A group of doctors has engaged in a lawsuit against the FDA and the Department of Health and Human Services over what they declare is an “illegal” restriction on making use of ivermectin to deal with COVID-19.
Lawyers 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 experts and clients to stop utilizing ivermectin as a COVID-19 treatment. Their claim versus HHS Secretary Xavier Becerra and FDA Commissioner Robert M. Califf implicates the federal government of unlawfully prohibiting an authorized drug from “off-label” usage.
“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 suit notes many examples of what the medical professionals call “formal, unequivocal, and conclusory actions” by the FDA to “prohibit or otherwise interfere with the use of ivermectin to treat COVID-19.”
Examples consist of a Dec. 10, 2021, FDA publication titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” which mentions that the company has actually not licensed or authorized ivermectin for usage in dealing with or avoiding COVID-19.
The FDA likewise cautioned that some people who have actually self-medicated with ivermectin to deal with COVID required medical attention, consisting of hospitalization since they overdosed by taking a variation of the drug meant for animals. The suit likewise mentioned 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.”
Many research studies have actually failed to recognize ivermectin, a drug that’s authorized for dealing with parasites, as a reliable treatment for COVID-19.
Most recently, a large clinical trial by scientists at Duke University concluded that ivermectin did not lower the length of COVID-19 signs or hospitalizations for clients. With more than 1,500 individuals with moderate or moderate COVID-19 signs registered in the research study, it was the biggest randomized trial carried out to date– though it has yet to be peer-reviewed.
While the medical professionals contest these findings, the claim highlights the court is not being asked to figure out whether ivermectin is a reliable 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.