A group of doctors have filed a lawsuit against the Food and Drug Administration and the Department of Health and Human Services over what they claim is an “unlawful” prohibition on the use of ivermectin to treat COVID-19.
Attorneys for Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik argued in a June 2 court filing that the FDA did not have the authority to direct public health professionals and patients to stop using ivermectin as a COVID-19 treatment. Their lawsuit against HHS Secretary Xavier Becerra and FDA Commissioner Robert M. Califf accuses the government of illegally banning an approved drug from “off-label” use.
“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship,” the complaint states. “Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”
The lawsuit cites numerous examples of what the doctors call “formal, unequivocal, and conclusory actions” by the FDA to “prohibit or otherwise interfere with the use of ivermectin to treat COVID-19.”
Examples include a Dec. 10, 2021, FDA publication titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” which states that the agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.
The FDA also warned that some individuals who have self-medicated with ivermectin to treat COVID needed medical attention, including hospitalization, because they overdosed by taking a version of the drug intended for livestock. The lawsuit also cited a tweet from the FDA that referenced these reports by saying, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
Numerous studies have failed to identify ivermectin, a drug that’s approved for treating parasites, as an effective treatment for COVID-19.
Most recently, a large clinical trial by researchers at Duke University concluded that iveremctin did not reduce the length of COVID-19 symptoms or hospitalizations for patients. With more than 1,500 people with mild or moderate COVID-19 symptoms enrolled in the study, it was the largest randomized trial conducted to date — though it has yet to be peer-reviewed.
While the doctors dispute these findings, the lawsuit emphasizes the court is not being asked to determine whether ivermectin is an effective COVID-19 treatment.
The case “is about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process,” the complaint states.
“I have kept over 3,900 patients out of the hospital, but it hasn’t been easy. Sadly, fighting the system has been a much bigger challenge than fighting the disease,” Dr. Mary Talley Bowden said in a statement. “Despite my excellent track record treating COVID patients, the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome. I am fighting back – the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.”
“If doctors are freed to treat patients according to their best judgment and unprejudiced evaluation of the medical literature, many thousands more deaths and serious disabilities will be averted,” added Dr. Robert Apter.