COVID-19 and the War Against Saving Lives
On March 26, 2020, approximately 15 days into an alleged emergency and life-threatening pandemic, Colorado’s Department of Regulatory Affairs (“DORA”), which oversees the Division of Professions and Occupations, issued draft guidance (see https://content.govdelivery.com/accounts/CODORA/bulletins/2833740) which threatened any doctor, pharmacist, and nurse (“Health Care Providers” or “HCP’s”) who prescribed Hydroxychloroquine and/or other off-label drugs for the treatment of COVID-19. DORA essentially likened the prescribing of off-label drugs for the treatment of COVID-19 to unprofessional conduct, when it stated:
Please note that the Colorado State Board of Pharmacy, the Colorado Medical Board and the Colorado Nursing Board have the authority to discipline their corresponding licensees who fail to meet their corresponding generally accepted standards of practice.
Due to the suspect nature of DORA’s position, I submitted a Colorado Open Records Act request (“CORA”) to DORA. I requested all information which DORA relied upon to issue the above Statement. Notably, DORA’s response to the CORA request revealed that the Statement was made without any direct evidence that: (1) off-label drugs such as Hydroxychloroquine were not appropriate for treating COVID-19; (2) various off-label drugs were being over prescribed and stock piled by Colorado citizens; and (3) compound pharmacies could not assist with any alleged drug shortages. Yet, notwithstanding DORA’s egregious stance, various Colorado HCP’s chose to disregard DORA’s threats and began to research the off-label use of various licensed drugs. What they found was shocking. Since 2002, scientific research had shown that Chloroquine (a close relative of Hydroxychloroquine) had a strong antiviral effect on the SARS-CoV-1 virus (SARS-CoV-1 originated in China in 2002). Given that Chloroquine had demonstrated to be highly effective against a 78% identical coronavirus less than 15 years ago, it is very curious that DORA immediately threatened to discipline HCP’s for prescribing Chloroquine and Hydroxychloroquine, not to mention other licensed drugs.
The FDA and Off Label Prescribing
The U.S. Food and Drug Administration (“FDA”) is the federal regulatory agency responsible for approving most human and animal food, all human drugs, biologics, animal products, and animal drugs; it also regulates cosmetics and other consumer products that emit radiation. See https://www.fda.gov/regulatory-information/laws-enforced-fda. The Food, Drug and Cosmetic Act (“FDCA”) was enacted in 1938 and authorizes the FDA to regulate drug and medical devices for safety and effectiveness, and issue food standards. Id. It is important to note that the FDCA gives the FDA authority to regulate drugs but not the practice of medicine. Explicit provisions in subsequent FDCA amendments, the FDA Modernization Act of 1997 and the FDA Amendments Act of 2007, prohibit the FDA from limiting the practice of medicine.
The state of Colorado has no prohibition against off-label prescribing by HCP’s with prescriptive authority. In its simplest terms, “off-label” use means any use of a drug that is not FDA-approved. See https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding- unapproved-use-approved-drugs-label. This is a bit of a misnomer, however, because the FDA does not approve uses of drugs. Instead, the FDA approves products and determines labeling for their intended uses. Thus, off label use is simply any use by HCP’s which deviates from the use or patient conditions described on the label. Off-label use is not prohibited by the FDA or the FDCA, and as previously noted, FDCA amendments explicitly prohibit the FDA from regulating physicians and the practice of medicine. Per the FDA, once a drug is FDA-approved, HCP’s may prescribe it “for an unapproved use when they judge that it is medically appropriate for their patient.” See https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding- unapproved-use-approved-drugs-label. It is for the professional judgment of a licensed physician – and not a pharmacist or the FDA – to determine that an off-label prescription is appropriate treatment for a patient. People v. Medina, 705 P.2d 961, 968 (Colo. 1985) (citing Davis v. Hubbard, 506 F.Supp. 915, 930 & 932 (N.D.Ohio 1980)) (The rules of informed consent are built on the principle “that only the patient has the right to weigh the risks attending the particular treatment and decide for himself what course of action is best suited for him.”).
The FDA takes the position in formally issued guidance that “[g]ood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment.” See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and- investigational-use- marketed-drugs-biologics-and-medical-devices. However, the FDA’s actions during COVID-19 set the stage for state licensure boards to target HCP’s who used off-label drugs to save lives.
On December 8, 2020, Senate Homeland Security and Governmental Affairs Committee Chair Sen. Ron Johnson held a hearing in Washington, D.C. to discuss prevention and treatment of COVID-19. Numerous witnesses praised the use of both Hydroxychloroquine and Ivermectin, as well as other off-label drugs for the prevention and treatment of COVID-19. Within days of Sen. Johnson’s hearing, Google analytics showed that Ivermectin internet searches rose dramatically. However, at the same time that Ivermectin was trending on the internet, censorship of Ivermectin began to occur. United States congressmen and women were censored on Twitter for praising Ivermectin. Governors began to censure state legislators who praised the use of Ivermectin. Social media outlets such as Facebook, Instagram, Youtube, and Twitter censored anyone who spoke about using drugs such as Ivermectin, Hydroxychloroquine and Chloroquine to successfully treat COVID-19. In August of 2021, the FDA began to publicly disparage Ivermectin. The FDA falsely labeled Ivermectin as a drug solely used by veterinarians for livestock. See https://twitter.com/US_FDA/status/1429050070243192839?lang=en (“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”).
I have represented numerous HCP’s who were targeted by Colorado’s licensure boards solely for prescribing Hydroxychloroquine and Ivermectin for the prevention and/or treatment of COVID-19. One of my clients saved over 3,000 lives. Yet, the Colorado Medical Board has relentlessly pursued the client’s license for over 2 years now. These HCP’s are spending 10’s of thousands of dollars in legal fees to fight for their licensure. Yet, when the Colorado Medical Board was asked to define COVID-19, the Board defined COVID-19 as an “upper respiratory infection and/or viral syndrome.” Guess what else falls under this definition? The common cold, the flu and hundreds of other syndromes. It has never been proven that SARS-CoV-2 causes COVID-19. Based upon the Colorado Medical Board’s inability to define COVID-19 as anything “novel,” it is clear that the Board continues to target HCP’s who refuse to practice “government medicine.”
Colorado licensure boards have statutory authority to investigate a licensee, irrespective of whether a patient has filed a complaint against the licensee. This creates a perfect storm. Licensees who refuse to be spoon fed the government agenda are targeted and censored. The licensure boards have weaponized critical thinking, the doctor/patient relationship, and informed consent. Can you imagine a world where there was no second opinion? Where a doctor in the confines of his exam room, could no longer speak freely to a patient?
Why would DORA threaten HCP’s who were frantically searching for treatments to save lives in an alleged novel pandemic? The answer lies in Section 564 of the Food, Drug and Cosmetic Act (“FDCA”) or 21 U.S.C. 360bbb-3. When circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an Emergency Use Authorization (“EUA”) to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives. Ultimately, the BIG picture is, that If there had been a successful treatment(s) for COVID-19, the COVID-19 vaccinations could not have been approved for EUA.
The war waged against Hydroxychloroquine and Ivermectin was unprecedented. Due to the actions of the federal government, state governments, and licensure boards thousands of lives were needlessly lost. Through the work of attorneys, whistleblowers, and the family members of victims the public will know the truth. Ivermectin, Chloroquine, Hydroxychloroquine and other licensed drugs were highly effective at preventing and treating COVID-19.
It is time. Humanity must unite. We will collectively hold the responsible parties accountable for the murder of our brothers and sisters.