances, it would be reasonable (to give to a patient).”
Dr. Eric Topol, director and founder of the Scripps Research Translational Institute in La Jolla, California, said he was surprised at how quickly Trump was able to obtain a dose of the experimental antibody mixture, within just a day of his diagnosis.
“They’re pulling out all the stops,” Topol said. “You just don’t know whether it’s because of the VIP syndrome – doing too much – or whether he’s started to show some signs that it’s taking a toll on his body.”
Remdesivir, sold by Gilead Sciences under the brand name Veklury, is an anti-viral developed to treat Ebola that has been repurposed to treat COVID-19. Earlier this year, the U.S. Food and Drug Administration authorized its use in hospitalized patients, and although there have been shortages, the company now promises hospitals will have an ample supply.
Research shows the drug can shorten by several days the hospital stay of patients who are seriously ill, but not in intensive care.
Remdesivir is generally given in a five-day course, intravenously.
Dr. Brian Garibaldi, a pulmonary critical care doctor treating the President said Saturday that Trump received his first dose Friday night and “our plan is to continue a five-day treatment course.” It’s not clear whether that means Trump will stay at Walter Reed until he finishes the treatment.
Conley said he tried the combination of the antibodies and remdesivir because the two work in different, complementary ways.
“We’re maximizing all aspects of his care,” Conley said, “attacking this virus in a multi-prong approach.”
Several of the doctors interviewed by USA TODAY supported the decision to try both drugs, though they noted that they’ve never been studied in combination.
Vitamins and over-the-counter remedies
Experts were perplexed by the remainder of items on the medication list released Friday.
For vitamin D, research has shown that people who have low levels of the vitamin in their bodies fare worse when they contract COVID-19, but bringing levels above normal appears to do nothing. It’s not clear whether Trump has a deficit of vitamin D, which is produced during exposure to direct sunlight and is also found in some foods.
Data also suggests patients with low levels of zinc in their blood fare worse with COVID-19 than those with normal levels. But again, there is no evidence that supplementing with zinc improves COVID-19 outcomes.
Researchers have suggested that melatonin, a natural sleep aid, may help reduce inflammation and therefore provide benefit to COVID-19 patients, though studies into its effectiveness are just beginning.
The antacid famotidine, sold over the counter as Pepcid, also has been discussed as a possible treatment for COVID-19. The heartburn medicine is generally considered safe, and there is some data suggesting a benefit, but the research did not meet a high standard, and the improvement seen could have happened just by chance, said Gandhi, of Mass General.
The Infectious Disease Society of America’s treatment guidelines, which Gandhi helps write, recommends against using the medicine to treat COVID-19 outside of a clinical trial, “not because it has a lot of side effects – it’s an antacid, it’s available over the counter – it’s just that there’s not good evidence that it has a benefit,” he said.
Aspirin is another head-scratcher, Prasad and others said.
It is not uncommon for people who have had heart attack or stroke to take a baby aspirin a day to prevent a repeat, but there is no evidence that the President takes it for that purpose. Because aspirin can thin the blood, it is generally not given to reduce a fever, which Trump had on Friday.
Conley said midday Saturday that the President had been “fever-free for over 24 hours,” though he did not specify whether Trump was taking fever-reducing medication.
Prasad said he’s not sure why Trump would be given any one of these unproven therapies, no less the combination. “I have some question marks about why he’s taking them,” Prasad said. “They’re not likely to be beneficial.”
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.