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This article was first published on the 26th of September 2022
After the untimely cardiac death of his father, Dr Aseem Malhotra, a consultant cardiologist and an internationally renowned expert in the prevention, diagnosis and management of heart disease, who was one of the first to receive the double Pfizer Covid-19 mRNA vaccine in January 2021, started to thoroughly examine the real world data relating to mRNA vaccines. His examination culminated in a two-part paper titled ‘Curing the pandemic of misinformation on Covid-19 mRNA vaccines through real evidence-based medicine’, the public release of which was embargoed until late last night. The paper reveals glaring holes in the pivotal Pfizer mRNA trials and findings drawn from available pharmacovigilance data (as well as the absence of robust safety data), which led Dr Malhotra to describe the mRNA vaccine roll-out into the entire population as “a reckless gamble, at best”. Endorsed by many leading medical professionals, the paper emphasises that conversations in which the difference between the absolute and relative risk reduction afforded by the Covid-19 mRNA vaccines was explained to patients (a mere 0.84%, as suggested by the Pfizer mRNA trial) simply did not happen, not to mention the “known, unknown and as yet to be fully quantified harms”. Published in the Journal of Insulin Resistance, the paper has led to calls for the suspension of all Covid-19 vaccines. – Nadya Swart
‘Peer-reviewed papers in the Journal of Insulin Resistance present findings leading to calls for the suspension of all Covid-19 vaccines’
In a two-part paper titled “Curing the pandemic of misinformation on Covid-19 mRNA vaccines through real evidence-based medicine”, real world data reveals that in the non-elderly population the number needed to vaccinate to prevent one death from Covid-19 runs into thousands and that re-analysis of randomised controlled trial data suggests a greater risk of suffering a serious adverse event from the vaccine than of being hospitalised with Covid-19.
Speaking about the report, Dr Malhotra said:
- “There has been a rise in out-of-hospital cardiac arrests and heart attacks linked to Pfizer’s Covid-19 mRNA vaccine, with plausible biological mechanisms of harm”
- “Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascular safety”
*See appendix below for reactions from the medical profession
2x Attachments (embedded below):
- ‘Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine’ – Part 1 and Part 2
About Dr Malhotra
Dr Malhotra is a consultant cardiologist, Fellow of the Royal College of Physicians, and President of the Scientific Advisory Committee of The Public Health Collaboration. An internationally renowned expert in the prevention, diagnosis and management of heart disease, he is an honorary council member to the Metabolic Psychiatry Clinic at Stanford University School of Medicine, California.
SUSPEND ALL COVID-19 MRNA VACCINES UNTIL SIDE EFFECTS (INCLUDING ADVERSE CARDIOVASCULAR OUTCOMES) ARE FULLY INVESTIGATED AND RELEASE RAW DATA, SAY LEADING DOCTORS
Doctor who promoted Covid-19 vaccine on TV calls for an immediate suspension to all Covid-19 vaccines to investigate serious side effects.
In new peer reviewed research, eminent consultant cardiologist Dr Aseem Malhotra exposes compelling evidence to suspend the roll out of all Covid-19 mRNA vaccines to investigate side effects and until all the raw data from clinical trials are released for independent scrutiny.
Recent re-analysis of Pfizer and Moderna randomised controlled trial data suggests the risk of suffering serious adverse effects of mRNA vaccines for individuals is significantly higher than the risk of being hospitalised with Covid-19.
There is a rise in out of hospital cardiac arrests and heart attacks linked to Pfizer’s Covid-19 mRNA vaccine, with a plausible biological mechanism of harm.
The son of a leading GP claims the Covid-19 vaccine is a likely contributory factor in his father’s sudden cardiac death. The Journal of Insulin resistance paper gets widespread praise and support by leading doctors that include the President of the International Vascular Society Professor, Sherif Sultan, Jay Bhattacharya, Professor of Medicine at the University of Stanford, Clinical Advisor to the Royal College of General Practitioners Dr Campbell Murdoch and Chair of the West Pennine Local Medical Committee, General Practitioner, Dr Amir Hannan MBE. *see quotes from the medical profession in section below*
Leading doctors have supported calls to suspend all COVID-19 mRNA vaccines until serious side effects are fully investigated and the raw trial data from Pfizer’s covid -19 vaccine trial is released for independent analysis to help determine the true benefits and potential harms for different age groups.
Writing in the peer-reviewed Journal of Insulin Resistance, one of the UK’s most eminent consultant cardiologists, Dr Aseem Malhotra, who was one of the first to take two doses of the vaccine and promote it on ITV’s Good Morning Britain (GMB), says that since the roll out of the vaccine the evidence of its effectiveness and true rates of adverse events have changed.
In a two part research paper entitled “Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine”, real world data reveals that in the non-elderly population the number needed to vaccinate to prevent one death from Covid-19 runs into thousands and that re-analysis of randomised controlled trial data (that first led to approval of the vaccines for BionTech/Pfizer and Moderna) suggests a greater risk of suffering a serious adverse event from the vaccine than of being hospitalised with Covid-19.
Dr Malhotra writes, “Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are sending deeply concerning signals, especially in relation to cardiovascular safety”.
Mirroring a potential signal from the Pfizer Phase 3 clinical trial, a significant rise in cardiac arrest calls to ambulances in England was seen in 2021 (an extra 14,000 compared to 2020) with similar data emerging from Israel in the 16–39-year-old age group where there was a 25% increase in heart attacks or cardiac arrests associated with the BionTech Pfizer vaccine administration but not associated with Covid-19.
Citing the FDA’s own website, Dr Malhotra also highlights that testing positive for antibodies is an unreliable marker for immunity or protection against Covid after vaccination. He writes, “It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally,” and, “Authorities and sections of the medical profession have supported unethical, coercive, and misinformed policies such as vaccine mandates and vaccine passports, undermining the principles of informed consent. These regrettable actions are a symptom of the ‘medical misinformation mess’—the tip of a mortality iceberg where prescribed medications are estimated to be the third most common cause of death globally after heart disease and cancer.”
Underlying causes for this failure include regulatory capture. Guardians that are supposed to protect the public are in fact funded by the very corporations that stand to gain from the sale of those medications. A failure of public health messaging has also resulted in wanton waste of resources and a missed opportunity to help individuals lead healthier lives with relatively simple—and low cost—lifestyle changes.
The unprecedented roll-out of an emergency use authorisation vaccine without access to the raw data, with increasing evidence of significant harms, compounded by mandates that appear to serve no purpose other than to bolster the profits of the drug industry, have highlighted modern medicine’s worst failings on an epic scale, with additional catastrophic harms to trust in public health.
There is a strong scientific, ethical and moral case to be made that the current COVID vaccine administration must stop until all the raw data has been subjected to fully independent scrutiny. Looking to the future, the medical and public health professionals must recognise these failings and eschew the tainted dollar of the medical-industrial complex. It will take a lot of time and effort to rebuild trust in these institutions, but the health of both humanity and the medical profession depend on it.
Dr Malhotra concludes, “We must use this as an opportunity to transform the system to produce better doctors, better decision making, healthier patients and restore trust in medicine and public health. Until all the raw data on the mRNA COVID-19 vaccines have been independently analysed, any claims purporting that they confer a net benefit to humankind cannot be considered to be evidence-based.”
REACTION FROM THE MEDICAL PROFESSION:
Sherif Sultan, Professor of Vascular Surgery and President of the International Vascular Society
“Doctor Aseem Malhotra’s literature review and analysis is a cause for global concern. We fully believe that vaccines are one of the great discoveries in medicine that has improved life expectancy dramatically. However, mRNA genetic vaccines are different, as long-term safety evaluation is lacking, but mandatory to ensure public safety. These findings raise concerns regarding vaccine-induced undetected severe cardiovascular side effects and underscore the established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals. Surveillance of potential vaccineside-effects and COVID-19 outcomes to identify public health trends and promptly investigate potential underlying causes needs immediate attention.”
Jay Bhattacharya, Professor of Medicine and Epidemiology at the University of Stanford
“Dr Aseem Malhotra has written a detailed narrative review of the literature on the uses and abuses of the mRNA covid vaccines. Dr Malhotra makes a good case that there is considerable heterogeneity across age groups and other comorbid conditions in the expected benefits and expected side effect profiles of the vaccine. He finds that, while there may be a case for older people to take the vaccine because the benefits may outweigh expected harm, that may not be the case for younger people. Dr. Malhotra’s paper calls for a pause in the use of the vaccine in younger people, such as the one recently adopted by Danish public health authorities and the Florida department of public health in the United States. He calls for investigation of side effect profiles of mRNA vaccines and for a halt to any vaccine mandate programs involving Covid vaccines. These papers should be considered carefully by all public health authorities who seek to adopt principles of evidence-based medicine in their recommendations to the public regarding the Covid mRNA vaccines.”
Dr Amir Hannan MBE, General Practitioner and Chairman of the West Pennine Local Medical Committee, Greater Manchester
“Dr Aseem Malhotra should be congratulated for putting this all together to help inform the public, the medical profession, the regulators, government, the pharmaceutical industry and wider society. Drug treatments and vaccinations can be an important part in helping to overcome disease and prevent illness, but we must remain vigilant against over reliance on the benefits and minimising or even suppressing the harms. Greater scrutiny of the data is needed and those overseeing medical practice to ensure the public and the profession remain safe. An urgent review is needed of the materials and information provided on the COVID-19 vaccines to help inform the public so that informed consent is gained through a shared decision-making process with education and training in light of the new evidence emerging.”
Dr Campbell Murdoch, General Practitioner and Clinical Advisor to the Royal College of General Practitioners
“Provision of safe and effective healthcare sits at the heart of medical services. As a GP, this is central to every action I take with patients. The healthcare regulator in England, the Care Quality Commission, requires this from all providers of medical care. As Dr Malhotra describes, to be able to provide safe and effective care, all healthcare professionals must practice evidence-based medicine. This is a combination of using the best available scientific evidence, the patient’s preferences, and the healthcare professional’s expertise. The combination of these three factors allows patients to make informed choices about what is best for their health.
“In the case of the COVID-19 vaccination, Dr Malhotra describes multiple systemic failures in the provision of safe and effective evidence-based medicine. Consequently, it has been impossible for patients and the public to make an informed choice about what is best for their health and life.
High quality healthcare requires organisations and individuals to act with complete integrity. Without this the delivery of safe and effective healthcare will always fail.
“Errors in healthcare can provide an opportunity to improve. It is now time to reflect and learn from the experience of the COVID-19 vaccination. Healthcare must always help, not harm.”
Dr Bob Gill, General Practitioner, activist and producer of the documentary The Great NHS Heist
“This important two-part review of the impact of the international roll-out of the mRNA vaccination program highlights significant concerns about the overstated benefits of vaccination especially in low-risk populations and the under-reporting of adverse events. Public information and consent to vaccination has not been balanced, neglecting discussion of individual risk versus benefit of having the shot. The quality of evidence provided by vaccine producers and lack of openness from the pharmaceutical industry risk longlasting damage to confidence in public health interventions.
Part Two of the review sets out how regulatory capture by pharmaceutical corporations and their immense financial power influences politicians and media to promote products at the expense of scientific scrutiny and unfettered access to research on which decisions of immense impact are made. Bias and conflicts of interest abound in the medical-industrial complex with well documented adverse outcomes for patients from over medicalisation and prescription drugs. Coercive vaccine mandates based on biased and short trials with unpublished raw data is the culmination of the unchecked power of the pharmaceutical industry to the exclusion of effective lifestyle factor risk reduction which was ignored by media and politicians alike.
Given the declining virulence of the infection and mounting evidence of vaccine-related harms, there can be no justification to continued mass roll-out of booster programs given that the short-term risks from the vaccine likely outweigh the benefits for the majority of the population, and we remain ignorant of the long-term risk to health.”
Dr Renee Hoenderkamp, General Practitioner, writer and broadcaster
“This is an important paper from Aseem. As a GP in a small practice, I have two young patients with post vaccine heart conditions confirmed. They were not counselled on the risk of this as part of an informed consent process. Surely any medical professionals should want their patients to fully understand the risks and benefits of a medication they take, and welcome that discussion? As the evidence evolves and we see clearly that the risk from both Covid-19 and the vaccine designed to protect against it differs massively by age, sex, co-morbidity, and previous infection, it becomes ever more important to give patients the information they need to make an informed decision. This important paper brings those risks and benefits into sharp focus and should allow the desperately needed discussion that has thus far been sorely missing from any examination of vaccination benefits and harms. Aseem opens up the discussion around both the harms and the ability to have a healthy discourse and I welcome it.”
About The Journal of Insulin Resistance
The Journal of Insulin Resistance is a peer-reviewed, clinically oriented open access journal covering advances in disorders related to insulin resistance. Articles will focus on pathophysiology, prevention, management and advancing therapy for different patient populations with insulin resistance and related disorders, including obesity, metabolic syndrome, type 2 diabetes, cardiovascular disease, nonalcoholic steato-hepatitis, Alzheimer’s dementia, and sexual dysfunction, amongst others. The journal will feature original research with a broad biomedical approach from bench to bedside, including basic research and clinical case studies, as well as review articles and editorials. Content will be of interest to an academic and clinician-based audience, ie medical practitioners, clinical educators, dietitians, nutritionists, nurse practitioners, pharmacists, and other health care professionals. Submissions in English (full article) will be considered for publication.
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