An Open Letter to the FDA on Ivermectin and COVID-19 Treatments | James Lyons-Weiler, PhD, The Institute for Pure and Applied Knowledge |

Re: Letter to The Federation of State Medical Boards | James Lyons-Weiler | Dec 31, 2021

Shannon Glueck, PharmDA

Acting Branch Chief

Branch 4

Division of Compounding II

Office of Compounding Quality and Compliance

Office of Compliance

Center for Drug Evaluation and Research

cc: United States Senate Committee on Health, Education, Labor and Pensions and Dr. Chaudhry.

The purpose of this letter is to inform you that both the medical community and the general public understand that your letter dated 12/13/2021 to the Federation of State Medical Boards is both misleading and dangerous, as it will lead to a continuation of harmful medical practices and the denial of early, aggressive treatments that have been shown to reduce morbidity and mortality associated with disease that results from the infection by the SARS-CoV-2 virus.

The public finds your letter to be misguided and spurious, to the point of nearly appearing erratic.

Your counterfactual letter claims that your position is based on a concern that

“Using ivermectin products in preventing or treating COVID-19 may pose risks to patient health or lead to delays in getting effective treatment of COVID-19”

and yet the standard of care for patients who test positive for the SARS-CoV-2 virus is to tell patients to go home and wait until they are sick enough to require emergency medical care. This, of course, causes patients to become incubators of the SARS-CoV-2 virus and the source of new variants.

Your letter poses ivermectin in a position of competition with other treatments; in fact, no available treatments are in competition with ivermectin, and each has their own risks and weak support; persons who receive monoclonal antibodies may experience worsening COVID-19 if provided too late, and Remdesivir only shows marginal reduction in absolute risk of hospitalization and no change in length of hospital stay. Patients being given Remdesivir and their families are not provided with a list of side effects as required under US and State laws governing informed consent, including that once hospitalized with severe COVID-19, no alternative treatment options other than Remdesivir, oxygen and mechanical ventilation will be considered by the attending medical staff other than palliative care.

It is worth pausing to reflect that there were no studies supporting the safety and efficacy of mechanical ventilation in COVID-19 before it was adopted by hospitals across the United States, and the fact that the allopathic medical community continues to treat severe COVID-19 primarily as pneumonia rather than an immunologic vascular disease show a lack of leadership by FDA, NIH and CDC. Others have stepped in to fill the leadership gap. These experts should be consulted at the earliest possible date, and include Dr. Pierre Kory, Dr. Peter McCollough, Dr. Paul Marek, and Dr. Harvey Risch, among others.

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