Running head: CHILDHOOD VACCINATION AND AUTISM

Analysis of Legal Case Involving the Correlation Between Early-Childhood Vaccination and Autism Jill F. Griffin University of North Carolina Greensboro

Running head: CHILDHOOD VACCINATION AND AUTISM

Evolution of Case The decision to administer medications in evidence-based medicine is predicated on the evidence born out by scientific research. The results of this research must stand up to review by disinterested peers and must be clearly defined and repeatable. Science attempts to remove the natural bias built into our mammalian brains so that we can eliminate common logical fallacies and obtain the most objective data possible. Frequently, conventions are challenged by those who do not fully understand or value the strict format of scientific and medical research. Childhood vaccinations are a perfect example of this, and have recently become hotly debated in connection to autism spectrum disorders. The community of supporters (Anti-vaccination) are bolstered by shoddy research performed by physicians and researchers who attempt to bypass the process of peer review, and refuse to accept any conflicting evidence. Many accuse highly respected research institutions of ethical wrong-doing by withholding information regarding the safety of vaccines and conspiring to promote unsafe vaccination of children. The idea that the vaccination of children is related to autism is generally linked to nowdiscredited research performed by Andrew Wakefield. Wakefield claimed to have evidence that the increased administration of MMR vaccine directly correlated to a rise in autism. Upon further scrutiny, his research methods were shown to be flawed and that indeed the rise in occurrence was related to a broadening of diagnostic criteria. (Taylor 2006) This, however, did not deter the anti-vaccination community and the focus was then changed to the mercury-based preservative, thimerosal, which MMR never contained. David Kirby popularized the idea that ethyl-mercury was linked to autism in

his book Evidence of Harm, and with the help of mass-media outlets and the anti-vaccination community was able to spread fear among many concerned parents. Because of the inherent difficulty of proving a negative claim, it has been challenging to combat the claims against vaccines in a public

Running head: CHILDHOOD VACCINATION AND AUTISM arena. This has allowed the perpetuation of these unfounded beliefs to untrained, credulous citizens.

This is also exacerbated by the relentless search for underlying causes by concerned parents of autistic children, and the inaccessibility of many scientific journals. The parents of Jamarr Blackwell likely fell victim to this campaign of misinformation. Their son was diagnosed with autism spectrum disorder and they sought answers. Scientific and medical journals, when accessible, offer esoteric and often unsatisfying explanations to the general public which leaves them susceptible to dubious explanations offered by the mass-media and other non-credible sources. Positions of Major Parties Involved in Case The plaintiffs in the case present several expert witnesses who make multiple claims about the methods by which ethyl-mercury/thimerosal is causally linked to the onset of autism in developing children. As is common with cases in Maryland involving scientific claims, they were held to the precedents of the Frye-Reed analysis, and Md. Rule 5-702. The testimonies of the witnesses varied according to their areas of expertise and even conflicted in some cases. The primary position, held by Dr. Mark Geier, was that the ethyl-mercury-containing preservative, thimerasol, was causally linked to the autism spectrum disorders. He claimed to have evidence of this via a trial he conducted utilizing differential diagnosis. His methodology and findings, however, were highly criticized by the scientific and medical community and were described as uninterpretable and, as such, noncontributory with respect to causality by the Institute of Medicine. The Center for Disease Control and Prevention was also critical of Geier's claims. The plaintiff dismissed this as a cover-up. Mark Geier, M.D. and Dr. Boyd Haley, testified to a conspiracy or other criminal activity within the CDC and other entities to hide information from them and others that would support the theoretical link between thimerosal and autism. The plaintiff's experts also proffered an alternative theory that certain genetic polymorphisms led to a possible susceptibility in certain individuals. This theory was completely unsupported by

Running head: CHILDHOOD VACCINATION AND AUTISM scientific evidence and the demonstration of proof of the theory was regarded by the court as a daunting hurdle under Maryland's Frye-Reed standard . The remaining testimonies were ruled out according to Md. Rule 5-702. The Defendant's, rather than rebut the arguments put forth by the plaintiff, sought to preclude, or dismiss the testimonies according to the above precedents. The defendant, Sigma Aldrich, also provided several expert witnesses to testify to the safety of thimerasol, the relevant toxicity of ethylmercury, and it's effects on the developing brain. These witnesses were also held up to the Frye-Reed analysis and Md. Rule 5-702 and were deemed credible and qualified as experts. Their testimony, along with the support of the Institute of Medicine (IOM), Center for Disease Control and Prevention (CDC), The American Academy of Pediatrics (AAP), World Health Organization (WHO), European Agency for the Evaluation of Medical Products (EMEA), and the Public Health Agency of Canada (PHAC) provided a clear indication to the court that the theories and research techniques provided by the plaintiff's experts were highly controversial and questionable. Involvement of Nursing Practice The profession of nursing is not directly involved in this case, but can benefit from its implications. It is important to recognize the susceptibility of the human mind to logical fallacies. Correcting misinformation can also save the lives of children and in the case of vaccination, protect herd-immunity. A short list of fallacies displayed in this case include: cherry picking, confusing correlation with causation, false attribution, moving the goalposts, post hoc ergo propter hoc, nonsequitur, special pleading, and confirmation bias. The ability to identify flaws in a reasoned argument can be a powerful tool for nurses when considering various claims made by medical professionals or patients. Settlement or Court Decision

The court upheld the motion to preclude the testimonies of the plaintiff's expert witnesses. The

Running head: CHILDHOOD VACCINATION AND AUTISM motion to preclude testimonies of the defendant was denied. The defense's witnesses testified that

autism spectrum disorder is generally known to be a highly genetic disorder but could be brought on, in rare cases, by prenatal exposure to certain chemicals such as valproic acid, or thalidomide. They also effectively dismantled any arguments put forward by the plaintiff's experts, and exposed the theories concerning thimerasol/ethyl-mercury toxicities to be unfounded. It was also noted by the court that Dr. Stephen Siebert, an expert for the plaintiff, was unable to answer questions concerning the distinctions among forms of mercury, the signs and symptoms of mercury poisoning, and the pharmakinetics of ethyl mercury. The court found the testimonies and theories presented by the plaintiff to be insufficient according to the Frye-Reed analysis and Md. Rule 5-702. Student's Preferred Solution and Rationale It is comforting to know that courts of law require significant levels of evidence to move forward with cases concerning medical claims. This case was handled exactly as it should have been and it exemplifies the need for collaboration with the Institute for Medicine. However, it is disconcerting to think about the financial burdens placed upon the defendant's in cases like this. The defendant must bear the financial burden of the legal defense regardless of the outcome. Perhaps, if the plaintiff were to bear these costs upon an unfavorable decision, it would encourage more thorough research before filing a lawsuit. It was surprising to see the level to which the plaintiff's experts avoided and dismissed contrary evidence concerning the toxicity of thimerasol and the genetic origin of autism. When faced with a virtual cornucopia of criticism and contrary-evidence, the only argument they could muster was that it was all part of a conspiracy to hide the truth from the public. Never mind that hundreds, possibly thousands of doctors and scientists would need to simultaneously participate in this conspiracy without any dissent of opinion. This shows the level to which the anti-vaccination community has invested itself in these beliefs. The true victims of these ideas are children, whose parents have been frightened

Running head: CHILDHOOD VACCINATION AND AUTISM into avoiding vaccination and ultimately expose their children to unnecessary risk. The unforeseen consequences are the reemergence of childhood diseases and the compromise of herd-immunity.

References
Blackwell v. Sigma Aldrich, Inc, 2007 Md. Cir. Ct. LEXIS 13 (Circuit Court of Maryland, Baltimore City, 2007. Kirby, D. (2005). Evidence of harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy. New York: Saint Martin's Press. Maryland Rules of Evidence, 5-702. Testimony by experts. Price, C. & Thompson, W. (2010). Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk [Special section]. Journal of the American Academy of Pediatrics. doi: 10.1542/peds.2010-0309) Taylor, B. "Vaccines and the changing epidemiology of autism." Childcare Health Development. 32.5 (2006): 511-19. Web. 23 Sep. 2011. <http://www.ncbi.nlm.nih.gov/pubmed/16919130>. Wakefield, A. (1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children [retracted}. The Lancet, 351(9103).