Problems Discovered after Drugs and Vaccines are Licensed
Let's diverge briefly from the vaccine discussion, to revisit the Vioxx catastrophe which I first detailed in a previous article, Safety & Efficacy Part 2. In that article, I explained how an FDA employee and whistleblower, David Graham, alerted US Government to the reality that the FDA is not protecting the American public from unsafe drugs. As Graham explained it, drug safety regulation is currently set up backwards. He said that instead of requiring drug makers to prove safety, in the same way that they have to prove a drug works and is effective before licensing, the FDA instead assumes the drug is safe. From that position, the FDA requires drug makers to discover and show with 95% certainty that the drug is harmful. Graham said that not only is it impossible to establish that degree of certainty of harm through clinical trials, he explains that drug makers are given zero incentive to do so. When the drug maker fails to prove the drug is harmful, then the FDA's assumption that the drug is safe, is declared true.
With Vioxx, the FDA declared it was safe in 1999, when in fact it caused heart attacks and death. Merck withdrew Vioxx from the market in 2004. The New York Times explains that since Vioxx's 2004 withdrawal from market, Merck has since been criminally convicted and criminally fined $950 million, for their illegal marketing actions. Merck has also since paid out at least $4.85 billion to settle at least 27,000 civil lawsuits, filed by the Vioxx vicitims or their surviving family members.
It has been said that Vioxx may have killed more Americans than were killed fighting in the Vietnam War. In a Globe and Mail article, it states that American Vioxx deaths are estimated to be between 39,000 and 61,000. Of course that is only a small fraction of the deaths, recognizing that Vioxx was a medication that was used worldwide, not just in the United States.
In Safety & Efficacy - Part 2, I explained that David Graham testified before US government, to explain how both the pharmaceutical company, Merck, and the FDA were long aware of evidence linking Vioxx to heart attacks and death and how both the drug maker and Government did nothing about it for four years. Unfortunately, because Merck and the FDA followed the deficient FDA laws throughout the Vioxx debacle, neither the FDA or Merck were charged with committing murder, despite thousands of people dying.
Though Merck did voluntarily plead guilty to a misdemeanour for knowingly and improperly marketing their medication, which resulted in the $950 million criminal fine, they maintain that they were unaware before 2004 that Vioxx was causing harm. That claim is the subject of ongoing debate.
The VIGOR study, at the heart of this debate, was conducted by Merck and it began shortly before Vioxx was approved for public use in May 1999 and was completed a year and a half later. It was executed to test whether Vioxx was less damaging to the stomach, compared to a different pain medication, naproxen, which is an over-the-counter drug also known as Aleve. The VIGOR study's data noted a significant difference in heart attack rates, between Vioxx recipients and naproxen recipients. In Graham's 2004 testimony to US Government, he discussed the early Vioxx studies (VIGOR and 090), which both indicated a possible heart damage signal, saying:
Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx...In November 2000, another Merck clinical trial named VIGOR found a 5-fold increase in heart attack risk with high-dose Vioxx.
An NPR article explains how Merck initially reacted to the heart signal of the VIGOR study:
November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 [2%] taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel's November meeting note that "while the trends are disconcerting, the numbers of events are small."
A Forbes article provides more detail about the earlier 090 study, stating:
..."a previous study compared 390 patients taking Vioxx to 588 patients taking a placebo. The study, called 090, showed that five, or 1.3%, of patients taking Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the placebo group. Although those numbers are small, they were statistically significant"...
Internal Merck documents reveal that as a result of the heart data from the VIGOR study, Merck found the signal concerning enough to warrant conducting a heart specific study, to learn definitively whether or not Vioxx was causing heart damage. Unfortunately for the public, Merck later decided against proceeding with such study. Documents show Merck speculated that a heart specific study would be too difficult to conduct and that such a study might cause public alarm. If so, they speculated that that alarm could result in the public choosing to not use Vioxx, which would affect their profits. Merck's unwillingness to follow through with additional logical testing has been interpreted by many as willful ignorance.
So, instead of proceeding with a study that could have definitively concluded whether or not Vioxx was causing heart damage, Merck changed course and instead theorized that naproxen likely had a protective effect on the heart, like asprin. A 2004 New York Times article stated:
[Merck] never directly tested the theory that it used to explain the worrisome results of the clinical trial in 2000. Merck was criticized for what some charged was playing down the drug's possible heart risks; in one case, it received a warning letter from the Food and Drug Administration for minimizing "potentially serious cardiovascular findings." And when outside researchers found evidence indicating Vioxx might pose dangers, Merck dismissed their data.
In 2001, Dr. Deepak L. Bhatt, a cardiologist at the Cleveland Clinic, proposed to Merck a study of Vioxx in patients with severe chest pain. Merck declined, saying the patients proposed for the study did not reflect typical Vioxx users. In Dr. Bhatt's view, the company feared what it might find if it directly examined the dangers of Vioxx, one of Merck's biggest products, with sales last year  of $2.5 billion.
"They should have done a trial like this," Dr. Bhatt said. "If they internally thought this drug was safe in patients with heart disease, there was no reason not to do it."
According to David Graham, the FDA should have done more, but because of the culture and flawed organizational structure, the FDA instead aids industry at the expense of public health. He stated:
As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured.
...For industry, every day a drug is held up from being marketed, represents a loss of one to two million dollars of profit. The incentive is to review and approve the drugs as quickly as possible, and not stand in the way of profit-making. The FDA cooperates with that mandate.
...The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe. Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe? There's no incentive for the companies to do things right.
What happened with Vioxx is a perfect example of how the manufacturer will NOT go out of their way to thoroughly look for a drug's harm. Despite two studies, 090 and VIGOR, showing a 7x and 5x greater risk of heart attack in Vioxx recipients, nothing was done by the FDA or Merck for four more years, and unfortunately, according to current FDA regulation, this is not a crime. VIGOR concluded that naproxen offered protective effects that only made it appear Vioxx was causing heart damage. Merck's "belief" in this unproven theory was both catastrophically irresponsible of them and wildly profitable for them.
How the Vioxx Catastrophe Relates to the Vaccine Debate
As explained in Parts 1, 2 and 3 of this series, long term health outcomes in the vaccinated population are never studied, ever, neither before nor after the vaccine is licensed for widespread public use. The US Centers for Disease Control and Prevention (CDC) has stated:
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.
In Part 1 of this series, I linked to a Tedx Talk given by Dr. Christine Stabell Ben. In it, she said:
Allow me to tell you what we discovered. In Guinea Bissau. We have a field station where we follow 200,000 people with regular home visits, and we register all deliveries, all vaccinations, all hospitalizations, health centre visits, all child deaths. And with this information, we started doing what no one else had done before, we evaluated the effect of vaccines on overall health. This may come as a surprise, but normally, vaccines are not assessed for their effects on overall health. They're only assessed for their protective effects against the vaccine disease. Everybody has been so convinced that vaccines only had protective effects against the vaccine so it didn't seem necessary to assess their effects on overall health. But when we started looking at the effect of vaccines on overall health, it quickly became clear that there was something wrong, something was clearly missing in this equation.
As we've discovered from the Vioxx catastrophe, it remains in the manufacturers' best interest to stay blind and ignorant to a drug's harm, and so the safety testing that vaccine makers do is extremely limited (see parts 1, 2, & 3 of this series for specific vaccine testing details). The FDA is complicit in allowing this minimal testing to happen. The FDA has long been aware that vaccine makers never compare the experimental vaccine to a placebo control, in randomized and blinded testing process - the method referred to as the "gold standard of research." Instead, the vaccine testing almost always compares the experimental vaccine to other vaccines or vaccine ingredients. The FDA subtly acknowledges that this testing format is inferior within their Code of Federal Regulations. The Code of Federal Regulations 21 CFR 201.57 states (emphasis mine):
Any statements comparing the safety or effectiveness of the drug with other agents for the same indication must, except for biological products [vaccines], be supported by substantial evidence derived from adequate and well-controlled studies as defined in 314.126(b) of this chapter unless this requirement is waived under 201.58 or 314.126(c) of this chapter. For biological products, such statements must be supported by substantial evidence.
The omission in that regulation is revealing. 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."
And yet despite this inadequate testing, sometimes it becomes obvious after licensing that unexpected and unwanted health changes are occurring in the population as a result of a vaccine. 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 the the next section of this article are described on a US 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 the US Department of Health and Human Services. 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.
So if the only possible long-term outcome of vaccination, within the body, is production of specific antibodies against a specific illness, and if during the body's process of developing those anti-bodies the only possible side effects that can manifest are short-term ones, like fever, pain and redness at the injection site, runny noses, etc, 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 also 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...
Vaccination and Autoimmune Disease
So impaired immune system actions can cause an autoimmune disorder, which is a condition where the body attacks itself. Let's look further into a general definition for what an autoimmune disorder is, using the Healthline website. Healthline explains (emphasis mine):
An autoimmune disease is a condition in which your immune system mistakenly attacks your body.
The immune system normally guards against germs like bacteria and viruses. When it senses these foreign invaders, it sends out an army of fighter cells to attack them.
Normally, the immune system can tell the difference between foreign cells and your own cells.
In an autoimmune disease, the immune system mistakes part of your body — like your joints or skin — as foreign. It releases proteins called autoantibodies that attack healthy cells.
Some autoimmune diseases target only one organ. Type 1 diabetes damages the pancreas. Other diseases, like lupus, affect the whole body.
...Because the incidence of autoimmune diseases is rising, researchers suspect environmental factors like infections and exposures to chemicals or solvents might also be involved.
A “Western” diet is another suspected trigger. Eating high-fat, high-sugar, and highly processed foods is linked to inflammation, which might set off an immune response. However, this hasn’t been proven.
Another theory is called the hygiene hypothesis. Because of vaccines and antiseptics, children today aren’t exposed to as many germs as they were in the past. The lack of exposure could make their immune system overreact to harmless substances.
Interesting again. They point out that infections, which I assume they mean infectious disease, and inflammation within the body may play a role in causing autoimmune disease. And the hygiene hypothesize theorizes that vaccines may inadvertently be playing a role by making our environment more clean and sterile. Their explanation implies that the germs we vaccinate against today are going extinct, and as a result people are not exposed to them anymore.
To quote an Australian Department of Health document, titled, Germs and disease, it says "Scientists have discovered many thousands of different types of germs. However, only some of these cause sickness in humans."
And in The Scientist Magazine, in an article titled, Viruses of the Human Body, it says (emphasis mine):
..."many viruses chronically infect humans without inducing disease, except perhaps in the very young, the very old, or the immunosuppressed.
...This flood of new information regarding our virome indicates that, even when in perfect health, we are chronically infected by several types of viruses and often transiently infected by yet others. The perception that every human virus causes disease is therefore yielding to a much more complex biological reality.
...Most viruses are neither consistently pathogenic nor always harmless, but rather can result in different outcomes depending on the health and immunological status of their hosts.
It seems the hygiene hypothesis is suggesting that vaccination has caused the near extinction of 16 types of germs (we vaccinate against 16 illnesses in the US and 15 illnesses in the Canada during childhood). And it also seems they are suggesting that because of the extinction of those 16 germs, our immune systems have forgotten that we are still exposed to thousands of other germs in our daily environment, of which many continue to infect us chronically and transiently on any given day. This hypothesis, that because we lack exposure to those 16 special germs, our immune system is now overreacting to harmless things and is attacking and killing the body instead, is hard to take seriously.
In contrast, I'd like to present an alternate theory, which points out that vaccines themselves might be causing autoimmune diseases outright, through their very nature of changing the immune system. The very premise of vaccination is to directly affect and alter the immune system itself, to cause the immune system to create antibodies where before there were none. That is common knowledge. What isn't common knowledge though, is:
the health authorities and manufacturers have assumed (not studied and proven) that vaccination only affects antibody production
the health authorities and manufacturers refuse to conduct long term targeted research and testing to determine all the ways that vaccination does affect immune system actions and functioning. (See Part 1 for specific details)
And when it comes to vaccines, we also know that:
vaccination does alter genes within the immune system cells and currently we have no idea what those gene alterations are, or did, nor do we know the affect those gene alterations had on immune system actions, functioning and performance
vaccination does simulate infection, eliciting the body to produce antibodies in response to the vaccine virus or bacteria, AND researchers already recognize that infection from wild bacteria and virus can lead to autoimmunity, and
vaccination does contain an adjuvant, which the sole purpose of an adjuvant is to create inflammation at the injection site, in an effort "to help" the immune system recognize it needs respond to the injection site. Once the immune system responds, it then notices the vaccine virus or bacteria. AND from Healthline's description above, researchers already hypothesize that inflammation resulting from Western diet may be causing autoimmunity
Recognizing that, it becomes reasonable to hypothesize that vaccines themselves might cause altered immune system actions which result in autoimmunity.
According to a research paper titled Autoimmunity and the Gut (emphasis mine):
Autoimmune diseases have increased dramatically worldwide since World War II. This is coincidental with the increased production and use of chemicals both in industrial countries and agriculture, as well as the ease of travel from region to region and continent to continent, making the transfer of a pathogen or pathogens from one part of the world to another much easier than ever before... The number of possible environmental triggers is vast and includes chemicals, bacteria, viruses, and molds.
There are many environmental factors that have changed and increased since WWII, in correlation with the increase in incidence of autoimmune diseases. To add to the listing they provide, I'd like to point out that the administration of vaccines have increased consistently and dramatically starting in the late 1940s. For example, between 1946-1948, shortly after WWII ended, Britain established legislation that allowed Government to more effectively roll out mass vaccination programs. Other countries throughout the world took similar mass vaccination steps during that same period of time. So vaccination is also a perfect correlative fit as well.
The paper goes on to say (emphasis mine):
Autoimmune diseases have registered an alarming increase worldwide since the end of the Second World War. This pandemic includes more than 80 autoimmune disorders and increases in both the incidence and prevalence of autoimmune disorders such as Crohn's disease, rheumatoid arthritis, multiple sclerosis, and type I diabetes. In the United States, it is far more commonly found in women and is one of the top 10 leading causes of death in female children and women of all age groups. The National Institutes of Health (NIH) estimates that 23.5 million Americans have an autoimmune disease. In contrast, cancer affects 13 million Americans. Symptoms involve many medical specialties and can affect all body organs.
Genetic predisposition, environmental factors (including infections), and gut dysbiosis play major roles in the development of autoimmune diseases. Autoimmunity develops over time, and preclinical autoimmunity precedes clinical disease by many years and can be detected in the peripheral blood in the form of circulating autoantibodies. Initially, symptoms of autoimmune disorders are vague and include fatigue, low-grade fever, muscle and joint aches, and malaise. They usually progress and become debilitating with significant morbidity. Patients are often seen by physicians only after their disease process has become symptomatic, clouding the understanding of the early events leading to disease.
So this paper is saying that before an autoimmune disease is accurately diagnosed, it is usually preceded by many years of vague symptoms, like fatigue, low-grade fever, muscle and joint aches, and malaise.
In contrast, vaccine safety trials monitor vaccine recipients closely for those symptoms, for 14 days or less, following receipt of each vaccine. After monitoring recipients closely for those 14 days for those symptoms, then as long as not too many participants drop dead suddenly, the vaccine is declared perfectly safe and it is then administered to an entire population, both the healthy and sick. After medicating the entire population, the Government admits they never again study the health of that entire population, to determine if the population's overall health improved, remained the same, or deteriorated, because in the CDC's word's, conducting such a study would not be "practical" or "ethical."
Even though the health authorities refuse to look into long term health outcomes further, in a vaccinated population, concerning connections are being made. The Autoimmunity and the Gut paper goes on to explain one role that vaccination has played, in causing at least two autoimmune conditions. The paper states (emphasis mine):
There are a host of environmental factors that trigger autoimmune disorders, including chemical toxicants, heavy metals, viruses, bacteria, emotional stress, and drugs. For example, adjuvants, such as aluminum hydroxide used in vaccines and medical silicones used in breast implants, can cause an autoimmune disorder known as Shoenfeld's syndrome. A recent study published in the journal Apoptosis demonstrates that hepatitis B vaccine causes liver cell destruction in Hepa1-6 cells. This cell death is attributed to the use of the adjuvant aluminum hydroxide, increasingly identified as a contributing cause of autoimmune disease in immunized patients. Studies show that hepatitis C is almost indistinguishable from autoimmune hepatitis based on biochemical and clinical features.
Narcolepsy and the Vaccines Pandemrix & Arepanrix
Let's get back to the Pandemrix / narcolepsy story. 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.
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 from earlier, that research stated a 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 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, with only 36% of the population participating (1,310,085 receiving the shot). 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 to nearly quadruple the expected rate of narcolepsy for every one million people. This is just one Alberta clinic, and 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.
Labelling Changes - A Consumer's Warning
Included within every box of vaccines is a package insert, often referred to as the "label" or "monograph." The product "label" is 20-60 page document, giving a detailed summary of:
the purpose of the medication
who should and should not take the medication
the best data proving safety and effectiveness based on all studies completed
the possible side effects of the drug
warnings of what might happen if you take the drug.
It is important to note that the 1-3 page handouts given to patients (or parents) in the doctor's office are NOT the package insert. Those brief 1-3 page handouts are condensed summaries and are often called "consumer information sheets."
Also important to note, health professionals are required to report any health conditions that occur in close proximity to receipt of a vaccine. As a result of that reporting, the manufacturers voluntarily update their product labels, or the FDA or other regulatory agencies require them to make updates.
One section of warning that is included in those package inserts is usually titled "Post-marketing," and the post-marketing introduction usually begins with a similar statement as quoted below:
Decisions to include these events in labelling were based on one or more of the following factors: 1) severity of the event, 2) frequency of reporting, or 3) strength of causal connection to [this vaccine].
Again, if you look at the FDA Code of Federal Regulations 21 CFR 201.57 you learn that only adverse effects that likely have a causal relationship with the vaccine, are to be included on these package inserts. The Code of Federal Regulations states:
For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.
So, if you see an adverse event or medical condition listed anywhere on the package insert, it's because the manufacturer and FDA have reason to believe that condition is linked to the vaccine.
Below is a consolidated list of all the serious and deadly health conditions that the manufacturers warn may be caused by vaccines. Instead of conducting the proper long term placebo controlled studies, to determine whether or not the vaccine causes these outcomes, they instead provide a vague blasé warning within their insert, with carefully chosen wording which gives the reader the impression that there is no causal relationship. This vague warning also gives the manufacturers legal protection. Should a person experience that medical condition following vaccination, and should that person sue the manufacturer for damages (in many countries like the US you can't sue the vaccine makers) the manufacturer then points to the lengthy product label saying, "We provided the appropriate information, in warning, and by accepting receipt of this vaccine the recipient subsequently agreed to accept any risk of those potential outcomes."
A listing of the various serious health conditions that vaccine makers point to, subtly, to give warning, are provided below (most condition names listed below do link to Government or manufacturer webpages that explain those various conditions in greater detail). I've noted each condition that is related to impaired immune system action:
It's interesting to see that in the manufacturers listing above, they admit that vaccination may be causing at least 11 different serious immune disorders or autoimmune diseases, in addition to the other 25 serious adverse events and health conditions listed.
Seeing as autoimmune diseases (which is the immune system attacking the body) have increased dramatically since WWII, then it only makes sense to start by looking first at the changes we imposed, intentionally and directly onto the immune system itself. Vaccination is the only environmental change that fits that bill. That's not to say other factors have not played a role, there may be many factors at play. BUT, vaccination is the ONLY environmental change that we have imposed since WWII, where its sole intent was to directly affect the immune system itself. Nothing else has had the same intent.
We regularly hear that vaccines rarely cause serious side effects, and such a statement is usually quantified by saying "serious adverse events occur only once in every one million doses of vaccine administered." But that statement is based upon assumption, not upon scientific testing and comparison against a never vaccinated control group.
Remember, according to the Autoimmunity and the Gut paper, it explained that autoimmune diseases can take years, before vague symptoms progress and become debilitating enough that a doctor is able to diagnose an autoimmune disease. Of course, we've learned directly from the manufacturers that most vaccine trial participants are monitored for a whopping 14 days or less, following each dose of vaccine received.
So, using the commonly stated claim that vaccination harms only one in a million recipients, it also becomes reasonable to use that same figure to hypothesize that maybe vaccination causes one additional occurrence of each of the above listed serious adverse events that the manufacturers warn of in their package inserts (27 serious outcomes NOT including the autoimmune diseases). And of course, we can hypothesize that vaccination may lead to the eventual development of each of the 80 autoimmune diseases, each occurring once in every one million vaccinations. With that hypothesis, that gives a total of 107 different serious possible adverse outcomes, and if each of those outcomes occurs only once in every one million vaccine appointments, then that would mean that a serious adverse event will happen immediately or symptoms will progress gradually over years, one time within every 9,345 vaccine appointments. And that reasonable hypothesis is a far cry from the one in a million that they assume occurs.
Canaidan researchers found one additional case of narcolepsy for every one million vaccinated. That subtle increased rate of narcolepsy in Canada would never have been detected, had it not been for an explosion of narcolepsy cases occurring in Finland, following Pandemrix vaccination. Only because of that explosion, because Finland asked, "Are you experiencing this too?" did Canada look. Of course when Canada was first confronted with Finland's inquiry, officials in Canada responded "No, there's no additional narcolepsy here." But after looking directly for it, they discovered evidence that their initial assumption was very wrong. And again, that comparison within the Candian study, and within all observational post-marketing studies for that matter, was a comparison between vaccinated and differently vaccinated people. What might be the result if we compare vaccinated people to the never vaccinated.
Vioxx Labelling Changes
One of the most challenging issues we face within this vaccine controversy, is time. For those of us who are deeply concerned about a lack of data for vaccine safety, we face the frustration that time has not been working in our favour. The studies we want to see done, they are not being conducted, nor does it appear that they will be conducted in the near future. Not only that, these studies will take years to complete.
And, although time can be a very frustrating th