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VacciShield: Pixie dust for an imaginary threat

vaccishield

I know by now I shouldn’t be, but I am still amazed by how readily so many people buy into the seemingly endless array of bogus sCAM nostrums. Many are marketed and hawked for the treatment or prevention of diseases that are poorly managed by science-based medicine. There are countless examples of dietary supplements that are purported to effectively treat back and joint pains, depression, anxiety, autism, chronic pain, and chronic fatigue; the list goes on and on. The lure for these treatments is at least understandable and, although frustrated that scientific literacy and rational thought loses out, I empathize with the desire to believe in them. On the other end of the spectrum is the even more ethically corrupt substitution of safe and effective treatments with products that are not. I encountered what I find to be possibly the most frightening and dangerous example of this recently at my practice. A family new to the area called to schedule a routine health-maintenance visit for their 5-year-old daughter. When our nurse reviewed the medical records the mother had faxed over, she noted that the child was unimmunized and explained to her that she would need to begin catch-up vaccinations. The mother matter-of-factly stated that her daughter was actually fully vaccinated with a vaccine alternative. She had received a series of homeopathic vaccines from a naturopath. I am not going to discuss this egregious example of sCAM here, though it was addressed in previous SBM posts.1,2 Instead I’d like to focus on another part of the sCAM spectrum. Here lies a form of sCAM that, in some ways, is even more difficult for me to comprehend. These are products invented, marketed, and sold solely for the treatment or prevention of fictitious diseases or problems that exist only in the realm of fantasy.

Vaccishield: yes, you clearly CAN make this sh** up.

A mother-naturopath by the name of Catherine Clinton has identified a little known condition that has launched her career as a producer and seller of one of the newest health-maintaining elixirs. At $27.99 USD for 1.36 ounces, she’s probably doing all right. It’s not a condition, exactly, that her elixir is aimed at. It’s more of a, well, I guess you can call it a state of unsupported peri-vaccination health, or something. In her own words, VacciShield was designed to “fill a gap that we saw in the vaccination process”. To be a little more specific, ND Clinton explains on her company’s website:

I became concerned about vaccinating my son and wanted another option to support him during vaccinations. I looked to the research to see if there was something I could do nutritionally to support health during this vulnerable time. So we created VacciShield to fill a gap that we saw in the vaccination process. VacciShield is designed for infants and kids to help support healthy brain, immune, gastrointestinal and detoxification function during vaccination.

The gap in the vaccination process she refers to is clearly something she found missing from her child’s routine pediatric care. A gap she has identified that, if not filled, places children at risk. At risk from what is not made clear anywhere on the company’s website. But since VacciShield is intended to support healthy brain, immune, gastrointestinal, and detoxifying function, I’m assuming she believes these body systems are at some sort of risk from vaccinations. Actually, it’s pretty clear what she’s referring to by her albeit vague terminology. And the name VacciShield is certainly not ambiguous. It is meant to shield children from the potentially damaging effects of vaccines, while still presumably allowing the benefits of the vaccines to slip through.

To be fair, ND Clinton’s vagueness about what, exactly, this product is supposed to shield against and how is not entirely her fault. The Dietary Safety, Health, and Education Act (DSHEA) of 1999 (under which all dietary supplements fall) prohibits her from making any specific health claims (such as “VacciShield protects your baby from vaccine-toxin-induced autism”). That would place VacciShield in the drug category, and would require the support of real scientific evidence and FDA oversight. As a dietary supplement, so-called “structure-function” claims (such as “supports healthy brain, immune, gastrointestinal, and detoxifying function”) are permitted providing they are truthful and non-misleading, and require only that the FDA be notified within 30 days of the supplement going on the market.

Now, these claims are truthful and non-misleading by only the most legal, non-scientific interpretation. The “active” ingredients in VacciShield include vitamins C, D3 (really a hormone), and E, zinc and selenium, the amino acid L-glutamine, and the nutrients choline and inositol, which are all involved in well-described biochemical or bio-synthetic processes in the body. As such, in the strictest, most uninformative way, these ingredients do “support” body function. In addition to the “active ingredients” mentioned above, VacciShield contains the probiotics Lactobacillus casei and Bifidobacterium lactis.

DSHEA disclaimer

Based on the ingredients she has chosen to include in this product, and the references she cites in support of them, it seems that ND Clinton’s concerns about vaccinating her son are fueled by just about every vaccine myth out there, including Wakefield’s MMR-induced leaky gut-autism myth, the too-many too-soon gambit, the glutathione-deficiency vaccine-induced autism hypothesis, the thimerosal-induced neurotoxicity myth, the intestinal flora dysregulation and autism hypothesis, and probably others all thrown into the mix.

But to play devil’s advocate, let’s look into the evidence in support of VacciShield’s claims (Note: at the end of this post I present a brief synopsis of each of the references cited on the VacciShield website.)

The probiotics

Without delving into the topic of probiotics and the microbiome, suffice it to say that there is, in fact, a growing but still murky body of evidence supporting a host of either protective or treatment effects of probiotics, including possibly enhancing the immune response to the live oral polio and rotavirus vaccines. The VacciShield website cites several references to support their inclusion of Lactobacillus casei and Bifidobacterium lactis in this product. None of these references, however, provide any evidence that can be construed as supporting the use of these probiotics when vaccinating, and some refer to studies that include probiotics not contained in VacciShield.

The vitamins

VacciShield contains small amounts of vitamins C, D3, and E. The VacciShield website cites several references to support their inclusion in this product. While some of these references document real immune-modulating and antioxidant effects, none provide any evidence suggesting benefits of supplementation during vaccination. The website states the following rationale for including these vitamins:

Vitmain C

Vitamin C has been shown in clinical research to support brain, immune, detoxification and gastrointestinal function in a growing child. Vitamin C is a powerful antioxidant that helps protect the body from free radical damage. Vitamin C is also necessary to hundreds of metabolic processes. Research out of Australia suggests Vitamin C’s ability to decrease the side effects of vaccination.

Glutathione, in its reduced state, plays an important role in the body as a free radical-scavenging anti-oxidant. The unsupported hypothesis that glutathione deficiency exists in children predisposed to autism has led some anti-vax pseudoscientists to believe that antioxidants (vitamin C is one) may protect against purported vaccine-induced autism. Other equally unsupported theories claim that thimerosal (now only in some influenza vaccines) lowers glutathione levels to cause neurotoxicity. It seems that this is the likely flawed rationale for the inclusion of vitamin C in this product.

Vitmain D3

Vitamin D3 has hormone like actions by binding to DNA receptors and promoting cell growth. Research highlights the vital role Vitamin D3 plays in maintaining healthy immune, brain, gastrointestinal and detoxification function. Recent research shows how vitamin D3 assists in the immune response to vaccination.

Vitamin D3, which is really a steroid hormone, has many important functions in the body, and there is evidence supporting its role in modulating immune responses. Though they are interesting examples of the important role that vitamin D3 plays in immune modulation, none of the references cited on the VacciShield website support its use as a dietary supplement around the time of vaccination. To claim that they do is an absolute over-reading or misrepresentation of the existing science.

L-glutamine

L-Glutamine is an amino acid found in breast milk and plays an important role in several metabolic processes. L-Glutamine is an important precursor to the major detoxification enzyme, glutathione. L-Glutamine fuels the cells that line the gastrointestinal tract, helping to maintain a healthy digestive tract. Recent studies in 2005 and 2007 showed that L-Glutamine improved intestinal barrier function in children ages 2 months to 6 years old.

These statements sound okay, but they do not give us even a clue as to why we would want to provide a child with extra L-glutamine around the time of vaccination. Unless, of course, you subscribe to some vague, pseudoscientific theory of vaccine toxin-induced, leaky gut, neurotoxicity. The use of these citations is truly beyond belief (make sure you see the summaries below…).

Zinc

Zinc has been shown in research to support brain, immune, detoxification and gastrointestinal function in a growing child. Zinc is an essential mineral that is necessary in hundreds of metabolic processes. Zinc helps maintain a healthy immune system as well as healthy growth and development. Research in 2009 highlighted zinc’s ability to enhance infants immune response to vaccination as measured through immune titers.

Again, these statements are (mostly) true. But replacing the word zinc with almost any biochemically active molecule would be equally true. The last bit about zinc’s ability to augment the immune response to vaccines is another huge stretch, or it simply indicates ND Clinton’s inability to grasp the science. The study cited refers to the finding that zinc supplementation of young Bangladeshi children enhanced their antibody response to the cholera vaccine. Zinc deficiency is extremely common in Bangladesh, but not so in the developed world. Supplementing well-nourished (and zinc-replete) children prior to vaccination is pointless.

Selenium

Selenium has been shown to be a necessary component of detoxification pathways as well as immune function. Selenium is an important precursor to the major detox enzyme glutathione peroxidase. Research with selenium and the polio vaccine shows how important selenium is to the handling of vaccines and immune function.

Yes. And thankfully children have more than enough selenium in their little bodies for all of their little body functions. There is not one stitch of evidence (including the ridiculous choice of references on the VacciShield website) suggesting that supplementation with additional selenium does anything to support a child through their vaccinations.

Choline and inositol

Choline and Inositol work together as primary sources of a healthy cell membrane. They help enhance brain development in infants and children.

Yes, again. And again, this has no relevance to the recommendation for supplementation.

None of the references cited to support supplementation provide any such evidence. Her references for choline are laughably irrelevant, and there is not a single reference for inositol.

In summary, there is no evidence that any of these ingredients improve the efficacy of any vaccine. Nor is there any evidence or reason to believe that an infant or child’s immune system requires “support” to either adequately respond to or be able to handle routinely administered vaccines. Much of the evidence referenced on the VacciShield website is related to the immune modulating and enhancing effects of the substances in question. Putting aside the fact that the evidence is badly misrepresented, it seems from the research cited that the primary benefit of VacciShield must be to augment the response to vaccines rather than to shield or protect against their damaging effects. Reading between the DSHEA-restricted lines on the product website, it is implied that vaccines somehow tax or overload a child’s immune system, thus making “immune support” beneficial. We have heard this canard many times, and it has been mercilessly dealt with ad nauseam elsewhere. Simply put, an infant’s immune system is more than adequately equipped to handle the antigen load of our current vaccine schedule. In fact, compared to the immune challenge faced by the act of simply going outdoors, not to mention fighting the common cold, a child’s vaccine visit is like a drop in the bucket. And though I won’t rehash this topic here, the “toxic threat” of vaccines is no threat at all. Those who claim otherwise are either ignorant of the science or are willful fear-mongers. In the end, VacciShield can be seen only as an expensive and useless solution to a non-existent problem. Not surprisingly, the website testimonials are over-the-top, and rather hilarious. My favorites are those crediting VacciShield for a trouble-free vaccination experience,

I have been using VacciShield since my children first starting immunizations and thanks to this great product, the side effects have been minimal. No fevers, swollen arms or legs and the best part, no panic from mom! I feel at ease taking them in now. I recommend this to all my friends who have children. It really works, and it’s great for all ages!!
Ditton in Oregon

On the other hand, maybe this is the trick for getting all of my vaccine-hesitant parents to get their children vaccinated…


Probiotic references:

Daily probiotic’s (Lactobacillus casei Shirota) reduction of infection incidence in athletes.” Int J Sport Nutr Exerc Metab. 2011 Feb;21(1):55-64.

  • A double-blind, placebo-controlled RCT demonstrating a reduction in the frequency of upper respiratory tract infections in athletes taking Lactobacillus casei during 4 months of winter training. It also demonstrated a significant increase in salivary IgA, which was hypothesized to play a role in the lowered incidence of infections.
  • There is no reason to conclude from these results that Lactobacillus casei can enhance the immune response to vaccines, particularly if increased secretory IgA is the responsible factor, as suggested by the authors.

Effect of probiotic supplementation in the first 6 months of life on specific antibody responses to infant Hepatitis B vaccination.” Vaccine 2010 Mar 19;28(14):2577-9.

  • This was an underpowered RCT that produced confusing results suggesting an increase in IgG antibody response in infants receiving a very specific schedule of hepatitis B vaccination, but not another schedule.
  • The authors state that the study was designed to evaluate the effect of probiotic supplementation in the first 6 months of life on eczema in at-risk infants, however eczema is mentioned nowhere in the paper, making me wonder whether the study endpoint may have been changed during the study, or that there were multiple-endpoints.
  • The probiotics used in this study (Bifidobacterium longum and Lactobacillus rhamnosus) were not the same as those in VacciShield, making this study no use as supporting evidence, though I don’t see how it would support the use of these probiotic even if they were.

Probiotic bacteria stimulate virus-specific neutralizing antibodies following a booster polio vaccination.” Eur J Nutr. 2005 Oct;44(7):406-13.

  • A double blinded RCT demonstrating a greater increase in poliovirus-specific serum IgA and IgG levels following vaccination with oral polio vaccine in patients receiving Lactobacillus rhamnosus or acidophilus compared with placebo.
  • Again, The probiotics used in this study were not the same as those in VacciShield, making this study inappropriate to use as supporting evidence.

Ability of probiotic Lactobacillus casei DN 114001 to bind or/and metabolise heterocyclic aromatic amines in vitro.” Eur J Nutr. 2009 Oct;48(7):419-27.

  • An in vitro study exploring the ability of Lactobacillus casei to absorb and/or metabolize several heterocyclic aromatic amines, which may be potentially carcinogenic dietary compounds.
  • This study has no relevance as a piece of supporting evidence for the use of this or any other probiotic during vaccination.

(Two additional studies cited as supporting evidence were not included here because they were simply topic overviews.)

Vitamin references:

Selected vitamins and trace elements support immune function by strengthening epithelial barriers and cellular and humoral immune responses.” Br J Nutr. 2007 Oct;98 Suppl 1:S29-35.

  • This is a journal supplement that summarizes the roles of selected vitamins and trace elements in immune function, discusses how deficiencies in these micronutrients may lead to immune disregulation, and then hypothesizes that supplementation may support the body’s natural defense system.
  • No evidence here.

Combined ascorbate and glutathione deficiency leads to decreased cytochrome b5 expression and impaired reduction of sulfamethoxazole hydroxylamine.” Arch Toxicol. 2010 Aug;84(8):597-607.

  • A study suggesting that guinea pigs fed a vitamin C and glutathione-restricted diet may be less able to metabolize reactive metabolites of the antibiotic sulfamethoxazole (SMX). The authors hypothesize that this mechanism could contribute to the higher risk of SMX hypersensitivity in patients with AIDS and antioxidant depletion.
  • To cite this as evidence for the use of vitamin C around the time of vaccination indicates either profound scientific illiteracy or outright fraud. That said, there are anti-vaccination pseudoscientists who believe subtle glutathione deficiency predisposes some children to autism following vaccination, or that thimerosal lowers glutathione levels to produce vaccine-induced neurotoxicity. There is no sound science to support these beliefs. Even if there was, the paper cited here still provides no evidence for the use of vitamin C with vaccination.

Ascorbic acid promotes detoxification and elimination of 4-hydroxy-2(E)-nonenal in human monocytic THP-1 cells.” Chem Res Toxicol. 2009 May;22(5):863-74.

  • This in vitro study demonstrated that pre-treating a human leukemia cell line with vitamin C decreased HNE-induced formation of reactive oxygen species and formation of protein carbonyls. HNE (4-Hydroxy-2(E)-nonenal) is a reactive aldehyde derived from oxidized lipids, and has been implicated in the pathogenesis of cardiovascular and neurological diseases. According to the authors, the study results suggest that the protective effects of vitamin C are related to its ability to reduce glutathione.
  • This is an in vitro study that has nothing to do with vaccines. Unless, again, you believe in the glutathione theory of vaccine-induced autism.
  • If you are looking for evidence to support the use of vitamin C with vaccinations, you will not find any here.

TLR-induced local metabolism of vitamin D3 plays an important role in the diversification of adaptive immune responses.” J Immunol. 2009 Apr 1;182(7):4296-305.

  • Discusses the role that naturally occurring vitamin D3 and calcitriol have on the adaptive immune response to injected antigens and actual infection.
  • Does not discuss the role or potential effect of vitamin D supplementation during vaccination.

TLR ligands that stimulate the metabolism of vitamin D3 in activated murine dendritic cells can function as effective mucosal adjuvants to subcutaneously administered vaccines.” Vaccine. 2008 Jan 30;26(5):601-13.

  • This study demonstrated in a mouse model that active metabolites of vitamin D3 produced locally are able to affect various aspects of innate and acquired immune responses. This may be useful in developing new forms of adjuvants (substances added to vaccines to “jump start” the immune response).
  • It in no way supports the notion of supplementing the diet with vitamin D3 when vaccinating.

Developmental vitamin D deficiency causes abnormal brain development.” Psychoneuroendocrinology. 2009 Dec;34 Suppl 1:S247-57.

  • The authors developed an animal model to test the biological plausibility of the hypothesis that developmental vitamin D deficiency may play a role in schizophrenia. They report structural brain changes in the developmentally deprived animals, and some subtle behavioral changes.
  • Really? Evidence for giving vitamin D to children prior to vaccinations?
  • This is getting ridiculous.

1,25-Dihydroxyvitamin D3 regulates genes responsible for detoxification in intestine.” Toxicol Appl Pharmacol. 2007 Jan 1;218(1):37-44.

  • Using microarray technology, the authors studied the effect of a single dose of vitamin D3 on gene expression in the intestine of vitamin D-deficient rats. They found increased expression of several phase I and phase II biotransformation genes, and an increased expression of antioxidant genes. They suggest that the results support the idea that vitamin D is a significant factor in detoxification and protection against environmental toxins.
  • Ok, so if you believe these results, and you believe that vaccines contain dangerous toxins that need to be eliminated, and you believe that administering vitamin D3 to children around the time of vaccination will stimulate the relevant enzymes to do the relevant detoxifying, then maybe you’ve hit on something here. Another enormous stretch.

Vitamin D receptor negatively regulates bacterial-stimulated NF-kappaB activity in intestine.” Am J Pathol. 2010 Aug;177(2):686-97.

  • By ablating the vitamin D receptor (VDR) in mice, the authors demonstrated that the VDR negatively regulates bacterial-induced intestinal NF-kappaB activation and attenuates response to infection. They conclude that VDR is an important contributor to intestinal homeostasis and host protection from bacterial invasion and infection.
  • And how does this support “protecting” children through vaccination with supplements of vitamin D3? It doesn’t.

L-glutamine references:

Intestinal barrier function and weight gain in malnourished children taking glutamine supplemented enteral formula.” J Pediatr Gastroenterol Nutr. 2005 Jan;40(1):28-35.

  • Malnourished infants/young children fed a formula supplemented with glutamine had a lower Lactulose/mannitol excretion ratio (used as a surrogate marker for intestinal permeability) than those receiving standard formula, indicating improved intestinal barrier function.
  • So? Again, if you believe that vaccines damage your intestinal barrier (there is NO evidence for this anywhere in the literature. ANYWHERE.), and your child is malnourished, then go at it.

Wasting and intestinal barrier function in children taking alanyl-glutamine-supplemented enteral formula.” J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):365-74.

  • Same authors and basically the same as the above.

Zinc and glutamine improve brain development in suckling mice subjected to early postnatal malnutrition.” Nutrition. 2010 Jun;26(6):662-70.

  • Malnourished Swiss mice that received subcutaneous injections of glutamine showed increased hippocampal gamma-aminobutyric acid and synaptophysin levels, and increased CA1 brain layer volume vs. controls.
  • Ok then, clearly we need to give our kids glutamine when they get their shots.
  • Are you laughing or crying? If neither, you need serious help. Or you need to buy some VacciShield…

Zinc references:

The influence of marginal zinc deficient diet on post-vaccination immune response against hepatitis B in rats.” Hepatol Res. 2006 May;35(1):26-30.

  • In vitro cell-mediated immune response and in vivo specific antibody response to hepatitis B vaccine was decreased in rats fed a diet with marginal zinc content. The authors suggest that marginal Zn deficiency might influence the efficacy of hepatitis B vaccination in humans.
  • See above.

Micronutrient deficiencies are associated with impaired immune response and higher burden of respiratory infections in elderly Ecuadorians.” J Nutr. 2009 Jan;139(1):113-9.

  • This was a cross-sectional study of elderly Ecuadorians in a low-income community in Quito, Ecuador. It demonstrated that the burden of infectious diseases, micronutrient deficiencies, and anemia was substantial in this elderly Ecuadorian population, and that deficiencies of essential vitamins and minerals place these elderly adults at risk for infections through their negative impact on immune function.
  • If you’re an elderly Ecuadorian with micronutrient deficiencies, it might be a good idea to take some zinc supplements. If your children live in a well-developed nation and are fortunate to be well-fed, stop wasting your money on products like VacciShield, and donate it to UNICEF instead.

Therapeutic potential of N-acetyl cysteine with antioxidants (Zn and Se) supplementation against dimethylmercury toxicity in male albino rats.” Exp Toxicol Pathol. 2012 Jan;64(1-2):103-8.

  • Combined treatment of zinc and selenium with N-acetyl cysteine (replenishes reduced glutathione stores) to dimethylmercury-exposed rats showed a substantial reduction in the levels of DMM-induced oxidative damage and comet tail length (a measure of DNA damage).
  • In the US there are no more thimerosal-containing vaccines (except for multi-dose vials of influenza vaccine).
  • Thimerosal contains ethyl mercury, not methyl mercury. There is a huge difference.
  • Thimerosal was never a risk to children and has been shown to have no linkage to autism (nor does industrial methyl mercury by the way…).
  • This can in no way be construed as evidence supporting the use of zinc supplementation for children receiving vaccines.

Selenium references:

High selenium status in individuals exposed to arsenic through coal-burning in Shaanxi (PR of China) modulates antioxidant enzymes, heme oxygenase-1 and DNA damage“. Clin Chim Acta. 2010 Sep 6;411(17-18):1312-8.

  • The authors conclude that inorganic arsenic exposure from coal-burning power plants in China is associated with oxidative stress, which may be prevented by high levels of selenium.
  • Do I really need to address this? No, because if you believe this is good evidence to support supplementing children with selenium prior to vaccination, then the cause is lost.

Influence of selenium on innate immune response in kids.” Folia Microbiol (Praha). 2009 Nov;54(6):545-8.

  • Supplementation of baby goats with inorganic selenium was found to up-regulate some in vitro immune responses but not others.
  • We’re scraping the bottom here. And why are we trying to upregulate immune response again?

Selenium-dependent and -independent transport of arsenic by the human multidrug resistance protein 2 (MRP2/ABCC2): implications for the mutual detoxification of arsenic and selenium.” Carcinogenesis. 2010 Aug;31(8):1450-5.

  • Explores the role played by selenium in the transport and detoxification of arsenic in human embryonic kidney cells.
  • No relevance to the use of selenium in vaccinating children.

An increase in selenium intake improves immune function and poliovirus handling in adults with marginal selenium status.” Am J Clin Nutr. 2004 Jul;80(1):154-62.

  • Selenium-deficient adults who received selenium supplements showed increases in some but not all measured immune responses to oral polio vaccine compared to controls.
  • These were adults who were selenium deficient, and the vaccine was the oral polio vaccine, which is no longer given in the US.
  • Children respond just fine to vaccines and do not need their immune response augmented.

Choline and inositol references:

Pre- and postnatal health: evidence of increased choline needs.” J Am Diet Assoc. 2010 Aug;110(8):1198-206.

  • Reviews the importance of choline in fetal development and suggests that pregnant woman may not consume adequate choline during pregnancy. Once again, this is not relevant to the discussion of supplementing children who receive vaccines.

Dietary choline reverses some, but not all, effects of folate deficiency on neurogenesis and apoptosis in fetal mouse brain.” J Nutr. 2010 Jun;140(6):1162-6.

  • This study demonstrated that choline supplementation could reverse some, but not all, of the damaging effects of folate deficiency in fetal mouse brains.
  • This is another evidentiary non sequitur. It is meaningless to the issue of peri-vaccination supplementation.

Early reduction of total N-acetyl-aspartate-compounds in patients with classical vanishing white matter disease. A long-term follow-up MRS study.” Pediatr Res. 2008 Apr;63(4):444-9.

  • Leukoencephalopathy with vanishing white matter is an autosomal recessive degenerative disease of the brain and spinal cord that can present in children or adults. It is not linked in any way to vaccines.
  • I can only guess that ND Clinton cited any references containing the terms choline and brain disease that came up in her PubMed search, because while the word choline does appear twice in this paper, it has no relevance to a deficiency state or anything else I can imagine her wanting to reference. Oops.

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