Only one covid-19 treatment is designed to keep people out
of the hospital. Many overburdened hospitals are not offering it.
Laurie McGinley
Dec. 31, 2020 at 3:00 p.m. GMT
Medical centers in the United States are balking at
providing the only treatment for covid-19 that aims to keep people out of the
hospital, leaving hundreds of thousands of doses of the medication unused.
Monoclonal antibodies — described as “unbelievable” by
President Trump, who received the treatment this fall — are designed for
patients newly diagnosed with covid-19, the disease caused by the coronavirus,
who have a high risk of developing complications and becoming seriously ill.
But for hospitals already strained by a surge of covid-19
cases, the outpatient pharmaceutical treatment presents a major logistical
challenge as exhausted staff scramble to care for patients and race to
inoculate front-line workers with the first coronavirus vaccines.
As of Wednesday, the federal government had allocated
550,000 doses to states and territorial health departments, which had
distributed 378,000 doses to health-care facilities, according to the
Department of Health and Human Services. But only 20 percent of the supply had
been used, HHS said.
Some hospitals, including Beth Israel Deaconess Medical
Center in Boston, have declined allocations, while others have simply not used
the antibody treatments. The slow rollout reflects myriad challenges involving
the intravenous drugs, which are made by Regeneron Pharmaceuticals and Eli
Lilly and were granted emergency use authorizations in November.
The treatments must
be given within 10 days of the onset of symptoms — a time when many
patients are hunkering down at home, hoping to get better. Clinics and
hospitals need to set up a special infusion space to keep contagious patients
away from other people, including cancer patients receiving chemotherapy.
Nurses must be pulled from other duties to monitor patients for the two-hour
sessions, in part to watch for rare allergic reactions.
Questions about the drugs’ effectiveness further complicate
matters. The Infectious Diseases Society of America recommends against routine
use of the drugs, citing a lack of evidence, and the National Institutes of
Health says “insufficient data” exists to recommend for or against the
medications. Clinical trials of the two antibody treatments continue.
“Right now, we are
swamped with both covid and non-covid patients,” said Pieter Cohen, an
associate professor at Harvard Medical School and physician at the Cambridge
Health Alliance, a health-care system in the Boston area that does not offer
the treatment.
“The last thing we
want is to use our resources for an unproven treatment,” said Cohen, who works
at the system’s Somerville, Mass., clinic.
The lagging demand was not anticipated by experts who warned
of a shortage, not a surplus, of antibody treatments. In clearing the products
in November, the Food and Drug Administration said they could be used broadly
for high-risk covid-19 patients, a group that includes millions of older people
and those with medical conditions such as diabetes. The Trump administration’s
Operation Warp Speed, which aims to develop drugs and vaccines for covid-19,
ordered 1.2 million doses for delivery by the end of January, said Janet
Woodcock, leader of Operation Warp Speed’s therapeutics arm.
Demand was expected to surge when Trump made a laudatory
video after receiving the Regeneron medication and promised to make the
antibody treatments free to patients needing them. Former New Jersey governor
Chris Christie (R) and Housing and Urban Development Secretary Ben Carson were
treated with monoclonal antibodies after developing covid-19. Trump attorney
Rudolph W. Giuliani told the New York Daily News he received the Regeneron
drug. Some people predicted only VIPs would get access to the drugs.
But many patients and doctors don’t know much about the
medicine and have not been asking for it, officials say. In an appearance on
CNBC on Dec. 15, HHS Secretary Alex Azar lamented a surprising surplus of the
medications, partly because “people are waiting too long to seek out the
treatments.” Such delays, he warned, meant that, for some patients, “it may be too late in order to get the benefit
of these antibody treatments that beat back the spread of the virus.”
Experts say states’ experiences vary, with some, including
Louisiana, Nebraska and Texas, embracing the treatment and others showing
little interest. HHS has predicted that the pace will pick up as more
facilities, including nursing homes, begin administering the drugs and mandatory reporting begins early in
January.
Monoclonal antibodies
are proteins created in the laboratory to mimic the human immune system.
The treatment works by imitating natural defenses instead of waiting for the
body to mount its own response and make it harder for the coronavirus to infect
human cells.
The Lilly product,
called bamlanivimab, is a single antibody cleared by the FDA on Nov.
9. Regeneron’s cocktail, made up of two
monoclonal antibodies, casirivimab and imdevimab, was authorized less than
two weeks later.
At UCLA Health, four
or so patients a day are being given the antibody treatments, according to
Tara Vijayan, an infectious-disease specialist there. “Implementation has been
difficult to say the least,” with lively debates about how to allocate space
and staff, she said. “It took a month of constant meetings for a drug that
doesn’t have a lot of data.”
Still, she said, with intensive care units reaching capacity
amid a covid-19 surge in Los Angeles, “if there are ways to reduce that, we
will try it.”
Operation Warp Speed’s Woodcock acknowledged the
difficulties of administering the antibody treatments for hospitals under
stress from a raging pandemic. “It is not easy,” she said. “These hospitals are
being hammered.”
But, she said, the medications could ease hospitals’ burdens
by reducing admissions. Although the clinical trials for the treatments are not
large, she said, “the totality of
evidence is very convincing” that the drugs can keep people out of the
hospital.
“This is the only thing we have for outpatients, other than
just telling them to stay home and isolate,” she said. She added that the
government is planning steps to increase uptake of the treatments.
Mark McClellan, a former FDA commissioner who has been
working to increase use of the drugs, said: “If it were my mom, I would want her to get it.”
But many doctors remain skeptical or undecided. Rajesh
Gandhi, an infectious-disease doctor at Massachusetts General Hospital and
Harvard Medical School, said his hospital is offering the treatment to
high-risk patients in clinical trials and outside of studies. He said he was
glad Regeneron and Lilly plan to complete their trials, saying additional data
is needed.
“We are still trying
to get a definitive answer to how beneficial this is” and which patients are
helped, he said.
One of the biggest obstacles for clinics is identifying patients within the 10-day
window during which the drugs are effective. Karen Bloch, an
infectious-disease doctor at Vanderbilt University Medical Center, said the
hospital uses coronavirus test results to identify eligible patients.
“We look at the test results and reach out to the folks who
fit,” said Bloch, who added that the medical center is providing the treatments
to 18 to 22 patients a day.
To keep covid-19 patients apart from other patients,
Vanderbilt created a free-standing area with walls, heat and light in what used
to be a parking garage. Bloch said she doesn’t know whether the treatments are
helpful, because she is not conducting a clinical trial.
“But from patients,
we are hearing good reports,” she said.
Tufts Medical Center in Boston has been offering the
treatment for about a month in its new Respiratory Infection Clinic, said Helen
Boucher, an infectious-disease specialist. “The demand has not been
overwhelming,” she said, “but it’s still early days.”
Woodcock said the government plans to ensure the drugs are
distributed to a wider range of facilities, including home-infusion companies
and other sites. CVS Health is running a pilot project to provide the medicine
at home. Woodcock said she also plans to talk to groups such as the American
Medical Association and to highlight “early adopters,” including the Mayo
Clinic and the state of Maryland, which has set up regional antibody infusion
centers, including in Baltimore’s convention center.
Lilly said it is working with hospitals and other providers
to try to ensure that patients who need bamlanivimab can get it. The company
said infusion centers are being created in several health facilities and
repurposed public spaces to provide the treatment during off hours.
Even as coronavirus vaccines steal the spotlight, McClellan
said, monoclonal antibodies will be needed “for people who don’t take the
vaccine, or don’t mount an immune response when they do. This is something we
need to set up and work out for the long term.”
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