Kansas Senate panel may lower scrutiny of doctors approving off-label use of drugs for COVID-19

TOPEKA — The Kansas Senate’s health committee plans to launch two days of hearings Tuesday on legislation exempting physicians from disciplinary action by licensing boards for unintended consequences of prescribing FDA-approved drugs ivermectin and hydroxychloroquine for off-label use against COVID-19.

The issue has been championed by Sen. Mark Steffen, a Hutchinson-area physician and Republican member of the Senate Public Health and Welfare Committee. Legislation designed to shield doctors from adverse exposure in terms of alternative COVID-19 treatments has been supported by Kansans for Health Freedom, an organization raising concerns about vaccinations deployed during the coronavirus pandemic.

“We need a huge showing at the Capitol for the hearing,” Kansans for Health Freedom said in an advisory to its supporters. “A group of doctors will be giving oral testimony, but we need our legislators at the Capitol to see that Kansans will not take this any longer. Doctors need to be allowed to freely treat their patients. We know that early COVID treatment works and doctors need to be allowed to treat without fear of action by licensing boards.”

On Monday, physicians at the University of Kansas Health System said intrusion of politicians into the work of doctors caring for COVID-19 patients was misguided and dangerous.

“This is politics, unfortunately, and not health care,” said Steve Stites, chief medical officer of the KU Health System. “It’s really bizarre to me that politicians … want to move into the area of medicine.”

He said the United States would have made better progress on controlling COVID-19 if effort put into the politics of the pandemic had been expended on the effort to control the virus.

The Kansas Department of Health and Environment reported Monday nearly 15,000 more cases of coronavirus infection as well as 71 additional hospitalizations and 17 more fatalities tied to the pandemic. The weekend uptick brought the state’s totals to 695,675 cases, 17,938 hospitalizations and 7,336 deaths.

State Rep. John Eplee, a Republican primary-care physician from Atchison, said in an interview there was no need for passage of a new provision in state law allowing doctors to prescribe drugs for off-label use. Doctors already have authority to do that within limits, but could be held accountable for negative outcomes of their actions.

Eplee said he wasn’t aware of any action by the Kansas Board of Healing Arts against a physician writing off-label prescriptions during the pandemic. He said he’d signed prescriptions for low-volume “placebo” amounts of ivermectin and hydroxychloroquine to patients who insisted on gaining access to those drugs.

He also said the two drugs highlighted by Steffen and others weren’t advocated by most physicians for prevention or treatment of COVID-19. Other medications authorized in the past two months by the U.S. Food and Drug administration could be “game-changers” and likely to erode public demand for ivermectin and hydroxychloroquine, he said.

The FDA hasn’t authorized ivermectin, typically used to treat or prevent parasites in animals, for human use against COVID-19. Ivermectin has not been shown to be safe or effective for these indications, the FDA said, but the agency advised patients who receive a prescription for the drug in relation to COVID-19 to precisely follow the doctor’s instructions.

Hydroxychloroquine is FDA-approved to treat malaria and autoimmune conditions, but the FDA affirmed in mid-January the drug had not been shown to be safe and effective for treating or preventing COVID-19.

In December, the FDA endorsed use of the antiviral medications paxlovid and molnupiravor for treatment of mild-to-moderate COVID-19. The FDA moved last week to expand use of the antiviral drug remdesivir to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the developments “bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant.”

Steffen, who has introduced a resolution objecting to vaccination of children against COVID-19, said it was a mistake to inhibit deployment of hydroxychloroquine. The drug was described by President Donald Trump as a “miracle” response to COVID-19. U.S. Sen. Roger Marshall, a Kansas physician from Great Bend, said he took the drug to avoid COVID-19.

In addition, Steffen said ivermectin was capable of reducing hospitalizations and deaths to the virus. He said Americans had been “starved for early outpatient treatments” due to opposition by federal and state health officials.

Dana Hawkinson, medical director of infection prevention for University of Kansas Health System, said much of the political debate about COVID-19 was driven by politicians opposed to masking recommendations and other guidance aimed at protecting the public.

“It is short-sighted myopia,” he said. “It’s dangerous.”

He said most research reports touting ivermectin had been withdrawn due to falsification or misrepresentation of data. Research not tainted by bias, he said, indicated ivermectin had “no benefit.”

Meanwhile, Hawkinson and Stites said they were troubled by Missouri Attorney General Eric Schmitt’s decision to file lawsuits against dozens of school districts to block enforcement of mask mandates. Schmitt asserted there was no data to support claims that face coverings were effective against COVID-19.

“It’s far past time that the power to make health decisions concerning children be pried from the hands of bureaucrats and put back into the hands of parents and families, and I will take school district after school district to court to achieve that goal,” Schmitt said in a statement.

“The idea that masks don’t work is just so troublesome,” Stites said. “People want to mangle the data for their own political gain.”

Hawkinson said the issue could be that some political figures struggled to accurately evaluate health research that contained caveats within findings.

“I’m not sure there are many attorneys general in the United States that are epidemiologists or physicians or trained Phds,” he said.