The lawsuit explicitly concerns the use of ivermectin

Jessica Hofer Wilkinson
For Clark County Today

Three physicians, including an emergency medicine doctor licensed in the state of Washington, have filed a lawsuit against the Federal Drug Administration (FDA) for attempting to interfere with their treatment of COVID-19 patients, explicitly concerning the use of ivermectin.

According to the complaint, “refusing to allow patients to receive effective early treatment for COVID-19 has led to innumerable hospitalizations and deaths, and caused extreme distress for patients, their families, and health professionals.”

In a press release on June 2, Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, three physicians with outstanding credentials and track records for treating patients with COVID-19, claim “the FDA acted outside its authority and illegally interfered with their ability to practice medicine by directing the public, including health professionals and patients, to not use Ivermectin” to treat COVID-19.

Ivermectin, a multipurpose drug discovered in the late 1970s and fully approved for human use decades ago, was awarded a Nobel Prize in 2015. It has been used by healthcare providers across the globe to treat COVID-19 patients throughout the pandemic.

Such treatment has seen jaw-dropping success.

And yet, despite its historical, worldwide popularity as a multi-faceted drug and its low side effect profile, the use of ivermectin for the treatment of COVID-19 was vehemently condemned by U.S. public health agencies and officials, namely the FDA, in a message echoed repeatedly by the media, for the past two years.

For example, on March 5, 2021, the FDA published an article on their website entitled, “Why You Should Not Take Ivermectin to Treat or Prevent COVID-19.” However, the lawsuit highlights that nowhere did the FDA “acknowledge that doctors can lawfully prescribe Ivermectin for that use.” The agency also did not acknowledge its lack of legal authority to limit off-label use of a drug already approved for human use. Only Congress may grant the organization such power, which it has not.

Similarly, in an Ivermectin Frequently Asked Questions (FAQ) article posted on their website, the FDA answers, “Should I take Ivermectin to prevent or treat Covid-19?” with a clear, “No.”

The most well-known message from the FDA regarding COVID-19 and the use of ivermectin is likely the agency’s tweet on August 21, 2021, which reached a massive audience of 14.5 million people. “You are not a horse. You are not a cow. Seriously, ya’ll. Stop it.” The tweet linked to the March 5th article on why people should not take Ivermectin for COVID-19. News networks shared the tweet across the country, with CNN and NPR chief among them.

America’s most popular podcaster, Joe Rogan, received relentless criticism by news networks for telling fans he took ivermectin as one of many treatments for overcoming COVID-19. So he confronted CNN’s senior medical correspondent, Sanjay Gupta, about CNN’s mischaracterization of Rogan’s Ivermectin use and the network’s manipulation of the facts. In a lengthy interview with Rogan, Gupta admitted, “[CNN] shouldn’t have said that.” In his defense of the reporting, Gupta cited the FDA’s tweet, which referred to the drug as a dewormer for animals. 

The FDA kept this impactful messaging style going as recently as April 26, 2022, when they tweeted, “Hold your horses, ya’ll. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.” 

The general public, which may or may not understand drug indications and appropriate dosing, was not the only intended audience of the FDA’s guidelines. The agency sent warning letters to the Federation of State Medical Boards and the National Association of Boards of Pharmacy and referenced their March 5, 2021 article about why people should not take Ivermectin to prevent or treat COVID-19. 

All three plaintiffs in the suit against the FDA allege the agency’s widespread and public attack on ivermectin caused them to be “pressured, unable to prescribe medication, and threatened with or subjected to professional discipline.” 

Pharmacists refused to fill their prescriptions for critically ill patients and denied it when early treatment was paramount. Hospital employers forced resignations. And, medical licenses were suspended. 

Plaintiff Dr. Robert L. Apter is licensed to practice medicine in Washington and Arizona and has over 40 years of experience in emergency medicine. He is a certified Diplomate of the American Board of Emergency Medicine and a Fellow of the American College of Emergency Physicians. Dr. Apter prescribed Ivermectin for many of the 6,000 patients he consulted for COVID-19. He reported a 99.98 percent patient survival rate. Dr. Apter was “referred to the Washington Medical Commission and Arizona Medical Board for disciplinary proceedings for prescribing Ivermectin to treat Covid-19.” 

Both bodies cited the FDA’s publications in their charges. 

“If doctors are freed to treat patients according to their best judgment and unprejudiced evaluation of the medical literature, many thousands more deaths, and serious disabilities will be averted,” said Dr. Apter. “Pronouncements from the FDA against the use of Ivermectin have been the basis for disciplinary actions against doctors, interfere with the doctor-patient relationship, and have had a severe chilling effect on the use of life-saving medication for a deadly disease.” 

“This case is about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process,” the complaint reads. “If the FDA is not limited to its statutory lane, its unlawful actions will no doubt persist and repeat themselves.” 

A distinguished critical care specialist, Dr. Pierre Kory, who testified to the effectiveness of ivermectin before Congress in the Spring of 2020, said, “We have pharmacists across the land who are refusing, refusing to fill these [prescriptions] because they’ve been manipulated and brainwashed into thinking that the FDA hasn’t approved the use, as if that matters. Off-label prescriptions and prescribing have been going on for decades. It’s encouraged when there are no effective treatments.” 

Dr. Mary Talley Bowden is licensed to practice medicine in Texas, the location for the court filing. She attests that she has treated more than 3,900 patients for COVID-19 with a success rate of over 99.97 percent. “The only patient who did not recover was already in the late stages of the disease and needed ventilator support before seeing Dr. Bowden,” her declaration reads. She was forced to resign her privileges at Houston Methodist Hospital for treating COVID-19 patients with Ivermectin. 

Arguably the most credentialed plaintiff in the suit, Dr. Paul E. Marik, a critical care specialist with over 40 years of experience, was forced to resign from two positions due to his treatment of patients for COVID-19. 

Dr. Marik holds several fellowships with colleges of physicians and is certified by multiple medical boards in numerous countries, with over 750 publications. He has been cited more than 40,000 times, according to the complaint, and identified in the top 0.01 percent of scholars on sepsis, which is a frequent result of COVID-19. He was a tenured professor at Eastern Virginia Medical School (EVMS) and Director of the ICU at Sentara Norfolk General Hospital until 2021. 

According to the suit, “Dr. Marik was directed by EVMS to remove [his protocol for treating COVID-19] from its servers and not speak publicly about Ivermectin following the FDA’s August 21, 2021 tweet deriding the drug as animal medication and directing against its use to treat COVID-19.” 

To say the FDA’s campaign against ivermectin had a significant impact on these physicians or treatment of COVID-19 patients by many physicians across the country would be a gross understatement. 

Dr. Marik claims the FDA misrepresented and ignored a “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.” 

Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik are ready to face the FDA’s leaders in court and demand answers for their influence over and interference in patient care. If the plaintiffs are correct, the cost of the FDA’s condemnation of Ivermectin is inconceivable.

Jessica Hofer Wilkinson is a freelance writer, home educator and mother of four and nursing home chaplain. She resides in Clark County.