Sunday, January 13, 2013

Unvax Study: We still need your help - AGE OF AUTISM

A: In this study the entire study population consists of homeschool children. Since all the children are homeschooled ? vaccinated, partially vaccinated and unvaccinated ? this will ?control? for differences in exposure to human sources of infection.

Asthma, autism, allergies, seizures etc. are prevalent within the homeschool population. This population, while not necessarily intermingling with public school kids regularly (many in fact do so mingle), do have a 54% rate of full compliance with vaccines, so they are nothing close to the Amish in that respect. Also they have a 15% rate of being vax free, which you will not find in a uniform public school population.

Q: IMHO, there tends to be a divide between the autism community and those of us in the trenches to protect our right to abstain and increase the numbers of those saying NO to shots.

A: But isn?t this study potentially a real bridge between the two said communities? This study addresses autism questions and general health issues. The answers have the potential to uphold our rights to abstain and say NO.

Thus far there has been all talk and no do, and since no-one else has had the gumption to get moving, how much longer do we have to wait?

Q: There are plenty of LARGE populations of unvaxed kids that could be used. Dr. Eisenstein has a huge patient base of unvaxed kids under the Homefirst practice in the Chicago area. Another advantage of using his database is that it is under the auspices of a medical professional, not random home schooling families that could be considered unreliable. Additionally, there are lots of schools in CA and elsewhere that have largely unvaxed populations within them. They go to school alongside fully vaxed kids, so there would be no way to easily malign the results.?

A: Dr Eisenstein has agreed to support this study as well as the planned follow-up study using his anonymized patient records. However, while Dr. Eisenstein?s patient population may show that the unvaccinated are healthier than the vaccinated, the study will still be criticized as somehow being a self-selected population like the Amish. The only study that would satisfy all of the critics would be a prospective randomized one, and hell will freeze first.

Homeschoolers are estimated at 1-2 million in the US. Such children differ in only minor ways from the general run of children in the US; for instance, the families have somewhat higher levels of income and education. This is well documented in the study proposal. It is hoped to use the records of children in Dr. Eisenstein?s clinic for a follow-up study, and Dr. Eisenstein has agreed to this. The records would of course be abstracted and analyzed so as to preserve anonymity and confidentiality. There is considerable evidence that self-reported data are as reliable and valid as data from official records; in fact, official data tend to underreport the relevant information. In the planned study, mothers are asked to provide details of vaccination that require reference to the children?s vaccination records. As for documenting health outcomes, mothers are asked to report ?physician-diagnosed? illnesses and conditions as well as such particulars such as whether a child was admitted to a hospital or had been fitted with ear tubes. The requested information will all be factual.

Q: WHOA! Who wrote the "proposal for the study", anyway? I take strong issue with, "Vaccination is one of the greatest discoveries in medicine, yet little is known about its long-term impact." According to the most commonly accepted understanding of the word "greatest", this statement seems highly prejudicial to me. Might it even put off some from donating? It seems more fitting to say, "Vaccination is one of the cornerstones of allopathic medicine, yet little is known about its long-term impact."

A: Many drafts of the current proposal were written. It is a fact that in any grant proposal one is always appealing for funds from organizations and people who have a particular attitude or vested interest in the subject of the research. If you want to get a study funded, you have to make it appealing to the potential funder.

A proposal for a study written to draw funding from a drug company is worded to show that they could get massive profit and advertising benefit from the proposed results, even if you?ve not even proved it. If there is no benefit to them, or it doesn?t fit into society?s perceptions, then an application isn?t even considered.

Q: My objection was the Generation Rescue paypal landing page...without prior explanation of the connection or reason why/how they were going to collect and be a fiduciary for a $1,000,000 University project...not the research itself.

A: GR?s role is only to collect the money and forward it to JSU for the study. Nothing more, nothing less. If you have further questions they should probably be addressed by GR. There is a link on the donation page for contact. [JB?s Note: We are passing 100% of donations on to Jackson State, we are only facilitators.]

Q: Does looking at the health of home-schoolers translate to the majority of the nation's children who are not home-schooled? In theory, home-schoolers have much less exposure to infectious disease than children in public schools, so if vaccines work (and I'm assuming that this study is not looking at vaccine effectiveness, and therefore presumes that vaccines are effective?), then the public school community could theoretically tolerate more ill-effects from vaccines since there's (arguably) a greater protective need/benefit there, i.e., would this study be vulnerable to the "well, vaccines may contribute to some chronic diseases, but getting the infectious diseases would be even worse for kids not looked at in this study" rebuttal?

A: This was addressed above. In brief, the ?within-group? design of the study (basing the study exclusively on homeschool children) automatically controls for the factor of differential exposure to infection. Homeschool children are very similar to US children as a whole. The study also asks questions about acute infectious illnesses in the children as well as chronic illness and other indicators of health and disease. This means that the effectiveness of vaccines against vaccine-preventable illnesses can also be determined.

In reality, many homeschooled children have a far greater variety of exposure to a wider range of age groups than children in school through activities such as choir, music, orchestra, drama, church, Sunday school, athletics, gymnastics, ballet, crafts ? and some older children do elective units at university, well before the usual age. Many homeschooling groups have weekly educational outings to science laboratories, factories, museums, parks, and a lot more study situations like stream cross sections, lake studies, animal studies, beach studies, bird watching, community gardening, forest walking are done by home schooling. Those families usually make a far greater use of community resources than children who are 8 ? 4 in the four walls of a classroom. (which if pediatricians realized would possibly become a source of great mental panic for them! ? Do we want to continue to let pediatricians think that homeschooling is essentially self quarantine, when it?s anything but?)

Q: Would the study rely on the reporting of parents? Isn't that an inherently unreliable source of data for strict scientific calculation purposes? Won't many parents report in a manner supportive of the outcome they want? Are we relying on parents' memories and/or the availability of medical records? Would the final results be at most and best only general indicators that could be criticized and dismissed for any or all of these reasons?

A: This question was addressed. Mothers know their children best! However the study is not based on recall. Mothers are asked to use their children?s vaccination records to answer the detailed questions about vaccination history; they are also being asked to report ?physician-diagnosed? illnesses. These procedures will greatly reduce subjectivity or bias. Mothers are also specifically asked about their attitudes to vaccination and their main reason for homeschooling, which will allow us to look at the association between vaccination status and health outcomes in children whose mothers are for or against vaccination. Questionnaires are used in conventional medical research. Two famous studies,?the Nurses Health Study and the Behavioral Risk Factor Surveillance Study,?are both based on mailed questionnaires.?

Q: Does limiting the reporting to formally diagnosed health conditions necessarily lead to a skewed result in that parents' decisions to go to the doctor vary widely based on economic factors and a host of other completely subjective factors?

A: Depending on the sample size it may be possible to answer this complex question because the investigators are asking about family income as well as uses of preventive health services and emergency services. The likelihood of particular diagnoses being influenced by family income or the use of health services could therefore be directed assessed

Q: Would this be a basis for criticizing or dismissing the outcome?

A: Family income and/or willingness to access health services will likely have limited impact on the likelihood of a child receiving a given diagnosis.

Q: Also, would this study assume that diagnoses are accurate? What effect might that have on the accuracy of the final results?

A: Yes, the study assumes that physicians mostly make accurate diagnoses. The limited amount of inaccuracies in diagnoses are unlikely to adversely affect the results because some of the diagnoses of special interest in this study are based on criteria that are relatively objective.

Q: How easily could such a study just be ignored, covered up, dismissed, etc. as has occurred with the decades of other studies showing problems with vaccines that have never seen the light of day? Why would this study be any different? What is really the larger problem, the politics (corruption, conflicts of interest, pharmaceutical control of media, etc.), or the lack of science? How far would $900,000 go toward exposing the corruption, conflicts of interest, etc.--to get a light shown on the studies that have already been done? Does it even matter how wonderfully this study would support an informed choice position on vaccines if the media will never report on it and no one ever hears about it?

A: Is this a justification as to why such a study should never be done?

Q: Has anyone already done a thorough search of the literature to see what else is already out there that is in any significant way similar to what this study proposes to do? E.g., I heard of a study years ago that looked at children's health before and after vaccination--the children were their own controls--and found that common childhood illnesses increased by a rate of 4-5 in the month following immunization compared to the month preceding it. Has anyone considered doing a review of what's already out there related to this matter, and wouldn't that cost a lot less? Would such a review potentially provide support for this kind of study?

A: See end of this doc for many references. This study, comparing the health outcomes of vaccinated and unvaccinated children, is unique in being based at an academic center. The study is also unique in focusing on homeschool children, who have lower vaccination rates than children in the general population. A study comparing vaccinated and unvaccinated children has been widely recommended for many years but for many reasons has not been carried out to date. This study will require at least $900,000 in funding and will provide strong evidence related to the outcomes of the routine childhood vaccination program.

Q: Do I understand correctly that this study would look at the broad connections between vaccines and chronic disease, but not be able to draw a causal relationship between the two? If this a necessary prerequisite to studies exploring the mechanisms by which the injuries actually take place? Wouldn't the latter be required to nail down the connection between any specific vaccine and injury or death?

A: This study is a cross-sectional observational survey. Unlike a randomized controlled trial, this type of study design does not allow conclusions about causality to be drawn. However, if differences in health outcomes between vaccinated and unvaccinated children differ greatly in magnitude (e.g., more than two-fold differences), then that will suggest the likelihood of some sort of causal connection, which can be explored in future studies. Because many acute and chronic conditions and many potential risk factors are being studied in addition to vaccination history, related to environmental exposures and maternal experiences, the study will provide a rich database for addressing a host of questions related to vaccination and health. ?

Brief Comment on the Project to Date (from the investigators? summary)

Title: Vaccination Status and Health Outcomes among Homeschool Children

Background and Rationale In response to public concerns regarding the measles, mumps and rubella (MMR) live-attenuated triple vaccine, over 20 well-designed epidemiologic studies have been carried out, all showing no association between MMR and autism spectrum disorder (ASD). There is also no known biological mechanism for such a link. However, recent Vaccine Court decisions as well as a number of studies purporting to show a link between vaccination and chronic illness have led to growing public fears of vaccine adverse effects. In fact, studies on the safety of the routine vaccination schedule are widely acknowledged to have been insufficient. To prevent public confidence from being further eroded and to stem declining rates of vaccine uptake, studies are needed to evaluate the impact of the vaccination schedule itself.

Objectives and Specific Aims The purpose of this cross-sectional study is to evaluate the health outcomes of the routine childhood vaccination program. To this end, an anonymous online survey will be carried out on biological mothers of homeschool children, regarding the children?s vaccination history and physician-diagnosed illnesses. The specific aims are:

1.?????? To test the hypothesis that there are no significant differences in prevalence rates of selected chronic illnesses (ADHD, allergy, asthma, autism, type 1 diabetes, learning disability, and seizures) between vaccinated and unvaccinated homeschool children ages 6-12 years, after controlling for potential confounding factors; and

2.?????? To determine what factor or combination of factors, including vaccination history, is most strongly associated with the selected conditions.

Methods Our preliminary research has shown that about 15% of homeschool children are unvaccinated. Since there are 1-2 million such children in the U.S., homeschoolers are an ideal group for this study. Families will be contacted through homeschool organizations via a partnership established between the investigators at Jackson State University and the National Home Education Research Institute (NHERI), Salem, OR. NHERI will contact and inform homeschool organizations nationwide about the study. The leaders of these organizations will in turn encourage their members to participate in the study by accessing a designated website. Mothers will be asked to use their children?s vaccination records and to record physician-diagnosed illnesses. The accumulated data will be checked for accuracy and completeness and analyzed using SAS (SAS Institute, Cary, NC, version 9.2).

Expected Results and Significance The study, now being piloted in the four states of Florida, Louisiana, Mississippi and Oregon, is expected to show that, among the population of 6-12-year-old homeschool children in the U.S., there are no increased risks of chronic illness associated with the routine childhood vaccination schedule. The study will have important implications for public health policy and practice related to children's health and health services.

Comment -- This web-based cross-sectional survey of biological?mothers of homeschool children ages 6-15?years has received ethical approval from the IRB of Jackson State University. In Year 1, which has just ended, the data collection instrument was designed and a small pilot study was carried out in four states: Florida, Louisiana, Mississippi and Oregon. Although the investigators now have sufficient data on which to base tentative conclusions, they intend to use the?pilot study as a learning experience and to roll out the study nationwide in Year 2. The analyses will be performed and reports written up and submitted for publication in Year 3.?Important lessons have been learned from the pilot study that will be implemented in the full study, e.g., the age-range will be expanded from 6-12 to 6-15 years, to allow for increased enrollments. The investigators also intend to engage more directly and fully with the homeschool community?in order to increase enrollments. Additional changes?to?the data collection instrument are also being considered. Implementing this study is widely recognized as a critical step in the overall evaluation of the routine childhood vaccination program. I sincerely hope that Generation Rescue?s open request for additional funds from interested parties?will?enable this study on?the?health outcomes of routine vaccination to be completed.

The JSU investigators have done a thorough job in pulling most of the pertinent studies. Here are their cited references: At the end are more vaccinated/unvaccinated studies, none of which have looked at the issue as this study promises to.

REFERENCES

Akinbami LJ, Moorman JE, Garbe PL Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics 2009; 123 (suppl 3):S131-S145.

Andrews D, Nonnecke B., Preece J. Electronic Survey Methodology: A Case Study in Reaching Hard-to-Involve Internet Users. International Journal of Human-Computer Interaction 2003;

http://www.informaworld.com/smpp/title~content=t775653655~db=all~tab=issueslist~branches=16 - v1616: 185 ? 210. DOI: 10.1207/S15327590IJHC1602_04

Afzal MA, Ozoemena LC, O?Hara A et al. Absence of detectable measles virus genome sequence in blood of autistic children who have had their MMR vaccination during the routine childhood immunization schedule of UK. J Med Virol 2006; 78:623-630.

Baker JP. Mercury, vaccines, and autism: one controversy, three histories. Am J Public Health 2008; 98:244-253.

Bielick S, Guzman L, Atienza A, Rivers A. Using a seeded sample to measure responses among homeschooling households. Survey Practice, December 2009. Retrieved January 15, 2010 from http://surveypractice.org/2009/12/09/homeschool/.

Bitnum A, Shannon P, Durward A, Rota PA, Bellini WJ, Graham C, Wang E, Ford-Jones EL, Cox P, Becker L, Fearon M, Petric M, Tellier R. Measles inclusion-body encephalitis caused by the vaccine strain of measles virus. Clin Infect Dis 1998; 29: 855-61.

Blanchard LT, Gurka M, Blackman JA. Emotional, developmental, and behavioral health of American children and their families: a report from the 2003 National Survey of Children?s Health. Pediatrics 2006; 117:e1202-e1212

Bloom B, Tonthat L. Summary Health Statistics for U.S. Children: National Health Interview Survey, 1997. Vital Health Stat 2002; 10: 203.

Calandrillo SP. Vanishing vaccinations: why are so many Americans opting out of vaccinating their children? Univ Mich J Law Reform 2004; 37:353-440.

Centers for Disease Control and Prevention. Prevalence of Autism Spectrum Disorders ? Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States, 2008. MMWR 2012; 61(3):1-19.

Choi BK, Manning ML. The immunization status of home-schooled children in America. J Pediatr Health Care 2010; 24:42-47.

Delong G. A positive association found between autism prevalence and childhood vaccination uptake across the U.S. population. Toxicol Environ Health A 2011; 74(14):903-16.

Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev 2005; 4:CD004407.

D?Souza Y, Fombonne E, Ward BJ. No evidence of persisting measles virus in peripheral blood mononuclear cells from children with autistic spectrum disorder. Pediatrics 2006; 118:1164-1175.

Dillman DA. Mail and Telephone Surveys: The Total Design Method. New York: Wiley-Interscience, 1978.

Directory of State Homeschool Organizations throughout the U.S., http://www.homefires.com/state.asp, retrieved 3/26/2008.

Eskenazi B, Rosas LG, Marks AR, et al. Pesticide toxicity and the developing brain. Basic Clin Pharmacol Toxicol 2008; 102:228-236.

Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, et al. The relationship of adult health status to childhood abuse and household dysfunction. Am J Prev Med 1998; 14:245-258.

Folkerts G, Walzl G, Openshaw PJ. Do common childhood infections 'teach' the immune system not to be allergic? Immunol Today 2000; 21:118?20.

Gallagher CM, Goodman MS. Hepatitis B vaccination of male neonates and autism. Ann Epidemiol 2009; 19(9):659 (Abstract).

Gerber JS, Offit PA. Vaccines and autism: a tale of shifting hypotheses. Clinical Infectious Diseases 2009; 48:456?61.

Grandjean P, Landrigan PJ. Developmental neurotoxicity of industrial chemicals. Lancet 2006; 368:2167-78.

Hertz-Picciotto I, Delwiche L. The rise in autism and the role of age at diagnosis. Epidemiology 2009; 20:84-90.

Institute of Medicine. Immunization Safety Review: Vaccines and Autism. Washington, DC: National Academy Press, 2004 (http://www.iom.edu).

Khalili D, Caplan A. Off the grid: Vaccinations among homeschooled children. J Law Med Ethics 2007; 35:471-77.

Kennedy AM, Gust DA. Parental vaccine beliefs and child?s school type. J School Health 2005; 75:276-280

Kuwaik GA, Roberts W, Zwaigenbaum L, Bryson S, Smith IM, Szatmari P, Mackinnon BM, Tanel N, Brian J. Immunization uptake in younger siblings of children with autism spectrum disorder. Autism 2012; Oct 8 [Epub ahead of print]).

Landrigan PJ. What causes autism? Exploring the environmental contribution. Curr Opin Pediatr 2010; 22(2):219-25.

McDonald KL, Huq SI, Lix LM, Becker AB, Kozyrskyj AL. Delay in diphtheria, pertussis, tetanus vaccination is associated with a reduced risk of childhood. asthma J Allergy Clin Immunol 2008; 121(3):626-31.

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McDowell SA, Ray BD (Eds.). The home education movement in context, practice, and theory: Editors? introduction [Special double issue]. Peabody J Educ 2000; 75(1 & 2):1-7.

Offit PA, Hackett CJ. Addressing parents? concerns: do vaccines cause allergic or autoimmune diseases? Pediatrics 2003; 111(3):653-659.

Offit PA. Vaccines and autism revisited ? The Hannah Poling case. N Engl J Med 2008; 358:2089-2091.

Perrin JM, Bloom SR, Gortmaker SL. The increase of childhood chronic conditions in the United States. JAMA 2007; 297:2755-9.

Poling JS. Vaccines and autism revisited. N Engl J Med 2008; 359:655-656 (letter).

Poling JS, Frye RE, Shoffner J, Zimmerman AW. Developmental regression and mitochondrial dysfunction in a child with autism. J Child Neurol. 2006;21:170?172.

Princiotta D, Bielick S, Chapman C. (2006, February). Homeschooling in the United States: 2003 statistical analysis report [NCES 2006-042]. Washington, DC: U.S. Department of Education, Institute of Education Sciences Retrieved 3/8/06 and 5/28/07 online http://nces.ed.gov/pubs2006/2006042.pdf.

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????????? J Educ 2000; 75(1 & 2), 71-106 [findings of a U.S. nationwide study].

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????????? Admission 2004; No. 185: 5-11 [includes findings of a U.S. nationwide study].

Ray BD. A homeschool research story. In Cooper BS (Ed.), Homeschooling in full view: A reader. Greenwich, CT: Information Age Publishing, 2005, pp. 1-19.

Ray BD. Academic achievement and demographic traits of homeschool students: a nationwide study. Journal of Academic Leadership 2010 (in press) [findings of a U.S. nationwide study].

Rice C. Prevalence of autism spectrum disorders?autism and developmental disabilities Monitoring Network, 14 sites, United States, 2002. Morb Mort Weekly Rep 2007; 56:12-28.

Roztocki N. Using internet-based surveys for academic research: opportunities and problems. Proceedings of the 2001 American Society of Engineering Management (ASEM) National Conference, Huntsville, AL; 2001, pp. 290?295.

Salmon DA, Moulton LH, Omer SB, DeHart MP, Stokley S, Halsey NA. Factors associated with refusal of childhood vaccines among parents of school-aged children: a case-control study. Arch Pediatr Adolesc Med 2005; 159:470-6.

Silbergeld EK. Mercury, vaccines, and autism, revisited. Am J Public Health 2008; 98:1350.

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Stanton, JM, An empirical assessment of data collection using the Internet. Personnel Psychol 1998; 51:709?725.

Stanwyck C, Jain N. Vaccination coverage among children in kindergarten?United Sates, 2006-2007 school year. Morbidity and Mortality Weekly Report 2007; 56:819-821.

Thompson R, Cook C, Heath F. A meta-analysis of response rates in web or internet-based surveys. Educ Psychol Measure 2000; 60:821-836 DOI: 10.1177/00131640021970934

Thompson WW, Price C, Goodson B, et al. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N Engl J Med 2007; 357:1281-1292.

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about 3-31-2009, from http://www.census.gov/compendia/statab/.

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and homeschooling rate, by selected characteristics: 1999, 2003, and 2007. Published

2009. Retrieved 1/15/10 from

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Wang PS, Beck AL, McKenas DK, Meneades LM, Pronk NP, Saylor JS, Simon GE, Walters EE, Kessler RC. Effects of efforts to increase response rates on a workplace chronic condition screening survey. Medical Care 2002; 40:752?760.

Wiebel RE, Caserta V, Benor DE, Evans G. Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program. Pediatrics 1998; 101(3):383-387.

Young HA, Geier DA, Geier MR. Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. J Neurol Sci 2008; 271:110-8.

Here are a few more from me:

In 1992, a New Zealand group called the Immunization Awareness Society (IAS) surveyed 245 families with a total of 495 children. The children were divided with 226 vaccinated and 269 unvaccinated. Eighty-one families had both vaccinated and unvaccinated children.

The differences were dramatic, with unvaccinated children showing far less incidence of common childhood ailments than vaccinated children (http://www.vaccineinjury.info/images/stories/ias1992study.pdf).

From a different survey in the South Island New Zealand city of Christchurch, among children born during or after 1977, none of the unvaccinated children had asthma events where nearly 25% of the vaccinated children were treated for asthma by age 10 (http://www.vaccineinjury.info/images/stories/ias1992study.pdf).

Many of the comments from non-vaccinating parents to VaccineInjury.info for the ongoing Bachmair survey mentioned vaccination danger and developing true immunity naturally were concerns (http://www.vaccineinjury.info).

Learn more: http://www.naturalnews.com/036220_vaccinated_children_disease_allergies.html#ixzz2Ekk1gUaY

Source: http://www.ageofautism.com/2013/01/unvax-study-we-still-need-your-help.html

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