Updated: Nov 11
Chapter 7: Article 3
The FDA acknowledges that vaccine testing is inferior compared to how drugs are tested Their regulations state that though pharmaceutical drugs need "substantial evidence" demonstrated through "adequate and well-controlled studies," vaccines aren't held to that same standard. Vaccine studies need NOT meet the standard of "adequate and well controlled."
The CDC has informed us that even though they vaccinate an entire population of children, they have never studied long term health outcomes in these children. They claim:
We...know there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects.
If you recall back to the Stanford Immunologists, they state:
[The immune system is] staggeringly complex, comprising at least 15 different interacting cell types that spew dozens of different molecules into the blood to communicate with one another and to do battle. Within each of those cells sit tens of thousands of genes whose activity can be altered by age, exercise, infection, vaccination status, diet, stress, you name it.
“That’s an awful lot of moving parts. And we don’t really know what the vast majority of them do, or should be doing,”... “We can’t even be sure how to tell when the immune system’s not working right, let alone why not, because we don’t have good metrics of what a healthy human immune system looks like.”
So, let me see if I have this straight. We don't test vaccines as rigorously as we test drugs. We never study a vaccine's long term affects. We don't understand how a vaccine affects the tens of thousands of genes in our cells. We don't understand what a healthy immune system looks like when its working optimally - what it does, or should be doing. Though we understand little about all of that, the CDC asserts "there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects."
Hmmm. In my humble opinion, such a statement seems a tad ignorant and arrogant.
Despite how little we know about the immune system, and despite how inadequately the health of the vaccinated population is followed or studied after vaccination, sometimes it becomes very OBVIOUS that vaccination is causing serious harm in a population. This was the case in Europe in 2010/11 following the 2009 pandemic immunization program.
The CDC website had the following to say (emphasis mine):
An increased risk of narcolepsy was found following vaccination with Pandemrix, a monovalent 2009 H1N1 influenza vaccine that was used in several European countries during the H1N1 influenza pandemic. Narcolepsy is a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally. This risk was initially found in Finland, and then some other European countries also detected an association. Most recently, scientists at the United Kingdom’s (UK) Health Protection Agency (HPA) have found evidence of an association between Pandemrix and narcolepsy in children in England. The findings are consistent with studies from Finland and other countries.
Two narcolepsy symptoms that you will hear discussed throughout this article are described on a USA government website, the National Institute of Neurological Disorders and Stroke. This department is a divison within the National Institute of Health (NIH) and the NIH is overseen by HHS, which is the highest level of government for all things medical. On this NIH website, they describe two (of six) narcolepsy symptoms as follows (bolding emphasis mine):
Excessive daytime sleepiness (EDS). All individuals with narcolepsy have EDS, and it is often the most obvious symptom. EDS is characterized by persistent sleepiness, regardless of how much sleep an individual gets at night. However, sleepiness in narcolepsy is more like a “sleep attack,” where an overwhelming sense of sleepiness comes on quickly. In between sleep attacks, individuals have normal levels of alertness, particularly if doing activities that keep their attention.
Cataplexy. This sudden loss of muscle tone while a person is awake leads to weakness and a loss of voluntary muscle control. It is often triggered by sudden, strong emotions such as laughter, fear, anger, stress, or excitement. The symptoms of cataplexy may appear weeks or even years after the onset of EDS. Some people may only have one or two attacks in a lifetime, while others may experience many attacks a day...The most severe attacks result in a total body collapse during which individuals are unable to move, speak, or keep their eyes open. But even during the most severe episodes, people remain fully conscious, a characteristic that distinguishes cataplexy from fainting or seizure disorders. The loss of muscle tone during cataplexy resembles paralysis of muscle activity that naturally occurs during REM sleep. Episodes last a few minutes at most and resolve almost instantly on their own.
We're often told the only possible long-term outcome of vaccination, is anti-body production and illness immunity. We're told that while the body works to develop those anti-bodies the only possible side effects are short-term, minor ones, like fever, pain, redness at the injection site.
If that's true, then how on earth did the Pandemrix vaccine cause a chronic disease which manifests as excessive daytime sleepiness with sudden muscle tone loss following strong emotions?
That National Institute of Neurological Disorders and Stroke website goes on to explain the suspected cause of narcolepsy. The website states (bolding emphasis mine):
Although the cause of narcolepsy is not completely understood, current research suggests that narcolepsy may be the result of a combination of factors working together to cause a lack of hypocretin. These factors include:
Autoimmune disorders. When cataplexy is present, the cause is most often the loss of brain cells that produce hypocretin. Although the reason for this cell loss is unknown, it appears to be linked to abnormalities in the immune system. Autoimmune disorders occur when the body's immune system turns against itself and mistakenly attacks healthy cells or tissue. Researchers believe that in individuals with narcolepsy, the body’s immune system selectively attacks the hypocretin-containing brain cells because of a combination of genetic and environmental factors...
And with that, it appears the CDC's elusive "plausible biologic" mechanism has been identified.
I'd like to turn your attention to a medical paper published in Finland, the country where the narcolepsy signal was first detected. Some excerpts from this Finnish paper state (emphasis mine):
A sudden increase in childhood narcolepsy was observed in Finland soon after pandemic influenza epidemic and vaccination with ASO3-adjuvanted Pandemrix. No increase was observed in other age groups.
...In the primary analysis, the incidence of narcolepsy was 9.0 [per 100,000 people] in the vaccinated as compared to 0.7/100,000 person years in the unvaccinated children and adolescents...No obvious change in the rate of unvaccinated was observed after the start of the campaign: By the time of media attention in August 2010, one case was recorded in the 227,288 unvaccinated, compared to an expected of 1.8 cases. With the estimated incidence in the vaccinated (9.0/100,000 person-years), one would have expected 20.6 unvaccinated cases.
...We found a 12.7-fold risk of narcolepsy in 4–19-year-old individuals within approximately 8 months after Pandemrix vaccination as compared to unvaccinated individuals in the same age group. This translates into a vaccine attributable risk of 1∶16,000.
...Our finding is supported by the recent results from Sweden, where a cohort study covering the entire population reported an almost 7-fold incidence of narcolepsy with cataplexy in children vaccinated with Pandemrix compared to those in the same age group who were not vaccinated...Preliminary passive reporting system data from France, Norway and Ireland also indicate higher than expected number of cases in children and adolescents after Pandemrix vaccination. On the other hand, it is perplexing that both Canada and the United Kingdom lack the signal.
Three years later, in 2014, a Canadian study looked at narcolepsy rates. That research concluded:
Results are compatible with an excess [narcolepsy] risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age.
...Our results showing an increased narcolepsy risk in vaccinated individuals less than 20 years of age are congruent with those of studies on a similar AS03 adjuvanted pandemic vaccine in Europe although the magnitude of the reported excess risk was much higher in Norway (90 per million), Finland (63 per million) in Sweden (36 per million), in Ireland (53 per million), and in England (18 per million). The origin of this difference is not known. Differences in the production process and composition of the two vaccines are a possible hypothesis. Underascertainment of narcolepsy cases in our study could also bias to some extend attributable risk estimates.
90 Cases per million, is 1 case for every 11,000 vaccine recipients. That's a far greater risk than the 1 in a million we are told about.
A Canadian W5 investigation (similar to the US 20/20 Investigations) states the following:
Pediatric sleep medicine specialist Dr. Manisha Witmans told W5 she has seen a baffling spike in [narcolepsy] cases among patients at her clinic, the Synergy Wellness Centre in Edmonton. Narcolepsy is a rare condition, and Witmans usually treats only two cases annually. In the last year and a half, however, she has diagnosed 10 pediatric cases, with four to five more awaiting definitive tests.
"I was shocked," said Witmans. "I noticed that the cases were more severe and in that most of the children that I see now have cataplexy and that can be unusual in children."
Witmans told W5 that she's not alone in seeing a sudden surge, as colleagues in Toronto, Seattle, Washington and Philadelphia are reporting similar increases in this rare brain disorder. She is now collecting data and hopes to make her report public in the coming months.
Using the 2014 Canadian study quoted above, that research stated narcolepsy occurs at a baseline rate of 0.11 cases of narcolepsy in every 100,000 unvaccinated people. The adjacent province of Alberta has a population of four million, which should translate into an expected rate of 4 narcolepsy diagnoses in the province. The research also stated that the vaccinated experienced one additional case of narcolepsy in every million vaccinated. It should also be noted that Alberta had one of the lowest rates of vaccination participation in Canada, with only 36% of the population getting vaccinated (1,310,085 recipients). In the W5 investigation, Dr. Witmans said that in just 1.5 years prior to this W5 investigation, she had diagnosed 10 kids with narcolepsy, and that she has 4-5 more kids awaiting diagnosis who are likely also narcopetic. So at her Alberta clinic alone, she is seeing double the annual rate, and quadruple the number of patients her practice typical encounters. This is just one Alberta clinic, so it is reasonable to believe that there may be other clinics in the two metropolitian cities of Calgary and Edmonton. Though the basic mathematics detailed here cannot conclude whether or not swine flu, the pandemic vaccine, or another cause is the culprit behind this increased rate of narcolepsy in Alberta, this mathematics does show the significant disconnect between the Quebec study's projected rates of narcolepsy following vaccination vs actual incidence on the ground.
The H1N1/narcolepsy situation is a PERFECT example to support that is catastrophically irresponsible for the CDC to state:
Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical.
The only unethical thing here is that our government officials subject the entire population of children to an inadequately tested product, then claim there's no need to observe our children's long term health outcomes.
CONTINUE to next article Ch7: Article 4
FDA Regulations showing vaccine clinical testing is inferior compared to pharmaceutical drug testing Here
CDC explains Narcolepsy is linked to Pendemrix vaccine Here
NIH - National Institute of Neurological Disorders and Stroke - Narcolepsy is an autoimmune disease Here
Healthline - definition for lay people - defining autoimmune disease Here
Australia Department of Health - there are 1000s of germs Here
Science Magazine - we are chronically and transiently infected by several germs Here
Finnish Study - Pandemrix vaccine linked to nearly 13x greater risk of narcolepsy Here
Quebec Study - Arepanrix vaccine linked to increased risk of narcolepsy Here
English Study - increased narcolepsy following ASO3 adjuvanted H1N1 vaccine Here
Pandemrix - Consumer Information Sheet Here
Pandemrix - 2008 application submitted to the European Medicines Agency Here
Arepanrix - 2010 Package Insert Here
Alberta Pandemic Vaccination Participation Here
CDC - long term health outcome not studied in vaccinated populations Here
Canadian Vaccine Package Inserts Here
American Vaccine Package Inserts Here
Alberta's Population Here
Narcolepsy UK Here
Science Article - Why a pandemic flu shot caused narcolepsy Here
Research - How a pandemic flu shot caused narcolepsy Here