WASHINGTON, D.C. – A federal lawsuit has been filed against the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) by a group of doctors who allege the agencies have been attempting to block the use of the now controversial drug, Ivermectin, as a treatment against COVID-19.
The lawsuit was filed in the U.S. Southern District of Texas in Galveston, and purports that the FDA – which had approved the anti-parasitic drug for human use in 1996 as a treatment for several different diseases, including infections caused by roundworms, threadworms, and other parasites – has been publishing documents and social media posts alleging that treating COVID-19 with Ivermectin was dangerous.
The plaintiffs – Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter – are insisting that the FDA has acted beyond the scope of their authority and that the agency had broken the law by interfering with their ability to treat their patients by spreading “misinformation” in an attempt to dissuade the medical community and the public from using Ivermectin to treat COVID.
The doctors behind the lawsuit are being represented by high-profile attorney Boyden Gray, who previously served as the U.S. Ambassador to the European Union during the administration of President George W. Bush.
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Bowden, an Ear, Nose, and Throat doctor who has a practice in Houston, Texas, claimed at a press conference on Wednesday that her use of Ivermectin had prevented approximately 3,900 of her patients suffering with COVID infections from having to be hospitalized.
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.”Dr. Mary Talley Bowden
The lawsuit references U.S. code that states that 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.”
Internist and critical care doctor Marik, who also spoke at the press conference, called the drug one of the “safest on this planet” and claimed that as many as 400,000 to 600,000 people may have died due to the FDA’s efforts to block the use of Ivermectin during the pandemic.
Many mainstream health professionals and organizations – including the FDA – have argued that Ivermectin is not an effective method of treating COVID-19 since the drug does not possess any anti-viral properties and can be harmful if taken improperly or in large enough doses.
However, Apter – who practices medicine in Arkansas and Washington – insisted at Wednesday’s press conference that he has come under investigation by state medical boards for prescribing Ivermectin to his patients, all of whom he claimed “did very well” while taking the drug.
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.”Dr. Paul Marik
According to Governmental Guidance, an emergency use authorization (EUA) – the procedural tool the FDA used to expedite the availability of COVID vaccines can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh potential risks. An EUA also only lasts as long as a public health emergency for which it was declared.