How is causality assigned for serious adverse events? Part 1
It is not rocket science ........ really!
Over the last two years, we have heard words such as safe and effective bandied about, without any qualification, in relation to the experimental genetic injections. It is understandable that lay people hear, perceive, and understand that there is no risk whatsoever with receiving these injections. However, there is no such thing as a medicine that has no risks [1].
The CDC, NIH, and FDA have played on the fears of the public, and have pushed the injections by downplaying and not adequately explaining the risks. This was a tactic to ensure as close to 100% uptake of the injections as possible, regardless of the collateral damage that this would inevitably cause. After drug safety issues began to mount, they have played the ostrich, hiding their collective heads in the sand, hoping people would not realize the injuries were related to the injections. As a result of this policy, ordinary people have found out from experience, that the experimental genetic injections are not safe for them.
Typically, when the injured have told their physicians that the adverse outcomes they experienced were caused by the experimental genetic injection(s) administered to them, their concerns were dismissed. Many have been prescribed anxiolytic (anti-anxiety) and/or antidepressant medications. Physicians are apparently good at gaslighting their patients.
On the other hand, drug safety training is not given to the average Physician or the average Pharmacist, consequently most Physicians and Pharmacists are completely devoid of any understanding of how to assign causality when an adverse event or outcome occurs. Nevertheless, I believe they should be able to use their common sense. At the start of the roll out of the experimental genetic injections, many physicians and pharmacists (at least in the US) received official notifications from their licensing bodies. They were advised that if their actions contribute to loss of confidence in the injections, they could lose their licenses to practice. The safest way to avoid this was to refer the injured to the CDC statements, and to not acknowledge that the injuries were caused by the injections. It appears that many Physicians will forget about the Hippocratic Oath they took to do no harm, when their licenses are at risk.
I must acknowledge the Physicians and Pharmacists who have courageously done the right thing. For them, there was no alternative but to do what their consciences told them was appropriate. They have advised the injured that their injuries were caused by the experimental genetic injections. They have reported the serious adverse reactions to VAERS. They have researched treatment for the injured, and made the necessary referrals to specialists. Many have lost their jobs, and/or received complaints that put their licenses at risk. After this is over, these are the Physicians and Pharmacists that we should be patronizing with our business. They can be trusted with our health, and the health of our families.
Conflicts of interest are very real, in the pharma and biotech setting. In my experience, even the pharmacovigilance teams in pharma and biotech are oftentimes ill-equipped to understand drug safety principles. Their task often consists only of reviewing and submitting forms to the health authorities. They are often incapable of thoroughly investigating the serious adverse reactions reported to them. On many occasions, I have had to advise the drug safety physicians, that their job is not to protect the interests of the pharma or biotech companies they work for, but to protect the patient that is experiencing the serious adverse reaction.
Nomenclature
By way of nomenclature, an ADVERSE EVENT is any untoward experience that occurs within a reasonable timeframe after administration of a medicine. During clinical trials, all ADVERSE EVENTS are collected. It is not always clear which ADVERSE EVENTS are caused by the investigational drug, and which are not.
After the causality is assigned, the ADVERSE EVENT is known as an ADVERSE REACTION or if serious, a SERIOUS ADVERSE REACTION.
A SERIOUS ADVERSE EVENT (SAE) is one that is life threatening, results in hospitalization, or causes death. However, remember that the SAE may not have been related to the investigational agent or medicine that was administered. Causality needs to be assessed and assigned before it can be considered related to the drug in question, at which point it becomes a SERIOUS ADVERSE REACTION (SADR).
In discussing the injuries and serious adverse events that have occurred after administration of the experimental genetic injections, many have spoken about the SEVERITY of the injuries. They often confuse SEVERITY with SERIOUSNESS.
SEVERITY is an important concept, but a SEVERE ADVERSE EVENT may not be a SERIOUS ADVERSE EVENT or SERIOUS ADVERSE REACTION.
How does this work in practice?
Causality assignment involves looking at a range of factors that could explain the adverse event. Tinnitus is a common adverse event that is associated with the administration of the the experimental genetic injections. After hearing the injured describe this adverse event, it is clear to me that it is SEVERE. However, it is also SERIOUS because many who have experienced tinnitus have sought out medical care, and been admitted to hospital. It has also been life threatening, because some have committed suicide because of it. This means tinnitus can be considered a SERIOUS ADVERSE EVENT; when causally linked to the injections, it is a SERIOUS ADVERSE REACTION. In terms of SEVERITY, it could be mild or it could be SEVERE or even EXTREMELY SEVERE.
Were your injuries / serious adverse reactions related to the experimental genetic injections?
Given you are on your own in making the determination of causality in relation to these injections, how can you arrive at an accurate causality? This Substack will give you the information that you need to make your own assessments. I am going to explain an important concept that is used (when possible) to determine and assign the causality for [serious] adverse reactions.
A serious adverse reaction is one that results in a life threatening outcome, or death. If you were left worse-off than you were before you were injected with the experimental genetic injections, and the event was related to the injections, you experienced a serious adverse reaction. If you are seeing physician after physician, with clinic visits and hospital stays, you have experienced a SERIOUS ADVERSE REACTION.
The serious adverse reactions can occur immediately, or they can occur long after the last injection. We have to remember that the Spike Protein is being produced in the cells in the body, after injection. The time period is unclear. This could be dependent on the person, on their physiology, or their previous health status. There does not appear to be a way of turning off the production of Spike Protein. This is surprising, because many years ago, gene therapy companies were working on switches. The switches were supposed to turn on the production of the therapeutic protein, as well as turn if off, when necessary.
A serious adverse outcome that came out of the blue a year after the injection should be assigned POSSIBLY RELATED to the experimental genetic injections, unless there is a good reason to believe otherwise. Most people are experiencing serious adverse reactions within minutes or hours of the injection. Many are already documented as caused by the experimental genetic injections, so we can consider that they are causally related to the administration of the injections.
Assessing and Assigning Causality
Let’s consider the normal drug prescribing process, not related to COVID19. After a medicine, DRUG A is administered, a serious adverse event or outcome may have been caused by:
The drug in question
The underlying illness that the drug was administered to treat
Co-morbidities that the patient is suffering from
Purely by chance
How can we pinpoint if an adverse event or outcome was caused by DRUG A? This is an important assessment to consider because the patient may not have many treatment options. Under normal circumstances, we would not want to remove a medicine from the patient’s treatment armamentarium, unless it is really necessary to do so.
While the patient was in hospital, the team of Physicians and Pharmacists evaluated all the medicines that the patient was taking. The serious adverse reaction occurred immediately after DRUG A was added to their other treatments. The serious adverse reaction could have been caused by a drug-drug interaction between DRUG A and the other drugs being taken, or by DRUG A alone. Let’s presume we can rule out a drug-drug interaction, for sake of making the argument easier to understand.
The timeframe of the onset of the serious adverse reaction is a very important consideration in assigning causality. Because the serious adverse reaction, occurred immediately after DRUG A was administered, we can conclude that the causality is POSSIBLY RELATED.
One way to strengthen the understanding of the causality of the serious adverse reaction in relation to DRUG A, is to remove DRUG A. Removal will need to allow for a washout period, but when DRUG A is out of the patient’s physiological system, we can then see if the patient has improved. This is called a DECHALLENGE.
The patient will be observed. What are the possible outcomes?
OUTCOME 1 - The patient will recover. The serious adverse reaction is reversed.
OUTCOME 2 - The patient will remain the same.
OUTCOME 3 - The patient will become worse.
OUTCOME 4 - There will be no difference in the patient’s condition.
After the DECHALLENGE, if the patient recovers / the serious adverse reaction is reversed, we can now conclude that the serious adverse outcome was PROBABLY RELATED to DRUG A.
To determine if the serious adverse outcome was DEFINITELY related to DRUG A, we would need to re-administer DRUG A. The potential for a life threatening outcome must be controlled for. When DRUG A is re-administered, i.e. the RECHALLENGE takes place, the outcomes are going to tell us if DRUG A was DEFINITELY related to the adverse outcome.
Here are the possible outcomes.
OUTCOME 1 - The patient will again experience the same serious adverse reaction they recovered from when DRUG A was removed. We can conclude DRUG A was DEFINITELY the cause of the serious adverse outcome.
OUTCOME 2 - The patient will remain the same
OUTCOME 3 - There will be no difference in the patient’s condition.
A RECHALLENGE must not be attempted if there is clear evidence based on experience with the drug that the adverse outcome was caused by DRUG A. It must always be borne in mind that the adverse outcome could be more serious than the first administration during the RECHALLENGE. The serious adverse reaction may even be life threatening the second time it is administered.
In my next Substack, I will explain why this is relevant for the experimental genetic injections. Watch out for Part 2 coming tomorrow.
References
The Safety Assessment of Medicines: Pre and Post-marketing. LH. Speid. Ph.D. Thesis, University of Wales, Department of Clinical Pharmacy, May 1991. The British Library.
“Lessons Learned From the TeGenero First-in-Man Phase 1 Clinical Trial Part 2: Implications for Future First-in-Man Phase 1 Studies,” Speid L. Regulatory Focus, May 2008 .
As always, you are encouraged to seek medical advice for your own personal situation. Whatever you read here, should not take the place of your own personal consultation with your qualified and competent medical advisors.
Work copyrighted and owned by Speid & Associates, Inc.
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Two choices:
1. Uncontrolled collapse - 8B starving humans in darkness (see the inflation riots... now imagine no food...) = murder, rape, cannibalism.
2. Pre-empt this with a vaccine purposed to cause a hyper contagious hyper lethal virus that kills billions. Those that isolate and avoid the virus remain isolated out of fear - even when their food stores are exhausted. Not a pleasant scenario however it would eliminate most if not all the violence involved in an uncontrolled collapse (I suspect Shanghai is a dry run to see how the hordes react to a total lockdown)
The men who run the world (and their minions) understand that an uncontrolled collapse = hordes seeking scapegoats... their protectors will abandon them as the system implodes (or worse - turn on them)... thus mass suicide is the best option for them as well.
Why?
Conventional Oil peaked in 2005 http://www.euanmearns.com/wp-content/uploads/2015/06/C-Cdec141.png
Shale in 2018.
According to Rystad, the current resource replacement ratio for conventional resources is only 16 percent. Only 1 barrel out of every 6 consumed is being replaced with new resources
https://oilprice.com/Energy/Energy-General/The-Biggest-Oil-Gas-Discoveries-Of-2019.html
Shale binge has spoiled US reserves, top investor warns Financial Times.
Preface. Conventional crude oil production may have already peaked in 2008 at 69.5 million barrels per day (mb/d) according to Europe’s International Energy Agency (IEA 2018 p45). The U.S. Energy Information Agency shows global peak crude oil production at a later date in 2018 at 82.9 mb/d (EIA 2020) because they included tight oil, oil sands, and deep-sea oil. Though it will take several years of lower oil production to be sure the peak occurred. Regardless, world production has been on a plateau since 2005.
What’s saved the world from oil decline was unconventional tight “fracked” oil, which accounted for 63% of total U.S. crude oil production in 2019 and 83% of global oil growth from 2009 to 2019. So it’s a big deal if we’ve reached the peak of fracked oil, because that is also the peak of both conventional and unconventional oil and the decline of all oil in the future.
Some key points from this Financial Times article: https://energyskeptic.com/2021/the-end-of-fracked-shale-oil/
Shale boss says US has passed peak oil | Financial Times https://www.ft.com/content/320d09cb-8f51-4103-87d7-0dd164e1fd25
Our fossil fuel energy predicament, including why the correct story is rarely told https://ourfiniteworld.com/2021/11/10/our-fossil-fuel-energy-predicament-including-why-the-correct-story-is-rarely-told/
SEE PAGE 59 - THE PERFECT STORM : The economy is a surplus energy equation, not a monetary one, and growth in output (and in the global population) since the Industrial Revolution has resulted from the harnessing of ever-greater quantities of energy. But the critical relationship between energy production and the energy cost of extraction is now deteriorating so rapidly that the economy as we have known it for more than two centuries is beginning to unravel https://ftalphaville-cdn.ft.com/wp-content/uploads/2013/01/Perfect-Storm-LR.pdf
There is no way out of this -- we have 8B people on this planet due to cheap energy. We've burned through most of the cheap energy -- collapse is guaranteed.
Heaven help us if those behind this plan fail. You do not want to be alive when the lights go out and the shops go empty. The horrors 8B will inflict upon each other ... are unspeakable.
I suffered excruciating and debilitating pain from brachial plexus syndrome. It is like you are being electrocuted from the inside. I went to see a new neurologist and was first seen by his PA. The FIRST question out of her mouth was "had you received a vaccine prior to this condition starting?" And when the doctor came in he asked me the same question. Of course I had not taken any vaccines since my small pox vaccine many decades ago as a child. It just never ceases to amaze me how parents are so willing to put the safety and at times the life of their child into the hands of a doctor especially the doctors of today.