In June, three doctors filed a lawsuit against the Food and Drug Administration (FDA) for interfering with using ivermectin to treat COVID-19. All three were disciplined for prescribing human-grade ivermectin to treat patients. The attorney for the physicians, Boyden Gray, asserted the FDA’s actions regarding ivermectin went against well-established law and practice regarding the off-label use of FDA-approved drugs.
When the suit was filed, Gray told the Epoch Times, “Congress recognized the importance of letting doctors be doctors and expressly prohibited the FDA from interfering with the practice of medicine.” He continued, “That is exactly what the FDA has done repeatedly throughout this pandemic, assuming authority it doesn’t have and trying to insert itself in the medical decisions of Americans everywhere.”
In a hearing on November 1, the FDA’s lawyers argued, “The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
That’s some pretty innovative hair-splitting. It is almost as if the FDA doesn’t know that in a medical system full of attorneys, statements like this would not chill the use of a drug:
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
The attached article even says, “The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.” The sentence implies to those who do not know better that the FDA must approve a medication for a specific use.
The language the agency used matters, though. A 20% bonus was provided if hospitals used “drugs of biologicals approved by the Food and Drug Administration (FDA) for COVID-19 .” Coupled with the bribe for hospital administrators, the FDA not “approving” ivermectin and other repurposed drugs for use effectively prohibited them.
However, if the FDA wants to play this game, someone should ask if it has “approved” the use of gonadotropin-releasing hormone (GnRH) agonists in young adults in cases of gender dysphoria. To be clear, the agency has not. Some of the reported side effects that bear investigation with these drugs are infertility, lifelong sexual dysfunction, and cardiac issues. Yet a search of the FDA’s Twitter profile does not contain a tweet saying, “You aren’t a dude, and no medication is going to change that.”
Nor does the agency seem bothered by the fact that Pfizermectin, also called Paxlovid, interacts with dozens of commonly used prescription and non-prescription medications. Precautions must be taken with medicines as divergent as hormonal contraceptives, cardiac medications, and cancer drugs when Paxlovid is prescribed. The FDA also does not seem bothered that patients who take it seem to suffer from “rebound” cases of Covid. Yet, this medication is approved by the FDA to be used in the outpatient treatment of COVID-19. So is remdesivir, which was never demonstrated to improve mortality rates. It only showed the ability to shorten hospital stays.
Perhaps most infuriating, the FDA does not seem bothered by the idea that people may have died in cases where the drug was withheld. Some doctors treated people infected with COVID-19 on an outpatient basis using combinations of medications that included ivermectin. These physicians, like Dr. Harvey Risch and Dr. Pierre Kory, estimate that 50% or more of the patients who died of Covid could have recovered if the outpatient protocols were used after they were developed. That equates to hundreds of thousands of people in the United States.
Other doctors were using these medications with inpatients. One is renowned critical care physician Dr. Paul Marik. According to his biography, Dr. Marik has written over 500 peer-reviewed journal articles and 80 book chapters and authored four critical care books. He is the world’s second most published critical care physician and has been cited over 43,000 times in peer-reviewed publications.
When Covid hit, Dr. Marik did what we all thought doctors were supposed to do. He sought to relieve his patients’ suffering and death by treating their symptoms with repurposed medications indicated by research and his practical experience. He found success treating patients in the ICU with the MATH+ protocol. The protocol included ivermectin along with steroids for inflammation and other existing medications. According to Dr. Marick, his mortality rate was half that of his colleagues.
Then a memo came from the hospital administration. It prohibited the use of the medications on the protocol Marik was using, including vitamin C. The only drug available for use was remdesivir because it was “approved” by the FDA, so it also carried a financial incentive. You can listen to Dr. Marik’s voice crack as he recounts being forced to helplessly watch his seven patients die and the subsequent removal of his hospital privileges.
Dr. Marik is one of the plaintiffs in the lawsuit against the FDA. His career and the lives of his patients are a direct cost of the FDA’s so-called “recommendations.” The agency cannot be allowed to whitewash its role in preventing doctors from practicing medicine through political and financial pressure or be held harmless for the lives its actions caused.