From the outset of the Covid-19 pandemic, members of the armed forces rightfully expected their commanders to ensure their best health options—to adapt to changing conditions and implement optimum treatment plans to assure force readiness. However, the Department of Defense failed to accept that natural immunity provided the best military option and were wholly silent on any therapeutic or preventative treatment plans with the exception of mandatory, universal vaccination of all military personnel. The department, along with their civilian counterparts at FDA, NIH, and CDC, used randomized control trials (RCT) as a cudgel to quell all competing options.
Rather than serving as an impartial tool to advance the understanding of treatment modalities in the battle against Covid 19, RCTs have been used by the FDA and CDC to suppress the ability of doctors to best care for their patients. To the lay public and the less astute in the medical community, RCTs are sacrosanct and their findings beyond reproach. But according to Dr. Harvey Risch, a world renown epidemiologist and Professor Emeritus at Yale, they are easily corrupted and do not yield useful information unless the trials enroll sufficient numbers of patients to identify statistically significant outliers, and the trials are designed to evenly match the placebo and treatment arms.
The FDA’s long history of insisting that time consuming, multiple, and large-scale RCTs be concluded before terminal cancer patients were allowed to access promising, investigational cancer treatments, prompted Congress to pass the 21st Century Cures Act in 2016. Section 3022 of the law mandates that agencies reviewing Emergency Use Authorization (EUA) requests must take into account all available treatments, and RCTs are not a necessary condition for approval.
In 2020 the Henry Ford Hospital conducted studies early in the Covid crisis that showed substantial reductions of hospitalization and death, if hydroxychloroquine was administered during the initial stages of hospitalization. The two petitions for an EUA were denied by the FDA, which demanded multiple, large-scale RCTs showing efficacy before approval. Dr. Risch stated in a September 2022 interview on Viva Frei that this rejection violated the 2016 law that was specifically intended for patients seeking all reasonable therapeutic options during emergency conditions.
Ivermectin similarly was denied EUA status for off-label treatment of Covid-19 despite numerous supportive clinical studies and its contribution to the public health triumph in Uttar Pradesh. Dr. Pierre Kory discussed the global disinformation campaign to discredit the drug in a series presented on his Substack site. One only need enter "Uttar Pradesh-Ivermectin" into a search engine to be inundated with articles disputing all beneficial aspects of Ivermectin in the treatment of Covid-19.
Members of the military were denied all EUA out-patient treatment options as a result of the impossibly high and probably illegal standards set by the FDA. Conversely, in-patient treatments with expensive, patented drugs like Remdesivir, Paxlovid, and Molupiravir were granted rapid EUA despite low patient volume trials showing subtle clinical benefit.
Until a recent Harvard-John Hopkins study that demonstrated an adverse risk-to-benefit profile for Covid vaccinations for college students (an age identical to most personnel entering the military), no studies have been conducted by any major U.S. health agency or academic institution assessing the risks and benefits of the vaccine. For two and half years the agencies tasked with protecting and advising Americans have been silent on the subject.
In an article last week that is symbolic of academic institutions covering their tracts, The New England Journal of Medicine, which has aggressively and unapologetically supported mask and vaccine mandates, made the following statement:
"We believe the decisions that have been made during this later stage of the pandemic — after the introduction of highly effective vaccines, and when the trade-off between the efficacy and the perceived harms of masking in public spaces was more nuanced — warrant reexamination by public health institutions."
If the medical landscape was so “nuanced,” how can this justify abridging a patient’s right to informed consent, shutting down businesses for arbitrary reasons of public health, promoting the intellectual and emotional stagnation of children with mask mandates, or over emphasizing the benefits and ignoring the risks of the mRNA vaccine used to treat rapidly mutating Omicron variants?
These “highly effective” vaccines fail in their primary purpose to protect against acquisition and transmission of disease. The so-called effectiveness relates to the CDC’s new definition of a vaccine that omits protection and relies on the ability of a vaccine to provoke an immune response.
Health agencies consistently downplay the adverse effects of the mRNA vaccine. VAERS and DMED reports are brushed away as exaggerations, and adverse events are treated like the cost of doing business or simply collateral damage. CDC Director Walensky’s conflicting reply to Senator Ron Johnson's inquiry underscores the agency’s unwillingness or inability to objectively examine the risks of vaccinating the general public and healthy military-aged personnel.
Young males are at particular risk for vaccine induced myocarditis, and as Dr. Risch points out:
“Myocarditis is not mild. The "mild" asymptomatic form damages the myofibrils of the heart and has long term adverse effects on cardiac health. Reports of the incidence of myocarditis, which combines symptomatic and non- symptomatic cases in males in the 18-35 age range, are estimated from 1/4000 to 1/400."
Are mandatory, annual bivalent Covid boosters in store for members of the armed forces? The pharmaceutical companies are maneuvering to have the annual Covid booster automatically treated like the influenza vaccine—no need for extensive trials, just a carte blanche authority to match the annual vaccine with the most current variant and distribute to the general population.
What could go wrong? It’s just collateral damage.