Overinformed Refusal Has to be Stopped
And Sanofi Pasteur is taking action with their new web-site.
The ImmYounity(SM) campaign provides consumer-friendly, accurate and science-based information about immunization that can be easily accessed at www.vaccines.com. The site contains useful facts and resources, including visuals that can be easily shared via social media and email, and is supplemented by educational brochures offered for use by health-care providers.
Sounds absolutely wonderful. Especially as they set the bar high in these statements on their Educate Others page.
- Make sure the author cites the sources where he or she got the information, along with links to these sources. Is information presented objectively, or is it biased?
- Does the Web site cite scientific evidence for the statements that are made? Can facts and opinions be easily distinguished?
This is certainly what insidevaccines strives to do. How does Vaccines.com hold up when you start looking at their references?
On their Vaccine Q & A page we found this question and answers:
Why are additives put in vaccines?
Additives in vaccines serve some of the same functions as food additives—they can act as preservatives and help extend shelf life, and are only used in very tiny amounts. Small amounts of additives are also used to kill or inactivate vaccines.67
Here are some additives you may have questions about:
Aluminum is used in some vaccines to allow for a better immune response. Infants are constantly exposed to aluminum in a number of ways: it’s present in air, water, food, even in breast milk. The amount used in vaccines, though, is a tiny fraction of the amount a baby would receive through breast milk or formula in the first 6 months of life. That small amount is eliminated quickly from a baby’s body.68
Antibiotics are used to prevent growth of bacteria during production and storage and rarely cause allergic reactions.67,68
Thimerosal is a preservative that is no longer in most children’s vaccines. It has been used in very small amounts to multidose vials of vaccine (which hold more than one dose) to prevent bacteria from contaminating the vaccine.8
If you have any concerns about what additives are in a specific vaccine, be sure to talk to your child’s health-care professional.
So, for supporting references we have 67, 68 and 8.
8 is US Food and Drug Administration (FDA). Thimerosol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm. Accessed August 15, 2011.
67 is CDC. Vaccines and Immunizations. Ingredients of Vaccines – Fact Sheet. http://www.cdc.gov/vaccines/vac-gen/additives.htm. Updated February 22, 2011. Accessed August 15, 2011.
68 is Vaccine Education Center at the Children’s Hospital of Philadelphia. Vaccine ingredients: what you should know. http://www.chop.edu/export/download/pdfs/articles/vaccine-education-center/vaccine-ingredients.pdf. Accessed August 15, 2011.
Secondary sources. Okay. So we’ll go and see if the secondary sources are supported by primary sources.
The FDA page has this list of supporting literature (reference #8) BibliographyStudies on Safety and Effectiveness of Thimerosal:
- Batts AH, Narriott C, Martin GP, et al. The effect of some preservatives used in nasal preparations on mucociliary clearance. Journal of Pharmacy and Pharmacology 1989; 41:156-159.
- Batty I, Harris E, Gasson A. Preservatives and biological reagents. Developments in Biological Standardization 1974;24:131-142.
- Beyer-Boon ME, Arntz PW, Kirk RS. A comparison of thimerosal and 50% alcohol as preservatives in urinary cytology. Journal of Clinical Pathology 1979;32:168-170.
- Gasset AR, Itoi M, Ishii Y, Ramer RM. Teratogenicities of ophthalmic drugs. II. Teratogenicites and tissue accumulation of thimerosal. Archives of Ophthalmology 1975;93:52-55.
- Goldman KN, Centifanta Y, Kaufman HF, et al. Prevention of surface bacterial contamination of donor corneas. Archives of Ophthalmology 1978;96:2277-2280.
- Keeven J, Wrobel S, Portoles M, et al. Evaluating the preservative effectiveness of RGP lens care solutions. Contact Lens Association of Ophthalmologists Journal 1995;21:238-241.
- Naito R, Itoh T, Hasegawa E, et al. Bronopol as a substitute for thimerosal. Developments in Biological Standardization 1974;24:39-48.
- Wozniak-Parnowska W, Krowczynski L. New approach to preserving eye drops. Pharmacy International 1981;2(4):91-94.
We don’t actually see anything in that list which indicates that thimerosal was found safe for injection into infants. What are we missing?
Reference #67 goes to the CDC. The CDC page is very scanty on references. They point people with questions to three places: First to a table of excipients sorted two ways. A helpful reference, but one that leaves a questioning parent with a heavy load of research in front of them. Second to an info sheet about aluminum from the Children’s Hospital of Philadelphia. Third to an article by Paul Offit published in Pediatrics. “Addressing Parents’ Concerns: Do Vaccines Contain Harmful Preservatives, Adjuvants, Additives, or Residuals?” Pediatrics Vol. 112 No. 6 December 1, 2003 pp. 1394 -1397 The article is available full-text.
The info sheet on aluminum makes an interesting statement:
About 50 percent of aluminum in vaccines or in food is eliminated in less than 24 hours; 85 percent is eliminated in two weeks and 96 percent is eliminated in three years. The ability of the body to rapidly eliminate aluminum accounts for its excellent record of safety.
Above, vaccines.com answer says:
That small amount is eliminated quickly from a baby’s body.
Here are the references provided to support the statements on the info sheet:
Baylor NW, Egan W, Richman P. Aluminum salts in vaccines— U.S. perspective. Vaccine 2002; 20: S18-S23.
Bishop NJ, Morley R, Day JP, Lucas A. Aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. New England Journal of Medicine 1997; 336: 1557-1561.
Committee on Nutrition: Aluminum toxicity in infants and children. Pediatrics 1996; 97: 413-416.
Ganrot, PO. Metabolism and possible health effects of aluminum. Environmental Health Perspective 1986; 65: 363- 441.
Keith LS, Jones DE, Chou C. Aluminum toxicokinetics regarding infant diet and vaccinations. Vaccine 2002; 20: S13- S17.
Pennington JA. Aluminum content of food and diets. Food Additives and Contaminants, 1987; 5: 164-232.
Simmer K, Fudge A, Teubner J, James SL. Aluminum concentrations in infant formula. Journal of Paediatrics and Child Health 1990; 26: 9-11.
Only two references that actually consider the question of aluminum in vaccines. Here is the abstract for the Baylor article:
Aluminum in the form of aluminum hydroxide, aluminum phosphate or alum has been commonly used as an adjuvant in many vaccines licensed by the US Food and Drug Administration. Chapter 21 of the US Code of Federal Regulations [610.15(a)] limits the amount of aluminum in biological products, including vaccines, to 0.85 mg/dose. The amount of aluminum in vaccines currently licensed in the US ranges from 0.85-0.125 mg/dose. Clinical studies have demonstrated that aluminum enhances the antigenicity of some vaccines such as diphtheria and tetanus toxoids. Moreover, aluminum-adsorbed diphtheria and tetanus toxoids are distinctly more effective than plain fluid toxoids for primary immunization of children. There is little difference between plain and adsorbed toxoids for booster immunization. Aluminum adjuvants have a demonstrated safety profile of over six decades; however, these adjuvants have been associated with severe local reactions such as erythema, subcutaneous nodules and contact hypersensitivity.
And here is the abstract from the Keith article:
Some vaccines contain aluminum adjuvants to enhance the immunological response, and it has been postulated that this aluminum could contribute to adverse health effects, especially in children who receive a vaccination series starting at birth. The pharmacokinetic properties and end-point toxicities of aluminum are presented. In assessing the relevance of dietary and medical aluminum exposure to public health, we estimated infant body burdens during the first year of life for breast milk and formula diets and for a standard vaccination schedule. We then compared those body burdens with that expected for intake at a level considered safe for intermediate-duration exposure. The methodology blends intake values and uptake fractions with an aluminum retention function derived from a human injection study using radioactive 26Al. The calculated body burden of aluminum from vaccinations exceeds that from dietary sources, however, it is below the minimal risk level equivalent curve after the brief period following injection.
Do you find these abstracts reassuring? We don’t.
To sum it all up very briefly, the argument is that the amount of aluminum in vaccines is very small, that it is quickly eliminated, that more goes into the body from food and that there is no evidence that the aluminum in vaccines does any harm. Which does not all add up to mean that aluminum in vaccines is actually safe.
We recommend that every concerned parent read Dr. Offit’s article. It is very revealing and very interesting. In addition to discussing thimerosal and aluminum he addresses a number of other vaccine ingredients that are less well known: gelatin, human serum albumin, bovine derived reagants, antibiotics, egg proteins, yeast proteins. The article has 97 references so it would be a valuable resource for further research.
We know that you are all getting sort of worn out…
But we should take a quick look at reference #68. It is another reference sheet from the Children’s Hospital of Philadelphia and has a select bibliography. You won’t be surprised to note that the last reference is Offit’s article from Pediatrics, discussed above. I’m not going to bother to cut and paste the list–go look at it yourself if you are interested!
Returning to our beginning:
Make sure the author cites the sources where he or she got the information, along with links to these sources. Is information presented objectively, or is it biased?
Does the Web site cite scientific evidence for the statements that are made? Can facts and opinions be easily distinguished?
Do you think that vaccine.com lives up to their hype? Considering that in most cases we had to dig down two or even three layers to get to some actual science, I’d give them a fail. And the science cited doesn’t actually support the claims made in most cases.
Finally, they don’t say this, but the science cited should be up-to-date. I went and looked on PubMed to see if there was some recent research on aluminum (since that is the ingredient we’ve discussed the most in this brief article).
I did a search limited to articles published in the last two years, looking at children from birth to age 18 and available in English. Look what I found:
Curr Med Chem. 2011;18(17):2630-7.
Aluminum vaccine adjuvants: are they safe?
Neural Dynamics Research Group, Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, V5Z 1L8, Canada. firstname.lastname@example.org
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. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences. In our opinion, the possibility that vaccine benefits may have been overrated and the risk of potential adverse effects underestimated, has not been rigorously evaluated in the medical and scientific community. We hope that the present paper will provide a framework for a much needed and long overdue assessment of this highly contentious medical issue.
- [PubMed - indexed for MEDLINE]
Next week we’ll take another look at their science and their sources. Preview: if you thought this was bad, there is worse to come!