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Doctors are often unaware of the only treatment for early Covid-19

<i>Kayana Szymczak/Bloomberg/Getty Images</i><br/>The FDA has issued emergency use authorization to monoclonal antibody drugs made by three pharmaceutical companies -- Regeneron
Bloomberg via Getty Images
Kayana Szymczak/Bloomberg/Getty Images
The FDA has issued emergency use authorization to monoclonal antibody drugs made by three pharmaceutical companies -- Regeneron

By Elizabeth Cohen, CNN Senior Medical Correspondent

On September 17, Mayra Arana made the phone call she says saved her life.

Arana had been vaccinated against Covid-19, but she developed a breakthrough infection. She feared the virus might kill her, since her immune system is weak after years of treatment for leukemia.

Arana’s family physician in California told her there wasn’t much she could do besides stay home and rest.

At home, following her doctor’s advice, Arana felt sicker by the hour. Her husband placed a pulse oximeter on her fingertip, and it showed her blood oxygen levels were dipping dangerously low.

“I’m Catholic, so I kept praying,” Arana said.

Getting more and more worried, Arana called her oncologist at the University of California San Francisco.

It turned out her family physician was wrong: There is a treatment for early-stage Covid-19.

By this point, Arana was so weak she couldn’t walk on her own. Her husband, a school bus driver and custodian, got her out of bed and drove her to UCSF Fresno, where she received four shots of the treatment, called monoclonal antibodies.

“The next day I could feel a difference. Two days later I could get out of bed and clean the house and feed my children,” Arana said. “I really do think the antibodies saved my life.”

An investigation by CNN shows Arana is not alone in her challenge to find monoclonal antibodies. Many patients who qualify for the drugs say their doctors never mentioned them, even though it has been nearly a year since antibodies were first authorized by the US Food and Drug Administration, they’re the only treatment for early Covid, and studies have shown they can dramatically reduce the risk of hospitalization and death.

The federal government has made efforts to educate doctors, including a presentation by Dr. Anthony Fauci at a White House briefing in August, but still problems have persisted.

“It’s unconscionable,” said Dr. Peter Chin-Hong, an infectious disease expert and professor at the UCSF School of Medicine. “We have an evidence-based drug, and it’s provided free by the government, but there are barriers built into the system to get it.”

If patients do manage to learn about antibodies, they can then face another challenge. As Covid-19 numbers surged this summer and early fall, some hospitals, and even community groups, rose to the occasion and started helping large numbers of patients gain access to the drugs. But some major, well-resourced medical centers say staffing and space shortages have prevented them from offering more than just a handful of treatments per day.

“Some [hospitals] simply are not in a position to reallocate resources for providing monoclonal antibody treatments,” said Akin Demehin, the American Hospital Association’s director of policy.

The end result is that many Covid-19 patients are left hunting on their own for the only drug that can help them.

“This has exposed flaws in our health care system that we need to fix,” said Dr. Lindsey Baden, an infectious disease specialist and associate professor at Harvard Medical School. “This is something we can do better and should do better.”

At a White House briefing at the end of August, Fauci, President Joe Biden’s senior medical adviser, implored doctors to use monoclonal antibodies more frequently, noting that they can reduce the risk of Covid-19 hospitalization or death by 70 to 85%.

“This is a very effective intervention for COVID-19.  It is underutilized, and we recommend strongly that we utilize this to its fullest,” Fauci said. “We want people out there, including physicians, as well as potential patients, to realize the advantage of this very effective way of treating early infection.”

When asked by CNN why more doctors and health centers aren’t getting antibodies to their Covid-19 patients, Fauci said, “I can’t explain that.”

“They work. We’ve just got to get people to realize that they work,” Fauci said. “I’ve been trying to get attention paid to how easy it should be to get this done, but I understand that a lot of doctors don’t fully appreciate that.”

The FDA has issued emergency use authorization to monoclonal antibody drugs made by three pharmaceutical companies — Regeneron, Eli Lilly, and GSK. The government purchased the drugs, which are free to patients and sometimes delivered intravenously and other times by shots.

While effective, antibodies are not a substitute for vaccination, which is more powerful because vaccines prevent infection from occurring in the first place. But monoclonal antibodies can be used preventively after exposure to the virus and also to prevent worsening of symptoms once people get sick. In addition, under a special program, Regeneron offers antibodies to people who are immune compromised and did not fully respond to vaccination.

A desperate search for antibodies

Starr Kidda did everything she could to get monoclonal antibodies for her father, and she failed.

Last month, Kidda’s 68-year-old father, John Daniell, who lives outside of Atlanta, tested positive for Covid-19, even though he was fully vaccinated. He had a fever for days and couldn’t get out of bed.

Monoclonals are laboratory-made antibodies that mimic what human antibodies do: work to block the virus that causes Covid-19 from attaching to human cells, making it more difficult for the virus to reproduce and cause harm.

Five days after he started feeling ill, Daniell had a video call with the physician’s assistant in his family doctor’s office. Daniell says she made no mention of antibodies, even though he is over 65.

Then his daughter, a psychologist with the US Department of Transportation, spoke on the phone with the doctor, but she said he also made no mention of monoclonal antibodies.

Kidda’s cousin, a nurse, then told her about the treatment, so Kidda called a government hotline for monoclonal antibodies and was given names and numbers for 10 treatment sites near her father’s home.

“Eight of them were like, ‘why are you calling us?’ ” she remembers.

The ninth treatment center said her father would need a referral from his doctor. Kidda called her father’s doctor, but she said he wouldn’t give a referral, and wouldn’t explain why.

The tenth center said it would take the first 50 people who showed up in the morning. Daniell arrived 15 minutes after the center opened and there were already more than 50 people in line.

Her father never did get an antibody treatment. It took him weeks to fully recover from the virus.

“I just don’t understand why it didn’t happen,” Daniell said.

“It was awful,” his daughter added. “It was very frustrating and upsetting that we as taxpayers are paying for this and he was eligible — I don’t know how it could be any clearer than that.”

As cases surged, some hospitals offered few antibody treatments

In the third week of September, when Daniell was battling Covid-19 in Georgia, the virus was raging through the state, with more than 4,000 new cases every day, according to the US Centers for Disease Control and Prevention.

Not all of those people qualified for antibodies. By federal rules, only patients with mild to moderate Covid-19 symptoms who’ve had symptoms for no more than 10 days are eligible. In addition, patients have to be at high risk for getting very sick with Covid-19, which includes people who are over age 65, or people who are 12 or older with certain health conditions.

Those criteria are quite broad, given that one of the medical conditions is being overweight, which includes nearly 75% of Americans over age 20, according to the US Centers for Disease Control and Prevention.

CNN reached out to a number of large, well-resourced medical centers to see what their experience had been.

Emory Healthcare, one of the largest and most prestigious hospital systems in Georgia, administered up to 75 monoclonal antibody treatments per week during the Covid-19 surge in mid-August through late September, according to spokeswoman Janet Christenbury.

“The demand for treatments during this time outweighed our resources to provide additional treatments,” Christenbury told CNN.

Beth Israel Lahey Health, in Massachusetts, administered six antibody treatments a day “at most,” spokeswoman Chloe Meck told CNN last month.

M Health Fairview, one of the largest health care providers in Minnesota, administers 30 doses per week, according to spokeswoman Aimee Jordan.

“Like other systems around the country, we are limited by the number of visits that we can do per day due to the national nursing shortage,” Jordan wrote to CNN.

For the past month, Boston Medical Center has offered the treatment to two patients a day, according to spokeswoman Jenny Eriksen Leary, who noted that the hospital was evaluating whether they can offer more treatments based on space requirements and projected utilization.

United Health Centers, which has 24 health centers in California’s Central Valley, does not offer monoclonal antibody treatments at all, according to spokesman David Phillips.

The American Hospital Association says it isn’t easy to administer monoclonal antibodies.

“There is much more that goes into the treatment than just the infusion or shots themselves,” Demehin, the association official, said, adding that many hospitals are facing severe staffing shortages.

“These treatments also require the right kinds of equipment, including infusion pumps, IV bags, seating areas for patients,” he wrote to CNN in an email. “You also need qualified staff to check patients in, deliver the infusions or shots, monitor for side effects, etc.”

Demehin added that when patients with Covid-19 come in for antibodies, “hospitals have to take extra care to ensure they have spaces that minimize the chance of non-COVID patients being exposed. Those spaces also need appropriate ventilation and the staff working with them need the right [personal protection equipment].”

A priority for hospital leadership

Still, even with these difficulties, some health care systems have managed to deliver antibodies on a large scale.

The Mayo Clinic is doing 30 to 40 procedures per day at its main hospital in Rochester, Minnesota, and was doing 50 per day on some days when Covid-19 cases were surging in late September, said Dr. Raymund Razonable, an infectious disease expert who heads up the hospital’s antibody program.

Mayo faced the same staff shortages and logistical barriers as other hospitals, but decided to make this happen when it saw the suffering of early Covid-19 patients and knew there was no other treatment, Razonable said.

“My leadership saw it the way I see it, and made it possible, activating electronic health systems, activating the nursing pool, and pharmacy group to help make it a successful program, and it’s worked from that day to this day,” he said. “As long as you get the buy-in from leadership, it gets done.”

Another step: educating physicians that monoclonal antibodies even exist.

“Not all physicians knew about this, and so that’s been one of the initial hurdles,” he said.

Razonable said when a Mayo patient tests positive for Covid-19, they are screened to see if they meet the eligibility requirements for monoclonal antibodies, and if they do, the hospital reaches out to them.

“Instead of waiting for patients to ask us, we call them, and they’re infused within two days,” Razonable said.

Ochsner Health in Louisiana also stepped up the challenge, administering 1,304 monoclonal antibody infusions the week of September 8.

“This was a priority for our CEO, for our COO. It came from them,” said Dr. Sandra Kemmerly, an infectious disease specialist and system medical director for hospital quality at Ochsner. “The decision came from the top that this is where we need to put resources so we can treat patients before they get sick and die.”

It doesn’t necessarily take a hospital system to connect patients with the monoclonal antibodies that could prove lifesaving.

In New York, months ago, “a shoemaker, a lawyer, and three housewives” saw the need for antibodies in their community, according to Shoshana Bernstein, a spokeswoman for the group.

In September, the group, called CPI, arranged for several hundred antibody treatments a week, she said.

Bernstein said the group accomplished this by monitoring websites for the US Department of Health and Human Services and for the National Infusion Center Association, to see where the government has delivered monoclonal antibodies. A hotline staff of 12 people, all volunteers, then call the locations — relentlessly — to arrange for patients to get treatment.

“It’s hours and hours of literally nonstop effort,” she said.

Bernstein said she often finds herself on the phone, explaining to physicians the benefits of antibodies and which patients are eligible for them.

“I’m not a medical professional, and here I am telling doctors things they don’t know,” Bernstein said. “And hands down, we have saved lives. I can’t walk down the street anymore without having someone say, ‘You saved my life.’ “

‘This is a solvable problem’

One large hospital system in Boston has made major strides towards providing more antibodies to their eligible patients.

In August, the Mass General Brigham in Massachusetts was administering just 27 monoclonal antibody treatments a week.

Now they’re doing over 150 per week at 11 different sites, according to spokesman Mark Murphy.

“They make sense in the right circumstances, and we need to make them easily available to our patients who could benefit,” said Baden, the Harvard professor and an infectious disease specialist at Brigham and Women’s Hospital.

Baden said some medical systems might have been slow to implement antibodies at first because they weren’t sure how well they worked. But as additional data emerged in real time, he said, the treatment’s effectiveness became clearer.

“As new data emerges, we make better judgements,” he said.

He added that it can be hard for institutions to operationalize a new treatment, even though it involves shots or infusions, both of which are given in hospitals countless times every day.

“It should be easy, but there’s infrastructure, there’s fluid bags and pumps that have to be set at the right rate, and the right tubing, and not every tubing is right for every pump, and you have to have a computer system that allows you to put in the right order and the right label on the right bag,” he said.

“None of this is rocket science, and I’m not raising this to say these are insurmountable,” he added. “These are speed bumps. But this is all solvable. This is a solvable problem.”

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CNN’s Justin Lape, Matina Douzenis and Jen Christinsen contributed to this report.

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