Experimental COVID drug President Trump took is in Fresno. Why don’t more doctors use it?
Fresno County health officials are encouraging local doctors to use a pair of drugs with emergency approval from federal regulators as a treatment to keep high-risk coronavirus patients from having to be hospitalized for more serious care.
The drugs, called multiclonal antibodies, received emergency use authorization from the U.S. Food and Drug Administration in November, but have yet to gain real traction as a therapy for COVID-19 patients in Fresno County.
In a Jan. 4 health advisory, the Fresno County Department of Public Health issued a recommendation to employ the two drugs – Eli Lilly & Company’s Bamlanivimab and a combination of two drugs produced by Regeneron Pharmaceuticals Inc. – as “an important tool in keeping patients from deteriorating and to assist the health care system from being overwhelmed.”
While two different vaccines have been made available for emergency use against COVID-19 to prevent people from getting the disease, the distribution and availability of those drugs has been slow.
By contrast, there’s no shortage of the antibodies, which is for people with mild or moderate cases of coronavirus disease to help them mount an immune response after they contract the virus.
Data shows reductions in emergency room visits
Physicians in Fresno County and the central San Joaquin Valley, as well as across California and the U.S. have been slow to refer their patients for treatment with monoclonal antibodies before the disease really takes hold and makes them sicker, said Dr. Rais Vohra, interim health officer for the Fresno County Department of Public Health.
“These antibodies have been tested and shown to be beneficial for patients who catch COVID,” Vohra said in a recent Zoom video briefing. “In the very early days before they get really sick from complications, these monoclonal antibodies can really just neutralize the virus before it replicates all over the body and creates a lot of damage in the lungs and other organs.”
In the January advisory to doctors, Vohra’s department reported that “preliminary data suggests a two-thirds to three-fourths reduction in emergency room visits and hospitalizations among high-risk COVID-19 positive patients who received monoclonal antibodies.”
How it works
The U.S. Food & Drug Administration granted emergency use approval to the two antibody formulas in November. Yet as recently as mid-January, fewer than 100 patients with confirmed COVID-19 infections in Fresno County had received intravenous infusions.
“We have a lot of antibody that’s not being used. It’s a relatively underutilized technology,” Vohra said. “On any given day we have hundreds of doses that are just sitting on our shelves, and we’re really urging all of our doctors, our clinics to really take advantage of this.”
“It’s a new drug. Doctors haven’t had a lot of experience with it,” he added. “Ultimately the doctors who are doing it are seeing really good success with it. … I just feel like we do need to have more doctors that are providing this antibody, so we’re trying to support getting that done by working with them and providing technical assistance as best as we can.”
According to the FDA, “monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.” In the case of the Regeneron and Bamlanivimab therapies, the antibodies “are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.”
Like a vaccine, the antibodies are intended to help jump-start a person’s immune system to fight the coronavirus. But while a vaccine is intended to keep a person from contracting the disease in the first place, the antibody treatment is for people who’ve already caught the virus but have only mild, moderate or no symptoms.
Both drugs are given through an intravenous infusion that can take up to an hour or longer. The treatments have not been authorized by the FDA for patients who are hospitalized for COVID-19 or who are on oxygen therapy. “They have to really be walking and talking and otherwise feeling pretty good,” Vohra said.
Trump used drug. But there are limitations
Prior to its emergency authorization by the FDA on Nov. 21, the Regeneron product was administered to President Donald Trump in early October – along with other treatments – after he was diagnosed with COVID-19 and hospitalized at the Walter Reed National Military Medical Center in Maryland.
Dr. Michael Synn, chief medical officer for the 1,400-member Santé Physicians group, said he’s been able to refer some of his coronavirus patients to one of a slowly growing number of facilities that are providing the antibody infusions in the Fresno area. “The effects of the treatment are like night and day,” Synn said. “The next day they start feeling better.”
Under the FDA’s emergency authorization, there are limitations on who can receive the monoclonal antibodies. Patients must have a positive test for COVID-19, and they have to be 65 years old or older; or be 55 or older with heart disease, hypertension or a chronic respiratory disease. Or, they must have other risk factors that make them vulnerable to serious complications from coronavirus, including obesity, diabetes, chronic kidney disease or receiving any disease treatments that suppress the immune system.
Children ages 12 to 17 can also receive the antibodies if they are obese, have sickle cell disease, congenital or other heart disease, have a neurological developmental disorder such as cerebral palsy, have asthma or other chronic respiratory disease requiring medication, or rely on technology for medical reasons that are not related to COVID-19.
There’s a catch, though: The FDA authorization does not allow the antibody treatment if it’s been more than 10 days since first symptoms of coronavirus disease. “Once someone has had COVID for more than 10 days, it’s more of an overwhelming infection,” said Dr. Ignacio Guzman, a family medicine specialist with Bautista Medical Group in Fresno.
In just the past few weeks, Guzman reported that he and his fellow physicians in two locations – one in the Sunnyside area of southeast Fresno, one in northeast Fresno –have done antibody infusions for about 60 patients in the past few weeks.
Guzman said he’s been impressed with the success he’s seen with patients at his practice – as much as a 70% or greater reduction in patients having to go to a hospital for treatment. “That’s significant; it helps our hospitals say below their capacity,” Guzman said. “That’s our aim in primary care to do that.”
In December and into mid-January, hospitals in Fresno County and throughout the central San Joaquin Valley experienced a surge of patients requiring inpatient care for more serious cases of coronavirus, stretching the ability of doctors, nurses, technicians and other staff to keep up.
Over the past week, the total number of available beds in intensive-care units for the sickest patients in Fresno County hospitals on any given day has wobbled between five and 13, compared to the 149 licensed ICU beds across hospitals in the county.
Why is it an underused treatment?
Several factors appear to be in play to explain why more doctors in Fresno and the Valley aren’t using the monoclonal antibodies to treat eligible COVID-19 patients.
But unlike the two different coronavirus vaccines that became available under FDA emergency use authorization in December and remain a relatively scarce resource for doctors and patients, “there’s is absolutely no supply issue whatsoever” with monoclonal antibodies, said Dale Dotson, emergency medical services coordinator for Fresno County.
Instead, it’s purely a demand issue on the part of physicians.
Every two weeks, the state Department of Public Health and the state pharmacist notify each of California’s 58 counties what their allotment of monoclonal antibodies will be. “Out of the allotments that are being offered, we’re taking only a tiny fraction of what’s being made available,” Dotson said.
Dotson and Vohra both said there are some practical concerns for hospitals, medical clinics or doctors’ practices for providing the infusion treatments in their facilities or offices.
“Remember, these people have COVID, so you have to have a space that can accommodate them where they’re not going to spread the virus to other patients and vulnerable populations,” Vohra said.
Dotson said the one-hour infusion time – along with a one-hour period to monitor for any adverse reaction – means a person who has a confirmed coronavirus infection is going to be in the office or a hospital’s outpatient infusion center for at least two hours.
“It’s not an ideal situation for a hospital or an emergency department to do from a staffing perspective,” he said. “We have some area hospitals that are doing some, but not a lot based on what’s being requested” from the available supply of antibodies.
Guzman agreed, adding that while administering IV drugs isn’t a complicated process, it can be time-consuming. “A lot of physicians and providers are not comfortable about having patients with COVID come into their offices,” he said. “You need the staffing for it, and not many primary-care providers are trained to do IVs” as an everyday part of their practice.
Synn, the Santé Physicians chief medical officer, said “the time and effort a provider would have to put into providing these treatments in their office setting ends up being something of an impracticality” for a doctor’s practice with a limited staff.
Some physicians, Synn added, remain unconvinced of the effectiveness of the antibody treatment.
“When we look at the data piece, the data is not powerful, therefore there are some skeptics about whether this treatment actually works,” he said. “But the folks who are ‘in the know,’ those who are on the front lines battling this disease, counter that their anecdotal information shows that monoclonal antibodies are very effective, and they advocate for more widespread use of this treatment.”
Vohra added that the FDA authorization for the therapy requires that patients who receive it cannot get COVID-19 vaccinations for three months after the treatment. That, he said, can cause some patients to have misgivings about getting the infusion, even though they already have the virus.
“When people hear that, they really get cold feet sometimes, which is kind of interesting,” he said. “Here you have someone who’s elderly, they have a high risk of being hospitalized, they may have heart disease, etc. – and now they have COVID, too. And now you have this medication that might help them.”
“The evidence shows that it has a really good shot at preventing hospitalizations,” he said. “But on the other hand, it means they have to wait to get the vaccine..”
Billing and reimbursement can also be an obstacle, Dotson said he’s heard in meetings of health-care providers. The antibody formula itself is currently being made available free of charge to health-care providers for their patients; medical practices can apply for reimbursement from the Center for Medicaid Services for the costs associated with administering the antibodies, according to the county.
More options on the way
Vohra said that more places are preparing to offer the antibody infusions for patients as doctors become more familiar with the new therapy.
“The good news is … compared to a couple of weeks ago we have a lot of different clinics that are starting to do this,” he said. “There’s primary care doctors, there’s one of our hospitals, Saint Agnes (Medical Center in Fresno), that are providing antibody infusions through their infusion center.”
“We’re really trying to get this to be something that hospitals feel comfortable doing and clinics feel comfortable doing,” Vohra added. The goal is for doctors “to know where to go and where to refer patients so that if people do want to get this done, they can get it done relatively easily.”
Synn said Santé has worked with several facilities to set up and equip infusion centers to provide the antibody treatment for referral patients and is working to establish more sites. “The centers that are providing the infusions are doing a tremendous service for our patients,” he said. “They’re expediting care and getting our patients in rapidly. (Patients say) the process could not be smoother or easier.”
“Because we have front-line health care workers who swear by it, our obligation to make sure this treatment is available to patients to reduce the overall burden on the health care system,” Synn added.
Dotson said a COVID-19 alternative care site at the Porterville Developmental Center in Tulare County – established by the state as a place where hospitals across the Valley could send recovering COVID-positive patients to make room in their own facilities for new patients – has launched an infusion center that’s available for referrals from doctors and hospitals in the region since it is already a care site for patients who have the virus.
This story was originally published February 5, 2021 at 5:00 AM.
