Research Proposal: An experiment to test the theory that childhood vaccinations cause Autism

Michelle Lynn Koczan

Michigan State University

CEP 822- Fall 2011

Research Proposal Abstract A disease that was once rare, Autism has grown at alarming rates over the last two decades. Many claim that the rise has to do with a broader classification of Autism, rather than the actual amount of cases. However, according to Edward Yazbak, M.D., the symptoms and classifications of Autism have changed multiple times since 1956, and it is now more specific than ever. In fact, he notes that it is very possible that Autism is actually under diagnosed (Yazbak, M.D. 2003). It is now estimated that 1 in 150 children have Autism, up from about 1 in 2,500 in the mid-1980s (Bradstreet et. al, 2003). It was believed for many years that there was a strong link between Autism and the vaccination MMR, (measles, mumps, and rubella) which children receive within the first year of life, based on a study by Andrew Wakefield in 1998. As a result, parents all around the world chose not to vaccinate their children for fear that they may become Autistic. This presented a problem all in itself. Various outbreaks of preventable, but serious diseases broke out in communities all over the United States. The most notable outbreak was whooping cough in California, the worst in over forty years (Melnick 2011). Last year, Wakefield’s studies were discredited by claims that he altered the results of his findings. With the large increase in cases of Autism in children, public education systems are adopting new programs to help accommodate these students. These programs cost about $30,000 a year per Autistic child, an astronomical expense (Yazbak, M.D. 2003). If vaccinations are not to blame for this “explosion” of cases, what is to blame? The most probable factor would be the environment. Exposure to mercury has been known “to cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autistic disorders…(Geier, 2006). It just so happens that there are other environmental attributes that could be responsible for the onset of Autism, and it happens at about the same time as the vaccinations that children receive. I. Problem to be Investigated

A. Purpose of the Study: A disease that was once rare, Autism has grown at alarming rates over the last two decades. Many claim that the rise has to do with a broader classification of Autism, rather than the actual amount of cases.

B. Justification for the Study : It was believed for many years that there was a strong link between Autism and the vaccination MMR, (measles, mumps, and rubella) which children receive within the first year of life, based on a study by Andrew Wakefield in 1998. As a result, parents all around the world chose not to vaccinate their children for fear that they may become Autistic.

C. Research Questions: a. Is there a significant amount of evidence to support the claim

that childhood vaccines cause Autism? b. Is this disease preventable?

c. What are some other possible causes for the increasing number of Autism cases?

d. What similarities do children with Autism have as far as environment and diet are concerned?

e. Would it make a difference if children were vaccinated at a later stage of childhood, or over a longer time period?

D. Definitions : All definitions are from the Autism Speaks web page: http://www.autismkey.com/autism-symptoms/

a. Autism is a developmental disability that affects a person’s verbal and non-verbal communication, understanding of language, and socialization with peers.

b. Pervasive Developmental Disorder – Not Otherwise Specified (PDD-NOS) Refers to a collection of features that resemble autism but may not be as severe or extensive. Also known as mild or atypical autism. Many with PDD-NOS are deemed "high functioning."

c. Asperger Syndrome (AS) Individuals with AS show crippling deficiencies in social skills. They have difficulties with transitions and prefer sameness. They often have obsessive routines and may be preoccupied with a particular subject of interest. They have a great deal of difficulty reading nonverbal cues (body language) and very often the individual with AS has difficulty determining proper body space. Often overly sensitive to sounds, tastes, smells, and sights, the person with AS may prefer soft clothing, certain foods, and be bothered by sounds or lights no one else seems to hear or see. Those with Asperger’s typically have a normal to above average IQ and many (not all) exhibit exceptional abilities or talents in specific areas of interest.

d. Rett’s Syndrome A rare disorder affecting girls. It’s a genetic disorder with hard neurological signs, including seizures, that become more apparent with age. Hypotonia (loss of muscle tone) is usually the first symptom then followed by hand-wringing stereotypy. The syndrome affects approximately 1 in every 10,000-15,000 live female births. The gene causing the disorder has now been identified.

e. Childhood Disintegrative Disorder Refers to children whose development appears normal for the first few years, but then regresses with the loss of speech and other skills until the characteristics of autism are exhibited. Deterioration of intellectual, social, and language skills over a period of several months is commonly seen.

E. Brief Overview of the Study: Thimerosal is an anti-bacterial compound found in vaccines to help preserve them. Traces of mercury can be found in

Thimersol, which is suspected to be the harmful component of that vaccine that causes Autism. Researchers have focused on mercury, and the effects that it has on the human brain, particularly in children. There is sufficient evidence that mercury is a cause for concern when relating to Autism cases. Through my research, I would test the amount of mercury found in each child following the MMR vaccination over various time periods: the day of the vaccination, 3 days after the vaccination, and one week after the vaccination.

II. Background and Review of the Literature

A. Theory Being Studied: The MMR vaccine given during the first year of life is the direct cause of Autism in children.

B. Directly Related Studies: a. In a case-control study conducted in Arizona in 2003, the level of

mercury concentrations in the urine of children with Autism was compared to children without Autism. A control population of 18 children was also identified without Autism. In the cases of the children with Autism, all had received the full vaccination schedule as recommended. In the control group, 10 had received the vaccinations, and the remaining 8, did not. It was found that the children with Autism had significantly more mercury in their systems than children who were not autistic.

b. In Denmark, researchers examined more than 1200 children with autism that was identified during 1990–1996. They found that the risk of autism did not differ between children vaccinated with thimerosal-containing vaccines and those vaccinated with thimerosal-free vaccines or between children who received greater or lower quantities of thimerosal. In addition, it was found that the rates of autism continued to increase even after the removal of thimerosal from all vaccines.

c. In the United States, researchers at the Centers for Disease Control and Prevention examined 140,887 US children born during 1991–1999. More than two hundred of these children were diagnosed with autism. The researchers found no relationship between receipt of thimerosal-containing vaccines and autism.

d. In England, scientists examined 12,810 children whom had complete vaccination records from the time of birth between the year 1991 and 1992, and they found no relationship between early thimerosal exposure and deleterious neurological or psychological outcomes.

C. Indirectly-Related Studies :

a. In a 2008 study, the leading US government funder of autism research proposed to run a randomized clinical trial of a treatment widely viewed by experts to be useless and potentially harmful, but that is broadly used for autism. Chelating agents are used to determine the amount of heavy metals in the human body, often to trace mercury or

lead. Scientists wanted to test the levels of mercury in children to help better understand the link between mercury and the onset of autism.

III. Procedures

A. Research Design – The research design that will be used is quantitative design. Traditional scientific experiments will be carried out in order to draw conclusions from the data.

B. Sample: For this research there will be children from three different age groups. The first group will consist of 3 boys and 3 girls age 12 months, the age when most children first receive this vaccination. The second group will consist of 3 boys and 3 girls age 18 months. The third group will consist of 3 girls and 3 boys age 24 months. These age groups are significant because they are the age groups in which many report that children first exhibit symptoms of Autism.

C. Instrumentation: There are three different ways that laboratories can test for mercury: blood sample, urine sample and hair sample. In this experiment I will be using urine samples using a chelating agent. A chelating agent pulls heavy metals in the human body together, allowing the child to excrete the metal through the urine. Samples of urine will be collected immediately following the vaccination, three days after, and one week after the vaccination is administered.

D. Procedural Details : The mercury levels found in the urine of the children will be compared by age group, sex, and time intervals. I will be searching for relationships between the level of mercury found in the urine immediately following the vaccination in all age groups and comparing the levels within different time intervals following the vaccination. Is there more mercury found in the child’s system immediately following the vaccination compared to a week later? Is there a significant difference between age group or sex?

E. Internal Validity: There is little threat to the internal validity. All of the children that participate will be children with no prior health complications, the urine samples will be collected in the exact same way, and all vaccinations will have the same amount of thimerosal in them.

F. External Validity: The results found in this study will help in further studies relating to mercury and the effects it has on autism. If the mercury levels are reasonably low on the children after the vaccination is administered, how are children being exposed to mercury that may be causing autism? Are there environmental factors to be considered?

G. Data Analysis: The data will be organized first by age group, then by time interval. This data will be compared in various different ways.

IV. Budget To determine a budget for this research proposal personnel, lab equipment, and supplies/consumables must be considered. IV. Works Consulted Autism Key. (December 2011). Autism Syptoms: Symptoms Definitions, symptom checklist, and information on related conditions. Retrieved from: http://www.autismkey.com/autism-symptoms/

Bradstreet M.D., Jeff et. Al. (Fall 2003). A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders. Journal of American Physicians and Surgeons, Volume 8, Number 3, pg 76-108. Retrieved from www.jpands.org/vol8no3/geier.pdf Cone, Marla. (January 2009). New Study: Autism Linked to the Enviorment. Scientific American. Retrieved from http://www.scientificamerican.com/article.cfm?id=autism-rise-driven-by-environment&page=2 Geier, David A. and Mark R. M.D., Ph.D. (Spring 2006). Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thumerosal-Contatining Vaccines. Journal of American Physicians and Surgeons, Volume 11, Number 1, pg 8-13. Retrieved from www.jpands.org/vol11no1/geier.pdf Hviid A, Stellfeld M, Wohlfahrt J, Melbye M. Association between thimerosal-containing vaccine and autism. JAMA 2003;290:1763-6. Madsen KM, Hviid A, Vestergaard M, et al. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 2002;347:1477-82. Verstraeten T, Davis RL, DeStefano F, et al. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. Pediatrics 2003;112:1039-48. Wadman, Meredith. (July 2008). Autism study panned by critics. Retrieved from http://www.nature.com/news/2008/080714/full/454259a.html Yazbak, M.D., F. Edward. (Winter 2003). Autism in the United States: a Perspective. Journal of American Physicians and Surgeons, Volume 8, Number 4, pg 103-107. Retrieved from www.jpands.org/vol8no4/yazbak.pdf