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Major Pharmaceutical Company Wants To Block Access To Clinical Trial Data Of Their Drugs In Fear of Profit Loss

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abbiveAbbVie (recently split off from Abbott Laboratories), maker of Humira, and InterMune, maker of Esbriet, have filed a lawsuit against the European Medicines Agency (the European equivalent of the FDA) to block access to clinical trial data on the benefits and harms of their drugs, claiming that these vital facts are “trade secrets” whose release would harm their profits. Medical researches have been denied to clinical trial information.

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Of course, when a drug causes cancer, release of clinical data information could potentially harm the profits of the company that makes it. Humira, a drug that is quickly becoming one of the best-selling drugs in the world, mainly because of the marketing techniques used by AbbVie, causes cancer.

Here’s one of their ads – don’t forget to feel bad about your plaque psoriasis.

The FDA warning label on Humira warns of increased risk of “Lymphoma and other malignancies” including “a rare type of cancer called hepatosplenic T-cell lymphoma” that “often results in death,” along with “increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.” Since the FDA is pretty slow on the uptake of actually putting adverse effects of drugs on their warning labels, I’ll mention that, in addition to Lymphoma, TB and other infections, Humira is also linked to the following:

  • Leukemia
  • Skin Cancer
  • Candidiasis
  • Kaposi’s Sarcoma
  • Histoplasmosis Cryptosporidium

All of which can lead to death.

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No wonder AbbVie wants to hide their data from their clinical trials. The data from their clinical trials is undoubtedly incriminating. And of course it would effect sales if people knew about the risk of cancer and death associated with this drug.

Though the effects of these drugs are horrifying, they are on the warning label, and thus aren’t newsworthy (though they should be, we all should be having fits over what these dangerous drugs are doing to people). What is newsworthy is the fact that AbbVie and InterMune are trying to block access to information about their drugs. This truly is an atrocity. Not only is AbbVie going to make a drug that maims and kills people, but they’re going to block access to the clinical data that describes what happened to the drug’s victims and how it happened, presumably so that they can lie about it, and, worse, Researchers won’t have access to the data and therefore they won’t be able to learn from it.

To hide information is an affront to science and the scientists who are trying to do research into the safety and efficacy of medicines. It is an affront to Doctors who are trying to make the best, informed decisions regarding medicine that they prescribe. It is an affront to Patients who have the right to informed consent before any pharmaceutical is administered or medical procedure is done. Informed consent is a bedrock of medicine, and thus it is an affront to medicine. Informed decisions are even a foundational principle of capitalism, so it is even an affront to capitalism, the thing that AbbVie and InterMune claim that they are trying to optimize. It is an affront to democracy as information is needed in order to hold those in power (sadly, corporations) responsible. Most importantly, it is an affront to the truth.

While the lawsuit is pending, ALL requests for AbbVie’s and InterMune’s clinical trial data, that were to be released on demand, are being denied until the suit is resolved. While I hope that the European courts will decide in favor of transparency, openness and truth over corporate profits, AbbVie and InterMune are benefiting in the meantime. It’s a pretty good bet that they’ll keep several hundred lawyers employed stopping up the system indefinitely, as they’re getting exactly what they want just by filing the suit and delaying.

This sets a horrible precedent in countless ways. It shows that transparency and truth are optional for big pharmaceutical companies, that optimizing profits is not only more important to these drug manufacturers than truth, transparency and safety, but that optimizing pharmaceutical company profits is also something that the European Medicines Agency is willing to protect; that truth, informed consent and access to complete information is something that is optional if a company has enough money, power and lawyers; that consumer protection rules and regulations can be obstructed simply by filing a law suit, etc.

Even though this suit is going on in Europe, don’t for a second think that it doesn’t effect those of us in North America. The European Medicines Agency (EMA) has released more data to North American researchers than to anyone else – so it already is a North American issue. The FDA make much less data available than the EMA, so the only way U.S. Activists or Researchers can access full data-sets is through the EMA. So, this legal action is blocking Americans right to know as well as Europeans. Also, if a big, powerful, rich, American corporation can manipulate the release of information in their favor by tying up the courts with absurd litigation in Europe, you can certainly bet that they can do it here.

An affront to truth and democracy anywhere is a fight that is worth fighting, especially when the truth that is being hidden is something that effects whether humans live or die.

What should be done about this?

First, AbbVie and InterMune should drop their suit. Here’s a petition encouraging them to do so –

https://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data

Second, the European Medicines Agency should continue to release information while the suit is pending. In stopping the release of clinical trial data they are effectively letting AbbVie and InterMune win before the battle is even fought in the courts.

Third, there should be some screaming about this. The media has been close to silent about this and it’s a failure on their part. Access to information is vital for journalism too, so journalists, get on this.

If AbbVie and InterMune’s suit and their line of thinking that their profits are more important than free access to information for patients, researchers, doctors, etc. is as offensive to you as it is to me, you can certainly join me in writing letters to political leaders, media outlets, etc., asking for outrage. I also took all money out of stock funds that could even possibly be invested in AbbVie or InterMune…. just a suggestion.

Post Script –

A huge thank you needs to go out to those at RxIsk.org RxISK is the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect — identifying problems and possible solutions earlier than is currently happening), Johanna Ryan, Dr. Derelie (Dee) Mangin and Dr. David Healy, author of Pharmagedon. Here are some posts on the topic at hand –

http://davidhealy.org/welcome-to-the-humiraverse/

http://davidhealy.org/stacy-london-what-not-to-take/

http://davidhealy.org/abbvie-petition-drug-hazards-are-not-trade-secrets/

Additional media sources –

http://www.bloomberg.com/news/2013-03-11/abbvie-sues-eu-regulator-to-block-clinical-trial-data-release.html

http://www.pharmalive.com/transparency-abbvie-sues-ema-over-trial-data

http://www.bizjournals.com/chicago/news/2013/03/11/abbvies-humira-focus-of-lawsuit-over.html

 

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Awareness

Multiple Scientists Explain How A Diet High In Protein Is NOT Good For Us – Even After Working Out

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In Brief

  • The Facts:

    The idea that we need to consume as much protein that is recommended to us by federal health regulatory agencies is not backed by much evidence. On the contrary, there is evidence suggesting that these guidelines are too high.

  • Reflect On:

    How truthful have our federal health regulatory agencies been? How much influence have big food corporations had on them? Has protein been used as a marketed tool? Is as much recommended really healthy, or unhealthy?

Protein is an extremely important and necessary component of every single cell in our bodies. Our bodies use protein for a number of things, from building muscle to repairing tissue, making enzymes, hormones and various other body chemicals. It’s essential, and we need it. But just as with anything else, too much of something can be detrimental, and this seems to be the case with protein. Even the recommended intake of approximately 60 grams per day for the average male, for example, is being called into question by multiple scientists and health experts.

Where did the idea that we need so much protein come from? Why do people take protein shakes after a workout? Why are vegans and vegetarians stigmatized with the idea that they do not get enough protein? Where did this type of thinking come from?

Protein is a huge money making tool for the food industry. It’s a great marketing tool, especially towards athletes and bodybuilders. The body building/athletic market alone provides a huge incentive to use protein as a marketing tool to drive up sales. But again, where is the science? Why do bodybuilders believe they need enormous amounts of protein to build muscle instead of just using food, and why aren’t we educated about the dangers of over-consuming protein?

For those of you who have looked into fasting, you know that multiple studies on fasting have shown extremely beneficial effects, from triggering autophagy and in turn repairing damaged DNA, to killing cancer cells and increasing longevity, to greatly reducing the risk of several different age-related diseases like Alzheimer’s  and Parkinson’s disease.

It was through my research into fasting where I came across, multiple times, the importance of a low-protein diet and how vital it is to retain the effects of fasting as well as good overall health.

Calorie restriction (CR) extends life span and retards age-related chronic diseases in a variety of species, including rats, mice, fish, flies, worms, and yeast. The mechanism or mechanisms through which this occurs are unclear.

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The quote above is from a review of literature that’s more than 10 years old. The work presented here is now showing some of these mechanisms that were previously unclear. Fast forward to today and we know a lot more.

A study published in the June 5, 2014 issue of Cell Stem Cell by researchers from the University of Southern California showed that cycles of prolonged fasting protect against immune system damage and, moreover, induce immune system regeneration. They concluded that fasting shifts stem cells from a dormant state to a state of self-renewal. It triggers stem cell based regeneration of an organ or system. (source)

There is so much literature on fasting and its benefits available for anybody who is curious. It’s easy to dive into the research through a scholarly search on Google, and there are multiple Youtube videos at your disposal of interviews with the scientists who are publishing these papers.

So, where does protein come in? Well, lower protein intake as well as fasting are correlated with a major reduction of IGF1 growth hormone.

A 2015 study published in Cell Metabolism is one of multiple studies that points out:

Mice and humans with Growth Hormone Receptor/IGF-1 deficiencies display major reductions in age-related diseases. Because protein restriction reduces GHR-IGF-1 activity, we examined links between protein intake and mortality. Respondents (n=6,381) aged 50–65 reporting high protein intake had a 75% increase in overall mortality and a 4-fold increase in cancer and diabetes mortality during an 18 year follow up period. These associations were either abolished or attenuated if the source of proteins was plant-based.

Before we go any further, I’d like to emphasize that there is a lot of literature suggesting that plant protein is far more beneficial than animal protein. I go into more detail and provide more sources in the articles linked below:

Plant-Based Protein VS. Protein From Meat: Which One Is Better For Your Body?

Scientist: Milk From Cows Has “The Most Relevant Carcinogen Ever Identified” & “Turns on Cancer.”

9 Things That Happen When You Stop Eating Meat

What about athletes and bodybuilders?

Who’s had this kind of protein intake before me? Nobody, right? So before these modern generations and all this push on protein nobody had a very high protein diet, not like this. So of course then that is, there is a danger of that we published a few years ago (referenced above), you know, three/four fold increase in cancer risk, seventy five percent increase in overall mortality. The mouse studies [and] the human studies, a great majority of them are negative for for high protein, and then if you look at the reasons for why they’re negative, well one of the things high protein controls is growth hormone and IGF1, and this pathway and axis really controls the growth and proliferation of cells. – Dr. Valter Longo, biogerontologist and cell biologist, one of the leading experts in the world regarding health science, longevity and the biological effects of fasting. (source)

Dr. Longo goes on to explain, as he references in his study above, that low protein intake means more longevity and more protection from diseases. In multiple interviews he recommends cutting in half your protein intake if you follow the daily recommended guidelines by health food authorities, I have also heard him say that after a heavy, strong workout, maybe only 30 grams, is required to build muscle.

If we look at the proliferation of multiple age-related diseases and cancers, the rates are extremely high and increasing. Could over-consumption of protein, among other reasons, have something to do with it?

Russel Henry Chittenden (1856-1943) looked into this issue in depth, before the mass marketing of high protein diets. He published 144 scientific papers as well as a text on protein requirements (Chittenden, 1904) that focused specifically on minimal protein requirements while resting or exercising.

Chittenden actually experimented on himself, and when he significantly decreased his protein intake, his health remained excellent without compromising any physical vigor or muscle. In this experiment he had less than 1 g per kg daily. He also did the same in a year long study, but with multiple athletic men in great health. They were also given the same low protein diet, and also suffered no deterioration of health or the ability to perform physical tasks. According to his research, even without a large protein intake, individuals were able to maintain their health and fitness levels.

In presenting the results of the experiments, herein described, the writer has refrained from entering into lengthy discussions, preferring to allow the results mainly to speak for themselves. They are certainly sufficiently convincing and need no superabundance of words to give them value; indeed, such merit as the book possesses is to be found in the large number of consecutive results, which admit of no contradiction and need no argument to enhance their value. The results are presented as scientific facts, and the conclusions they justify are self-evident. (source)

The bottom line? We don’t need as much protein as we’ve been made to believe.

Related CE Article: Fasting Does Not Burn Muscle: Here’s The Proof

The Takeaway

Personally, I’ve been experimenting with gaining muscle this year without any specific focus on protein post-workout, and I am gaining muscle instead of losing muscle. My gains are as strong as they were when I was in my late teens when I was really into bodybuilding. Right now, I am eating normal food, on a vegan diet, with half the amount of protein that’s recommended (less than 0.8 grams per 1 kilogram of body weight). My experience matches up with the information that’s been shared above.

Over-protein consumption seems to have been the result of food industry marketing. Why has nobody ever asked for any type of scientific proof or experiments when it coms to how much protein the human body requires? Why have we simply believed that a diet high in protein is an absolute necessity, simply based on the fact that we know protein from food is necessary? Why didn’t we ask for proof until now?

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In order to stay truly independent, we need your help. We are not going to put up paywalls on this website, as we want to get our info out far and wide. For as little as $3 a month, you can help keep CE alive!

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Lyme Disease: The CDC’s Greatest Coverup & What They Don’t Want You To Know

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Image by Catkin from Pixabay

Lyme disease, do you have it? If you did, you probably wouldn’t know – unless you’re one of the chronic sufferers that have had to visit over 30 doctors to get a proper diagnosis. Lyme disease tests are highly inaccurate, often inconclusive or indicating false negatives.

Why? Because this clever bacteria has found a way to dumb down the immune system and white blood cells so that it’s not detectable until treatment is initiated. To diagnose Lyme properly you must see a “Lyme Literate MD (LLMD),” however, more and more doctors are turning their backs on patients due to sheer fear of losing their practices! Insurance companies and the CDC will do whatever it takes to stop Chronic Lyme Disease from being diagnosed, treated, or widely recognized as an increasingly common issue.

Lyme is considered by the medical field to “only” transmit by way of a tick infected with bacteria. However, the CDC itself admits it is under-reported, and believes there are between 300,000 to half a million new cases each year. That makes Lyme disease almost twice as common as breast cancer and six times more common than HIV/AIDS. Where are all of these new cases coming from? (It’s interesting to note that since Avril Lavigne recently went public with her Chronic Lyme Disease battle, mainstream news outlets like The Daily Mail have been mentioning Lyme can be transmitted by mosquitoes, too!)

lyme-disease-tick

When Lyme isn’t detected in the early stages, it becomes Chronic Lyme, a condition which the CDC and IDSA both deny even exists. They will continue to deny it, because if there’s one thing insurance companies hate, it’s chronic disorders they have to spend time and money treating. Therefore, a panel with ties to insurance companies gathered to write up official Lyme guidelines that assure patients are only allowed a few weeks of antibiotic treatment and are not to be diagnosed with Chronic Lyme Disease (even if clear symptoms persist and invade the nervous system). Over half of the panelists who wrote the IDSA Lyme guidelines announcing that Chronic Lyme is not real — including the panel chairman — have obvious conflicts of interest including financial interests in drug companies, diagnostic tests, and patents, as well as consulting agreements with insurance companies. Researchers and scientists with evidence in support of Chronic Lyme were intentionally excluded from the panel. Because of these unjust Lyme guidelines, insurance companies have the “right” to deny coverage for the treatment of long-term Lyme disease. Doctors have even lost their practices for successfully diagnosing and treating Chronic Lyme, as shown in the film Under Our Skin. In the case of Dr. Joseph Jemsek of North Carolina, he not only lost his license, but also his livelihood. Dr. Jemsek can no longer practice simply because he gave antibiotics to Chronic Lyme sufferers, and was then sued by BCBS for 100 million dollars, following which he had to declare bankruptcy. You can read his closing remarks to the NC Medical Board just before they pulled his license here. You can also watch his story in the documentary at the end of this post.

Busted – Big Pharma bucks taint the IDSA

Connecticut Attorney General Richard Blumenthal investigated the IDSA panel members for possible violation of antitrust laws and conflicts of interest.

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Of the 14 panel authors of the first edition guidelines: 6 of them or their universities held patents on Lyme or its co-infections, 4 received funding from Lyme or co-infection test kit manufacturers, 4 were paid by insurance companies to write Lyme policy guidelines or consult in Lyme legal cases, and 9 received money from Lyme disease vaccine manufacturers. Some of the authors were involved in more than one conflict of interest. (Source: ‘Under Our Skin [2008])

Study: Strong Evidence Of Sexual Transmission

The bacteria that causes Lyme disease is Borrelia burgdorferi, a type of corkscrew-shaped bacteria known as a spirochete. The Lyme spirochete is a cousin to Treponema pallidum, the spirochete that causes syphilis.

Dr. Alan MacDonald, MD who appears in the documentary ‘Under Our Skin’ (2008), says in the film that he found found Borrelia (Lyme) DNA in 7 out of 10 postmortem Alzheimers patients’ brains. This makes perfect sense, since syphilis, its cousin, also invades the brain in tertiary or neurosyphilis. Dr. Klinghardt, MD (also quoted from ‘Under Our Skin’) stated that he’s “never had a single patient with Alzheimer’s, ALS, Parkinson’s Disease or Multiple Sclerosis who tested negative for Borrelia.”


Dr. Alan MacDonald, MD talks about Lyme.

Why are so many people suffering from Lyme disease and its allegedly associated chronic disorders, such as Alzheimers and ALS? A new study suggests that just like its spirochete cousin that causes syphilis, Lyme disease may be sexually transmitted! The study was presented at the annual Western Regional Meeting of the American Federation for Medical Research, and an abstract of the research was published in the January issue of the Journal of Investigative Medicine.

Medical Daily reports,

The study — presented at the annual Western Regional Meeting of the American Federation for Medical Research — a collaborative effort by an international team of scientists — tested semen samples and vaginal secretions of three groups of patients to investigate whether passing Lyme disease to a partner through unprotected sex is a possibility. The study observed control subjects without evidence of Lyme disease, random subjects who tested positive for Lyme disease, and married heterosexual couples engaging in unprotected sex who tested positive for the disease. The presence of B. burgdorferi and identical strains of the bacterium were of particular interest to the researchers in unprotected sex in spouses.

The control subjects were found to test negative for the bacterium in semen samples or vaginal secretions, as expected by the researchers. The researchers found traces of B. burgdorferi in the vaginal secretions of all women with Lyme disease. In contrast, approximately half of the men with the disease tested positive for the bacterium in semen samples. In addition, one of the heterosexual couples with Lyme disease were found to have identical strains of the bacterium in their genital secretions.

One researcher in the study notes, “There is always some risk of getting Lyme disease from a tick bite in the woods. But there may be a bigger risk of getting Lyme disease in the bedroom.”

“Our findings will change the way Lyme disease is viewed by doctors and patients,” said Marianne Middelveen, lead author of the study. “It explains why the disease is more common than one would think if only ticks were involved in transmission.” But will this actually change the way Lyme disease is viewed? Or will the money funneled in by insurance companies and vaccine manufacturers continue to blind and corrupt the IDSA board members? When is enough, enough?

The study was a joint effort by a team of scientists which included dermatologists, molecular biologists, microbiologists, internists, and family practitioners. The most revealing aspect of the study, in my opinion, is the fact I mentioned earlier: one of the heterosexual couples with Lyme disease showed identical strains of the Lyme spirochete in their genital secretions. “The presence of the Lyme spirochete in genital secretions and identical strains in married couples strongly suggests that sexual transmission of the disease occurs,” said Dr. Mayne.

Gestational Transmission From Mother To Child

From LymeDisease.org:

A North Carolina State University researcher has discovered that Bartonella (a common Lyme co-infection) can be passed to unborn babies, causing chronic infections and possibly birth defects. Dr. Ed Breitschwerdt and his research group tested blood and tissue samples taken over a period of years from a mother, father and son who had suffered chronic illnesses for over a decade. Autopsy samples from their daughter–the son’s twin who died shortly after birth–contained DNA evidence of B. henselae and B. vinsonii subsp. berkhoffi infection, which was also found in the other members of the family. Breitschwerdt’s research appears online in the April 14 Journal of Clinical Microbiology.

You can read a transcript of one of Breitschwerdt’s interviews on Bartonella here.

Multiple Strains Of Lyme?

In 2002, W.T. Harvey, an MD from Houston, began finding large numbers of chronically ill Borrelia burgdorferi PCR- and seropositive patients in the area around his home and practice. Houston, Texas is declared a zoonotically “non-endemic” area, so he set out to understand just how this epidemic was occurring. W.T. Harvey had no competing financial interest (as the CDC and IDSA do) and received no grants when writing his study on Lyme.

“In order to understand this finding prior to sufficient data availability, we chose to examine critically the currently accepted but troublesome ‘Lyme disease’ concepts,” Harvey’s study reads. “Our method was to analyze each foundation ‘Lyme disease’ premise within the context of available medical and veterinary literature, then to reconstruct the disease model consistent with the preponderance of that data. We find the present conceptualization of the illness seriously truncated, with a high likelihood of two distinct but connected forms of human B. burgdorferi infection. The yet-unrecognized form appears to have a broader clinical presentation, wider geographic distribution, and vastly greater prevalence. We conclude that ‘Lyme disease’ currently acknowledges only its zoonosis arm and is a limited conceptualization of a far more pervasive and unrecognized infection state that must be considered a global epidemic.

Could You Have Lyme From Your Pets?

Suzy Cohen of suzycohen.com is a registered pharmacist and best-selling author. When she graduated from pharmacy school in 1989, she believed that medication was the answer to helping patients get healthy. When that didn’t always work, she began to do some serious research. In one article addressing the truth about Lyme, she writes:

“Most Lyme sufferers have pet cats and dogs, they are not aware that their pets gave it to them. But it happens like this, your pets go out into the yard to do their duty, and ticks jump on them, especially in May and June, their breeding season but any time of the year is possible. Your pet totes these ticks into your house and then you cuddle with your pet. The ticks get on you, and numb your skin. They are teeny tiny, about the size of a poppy seed and you’ll never know you got bit. They like every part of your body, but especially warmer areas, like armpits for example. You may never know. Sometimes the Lyme can happen from a cat scratch or bite. When I ask pet owners about their pets, they go into a bit of denial, because of the great love they have for pets. But you have to realize pets, for as delightful as they are, are tick taxis. If you have Lyme, and get bit again by your pet, you are potentially introducing new coinfections or re-innoculating yourself with more Lyme organisms. It explains why some people just can’t get well, or get setbacks even under treatment.”

Borrelia spirochetes have been found in the urine of infected dogs, among several other animals. Studies on mice have found that the spirochetes in urine remained viable for 18-24 hours and concluded that “[u]rine may provide a method for contact non-tick transmission of B. burgdorferi in natural rodent populations particularly during periods of nesting and/or breeding.” Evidence for direct contact transmission has been demonstrated in mice. These findings suggest that further research is needed to evaluate alternate methods of Lyme transmission, such as by the urine of infected animals to humans. 

Conclusion & How To Learn More:

“Lyme is one of the many microbes that has entered our system. And I feel as a physician that things are getting to a degree that’s serious. We’re watching other mammals die out and just think, ‘well, I’m glad it’s not me.’ However, as our environment becomes increasingly polluted, so do our bodies. And then we grow bugs [parasites, pathogens] in us that are not compatible with human life anymore.” 
Dr. Klinghardt, MD, ‘Under Our Skin’ (2008).
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As Dr. Klinghardt said, this is getting serious. Or as Dr. Harvey put it, this is an epidemic. These patients, along with solid science, are being purposefully ignored because IDSA panelists have been bribed and bought. 

Could you have Lyme? I suspect I might after a series of flea bites in 2011, and I’m almost positive my mother has had it for a very long time. Her doctors are finally thinking the same. This is no shock to me; as Dr. Klinghardt stated above, Lyme is one of the many microbes that has entered our system. We are all exposed to pathogens and parasites on a daily basis, and are never taught anything about how to cleanse or maintain a largely uninhabitable inner environment (hint: a strong immune system)! In fact, I’m on my third parasite cleanse and still passing worms. What else are we housing that we don’t know about? Why is all of this information ignored?

Lyme presents itself in symptoms often misdiagnosed as Crohn’s Disease, Chronic Fatigue Syndrome, ALS, MS, Alzheimer’s, Colitis, Encephalitis, Fibromyalgia, Fifth’s Disease, Arthritis, Cystitis, IBS, Lupus, Prostatitis, Psychiatric Disorders (bipolar, depression), Sjogren’s Syndrome, sleep disorders, thyroid disease, and more.

This is a long list, and the number of people who go misdiagnosed or undiagnosed altogether is staggering. As I said, Lyme and hundreds of other pathogens and parasites have taken up residence in our bodies. We have improved our outer practices of hygiene, yet have increased our sources of autointoxication: GMO foods, processed food-like products, overeating, fluoride in water, and chemicals in everything from household cleaners to plastics – just to name a few.

Please watch “Under Our Skin” to learn more about Chronic Lyme disease and how the medical industry continues to ignore this epidemic. The full documentary is available here with a short preview below.

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Japan Leads the Way: No Vaccine Mandates and No MMR Vaccine = Healthier Children

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In Brief

  • The Facts:

    This article was written By Kristina Kristen, Guest Writer, for Children's Health Defense, posted here with permission.

  • Reflect On:

    How much do pharmaceutical companies really care about our health? Why is important information on vaccines never acknowledged and countered by the mainstream?

In the United States, many legislators and public health officials are busy trying to make vaccines de facto compulsory—either by removing parental/personal choice given by existing vaccine exemptions or by imposing undue quarantines and fines on those who do not comply with the Centers for Disease Control and Prevention’s (CDC’s) vaccine edicts. Officials in California are seeking to override medical opinion about fitness for vaccination, while those in New York are mandating the measles-mumps-rubella (MMR) vaccine for 6-12-month-old infants for whom its safety and effectiveness “have not been established.”

The U.S. has the very highest infant mortality rate of all industrialized countries, with more American children dying at birth and in their first year than in any other comparable nation—and more than half of those who survive develop at least one chronic illness.

American children would be better served if these officials—before imposing questionable and draconian measures—studied child health outcomes in Japan. With a population of 127 million, Japan has the healthiest children and the very highest “healthy life expectancy” in the world—and the least vaccinated children of any developed country. The U.S., in contrast, has the developed world’s most aggressive vaccination schedule in number and timing, starting at pregnancy, at birth and in the first two years of life. Does this make U.S. children healthier? The clear answer is no. The U.S. has the very highest infant mortality rate of all industrialized countries, with more American children dying at birth and in their first year than in any other comparable nation—and more than half of those who survive develop at least one chronic illness. Analysis of real-world infant mortality and health results shows that U.S. vaccine policy does not add up to a win for American children.

Japan and the U.S.; Two Different Vaccine Policies

In 1994, Japan transitioned away from mandated vaccination in public health centers to voluntary vaccination in doctors’ offices, guided by “the concept that it is better that vaccinations are performed by children’s family doctors who are familiar with their health conditions.” The country created two categories of non-compulsory vaccines: “routine” vaccines that the government covers and “strongly recommends” but does not mandate, and additional “voluntary” vaccines, generally paid for out-of-pocket. Unlike in the U.S., Japan has no vaccine requirements for children entering preschool or elementary school.

Japan also banned the MMR vaccine in the same time frame, due to thousands of serious injuriesover a four-year period—producing an injury rate of one in 900 children that was “over 2,000 times higher than the expected rate.” It initially offered separate measles and rubella vaccines following its abandonment of the MMR vaccine; Japan now recommends a combined measles-rubella (MR) vaccine for routine use but still shuns the MMR. The mumps vaccine is in the “voluntary” category.

Here are key differences between the Japanese and U.S. vaccine programs:

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  • Japan has no vaccine mandates, instead recommending vaccines that (as discussed above) are either “routine” (covered by insurance) or “voluntary” (self-pay).
  • Japan does not vaccinate newborns with the hepatitis B (HepB) vaccine, unless the mother is hepatitis B positive.
  • Japan does not vaccinate pregnant mothers with the tetanus-diphtheria-acellular pertussis (Tdap) vaccine.
  • Japan does not give flu shots to pregnant mothers or to six-month-old infants.
  • Japan does not give the MMR vaccine, instead recommending an MR vaccine.
  • Japan does not require the human papillomavirus (HPV) vaccine.

No other developed country administers as many vaccine doses in the first two years of life.

In contrast, the U.S. vaccine schedule (see Table 1) prescribes routine vaccination during pregnancy, calls for the first HepB vaccine dose within 24 hours of birth—even though 99.9% of pregnant women, upon testing, are hepatitis B negative, and follows up with 20 to 22 vaccine doses in the first year alone. No other developed country administers as many vaccine doses in the first two years of life.

The HepB vaccine injects a newborn with a 250-microgram load of aluminum, a neurotoxic and immune-toxic adjuvant used to provoke an immune response. There are no studies to back up the safety of exposing infants to such high levels of the injected metal. In fact, the Food and Drug Administration’s (FDA’s) upper limit for aluminum in intravenous (IV) fluids for newborns is far lower at five micrograms per kilogram per day (mcg/kg/day)—and even at these levels, researchers have documented the potential for impaired neurologic development. For an average newborn weighing 7.5 pounds, the HepB vaccine has over 15 times more aluminum than the FDA’s upper limit for IV solutions.

Unlike Japan, the U.S. administers flu and Tdap vaccines to pregnant women (during any trimester) and babies receive flu shots at six months of age, continuing every single year thereafter. Manufacturers have never tested the safety of flu shots administered during pregnancy, and the FDA has never formally licensed any vaccines “specifically for use during pregnancy to protect the infant.”

Japan initially recommended the HPV vaccine but stopped doing so in 2013 after serious health problems prompted numerous lawsuits. Japanese researchers have since confirmed a temporal relationship between HPV vaccination and recipients’ development of symptoms.

U.S. vaccine proponents claim the U.S. vaccine schedule is similar to schedules in other developed countries, but this claim is inaccurate upon scrutiny. Most other countries do not recommend vaccination during pregnancy, and very few vaccinate on the first day of life. This is important because the number, type and timing of exposure to vaccines can greatly influence their adverse impact on developing fetuses and newborns, who are particularly vulnerable to toxic exposures and early immune activation. Studies show that activation of pregnant women’s immune systems can cause developmental problems in their offspring. Why are pregnant women in the U.S. advised to protect their developing fetuses by avoiding alcohol and mercury-containing tuna fish, but actively prompted to receive immune-activating Tdap and flu vaccines, which still contain mercury (in multi-dose vials) and other untested substances?

Japan initially recommended the HPV vaccine but stopped doing so in 2013 after serious health problems prompted numerous lawsuits. Japanese researchers have since confirmed a temporal relationship between HPV vaccination and recipients’ development of symptoms. U.S. regulators have ignored these and similar reports and not only continue to aggressively promote and even mandate the formerly optional HPV vaccine beginning in preadolescence but are now pushing it in adulthood. The Merck-manufactured HPV vaccine received fast-tracked approval from the FDA despite half of all clinical trial subjects reporting serious medical conditions within seven months.

Best and Worst: Two Different Infant Mortality Results

The CDC views infant mortality as one of the most important indicators of a society’s overall health. The agency should take note of Japan’s rate, which, at 2 infant deaths per 1,000 live births, is the second lowest in the world, second only to the Principality of Monaco. In comparison, almost three times as many American infants die (5.8 per 1,000 live births), despite massive per capita spending on health care for children (see Table 2). U.S. infant mortality ranks behind 55 other countries and is worse than the rate in Latvia, Slovakia or Cuba.

If vaccines save lives, why are American children dying at a faster rate, and…dying younger compared to children in 19 other wealthy countries—translating into a 57 percent greater risk of death before reaching adulthood?

To reiterate, the U.S. has the most aggressive vaccine schedule of developed countries (administering the most vaccines the earliest). If vaccines save lives, why are American children “dying at a faster rate, and…dying younger” compared to children in 19 other wealthy countries—translating into a “57 percent greater risk of death before reaching adulthood”? Japanese children, who receive the fewest vaccines—with no government mandates for vaccination—grow up to enjoy “long and vigorous” lives. International infant mortality and health statistics and their correlation to vaccination protocols show results that government and health officials are ignoring at our children’s great peril.

Among the 20 countries with the world’s best infant mortality outcomes, only three countries (Hong Kong, Macau and Singapore) automatically administer the HepB vaccine to all newborns—governed by the rationale that hepatitis B infection is highly endemic in these countries. Most of the other 17 top-ranking countries—including Japan—give the HepB vaccine at birth only if the mother is hepatitis B positive (Table 1). The U.S., with its disgraceful #56 infant mortality ranking, gives the HepB vaccine to all four million babies born annually despite a low incidence of hepatitis B.

Is the U.S. Sacrificing Children’s Health for Profits? 

Merck, the MMR vaccine’s manufacturer, is in court over MMR-related fraud. Whistleblowers allege the pharmaceutical giant rigged its efficacy data for the vaccine’s mumps component to ensure its continued market monopoly. The whistleblower evidence has given rise to two separate court cases. In addition, a CDC whistleblower has alleged the MMR vaccine increases autism risks in some children. Others have reported that the potential risk of permanent injuryfrom the MMR vaccine dwarfs the risks of getting measles.

Why do the FDA and CDC continue to endorse the problematic MMR vaccine despite Merck’s implication in fraud over the vaccine’s safety and efficacy? Why do U.S. legislators and government officials not demand a better alternative, as Japan did over two decades ago? Why are U.S. cities and states forcing Merck’s MMR vaccine on American children? Is the U.S. government protecting children, or Merck? Why are U.S. officials ignoring Japan’s exemplary model, which proves that the most measured vaccination program in the industrialized world and “first-class sanitation and levels of nutrition” can produce optimal child health outcomes that are leading the world?

A central tenet of a free and democratic society is the freedom to make informed decisions about medical interventions that carry serious potential risks. This includes the right to be apprised of benefits and risks—and the ability to say no. The Nuremberg Code of ethics established the necessity of informed consent without “any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion.” Forcing the MMR vaccine, or any other vaccine, on those who are uninformed or who do not consent represents nothing less than medical tyranny.


Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

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