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'Very low rung in quality ladder': Critique of ICMR study on 'sudden deaths' post-2021

By Bhaskaran Raman* 

Since about mid-2021, a new phenomenon of extreme concern has been observed throughout the world, including India: unexplained sudden deaths of seemingly healthy and active people, especially youngsters. In the recently concluded Navratri garba celebrations, an unprecedented number of young persons succumbed to heart attack deaths. After a long delay, ICMR (Indian Council for Medical Research) has finally has published a case-control study on sudden deaths among Indians of age 18-45.
The weight of ICMR behind the study was apparent as it even tweeted about it from its official X handle. The study concluded that the Covid-19 “vaccines” were not to blame for the sudden deaths, but instead blamed Covid-19 hospitalization, family history, binge drinking, and intense exercise. However, the study falls significantly short of credibility on various counts, as we detail below.

Flaw-1: The (missing) elephant in the room

The study is what is called a case-control study. Scientifically, case-control studies occupy a very low rung in the quality ladder, as they cannot establish causal factors with confidence. For establishing causality (or lack of the same), randomised controlled trials (RCT) are much better, where participants are chosen randomly and long-term follow-up is conducted. Such RCTs were indeed started in 2020 for the Covid-19 “vaccines”.
So the relevant question is: where are the results from those RCT studies, with long-term safety follow-up of vaccine and control (placebo) groups? The skirting of this question by ICMR is an indictment in itself. Not presenting results from the original RCTs is a disservice to science and the crores of Indians who have been vaccinated.
The ICMR study has also avoided comment on the AEFI (Adverse Event Following Immunization) reports during the country-wide vaccination drive. Were the sudden death cases in the study, reported by the survirors in the family, to the AEFI system? If so, was there follow-up investigation? If not, why was no report done? Avoiding these critical questions is highly worrisome.

Flaw-2: Not explaining the increase in sudden deaths

Sudden heart attack deaths are nothing new, of course. The concern has been that there has been a noticeable increase in such sudden deaths in 2021 and later compared to pre-2021. The ICMR study fails to explain this. Blaming family history, binge drinking, drug usage, physical exercise is thus absurd, since none of these increased in 2021 compared to prior years, at least not as per the study.
The study simply claims sudden deaths are more common among those with a family history or binge drinking. That is perhaps well known, even commonsensical. What has changed since 2021 – the paper does not even attempt to answer this.

Flaw-3: Indictment by data

Although the study’s conclusion exonerates the role of Covid “vaccines” in the sudden deaths, the study’s own data indicts the “vaccines”. Table-I of the research paper lists that 20.4% of the sudden death cases were single dosed. Given that most vaccination had pretty much ended by mid-2022, we expect that the number of single dosed should be near zero.
But it is not the case, especially in the sudden-death “case” group. Why? Did they die a sudden death before their second dose was due? Or did they develop serious adverse events after the first dose, due to which the second dose was not advised by their doctor? These questions are not even raised, leave alone answered in the study.

Flaw-4: Incorrectly blaming Covid-19 hospitalization

In the study, only 2.3% of the sudden deaths were hospitalized for Covid-19. Therefore it is absurd for the study to blame Covid-19 hospitalization for the sudden deaths. Further, it is disingenuous to blame Covid-19 hospitalization for sudden death after projecting the Covid “vaccines” as preventing hospitalization and severe outcome. Blaming Covid-19 also conveniently ignores the fact that there were no such reports of sudden deaths anywhere in the world in all of 2020: the year of the pandemic.

Flaw-5: Failure to separate Covaxin vs Covishield

Covaxin and Covishield use completely different technologies. There is no apriori reason to expect that they will have similar side effect profiles. In not looking at the effect of each “vaccine” separately, the study is deeply flawed scientifically.

Flaw-6: Conflicts of interest

The paper reports that no funding has been received and that there is no conflict of interest. Nothing could be further from the truth. ICMR has commitments of crores of rupees in funding from BMGF (Bill & Melinda Gates Foundation) which has investments in vaccines. ICMR has also made tens of crores of rupees from Covaxin sales.
Aside from these financial conflicts of interest, the study is also riddled with professional conflicts of interest. The journal in which the study is published, Indian Journal of Medical Research, is run by ICMR itself! The study is thus a case of ICMR exonerating its own product, published in its own journal. This is hardly credible.

Flaw-7: Other discrepancies

There are several other problematic aspects in the study:
  • Not separating by age-group: While all deaths are tragic, sudden deaths of young adolescents are especially heart-breaking (literally). These instances have especially increased since the Covid “vaccine” rollout. It is also known that myocarditis risk of the Covid “vaccines” is especially high for young males. Therefore the study should have looked at separate age-groups, e.g. under-25 and over-25, but it failed to do so.
  • Exclusion of alcohol frequency in final analysis: Quite unlike Covid-19 hospitalization, the number of alcohol users among the sudden death cases was very high at 27.4%. Further, the study’s own initial analysis (table-2) showed the highest dependence of sudden deaths on alcohol frequency. However, alcohol frequency was excluded in the final analysis (table-3). This raises eyebrows.
  • Data discrepancy: In Table-I, the n value is different between “vaccination status” and “Received COVID-19 vaccine before death of cases”. Why? If you look at the details, the number of unvaccinated is the same, but only the number of vaccinated is quite different. For example, for “any vaccination” it is 577 among “cases”, but in the numbers in the rows below, 266+22 adds up to only 288. What happened to the remaining (577-288)=289 “Cases”? This discrepancy is significant given the above indictment.
  • Deaths in the control group? While the description of the control group chosen for the study appears to suggest that this group consists of people who are alive, the entry in table-1 for “Days between vaccination and death of cases” for the control group raises eyebrows. This cannot be a typing error and points to some unexplained methodological flaw.
  • Assumption of 15% “vaccine” coverage: In selecting the sample size for the study, the authors assume 15% “vaccine” coverage in India. This is not even in the right ball-park for a study done in 2023.
  • Choice of study period: The peak of first dosage in India was April/May 2021. So the choice of starting the study period from Oct 2021 is odd, to say the least. The choice is not explained in the study paper.
  • Exclusion criteria: The study excludes those who died after 24-hours of hospitalization, and also those with comorbidities. These form a large 69% of the recorded sudden deaths. While it is instructive to look at instances of sudden+unexplained deaths, it must be noted that if the same exclusion criteria were applied to Covid itself, it cannot be called a pandemic, as the overwhelming majority of those who died were old and comorbid.
Given these flaws, the study is a disservice to science and to the victims of the sudden deaths. To restore credibility, ICMR must release the data (suitably anonymized to protect privacy) from the original vaccine randomised controlled trials (RCTs), as well as the data from this study, open to the public for scrutiny.
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*Professor at IIT Bombay. Author of the book “Math Murder in Media Manufactured Madness”, presenting simple math to illustrate various absurdities related to the mainstream Covid-19 narrative; available at: https://bhaskaranraman.in/. Views are personal

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