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 Donald 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 last month.
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 last month, 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 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 next month.
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.”