Experts fear ivermectin lawsuit could undermine US public health

In 2021, a bizarre treatment for COVID-19, the anti-parasite drug ivermectin, began to emerge on social media. The Food and Drug Administration (FDA) is now facing criticism for its efforts to refute claims that the drugs can prevent the deadly virus.

A group of doctors is now suing the FDA, saying they have been personally harmed by the agency’s efforts to refute claims about the drugs’ effectiveness against COVID. Some experts fear the FDA could face punishment for refuting misinformation about the drug, which could weaken the public health message in the US.

After a questionable study surfaced in 2021, which was later retracted, claiming that ivermectin could cure COVID, many Americans began looking into 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 are allowed to prescribe it as needed. Although it is intended to treat parasitic diseases, many doctors, hoping to cash in on the ivermectin trend, began prescribing it off-label for Covid. The drug has never been proven effective against COVID, and several studies examining its efficacy have found it ineffective against the virus.

Some anecdotal reports emerged that people were looking for a veterinary version of the drug used for horses or cows to fight the infection.

An infamous tweet from the FDA responding to these stories is now the center of a current lawsuit.

ivermectinSmith Collection/Gado/Getty Images

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

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

The FDA decided to target that practice through horse messaging and others like it. The message circulated widely in legacy and online media, they write in their suit. Not mentioned in most messages: Ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat coronavirus, some people were using it off-label for that purpose.

The plaintiffs say he prescribed off-label medications to thousands of his patients. He claims that the FDA’s ivermectin message has interfered with his own personal medical practice.

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

Christopher Robertson, JD, Ph.D. And Tina Watson, a legal expert at Boston University, writes in the New England Journal of Medicine that if the case against the FDA is ultimately won, the agency’s ability to protect the public and support evidence-based medicine could be eroded.

He calls the Fifth Circuit’s decision surprising. The judge in the case writes that the FDA does not have the authority to endorse, condemn, or advise on medical decisions, only the power to inform or announce.

The agency regularly releases consumer-directed information; For example, its website instructs consumers about the proper use of antibiotics and also includes relevant clinical information, the Boston experts write. The opinion suggests that the FDA may need to reevaluate each of these communications as an impractical proposal.

The Fifth Circuit is now suggesting that the FDA cannot put its views into this free marketplace of ideas, even if its speech is truthful and may be helpful to the public, they continue. …Meanwhile, junk science has become rampant on social media and is harming public health.

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