University of Utah, other health systems struggle to provide the same coronavirus treatment Trump received

Antibody treatment has benefits, but forces health systems into making tough choices.

(Francisco Kjolseth | The Salt Lake Tribune) The sun sets on the University of Utah Hospital on Friday, Oct. 16, 2020.

Washington • Ben Carson, Chris Christie and Donald J. Trump are not the sturdiest candidates to conquer the coronavirus: older, in some cases overweight, male and not particularly fit. Yet all seem to have gotten through COVID-19, and all have gotten an antibody treatment in such short supply that some hospitals and states are doling it out by lottery.

Now Rudy Giuliani, the latest member of Trump’s inner circle to contract COVID-19, has acknowledged that he received at least two of the same drugs the president received. He even conceded that his “celebrity” status had given him access to care that others did not have.

“If it wasn’t me, I wouldn’t have been put in a hospital frankly,” Giuliani, the president’s personal lawyer, told WABC radio in New York. “Sometimes when you’re a celebrity, they’re worried if something happens to you they’re going to examine it more carefully, and do everything right.”

Giuliani’s candid admission once again exposes that COVID-19 has become a disease of the haves and the have-nots. The treatment given Trump’s allies is raising alarms among medical ethicists as state officials and health system administrators grapple with gut-wrenching decisions about which patients get antibodies in a system that can only be described as rationing.

“We should not have Chris Christie and Ben Carson — and in the case of Carson with intervention by the president — get access,” said Arthur Caplan, a medical ethicist who works with drug companies on how to ration scarce medicines, referring to the secretary of housing and urban development’s admission that the president “cleared” him for the therapy. “That is not the way to secure public support for difficult rationing systems.”

The treatments — a monoclonal antibody developed by Eli Lilly and a cocktail of two monoclonal antibodies developed by Regeneron — won emergency use authorization, or an EUA, from the Food and Drug Administration last month for outpatients with “mild to moderate” disease who are at high risk for progressing to severe disease or for being hospitalized.

With cases soaring, the pool of potential patients is vast.

“One of the challenges is the EUA criteria really are so broad, it could be half of the people with COVID could qualify, but there is clearly not enough,” said Erin Fox, the senior pharmacy director for University of Utah Health, who has helped her state draft criteria to determine who is eligible for the drugs. “Unfortunately, that leaves each hospital or each state to develop their own rationing criteria.”

Even some top officials at the FDA — both career employees and political appointees — have privately expressed concern in recent months that people with connections to the White House appeared to be getting access to the antibody treatments, according to three senior administration officials.

Giuliani, 76, appeared unaware of the scarcity issues, telling interviewers that politicians have taken masks and business closures too far now that COVID-19 is “a treatable disease.”

In fact, the antibody treatments are so scarce that officials in Utah have developed a ranking system to determine who is most likely to benefit from the drugs, while Colorado is using a lottery system. Dr. Matthew Wynia, director of the Center of Bioethics and Humanities at the University of Colorado, said that giving the powerful access was patently unfair.

“That’s one of the reasons why we decided that we would allocate this only through the state and only through this random allocation process,” he said, “so that no one could get a leg up by virtue of their special connections.”

And there are other complicating factors keeping many people from getting the therapies as well. The infusions must be administered in outpatient settings, but infusion centers, which also care for immune-suppressed cancer patients, are loath to treat people who have an infectious disease. And many emergency rooms are so overrun that they do not have the space.

In Utah, Fox said her hospital had shipped much of the supply of antibodies to rural hospitals, which had more room. Both she and Wynia in Colorado expressed concern that the therapies might not be distributed equitably across racial and ethnic lines, with hard-hit minority communities not getting their fair share.

The scarcity is such a problem that the National Academies of Sciences, Engineering and Medicine is holding a session next week to help medical professionals sort their way through rationing questions.

“We’ve been trying to get the word out so that as patients might get a positive test they could get information that they might qualify for treatment, but that only works for people with a lot of resources,” Fox said.

Politicians are not the only ones with resources getting access.

In an interview on Wednesday, one prominent businessman, who spoke on condition of anonymity to avoid harming his reputation, described his aggressive efforts to track down the Regeneron treatment — including calling friends who were hospital executives and hospital donors — after he tested positive last week.

Eventually he was directed to an emergency room in his city, which was expecting him. He was given an infusion of the drug on Monday. He is feeling much better, he said.

Both Trump and Christie, a longtime friend of his and former New Jersey governor, got the antibodies before they were approved by the FDA. Caplan, the medical ethicist, said he had no problem with Trump, 74, getting the therapy — he is, after all, the president, “a special person unto him- or herself.”

But Christie’s access appeared to be extraordinary. Christie, 58, was offered participation in a Regeneron clinical trial but turned it down, a person familiar with his treatment said, fearing he might receive a placebo. Instead, he received the Eli Lilly treatment. He is overweight and has asthma, and thus may have been a good candidate, Caplan said, though he wondered if similarly situated patients would have gotten the drug.

Carson, 69, got the Regeneron cocktail after it was approved, then took to Facebook last month to say he was “desperately ill” with the coronavirus until the president intervened.

“President Trump was following my condition and cleared me for the monoclonal antibody therapy that he had previously received, which I am convinced saved my life,” he wrote, adding that “we must prioritize getting comparable treatments and care to everyone as soon as possible.”

Giuliani’s treatment is less clear. Calling into ABC Radio from his hospital bed on Tuesday, he said specifically that he had received two drugs — remdesivir, which has FDA approval for treatment of COVID-19, and dexamethasone, a steroid.

But he also said he had received the same treatment “cocktail” as the president: “Exactly the same, his doctor sent me here; he talked me into it,” Giuliani said of Trump’s physician, adding, “The minute I took the cocktail yesterday, I felt 100% better. It works very quickly, wow.”

The therapies are being allocated by the Department of Health and Human Services to states and jurisdictions based, the department’s website says, on a “percentage of the country’s total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients during a seven-day reporting period.”

California, for example, has been allocated 17,760 doses of the Eli Lilly therapy and 5,728 doses of the Regeneron cocktail (the Eli Lilly drug is in greater supply). Maine, with many fewer people and COVID-19 cases, has been allocated 330 and 98 doses of those therapies.

Health Secretary Alex Azar told reporters on Wednesday that so far, 278,000 doses of the two therapies have been allocated. There were almost that many coronavirus cases (220,225) diagnosed in the United States on Tuesday alone.

Once state and local health agencies determine which hospitals or medical facilities should get the drugs, they are shipped out by a third-party distributor. Then it is up to health care providers to figure out what to do with them. Dr. Peter Slavin, the president of Massachusetts General Hospital, said in an interview Tuesday that access there would be by lottery.

“The notion that we are going to be able to treat a significant percentage of the people who qualify for the drug with the drug — it’s not going to happen,” he said.