Is COVID shot condemnation going mainstream?
A new research paper has been published containing such a comprehensive and detailed critique of the COVID shots that some have concluded that the tide against experimental mRNA “vaccines” has begun to turn. While their optimism may be misplaced, the paper is novel in many significant ways: it calls the shots “experimental agents that deploy gene codes”; it presents their risks without any mention of benefits; and it relabels “vaccine hesitancy” as “educated hesitancy.”
The research paper is titled: “Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines” and appears in the International Journal of Risk & Safety in Medicine, published by Sage Journals, a respected mainstream platform. The authors set out not only to clarify the nature of the shots but also to place them within the broader picture of dangerous drugs, providing a brief overview of other products found to carry too great a risk and which were then withdrawn.
Objective: To examine key pharmaceutical product withdrawals and derive lessons that inform the current use of gene-based COVID-19 vaccines.
Death by delay
While there are thousands of drugs enjoying FDA approval, many of which are acknowledged to have serious adverse effects, less than 500 have been withdrawn over the past 70 years.
In the last 7 decades, from 1953 onwards, more than 462 medicinal products have had to be recalled from sale because of adverse drug effects that frequently include fatalities.
The authors also point out that, even after dangerous side effects are noted, it generally takes regulators an inordinately long time to take action:
The median interval between the first reported adverse reaction and the year of first withdrawal for a drug is 6 years.
A history of corruption
In the 1990s, the manufacturers of Paxil (Paroxetine), a popular SSRI antidepressant drug, decided to market it for adolescents. They conducted two randomized controlled trials on adolescents with depression, but the results were discouraging. The first study showed that Paxil was no better than placebo (as are many other antidepressants); the other showed a slight and non-significant benefit with Paxil — and also that taking the drug increased the risk of suicide. The manufacturers nonetheless proceeded with their initial plans and presented the second trial as a success, claiming that Paxil was “generally well tolerated and effective.”
It was only in 2012 that the company, GSK, finally admitted its crimes, pleading guilty to fraud and failure to report safety data. They paid out $3 billion in fines.
Avandia, a diabetes drug, gained FDA approval in 1999. By 2007 it was clear that the drug increased the risk of death due to cardiovascular causes — the increased risk was calculated to be around 64 percent. Nonetheless, that year, a panel of FDA advisers voted 22 vs 1 against withdrawing the drug. It was finally banned three years later following further allegations. Experts estimate that it caused around 100,000 heart attacks, strokes, and deaths.
One of the most notorious cases of drug fraud relates to Vioxx, marketed by Merck. The FDA approved Vioxx, a pain killer, in 1999, even after it was informed by Merck that the company had hidden several adverse events that emerged in the drug’s clinical trials. 18 months later the full clinical trial data were released, which showed that taking Vioxx multiplied the risk of suffering a cardiovascular adverse event by 2.38. Merck had known all along but continued to promote Vioxx as “safe and effective.”
The research paper’s authors conclude, in relation to Vioxx, that,
The FDA appears to have been complicit with Merck in early suppression of the adverse event data.
Only in 2002 did the FDA order Merck to include a warning of cardiovascular risks in the drug’s package insert. Merck ultimately withdrew the drug in 2004 — the largest prescription drug recall in history. By that point, an estimated 80 million people had used Vioxx globally (20 million in the United States) and it is believed that around 150,000 suffered a myocardial infarction with a fatality rate of approximately 40 percent.
Merck established a settlement fund of $4.85 billion, the largest ever in US history at the time. It failed to dent the company’s finances; over the ensuing two decades, Merck’s value has increased six-fold to over $300 billion.
These were not vaccines
The paper’s authors refer to the COVID shots as “COVID-19 gene-based vaccines.” Over 13 billion doses have been given to-date; more people worldwide have been exposed to them than to any other drug in history, with the possible exception of polio vaccine.
Are the COVID shots vaccines? The paper’s authors stress that these substances use “a new mechanism ... completely distinct from traditional vaccine technologies,” and that calling them “vaccines” is misleading and possibly deceitful:
Use of the term “vaccine” for novel experimental agents that deploy gene codes may convey a false sense of assurance in the absence of supportive data and thus may mislead. In pharmacological design terms, these products are “pro-drugs”. They must enter cells and undergo translation of genetic code before intended outcomes unfold), and in this sense they operate as “synthetic viruses”. Unintended consequences are thus possible...
Blind eyes
“Agents that deploy gene codes” are, when officially defined as such, treated very differently by regulators from drugs defined as vaccines, as a previous Gold Report analysis noted. One might also assume that monitoring of adverse events with the COVID shots would have been far more rigorous than it was had they been categorized as experimental gene therapy.
Instead, the official narrative surrounding the shots continued to be that they were “safe and effective” and that “millions of lives were saved” due to them, even as the number of VAERS reports mounted to unprecedented heights.
The report’s authors add that there was also plenty of other evidence, dating back to 2021, that the shots were harming many, such as insurance company data which showed a spike in the numbers of death and disability claims correlating with the shots (and not with COVID infection itself).
FDA in the dock
The report’s authors certainly do not exonerate the pharmaceutical industry, but it is clear from their analysis that, without collusion at the highest levels of government, Pharma companies could never have succeeded in marketing their products to such a degree.
They single out the FDA, established to protect the public from unscrupulous or merely careless manufacturers, for censure, noting that it could have examined why Pfizer, in its Phase 3 clinical trials, removed 251 more people from the cohort that received the shots than it did from the placebo group, and that it should have investigated the disparity in the numbers of deaths in the two groups using the complete trial data, not the abridged report Pfizer submitted to it:
Additionally, the Pfizer-BioNTech phase III trial report submitted to the FDA for Emergency Use Authorization listed 2 deaths in the mRNA vaccine arm and 4 deaths in the placebo arm. However, documents released under court order revealed a further 4 deaths in the vaccine arm and 1 death in the placebo arm, to give the total number of deaths before the data cut-off date as actually 11 (6 vaccine, 5 placebo) versus the 6 disclosed ...
By the end of the truncated Pfizer phase III trial there were 21 deaths in the vaccine arm and 17 in the placebo arm and the difference was accounted for by cardiovascular mortality.
If the FDA had taken these concerns more seriously, they might have demanded that the Pharma companies continue to monitor both groups for a period of years rather than weeks. Instead, the companies were allowed to dissolve the placebo group and “vaccinate” all the people in it so that no further comparisons could be made. The report’s authors write:
Moreover, rigorous assessment of long-term safety of these experimental gene-based products has been effectively sabotaged by the early dissolution of the placebo arm in phase III clinical trials. Despite this, the interim and extensive publication of these abbreviated clinical trials in the NEJM has been used to support marketing and the public health message of “safe and effective.”
Medical journal collusion
Another institution that might have sounded a warning on the shots but acted more as a cheerleader was the world of medical journals. Almost without exception, journals reported Pharma claims without questioning, probing, or overly analyzing. They regurgitated the “over 90-percent effective” statistic without clarifying that this related to relative risk and that the absolute difference in risk was just a few percentage points. And they refused to send counter-narrative research to peer review, so that when such studies were published on preprint servers, they were derided as substandard.
One notable exception, at times, was the British Medical Journal. In 2022, its senior editor, Dr. Peter Doshi, published an article which concluded that receiving the COVID shots was more likely to put a person in hospital than keep them out of it.
A more recent BMJ study examined excess mortality in 47 Western nations and concluded that there had been over 3 million excess deaths between January 2020 and December 2022. Obviously this figure includes those who died due to COVID itself, and this has been the usual approach of medical journals which want on the one hand to reveal the dangers of the shots yet on the other hand to dodge censorship.
Another way of dodging censorship has been to first praise the shots as “life-savers” and then half-bury the dangers somewhere in the middle of the research paper. This latest paper has not, by contrast, used any method at all to get around censorship. It has simply stated the dangers without any sugar-coating and, somehow, made it through peer review and into the mainstream.
That this is highly unusual is stressed by the authors who note that “distortion of clinical trial data” is commonly done by journals and not only when it comes to the COVID shots:
Distorted data, particularly due to commercial bias, is regularly published in medical journals. A Cochrane Review meta-analysis found odds ratios exist for a sponsored drug trial to find results, (OR 2.05) and provide conclusions (OR 2.69) in favor of the drug versus an independent trial for the same agent.
Warped leadership
Under the Biden administration, public health officials cooperated with the labelling of the COVID shots as “safe and effective.” But this collusion did not start in 2021. Rushing the development of the shots at “warp speed” was, the report’s authors write, a terrible mistake that certainly cost many lives.
... haste, especially at “warp speed”, should be alien to good medical science. It is likely that novel technology, haste in vaccine development and mass production all contributed to the reported phenomenon of “batch toxicity” based on official pharmacovigilance data.
The next disastrous move on the part of government was to redefine the term “vaccine” once it became clear that the shots did not provide immunity. Suddenly, “vaccine” meant protection rather than immunization:
In terms of efficacy, failure to prevent infection or transmission of the COVID-19 variants eventually led the US Centers for Disease Control and Prevention (CDC) to reinvent their definition for “vaccine” as no longer the provision of “immunity,” but as “protection” against disease severity – now a narrative challenged by more recent data.
The report’s authors pinpoint the mandates, however, as the most grievous error made, as they resulted in young, healthy people at miniscule risk of serious illness or death from COVID being irreparably harmed by the shots:
Perhaps the greatest failure of gene-based vaccine use is the political act to mandate therapy. Mandates are relatively rare in medical history. Vaccine passports to engage in normal life resemble measures under totalitarian rule. The deadlines for COVID-19 vaccine mandate compliance correlated closely with excess morbidity and mortality.
It is particularly tragic that mandates have been applied to the young, fit, and healthy in our workforce, at minimal risk from the coronavirus itself, some of whom have paid the ultimate price with loss of life. In fact, at a global level the median pre-vaccination infection fatality rate (IFR) was estimated at 0.03% for the 0 – 59-year-old population, while for children aged 0–19 years the median IFR was 0.0003%. These observations indicate that children and adolescents are essentially at zero risk of COVID-19 mortality. [emphasis added]
Educated hesitancy
Given the abundance of good reasons to be wary of the COVID shots, therefore, the paper’s authors choose to call people who refuse them “educated” rather than label them with a pejorative term. They point out that those with degrees have proven more reluctant to get the shots, as have people in a good position to know all about them — healthcare workers on the frontlines.
Given the novel nature of gene-based COVID-19 vaccines, it may be no surprise that “vaccine hesitancy” among those with tertiary qualifications was highest with PhD doctorates ... and among healthcare workers was highest for “emergency medical technicians/paramedics” ... reflective of both research and coal-face clinical experience. This could thus be referred to as “educated hesitancy”, found in a cohort most familiar with the imperfections of corporate sponsorship, market authorization and medical literature, and a cohort on the frontline.
They add that, “Educated hesitancy towards these products has been ridiculed.”
How many more deaths will it take?
Of course, when it came to other dangerous drugs such as the now-withdrawn Swine Flu vaccine, people who opted out were not generally ridiculed once the risks were known. The paper’s authors note that it took just 10 death reports for one version of the polio vaccine to be withdrawn; the Swine Flu vaccine of 1976 was recalled after just 25 death reports (ultimately, 53 people were confirmed to have died following that vaccine).
Wanted: A return to honest and transparent science
The authors conclude that a number of factors are responsible for the corruption of drug marketing and that addressing the problem will require a number of different strategies. This is an urgent need, given that more gene-based therapies are in various stages of development, primarily because it is so cheap to mass-produce such drugs:
Gene-based medicine in blanket form, with mass production at extremely low cost, is expected to become a significant market trend.
Given the immense power of the Pharma lobby, however, dealing with ingrained problems will not be simple:
The global pharmaceutical industry has grown in recent decades and now represents one of the most valuable in the world. Revenue of the worldwide market in just 2 decades has risen from 390 billion USD (in 2001) to 1482 billion USD (in 2022).
One way to keep the drug manufacturers in check is to more closely monitor adverse events and ensure that placebo cohorts are maintained intact in the long-term, not just for a few months:
Beyond any clinical trial data and the process required to obtain initial approval from regulatory authorities, is the absolutely vital need to recognize that all therapeutic agents must be continuously monitored and subject to the red flags of vigilant surveillance...
Even that will not suffice unless regulators take prompt action when safety signals emerge:
Broadly, all pharmaceutical products are continuously experimental, observed and tracked by pharmacovigilance systems worldwide. The population ultimately becomes the long-term experiment... [emphasis added]
The authors also insist that transparency must become part of the system, with raw data from the clinical trials made freely available.
Access to raw data, open discussion, freedom from censorship, and heightened, active pharmacovigilance must be nurtured, if the health of humanity is to be better protected and if trust in the medical profession is to be fully restored.
