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That Was Then, This Is Now: Open Season on Vaccinating Pregnant Women

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By the World Mercury Project team

Instinctively, most of us know that pregnancy is a time when it makes sense to be cautious. After all, as even popular culture attests, “precious cargo” is involved. With medications, focus group research indicates that when the risks of a given medication are unknown, most women are not willing to take the medication during pregnancy.

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To help pregnant women navigate potential risks to themselves and their “cargo,” WebMD furnishes a long checklist of substances known to cause birth defects, including acne drugs, some antidepressants and heavy metals such as lead and organic mercury. However, when it comes to flu shots (some of which contain organic mercury), the website tells women that the vaccines are completely safe any time during pregnancy. The website’s certitude in this regard rests on the assurances of entities like the Centers for Disease Control and Prevention (CDC), which has long recommended influenza vaccines for pregnant women. CDC’s rationale is that the vaccines are needed to help pregnant women avoid the “excess” influenza-related deaths that apparently occurred during early-20th-century influenza pandemics.

Published reports point to an increased risk of miscarriages and elevated risks of birth defects and autism in the offspring of mothers who received influenza vaccines during pregnancy—

Changing recommendations

Around 2006, CDC took stock of the persistently low compliance with its influenza recommendations, largely ignored by both doctors and pregnant women, and began more aggressively promoting flu shots for pregnant women. In an update in the Morbidity and Mortality Weekly Report, CDC cited as evidence of the vaccines’ safety during pregnancy a grand total of two retrospective epidemiological studies of medical records—one of which was published in 1973.

In 2011, CDC and other medical trade organizations also began recommending that all pregnant women get the Tdap vaccine (tetanus-diphtheria-acellular pertussis), which, among other ingredients, contains neurotoxic aluminum. Tdap coverage in pregnancy increased substantially following this recommendation, particularly in women who also received other vaccines during pregnancy. The FDA’s original approval of the two Tdap brands (Boostrix and Adacel) in the mid-2000s was as a booster for teens and adults, and the product inserts state that Tdap should be given during pregnancy only “when benefit outweighs risk.” At the time of the 2011 recommendation, no prelicensure studies of Tdap safety during pregnancy were available, so most of the (largely unpublished) data used to justify the recommendation came from post-licensure pregnancy pharmacovigilance conducted by vaccine manufacturers. To this day, online information for Boostrix states that “it is not known whether Tdap vaccine will harm an unborn baby.”

How have these vaccine recommendations worked out for pregnant women and their babies? Published reports point to an increased risk of miscarriages and elevated risks of birth defects and autism in the offspring of mothers who received influenza vaccines during pregnancy—described by World Mercury Project on multiple occasions. Although evidence about Tdap is still emerging, the global VigiBase database (launched in 1978 to collect reports of vaccine-related adverse events from heterogeneous systems in 110 countries) indicates that three-fifths (58%) of all the Tdap-related adverse events reported to VigiBase have occurred since 2010, half (49%) have been in females and 7% have been in the 18-44-year age group. Admittedly, the non-systematic nature of the VigiBase data makes it difficult to interpret these trends, but it still seems surprising that the default official position shared by academics and regulators is that “there is no documented causal evidence of developmental or reproductive toxic effects in humans following the use of [any] approved vaccine.”

…experts emphasize that toxicity is both dose and time-dependent, and that toxicity testing must investigate time-dependent effects. The vaccines destined for pregnant women have not been subjected to this type of nuanced scrutiny.

Looking back

Prevailing notions of what is “ethically permissible or necessary” with regard to the medical protection of pregnant women appear to be somewhat malleable. There was, in fact, a time when regulators did not display the same levels of insouciance about vaccine and drug administration during pregnancy. Formerly, federal policy (at least on paper) deemed it prudent to exclude women of childbearing age and pregnant women from taking part in clinical trials to test new drugs. This precautionary stance—grounded in established toxicological principles—aimed to forestall developmental toxicity disasters such as the one that occurred with thalidomide. In 1993, however, mounting pressure from various sectors persuaded the Food and Drug Administration (FDA) to abolish the perceived “medical research gender gap.” The FDA’s Center for Drug Evaluation and Research (CDER) reversed course and began encouraging routine inclusion of reproductive-age women in clinical trials—but it continued to note the special circumstances of pregnant women (and is just now getting around to formalizing scientific and ethical guidance pertaining to pregnant women’s participation in drug trials).

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Over at the FDA’s sister office CBER (Center for Biologics Evaluation and Research), which oversees vaccines and other “biologics,” officials initially seemed to share CDER’s apparent restraint concerning pregnant women. In 1996, CBER’s Office of Vaccines Research and Review (OVRR) wrote up a detailed two-page memorandum on reproductive toxicity and vaccines. It then invited the public to submit written comments(in 2000) and eventually published “Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications” (in 2006).

The memo and subsequent guidance spelled out the critical need to conduct preclinical studies in animal models to assess reproductive and developmental toxicity “prior to licensure of vaccines intended for maternal immunization and/or women of childbearing age” (see table below). However, the documents admitted that “lack of adverse effects on embryo/fetal development in an animal study does not necessarily imply absence of risk for humans.” Moreover, given the FDA’s emphasis (in a header on every page) that all of the recommendations included in its guidance are non-binding, the extent to which vaccine manufacturers choose to abide by them is largely unknown.

…neither the FDA nor the WHO commented on the possible conflicts-of-interest inherent in having vaccine manufacturers conduct their own pharmacovigilance.

In 2013, when the World Health Organization’s (WHO’s) Global Advisory Committee on Vaccine Safety reviewed the safety of the growing number of vaccines intended for pregnant women, it noted “the limited amount of clinical trial data on pregnant women” and, like the FDA, emphasized the importance of “enhanced pharmacovigilance in the post-licensure phase.” However, neither the FDA nor the WHO commented on the possible conflicts-of-interest inherent in having vaccine manufacturers conduct their own pharmacovigilance.

 Numerous challenges

Even under the best of circumstances, vaccine development for pregnant women poses special challenges. As one researcher recently stated:

Not only do vaccines for pregnant women require evidence of immunogenicity, potency, stability, and limited reactogenicity, they must also provide efficacy in decreasing morbidity for the pregnant woman, her fetus, and the neonate, demonstrate safety or lack of evidence of harm, and offer benefit or potential benefit of vaccination during pregnancy.”

Conducting the types of preclinical developmental toxicity studies and after-the-fact monitoring activities described in the FDA documents comes with its own set of challenges. These include:

  • Identifying suitable animal models for preclinical studies, particularly because not all species (e.g., primates, rodents or rabbits) are appropriate for all research questions.
  • Assessing whether adverse effects on the developing embryo or fetus were caused by the vaccine antigen or by other vaccine constituents (such as adjuvants, preservatives and stabilizers).
  • Evaluating adverse influences of vaccine-induced antibodies on both fetal and postnatal
  • Determining whether maternal vaccination affects immune development in the offspring.

Toxicologists also continually call attention to the fact that even very small doses of substances such as mercury “may cause extensive adverse effects later in life.” These experts emphasize that toxicity is both dose and time-dependent, and that toxicity testing must investigate time-dependent effects. The vaccines destined for pregnant women have not been subjected to this type of nuanced scrutiny.

Where are the warnings?

A recent assessment of titanium dioxide nanoparticles—a modern product included in many cosmetics and drugs—warned of significant and potentially devastating effects on “millions of pregnant mothers and their offspring.” Vaccines contain an array of nanoparticulate ingredients (some intended and some not), but no comparable studies have emerged nor have warnings been issued. In general, published discussions of vaccine safety during pregnancy exhibit a linguistic slant toward describing risks to the fetus as “perceived” and “potential” rather than actual. Whether regulatory agencies’ former professed interest in protecting pregnant women from exposure to potential toxins was ever sincere or not, by and large, it appears to have become a historical footnote.

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Awareness

Johnson & Johnson Found To Have Knowingly Allowed Asbestos In Their Baby Powder

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In Brief

  • The Facts:

    Johnson and Johnson have recently lost lawsuits for negligence in knowingly allowing carcinogenic substances in their talc-based hygiene products.

  • Reflect On:

    Are we starting to turn the page on an era where human health and safety are not the prime considerations in the manufacturing of consumer products?

We are starting to awaken to the fact that it seems to be the rule, and not the exception, that large Western corporations put profits above human health considerations. The only time they seem to give any regard to human health concerns is when their forecasts of potential lawsuits down the road would likely exceed the cost measures needed to ensure the safety of their product.

Johnson & Johnson is just one of a long line of corporate perpetrators who believed that covering up and lying about known health concerns would make better business sense than taking the time and resources to actually address those health concerns within their products.

Contaminated Baby Powder: The Height Of Indignity

One would think, regardless of an understanding that the bottom line is a priority for most private companies, that the health and safety of a nursing mother and her newborn child would be sacrosanct for any industry. The reality is that this is simply not the case, even though J&J could have mitigated this problem from the start.

Companies that mine talc are required to take extra steps to ensure the absence of asbestos in their talc. Instead, J&J allegedly went to great lengths to fake it.

Not only did the company know about the asbestos contamination, evidence suggests, but J&J also failed to warn its customers about the link between Baby Powder and cancer or replace its talc with a safer alternative. As a result, J&J guaranteed its customers’ exposure to asbestos.

And regardless of their size or numbers, asbestos fibers are lethal at any capacity. As the World Health Organization (WHO) has stressed repeatedly, there is no safe level of exposure. (source)

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The Testimony of Scientist James Webber

Baby Powder’s contamination with asbestos (a mineral that naturally occurs near talc) has long been the subject of lawsuits. But only in recent years has evidence begun to unravel J&J’s defense – that the company had no idea – and threatened its success in lawsuits to come.

In March, a California jury awarded $29 million to Terry Leavitt, a woman who said that asbestos in Johnson & Johnson’s talcum-powder-based products caused her terminal mesothelioma. Environmental scientist James Webber testified in her high-profile California trial and made these observations:

During several hours on the stand, Webber explained how he ran tests that showed “clear” evidence of asbestos contamination in the mines from which J&J sourced talc.

“The testing I have seen [shows] that it was present at least as early as 1971 and up through the late 1990s,” said Webber, who ran an asbestos laboratory in New York state.

Despite denying it publicly, J&J had observed this contamination in internal memos. Its notes dismissed the amount of asbestos in its talc as “but a trace,” Webber alleged. But that was just an optimistic interpretation of superficial testing, he said: the tests used methods too weak to detect microscopic asbestos fibers. Webber insisted the actual tests results revealed there could be millions of asbestos fibers per gram of talc.

And J&J’s inaccurate reports were allegedly only the tip of the iceberg. In some instances, Webber said, photos attached to J&J’s reports revealed that “they had been seeing it and not reporting it.”  (source)

And It’s Getting Worse

The $29 million verdict, in California Superior Court in Oakland, was the latest defeat for the healthcare conglomerate facing more than 13,000 talc-related lawsuits nationwide. And things may be getting even worse for J&J, according to ZeroHedge:

Johnson & Johnson shares are down over 5% after Bloomberg reports that, according to people with knowledge of the matter, the U.S. Justice Department is pursuing a criminal investigation into whether Johnson & Johnson lied to the public about the possible cancer risks of its talcum powder…

Now, a grand jury in Washington is examining documents related to what company officials knew about any carcinogens in their products, the people said.

The Takeaway

It seems as though corporations have long been willing to take the calculated risk of short-cuts and denials instead of ensuring that their products are safe for public use. My suspicion is that a part of our collective awakening process will be issuing in a new business paradigm in which human health and safety become paramount.

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Awareness

Prescription Infant Formulas Found To Be Contaminated With Aluminum

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In Brief

  • The Facts:

    Multiple brands of prescription infant formula were found to contain high levels of aluminum.

  • Reflect On:

    Should we be questioning the quality of products that come from pharmaceutical production? Do we veer away from natural methods of raising children more than we should? At what cost?

You may not think aluminum is a big deal, but it is. For anybody who has looked into aluminum toxicology, it’s quite clear and apparent that it has no place inside of any living biological organism. Putting it simply, it wreaks havoc on our biology. High amounts of aluminum have been found in the brains of people with Alzheimer’s disease, with experts in the field believing that aluminum brain accumulation may be one of the main causes of Alzheimer’s disease.

It’s also been discovered within the brains of MS patients, and some of the highest aluminum content ever recorded in brain tissue has also been discovered in people with autism. Aluminum is associated with several diseases. But an adult body can do a great job of flushing out aluminum.

Despite the fact that aluminum has no place within earth’s biota, it’s still present in many of our medications, our food, and even in the water that we drink due to contamination since the industrial revolution. Aluminum inside the body is a new phenomenon and still understudied. Again, there is a threshold, and aluminum that is injected via vaccines doesn’t exit the body–there is strong evidence that it remains inside the body and ends up in distant organs and eventually inside of the brain. If you want to access more studies on that topic, you can read this article I published that provides them and goes into more detail. You can also watch this interview with Christopher Exley, where he also points to that fact.

A new study published in the International Journal of Environmental Research and Public Health has shown that multiple popular infant prescriptions are contaminated with aluminum. You may be asking how much aluminum, but the authors make it a point to stress that there are no safe amounts of aluminum levels that can be inside of a human body, let alone a newborn baby. That being said, the amounts found are listed within the abstract of the study:

Historical and recent data demonstrate that off-the-shelf infant formulas are heavily contaminated with aluminium. The origin of this contamination remains to be elucidated though may be imported via ingredients, packaging and processing. Specialised infant formulas exist to address health issues, such as low birth weight, allergy or intolerance and medical conditions, such as renal insufficiency. The aluminium content of these prescription infant formulas is measured here for the first time. We obtained 24 prescription infant formulas through a paediatric clinic and measured their total aluminium content by transversely heated graphite furnace atomic absorption spectrometry following microwave assisted acid/peroxide digestion. The aluminium content of ready-to-drink formulas ranged from 49.9 (33.7) to 1956.3 (111.0) μg/L. The most heavily contaminated products were those designed as nutritional supplements for infants struggling to gain weight. The aluminium content of powdered formulas ranged from 0.27 (0.04) to 3.27 (0.19) μg/g. The most heavily contaminated products tended to be those addressing allergies and intolerance. Prescription infant formulas are contaminated with aluminium.

Another very important point made right off the bat by the authors:

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Human exposure to aluminium is a serious health concern. Aluminium exposure in infants is understandably a burgeoning issue. While infant exposure to aluminium continues to be documented, its consequences, immediate and in the future, have received only scant attention and research is required to understand the biological availability of aluminium through formula feeding. For example, how much aluminium is absorbed across the neonate gut and its subsequent fate, including excretion.

There is already too much aluminium in infant formulas and herein we have measured its content in a large number of prescription formulas, products which are fed to vulnerable infants in their first months of life. Many of these products are heavily contaminated with aluminium.

As for the specific infant formulas, you can refer to the study. The researchers obtained 24 prescription infant formulas via the Paediatric Clinic of Russells Hall Hospital in Dudley, United Kingdom. The ready-to-drink and powdered products were new, ready-to-be used and unopened samples. These formulas are for babies with some sort of growth restriction, like for preterm infants or infants who have poor weight gain. There were also powdered formulas for allergies and intolerances and powdered formulas with additional amino acids.

The authors contacted each manufacturer and expressed that they denied knowing that there was any aluminum in their products, which means it’s still a mystery as to their source. The authors hypothesize on a number of ways that aluminum could be entering into the formulas.

In their conclusion, the authors emphasize that:

Where possible, breast milk feeding should be prioritised, as the aluminium content of breast milk is invariably an order of magnitude lower than in formula feeds. Where infant formulas are the only source of nutrition for many infants in their first weeks and months of life, aluminium ingested in formula feeds will be the major contributor to their body burden of aluminium. The last thing that vulnerable infants fed specialised formulas for their specific nutritional/medicinal need is additional aluminium in their diet.

Detoxing

There is a lot of information out there on how a person can detox from aluminum and other heavy metals. There are multiple studies, and based on what I’ve looked into, water with high amounts of Silica are effective in draining aluminum out of your body and brain. Herbs like cilantro and substances like chlorella and spirulina are also great for removing some metals. The information is out there, so be sure to do your research.

The Takeaway

It’s concerning to think about what these corporations are doing. Again, aluminum should hold no place in our society, it should’ve remained well below our surface as part of the Earth’s crust for a reason. It wasn’t until humans began digging it out and using it for a number of things, irresponsibly I might add, that we started to see the health implications which still go largely ignored by the medical community.

In fact, heavy metal accumulation and detoxification of aluminum haven’t been addressed at all, which is odd given the fact that heavy metal accumulation is linked to a variety of diseases.

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Awareness

9 Studies You Should Be Aware of Before Trying The Ketogenic Diet

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In Brief

  • The Facts:

    The Ketogenic diet is a popular fad diet that promotes quick weight loss and symptom management for bodies that are dealing with poor lymph, kidney and digestion health.

  • Reflect On:

    Based on the studies that are emerging, is our desire for quick weight loss more important than living a long and healthy life? Are we learning about these diets primarily through those with strong ties to upholding these diets?

The ketogenic diet has popped up as a popular approach to weight loss in the last few years. Is it successful at that? Sure, it is. I’ve experimented with the diet myself years ago when I was looking to lose some belly fat. I was entering into ketosis in a different way than most, as I was not eating any animal products, but it does in fact work.

But like any animal product based diet, what are the consequences of eating so much food that does not truly jive with our human bodies? Not only that, is fast weight loss more important than keeping our morality rate down?

In the last few years, we’ve reported a lot on the Keto diet and the various ways it can be done. We have explored the studies, the results and in some ways, we supported it. But lately, I have been thinking about how supporting this could actually be encouraging people to jump into these diets, including the paleo diet, when in reality these diets increase mortality rates and are not healthy for the human body.

It became a thought in the back of my mind, I have always strived to put the best information out that I can through this platform to promote good health. And so we must look at that, even if that means upsetting some people who currently are on paleo or keto and are seeing some good weight loss or symptom management. The truth is, like the many people I’ve seen crash on these diets after a few years, I want people to know the truth of what’s going on out there. And how we can get beyond diets that symptom manage, and instead get onto diets that truly heal.

Anytime we have fad diets, which paleo and keto are, we see products and bias pop up all over the place to support the continuation of these trends. It becomes less about health and more about upholding an identity or a business.

So as I recently looked into what experts are saying about these diets, I came upon two important videos I think everyone should check out. Both have been embedded below. Remember, it’s not that I care what you choose in your own life, or that I feel there is a right or wrong, it’s that I believe we should be informed and I wish to use this platform to promote as best a message as I can.

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The Videos

Thanks to Plant-Based News for creating such a good channel and resource of information on YouTube.

In this video, several plant-based health experts talk through 9 nutrition studies that would be of interest to low carb keto diet proponents. To read the 9 studies, click here.

Next up, Dr. Kim Williams (past President of the American College of Cardiology) shares his insights about the ketogenic.

Related Articles

Diabetic Shares Why He Quit ‘The Ketogenic Diet’

Doctor Explains Why She Never Recommends The ‘Ketogenic Diet’

The Biggest Misconception About The ‘Ketogenic Diet’…You Don’t Actually Have To Follow It

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