Local doctor disappointed with FDA ban on COVID treatments, says patients have seen ‘miraculous’ results

AMMON — A local doctor believes the Food and Drug Administration’s choice to revoke its emergency authorization for COVID-19 antibody drugs from Regeneron and Eli Lilly was the wrong move.

The FDA’s announcement last week said both antibody drugs can no longer be used because they don’t work against the Omicron variant, which currently accounts for more than 99% of U.S. infections. But Dr. Brian Jones, owner of Jones Family Medicine in Ammon and a hospitalist at Eastern Idaho Regional Medical Center, said in the last several weeks, his clinic has been using REGEN-COV and Bamlanivimab/Etesevimab, and he’s seen patients “miraculously get better with it.”

He explained that of the roughly 550 people he’s given infusions to since his clinic started offering it in Aug. 2021, only one person has been admitted to the hospital. In the beginning, the patients were mostly unvaccinated, but Monday night, the vast majority of the 18 patients who received transfusions were vaccinated.

“Today (Tuesday) was the hardest day because I had elderly patients call and they’re in tears saying, ‘Can I get the treatment?’ and I have to tell them, ‘No, it’s no longer approved,'” Jones told EastIdahoNews.com. “I have 100 sitting in my fridge. … Knowing that I have a treatment and that I took an oath to do no harm and then to have to tell them I can’t give it to them, that’s the hardest thing.”

Start of the pandemic

Jones has a friend who is a medical professional who went to help COVID patients in New York in March 2020. This was during the time when Jones said 80% of people on ventilators were dying and bodies were stacked in the morgue. His friend would tell him what trends he was seeing in ill patients, such as blood clots, and Jones would take that information and talk to his team at EIRMC, so they could come up with a standard of care.

“At first, we were trying to scramble to look at the labs and what do these mean,” he said. “We were trying to figure out how to predict who would die, who would need a vent and who wouldn’t need a vent.”

It got to the point where so many people were dying — at EIRMC alone, he said from September to December 2020, 30 to 40 patients died each month due to COVID — that another friend of his who owns a hospice company reached out and asked if the two of them could start a hospice general inpatient program. This is for patients who are dying and are too sick to go home. They’re given comfort care with things such as morphine for pain and medicine for anxiety.

Jones recalls caring for a mother in the Intensive Care Unit who had been on and off the ventilator but her lungs were damaged from fighting the infection, and she was told she needed to be intubated again. The patient said no and requested hospice care.

“She sang a lullaby to her daughter on the iPad (because no visitors were allowed) one last time and it was at that moment, I was like, ‘Holy cow. We need to figure out something,'” Jones explained.

As research emerged about REGEN-COV, Jones said it was “pretty positive.” His friend who traveled to New York started using monoclonals at his clinic in Nevada and because of the success he was having, he told Jones he needed to start using them too.

REGEN-COV and Bamlanivimab/Etesevimab proves successful

Jones began reaching out to pharmacies but at the time, he said nobody knew how to get the drug. Jones eventually got his hands on REGEN-COV and with the help of another nurse, they began administering the infusions at his clinic in August.

“These are high risk patients,” Jones said about who’s received infusions. “These are patients with cancer, who are pregnant, who are immunosuppressed from RA or lupus treatments, who are cardiac or renal transplant patients. These are patients that probably would’ve died had COVID had a good chance out of them. These are life-saving drugs.”

He added, “It was night and day. Patients were better in 24 to 36 hours. Finally, I said, ‘We could probably get out of this pandemic. This is going to help save lives.'”

Jones said the data shows REGEN-COV reduced people’s chance of death and hospitalization by 70% and it helped people get better quickly because it stopped the virus from entering into a person’s cells and replicating.

Juan Pena, one of Jones’ local patients, said he benefited twice from the drugs that have since been banned. He had COVID for the first time in November 2020 and it was a “horrible experience.” Along with the common symptoms such as loss of taste and smell, he developed fatigue, achy joints and pains, minor suicidal thoughts/depression and Multisystem Inflammatory Syndrome (MIS-A), which is a condition where problems can occur in different parts of the body like the heart, gastrointestinal tract, skin, or brain.

“I told my wife if I get COVID this bad again … I want to die,” Pena remembers saying. “At this point in time, I was death prepping myself. It sounds bad, but this is what you do. You make sure your life insurance policy is up to date, your house and everything is covered financially so if you pass on, your wife and kids can live comfortably without you.”

Pena continued to deal with the effects of COVID for months. He decided to get vaccinated in August and thought it would be a “cure-all” to the pain he’d been feeling, but quickly realized it wasn’t. His neurological problems intensified and the aches and pains were persistent.

By happenstance, Pena met Jones’ wife, who introduced him to her husband. Jones said given his prior experience with COVID-19 and lasting deficits, combined with his prolonged exposure, Pena qualified for the monoclonal antibody treatment. On Nov. 14, 2021, Pena received the REGEN-COV infusion at Jones Family Medicine. Within 24 hours of the infusion, his aches and pains were gone, he no longer had brain fog and he felt better all around.

“All the things I suffered with for the past year – I’m seeing things different. I’m feeling different. I’m progressing. There’s a light at the end of the tunnel,” Pena explained. “That’s what the infusion of Regeneron did for me.”

Pena got COVID again this month and had another infusion from Jones Family Medicine, this time of Bamlanivimab/Etesevimab. He was never told what variant he had — although it’s likely it was the rapidly spreading Omicron — but 24 hours after the infusion, Jones said he had “absolutely no symptoms of COVID.”

“To allow the local or federal government to say we show that this (REGEN-COV and Bamlanivimab/Etesevimab) doesn’t work, I’m a testimonial (that it does),” Pena stated.

Supply shortage

Back in 2021, not long after Jones received his monoclonal antibodies from the state, Gov. Brad Little announced monoclonal clinics would open in Idaho. Jones said that’s when the federal government started to “sure up the supply.” When he went to order the infusions off the state website, the website didn’t work anymore and there was no federal website set up to order the monoclonals.

A system to regulate the monoclonal antibody requests was eventually put together, and Jones received 150 of the state’s 842 vials from the federal government the first time he ordered from them.

“I had patients come from California, one from South Carolina, probably 25 from Utah, several from Jackson Hole, Wyoming and from Island Park. People would get in the car and drive (for this treatment),” he said. “What happened is in California, Arizona, Utah, all these states started drying up. They did not have the treatment.”

The problem is that monoclonals take a long time to make in the lab and that’s why they’re having a hard time meeting demand, according to Jones.

Two weeks ago, his clinic received six doses of Sotrovimab, which is the only monoclonal the FDA says works against Omicron. In one evening, Jones said five of their six vials were already being given to heart and renal transplant patients.

FDA’s announcement

While Jones said he understands what the data says and why the government is saying Sotrovimab should be the only monoclonal antibody used with Omicron, he still believes REGEN-COV and Bamlanivimab/Etesevimab are effective.

“I think they’re trying to do their best to follow the data but I have patients who swear they are a billion times better after getting this infusion,” Jones stated.

He believes hospital numbers will increase as a result of only being allowed to use one monoclonal antibody drug as a treatment for Omicron.

“I’m hopeful that Omicron gets enough people sick to where we start to have herd immunity and there are less carriers around,” Jones said. “The problem is variants are the wild card. While we often think of variants as getting weaker, they sometimes can get stronger or more deadly.”

Jones feels like people are “burned out” by “how many waves we’ve gone through,” but he wants the community to know there are people who care and are fighting to find a cure and a way to treat this.

“The hard part is doing that within a system that sometimes restricts you or limits your ability to treat, but what I’d say is keep on living,” Jones said. “At some point, you have to continue on despite so many people having life-long changes and consequences from this virus.”