Though the FDA has approved ivermectin to treat certain infections, the department has urged the public not to use the drug to treat COVID-19. Neither HHS nor the FDA immediately responded requests for comment for this story.
“Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is—and always has been—reserved to states,” the lawsuit said. “The FDA breached this critical boundary between federal and state authority by directing the public, including health professionals and patients, not to use ivermectin to treat COVID-19, even though the drug remains fully approved for human use.”
The filing emphasizes that the case is not about the efficacy of ivermectin in treating COVID-19: rather, it said, “it’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.”
“Since the pandemic began, I have had one mission – help my patients,” Bowden said following the filing. “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.”
Bowden was “derided by Houston Methodist Hospital and forced to resign her privileges there as a result” of her ivermectin recommendations for treating COVID-19, the lawsuit said, stating that Bowden treated over 3,900 patients for COVID-19 “with a success rate over 99.97%.”
“Sadly, fighting the system has been a much bigger challenge than fighting the disease,” she continued. “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.”
The lawsuit cites a slew of FDA warnings not to use ivermectin, including an August 2021 tweet saying, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
You are not a horse. You are not a cow. Seriously, y’all. Stop it. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) August 21, 2021
“This is not the first pandemic our country has faced, nor will it be the last,” the lawsuit said. “And COVID-19 isn’t going away. If the FDA is not limited to its statutory lane, its unlawful actions will no doubt persist and repeat themselves.”
“Moreover,” the filing continues, “if the FDA is allowed to interfere with the practice of medicine now under cover of a pandemic, this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”
Dr. Apter, who is licensed to practice medicine in Arizona and Washington and is a certified Diplomate of the American Board of Emergency Medicine according to the doctor’s law firm, argued in a statement following the filing that “many thousands more deaths and serious disabilities will be averted” if doctors are freed to “treat patients according to their best judgment and unprejudiced evaluation of the medical literature.”
“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,” he added.
According to the lawsuit, Apter was referred to the Washington Medical Commission and Arizona Medical Board for disciplinary proceedings after he prescribed ivermectin to treat COVID-19.
“The referrals include copies of the FDA’s publications directing against the use of ivermectin to treat COVID-19,” the lawsuit said. “He explains that state regulatory boards rely heavily on pronouncements from the FDA.”
Apter had completed over 6,000 coronavirus patient consultations through MyFreeDoctor.com with a patient survival rate of more than 99.98%, according to the filing, which notes that “he has frequently prescribed ivermectin to these patients, finding the treatment effective.”
The filing describes how Dr. Marik, a highly distinguished critical care specialist who has practiced for decades, developed a protocol for Eastern Virginia Medical School for treating COVIVD-19 called the EVMS COVID-19 Management Protocol. After “Marik and others observed that the drug was effective to treat COVID-19”, they added it to the EVMS COVID-19 Management Protocol.
But EVMS directed Marik to remove the protocol from servers and refrain from speaking 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,” the lawsuit claimed.
“The FDA’s actions harmed Dr. Marik’s ability to practice medicine,” the filing continued. “He was forced to resign from his positions at EVMS and Sentara Norfolk General Hospital for promoting the use of ivermectin—as well as other safe, cheap, and effective off-label FDA- approved drugs—to treat COVID-19 following the F DA’s attempts to stop use of those drugs for that purpose.”
Marik said that the FDA’s public statements on the drug have been “misleading” and have raised “unwarranted concern.”
“The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19,” he said. “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 60 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.”