Peer-reviewed Paper - Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine

A look at the true benefits and harms of mRNA

A British doctor, Aseem Malhotra, has just had a two part, peer-reviewed paper published in the Journal of Insulin Resistance. The aim of the paper was to gain a better understanding of the true benefits and potential harms of the mRNA Covid vaccines. You can read Part 1 and Part 2 in full by clicking on the links.

Dr Malhotra. a cardiologist by trade, was originally a strong Covid vaccine advocate. He volunteered in a vaccine centre, was one of the first people to be double dosed and appeared on morning television to encourage everyone to get vaccinated. He was surprised and concerned at vaccine-hesitant patients when they asked about ‘anti-vax’ propaganda.

That was until, sadly, in July 2021, his father suffered a cardiac arrest and died. His father had been the former deputy chair of the British Medical Association (BMA) and honorary vice president. The 73 year old gentleman was extremely fit and active and heart scans from a few years earlier had revealed no significant problems. Dr Malhotra was shocked to read his father’s post mortem which found that two out of three of his major arteries had severe blockages.

Aseem couldn’t explain the post mortem findings and became more concerned in November 2021 after reading a peer-reviewed abstract in Circulation Journal. In the study, the mRNA vaccine was associated with significantly increasing the risk of a coronary event within five years from 11% pre-mRNA vaccine to 25% 2-10 weeks post vaccine.

He began to question his father’s death and wondered whether the Pfizer vaccination he had received six months earlier could have contributed in some way. After six months of critically appraising the data and speaking to eminent scientists, he reluctantly concluded that, contrary to his own dogmatic beliefs, Pfizer’s vaccine was far from being as safe and effective as first thought.

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Questioning the data

During his reassessment of the Covid vaccine he recalled a conversation with a cardiologist colleague who decided against vaccination due to his low personal risk and concerns about short and long term harms. His colleague was particularly alarmed that, during the trials, there had been four cardiac arrests in the vaccine group but only one in the placebo group.

Next, Dr Malhotra assessed the 95% efficacy claims. Whilst this relative risk reduction made good sales material, the true value of a treatment can only be established by looking at the absolute individual risk reduction.

This turned out to be 0.84%, in other words, in a trial of 20,000 people (10,000 in the vaccine group and 10,000 in the placebo group), 4 people in the vaccine group and 88 people in the unvaccinated group would end up testing positive for Covid. Another way to express that is that you would need to vaccinate 119 people to prevent one positive test.

This absolute risk reduction figure (0.84%) is extremely important for doctors and patients to know but how many of them were told this when they received the shot? Transparent communication of risk and benefit of any intervention is a core principle of ethical evidence-based medical practice and informed consent.

The trials did not show statistically significant reductions in serious illness or mortality and in fact there were actually more deaths (19) in the vaccine group versus the placebo group (17). Furthermore, there were only nine severe cases of Covid in the placebo group, representing 0.04%. And this was in regions specifically chosen for their high prevalence of infection.

To find protection against death, then the 119 figure above (people vaccinated to prevent one positive test) must be multiplied by the number of infections that would lead to a single death in each age group. So, Dr Malhotra calculates his rate of death from Delta was 1 in 3,000 meaning the absolute risk reduction of the vaccine protecting him from death is (1 x 3000 x 119) 1 in 357,000.

As also pointed out in a recent editorial by John Ioannidis in BMJ evidence-based medicine the inferred efficacy of the vaccine from non-randomised studies may be ‘spurious’, with bias being generated by ‘pre-existing immunity, vaccination misclassification, exposure differences, testing, disease risk factor confounding, hospital admission decision, treatment use differences and death attribution’.

What should be part of the shared decision-making informed consent discussion when any member of the public is considering taking the shot is something along these lines: Depending on your age, several hundreds or thousands of people like you would need to be injected in order to prevent one person from dying from the Delta variant of COVID-19 over a period of around three months. For the over 80s, this figure is at least 230, but it rises the younger you are, reaching at least 2600 for people in their 50s, 10 000 for those in their 40s, and 93 000 for those between 18 and 29 years. For omicron, which has been shown to be 30% – 50% less lethal, meaning significantly more people would need to be vaccinated to prevent one death. How long any protection actually lasts for is unknown; boosters are currently being recommended after as short a period as 4 months in some countries.

But how many people have had a conversation that even approaches an explanation similar to that? This is before we get into the known, unknown and as yet to be fully quantified harms.

Harms

Concerns have been raised about trial participants being limited as to the type of adverse event they could report. Furthermore, hospitalised participants were withdrawn from the trial and not reported in the final results. To make matters even worse, after two months, the FDA allowed the placebo group to be unblinded and get vaccinated, completely removing any control group with which to assess adverse events.

Dr Malhotra sticks with his field of expertise, cardiology and discusses one of the most common vaccine-induced harms, myocarditis. Whilst authorities say that myocarditis is more likely after infection than vaccination, other studies have shown the opposite. There is no evidence of myocarditis until vaccination began in 2021, a full year after millions of youngsters naturally caught Covid.

Although vaccine-induced myocarditis is not often fatal in young adults, MRI scans reveal that, of the ones admitted to hospital, approximately 80% have some degree of myocardial damage. It is like suffering a small heart attack and sustaining some – likely permanent – heart muscle injury. It is uncertain how this will play out in the longer-term, including if, and to what degree, it will increase the risk of poor quality of life or potentially more serious heart rhythm disturbances in the future.

The UK’s Yellow Card reporting system is addressed and determined to be far from adequate to cope with a rapid roll out of a brand new product. 9.7 million doses were administered before the clotting problems with AstraZeneca were detected. In Denmark, they detected the problem after only 150,000 doses.

Since the beginning of the vaccine roll-out, there have been almost 500,000 adverse events reported involving over 150,000 individuals. This shows around 1 in 120 suffer an adverse event that is beyond mild. This number is unprecedented and represents the same as the total number of reports received in the first 40 years of the Yellow Card system being active. The MMR vaccine reports around 1 in 4000 suffer an adverse event.

The paper also looks at VAERS in the US which has recorded over 24,000 deaths, 29% occurring within 48 hours of vaccination and 50% within two weeks. Before 2020 there were approximately 300 deaths recorded per year.

Of most concern is that these reporting systems are actually likely to be underestimates with one paper suggesting that only 1% of serious adverse events are ever reported to the FDA. Another analysis estimated that only 10% of serious adverse events were ever reported on the Yellow Card system.

Moreover, these reporting systems will generally miss medium and long term harms as it is more difficult to attribute to vaccination.

According to ambulance service data, in 2021 there were an extra 20,000 (20% increase) cardiac arrest calls compared to 2019 and 14,000 more than 2020 in the UK.

Similarly, a recent paper in Nature revealed a 25% increase in both acute coronary syndrome and cardiac arrest calls in the 16- to 39-year-old age groups significantly associated with administration with the first and second doses of the mRNA vaccines but no association with COVID-19 infection.

More harm than good?

One has to raise the possibility that the excess cardiac arrests and continuing pressures on hospitals in 2021/2022 from non-COVID-19 admissions may all be signalling a non-COVID-19 health crisis exacerbated by interventions, which would of course also include lockdowns and/or vaccines.

Given these observations, and reappraisal of the randomised controlled trial data of mRNA products, it seems difficult to argue that the vaccine roll-out has been net beneficial in all age groups.

Dr Malhotra concludes the first part by saying that whilst risks from vaccination remain constant, the benefits reduce over time as the virus become less virulent and variants are not targeted by outdated products. He recommends a pause and reappraisal of vaccination policies.

Pandemic of misinformation

In part 2, Dr Malhotra explores the pandemic of misinformed doctors and a misinformed and unwittingly harmed public.

According to one senior doctor in regular contact with England’s Chief Medical Officer, Chris Whitty, most of his colleagues in leadership positions influencing health policy may not have been critically appraising the evidence and were instead relying on media stories on COVID-19 and the vaccines.

He says there are four key drivers and seven sins that are the root of medical misinformation:

• Driver

  • Much published medical research is not reliable or is of uncertain reliability, offers no benefit to patients or is not useful for decision makers;

  • Most healthcare professionals are not aware of this problem;

  • Even if they are aware of this problem, most healthcare professionals lack the skills necessary to evaluate the reliability and usefulness of medical evidence; and

  • Patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision making

• Sins

  • Biased funding of research (that’s research that’s funded because it’s likely to be profitable, not beneficial for patients)

  • Biased reporting in medical journals

  • Biased reporting in the media

  • Biased patient pamphlets

  • Commercial conflicts of interest

  • Defensive medicine

  • An inability of doctors to understand and communicate health statistics.

There are six components essential to informed decision making: (1) description of the nature of the decision; (2) discussion of alternatives; (3) discussion of risks and benefits (in absolute terms); (4) discussion of related uncertainties; (5) assessment of the patient’s understanding; and (6) elicitation of the patient’s preference.

If the administration of the vaccine did not adhere to these principles (which is likely widespread, consistent with historical evidence), then it is also a significant breach of General Medical Council duties of a doctor to ‘give patients the information they want or need in a way that they can understand’.

The paper continues to look at institutional corruption and erosion of public trust, the failure of regulation, biased reporting in the media and censorship of legitimate scientific debate.

A hard hitting, yet sensible paper which should be read by everyone, especially doctors who lost their critical thinking skills over the last few years. Dr Malhotra is a regular on TV so will this be reported in the MSM…I doubt it.

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