Judge's ivermectin ruling dismisses science and jeopardizes public health

By Thomas M. File, Jr., MD and Joel A. Kammeyer, MD, MPH

A Butler County judge ignored scientific evidence and proven patient care when he ordered West Chester Hospital to treat a seriously ill COVID-19 patient with the livestock deworming drug ivermectin. This drug, which has been proven safe and effective for treating head lice and other parasitic infections in humans, has come under intense scrutiny as it is being promoted among some as the latest COVID-19 miracle treatment. It isn't. Ivermectin is scientifically unproven as a treatment or as a preventative measure for COVID-19.

As members of the Infectious Diseases Society of Ohio, which represents infectious diseases physicians on the front lines of Ohio's pandemic response, we've seen far too much pain in communities across our state during the last year and half. We are working around the clock to prevent additional suffering and loss of life and ensure everyone we treat gets the best care, supporting the best possible outcome. That is why it is absolutely essential to the health of Ohio and the nation that all COVID-19 therapies be adequately studied and that data supporting their use be evaluated in a factual, transparent manner.

The U.S. Food and Drug Administration (FDA) is the gold standard for evidence-based pharmaceutical research. It is FDA's rigorous processes that ensure treatments are safe and effective, inform physicians and clinicians on their optimal use and build the public's trust. Though they have authorized nine treatments for COVID-19 to date because they were found to be safe and effective, FDA and the Centers for Disease Control and Prevention (CDC) have repeatedly warned against using ivermectin to treat COVID-19. The data isn't there to support its use. Large doses have caused severe illness and even death in humans.

We also are members of theInfectious Diseases Society of America, a community of over 12,000 physicians, scientists, and public health experts regularly develops clinical practice guidelines that are grounded in a systematic review of the available evidence. This thorough review is intended to provide practitioners with evidence-based recommendations to help both practitioners and patients make informed decisions about care. IDSA's treatment guidelines panel, which includes infectious diseases experts from institutions around the world, including the Cleveland Clinic, Case Western Reserve University, and Vanderbilt University drew the same conclusion as the FDA and CDC on ivermectin. The evidence to support safety and efficacy is very low for both hospitalized patients and outpatients. Furthermore, well-designed, adequately powered, and well-executed clinical trials are sorely needed to learn more.

Everyone wants this pandemic to end, no more so than people impacted by COVID-19 and the front-line physicians and clinicians working desperately to save lives. Efforts to influence the practice of medicine through lawsuits, including this tragic Ohio court decision, could expose patients to serious harm and undermine the evaluation of COVID-19 treatments. When our legal system interferes with people's care and safety, patients lose.

Dr. File is Chair, Infectious Disease Division and Co-Director, Antimicrobial Stewardship Program at Summa Health in Akron, Ohio. He is also the Immediate Past President of the Infectious Diseases Society of America.

Dr. Kammeyer is Associate Division Director, Division of Infectious Diseases, University of Toledo College of Medicine. He is also President-Elect of the Infectious Diseases Society of Ohio.

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