Monoclonal antibodies could considerably reduce the threat from the coronavirus, as they have been found to reduce viral loads before infection becomes severe, something that other once-promising drugs such as hydroxychloroquine and ivermectin have failed to do.
Yet, although monoclonal antibodies were given emergency use authorization by the Food and Drug Administration in November, they were not widely used during the winter surge when thousands of people died. The therapy is still not a treatment in widespread use in much of the nation.
Dr. Perry Cook, a hematologist and oncologist at New York-Presbyterian Brooklyn Methodist and Weill Cornell hospitals in New York City, told the Washington Examiner that a number of his cancer patients, after receiving a positive COVID-19 test, received no counseling on what to do other than go home and wait. They only received monoclonal antibodies after he consulted with them.
Cook has lamented that the treatment was difficult to find in New York City. Along with a colleague, he recently contacted all the hospitals in the city’s five boroughs and found only three that would provide the therapy to patients at high risk.
“It’s a closely held secret in New York City,” he told the Washington Examiner. “There is nobody in New York that is advertising monoclonal antibodies for people at high risk.”
Monoclonal antibodies are proteins developed in a laboratory that are designed to mimic the way the immune system attacks a pathogen. The two monoclonal antibody treatments currently available are bamlanivimab, produced by Eli Lilly, and REGN-COV2 produced by Regneron, a cocktail of two treatments known as casirivimab and imdevimab. Although the FDA issued an emergency use authorization for both drugs in November, some well-connected people, such as former President Donald Trump and former New Jersey Gov. Chris Christie, received the treatment even earlier.
The treatment is restricted to high-risk patients who have mild-to-moderate cases of the disease. High-risk includes people aged 65 and older and those who are obese, have kidney disease, diabetes, an immunosuppressive disease, or are currently receiving immunosuppressive treatments such as chemotherapy. It can stop the virus from replicating, thereby preventing severe cases of COVID-19 that can result in hospitalization.
Dr. Comilla Sasson, a professor of emergency medicine at the University of Colorado, noted problems in Colorado similar to those in New York City.
“It is hard to know where to go to get a monoclonal antibody infusion done here in Colorado because they are not being done ubiquitously. Not every emergency department is doing it,” Sasson said.
She said that whether the treatment is offered is highly variable, depending on the city, hospital, or physician involved. It may also depend on whether the provider believes in the treatment or is even aware of it.
Although about 3 million vaccines are being administered daily in the United States, barely one-third of the population has received at least one dose, and only 1 in 5 have been fully vaccinated. Parts of the U.S. may be experiencing another COVID-19 surge due, in part, to the more infectious variant from the United Kingdom.
Monoclonal antibodies could reduce that threat if their use was more widespread.
“I think it would, and that’s based on my own anecdotal experience of having treated about 1,000 patients with this drug,” Sasson said.
“I think COVID would be much less of a threat,” said Cook. “But the treatment would have to be combined with frequent screening and the availability of an intervention.”
Early research reported by Regeneron found that its cocktail reduced viral load in patients by tenfold and reduced COVID-19 related medical visits by 57%. A study of bamlanivimab found that it reduced viral load by more than threefold. Additionally, only 1.6% of patients who received it were hospitalized versus 6.3% who had the placebo.
Even after the nationwide vaccination campaign, the treatment would be useful for patients with autoimmune diseases who can’t have vaccines. It could be used for people who decide not to take the vaccine.
“That’s a frustrating group, but every life is worth saving,” said Cook.
Sasson said that one reason the treatment is not widely used is timing. The FDA issued its emergency use authorizations in late November as another surge in cases had begun.
“The last thing the hospitals wanted was an influx of patients coming to get monoclonal antibody infusion,” she said. “The thinking [among hospitals] was that we can’t have more patients coming to the hospitals because we are already being overrun.”
Giving the treatment is a challenge for hospitals as it has to be done in an outpatient setting, a part of the hospital where the patient receives treatment but does not stay overnight in the hospital. It also takes about three hours to finish.
Now, Sasson thinks some of the reluctance over monoclonal antibodies is fatigue caused by previous COVID-19 treatments that have proven ineffective.
“I think there has been some hesitancy from physicians over whether there is enough data to say whether these things work,” Sasson said. “It’s an emergency use authorization drug, and as a community, we’ve been burned before.”
Early in the pandemic, the FDA gave an emergency use authorization to the drug hydroxychloroquine to treat COVID-19, which it later rescinded for lack of evidence of its effectiveness.
Cook claims that part of the problem stems from the economics. The federal government provided monoclonal antibodies to hospitals and other providers without cost, and providers can charge an administrative fee when they use the treatment. But that may not be enough.
New York-Presbyterian Hospital, where Cook works, has an empty infusion center. He has been trying, with no success, to persuade his hospital to turn it into a monoclonal antibody infusion center.
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“They’re reimbursed a modest amount for the administration of the drug,” Cook said. “But that probably does not cover the cost of the physicians, nurses, and the cleaning needed to run the place.”
