“Correlation does not necessarily mean causation” is the repeated refrain heard from the FDA/CDC to obfuscate the clear signs of causation – if not the clear dangers – posed by the covid vaccination program.
It is telling that this same justification for ignoring the high level of correlation between vaccine and adverse events, was unthinkable in the past.
In any other instance of vaccine rollout and adverse event monitoring – a tiny fraction of reported adverse events were enough to immediately cease those vaccine campaigns.
What is it that has changed that an unprecedented level of serious adverse events has not been enough to stop this vaccine campaign in its tracks?
What has changed is that the FDA/CDC have taken liberties under “Emergency Use Authorization” and have far beyond the scope of this kind of authorization. They have mistakenly taken this authorization to mean that they are absolutely free from well established and rigorous scientific and medical protocols.
This is wrong - and to the extent that regulatory restraints were loosened under the EUA, it does not excuse misleading the Public and it does not excuse continuing under that same authority when the emergency has long since vanished.
Also telling is that in the context we find ourselves, this argument renders scientific/medical judgment and inquiry meaningless. It is as absurd of a statement in the current context as arguing that covid-19 did not cause deaths because “correlation does not mean causation.”
The same tools or indicators that physicians employed to signal or determine the harm related to covid-19 are the same tools and indicators used to indicate the harms of the covid vaccines.
The point is simply this, that even if correlation does not necessarily mean causation – the level of correlation is so high – and the adverse events are so serious – that, following normal medical and scientific practice, the vaccine must be pulled from market until and unless the cause of the adverse events can be determined – if that cause is indeed not yet known. There is a good chance, that scouring the tremendous data of the last three years, the causation is there and only a careful review of the existing data and evidence is required.
In a recent letter to the FDA/CDC Florida Surgeon General Dr. Ladapo expressed concerns about data from Florida showing an overall increase in morbidity and mortality since the vaccine roll-out.
In response the CDC/FDA sent a joint letter of reprimand implying Dr. Ladapo was harming patient health by spreading misinformation about the vaccines. Several poorly executed studies were cited as the basis for government policies. Data and evidence submitted by Dr. Ladapo were dismissed as unreliable or not significant and none of his concerns were adequately addressed.
We imagine that Dr. Califf and Dr. Wallensky have a good working knowledge of how medicine is practiced but COVID management appears to have its own special rules and privileges. Without addressing in any meaningful way the concerns raised by Dr. Ladapo, the letter cites questionable data and poorly executed studies as evidence in support of their safe and effective never ending vaccination campaign.
The studies are further rife with conflicts of interest as researchers and industry sponsors are working side by side to establish predetermined conclusions. The letter also neglects to mention that the FDA advisory board tasked with recommending ongoing boosters advised against such a practice except in very limited settings. Dr. Wallensky took it upon herself to ignore this guidance and move forward to recommend boosters for practically the entire American population.
The medical community at large is extremely disturbed by the actions of these public health agencies and their complete ignorance or disregard of basic fundamental medical practice principles and ethics.
As the CDC and FDA seem to have forgotten the standard procedures and protocol which must be applied to the roll out of a novel medical therapeutic, we are writing to remind them that their sole responsibility is to protect the health related interest of the American public. Included in that responsibility is extreme vigilance when a novel untested therapeutic is introduced under emergency law bypassing all established clinical trial and minimal safety requirements.
The precautionary principle in medicine always puts the burden of proof on the intervention, not the other way around. This is applied to all other pharmaceuticals in use. Use in pregnant women and children requires the highest level of evidence.
It is absurd to continue with the categorical statement that the vaccines are “safe and effective” when data accumulated in the past three years clearly contradicts that statement. To hold a dogmatic belief in vaccination is contrary to sound medical practice.
Of course we know that “correlation does not necessarily mean causation”, but this statement should not be used as bland cliché to ignore evidence that is hitting us in the face, about the causal relationship between the “vaccines” and severe adverse outcomes. The “burden of proof” is always on any proposed intervention. If we have evidence to suspect an intervention might be causing harm, we stop it - period
A minimally tested medical therapeutic cannot be recommended much less mandated if there is potential for significant harm or the potential for significant harm is unknown. There is no debate about this. There is no proof of harm for causation, in other words the burden of responsibility is on the pharmaceutical manufacturers to prove without doubt that the correlation identified does not indicate causation. Until and unless they are able to do that the vaccines cannot be mandated and should be pulled from the market so this can be sorted out.
Medical professionals, witnessing increased adverse events in their practices post vaccination, using well established criteria have determined it is highly probable that the novel COVID mRNA vaccines are the most likely cause of these unprecedented and bizarre medical issues. Public health officials feel there are too many confounding factors and no way to determine that the vaccine rollout is actually responsible for causing the unprecedented morbidity and mortality being experienced on a global scale. Either way, there is no basis for continued recommendation to get vaccinated or boosted for COVID until we can definitively determine these vaccines are NOT the key driving factor in the uptick in health issues especially among previously healthy young people.
Analyzing COVID and the medical communities’ response to the COVID outbreak through the lens of traditional medicine.
The argument "that these AEs occurred after the 'vaccine' does not mean they actually caused them” or "correlation does not mean causation” cannot be applied to COVID vaccines. In this case, there is enough evidence to conclude causation that needs to be seriously considered. There is no controversy that there are three years of real time real life data indicating these vaccines have the potential to cause unprecedented harm.
Medical professionals have a primary job. That job is to determine causation from correlation. Core medical training teaches professionals how to analyze available data and evidence and relate it to a patient’s medical history to determine the most likely cause of a problem.
Actual vs perceived threat.
The actual IFR of COVID is well-documented to be on par with other infectious disease of this nature. However, ask any public citizen, more often than not, they will think their chance of dying is very high close to one hundred percent if they get COVID, worse they also strongly believe their chance of killing someone because they gave them COVID is just as high.
Traditionally situations like this would be handled in a medical setting. Primary doctors would make it their business to know things like the IFR, RRR ARR and in one to one conversations provide individualized advice based on each patients unique situation.
COVID era medicine aims to create a new medical paradigm. Fact checkers, with no verifiable educational background, have trumped established and credentialed experts as medical authorities. A single authority figure can advise an entire population without having seen, spoken to or examined a single patient. Self-testing, self-diagnosing and self-treatment are being positioned to replace the wisdom and expertise of medical professionals with decades of training and education. In a setting where medical advice is based on superficial and unreliable information heard on cable news, it is easy to confuse and confound established methods of sound medical practice.
The response to COVID-19 should have followed well-established measures used successfully in medicine and public health for many decades. There is an abundance of literature that demonstrates that COVID-19 does not represent a significant risk for the majority of the population, affecting selectively elderly, obese and chronically ill individuals (1-6).
Standard Procedures and protocols
“From a regulatory perspective, any death that occurs after an investigational product within 30 days is attributed to the article under investigation.”
“For traditional vaccines, special adverse events of interest (autoimmune problems, etc.) have a 24-month window of observation and potential concern. This window is extended to five years for genetic products (e.g., mRNA and adenoviral DNA).”
“Sadly, in the US domestic VAERS data, as of May 20, 2022, there have been 13,045 Americans that have died shortly after taking one of the mandated COVID-19 vaccines”
“If the Bradford Hill assessment method is used, one could evaluate objectively in a population whether or not the COVID-19 vaccines are causing deaths:
A very strong signal, with >13,000 US deaths is seen; the acceptable regulatory limit is far smaller ~50 for a product such as vaccination,
A tight temporal relationship, with most deaths occurring within a week of the shot is also observed. The criterion of temporality cannot be questioned, since all reported adverse events are occurring post-vaccination, with more events close to the date of dose-administration.
“Thus, the Bradford Hill criteria are fully satisfied. We can be certain that it is more probable than not, or even a clear and convincing level of evidence, that the COVID-19 vaccines are causing death in large numbers of individuals.”
(https://www.americaoutloud.com/bradford-hill-criteria-for-cause-of-death-after-covid-19-vaccination/)
It is true that correlation does not necessarily mean causation however, correlation is the first step in establishing causation, which is why it is an important element in any investigation. More often than not very strong correlations point to causal relations.
As pointed in the article cited above, a well- established and accepted protocol commonly used to assess causality are Bradford Hill assessment method based on a number of key factors (7).
There is no doubt that there is a very strong association between these “vaccinations” and many adverse effects – the most prominent being myocarditis-pericarditis – but including many others like herpes-zoster, thromboembolic events, hepatitis, hematological reactions, axillary lymph nodes, menstrual disorders, corneal implant rejections, and death. These are internally consistent and cohesive with non-fatal syndromes (myocarditis, Guillain-Barre syndrome, deep venous thrombosis, etc.) (8-16).
An important criterion for causality is Biological Plausibility. Several biologic mechanisms have been described to explain the observed adverse events specifically the well-documented mechanism of action with the Spike protein damaging organs and causing blood clotting (17-22).
Another criterion that is satisfied is consistency of findings. Similar findings are reported when comparing different geographical region and are externally consistent among separate databases US CDC VAERS, UK Yellow Card, and EU EUDRA (23-27).
Randomized experimental data from the largest program with Pfizer/BNT vaccine show there are more overall deaths with Pfizer than placebo,
Last but not least, there is the criterion of dose-response. Findings in the literature suggest that people with more doses of the “vaccine” have poorer outcomes compared with those who have fewer doses. Interestingly, in the study cited below (a cohort study from Cleveland Clinic), the authors focus on other findings related to the “effectiveness of the vaccine” and only in a very casual manner mention a very important finding of the study; those participants with more “booster doses” of the “vaccine” had higher incidences of COVID-19 compared with those who had fewer doses (28).
Contrary to what the official agencies have tried to convey, having COVID-19 naturally does not increase the risk of having myocarditis. If we remember, we never heard of people getting myocarditis from COVID-19 in 2020, before the development of the “vaccines” (29-31).
But to date public health authorities continue to chant their safe and effective mantra, use manipulated studies and flawed data and refuse to address or acknowledge concerns raised worldwide by medical professionals and researchers.
The precautionary principle in medicine always puts the burden of proof on the intervention, not the other way around. This is applied to all pharmaceuticals in use. Since the COVID vaccines were minimally tested and rushed to market a higher level of vigilance is essential and would be demanded. Any red-flag event should have halted vaccine use until further investigations could be adequately completed. However operation warp speed kept moving full speed ahead ignoring all established safe-guards.
The letter to Doctor Ladapo cites international collaboration but forgets to mention many countries are no longer advising vaccines or boosters for a significant portion of their population.
Pandemic Protocols
The vaccines available to the American public are not FDA approved, were released with minimal and poorly done testing, under EUA. The FDA advisory board recommended against advising boosters but an individual decision to ignore the recommendation and follow personal bias led to the recommendation for boosting the entire population.
Real –time data contradicts that these products underwent standard rigorous scientific and regulatory procedures and protocols. This is evident in the warp speed at which vaccines were released, omitting years of study and data typically required before a product can be considered safe for human trials. It is also evident from sworn testimony of pharma executives admitting there was no time to bother with safety and efficacy studies, “as we needed to move at the speed of science.”
“Normally, the benefit provided by a new drug must be demonstrated in extensive clinical studies (“phase 3 trials”) in order for this drug to be approved for the market; this involves a thorough review of the trial documentation by the authorities. The COVID “vaccines” were given “temporary” or “conditional” approval worldwide based on very much shortened phase 3 trials, which lasted only 2 months instead of 12 months, and on insufficient or missing animal studies, i.e. they received only an “emergency approval. To date, the clinical trials have not demonstrated any relevant benefit, pivotal documents overall were demonstrably completely inadequate, and moreover the data from the phase 3 studies were manipulated” https://doctors4covidethics.org/the-watson-et-al-modeling-study-did-covid-vaccinations-really-prevent-14-million-deaths/
The details of the rigorous scientific and regulatory standards for safety and efficacy shared are lacking and do not address what patients are experiencing and medical professionals are witnessing as reflected in VAERS and clinical practices across the country and around the world.
Critical to remember is the fact that public health agencies cited VAERS as one of the mechanism which would allow operation warp speed to move forward since it would serve as a warning system. As elementary as this may seem warning systems do not work if alarming red flags are intentionally and persistently ignored or dismissed.
There are no expectations on VAERS reporting. It is simply a warning system. Historically, this system has been used to identify something has the potential to be a problem. The threshold for halting a roll-out for a novel minimally tested product is very low. We do not kill or diasable a significant percentage of the population before deciding to look into the cause of death. The VAERS system records adverse events following vaccination. Adverse events following COVID vaccines have far exceeded events caused by any other vaccine, either individually or all combined. Traditionally, this would be a hard stop. The minimal effectiveness of the COVID vaccines does not justify its continued use given the alarms and unknowns which are now indisputable.
Vaccines, like any other medical products, need to be carefully and cautiously assessed. And like any other medical therapeutic, if they do a poor job and do not deliver the promised outcomes, they cannot be advised to any patient for any reason. There should be no such thing as a protected class of medical products that cannot be scrutinized. Vaccine hesitancy is a malignant phrase used to dismiss legitimate patient concerns. Labeling patients with terms like anti-vaxer in a medical setting, is a discriminatory practice, which should not be tolerated by physicians or patients.
The FDA’s decision to move forward with untested medical therapeutics followed by the CDC recommending these EUA interventions be added to the childhood schedule shows a complete disregard of our rights and their responsibility to protect us from predatory corporate practices.
To take the high and unprecedented level of correlation here, and throw it aside side by throwing vague or unverified variables into the air is simply a method to confuse the unsuspecting public.
There has been a clear link established between covid vaccines and serious adverse events. This link demands that this entire project be stopped immediately. At the very least, the FDA/CDC has no justification for defaming Dr. Ladapo for spreading “misinformation.”
Another thing to keep in mind – is that the correlation and causation babble that the FDA/CDC is pointing to now, is not the same as the causation which will ultimately hold it and other stakeholders responsible for intentionally misleading the Public.
In the legal context, the conduct of the government officials and stakeholders will be parsed, and the opinion of scientific and medical experts on the right side of this issue will also be weighed and considered.
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So glad I found my tribe. Sharing.
All you have is claims. Not a single citation from my credible source. You are as illegitimate as the 1919 Chicago White Sox.