By Marie Rosenthal, MS

The American Medical Association (AMA) and Wisconsin Medical Society (WisMed) filed an amicus brief arguing against ivermectin as a court-ordered intervention for COVID-19 because there are insufficient data to prove its effectiveness against the disease. In a case before the Wisconsin Supreme Court, the medical societies called the intervention “substandard care.”

The amicus brief in the case of Gahl v. Aurora Health warned against the court compelling the use of a ivermectin, which medical consensus says is unsupported by available medical evidence. Both the CDC and FDA have issued advisories against the use of ivermectin for the prevention or treatment of COVID-19, and the National Institutes of Health, World Health Organization and Merck—the manufacturer of ivermectin—said there is insufficient evidence to support the use of ivermectin to treat COVID-19.

Two members of the Infectious Disease Special Edition advisory board, Rajesh T. Gandhi, MD, and Shmuel Shoham, MD, were asked to comment on the issue, because they sit on the treatment guidelines panel for COVID-19 issued by the Infectious Diseases Society of America, although their comments below express their own opinions and not necessarily those of the panel. The guidelines state that the data do not support the use of ivermectin for COVID-19, but make several recommendations for medications with data to support their use, including nirmatrelvir/ritonavir (Paxlovid, Pfizer), remdesivir (Veklury, Gilead), and molnupiravir (Merck/Ridgeback).

“There are now medicines available that have been proven to be effective against COVID-19. It’s time to stop using medicines that have not been found to be effective and to use proven treatments instead,” said Dr. Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and a professor of medicine at Harvard Medical School, in Boston.

Background

Allen Gahl, who has the healthcare power of attorney for his uncle, John Zingsheim, filed a petition in October 2021 to compel Aurora Health to use ivermectin to treat his uncle. Mr. Zingsheim, who was hospitalized and later put on a ventilator for COVID-19, had accepted some of the standard treatments for COVID-19, but had refused others, such as the FDA-approved treatment remdesivir. 

Mr. Gahl reportedly discovered ivermectin online and received a prescription for his uncle by a physician, who had never examined Mr. Zingsheim, and who did not have admitting or courtesy privileges at Aurora Health. The physicians at Aurora refused to honor the prescription because ivermectin is not the standard of care for COVID-19, court documents showed. Aurora argued that there "is no legal authority in Wisconsin that would authorize a court to compel a licensed health care provider to render treatment or to administer a medication that the provider reasonably believes would be below the standard of care in light of the provider's medical education, training and experience." 

Judge Lloyd Carter of Waukesha County Circuit Court, Wisconsin, directed the hospital to give the ivermectin. However, Mr. Gahl had to provide the drug and make sure a physician approved by the hospital administered the ivermectin.

Aurora appealed the order to the state Court of Appeals, which stayed the order, until it reached an opinion. In a 2-1 vote, the court reversed Mr. Carter’s order, and the case was appealed to the state supreme court. (Earlier court documents show that he had been steadily improving in October 2021. Mr. Zingsheim is no longer a patient, according to the Aurora appeal, but no other information is available as to his outcome.) 

“A patient should not be forced to receive care that they don’t want, and a physician should not be forced to provide care that they do not believe is in the best interest of their patient,” Dr. Shoham, a professor of medicine at The Johns Hopkins University, in Baltimore, told Infectious Disease Special Edition

The AMA and WisMed stated in the brief that most of the studies showed that ivermectin was ineffective against COVID-19. “The few dissenting studies that exist have ‘substantially evaporated under close scrutiny’ and even ivermectin’s manufacturer ‘do[es] not believe that the data available support the safety and efficacy of ivermectin for preventing or treating COVID-19. Thus, the consensus view of reasonable medical providers is that, apart from clinical trials, ivermectin should not be administered to treat COVID-19,” they wrote.

To provide patients with competent treatment, the AMA and WisMed urged the court to acknowledge the standard of care for the treatment of COVID-19 does not require physicians to administer ivermectin.

Early in the pandemic, the AMA, American Pharmacists Association and ASHP issued a joint statement that opposed the ordering, prescribing or dispensing of ivermectin for COVID-19, because it is neither approved nor available under an emergency use authorization for COVID-19.

“In addition, we are urging physicians, pharmacists and other prescribers—trusted healthcare professionals in their communities—to warn patients against the use of ivermectin outside of FDA-approved indications and guidance, whether intended for use in humans or animals, as well as purchasing ivermectin from online stores. Veterinary forms of this medication are highly concentrated for large animals and pose a significant toxicity risk for humans.”

Calls to poison control centers due to ivermectin ingestion increased after the pandemic began. A CDC Health Alert Network Advisory recommended against its use, emphasizing the potentially toxic effects of this drug, including nausea, vomiting and diarrhea, overdoses associated with hypotension and neurologic effects, such as confusion, hallucinations, seizures, coma and death.

Mr. Gahl’s attorney, Karen L. Mueller of Amos Center for Justice and Liberty, in Chippewa Falls, Wis., did not reply to requests for comment by the time this story was posted.