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FDA Acknowledged That Vaccine Technology Outpacing Ability to Predict Adverse Events

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 Lyn Redwood, R.N., M.S.N., Executive Director, World Mercury Project

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Recently, top-tier autoimmunity researchers described vaccine safety science as a “hazardous occupation.” In their view, this is because uncompromising vaccine proponents are instantly ready to mount vociferous personal attacks on anyone who raises questions about any aspect of vaccine safety, even if the questions are buttressed by impeccable, high-quality science. Vaccine safety was not always such a taboo topic. In 1961, a leading polio researcher put forth the view in Science that “even after licensing, a new vaccine product must be considered to be on trial” because of the many “new variables” that accompany large-scale vaccine production and rollout.

uncertainties about new vaccine technologies could easily result in a “black box” situation of unforeseen and unpredictable vaccine outcomes.

A leading Food and Drug Administration (FDA) official contended in 1999  that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a “black box” vaccine” referring to a situation of unforeseen and unpredictable vaccine outcomes.”

Dr. Patriarca also voiced concerns that with live attenuated vaccines “there is the potential for these vaccines, many of which have been poorly characterized to recombine with viruses that may be present in the vaccine.  Some of these viruses are latent and persist for a while, so it is very important to assure that these things are safe before they are given to people.”

In the two decades since the FDA official’s prescient words of warning, numerous published studies have highlighted vaccine safety concerns that were either unexplored or neglected prior to the introduction of the vaccines in question. Troubling issues have included the presence of adventitious agents and contaminants in vaccines and the rise of new allergies associated with synthetic vaccines. Studies also highlight major gaps in the methods, protocols and timelines used to assess vaccine safety.

First rotavirus vaccine debacle

The checkered history of rotavirus vaccines in the U.S. confirms the vital need for new vaccines to remain “on trial” after their launch in the general population. In 1998, the U.S. government licensed the first rotavirus vaccine, RotaShield, a tetravalent live-attenuated vaccine that used a genetically engineered rhesus monkey rotavirus along with three rhesus-human reassortant viruses. Other rhesus-based rotavirus vaccines previously had “failed to prove safe for administration in infants.” According to a detailed account of RotaShield in the Milbank Quarterly, the vaccine’s manufacturer, Wyeth, bragged about the vaccine as one of its “new, breakthrough therapies” and expressed the hope of establishing a large, profitable market in the U.S. as a prelude to marketing RotaShield in developing countries.

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…reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction.

Despite the initial optimism, Wyeth had to commercially withdraw RotaShield one year later, when reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction. For infants in their first year of life, intussusception risks increased 20 to 30 times within two weeks of receiving the first dose of RotaShield.

According to the Milbank Quarterly description, a 1997 pre-licensing regulatory review meeting led by the FDA’s Vaccines and Related Biological Products Advisory Committee had given Wyeth’s hired hand (a university professor) “a minute or two maximum” to discuss intussusception risks. There were “no follow-up questions…and no further discussion…during the remainder of the meeting,” despite the scientist’s expressed concern that “with larger numbers perhaps a causal relationship might emerge.” Nor did attendees consider intussusception at subsequent meetings of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), where, despite the professor sharing her intussusception data, vaccine cost-effectiveness was the focus of discussion. It was not until an estimated 500,000 children received at least one million doses of RotaShield that the FDA suspended the vaccine, at first temporarily and then permanently, without ever explaining the “precise mechanism” by which RotaShield caused intussusception. Ironically, the government subsequently trumpeted the RotaShield story as proof that “the systems established to detect and respond to vaccine safety concerns are effective.”

The second rotavirus vaccine debacle

Two new genetically engineered oral rotavirus vaccines entered the vaccine marketplace in 2006 and 2008, respectively: RotaTeq, a pentavalent (five-strain) bovine-human reassortant rotavirus vaccine made by Merck, and Rotarix, a live-attenuated single-human-strain rotavirus vaccine manufactured by GlaxoSmithKline (GSK). Although pre-licensure trials found no evidence of an association between the two vaccines and intussusception, post-licensure monitoring later indicated a statistically significant increased risk of intussusception events for all rotavirus vaccines. Unlike with RotaShield, FDA merely instructed Merck, in 2013, and GSK, in 2014, to update their labeling and prescribing information to include brief statements about increased intussusception risks but otherwise allowed the two vaccines to remain on the market.

…the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Meanwhile, the much-vaunted industry and governmental safety systems that ushered the two rotavirus vaccines to market failed to detect an additional and highly concerning problem, which an academic research team “unexpectedly” identified in 2010. While conducting “a novel, highly sensitive analysis not routinely used for adventitious agent screening,” the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Although the short- and long-term dangers from PCV1 and PCV2 are as yet unknown, the pioneers of genetic engineering foresaw horizontal gene transfer—the direct uptake and incorporation of genetic material from unrelated species—as a clear risk of genetically engineered vaccines. Unlike chemical pollutants, nucleic acids are infectious and can invade cells and genomes, multiplying, mutating and recombining indefinitely. Potential hazards of horizontal gene transfer include generation of new disease-causing viruses and bacteria (or reactivation of dormant viruses); spread of drug and antibiotic resistance genes among viral and bacterial pathogens; and random insertion into genomes of cells resulting in cancer.

If this contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At issue, in the example of RotaTeq and Rotarix, are the dangers of incorporation of adventitious PCV contaminants from live rotavirus vaccines into the human host or host-related bacteria (such as the gut flora)—dangers unrecognized and, therefore, unexplored before the two vaccines went to market. There is also additional cause for concern based on research demonstrating that the pathogenic potential of PCV2 to cause an AIDS-like disease in pigs is unleashed when there is simultaneous vaccine-induced immune system activation. In light of this research, the current recommendationto administer PCV2-contaminated rotavirus vaccine along with five other vaccines—hepatitis B (HepB), diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzaetype b (Hib), pneumococcal conjugate (PCV) and inactivated poliovirus (IPV)—represents a high-risk scenario for disease in humans. If the contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At a 2010 meeting convened by FDA to discuss the PCV contamination, a GSK executive went so far as to concede that “evolving technologies can lead to new findings that were not known at the time of licensure.” Nonetheless, the GSK researchers expressed little worry, having framed the presence of the PCV DNA in their vaccine as a simple “manufacturing quality issue” rather than a safety risk. GSK even put a positive spin on the matter, suggesting that the PCV investigation “could serve as a model for risk assessment in the event of new technologies identifying adventitious agents in the manufacturing of other vaccines.”

Are unforeseen outcomes inevitable?

Shortly after the GSK discovery, FDA recommended that physicians temporarily suspend use of Rotarix and switch to RotaTeq, but when Merck’s vaccine was found to contain similar contaminants, FDA reversed course and allowed continued use of both. Instead of calling for new safety studies and completing a new risk-benefit analysis (taking into consideration that mortality from rotavirus disease in the U.S. is very low), the FDA once again reassured the public that the benefits of rotavirus vaccination outweighed any “hypothetical” health risks of PCV contamination. The agency’s sole follow-up action was to rubber-stamp updates to the Merck and GSK package inserts to “reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine[s].”

Can the assertion that the benefits outweigh the risks be taken at face value? Consider the history of the oral polio vaccine, which has used seed stocks contaminated with multiple strains of simian virus 40 (SV40) for over four decades. SV40 has been detected in the brains of deceased cancer patients who received the oral polio vaccine, and a 2002 Institute of Medicine report cited strong biological evidence that SV40 can transform normal cells into malignant cells. Whether the porcine circovirus contamination that afflicts the two current—and highly engineered—rotavirus vaccines will turn out to have insidious long-term health effects remains an unanswered question. Nonetheless, history indicates that we should not be surprised when novel and difficult-to-control vaccine technologies generate unforeseen outcomes.

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Study Reveals Popular Vaccine “May Kill More Children From Other Causes Than It Saves”

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In Brief

  • The Facts:

    Multiple studies have shown and emphasized that the DTP vaccine may actually kill more children than it protects from DTP. This is one of the latest to show it, known as the Mogensen study.

  • Reflect On:

    Reflect on the fact that this information is never really brought up within the mainstream medical community. All it takes is one CDC study to "debunk" several studies that show opposite results. What's really going on here? Is our health a priority?

There are numerous vaccine safety issues. It can boggle your mind how health authorities and pharmaceutical companies can deem them to be completely safe, necessary, and responsible for saving millions of lives. When people hear this, they usually just believe it without ever looking into it and doing their research, and don’t realize they are only presented with one side of the story. If you have 100 studies raising an issue with a vaccine, all it takes is one study from the CDC to say it’s safe, and that’s the research medical associations dish out to doctors as well as medical schools. After all, the pharmaceutical companies are the ones paying for the whole shebang; what they say, goes.

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue.” – Richard Horton, current Editor-in-chief of The Lancet 

Heavy Metals

One example would be the vaccine ingredients themselves. Heavy metals, like aluminum and mercury, have been added to vaccines for approximately 100 years without any appropriate safety testing. Numerous studies point this out.  You can access some of those studies and see some examples here.

Fast forward to 2017: researchers have now identified, in animal models, that the aluminum from a vaccine does not exit the body like aluminum from, let’s say, our food; it actually stays in the body, travels to distant organs and eventually ends up in the brain. Not only that, researchers also found some of the highest brain aluminum content ever measured in autopsies of the brains of people who were autistic.

You can read more about that and access those studies in the articles linked below:

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Study Shows Where ‘Almost 100 Percent of Aluminum From Vaccines Could Go Inside A Baby’s Body’

‘Some of the Highest Values For Brain Aluminum Content Ever Measured’ Found In People With Autism

It is simply no longer possible to believe…or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine. –  Dr. Marcia Angell

Questioning Vaccine Safety Is Suppressed

With all of these issues, why is there such a harsh reaction to questioning vaccine safety? Why can’t a doctor or professor keep their job if they question vaccine safety? Isn’t science about openly questioning? The day we stop questioning, when there are clearly multiple concerns and questions to be asked and addressed, is the day we abandon the possibility of doing real science.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”  – Arnold Seymour Relman (1923-2014), Harvard professor of medicine and former Editor in Chief of The New England Medical Journal (source)

The issue here is, vaccines are marketed as completely safe, and anybody who questions vaccines is made out to look crazy, dumb, or unscientific. This couldn’t’ be further from the truth, and there are a number of valid reasons why parents should not be forced to vaccinate their child. 

The DTP Vaccine

Robert F. Kennedy Jr. has long been a vocal critic of the lack of scientifically-based vaccine testing:

The public in both poor and rich countries has a right to scientifically-based evidence that international vaccine programs are as safe as possible and that they have been thoroughly safety-tested.  The best metrics for measuring safety are studies comparing health outcomes of vaccinated versus unvaccinated cohorts.  Yet, both the CDC and the WHO have aggressively discouraged the pursuit of such studies. – RFK Jr.

He wrote an article that goes into more detail about the DTP vaccine, it’s history, and what the current research suggests. It is becoming difficult to avoid the conclusion that the DTP vaccine is causing more harm than good.

Study Finds Higher Mortality In Infants Who Received The DTP Vaccine Compared To Those Who Didn’t

In the video below, I go into more detail about the DTP vaccine. HERE is the study I reference in the video.

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Simple Exercises To Help Reverse Damage Caused From Excessive Sitting

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In Brief

  • The Facts:

    In our modern lifestyle, we are sitting too much and for too long periods of time. This level of sedentary lifestyle is not natural for our bodies and could lead to very serious health issues if we do not address this issue.

  • Reflect On:

    How could you be more active throughout your regular day to reduce the impacts of sitting too much? Can you make some of these simple excises a daily habit to help limit the damages of sitting?

If you are here and reading this, chances are you have a job that involves long periods of sitting, and most likely staring at a screen. This has become the norm in our modern society and because our bodies are designed to move, to stretch and well, basically to be used, sitting for extended periods of time is causing us some serious damage. Some people are going as far as to say that sitting is the new smoking.

Have you experienced those moments when you finally get up from a sitting position and your butt is completely numb? Excessive sitting causes your legs and hips to become tight and leaves your glutes completely inactive, which does nothing to strengthen these areas. Then there is the dreaded slouch over the desk and computer that could be ruining your posture as well.

Think about how our society was before the industrial revolution, stock market and even recently with the invention of the computer. Us humans were tending our own gardens, washing and hanging our own clothes, we didn’t have cars and were, by default, much more active than we are today. We didn’t even have couches to sit on at the end of the day or more screens, in various shapes and sizes to stare at whilst sitting. It is straight up unnatural for our bodies to spend so much time being inactive and we are starting to see the consequences.

However, having awareness is the first step towards change, and there are some simple ways that you can begin to undo the damage that is caused by sitting. So without further a due, here are 7 simple exercises you can do now to reduce the damage caused by sitting.

Sit Less & Move More

Prevention is the best remedy. By simply being aware of how much you are sitting, you can begin to negate its effects. Whenever possible stand up, go for a little walk around the office, perhaps a little stretch or plank while you’re at it. To remind yourself to do this you can set a timer to go off every 30-60 minutes.

Consider using a standing desk perhaps to keep you on your feet and activating your muscles for longer, although you will still want to ensure you are incorporating some movement, as standing for hours on end is not necessarily good for you and your body either. A friend suggested a great idea to me once, which was to drink plenty of water. This will force you to get up often, not only to get more water but to also relive your bladder, this sounds silly, but it totally works. Plus, there’s nothing wrong with staying hydrated!

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Stretch Out Those Hips

If you are really tight, the following exercises may be difficult at first, don’t push it only go to your level of comfort. With time you will gain the flexibility to go deeper as it will get easier after a while.

Squats

Nothing like some good old-fashioned squats to engage your glutes and your legs. Stand up tall, have the feet about hip width apart and facing a little bit outwards, bend down so your knees are at about a 45-degree angle, come up and flex your glutes when you do. Repeat 10 times to start, increasing every time you do this.

Downward Dog

This is a classic move that you may already know if you’ve ever taken a yoga class. If you haven’t — no sweat, it’s a fairly simple exercise. Stand up straight and bend over, place your hands in front of you on the ground and slowly walk them out. If you are on your tiptoes for this, that’s totally fine, you want your body to be in a “V” shape. Hold this pose for 10 – 15 seconds at first, then increase the duration as you get comfortable. To come out of this position, walk your hands slowly back to your feet than stand up tall. You may be able to eventually have your feet flat on the ground as you do this, but it may take some time to achieve this.

Plank Position

The plank position is great for whole body strength. Simply get into a standard push up position, or rest your elbows on the floor, ensure your back is flat, like a plank and hold for 20 seconds to start. Over time, you can increase the duration of this exercise. It is an excellent way to strengthen the core and gets your legs and glutes involved as well.

Glute Bridge

Lay on your back on the ground, bring your legs up so your feet are about 1 foot away from your butt, place your hands flat on the floor and begin to raise your pelvis off the ground. Repeat 20 times, ensuring to flex those glutes every time you lift up. As this becomes easier, increase the number of repetitions.

Spinal Twist

Sit on the floor with your legs out in front of you. To start, bring in your right knee and cross your foot across your left leg, hug your right leg into your body while sitting up straight. Hold this pose for 10 seconds then switch legs. As this becomes easier you can move on the

Leg Swings

Start this exercise by finding something to hold onto for balance. Start by swinging your right leg backward and forwards as high and as far back as feels comfortable to you. Repeat 20 times then switch legs.

Next up is side to side leg swings. Keep holding onto something for balance and swing your right leg out to the side as high as is comfortable and then in front of you towards your left as far as you can. Again, do 20 swings then switch legs. You may repeat if you are feeling especially tight.

Much Love

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Family Constellation Therapy & It’s Role In Healing Autism

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In Brief

  • The Facts:

    Trans-generational traumas add to our toxic burden and predispose us to illness. Misfortune or unresolved conflict in our ancestry can create disturbances which filter down into the psyche, nervous system and metabolic functioning.

  • Reflect On:

    What conflict exists in your ancestry? Could it be impacting your family's health?

Family Constellation Therapy, sometimes known as Systemic Constellations, was created by Bert Hellinger, a German psychotherapist. This amazing method is used to uncover the source of chronic conditions, illnesses and emotional difficulties that may have roots in the inter-generational family systems, rather than the individual, and may be connected to a key stress event.

Could resolving past family trauma help unlock the symptoms known as autism? Sadly, some form of autism is now observed in 1 in 55 children and is growing at a rate of more than 1,100 percent. Western medicine focuses on medication to suppress symptoms and alternative approaches focus on treating the underlying biomedical, physical, psychological and environmental causes of autism.

However, illness not only originates in our physical body, but can also originate in our energetic and spiritual body as well. So, it becomes imperative that we treat the entire person for a fuller recovery.

“Autism spectrum disorders can only be fully healed by restoring the self-regulation of the system and making it fully functional.” – Dr. Dietrich Klinghardt

This moving and powerful work in the family’s energetic field is also referred to as “the knowing field.” And, is used to examine the emotional factors connected to conditions such as illness, allergies, alcoholism, ADHD and autism. Some parents of children on the autism spectrum have experienced profound transformations as a result of this work for themselves, as well as for their families.

These children are often the recipients of unhealed trans-generational family issues because of their extraordinary energetic sensitivities.  This perpetuates their illness.

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Family constellation therapy work, focuses deeper on the ancestral family blueprint – the family soul. Our souls carry information from one lifetime to the next and from one generation to the next.

Children often hold the energetic field of their ancestors. This appears especially true with children with autism, because they are super-sensitive and spiritual souls. Who, often become unconsciously entangled with others in their family in the name of belonging or wanting to help restore balance in their family system. The purpose of a Family Constellation therapy session is to reveal that hidden dynamic and point the way toward resolution. And, there are often magical improvements in these children when we resolve issues in the family history.

The Forgotten One

One of the participants in a group “Michelle,” has a brother with severe autism who couldn’t speak and was very self-destructive. She was afraid that he could never live a more “normal” life because he refused all biomedical treatment and other therapies offered to him. In the initial set-up, the facilitator had Michelle, her brother, and both parents of her family represented  in “the field.”

The participant representing her brother was hiding under a nearby chair and was rocking back and forth. Both parents were standing in the field, seemingly disinterested in what was going on. The sister (Michelle) kept looking down at the floor. Later in the set-up, it was revealed that the sister was looking down at a baby—a baby who had died of birth defects three generations ago. This baby hadn’t been properly acknowledged or mourned.

In essence, the brother with autism had taken the place of the “forgotten” baby. Representatives for the great-grandparents (the forgotten baby’s parents) were brought into “the field.” Then, the baby was embraced by the parents and a short dialogue was exchanged. The baby reported that he felt more at ease, relaxed and became more comfortable. A healing took place that was so profound.  A year later, “Michelle” reported that her brother was starting to take a more active role in his recovery and was beginning to accept treatment.

War and Mental Illness

“Andrew,” a man in his twenties who was diagnosed with Asperger’s, participated in my group. He claimed that mental illness and psychosis ran in his family. He cried as he explained that he was taking multiple medications for bi-polar disorder. He claimed it was difficult for him to hold down a job.  He often felt very alone. He stated that he did not have a good relationship with his parents. He said that his mom was “crazy.” The parents divorced when he was very small and he blames himself and his issues for why they split.

In the initial set-up of “his field,” Andrew was represented along with mental illness and his parents.   As it unfolded, it became more obvious that something profound had happened in the past. Mental illness began taking on characteristics of a war and hidden dynamics were revealing themselves.

Later in the set-up, Andrew’s representative started choking, like he was trying to catch his breath. He was mumbling, “I deserve death because I have killed others.”

It was uncovered that his great-great grandfather was in World War I and was killed during a mustard gas attack. Andrew was doing service to the family out of deep love. He took on the feelings of the victim and the perpetrator, which caused him deep inner conflict. Hence, he was carrying the burden of mental illness and autism. In doing this soul work, Andrew was able to find resolution for himself as well as all the members of his family.

In conclusion, trans-generational traumas add to our toxic burden and predispose us to illness. Misfortune or unresolved conflict in our ancestry can create disturbances in the family field, which filter down into the psyche, nervous system and metabolic functioning. Children with health issues are particularly sensitive to such disturbances.

Therapy and biomedical interventions may even succeed better after a healing Family Constellation session with an experienced facilitator. Fortunately, it is never too late to heal wounds from the past. Constellation work is unique in that any living family member can do this intervention for the benefit of all.


Learn more about my family’s healing journey (including everything that has worked for me and many of my clients) in my book Healing Without Hurting. And to receive more info on how you and your family can overcome ADHD, apraxia, anxiety and more without medication SIGN UP HERE.

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