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BREAKING - Dr. Mary Talley Bowden Reacts To FDA Settlement On Ivermectin
Agency Capitulates By Removing False Claims On Ivermectin From Social Media And Internet
Dr. Peter McCullough
March 25, 2024

https://petermcculloughmd.substack.com/p/breaking-dr-mary-talley-bowden-reacts

Thursday evening March 21, 2024, in an unprecedented court case, the US FDA led by Commissioner Robert Califf, MD, a previously respected Duke Cardiologist, has settled a court case and taken down all of its false and misleading claims on ivermectin. The drug has been part of community standard of care for the treatment of COVID-19 with an excellent safety profile and signals of benefit in 101 studies.

During 2021, in what has been called “A War on Ivermectin” the US FDA engaged in false and misleading tweets and public messaging to dissuade doctors, pharmacists, and patients from using the drug in The McCullough Protocol and similar multi-drug regimens for acute COVID-19.

Brenda Baletti, Ph.D. reporting for Childrens Health Defense stated: “In their lawsuit, Drs. Bowden, Marik and Apter alleged the FDA acted outside of its authority by directing the public, including health professionals and patients, not to use ivermectin -- even though the drug is fully approved by the FDA for human use.

https://childrenshealthdefense.org/defender/fda-ivermectin-covid-treatment-lawsuit-social-media/

They alleged the FDA was carrying out a “crusade” against ivermectin as a treatment for COVID-19 that “unlawfully interfered” with the doctors’ ability to practice medicine.

The suit, filed in the U.S. District Court for the Southern District of Texas, Galveston Division, also named the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra and Dr. Robert Califf, acting FDA commissioner.

The complaint alleged the FDA cannot ban off-label use of particular drugs or advise whether patients should take approved drugs. Doing so, they said, is intervening in the doctor-patient relationship.

The plaintiffs said their lawsuit wasn’t about whether ivermectin is an effective treatment for COVID-19. It was about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.

U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling the FDA has “sovereign immunity” and granting it protection against most civil lawsuits. Brown also said the plaintiffs had not proven they were directly harmed by any FDA action.

But the 5th U.S. Circuit Court of Appeals in New Orleans overturned the dismissal in September 2023, ruling the agency did exceed its authority under federal law.

According to the ruling, the agency is “not a physician” and “FDA can inform, but has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”

The court’s finding that the FDA exceeded its regulatory authority, Marik said, “is a major win because it’s saying that the FDA can approve drugs, but they can’t interfere with the patient-physician relationship.”

Listen to reaction on this stunning development from lead Texas plaintiff Dr. Mary Talley Bowden who is an authority on management of acute COVID-19, vaccine injury syndromes, and routine illnesses that affect the upper airway and breathing.

On behalf of John Leake and the Courageous Discourse audience, I congratulate Dr. Bowden, her co-plaintiffs Dr. Robert Apter (Emergency Medicine), Dr. Paul Marik (Pulmonary, Critical Care Medicine), and Boyden, Gray & Associates, the Washington, D.C.-based law firm, who fought against fraudulent, public deception by the US FDA.