A drug that could protect high-risk Covid-19 patients from serious illnesses is sitting unused on the shelves, as a record number of people have been admitted to hospital.
On Thursday, federal and state-level public health officials pleaded with the country to take advantage of the wide range of monoclonal antibody treatments, the only available therapy that could possibly keep patients out of the hospital.
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“This is the first time I can remember during the pandemic when our resources far exceeded demand,” said Dr. William Fales, medical director of the Michigan Department of Health and Human Services, said Thursday during a media conference hosted by the U.S. Department of Health and Human Services. Fales estimates that only 10 percent of Covid-19 patients in the state eligible for therapy received it.
Monoclonal antibodies are laboratory manufactured drugs that are intended to mimic natural antibodies to SARS-CoV-2, the virus that causes Covid-19. It is recommended for people at high risk of becoming very ill with the virus, including everyone over the age of 65 and people with underlying health conditions.
At least one study has shown that treatment can lower the amount of virus in the person’s system. But no research on gold standards proves that monoclonal antibodies do offer this advantage. Most reports are anecdotal.
Fales said his team noted that hospitalization during the two weeks after monoclonal antibody treatment was about 5 percent. This is about half of the percentage of patients who received placebos in studies on the monoclonal antibody treatment of the drug manufacturer Regeneron, according to the emergency consent of the Food and Drug Administration.
Dr. Andrew Thomas, chief clinical officer at Ohio State University’s Wexner Medical Center, suggested during a media call on Wednesday that the use of monoclonal antibodies eased the hospital system.
Thomas said his system rapidly increased the use of monoclonal antibodies. “I would like to think that is why we have reduced hospitalizations,” he said.
Dr. Jonathan Parsons, head of the treatment of monoclonal antibody treatments at the Ohio State Center, said, “Everyone who is tested by our burglary program is recorded in an electronic medical record.” Parsons staff then contact primary care providers for patients who test positive and ask if they would like to refer patients for monoclonal antibodies.
According to Eddy Bresnitz, state epidemiologist in New Jersey, monoclonal antibodies may have played a role in a recent breakdown of Covid-19 hospitalizations in the state. “It’s worth it,” Bresnitz told a news conference on Thursday.
So why do people not get it?
Simply put, a lack of time, resources and awareness.
Obstacles to administration
Monoclonal antibodies should be given shortly after someone has tested positive. “This medicine works best when administered early,” Surgeon General Jerome Adams said during Thursday’s briefing.
The two monoclonal antibody products approved by the FDA for emergency use, from drug manufacturers Eli Lilly and Regeneron, must be given within the first week of illness.
But because the test is still lagging behind in most parts of the country, many patients have to wait a few days to find out if they are infected. By simply waiting for the test results, patients can leave the time they can possibly get for treatment.
However, this barrier should not be a factor in the acquisition of monoclonal antibodies, says Dr. John Redd, Chief Medical Officer for the Office of the Assistant Secretary of Health and Human Services for preparedness and response.
“To get these drugs, you do not have to do a PCR test,” Redd said during Thursday’s briefing. (A PCR or polymerase chain reaction is considered the gold standard, but it may take days to get a result.)
Instead, Redd said, “a quick test is very appropriate.” Quick tests can yield results within minutes, but it has higher false negatives.
Those at the forefront of treating Covid-19 patients say it is not that easy.
Monoclonal antibodies are administered intravenously, during one hour of infusion, with an appointment lasting three to four hours. Because Covid-19 patients are contagious, they need to be separated from other vulnerable patients who require outpatient infusions, such as those receiving chemotherapy for cancer.
Dr. Peter Chin-Hong, a specialist in infectious diseases at the University of California, San Francisco, said some patients may reject treatment because they feel better. But it could be a mistake. It has become clear that some patients may feel better before they suddenly get worse.
For many others, logistical problems hinder.
Public transportation and driving stocks, such as Uber, are out of the question for those with active Covid-19. In addition, Chin-Hong said, some patients simply cannot afford three hours outside of their work or family responsibilities.
Chin-Hong estimates that his health care system used less than 20 percent of the monoclonal antibodies in stock.
In addition, special infusion centers must be set up and staffed. Some believe this is an unreasonable demand on health systems that have already been stretched.
“If we had this pandemic under control, we would be able to set up infusion centers. We would be able to test quickly. But we do not have the resources,” says Dr. Pieter Cohen, an associate professor at Harvard Medical School and a physician at the Cambridge Health Alliance Respiratory Clinic near Boston.
“We are completely overwhelmed with sick patients,” Cohen said.
Chin-Hong agreed. “These patients are generally good, and you want to focus on the sick patients,” he said.
“I think this is where people’s mindset is – especially now in California,” he said. The state has had an increase in Covid-19 cases. In the state’s most populous province, Los Angeles, an average of 10 people are tested positive for the virus every minute.
The obstacles are not lost on at least some of those leading the federal response. “We acknowledge that the health care system is very stressed,” said Dr. Janet Woodcock, head of the therapeutic operation for Operation Warp Speed, said during the media call on Thursday.
“On the other hand, if we do not, the likelihood is that we will have even more overwhelming hospitals and health workers,” Woodcock said, adding that her team believes efforts to set up such infusion centers ‘worthwhile’ to reduce the burden on healthcare systems.
Some independent kidney dialysis centers across the country have announced that they will begin administering monoclonal antibodies to Covid-19 patients during shifts set up for those patients only. Covid-19 has been shown to be particularly troublesome for patients with kidney disease.
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Another factor may be the lack of awareness among both patients and providers that the treatments are available.
At a media conference on Tuesday, Health and Human Services Secretary Alex Azar was tasked with targeting patients with monoclonal antibodies, which “should ask their doctors or healthcare providers why they are not being offered these antibody therapies.”
However, the online tool of HHS offers little help to those who are trying to find monoclonal antibody resources. The site has no data for people in at least 31 states, including Alabama, Kansas, Michigan, New Jersey, New York, North Carolina, and Washington.
A HHS spokesman said Thursday the team is working “as quickly as possible” to update the site and that it expects more resources to be available by next week.
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