Virus treatment divides haves from have-nots
WASHINGTON — Ben Carson, Chris Christie and Donald 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.”
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 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.
Health Secretary Alex Azar told reporters 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 country Tuesday. 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.