USA TODAY US Edition

Costs and care

Trump also had access to experiment­al drug

- Karen Weintraub

We compare the treatment the president receives for COVID-19 with what the average patient receives.

President Donald Trump has had the best possible care for his COVID-19, his doctors have repeatedly assured America.

“He’s on a routine regimen of COVID therapy,” his physician Sean Conley added Monday in a news conference.

It’s true that while he’s had outstandin­g care, Trump’s therapies have been similar to those available to most other hospitaliz­ed COVID-19 patients – with two major exceptions.

The president received a dose of an experiment­al drug only tried so far in about 2,000 people as part of a research trial, and he’s gotten everything far sooner than a typical COVID-19 patient would.

Here’s a breakdown of the president’s treatment and how it differed from that available to most Americans:

Earlier on everything

Even his diagnosis came much faster. Average Americans wait a few days after they start feeling sick to getcoronav­irus tests – if they can even get one – and days longer for results. But Trump was tested and his positive diagnosis confirmed on Thursday, within 24 hours of first feeling fatigued on a flight back to Washington, D.C., from a speech in Duluth, Minnesota.

He rapidly received the one nonstandar­d drug, a combinatio­n of so-called monoclonal antibodies, and was hospitaliz­ed on Friday afternoon, less than 48 hours after his diagnosis, “out of an abundance of caution.”

Most Americans can get a medical profession­al on the phone in that timeframe, but would likely be told to stay at home, take a fever-reducer like Tylenol, and monitor their breathing.

Trump’s doctors have been somewhat cagey about the president’s early symptoms, other than to describe a high fever and low energy.

His blood oxygen saturation level – a measure of the amount of oxygen in the blood – may have briefly fallen as low as the 80s twice on Friday and Saturday, Conley hinted. But it bounced back right after he received oxygen, Conley said, reassuring­ly, and measured a normal 95% to 97% on Tuesday.

Most people wouldn’t know if they had oxygen level drops like that, unless they have a pulse oximeter at home, but usually would be admitted to the hospital if their oxygen levels dropped below about 94%, especially if they were having trouble breathing.

Monoclonal antibodies

Before Trump headed to the hospital, less than 48 hours after his first symptom, he had already received a dose of a monoclonal antibody made by Regeneron, a New York biotech company.

The drug, REGN-COV2, is intended to mimic the natural process of the immune system, providing it with molecules called antibodies the body normally manufactur­es to fight off specific diseases. It is currently being tested in people at various stages of the disease, including patients who have been diagnosed and are symptomati­c but not hospitaliz­ed, as was Trump.

REGN-COV2 includes two antibodies. One comes from a person who recovered from COVID-19, the other is from a mouse engineered to have a human immune system. Both target a protein on the surface of the coronaviru­s that causes COVID-19.

This drug and similar monoclonal antibodies, including one made by Eli Lilly and Co., of Indianapol­is, remain under developmen­t and are not yet approved for use in the United States or elsewhere. Trump was able to get it under a “compassion­ate use” exemption, which the company said it has granted to fewer than 10 people so far, after requests from their doctors and approval by the U.S. Food and Drug Administra­tion, a process that typically takes days to weeks.

Otherwise, about 2,000 people have taken REGN-COV2 as part of clinical trials designed to ensure that it is

safe and effective.

Trump and the others wouldn’t have been charged for the drug because it is not available for sale. Trial participan­ts receive a stipend to compensate them for their time.

Prices aren’t set for drugs until they’re approved by the FDA.

But monoclonal antibodies are usually extremely expensive. Cancer-related monoclonal antibodies often cost nearly $100,000 a year, according to one 2018 study. For COVID-19, monoclonal antibodies are expected to be orders of magnitude cheaper, likely on the order of a few thousand dollars for a singledose regimen.

Supply will likely remain tight even after approval because such biologic drugs are complex and time-consuming to manufactur­e. The company estimates between 70,000 and 300,000 treatment doses will be available under an agreement with the U.S. government, which would provide the treatment for free to COVID-19 patients.

Doctors have long put a lot of faith in monoclonal antibodies.

Dr. Rajesh Gandhi, an infectious disease specialist at Massachuse­tts General Hospital and Harvard Medical School in Boston, described monoclonal antibodies as “one of the more promising medication­s.”

“It’s really interestin­g and potentiall­y important,” he said because it has the potential, when given early as it was to Trump, to prevent infections from becoming serious.

Remdesivir

Soon after arriving at the hospital Friday evening, Trump was given the first of five doses of remdesivir, an antiviral. The drug, made by Gilead Sciences of California, was developed to treat Ebola but has been repurposed to use against COVID-19.

It has been shown effective in patients who are hospitaliz­ed with breathing problems, but not sick enough to require ventilatio­n. In that group, research has shown remdesivir can reduce the time a patient has to stay in the hospital, although three different trials of the drug have shown three different results.

Theoretica­lly, because the drug is an antiviral, it should be more effective the earlier it is given in the course of disease, when the virus is just taking hold. But remdesivir has to be delivered intravenou­sly at the moment (it may eventually be available in an inhaled form or as a pill), so most of the people who have taken it, and nearly 90% of the patients studied in the trial were defined as having “severe disease,” so were likely far along in their infection.

Trump got it on Day 2.

Sold under the name Veklury, remdesivir has been in shortage in the United States for most of the summer, though that seems to be easing. “Gilead is now meeting real-time demand for Veklury in the United States and anticipate­s meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19,” according to a company news release from last week.

Private insurance companies will pay $520 per vial or $3,120 for a five-day course of treatment, while the company will charge the U.S. government $390 per vial, or $2,340 per patient.

“At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access,” the company’s chairman and CEO, Daniel O’Day, said in June in announcing the pricing.

Most Americans hospitaliz­ed with COVID-19 now get remdesivir.

It’s a good drug, but not a game changer, said John Wherry, director of the Penn Institute of Immunology, at the University of Pennsylvan­ia Perelman School of Medicine. “Remdesivr does work to some extent, especially when treating early in the disease,” he said.

Dexamethas­one

Late Saturday, three days after his first symptoms and two days after his diagnosis, Trump was given the steroid dexamethas­one.

This drug, though cheap and accessible, is usually reserved for people with very low oxygen saturation levels or those on ventilator­s. Because of the lack of data on Trump’s oxygen levels, it’s unclear whether he met those criteria.

Steroids do not provide a benefit when given to people in earlier stages of

COVID-19, studies have shown, and can even be dangerous because they tamp down the immune system’s ability to fight off the virus.

Dexamethas­one and other steroids are off-patent and inexpensiv­e – just $25 for a 4 mg dose, according to the website drugs.com, while 10 mg costs about $35. They are widely used in the United States and around the world.

Learning about their effectiven­ess, especially for very ill patients, has been a boon to COVID-19 treatment everywhere, said Dr. Roger Shapiro, an infectious disease specialist at the Harvard T. H. Chan School of Public Health, Harvard Medical School and Beth Israel Deaconess Medical Center, all in Boston.

“Steroids were a real success story for people with severe disease,” he said. “The reduction in mortality was really striking.”

But Shapiro said he was surprised that Trump received steroids so soon after his diagnosis. “Most everyone expects that steroids do the most good in the late stages,” he said. “That’s why a lot of people were scratching their heads about Trump getting steroids so early in the illness.”

Other important advances

The president has now exhausted the available care options.

No other treatments have been authorized for COVID-19, though a large number are in clinical trials, including some that help reduce immune over-reactions that are common in COVID-19 and others that aim to prevent potentiall­y lethal blood clots.

Hopefully, Trump will continue to improve, but if not, his care will likely be the same as everyone else’s: mostly what’s called supportive care, like oxygen and fluids.

Most very ill patients, particular­ly at major teaching hospitals, are encouraged to participat­e in clinical trials – potentiall­y helping themselves and others, said Dr. Gabriela Andujar Vazquez, an infectious disease specialist at Tufts Medical Center and Tufts University Medical School in Boston.

“You come to Tufts, you would be offered every single thing that’s has been put out there that seems to be safe,” she said.

Although there are no numbers on how many deaths are now prevented by improved medical care, doctors treating COVID-19 patients agree care has improved since the winter and spring when COVID-19 was brand new and some hospitals were totally overwhelme­d with patients.

“Across the country, we’ve gotten better at treating people,” said Dr. Mark Rupp, chief of the division of infectious diseases at Nebraska Medical Center in Omaha. “I think we’ve gotten better at what the virus looks like and what we can expect and the supportive care that goes along with it.”

Doctors also have learned about treatments that aren’t helpful, like a combinatio­n of HIV drugs tested early on and shown to be ineffectiv­e.

And they’re no longer throwing the kitchen sink at their patients, Rupp said.

“What we call ‘compassion­ate release of medication­s’ is really not always compassion­ate,” he said, warning that doctors who provide such overtreatm­ent can endanger people in their care. “Your heart is in the right place, you’re wanting to do good, but you’ve lost sight of the science and the data and being true to that.”

The next step for researcher­s, Gandhi said, will be studying how drugs like remdesivir and dexamethas­one work together and the best timing for both, as well as adding those drugs to others to see if outcomes improve.

On Monday afternoon, Conley, Trump’s physician, said the president was healthy enough to go home, an assurance that concerned many health profession­als who saw him later on a White House balcony, apparently struggling to breathe.

“Though he may not be entirely out of the woods yet, the team and I agree that all our evaluation­s, and most importantl­y, his clinical status, support the president’s safe return home,” Conley said.

Of course, the president’s home is not like any other. “He’ll be surrounded by world-class medical care, 24/7,” Conley concluded.

 ?? ALEX BRANDON/AP ?? President Donald Trump returns to the White House on Monday after leaving Walter Reed National Military Medical Center in Bethesda, Md. Trump announced he had been diagnosed with COVID-19 on Oct. 2.
ALEX BRANDON/AP President Donald Trump returns to the White House on Monday after leaving Walter Reed National Military Medical Center in Bethesda, Md. Trump announced he had been diagnosed with COVID-19 on Oct. 2.

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