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Is The FDA Trying to Ban Over-The-Counter Homeopathy?

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This article is from Greenmedinfo.com, printed here with their permission. It was written by Larry Malerba, DO, DHt,  a classical homeopath, osteopathic physician.  For more from Greenmedinfo, sign up for their newsletter here.

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Is the FDA acting out of malicious intent or willful ignorance in publishing a new draft guidance on homeopathics which would effectively treat them like pharmaceutical drugs, with similar regulatory requirements? 

FDA’s Regulatory Overreach Reflects Poor Understanding of Homeopathy

When FDA announced a “draft guidance” in December 2017 stating its latest intentions regarding the regulation of homeopathic products, it became clear that the agency had paid little attention to the concerns of the homeopathic community of practitioners, consumers, patients, and manufacturers. It turns out that the FDA’s public hearing held in 2015—during which numerous representatives of homeopathic interests from across the U.S and around the globe gave overwhelmingly positive testimony as to the safety, efficacy, and unique nature of homeopathic medicines—was just a pretense designed to give the appearance that it was taking the public’s concerns into account.

Hiding behind rhetoric emphasizing concerns for the safety of consumers—“FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients”—FDA is intending to launch a two-pronged initiative that exaggerates the risks associated with homeopathic products and denies the existing evidence in support of their safety and effectiveness.

Regarding the Safety of Homeopathic Medicines

FDA has chosen to use a very small number of unsubstantiated accounts of adverse events supposedly associated with homeopathic products in order to justify overregulation of the industry as a whole. Failing to acknowledge that the current regulatory framework, Compliance Policy Guide 400.400 (adopted in 1988), is more than sufficient to accomplish its stated goal of protecting the public from potential harm, FDA appears bent on tearing that policy down in favor of either a new and unnecessarily stringent policy or no replacement policy at all.

No policy at all would likely result in confusion about FDA’s expectations of homeopathic manufacturers and could provide opportunity for FDA to exploit the lack of clear regulatory bounds. Ronald Whitmont, MD, President of the American Institute of Homeopathy (AIH), echoes this sentiment:

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“What is clear is that FDA has ignored the homeopathic community’s requests to update this guidance. By withdrawing CPG 400.400 the FDA is removing the only clear guidelines that have served to help the FDA, the homeopathic manufacturers, and the public to understand the policies surrounding the marketing and labeling of homeopathic products.  

The AIH is very concerned that the withdrawal of this document will create a situation where anything can be labeled “homeopathic” and muddy the waters around what actually is homeopathic. The AIH is also concerned that withdrawal of the guidance would allow the FDA to act capriciously and to interpret the new guidelines more broadly than they should be.

If the FDA is unhappy with the current CPG 400.400 we advise that they amend it to make it a better, more comprehensive guideline, not one with less clear instructions that could result in abuses from both manufacturers and regulators. Only the public will suffer when this happens.”

I have written previously about FDA’s trumped-up scare tactics regarding homeopathic teething tablets. For decades, homeopathic medicines have been subject to unrelenting criticism from mainstream science and conventional medicine. Critics contend that the quantities of ingredients used are too small to have any physiological effects and, all observed effects must, therefore, be written off as placebo effects. In other words, the predominating belief is that homeopathic doses are too small to be of any health concern.

Astonishingly, we are witnessing a suspicious about-face whereby homeopathic medicines have apparently morphed overnight in the minds of FDA officials from useless placebos to dangerous toxins. Although the scientific community is talking out of both sides of its mouth, it can’t have it both ways. Truth be told, any qualified homeopathic doctor will tell you that neither assertion is the case. While homeopathic medicines are clearly not placebos, they are also nothing like conventional pharmaceuticals.

Homeopathic medicines are in a class completely on their own, which is why when homeopathic physician and New York State Senator, Royal Copeland, MD, sponsored legislation creating the Food, Drug and Cosmetic Act of 1938, it was abundantly clear to the U.S. Congress that homeopathic products did not pose a risk and did not warrant the type of scrutiny that the modern-day FDA now claims it deserves.

Although the safety profiles of homeopathic medicines are unparalleled, FDA wants you to believe otherwise. A handful of isolated and unproven cases of seizures supposedly caused by homeopathic Belladonna elicited a “warning against the use” of teething tablets and a thorough review of FDA’s oversight of the entire homeopathic industry.

By contrast, here is a list of 200 drugs admittedly known to be able to produce seizures as possible side effects. I don’t see FDA clamoring to warn people against using these drugs. And I certainly don’t see them undertaking an audit of the entire pharmaceutical industry. When the safety of homeopathic products is compared against the track records of almost all conventional pharmaceuticals, FDA’s egregious double standard becomes unavoidably apparent.

If you understand homeopathy and you’ve seen it work, you know that safety is a virtual non-issue. If a remedy is manufactured according to standards of the Homeopathic Pharmacopeia of the United States (HPUS), there is no reason for concern and no need for FDA to think it would need greater oversight. Therefore, the only way a homeopathic medicine can cause harm is if it has been manufactured recklessly in a manner that does not follow proper protocol. A properly made homeopathic dilution, by definition, cannot be toxic because the degree of dilution is too great. For FDA to believe otherwise is unscientific and disingenuous.

Another completely specious contention that FDA makes in its draft guidance is that homeopathic treatment “may cause users to delay or discontinue medical treatments that have been found safe and effective.” This is a classic anti-homeopathy activist talking point, one that makes a number of bogus assumptions, and one that is inherently defamatory of the homeopathic medical profession. It implies that homeopathic treatment is inferior, that it does not constitute safe and effective treatment, and that turning to conventional allopathic drug therapy is always the superior, safe, and effective thing to do.

There is no possible justification for such a statement given that one Johns Hopkins study concluded that medical error is the third leading cause of death in the U.S., a number that represents more than 250,000 deaths per year. And FDA wants to ratchet up regulation of homeopathy due to a few uncorroborated case of seizures from one homeopathic product? Something smells very fishy, indeed.

The Homeopathic Industry Agrees That Safety Standards Are Needed

Now, it is true that unscrupulous parties have been known to market so-called homeopathic products that don’t follow proper manufacturing guidelines as set out by the HPUS or don’t adhere to “current good manufacturing practices” (cGMP). If and when that happens, FDA already has the regulatory authority to effectively handle such infractions. As such, there is no need to make any changes in regulatory policies regarding homeopathic products. Nevertheless, FDA appears ready to jump the shark, giving the clear but erroneous impression that homeopathic products have suddenly become a safety concern.

The homeopathic industry does not disagree with FDA regarding the need for safety standards. However, it objects to the need for revised standards that place homeopathic products at risk for overzealous and punitive regulatory actions. Current FDA policy as stated in Compliance Policy Guide 400.400 is both adequate and effective. Eric L. Foxman, R.Ph., Secretary of the American Association of Homeopathic Pharmacists, is rightfully concerned, and has this to say about FDA’s proposed actions:

“In its apparent zeal to address problematic products, the FDA has decided to do away with the existing regulatory framework under which the industry and the agency have worked together for over 25 years. This is poorly considered and ill advised. In fact, without some of the aspects of the existing Compliance Policy Guide, many more problematic homeopathic products could conceivably be brought to market. This could lead to the marketing of more adulterated, misbranded or fraudulent products masquerading as homeopathic. That would be an abdication of FDA’s role as a public heath agency, and would be a giant step backwards for homeopathy and, especially, the American consumer.”

Although the homeopathic manufacturing industry has tried to maintain a good faith relationship with FDA, the agency, in my opinion, has not acted in kind. Historically speaking, the two parties once did have a good working relationship, but this has not been the case for decades.

Regarding the Purported Lack of Evidence in Support of Homeopathy

FDA’s announcement and its new draft guidance statement make repeated references to the “unproven” nature of homeopathic medicines. Emboldened by another agency that also has little knowledge of homeopathic medicines, FDA makes reference to FTC’s claim that, “companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.”

Here, in direct violation of the spirit of an act of Congress that created the Food, Drug and Cosmetic Act, the modern FDA appears to be setting the stage for the possibility of removing the special status of homeopathic medicines. This would give them the same status as conventional drugs, potentially subjecting them to the same regulatory approval process.

This would likely bankrupt the industry, since homeopathic drugs would not be able to command the same outlandish prices that conventional pharmaceuticals have used to gouge the public and to pay for the exorbitant costs of the drug approval process. It amounts to a form of organized governmental crime that only the most obscenely wealthy companies can afford.

(I would like to make clear that this is not the opinion of the homeopathic manufacturers. They do not interpret FDA’s intent in the same conspiratorial way as do I and some others. They are of the opinion that FDA is looking to do its job to protect the public, and not out to undermine homeopathy. It is also important to note that while FDA’s actions could impact the manufacture and marketing of certain homeopathic products, it has no jurisdiction over those who practice homeopathic medicine.)

This brings us to the critically important issue of what it is that actually constitutes scientific evidence. First and foremost, I must state with unequivocal certainty that any claim that there is a lack of research evidence to support homeopathy is an absolute falsehood. Those who make such claims are either deliberately lying, are repeating bogus talking points that they have read or heard elsewhere, or do so out of pure ignorance. There are literally thousands of research trials, many of which shine favorably upon homeopathy. To examine the evidence and then deny its existence is to be deliberately obtuse.

Dr. Samuel Hahnemann developed his system of treatment by similars 200 years ago by studying the effects of his diluted medicines on healthy test subjects. FDA acknowledges this methodology, which Hahnemann called “proving.” It is an inherently safe process that involves using highly diluted medicines that are incapable of producing toxic effects. Diluted medicines are made, they are proven on test subjects, and the resulting information is used as a guide to treat people with symptoms that match the symptom patterns of the remedy provings. There is good reason to believe that it was Hahnemann himself who conducted the very first placebo-controlled, blinded research trials.

In addition to provings and modern research trials, homeopathy also has a vast body of clinical literature that dates back 200 years. Included in the literature, which was written almost exclusively by experienced physicians, are thousands upon thousands of clinical case studies. Physicians painstakingly documented the patients they encountered, the symptomatic presentation of their complaints, the remedies administered to them, and the short and long term outcomes of treatment. This process continues to this day, with countless case histories having been published in numerous international homeopathic journals both new and old.

What happens when we try to evaluate homeopathic products according to conventional pharmaceutical research standards? What all homeopathic practitioners understand—and FDA does not—is that successful homeopathic treatment is critically dependent upon context. It is not possible to get reliable results by choosing a target symptom or two to treat in isolation from all other symptoms of the patient. This type of symptomatic focus is the very thing that defines allopathic medicine. In contrast to a conventional cough suppressant drug, for example, there is no such thing as a homeopathic remedy that can be used to treat coughs in general. Each cough is unique and must be treated accordingly.

For example, Drosera is a well-known remedy for coughs of a specific type. It is especially suited to violent coughing paroxysms that can result in vomiting and even nosebleeds. The attacks are more likely to flare up after midnight. Pulsatilla, on the other hand, suits coughs that are much less aggressive. The cough gets worse when lying down, forcing the person to sit up to get relief. The person who needs Pulsatilla also complains of feeling worse in a warm room, needs fresh air to feel better, and experiences a noticeable decrease in thirst. Spongia is a remedy suited for hoarse, dry coughs. There is often tickling in the throat, which can be quieted by drinking warm drinks.

This is just a small sample of potential homeopathic cough remedies and their unique characteristics. While these types of details have little to no bearing on conventional drug therapy choices, they are crucial factors that determine successful homeopathic prescriptions.

Now imagine what would happen if FDA required a study to “prove” the value of Drosera in treating coughs. Of 100 test subjects, how many do you think would fit the criteria to justify a prescription of this particular homeopathic medicine? Very few, indeed. How long would it take to find 100 test subjects that do have symptom patterns that match Drosera? I suspect it would take years even under the best of circumstances.

Furthermore, although Pulsatilla is well-indicated for certain types of coughs, it can also be used it to successfully treat a wide spectrum of health problems, including hot flashesear infectionsgallbladder attackseczemadepression, and many more. Unlike most pharmaceutical drugs, homeopathic medicines do not have single indications. They have many uses. This basic truth adds even further confusion to FDA’s already poor understanding of homeopathic products.

So when FDA demands proof of homeopathic effectiveness according to conventional medical standards, the deck is already stacked against any prospect of success. Conventional drug trials are very poorly suited to understanding the benefits of homeopathic medicines. Each homeopathic medicine has many potential therapeutic indications, and there are many potential homeopathic remedies that can help the various individuals diagnosed with the same illness.

The irony here is that FDA requires a homeopathic label to include a specific indication for its use, and then asks for proof that it can help that condition. FDA is under the false impression that it can treat homeopathic products as if they are no different from allopathic drugs. Furthermore, FDA’s latest draft guidance states the following:

Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed.

Although this guidance clearly implies that FDA should consult qualified experts when making judgments regarding homeopathic medicines and their uses, there are no such experts on FDA’s staff. Neither does FDA have any ongoing official working relationships with outside experts in spite of requests from the homeopathic community that FDA fulfill this obligation. FDA lives in an allopathic bubble with no conception of the true nature of homeopathic products, how they work, or how they should be regarded. It is clear that FDA just doesn’t get it; it has little understanding of how homeopathy works or how it should be evaluated.

There are only two plausible explanations for FDA’s misguided attitude toward homeopathy. One is that it is acting with malicious intent to undermine the homeopathic industry, and to subvert an act of Congress, in which case it would not be far-fetched to assume that they are being encouraged to do so by Big Pharma, which is the one party that stands the most to gain from this fiasco. Given FDA’s multiple references to the recent growth of the homeopathic market, this is not an unreasonable conclusion.

The other explanation is that FDA is acting out of willful ignorance. They act like they are listening but their minds are closed. Notwithstanding the possibility of good intentions to guard the public safety, FDA’s actions reveal that it has a very poor grasp of homeopathy, and it does not seem interested in learning from true homeopathic experts.

So what is the best way to study the effects of homeopathic medicines? In terms of conventional research methodology, the protocol most suited to studying homeopathy is one that treats each individual according to his or her unique symptom pattern. It would involve treating a particular disease category, such as ear infections for example, with as many different remedies as are needed to treat the various individuals involved in the study. Each case of ear infection would receive the single remedy that best matches its symptomatic expression. It might require 10, 15, 20 or more different remedies in order to properly treat all of of kids in the study. Of course, this does not satisfy FDA’s conception of a properly conducted research trial. Nevertheless, it is the only way to give homeopathy a fair shake.

As far as homeopaths are concerned, the types of evidence best suited to homeopathy are provings and case studies as previously described. Ironically, and perhaps conveniently for disbelievers, this is the type of evidence that modern medicine now derisively calls “anecdotal.” Medical science has devolved to a point where it trusts the statistical trickery of research trials that evaluate only a few limited parameters (such as the ability to suppress a cough) more than it trusts the first-hand experiences of patients and their doctors (case studies).

Modern standards of medical evidence are badly out of kilter. The first step in rectifying the imbalance will be for medicine to acknowledge the truth of the safety and effectiveness of homeopathy and the many lessons that it has to teach about health and healing.

We Must Continue to Stand for Freedom of Medical Choice

Here’s what you can do…

1. One way to help right now is to submit positive comments (not criticisms of FDA) to FDA in support of homeopathy. Tell FDA that its current regulatory guidelines (Compliance Policy Guide 400.400) for homeopathic products are more than adequate and that any further changes place your right to choose in jeopardy. The period for public comment before FDA makes its final decisions about this critically important policy closes on March 20, 2018. (Comment here)

2. The Homeopathic Pharmacists of the United States also urge those who live in certain states (CO, NM, PA, TN, WA, UT) to urge their legislators to tell FDA not to scrap the current guidelines regarding the regulation of homeopathic products. All you have to do is sign your name to the letter. Even better if you add your own personal story of homeopathic success. (Take Action Here)

About the author:

Larry Malerba, DO, DHt is a classical homeopath, osteopathic physician, and educator whose mission is to build bridges between holistic healing, conventional medicine, and spirituality. He is the author of Green Medicine and Metaphysics & Medicine. His new book, Dynamic Medicine: The World According to Homeopathy, offers an insightful introduction to the best kept secret in the holistic health world. Dr. Malerba is board certified in Homeotherapeutics and past president of the Homeopathic Medical Society of the State of New York.
www.DrMHomeopathy.com
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Awareness

Epigenetic Memories Are Passed Down 14 Successive Generations, Game-Changing Research Reveals

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In Brief

  • The Facts:

    It's amazing how much information can be passed on to our offspring. Scientist have discovered that our DNA has memories, and these can also be passed down. We are talking about thoughts, feelings, emotions and perceptions.

  • Reflect On:

    Biological changes are shaped by our environment, as well as our thoughts, feelings, emotions and reaction to that environment. Our DNA can be changed with belief, the placebo is a great example. Thoughts feelings and emotions are huge in biology.

This article was written by the Greenmedinfo research group, from Greenmedinfo.com. Posted here with permission.

Until recently, it was believed that our genes dictate our destiny. That we are slated for the diseases that will ultimately beset us based upon the pre-wired indecipherable code written in stone in our genetic material. The burgeoning field of epigenetics, however, is overturning these tenets, and ushering in a school of thought where nurture, not nature, is seen to be the predominant influence when it comes to genetic expression and our freedom from or affliction by chronic disease.

Epigenetics: The Demise of Biological Determinism

Epigenetics, or the study of the physiological mechanisms that silence or activate genes, encompasses processes which alter gene function without changing the sequence of nucleotide base pairs in our DNA. Translated literally to mean “in addition to changes in genetic sequence,” epigenetics includes processes such as methylation, acetylation, phosphorylation, sumolyation, and ubiquitylation which can be transmitted to daughter cells upon cell division (1). Methylation, for example, is the attachment of simple methyl group tags to DNA molecules, which can repress transcription of a gene when it occurs in the region of a gene promoter. This simple methyl group, or a carbon bound to three hydrogen molecules, effectively turns the gene off.

Post-translational modifications of histone proteins is another epigenetic process. Histones help to package and condense the DNA double helix into the cell nucleus in a complex called chromatin, which can be modified by enzymes, acetyl groups, and forms of RNA called small interfering RNAs and microRNAs (1). These chemical modifications of chromatin influence its three-dimensional structure, which in turn governs its accessibility for DNA transcription and dictates whether genes are expressed or not.

We inherit one allele, or variant, of each gene from our mother and the other from our father. If the result of epigenetic processes is imprinting, a phenomenon where one of the two alleles of a gene pair is turned off, this can generate a deleterious health outcome if the expressed allele is defective or increases our susceptibility to infections or toxicants (1). Studies link cancers of nearly all types, neurobehavioral and cognitive dysfunction, respiratory illnessesautoimmune disorders, reproductive anomalies, and cardiovascular disease to epigenetic mechanisms (1). For example, the cardiac antiarrhythmic drug procainamide and the antihypertensive agent hydralazine can cause lupus in some people by causing aberrant patterns of DNA methylation and disrupting signalling pathways (1).

Genes Load the Gun, Environment Pulls the Trigger

Pharmaceuticals, however, are not the only agents that can induce epigenetic disturbances. Whether you were born via vaginal birth or Cesarean section, breastfed or bottle-fed, raised with a pet in the house, or infected with certain childhood illnesses all influence your epigenetic expression. Whether you are sedentary, pray, smoke, mediate, do yoga, have an extensive network of social support or are alienated from your community—all of your lifestyle choices play into your risk for disease operating through mechanisms of epigenetics.

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In fact, the Centers for Disease Control (CDC) states that genetics account for only 10% of disease, with the remaining 90% owing to environmental variables (2). An article published in the Public Library of Science One (PLoS One) entitled “Genetic factors are not the major causes of chronic diseases” echoes these claims, citing that chronic disease is only 16.4% genetic, and 84.6% environmental (3). These concepts make sense in light of research on the exposome, the cumulative measure of all the environmental insults an individual incurs during their life course that determines susceptibility to disease (4)

In delineating the totality of exposures to which an individual is subjected over their lifetime, the exposome can be subdivided into three overlapping and intertwined domains. One segment of the exposome called the internal environment is comprised of processes innate to the body which impinge on the cellular milieu. This encompasses hormones and other cellular messengers, oxidative stress, inflammation, lipid peroxidation, bodily morphology, the gut microbiotaaging and biochemical stress (5).

Another portion of the exposome, the specific external environment, consists of exposures including pathogens, radiation, chemical contaminants and pollutants, and medical interventions, as well as dietary, lifestyle, and occupational elements (5). At an even broader sociocultural and ecological level is the segment of the exposome called the general external environment, which may circumscribe factors such as psychological stress, socioeconomic status, geopolitical variables, educational attainment, urban or rural residence, and climate (5).

Transgenerational Inheritance of Epigenetic Change: Endocrine Disruptors Trigger Infertility in Future Generations

Scientists formerly speculated that epigenetic changes disappear with each new generation during gametogenesis, the formation of sperm and ovum, and after fertilization. However, this theory was first challenged by research published in the journal Science which demonstrated that transient exposure of pregnant rats to the insecticide methoxychlor, an estrogenic compound, or the fungicide vinclozolin, an antiandrogenic compound, resulted in increased incidence of male infertility and decreased sperm production and viability in 90% of the males of four subsequent generations that were tracked (1).

Most notably, these reproductive effects were associated with derangements in DNA methylation patterns in the germ line, suggesting that epigenetic changes are passed on to future generations. The authors concluded, “The ability of an environmental factor (for example, endocrine disruptor) to reprogram the germ line and to promote a transgenerational disease state has significant implications for evolutionary biology and disease etiology” (6, p. 1466). This may suggest that the endocrine-disrupting, fragrance-laden personal care products and commercial cleaning supplies to which we are all exposed may trigger fertility problems in multiple future generations.

Transgenerational Inheritance of Traumatic Episodes: Parental Experience Shapes Traits of Offspring

In addition, traumatic experiences may be transmitted to future generations via epigenetics as a way to inform progeny about salient information needed for their survival (7). In one study, researchers wafted the cherry-like chemical acetophenone into the chambers of mice while administering electric shocks, conditioning the mice to fear the scent (7). This reaction was passed onto two successive generations, which shuddered significantly more in the presence of acetophenone despite never having encountered it compared to descendants of mice that had not received this conditioning (7).

The study suggests that certain characteristics of the parental sensory environment experienced before conception can remodel the sensory nervous system and neuroanatomy in subsequently conceived generations (7). Alterations in brain structures that process olfactory stimuli were observed, as well as enhanced representation of the receptor that perceives the odor compared to control mice and their progeny (7). These changes were conveyed by epigenetic mechanisms, as illustrated by evidence that the acetophenone-sensing genes in fearful mice were hypomethylated, which may have enhanced expression of odorant-receptor genes during development leading to acetophenone sensitivity (7).

The Human Experience of Famine and Tragedy Spans Generations

The mouse study, which illustrates how germ cells (egg and sperm) exhibit dynamic plasticity and adaptability in response to environmental signals, is mirrored by human studies. For instance, exposures to certain stressors such as starvation during the gestational period are associated with poor health outcomes for offspring. Women who undergo famine before conception of her offspring have been demonstrated to give birth to children with lower self-reported mental health and quality of life, for example (8).

Studies similarly highlight that, “Maternal famine exposure around the time of conception has been related to prevalence of major affective disorders, antisocial personality disorders, schizophrenia, decreased intracranial volume, and congenital abnormalities of the central nervous system” (8). Gestational exposure to the Dutch Famine of the mid-twentieth century is also associated with lower perceived health (9), as well as enhanced incidence of cardiovascular disease, hypertension, and obesity in offspring (8). Maternal undernourishment during pregnancy leads to neonatal adiposity, which is a predictor of future obesity (10), in the grandchildren (11).

The impact of epigenetics is also exemplified by research on the intergenerational effects of trauma, which illuminates that descendants of people who survived the Holocaust exhibit abnormal stresshormone profiles, and low cortisol production in particular (12). Because of their impaired cortisol response and altered stress reactivity, children of Holocaust survivors are often at enhanced risk for post-traumatic stress disorder (PTSD), anxiety, and depression (13).

Intrauterine exposure to maternal stress in the form of intimate partner violence during pregnancy can also lead to changes in the methylation status of the glucocorticoid receptor (GR) of their adolescent offspring (14). These studies suggest that an individual’s experience of trauma can predispose their descendants to mental illness, behavioral problems, and psychological abnormalities due to “transgenerational epigenetic programming of genes operating in the hypothalamic-pituitary-adrenal axis,” a complex set of interactions among endocrine glands which determine stress response and resilience (14).

Body Cells Pass Genetic Information Directly Into Sperm Cells

Not only that, but studies are illuminating that genetic information can be transferred through the germ line cells of a species in real time. These paradigm-shifting findings overturn conventional logic which postulates that genetic change occurs over the protracted time scale of hundreds of thousands or even millions of years. In a relatively recent study, exosomes were found to be the medium through which information was transferred from somatic cells to gametes.

This experiment entailed xenotransplantation, a process where living cells from one species are grafted into a recipient of another species. Specifically, human melanoma tumor cells genetically engineered to express genes for a fluorescent tracer enzyme called EGFP-encoding plasmid were transplanted into mice. The experimenters found that information-containing molecules containing the EGFP tracer were released into the animals’ blood (15). Exosomes, or “specialized membranous nano-sized vesicles derived from endocytic compartments that are released by many cell types” were found among the EGFP trackable molecules (16, p. 447).

Exosomes, which are synthesized by all plant and animal cells, contain distinct protein repertoires and are created when inward budding occurs from the membrane of multivesicular bodies (MVBs), a type of organelle that serves as a membrane-bound sorting compartment within eukaryotic cells (16). Exosomes contain microRNA (miRNA) and small RNA, types of non-coding RNA involved in regulating gene expression (16). In this study, exosomes delivered RNAs to mature sperm cells (spermatozoa) and remained stored there (15).

The researchers highlight that this kind of RNA can behave as a “transgenerational determinant of inheritable epigenetic variations and that spermatozoal RNA can carry and deliver information that cause phenotypic variations in the progeny” (15). In other words, the RNA carried to sperm cells by exosomes can preside over gene expression in a way that changes the observable traits and disease risk of the offspring as well as its morphology, development, and physiology.

This study was the first to elucidate RNA-mediated transfer of information from somatic to germ cells, which fundamentally overturns what is known as the Weisman barrier, a principle which states that the movement of hereditary information from genes to body cells is unidirectional, and that the information transmitted by egg and sperm to future generations remains independent of somatic cells and parental experience (15).

Further, this may bear implications for cancer risk, as exosomes contain vast amounts of genetic information which can be source of lateral gene transfer (17) and are abundantly liberated from tumor cells (18). This can be reconciled with the fact that exosome-resembling vesicles have been observed in various mammals (15), including humans, in close proximity to sperm in anatomical structures such as the epididymis as well as in seminal fluid (19). These exosomes may thereafter be propagated to future generations with fertilization and augment cancer risk in the offspring (20).

The researchers concluded that sperm cells can act as the final repositories of somatic cell-derived information, which suggests that epigenetic insults to our body cells can be relayed to future generations. This notion is confirmatory of the evolutionary theory of “soft inheritance” proposed by French naturalist Jean-Baptiste Lamarck, whereby characteristics acquired over the life of an organism are transmitted to offspring, a concept which modern genetics previously rejected before the epigenetics arrived on the scene. In this way, the sperm are able to spontaneously assimilate exogenous DNA and RNA molecules, behaving both as vector of their native genome and of extrachromosomal foreign genetic material which is “then delivered to oocytes at fertilization with the ensuing generation of phenotypically modified animals” (15).

Epigenetic Changes Endure Longer Than Ever Predicted

In a recent study, nematode worms were manipulated to harbor a transgene for a fluorescent protein, which made the worms glow under ultraviolet light when the gene was activated (21). When the worms were incubated under the ambient temperature of 20° Celsius (68° Fahrenheit), negligible glowing was observed, indicating low activity of the transgene (21). However, transferring the worms to a warmer climate of 25°C (77° F) stimulated expression of the gene, as the worms glowed brightly (21).

In addition, this temperature-induced alteration in gene expression was found to persist for at least 14 generations, representing the preservation of epigenetic memories of environmental change across an unprecedented number of generations (21). In other words, the worms transmitted memories of past environmental conditions to their descendants, through the vehicle of epigenetic change, as a way to prepare their offspring for prevailing environmental conditions and ensure their survivability.

Future Directions: Where Do We Go From Here?

Taken cumulatively, the aforementioned research challenges traditional Mendelian laws of genetics, which postulate that genetic inheritance occurs exclusively through sexual reproduction and that traits are passed to offspring through the chromosomes contained in germ line cells, and never through somatic (bodily) cells. Effectively, this proves the existence of non-Mendelian transgenerational inheritance, where traits separate from chromosomal genes are transmitted to progeny, resulting in persistent phenotypes that endure across generations (22).

This research imparts new meaning to the principle of seven generation stewardship taught by Native Americans, which mandates that we consider the welfare of seven generations to come in each of our decisions. Not only should we embody this approach in practices of environmental sustainability, but we would be wise to consider how the conditions to which we subject our bodies—the pollution and toxicants which permeate the landscape and pervade our bodies, the nutrient-devoid soil that engenders micronutrient-poor food, the disruptions to our circadian rhythm due to the ubiquity of electronic devices, our divorce from nature and the demise of our tribal affiliations—may translate into ill health effects and diminished quality of life for a previously unfathomed number of subsequent generations.

Hazards of modern agriculture, the industrial revolution, and contemporary living are the “known or suspected drivers behind epigenetic processes…including heavy metals, pesticides, diesel exhaust, tobacco smoke, polycyclic aromatic hydrocarbons, hormones, radioactivity, viruses, bacteria, and basic nutrients” (1, p. A160). Serendipitously, however, many inputs such as exercise, mindfulness, and bioactive components in fruits and vegetables such as sulforaphane in cruciferous vegetables, resveratrol from red grapes, genistein from soy, diallyl sulphide from garlic, curcumin from turmeric, betaine from beets, and green tea catechin can favorably modify epigenetic phenomena “either by directly inhibiting enzymes that catalyze DNA methylation or histone modifications, or by altering the availability of substrates necessary for those enzymatic reactions” (23, p. 8).

This quintessentially underscores that the air we breathe, the food we eat, the thoughts we allow, the toxins to which we are exposed, and the experiences we undergo may persevere in our descendants and remain in our progeny long after we are gone. We must be cognizant of the effects of our actions, as they elicit a ripple effect through the proverbial sands of time.

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References

1. Weinhold, B. (2006). Epigenetics: The Science of Change. Environmental Health Perspectives, 114(3), A160-A167.

2. Centers for Disease Control and Prevention. (2014). Exposome and Exposomics. Retrieved from https://www.cdc.gov/niosh/topics/exposome/

3. Rappaport, S.M. (2016). Genetic factors are not the major causes of chronic diseases. PLoS One, 11(4), e0154387.

4. Vrijheid, M. (2014). The exposome: a new paradigm to study the impact of environment on health. Thorax, 69(9), 876-878. doi: 10.1136/thoraxjnl-2013-204949.

5. Wild, C.P. (2012). The exposome: from concept to utility. International Journal of Epidemiology, 41, 24–32. doi:10.1093/ije/dyr236

6. Anway, M.D. et al. (2005). Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science, 308(5727), 1466-1469.

7. Dias, B.G., & Ressler, K.J. (2014). Parental olfactory experience influences behavior and neural structure in subsequent generations. Nature Neuroscience, 17(1), 89-98.

8. Stein, A.D. et al. (2009). Maternal exposure to the Dutch Famine before conception and during pregnancy: quality of life and depressive symptoms in adult offspring. Epidemiology, 20(6), doi:  10.1097/EDE.0b013e3181b5f227.

9. Roseboom, T.J. et al. (2003). Perceived health of adults after prenatal exposure to the Dutch famine. Paediatrics Perinatal Epidemiology, 17, 391–397.

10. Badon, S.E. et al. (2014). Gestational Weight Gain and Neonatal Adiposity in the Hyperglycemia and Adverse Pregnancy Outcome Study-North American Region. Obesity (Silver Spring), 22(7), 1731–1738.

11. Veenendaal, M.V. et al. (2013). Transgenerational effects of prenatal exposure to the 1944-45 Dutch famine. BJOG, 120(5), 548-53. doi: 10.1111/1471-0528.

12. Yehuda, R., & Bierer, L.M. (2008). Transgenerational transmission of cortisol and PTSD risk. Progress in Brain Research, 167, 121-135.

13. Aviad-Wilcheck, Y. et al. (2013). The effects of the survival characteristics of parent Holocaust survivors on offsprings’ anxiety and depression symptoms. The Israel Journal of Psychiatry and Related Sciences, 50(3), 210-216.

14. Radke, K.M. et al. (2011). Transgenerational impact of intimate partner violence on methylation in the promoter of the glucocorticoid receptor. Translational Psychiatry, 1, e21. doi: 10.1038/tp.2011.21.

15. Cossetti, C. et al. (2014). Soma-to-Germline Transmission of RNA in Mice Xenografted with Human Tumour Cells: Possible Transport by Exosomes. PLoS One, https://doi.org/10.1371/journal.pone.0101629.

16. Zomer, A. et al. (2010). Exosomes: Fit to deliver small RNA. Communicative and Integrative Biology, 3(5), 447–450.

17. Balaj, L. et al. (2011) Tumour microvesicles contain retrotransposon elements and amplified oncogene sequences. Natural Communications, 2, 180.

18. Azmi, A.S., Bao, B., & Sarkar, F.H. (2013). Exosomes in cancer development, metastasis, and drug resistance: a comprehensive review. Cancer Metastasis Review, 32, 623-643

19. Poliakov, A. et al. (2009). Structural heterogeneity and protein composition of exosomes-like vesicles (prostasomes) in human semen. Prostate, 69, 159-167.

20. Cheng, R.Y. et al. (2004) Epigenetic and gene expression changes related to transgenerational carcinogenesis. Molecular Carcinogenesis, 40, 1–11.

21. Klosin, A. et al. (2017). Transgenerational transmission of environmental information in C. elegans. Science, 356(6335).

22. Lim, J.P., & Brunet, A. (2013). Bridging the transgenerational gap with epigenetic memory. Trends in Genetics, 29(3), 176-186. doi: 10.1016/j.tig.2012.12.008

23. Choi, S.-W., & Friso, S. (2010). Epigenetics: A New Bridge between Nutrition and Health Advances in Nutrition: An International Review Journal, 1(1), 8-16. doi:10.3945/an.110.1004.

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Brain Imaging Shows Autistic Brains Contain HIGH Amounts of Aluminum

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In Brief

  • The Facts:

    A study published early in 2018 identified very high amounts of aluminum lodged in the brains of multiple people with autism.

  • Reflect On:

    We know little about where the heavy metals used as adjuvants in vaccines end up in the body. We now know that injected aluminum doesn't exit the body like aluminum intake from other sources. When injected, it ends up in the brain.

A study published earlier in 2018 should have made headlines everywhere, as it discovered historically high amounts of aluminum in autistic brains. The study was conducted by some of the worlds leading scientists in the field.

Five people were used in the study, four males and one female, all between the ages of 14-50. Each of their brains contained unsafe and high amounts of aluminum compared to patients with other diseases where high brain aluminum content is common, like Alzheimer’s disease, for example.

Of course, this caused people to downplay the study, citing a low sample group, but that’s not entirely a valid argument given the reason why this study was conducted. As cited in the study above, recent studies on animals, published within the past few years, have supported a strong connection between aluminum, and aluminum adjuvants used in human vaccinations, and Autism Spectrum Disorder (ASD.)

Studies have also shown that injected aluminum does not exit the body, and can be detected inside the brain even a year after injection. That being said, when we take aluminum in from sources such as food, the body does a great job of getting it out, but there is a threshold. It’s important to acknowledge that the aluminum found in the brain, could be due to the presence of aluminum adjuvants in vaccines. This latest study also identified the location of aluminum in these tissues, and where they end up. This particular study was done on humans, which builds upon, and still supports, the findings of the animal studies.

This is also important because the majority of studies that previously examined human exposure to aluminum have only used hair, blood and urine samples. The study also makes a clear statement regarding vaccines, stating that “Paediatric vaccines that include an aluminum adjuvant are an indirect measure of infant exposure to aluminum and their burgeoning use has been directly correlated with increasing prevalence of ASD.”

 Aluminum, in this case, was found in all four lobes of the brain.

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The aluminum content of brain tissues from donors with a diagnosis of ASD was extremely high (Table 1). While there was significant inter-tissue, inter-lobe and inter-subject variability the mean aluminium content for each lobe across all 5 individuals was towards the higher end of all previous (historical) measurements of brain aluminium content, including iatrogenic disorders such as dialysisencephalopathy[13][15][16][17][18][19]. All 4 male donors had significantly higher concentrations of brain aluminum than the single female donor. We recorded some of the highest values for brain aluminum content ever measured in healthy or diseased tissues in these male ASD donors

We Know, And Have Known, Aluminum Is Not Safe, Yet We Ignore It

When we talk about the ‘safe’ amount of aluminum here, there is no such thing. Aluminum is extremely toxic to any biological process, it’s not meant for us which is why it stayed deep within the Earth until we took it out. It has no place within us, and that’s simply due to the fact that it causes nothing but havoc. This makes it odd that we would put them in vaccinations despite the fact that for 100 years there has been no appropriate safety testing.

Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans.

The quote above comes from a study published in 2011, it’s 2018 now and we’ve come along way in our understanding. We are starting to see even more research confirming the statement above.

Almost every study you read regarding previous studies on aluminum adjuvants within vaccines emphasized how the nature of its bioaccumulation is unknown, and a serious matter. We now know that it goes throughout the body, into distant organs eventually ends up in the brain.

Another fairly recent study from 2015 points out:

Evidence that aluminum-coated particles phagocytozed in the injected muscle and its draining lymph notes can disseminate within phagocytes throughout the body and slowly accumulate in the brain further suggests that alum safety should be evaluated in the long term.(source)

The pictures below come from the recent 2018 study and show ‘bright spots’ that indicate heavy metals in the brain.

 

The more recent study discussed in this article is adding to that evidence. Below you can watch one of the most recent interviews with Dr. Eric Exly, one of the world’s foremost leading authors on the subject, and one of the authors of this most recent study. He is a Biologist (University of Stirling) with a Ph.D. in the ecotoxicology of aluminum. You can read more about his background here.

Take Away

People need to understand that despite media bullying, it’s ok to question vaccine safety, and there is plenty of reason to. There are many concerns, and heavy metals are one of them. In fact, the persistence and abundant presence of heavy metals in our environment, foods and medications is a concern, one that has been the clear cause for a variety of health ailments, yet it’s one that’s hardly addressed by the medical industry.

You can detox from this with items such as Spirulina, and waters that contain a high Silica content. There are studies that show various methods of detoxing can be used to get this lodged aluminum, or some of it, out of your body, organs and brain. This is where educating yourself regarding the medicinal value of food and nutrition is a key Perhaps this can be a motivation to better your diet, especially if you have, are someone, or know someone with an ASD diagnosis.

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The CDC’s Influenza Math Doesn’t Add Up: Exaggerating the Death Toll to Sell Flu Shots

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In Brief

  • The Facts:

    The flu shot is irresponsibly marketed, unnecessary and in some cases dangerous. This perspective comes from many people and health professionals, yet it's a narrative that's constantly ignored.

  • Reflect On:

    Is a flu shot really necessary? Are our immune systems suffering from a lack of real immunity? Are vaccines doing more harm than good?

Every year at about this time, public health officials and their media megaphones start up the drumbeat to encourage everyone (including half-year-old infants, pregnant women and the invalid elderly) to get a flu shot. Never mind that more often than not the vaccines don’t work, and sometimes even increase the risk of getting sick.

To buttress their alarmist message for 2018-2019, representatives from the Centers for Disease Control and Prevention (CDC) and other health agencies held a press conference and issued a press release on September 27, citing a particularly “record-breaking” (though unsubstantiated) 80,000 flu deaths last year. Having “medical experts and public health authorities publicly…state concern and alarm (and predict dire outcomes)” is part and parcel of the CDC’s documented playbook for “fostering public interest and high…demand” for flu shots. CDC’s media relations experts frankly admit that “framing” the current flu season as “more severe than last or past years” or more “deadly” is a highly effective strategy for garnering strong interest and attention from both the media and the public.

If accurate, 80,000 deaths would represent an enormous (and mystifying) one-year jump—tens of thousands more flu deaths compared to the already inflated numbers presented for 2016 (and every prior year).

Peter Doshi (associate editor at The BMJ and a MIT graduate) has criticized the CDC’s “aggressive” promotion of flu shots, noting that although the annual public health campaigns deliver a “who-in-their-right-mind-could-possibly-disagree message,” the “rhetoric of science” trotted out each year by public health officials has a “shaky scientific basis.” Viewed within the context of Doshi’s remarks, the CDC’s high-flying flu numbers for 2017-2018 raise a number of questions. If accurate, 80,000 deaths would represent an enormous (and mystifying) one-year jump—tens of thousands more flu deaths compared to the already inflated numbers presented for 2016 (and every prior year). Moreover, assuming a roughly six-month season for peak flu activity, the 80,000 figure would translate to an average of over 13,300 deaths per month—something that no newspaper last year came close to reporting.

The CDC’s statistics are impervious to independent verification because they remain, thus far, unpublished—despite the agency’s pledge on its website to base its public health pronouncements on high-quality data derived openly and objectively. Could the CDC’s disappointment with influenza vaccination coverage—which lags far behind the agency’s target of 80%—have anything to do with the opacity of the flu data being used to peddle the unpopular and ineffective vaccines?

Fudging facts

There are a variety of reasons to question the precision with which the CDC likes to imbue its flu statistics. First, although the CDC states that it conducts influenza mortality surveillance with its partner agencies, there is no actual requirement for U.S. states to report adult flu deaths to the CDC. (In public health parlance, adult influenza deaths are not “reportable” or “nationally notifiable.”) In fact, the only “flu-associated deaths” that the CDC requires states and other jurisdictions to report are deaths in children—180 last year.

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…when actual death certificates are tallied, influenza deaths on average are little more than 1,000 yearly.

How did the CDC reach its as-yet-unpublished conclusion—widely shared with the media—that 79,820 American adults in addition to 180 children died from the flu in 2017-2018? The agency states that it relies on death certificate data. However, members of the Cochrane research community have observed that “when actual death certificates are tallied, influenza deaths on average are little more than 1,000 yearly.”

Other knowledgeable individuals have also noted that the death records system in the U.S. is subjective, incomplete and politicized, and have suggested that citizens should adopt a “healthy skepticism about even the most accepted, mainstream, nationally reported CDC or other ‘scientific’ statistics.” This skepticism may be especially warranted for the influenza stats, which are so inextricably intertwined with the CDC’s vaccination agenda that the statistical techniquesand assumptions that the agency uses focus specifically on “project[ing] the burden of influenza that would have occurred in the absence of vaccination.”

skepticism may be especially warranted for the influenza stats, which are so inetricably intertwined with the CDC’s vaccination agenda.

Notwithstanding its incessant use of influenza statistics to justify its flu vaccine policies, the CDC tries to have it both ways, cautioning that because “influenza activity reporting…is voluntary,” influenza surveillance in the U.S. “cannot be used to ascertain how many people have become ill with influenza during the influenza season.” A larger problem is that the vital statistics that form the basis of the CDC’s surveillance data conflate deaths from pneumonia and influenza (P&I). The CDC concedes that this conflation complicates the challenge of specifically estimating flu deaths:

The system “tracks the proportion of death certificates processed that list pneumonia or influenza as the underlying or contributing cause of death. This system…does not provide an exact number of how many people died from flu” [emphasis added].

Curiously, the CDC presented its cause-of-death data slightly differently prior to 2015. Through 2014, the agency’s annual National Vital Statistics Reports included tables showing influenza deaths and pneumonia deaths as separate line items. Those reports made it abundantly clear that pneumonia deaths (at least as transmitted by death certificates) consistently and dramatically outstripped influenza deaths. The table below illustrates this pattern for 2012-2014.

Starting in 2015, the annual vital statistics reports began displaying P&I together and eliminated the distinct line items. At present, only one tool remains to examine mortality associated with influenza as distinct from pneumonia—the CDC’s interactive FluView dashboard—which provides weekly national breakdowns. The dashboard shows the same general pattern as in the annual reports—that is, lower numbers of influenza deaths and much higher numbers of pneumonia deaths. Bearing in mind all the shortcomings and potential biases of death certificate data, dashboard reports for the first week of March (week 9) for the past three years show 257 influenza deaths versus 4,250 pneumonia deaths in 2016, and 534 and 736 flu deaths (versus over 4,000 annual pneumonia deaths) in 2017 and 2018, respectively.

When clinicians in outpatient settings do order testing, relatively few of the “flu” specimens—sometimes as low as 1%—actually test positive for influenza.

Semantic shenanigans

Semantics also play a key role in the CDC’s slippery communications about “flu.” For example, CDC’s outpatient surveillance focuses on the broad category of “influenza-like illness” (ILI)—an almost meaningless term describing general symptoms (fever, cough and/or sore throat) that any number of non-influenza viruses are equally capable of triggering. Cochrane lists several problems with the reliance on ILI to make inferences about influenza:

  • There is “no reliable system to monitor and quantify the epidemiology and impact of ILI” and no way of knowing what proportion of ILI is caused by influenza.
  • There are almost no reliable data on the number of ILI-related physician contacts or hospitalizations—and no one knows what proportion of ILI doctor visits and hospitalizations are due to influenza.

“Pneumonia,” too, is a catch-all diagnosis covering lung infections caused by a variety of different agents: viruses (non-influenza as well as influenza), bacteriafungiair pollutants and many others. Interestingly, hospitalization is a common route of exposure to pneumonia-causing pathogens, and mortality from hospital-acquired pneumonia exceeds 60%. In a plausible scenario, an adult hospitalized for suspected (but unconfirmed) “flu” could acquire a lethal pneumonia bug in the hospital, and their death might be chalked up to “flu” regardless of the actual facts, particularly because clinicians do not necessarily order influenza testing. When clinicians in outpatient settings do order testing, relatively few of the “flu” specimens—sometimes as low as 1%—actually test positive for influenza. Over the past couple of decades, the proportion of specimens testing positive has averaged around 15%—meaning that about 85% of suspected “flu” specimens are not, in fact, influenza.

Roughly four-fifths of the vaccine injury and death cases settled through the National Vaccine Injury Compensation Program are flu-vaccine-related.

Propaganda with a purpose

It takes little subtlety to recognize that the principal reason for flu hyperbole is to sell more vaccines. However, more and more people—even infectious disease specialists—are realizing that flu shots are fraught with problems. Roughly four-fifths of the vaccine injury and death cases settled through the National Vaccine Injury Compensation Program are flu-vaccine-related. A University of Toronto-based expert recently stated, “We have kind of hyped this vaccine so much for so long we are starting to believe our own hype.”

Pro-flu-vaccination studies—through their skillful placement in prestigious journals—tend to drown out other influenza studies that should be ringing warning bells. Published peer-reviewed studies show that:

  • Previous influenza vaccination, particularly in those who get a flu shot every year, diminishes or “blunts” the already low effectiveness of flu shots.
  • Getting vaccinated against influenza increases susceptibility to other severe respiratory viruses and also to other strains of influenza.
  • Mothers who receive influenza vaccines during pregnancy face an increased risk of miscarriages and their offspring face elevated risks of birth defects and autism.

A systematic review of influenza vaccine trials by Cochrane in 2010 urges the utmost caution. Noting that “studies funded from public sources [have been] significantly less likely [than industry-funded studies] to report conclusions favorable to the vaccines,” and citing evidence of “widespread manipulation of conclusions,” the Cochrane reviewers’ bottom line is that “reliable evidence on influenza vaccines is thin.” We should all keep those words in mind the next time the CDC and the media try to mischaracterize flu facts and science.

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. Please visit our crowdfunding page.

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