Ivermectin lawsuit could undermine US public health, experts fear

In 2021, a strange cure for COVID-19, the parasiticide ivermectin, began to appear on social media. The Food and Drug Administration (FDA) is now under fire for its efforts to debunk claims that the drugs could stop the deadly virus.

A group of doctors is now suing the FDA, saying the agency’s efforts to debunk claims about the drugs’ effectiveness against COVID caused them personal harm. Some experts fear that the FDA’s penalty for retracting false information about the drug could undermine public health communication in America.

After a questionable, later retracted, study came out in 2021 that suggested ivermectin could cure COVID, many Americans began looking for it. It became especially popular among people in communities who were skeptical of COVID-19 vaccines and other pandemic measures such as masking and social distancing.

Ivermectin is an FDA-approved drug, which means doctors can prescribe it as they see fit. Although it is intended to treat parasitic diseases, many doctors, hoping to cash in on the ivermectin craze, began prescribing it in an unusual way as a COVID drug. The drug has never been shown to be effective against COVID, and several studies examining its effectiveness have found it ineffective against the virus.

There were some anecdotal reports of people seeking veterinary versions of the drug that were intended for use in horses or cows to fight infections.

The now infamous FDA tweet responding to these stories is now at the center of this lawsuit.

IvermectinSmith Collection/Gado/Getty Images

You are not a horse. You are not a cow. Seriously, y’all. Stop it, FDA wrote on a platform now known as X.

Three doctors are the plaintiffs in the lawsuit, which was first filed in September. Robert Apter, MD, an Arizona physician; Paul Marik, MD, a physician at Eastern Virginia Medical School; and Mary Talley Bowden, MD, a Texas physician who made national headlines when Houston Methodist Hospital suspended her for spreading false information about the vaccine.

The FDA decided to target this practice through horse messaging and others like it. Messages traveled widely through traditional and online media, they write in their suits. Left unmentioned in most posts: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for this purpose.

The plaintiffs say they have prescribed the drugs to thousands of their patients. They claim that the FDA’s ivermectin messages interfered with their own medical practice.

The FDA moved to dismiss the lawsuit, which was upheld by a Texas district court. However, the Fifth Circuit revived the case on appeal. This means that the FDA could face punishment for its statements about ivermectin​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ and reduce the freedoms of the agencies to discuss public health issues.

Christopher Robertson, JD, Ph.D. and Tina Watson, legal experts at Boston University, write in the New England Journal of Medicine that if the lawsuit against the FDA ultimately wins, the agency’s ability to protect the public and support evidence-based medicine could be undermined.

They describe the Fifth Circuit’s decision as puzzling. The judges in the case write that the FDA does not have the authority to approve, adjudicate or advise on medical decisions, only the power to report or report.

The agency routinely publishes consumer information; For example, its website instructs consumers on the appropriate use of antibiotics and includes related clinical information, the Boston experts write. The statement suggests that the FDA may need to reevaluate each of these data as an impractical proposition.

The Fifth Circuit now suggests that the FDA cannot insert its views into this free market of ideas, even if its speech is true and could be useful to the public, they continue. …Meanwhile, junk science is spreading on social media and harming public health.

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