Filed in the US Southern District of Texas in Galveston, the complaint notes that the FDA has approved ivermectin for human use since 1996 for a multitude of diseases. But after the onset of the COVID-19 pandemic, the agency began publishing documents and social media posts to give the impression that the anti-viral drug was dangerous for human consumption.
The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, argue the FDA acted outside of its authority and illegally interfered in their ability to practice medicine by publicly directing health professionals and patients to not use ivermectin.
Bowden, a Houston-area Ear, Nose, and Throat specialist, asserted during a virtual press conference Wednesday that she had kept 3,900 COVID patients out of the hospital by using ivermectin and other medications, but that FDA statements interfered with her work.
“The FDA smear campaign against ivermectin is a daily hurdle I must overcome,” Bowden said. “Still two and a half years into this, this is still a hurdle. Pharmacists won’t dispense it, insurance companies won’t pay for it, and I have patients who want reassurance that it is safe to take. I tell them it’s actually the safest medication I’ve ever prescribed.”
FDA publications and actions cited by plaintiffs include a 2021 social media post with pictures of a horse captioned “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” and a link to an agency article titled, “Why You Should Not Take Ivermectin to Treat or Prevent COVID-19.” According to the plaintiffs, the original article stated the FDA’s official position against using ivermectin without acknowledging that doctors could legally prescribe the drug.
The complaint cites US-code stating the FDA “may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
Marik, an internist and critical care doctor certified by boards in the US, Britain, Canada, and South Africa, told reporters that ivermectin is a highly effective drug for the prevention and treatment of COVID-19 and one of the “safer [drugs] on this planet.”
Saying there were more deaths associated with the use of Tylenol than ivermectin, Marik said the FDA’s “illegal” attempts to block the use of ivermectin could be responsible for between 400,000 and 600,000 COVID deaths. He added that there have been “a thousand more deaths” related to COVID-19 vaccinations over the past year and a half than ivermectin-related deaths over the last 25 years.
The US Centers for Disease Control reports there have been more than one million American deaths involving COVID-19 since the onset of the pandemic.
Early COVID-19 treatments met opposition from other government agencies. The Texas Department of State Health Services has issued poison warnings about ivermectin, and in 2020 the State Board of Pharmacy attempted to prohibit prescriptions for hydroxychloroquine dispensed without a diagnosis but abandoned the rule six weeks later.
Apter, licensed to practice medicine in both Arkansas and Washington, claims to have completed over 6,000 patient consultations for COVID-19 with a patient survival rate of over 99.98 percent, but says that the FDA’s statements have interfered with his ability to exercise professional medical judgment .
“The FDA’s illegal pressing of doctors to not prescribe, and the pharmacists to not fill prescriptions of ivermectin for COVID-19 is a direct cause of the threats to my medical license,” Apter told reporters. “I am 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.”
Apter said in each investigation, the pharmacists cited FDA statements and publications on ivermectin use for COVID-19.
Plaintiffs are asking the federal courts to declare the FDA actions or opinions regarding off-label use of ivermectin unlawful and to enjoin the agencies from further interference.
Bowden too has faced complaints about her use of ivermectin to treat COVID-19 patients. Earlier this year state Sen. Bob Hall (R-Canton) called for reforms to the Texas Medical Board to limit complaints to patients or their families or caregivers, that complaints should consist of only sworn and notarized statements, and that doctors subject to investigation should be given a copy of the complaint.
The plaintiffs in the federal lawsuit are represented by Boyden Grayan attorney who worked for the Reagan and George HW Bush administrations and served as the US Ambassador to the European Union during the George W. Bush administration.
“Sadly, fighting the system has been a much bigger challenge than fighting the disease,” said Bowden. “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.”