FDA, HHS sued by doctors over controversial drug ivermectin

Published: Jun 21, 2022

By Mark Terry

BioSpace

Earlier this month, three physicians filed a lawsuit against the Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra, the U.S. Food and Drug Administration, and FDA Commissioner Robert M. Califf in a Texas court. They allege the FDA acted outside its authority and “illegally interfered with their ability to practice medicine” by discouraging the use of ivermectin to treat COVID-19. The physicians are Dr. Robert L. Apter, M.D., Dr. Mary Talley Bowden, M.D. and Dr. Paul E. Marik, MBBCh, MMed.

Bowden is an ear, nose and throat specialist in the Houston area. Marik is an internist and critical care physician board-certified in the U.S., Britain, Canada and South Africa. Apter is licensed to practice medicine in Arkansas and Washington.

The complaint argues that the FDA approved ivermectin for human use in 1996 for several diseases, but after the beginning of the COVID-19 pandemic, the regulator published documents and social media posts saying the drug was dangerous for use with people. That’s something of an oversimplification, in that there were well-reported cases of people using a veterinary-grade version of the drug to self-treat COVID-19.

Ivermectin is approved by the FDA to treat intestinal strongyloidiasis and onchocerciasis, both caused by parasitic worms. The drug is also approved for veterinary use to prevent heartworm and other parasites, but these are different products and are not safe for people.

Ivermectin does have anti-inflammatory properties but is not generally classified as an anti-viral medication. It has also been approved for use as a topical treatment for head lice. Because of its anti-inflammatory properties and because it was cheap and available, some researchers and physicians around the world began using or testing it to treat COVID-19. Some early studies suggested it was helpful, but others did not, with some even suggesting it made the disease worse.

The drug became a political flashpoint as former President Donald Trump recommended it, as well as malaria drug hydroxychloroquine and other unproven approaches such as light therapy. Ivermectin gained a fervent following by Trump supporters and similar politicians, such as Rep. Marjorie Taylor Green (R-Ga.), who tweeted in December 2020, “Ivermectin, monoclonal antibodies & other treatments are saving lives.”

In the spring of 2021, the FDA launched an ongoing webpage titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” There were four primary points: one, it is not approved for COVID-19 in humans and is not an anti-viral drug; two, taking large doses is dangerous and can cause serious health issues; third, if you have the drug via prescription for an FDA-approved use, get it from a legitimate source and take as prescribed; and four, don’t use drugs intended for animals.

In March 2021, the World Health Organization reported that evidence on ivermectin’s use against COVID-19 was inconclusive and recommended it only be used to treat the disease within clinical trials. A study published in The New England Journal of Medicine in May concluded that “The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), is unclear.” The authors based it on a randomized, control trial of 3,515 patients, 679 who received ivermectin, 679 who received a placebo and 2,157 who received something else. Patients receiving ivermectin did not have a lower incidence of medical admission to a hospital from disease progression.

In a press release, Bowden said, “Since the pandemic began, I have had one mission – help my patients. I provided access to testing when testing was hard to find. I provided treatment when other doctors told my patients to stay home. 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. 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.”

Marik, whose degrees (MBBch, MMed) are from the University of the Witwatersrand, Johannesburg, South Africa, stated, “The FDA’s public statements on ivermectin have been misleading and raised unwarranted concern over a critical drug in preventing and treating COVID-19. The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19. To do this is to ignore both statutory limits on the FDA’s authority and the significant body of scientific evidence from peer-reviewed research, over 80 medical trials, and results from ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.”

The Texas Department of State Health Services had issued poison warnings about the drug. In 2020 the Texas State Board of Pharmacy also tried to prohibit prescriptions for hydroxychloroquine dispensed without a diagnosis, but that only lasted six weeks.

Apter indicates she is being investigated by three state medical boards, “each threatening my medical license based on complaints from pharmacists that I have prescribed ivermectin for COVID-19. In all these cases the patients did very well.”

Bowden has received complaints about her use of ivermectin as well.

Marik has a reputation for being outspoken in a number of areas. In a January 2017 Letter to the Editor at Emergency Medicine News titled, “Dr. Marik’s Views Should Not be Taken Serious,” Dr. Anthony O. Cruz, M.D., a physician with Henry Ford Hospital in Detroit, responded to an article by Marik, saying, “…I was stunned by the overtly contrary perspectives presented in this article…. This is especially true for those who are, like I was, not entirely familiar with the author and his reputation as an outspoken skeptic. This article [“Humans Are Not Yeast”] flies in the face of our current mainstream understanding of pathophysiology with respect to acidosis, lactate physiology, and oxygen utilization dynamics, and delivers harsh criticism of sepsis treatment strategies.”

The lawsuit is being represented by Boyden Gray, an attorney who worked for the Reagan and George H.W. Bush administrations and served as the U.S. Ambassador to the European Union during the George W. Bush administration.