Postural Orthostatic Tachycardia Syndrome (POTS)

By Peter A. McCullough, MD, MPH

One of the most common symptomatic complaints after COVID-19, vaccination, and now in most persons who have both exposures is POTS (postural orthostatic tachycardia syndrome). This is a disorder where there is a lack of synchronization between the heart, brain, spinal cord sympathetic chain of ganglia, adrenal gland, and the blood vessels both arterial and venous. The Spike protein on SARS-CoV-2 and flooding the system after vaccination damages neurological tissue, the adrenal glands, and the heart. The end result can be inappropriately elevated heart rate and either low or high blood pressure causing dizziness. I have seen cases of syncope with facial trauma as a result of this bothersome condition. Kwan et al has shown (n=284,592) that the risk for POTS is substantial, just after heart damage as the highest risk cardiovascular side effect of COVID-19 vaccination.

Most of the care for POTS is supportive (lower leg compression stockings, increased salt and fluid intake, exercise). I have found in severe cases with adequate blood pressure that the use of nadolol can control the tachycardia and help while the patient has cardiovascular-neurological reflexes return to normal over a period of months. Since most children and adults in the US have recovered from COVID-19, there is no reason to take additional vaccines and risk POTS, myocarditis, or both.

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Kwan, A.C., Ebinger, J.E., Wei, J. et al. Apparent risks of postural orthostatic tachycardia syndrome diagnoses after COVID-19 vaccination and SARS-Cov-2 Infection. Nat Cardiovasc Res (2022). https://doi.org/10.1038/s44161-022-00177-8

Steroids: Too Little Too Late in COVID-19 Respiratory Illness

By Peter A. McCullough, MD, MPH

To this day, the Infectious Disease Society of America and the National Institutes of Health Guidelines do not advise prehospital use of corticosteroids in COVID-19 illness. Conversely oral and or nebulized steroids have been a part of the FLCCC and McCullough protocols since 2020. Justification for early steroids sadly comes from an autopsy study of fatal cases by Kato et al who evaluated 61 cases from the NIH, Cornell, and University of North Carolina Chapel Hill.

Kato T, Asakura T, Edwards CE, Dang H, Mikami Y, Okuda K, Chen G, Sun L, Gilmore RC, Hawkins P, De la Cruz G, Cooley MR, Bailey AB, Hewitt SM, Chertow DS, Borczuk AC, Salvatore S, Martinez FJ, Thorne LB, Askin FB, Ehre C, Randell SH, O’Neal WK, Baric RS, Boucher RC. Prevalence and Mechanisms of Mucus Accumulation in COVID-19 Lung Disease. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1336-1352. doi: 10.1164/rccm.202111-2606OC. PMID: 35816430.n…

The bottom line is that after 20 days, SARS-CoV-2 is gone from the trachea and the big problem is mucus plugging and congestion. Within the small blood vessels of the lungs, blood clots are forming. Kato showed the only factor associated with reduced mucus in these fatal cases was dexamethasone most commonly used at 6 mg a day in the IDSA and NIH protocols. For reference, dexamethasone is routinely administered for brain swelling at 10 mg intravenously every 4-6 hours. In respiratory inflammation (asthma, allergic pneumonitis), the most commonly administered steroid is intravenous solumedrol 60-125 mg every 6 to 12 hours. In the McCullough protocol, I did not hesitate to initially recommend oral prednisone 60 mg a day and later come into the practice of using 20 mg every 12 hours with a 5-10 day taper. It is interesting to note none of these deceased patients received the FLCCC or McCullough protocols prior to admission. If they did, they wouldn’t be on the autopsy table.

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Kato T, Asakura T, Edwards CE, Dang H, Mikami Y, Okuda K, Chen G, Sun L, Gilmore RC, Hawkins P, De la Cruz G, Cooley MR, Bailey AB, Hewitt SM, Chertow DS, Borczuk AC, Salvatore S, Martinez FJ, Thorne LB, Askin FB, Ehre C, Randell SH, O’Neal WK, Baric RS, Boucher RC. Prevalence and Mechanisms of Mucus Accumulation in COVID-19 Lung Disease. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1336-1352. doi: 10.1164/rccm.202111-2606OC. PMID: 35816430.

Conservative Risk Benefit Analyses Decide Against COVID-19 Vaccination

By Peter A. McCullough, MD, MPH

To this day some US Colleges are mandating COVID-19 vaccination with the bivalent boosters for Omicron BA4/BA5 which are now obsolete since the predominant strains are BQ1 and BQ1.1. To make matters worse, the bivalent boosters failed to stop Omicron in animal studies despite having an antibody rise—thus showing antibodies are invalid surrogates of vaccine efficacy. Parents and students are becoming increasingly leery of additional COVID-19 vaccination based on the results of Bardosh et al.

Bardosh K, Krug A, Jamrozik E, et al

COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities

Journal of Medical Ethics Published Online First: 05 December 2022. doi: 10.1136/jme-2022-108449

This group found the risks of COVID-19 vaccination including serious adverse events (life threatening, hospitalization, and death) and myocarditis far outweigh any theoretical benefits. If Bardosh would have considered the two prospective cohort studies by Mansanguan and Le Pessec, the myocarditis rates would have been sharply adjusted up to 25,000 cases per million. Additionally, since no prospective randomized placebo controlled trial has demonstrated reductions in COVID-19 hospitalization and death as a primary or secondary endpoint, that theoretic benefit of vaccination could have been dropped to zero. Most of the colleges and universities mandating COVID-19 vaccination have platitudes in their mission statement like that of Yale University: “Yale is committed to improving the world today and for future generations through outstanding research and scholarship, education, preservation, and practice.” This leaves the world wondering about the ineptitude of Yale leadership on the application of scholarship to their policies. Next time you are in a discussion about college mandates, please feel free to share this Substack.

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Bardosh K, Krug A, Jamrozik E, et alCOVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities. Journal of Medical Ethics Published Online First: 05 December 2022. doi: 10.1136/jme-2022-108449

Every Bit of Heart Muscle Matters Pfizer and Moderna Start Cardiac Studies–Two Years Too Late

Pathological Syncytia Formation with mRNA Vaccines

By Peter A. McCullough, MD, MPH

One of the curious findings from the original randomized trials of mRNA vaccines was an explosive rate of early infection after the first injection as compared with placebo. In a recent paper from Sfera et al, the description of pathological syncytia or fusion between immune cells is described: “The LNP technology, to put it simply, mimics viral envelopes with externalized phosphatidylserine (ePS), a universal “eat me” signal, that directs immune cells to engulf the particle.

Sfera A, Thomas KG, Sfera DO, Anton JJ, Andronescu CV, et al. (2022) Do Messenger RNA Vaccines Induce Pathological Syncytia?. Int J Pathol Clin Res 8:137. doi.org/10.23937/2469-5807/1510137

However, as ePS is also a potential “fuse me” signal, LNP may inadvertently facilitate the formation of pathological syncytia. Moreover, ePS may activate a disintegrin and metalloprotease 10 and 17 (ADAM10) (ADAM 17), master regulators of syncytia formation, contributing further to the unintended consequence of cell-cell fusion…As mRNA vaccines are based on pre-fusion epitopes, the fusion pathology may be undeterred, allowing viral infection by syncytia formation to continue unabated. This is significant, as it could account for the reoccurrence of COVID-19 symptoms in fully vaccinated individuals.” The authors point out that SARS-CoV-2 utilizes more than just the ACE2 receptor to gain entry into the fused cells and by overlooking this possibility, vaccine developers have made a blunder. This is further complicated by the choice of lipid nanoparticles and polyethylene glycol which facilitate entry into organs were syncytia as well as Spike protein will incite inflammation and immune system regulation. Sfera also considers pregnancy: “Several studies demonstrated that SARS-CoV-2 can activate HERV-W, an ancestral gene that encodes for the physiological placental fusogen syncytin-1 responsible for the merger of trophoblasts during the early pregnancy. This suggests that the reproductive post-vaccine events may be triggered by the furin cleavage site pathology.” Such processes could occur in the gravid uterus and compound the bleeding and clotting risks of ill-advised vaccination is this special population. In summary Sfera et al point out the following blind spots of well-funded DARPA consultants, BARDA funded academic researchers, and later by Pfizer and Moderna in mRNA vaccine development: 1) pathologic syncytia formation, 2) use of lipid nanoparticles with PEG, 3) failure to consider SARS-CoV-2 could use alternative points of cell entry other than ACE2 (metalloprotease pathway, antibody dependent enhancement, cell penetrating peptides, viroporins). With billions of people rushed into indiscriminate mRNA vaccination, virologists and immunologists will be picking up the pieces of a failed vaccine campaign that has left so many at risk for more SARS-CoV-2 infections and progressive complications over the months and years to come.

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Sfera A, Thomas KG, Sfera DO, Anton JJ, Andronescu CV, et al. (2022) Do Messenger RNA Vaccines Induce Pathological Syncytia?. Int J Pathol Clin Res 8:137. doi.org/10.23937/2469-5807/1510137

Message of Medical Freedom Ringing Out

By Peter A. McCullough, MD, MPH

I have noticed throughout the COVID-19 crisis, there has been a distinct absence of town halls, university public presentations, and health department open briefings on the pandemic. Stonewalling for three years has resulted in pent up anxiety over many aspects of public health particularly mass vaccination. After two years of flooding the zone with “safe and effective” our public health agencies are out of ammunition. Questions are pouring in about heart damage, blood clots, and neurologic syndromes. Many people want to hear confirmation of their suspicions from doctors in positions of medical authority. A rare public event was organized and hosted by Dr. Sally Priester at Centro De Bellas Artes San Sebastian, San Sebastian, Puerto Rico. As I spoke on stage in front of the pensive crowd, most of whom had been vaccinated, I could imagine the concerns they have developed seeing friends and family developing side effects and some some cases losing their lives.

Dr. McCullough on stage at Centro De Bellas Artes San Sebastian, San Sebastian, Puerto Rico, December 10, 2022

I was followed by an impromptu exhortation from Javier Jiménez Pérez, a Puerto Rican politician and the current mayor of San Sebastián, Puerto Rico. Jiménez is affiliated with the New Progressive Party and asserted in Spanish that his city has always promoted freedom of choice and respect for bodily autonomy.

Javier Jiménez Pérez current mayor of San Sebastián, Puerto Rico, December, 10, 2022

It was clear afterword that what Jimenez did not have over the past few years was medical backup from doctors in his town who put patient safety and bioethics above the heavily funded government mission to get “a needle in every arm.”

Dr. McCullough and Javier Jiménez Pérez, San Sebastián, Puerto Rico, December 10, 2022

Most people left that day understanding that if they felt well now after the shot, they are fortunate and under no conditions should they step up to the Russian Roulette wheel for another injection and spinning of fate.

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Membranous Nephropathy after COVID-19 Vaccination

By Peter A. McCullough, MD, MPH

On my last flight I was searching for a seat and a kind woman who appeared to recognize me, smiled at an open seat next to her. I sat down and learned she is married to a prominent government official with whom she was traveling. As we talked she told me her story of taking one of the mRNA COVID-19 vaccines and then developing membranous nephropathy. This is a disorder caused by auto-antibodies directed against the phospholipase A2 receptor on podocytes, which are critical cells in the kidney’s filtration apparatus. Membranous nephropathy like so many side effects is due to the Spike protein and can occur with SARS-CoV-2 infection and with vaccination. Ma and coworkers recently described five cases with the infection and 37 more after COVID-19 vaccination—all with the genetic vaccines except for one with a killed virus vaccine.

Ma Q, Li X, Xu G. New-Onset and Relapsed Membranous Nephropathy post SARS-CoV-2 and COVID-19 Vaccination. Viruses. 2022 Sep 28;14(10):2143. doi: 10.3390/v14102143. PMID: 36298697; PMCID: PMC9611660.

The woman developed significant edema and renal failure requiring escalating treatment including rituximab. More than a year later, she is not out of the woods and may face the need for dialysis in the future. She told me her doctor was honest with her and agreed her condition was caused by the vaccine. While the majority of cases reported by Ma et al had partial recoveries, the prognosis remains uncertain. I was delighted to see this woman sitting with her husband in the gallery of the Kennedy Caucus Room at the recent US Senate Roundtable chaired by Senator Ron Johnson on December 7, 2022. How much more will we learn over time about long-term safety of the COVID-19 vaccines taken by nearly two thirds of the world’s population? The potential enormity of disease and disability in the future is unfathomable.

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Ma Q, Li X, Xu G. New-Onset and Relapsed Membranous Nephropathy post SARS-CoV-2 and COVID-19 Vaccination. Viruses. 2022 Sep 28;14(10):2143. doi: 10.3390/v14102143. PMID: 36298697; PMCID: PMC9611660.

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