Ivermectin Lawsuit Could Harm US Public Health, Experts Fear

In 2021, a strange cure for COVID-19 started appearing on social media, the anti-parasite drug ivermectin. The Food and Drug Administration (FDA) is now under fire for its efforts to disprove claims that drugs can prevent the deadly virus.

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

After a questionable study that was eventually retracted that said ivermectin could cure COVID appeared in 2021, many Americans began to look for it. It has become especially popular among people in communities skeptical of vaccines for COVID-19 and other pandemic measures such as masking and social distancing.

Ivermectin is an FDA-approved drug, meaning doctors are allowed to prescribe it as they see fit. Although it was meant to treat parasitic diseases, many doctors hoping to cash in on the ivermectin craze began prescribing it off-label for COVID. The drug has never been proven effective against COVID, and many studies investigating its effectiveness have found it to be ineffective against the virus.

Some anecdotal reports have emerged of people seeking veterinary versions of the drug, for horses or cattle, to use to fight infections.

A popular Tweet today from the FDA responding to these stories is now at the center of the current lawsuit.

IvermectinSmith Collection/Gado/Getty Images

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

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

The FDA decided to target that practice through the horse message and others like it. The messaging has traveled widely across legacy and online media, they write in their suit. Left unmentioned in most of the messaging: ivermectin also has a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people use it off-label for that purpose.

The plaintiffs say they prescribed the drug off-label to thousands of their patients. They say the FDA’s ivermectin messaging has interfered with their own individual medical practice.

The FDA moved to dismiss the lawsuit, which was granted by a District Court in Texas. However, the Fifth Circuit revived the case after an appeal. This means the FDA could face punishment for its statements on ivermectin, and reduce the agency’s independence when discussing public health topics.

Christopher Robertson, JD, Ph.D. and Tina Watson, legal experts from Boston University, wrote in the New England Journal of Medicine that If the case against the FDA ultimately prevails, the agencies’ ability to protect the public and support evidence-based medicine will can be damaged.

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

The agency regularly releases information directed at the consumer; for example, its website educates consumers about the appropriate use of antibiotics and includes relevant clinical information, the Boston experts wrote. The opinion suggests that FDA may need to reevaluate each of these communications as an impractical proposition.

The Fifth Circuit now suggests that the FDA cannot inject its views into the free market of ideas, even if its speech is factual and may help the public, they continue. …Meanwhile, junk science proliferates on social media and harms public health.

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