How health agencies obtained a license to KILL
And how a logical sleight of hand is handcuffing citizens into approval
It would have been all to easy to assume that rogue health agencies could not have existed in this day and age. Little is required to understand that we live in the information age, where internal health documents, policies and even scientific opinion of those that form such plans can be beamed into our living room, our state of the art cinema style widescreen televisions being lit up at just a click of a button.
What agency with ill motives therefore could withstand this kind of scrutiny? With potentially millions of people pouring over their decisions, wouldn’t such daylight disinfect shoddy and self-serving health practices?
But what about the mainstream media? Yes, true. The benefit of their presence allows the mass of complexities to argue and debate over to be reduced into a single nice easy assumption, that any major failing would surely be revealed by them. It would benefit them to do so. It pays their bills. What an easy way to de-stress from our already hectic daily lives, let them do the work - one false assumption away from doom.
But what if another deception other than a corrupt media is at play? And I’m not even talking about World Economic Forum, Bill Gates, Mr Global, corporate interests or even mass formation psychosis. No, I’m talking about something dark that was imbedded in the recent past. Something that would be completely devastating for humanity if it fell into the wrong hands. And as terrifying as an imperceptible black hole floating indiscriminately around our galaxy, it exists and it’s floating around undetected.
A single phrase. A calculation which determines the health care for everyone. And it reads logically, completely logically. It couldn’t be wrong.
But, like the assumption made about our media, it’s the boiling down of complexities to just one thing which puts doom one false assumption away. And this calculation does that. Even the brightest, most qualified and most well meaning minds around the world have accepted it’s utility and once used, it could mean the destruction of health for millions, if not billions of people, that is, if they survive the worst outcome.
I guess you are wondering what on earth the upside could possibly be for allowing the existence of something so destructive?
After all, the benefits should outweigh the risks
This phrase sounds correct doesn’t it? Logical. I bet you are thinking, this can’t be the point of the publication? What’s wrong with it? It sounds just so innocuous. Even in the most dire of circumstances. And that’s the point.
THIS SINGLE PHRASE ALLOWS MASSIVE IMPORTATION OF HARMS. All under the radar. As long as the benefits are judged to outweigh the risks, then it’s a green light.
Oof. One sure would want maximum security around that capability. For it to fall into the wrong hands and be button pressed for any other reason than to avert the gravest of civilizational threats would be unthinkable.
But guess who is in possession of this orthodoxy?
Why of course captured agencies such as the FDA, MHRA, EMA and probably any other drug authorising health agency across the world. Agencies where parties with interests other than health are running amok inside. And that button is right there sticking out like a sore thumb begging to be pushed for those that wish to profit.
And here’s the kick in the stomach, they’ll get billions of people around the world to agree to it too. And they already have.
A dramatic take? In an outrageous statement, one particular health agencies has admitted to being “from watchdog to enabler” (Link Link) and has recently issued guidance for “regulatory flexibilities” (Link). One needn’t even read in between the lines to understand that pharmaceutical companies stand to benefit immensely.
Check out these safety standards currently in use by health agencies:
“If this independent and unbiased review (by CDER) establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale” - FDA in 2022 Link
“For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions“ - MHRA in 2021 Link
“The Agency can recommend the authorisation of a medicine whose benefits are judged to be greater than its risks” European Medicines Agency in 2017 Link
Is that not like saying, “as long as the benefits are above zero, no matter what the harms, the drug is judged to be safe”? Furthermore, doesn’t an increase in benefit also increase the acceptable harms? One would not want to say that out loud and thus it is no surprise these agencies manage to detach themselves from the consequences of their determinations as the words “known”, “judged” and “expected benefits” are no doubt inserted tactically in these brief definitions. This is a problem and to make this threat more concrete, according to UKHSA (of UK), in their Vaccine Surveillance Report week 51 (2021), they state that “Estimates suggest that 127,500 deaths and 24,144,000 infections have been prevented as a result of the COVID-19 vaccination programme, up to 24 September”(Link). Is it not unreasonable to state that these definitions alone allow for the death of 100,000 people even if “reality” wouldn’t tolerate such a toll?
Leaving that door open doesn’t look good. However was this state of affairs always so? Past medical books that should lay out standards of safety were therefore scanned for key words. So did similar calculations exist there in the past?
In a seemingly radical departure from today, the Adverse Effects of Antihypertensive Drugs by G P Freis and Edward D published in 1954, (Link) contains the interesting phrase “it behooves us, therefore, when embarking on a program of chemotherapy to be cognizant fully of their inherent dangers as well as anticipated benefits” Note the lack of a specific safety bar and that the axioms of risk and benefit are not leveraged against each other. Perhaps the authors knew something regulatory agencies of today did not.
Going back even further to a book originally completed as long ago as 1025, the Canon of Medicine of Avicenna (Link) reveals the phrase “That is, one must beware of giving drugs possessing injurious (mordant, pungent or toxic) qualities, to very sensitive organs, or organs of special sense—for instance, plants belonging to the euphorbia group”.
However, like A Text-book of Medical Practice for Practitioners and Students by William Bain in 1904 (Link), none of these books were found to contain any obvious relative safety definition.
Compared with a prominent medical book of today, in a joyride many advertisers would be envious of, simply typing in the word “outweigh” into Harrison’s Principles of Internal Medicine 19th edition (2015) unveils a stunning 54 entries machine-gunned into the pages and a browse of who edited this book reveals guess who? - a certain Anthony Fauci on the second line. Only in the case of an embryo and fetus is a wide margin of safety ever stipulated and even that is not wholesale. Relative safety here is alive and well.
(search could only handle 34 results on this alternative Link!)
Although a limited analysis, it strongly appears that determinations of worth up until even the mid 20th century are poles apart compared with today. They may have been emergent and not fully optimised but benefited from being unpolluted by outside needs.
Big changes however, have occurred in recent times. Framed as a positive requirement in the online article Benefit–risk evaluation: the past, present and future (Link), they say that “In the late 1990s and early 2000s, while there was an increasing pressure from regulatory agencies for pharmaceutical companies to perform BR evaluation more routinely and systematically, there were only a few publications in the literature and a few guidelines from the regulators on how to perform BR analyses”.
The regulatory agencies are the ones who possess the magic formula which they only understand, therefore they are the authority - a reasonable take under the circumstances? And that “pressure” emerging from the regulatory agencies? Who is to say these are not bought and paid for pharmaceutical requirements?
If this is true, the pollution is worsening. In an attempt to squeeze more juice out of their formula, on 30th September 2021 the FDA issued a draft guidance: Benefit-Risk Assessment for New Drug and Biological Products. Amongst other things, this was to reduce uncertainty, uncertainty which otherwise would surely possess the salutary benefit of airing benefit-risk calculations on the side of caution. They said that the “FDA expects sponsors to focus their development activities in such a way that the data and information generated by those activities will minimize uncertainty” and “even in the area of rare disease drug development where patients express a desire for access and willingness to accept risk”. (FDA Articulates High Benefit-Risk Expectations For Drug Developers, Link). It also makes the FDA look good.
Are we seeing positive developments by independent and distinct health agencies who are looking after your health needs or are we seeing outrageous and ever growing encroachment by those only invested in themselves?
The author here thinks the latter.
Just one more thing - why would it be needed to repeat a safety definition to qualifying medical doctors and professionals over and over - as if they didn’t know that the benefits should at least outweigh the risks? It doesn’t make sense. Unless of course the use is for another purpose.
Repeating the phrase over and over turns it into a mantra and from there, it’s far easier to confuse this single ethical boundary out of potentially many which could have always been on the table, for the threshold to commit to a proactive course of action.
The following may appear strong but the revelations beg the questions: Is a relative safety definition a real life calling card for demonic possession and is this therefore the most dangerous mantra to ever exist?
What do you think?
THE DANGERS OF RELATIVE SAFETY REQUIREMENTS IN A NUTSHELL
Relative safety:
1. Is considered “safe” and the go-to method in decision making.
2. Presents as pitting health versus injury but in that contest actually ties them together forming a value system. Increasing the benefits increases the permissible injuries. Compromised humans and computer models are the arbiters of deciding which one "wins".
3. Sets standards of success relative to zero.
4. Can be applied on a population level with one person's health exchanged for another. People become a resource instead of the product.
5. Allows for the massive importation of injury and death. The little overall benefit required is valued and emphasised above any of that and need only be "expected". Detrimental health becomes excusable and lives disposable.
6. Deceives those in need to accept poor standards under the guise that the formula does them a favour in making a product available early.
7. Confuses with a mantra and ethical boundary to induce health professionals into being proactive armed with this formula. Is seen as logical. Citizens are immensely at risk too.
8. Definitions are highly memorable, replicable and infective. Anyone valuing uniformity will aid it's perniciousness.
9. Captures individuals and robs personal agency.
10. Frames the entire calculation as mundane even if weights placed upon the formula are increased dramatically.
11. Passes on injury ready for a further cure to then "outweigh" those further side effects in an endless loop without policy to ensure against that. Human bodies become a laboratory.
12. Keeps dangerous products in stasis so they can rarely be recalled and rectified. Safer products may therefore be relegated to oblivion and never developed to their capability.
13. Often has an inbuilt excuse for miscalculation, getting the policymakers off the hook.
14. Becomes a target for pharmaceutical companies to aim the quality of their products at.
15. Prostitutes the cost/benefit thinking of a personal decision of the average Jo on the street in place of actual product regulation.
CONCLUSION
Relative safety definitions are being used en masse by regulatory agencies who seem to regard these as dogma, with attributes in these definitions that would only favour endless profits by Big Pharma rather than locking in health to the individual. If the authorities say a product is fit for release, they may as well say that safety developments are over in the same breath - the manufacturers no longer need do any more work to make millions of dollars. With thresholds set for expediency, they maximise injury whilst minimising benefit. By only needing to outweigh the risks, they need only skim the bare minimum benefit off the top each time - that is, after factoring in huge amounts of biological labour to give rise to that.
Putting vast numbers of people a simple miscalculation away from a negative is unethical and absurd and such miscalculations turn to inevitability once projections based on computer models by people invested in profit are involved. Entire populations are now burdened with avoiding these banana skins thrown down at them over and over again, however, like health professionals, they have already been indoctrinated into a myopia. With the fingerprints of Big Pharma's needs all over, it will only be a question of when and not if there will be a human catastrophe, not least anything else already occurring, and to top it off, with injury and death rubber stamped for approval.
It is highly likely with these formulas and under these conditions that the market is already flooded with products one grade in quality above that of a train wreck - and packaged neatly and reassuringly by the ubiquitous and trusted names of Big Pharma.
These definitions which all health product development, capital and logic are filtered through need to be removed immediately and be replaced with something that will stop the ever increasing degradation and finally heal humanity. Let’s start today.
It’s interesting that the legal action which includes Lisa Shaw’s husband is being brought under the Consumer Protection Act 1987.
https://www.bbc.co.uk/news/uk-england-tyne-65187992
I haven’t read the Act, but it hails from a different age and no doubt incorporates a different standard of safety.
Interesting that the quote in the BBC article from AstraZeneca copied below includes the phraseology you are highlighting.
It added evidence from clinical trials and data showed the Covid vaccine had "an acceptable safety profile" and that the benefits "outweigh the risks of extremely rare potential side effects".