FDA settles lawsuit over ivermectin content that doctors say harmed their practice | CNN


The US Food and Drug Administration has settled a lawsuit over some of its posts about ivermectin, including what may have been one of its most popular social media campaigns of the pandemic era.

In August 2021, to discourage people from using ivermectin to prevent or treat Covid-19, the The FDA tweeted You are not a horse. You are not a cow. Really. stop it and posted a similar message on Instagram. The tweet got nearly 106,000 likes.

The antiparasitic drug, which is prescribed to treat neglected tropical diseases in humans such as river blindness and scabies, can also be bought over the counter at livestock supply centers to help deworm animals such as horses and cows

Some conservatives Outlets promoted the drug as safe and effective against Covid, even though the FDA and the World Health Organization encouraged people not to use it, saying it was ineffective against Covid and could even be dangerous if someone took too much.

Some media personalities and conservative lawmakers said that information on the effectiveness of ivermectin was being downplayed because of its low price. It was also hailed as a miracle drug Dr. Pierre Kory, pulmonologist and president of the Frontline COVID-19 Critical Care Alliance, who testified at a US Senate committee hearing in December 2020. Even popular podcaster Joe Rogan, who took the drug along with several other medications after testing positive for Covid. , had a lively discussion with CNN’s chief medical correspondent, Dr. Sanjay Gupta, at the time.

In August 2021, the US Centers for Disease Control and Prevention issued a health advisory warning physicians and the public about a rapid increase in ivermectin prescriptions and an increase in reports to poison control centers of serious illnesses caused by the drug. Some people who took higher-than-recommended doses or used the animal formulation developed neurological symptoms, and some were hospitalized, the studies show.

The FDA said in an email to CNN on Wednesday that it has opted to settle that lawsuit rather than continue litigating claims that are between two and nearly four years old.

The agency added that it has not admitted to any wrongdoing or wrongdoing, disagrees with the plaintiffs’ contention that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and maintains its authority to communicate with the public about the products it served. regulates

The FDA has not changed its position that currently available clinical trial data do not show that ivermectin is effective against COVID-19. The agency has not authorized or approved the use of ivermectin to prevent or treat COVID-19.

The lawsuit was filed in June 2022 by Drs. Rober Apter, Mary Talley Bowden and Paul Marik v. FDA, US Department of Health and Human Services and their leaders. He stated that the agencies they were interfering with his ability to practice medicine by overriding his own authority and violating the Administrative Procedure Law.

The suit says the doctors have been pressured, failed to prescribe drugs and threatened or subjected to professional discipline.

Bowden, for example, began recommending ivermectin to treat Covid in early 2020 and, according to the lawsuit, was sneered at by Houston Methodist Hospital and forced to give up his privileges there as a result. Marik was forced to resign from his positions at East Virginia Medical School and Sentara Norfolk General Hospital to promote the use of ivermectin after the FDA’s actions, according to the lawsuit.

The FDA told CNN on Wednesday that the lawsuit challenged its authority to issue a consumer update in March 2021, several tweets and other social media posts from 2021 and 2022 that linked to the article, and two FAQs published in 2020, which the FDA said they had has now been pulled from the agencies’ website. Posts and other materials will be removed and archived in accordance with law.

The FDA initially claimed sovereign immunity, and a lower court judge in Texas dismissed the suit. The doctors appealed the case to the 5th Circuit, which reinstated the lawsuit last year, and its judges heard arguments last month.

Attorneys representing the doctors said in a statement posted on Boyden Gray PLLC’s website that the FDA has agreed to take down its most viral social media campaign of all time and asserted that the FDA’s advice on the use of off-label ivermectin was illegal.

Today’s agreement with the FDA is a major victory for the doctor-patient relationship, Marik said in the statement. It vindicates our position that the FDA exceeded its regulatory authority by attempting to dictate appropriate medical care.

Independent presidential candidate Robert F. Kennedy Jr. posted Wednesday on X, formerly Twitter, that the FDA is biased against many low-cost, generic and/or natural therapies and implied that the FDA is in agreement with the pharmaceutical industry.

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