Culture & the Family

Government dictates for patient treatment concern doctors

November 2, 2021

Ray Carter

Amidst the COVID-19 pandemic, perceived government interference in patient treatment, combined with perceived pressure from regulatory entities to restrict certain treatments, are reason for concern, according to some Oklahoma doctors.

“The government is trying to overreach their authority,” said Dr. John Sutton, a Woodward doctor whose practice has included service at three nursing homes in Woodward and Dewey counties. “Doctors have been pretty autonomous ever since there was a first doctor. The doctor could think for himself and do what he thought was right for a patient. And I don’t think the government ought to be telling doctors how to practice medicine.”

Throughout the pandemic, doctors have had to operate on the fly and adjust treatment strategies as information became available. In many instances, that approach has involved prescribing medications for off-label use as COVID treatments, meaning the medicines were not originally authorized for treating coronavirus but have shown some promise. Ivermectin and hydroxychloroquine have been some of the most prominent examples, but their use has become bogged down in politics more than science, according to critics who say doctors should not have to fear pushback for prescribing those drugs.

All three nursing homes served by Sutton have experienced COVID-19 outbreaks. The first home experienced an outbreak before vaccines were widely available and before “ivermectin was even in the discussion,” Sutton said.

“I treat them and guess what? They get better. I can’t stand back and do nothing when I know I can help people.” —Dr. David Jayne

That nursing home experienced a 30-percent mortality rate among those who contracted the virus, he said.

By the time an outbreak occurred at the second nursing home, both ivermectin and monoclonal antibodies were known treatments and were provided to residents. Sutton also ordered that all residents be provided ivermectin “whether they had the disease or not.”

Of 56 residents in that home, only one died from COVID.

“The thing that was different from the first nursing home was the monoclonal antibodies and the ivermectin,” Sutton said.

When the third nursing home had an outbreak, a similar course of treatment was pursued. Out of 75 residents, only one died.

“I’m pretty proud of my results,” Sutton said, “because you hear on the news media where nursing homes had a total disaster. Some of them had 80-percent mortality, and a lot of them had 30- to 50-percent mortality.”

Sutton concedes his experience is an “anecdotal thing” and not “a definite study,” but he said the results are hard to ignore.

“I can’t definitely say ivermectin worked,” Sutton said. “It sure seemed, in my little world, seemed to work. And nobody—absolutely nobody—had any side effects from it.”

Other Oklahoma doctors report similar outcomes.

Dr. David Jayne, a board-certified family practitioner in Edmond, said he has prescribed ivermectin for hundreds of patients with COVID and achieved “extremely high results.” Of that total, he said only one patient was hospitalized and “no one on a ventilator, no one’s died.”

Those treated by Jayne have been as old as 93.

As a cardiologist, Dr. Dwayne Schmidt said primary care is far from his focus, but patients “seek me out” because they know he is “open” to prescribing ivermectin for this disease due to the overwhelming supportive data from around the world. In his experience, Schmidt said ivermectin has been “very effective if it’s used in adequate dosages and early in the disease process.”

Despite those on-the-ground results, officials perceive government-and-regulatory hostility to prescribing ivermectin and similar drugs based on politics, not science.

Monoclonal antibody treatments have been approved for COVID-19 treatment, and states including Florida and Texas prioritized use of those treatments in response to COVID-19. But the Biden administration recently announced it would direct nationwide distribution of the treatments in the name of 50-state equity, effectively rationing it. Florida Gov. Ron DeSantis said the Biden administration’s plan resulted in a “huge cut” in monoclonal antibody treatments in his state.

Vaccines Only?

That leaves COVID-19 vaccines as the primary, formally approved method of addressing COVID-19. However, while the vaccines are believed to reduce the severity of illness, they are not a bulletproof shield of protection, particularly among the most vulnerable populations.

According to the Oklahoma Department of Veterans Affairs, 64 patients at the eight veterans centers it operates statewide died while COVID-positive between Jan. 1 and Oct. 15, 2021. Thirty-two individuals died prior to the availability of COVID vaccinations. Of the remaining 32 patients who died while COVID-positive, 23 were fully vaccinated, four had received one dose of a two-shot vaccination, and only five were unvaccinated.

Among the broader state population, breakthrough infections and hospitalizations also continue.

The most recent state Weekly Epidemiology and Surveillance Report showed that as of Oct. 16 there had been 278 fully vaccinated and 79 partially vaccinated individuals hospitalized with COVID in the prior 30 days.

Research also indicates vaccination alone does not negate the virus’ impact.

A study published in the European Journal of Epidemiology reviewed COVID-19 data from 2,947 counties in the United States, based on White House COVID-19 Team data. The study found “no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases” at the county level and “no significant signaling of COVID-19 cases decreasing with higher percentages of population fully vaccinated.”

The study noted that of the five U.S. counties with the highest rates of full vaccination, the U.S. Centers for Disease Control and Prevention (CDC) had nonetheless recently identified four as “high” transmission counties.

“The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re-examined, especially considering the Delta (B.1.617.2) variant and the likelihood of future variants,” the study stated.

Doctors say many patients who contract COVID-19 are being given few options other than to hope they don’t become severely ill.

In recent weeks, Jayne said four patients came to him after having gone to an emergency room due to their COVID-19 symptoms. Those patients were sent home with an inhaler and told to come back if they got worse.

“I treat them and guess what? They get better,” Jayne said. “I can’t stand back and do nothing when I know I can help people.”

Regulatory Threats?

Doctors worry that regulatory boards appear poised to penalize doctors who provide COVID-19 treatments other than vaccination or monoclonal antibodies, potentially due to political pressure.

In a recent letter, the Federation of State Medical Boards said doctors “who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license.” In a joint statement, the American Board of Family Medicine, the American Board of Internal Medicine, and the American Board of Pediatrics declared they “support FSMB’s position.”

While those groups do not specifically declare off-label prescribing of ivermectin to represent “misinformation,” doctors are concerned that message is implied, even though those who prescribe ivermectin are not automatically vaccine critics.

“I’m not an anti-vaxxer, except for in children,” Sutton said. “I don’t think children ought to be vaccinated, but adults, I think they should.”

Jayne feels he has been targeted by the Oklahoma Board of Medical Licensure & Supervision for his willingness to prescribe ivermectin to COVID patients. A recent letter from the board advised him that “in cases where you are prescribing medications for ‘off label’ usage, a detailed informed consent would be advised.”

Jayne said informed consent is common in medical practice, and that off-label prescribing of other drugs has not caused regulators to demand a “detailed” consent process.

“If you look at the approval for amoxicillin, it’s for strep infections,” Jayne said. “But I use it for sinuses, ear infections, dental infections. It’s used off-the-label probably 80 percent of the time. And has that ever been a problem until now?”

Lyle R. Kelsey, executive director of Oklahoma Board of Medical Licensure and Supervision, said the board “has not pressured any physicians on either side of this issue” and has no “stance on off-label drug use” since that practice “has been widely known and utilized for years.”

A recent opinion issued by the attorney general of Nebraska has bolstered the cause of doctors who prescribe drugs for off-label use as COVID treatments.

Asked if prescribing ivermectin or hydroxychloroquine for COVID-19 could subject doctors to the loss of licensure under that state’s laws, Nebraska Attorney General Douglas J. Peterson conducted a review of available medical research and practices and concluded that “the available data does not justify filing disciplinary actions against physicians simply because they prescribe ivermectin or hydroxychloroquine to prevent or treat COVID-19.”

The opinion noted a recent systemic review cited “more than a handful of studies” that indicated ivermectin has antiviral properties “against an increasing number of RNA viruses, including influenza, Zika, HIV” and Dengue. Another review summarized that ivermectin’s antiviral properties have been demonstrated through studies for 50 years. Studies have also found ivermectin has anti-inflammatory capacity, which some believe aids in the fight against COVID-19. And, Peterson’s opinion noted, for “more than three decades, ivermectin has also shown itself to be very safe.”

Peterson noted the nation of Peru deployed mass ivermectin-based COVID-19 treatments from April 2020 to November 2020 and saw excessive deaths decrease 14-fold during that time. The state of Uttar Pradesh in India, which has a population of around 200 million, also implemented large-scale use of ivermectin to combat COVID-19, and the state of Goa in India did the same in May 2021. El Salvadore’s Ministry of Public Health has also included ivermectin as a recommended treatment for early-stage COVID.

“I just cannot understand why in this country we’re so against it when other countries have used it a lot,” Sutton said. “In this country, man, if you use it, you’re almost getting a felony slapped on you.”

Yet, in what critics view as bowing to political pressure, some large pharmacy chains have reportedly stopped filling prescriptions for ivermectin. At the same time, Peterson’s opinion noted that the Association of American Physicians and Surgeons reports physicians are writing about 88,000 ivermectin prescriptions per week.

The combination of increased medical demand due to COVID and artificially reduced supply has apparently caused ivermectin prices to increase.

“It’s been disappointing how inflated the prices have become with ivermectin,” Schmidt said. “It should cost $7 or $8 for a five-day prescription, but it’s $100 to $200.”

Hostility to ivermectin and other off-label drugs as COVID treatments appears driven primarily by politics, not medical science, critics say.

“None of this makes sense from any medical standpoint. None,” Jayne said. “They have thrown out the window everything that I’ve ever learned about ethical medical practice, ethical research, and about taking care of patients.”

Sutton said doctors should be free to prescribe ivermectin to treat COVID until science demonstrates it is not beneficial.

“There’s been all kinds of studies done, but none of them are really good studies,” Sutton said. “Until I see a decent study that says it does not help, then I’m going to keep doing it.”