Autism, Medicine, and the Poison of Enthusiasm and Superstition

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449 Journal of Health & Biomedical Law, VII (2012): 449-492 © 2012 Journal of Health & Biomedical Law Suffolk University Law School Autism, Medicine, and the Poison of Enthusiasm and Superstition John Thomas* Science is the great antidote to the poison of enthusiasm and superstition. Adam Smith 1 In the late 1990s, Andrew Wakefield, a British gastrointestinal surgeon and researcher, 2 began to formulate a novel theory about the relationship between the * Professor of Law, Quinnipiac University School of Law. J.D., 1982, University of Arizona, LL.M., 1988, M.P.H., 1996, Yale University. I thank my colleagues who suffered through my presentation of an earlier draft and, especially, to Neil Feigenson for his insightful comments. 1 ADAM SMITH, AN INQUIRY INTO THE NATURE AND CAUSES OF THE WEALTH OF NATIONS, bk. V, ch.1, para. 203 (5th ed. 1904), available at http://www.econlib.org/library/Smith/smWN20. html#B.V. The first of those remedies [for social ignorance] is the study of science and philosophy, which the state might render almost universal among all people of middling or more than middling rank and fortune; not by giving salaries to teachers in order to make them negligent and idle, but by instituting some sort of probation, even in the higher and more difficult sciences, to be undergone by every person before he was permitted to exercise any liberal profession, or before he could be received as a candidate for any honourable office of trust or profit. If the state imposed upon this order of men the necessity of learning, it would have no occasion to give itself any trouble about providing them with proper teachers. They would soon find better teachers for themselves than any whom the state could provide for them. Science is the great antidote to the poison of enthusiasm and superstition; and where all the superior ranks of people were secured from it, the inferior ranks could not be much exposed to it. Id. 2 Rebecca Smith, Andrew Wakefield - the Man Behind the MMR Controversy, THE TELEGRAPH, Jan.

Transcript of Autism, Medicine, and the Poison of Enthusiasm and Superstition

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449

Journal of Health & Biomedical Law, VII (2012): 449-492

© 2012 Journal of Health & Biomedical Law

Suffolk University Law School

Autism, Medicine, and the Poison of Enthusiasm and

Superstition

John Thomas*

Science is the great antidote to the poison of enthusiasm and superstition.

Adam Smith1

In the late 1990s, Andrew Wakefield, a British gastrointestinal surgeon and

researcher,2 began to formulate a novel theory about the relationship between the

* Professor of Law, Quinnipiac University School of Law. J.D., 1982, University of Arizona,

LL.M., 1988, M.P.H., 1996, Yale University. I thank my colleagues who suffered through my

presentation of an earlier draft and, especially, to Neil Feigenson for his insightful comments. 1 ADAM SMITH, AN INQUIRY INTO THE NATURE AND CAUSES OF THE WEALTH OF NATIONS, bk.

V, ch.1, para. 203 (5th ed. 1904), available at http://www.econlib.org/library/Smith/smWN20.

html#B.V.

The first of those remedies [for social ignorance] is the study of science and

philosophy, which the state might render almost universal among all people of

middling or more than middling rank and fortune; not by giving salaries to

teachers in order to make them negligent and idle, but by instituting some sort

of probation, even in the higher and more difficult sciences, to be undergone

by every person before he was permitted to exercise any liberal profession, or

before he could be received as a candidate for any honourable office of trust

or profit. If the state imposed upon this order of men the necessity of

learning, it would have no occasion to give itself any trouble about providing

them with proper teachers. They would soon find better teachers for

themselves than any whom the state could provide for them. Science is the

great antidote to the poison of enthusiasm and superstition; and where all the

superior ranks of people were secured from it, the inferior ranks could not be

much exposed to it.

Id. 2 Rebecca Smith, Andrew Wakefield - the Man Behind the MMR Controversy, THE TELEGRAPH, Jan.

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childhood measles, mumps, and rubella (“MMR”) vaccine and the onset of autism.3 He

and a dozen colleagues conducted a study of eleven boys and one girl between the ages

of three and ten.4 “We saw several children who, after a period of apparent normality,

lost acquired skills, including communication,” observed Wakefield and his coauthors in

a paper published in The Lancet in 1998.5 Wakefield’s team conducted a number of

diagnostic procedures on the children, including ileocolonoscopy and biopsy, MRI,

electroencephalography, and lumbar puncture.6 They concluded that all of the children

had an “intestinal dysfunction” that was associated with “autistic-spectrum disorders” in

a way that “suggests that the connection is real and reflects a unique disease.”7 They

labeled that disorder “autistic enterocolitis.”8

Wakefield added that his study “did not prove an association between measles,

mumps, and rubella vaccine and the syndrome described.”9 But, he warned, “If there is

a causal link between measles, mumps, and rubella vaccine and this syndrome, a rising

incidence might be anticipated after the introduction of this vaccine in the U.K. in

1988.”10

Before the publication of Wakefield’s findings, the MMR inoculation rate in the

U.K. was 92 percent, nearly the herd immunity requirement of 95 percent necessary to

immunize an entire community.11 Following the publication, the inoculation rate

29, 2010, available at http://www.telegraph.co.uk/health/healthnews/7091767/Andrew-Wake

field-the-man-behind-the-MMR-controversy.html (tracing the MMR controversy and Wakefield’s

subsequent journey). 3 Andrew Wakefield et al., RETRACTED: Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis,

and Pervasive Developmental Disorder in Children, 351 THE LANCET 637, 637-41 (1998), available at

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(97)11096-0/fulltext

(discussing onset of behavioral symptoms associated with measles, mumps, and rubella

vaccination). 4 Id. at 637. 5 Id. 6 Id. 7 Id. at 637-39. 8 Brian Deer, Wakefield’s “Autistic Enterocolitis” Under the Microscope, 340 BRIT. MED. J. 838, 838

(2010), available at http://briandeer.com/solved/bmj-pathology.pdf. 9 Wakefield et al., supra note 3, at 641. 10 Id. 11 Brian Deer, MMR Doctor Andrew Wakefield Fixed Data on Autism, THE SUNDAY TIMES, Feb. 8,

2009, available at http://www.thesundaytimes.co.uk/sto/public/news/article148992.ece; see also

How the MMR Scare Led to the Return of Measles, THE SUNDAY TIMES, Feb. 8, 2009, available at

http://www.thesundaytimes.co.uk/sto/public/news/article149001.ece. “Herd immunity” refers

to communal resistance to the spread of disease because the prevalence of immunity, most often

accomplished through vaccination, minimizes the likelihood of one with the disease encountering

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dropped to below 80 percent.12 In 1998, the year of publication, there were fifty six

measles cases in the U.K.13 By 2008, there were 1,348 cases and two confirmed deaths.14

As the measles resurged, criticism mounted. When subsequent studies failed to

find any proof of the connection between MMR vaccine and autism, ten of Wakefield’s

twelve co-authors renounced the study’s conclusions.15 In addition, London’s Sunday

Times reported that Wakefield had falsified his findings.16 On January 28, 2010, the

U.K.’s General Medical Council (“GMC”) concluded what has been called the “longest

and most complex disciplinary hearing ever held,”17 with findings that detailed

Wakefield’s “callous, unethical, and irresponsible” conduct.18 In response, on February

2, 2010, The Lancet retracted Wakefield’s paper.19 In May 2010, the GMC barred

Wakefield from practicing medicine in the U.K. by removing his name from the Medical

Register.20 Finally, in January 2011, the British Medical Journal opined in an editorial that

Wakefield’s paper in The Lancet had been an “elaborate fraud.”21

While the MMR-Autism controversy wound its way through medical journals

one who is susceptible to contracting it. See T. Jacob John & Reuben Samuel, Herd Immunity and

Herd Effect: New Insights and Definitions, 16 EUR. J. EPIDEMIOLOGY 601, 601 (2000). 12 See How the MMR Scare Led to the Return of Measles, supra note 11 (citing a drop in inoculation

rates from 92 percent to below 80 percent following the publication of Wakefield’s paper). 13 See Deer, supra note 11. 14 Id. 15 See Experts Say Autism Bowel Disease May Not Exist, DISCOVERY ONLINE (Apr. 16, 2010),

http://www.intelihealth.com/IH/ihtIH/WSDSC000/333/8014/1364958.html. 16 Deer, supra note 11. 17 Sally Beck, Judgement Day for MMR Rebel: An Investigation that has Blighted Doctor's Life for 12 Years

Finally Approaches Conclusion, MAIL ONLINE, http://www.dailymail.co.uk/news/article-1245518

/Judgement-day-MMR-rebel-investigation-blighted-doctors-life-12-years-finally-approaches-

conclusion.html (last updated Jan. 23, 2010, 11:57 PM). 18 GEN. MED. COUNCIL, FITNESS TO PRACTISE PANEL HEARING, 28 JANUARY 2010 49, 54-55,

available at http://www.rescuepost.com/files/facts-wwsm-280110-final-complete-corrected.pdf. 19 Simon H. Murch et al., Retraction of an Interpretation, 363 THE LANCET 750, 750 (2004). 20 See James Meikle & Sarah Boseley, MMR Row Doctor Andrew Wakefield Struck off Register, THE

GUARDIAN (May 24, 2010), available at http://www.guardian.co.uk/society/2010/may/24/mmr-

doctor-andrew-wakefield-struck-off. 21 Fiona Godlee et al., Wakefield’s Article Linking MMR Vaccine and Autism Was Fraudulent, 342

BRIT. MED. J. 64, 64 (2011), available at http://www.bmj.com/content/342/bmj.c7452.full. In

response, in January 2012, Wakefield filed a lawsuit against the British Medical journal, its editor

in chief, and Brian Deer. Ian Sample, Andrew Wakefield Sues BMJ for Claiming MMR Study Was

Fraudulent, THE GUARDIAN (Jan. 5, 2012, 1:17 PM), available at http://www.guardian.co.uk/

society/2012/jan/05/andrew-wakefield-sues-bmj-mmr. The lawsuit, pending in federal district

court in Texas, alleges that the defendants defamed Wakefield. Id.

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and ethics tribunals in the U.K., it presented in the court system in the U.S. With the

1986 enactment of the National Childhood Vaccine Injury Act, Congress created the

Vaccine Injury Compensation Program (“VICP”).22 The Program provides an exclusive

forum for claims for injuries caused by a number of childhood vaccines, including the

MMR vaccine.23 The claims are resolved not by juries but by Special Masters.24

The VICP consolidated the more than five thousand MMR-autism cases into

the Omnibus Autism Proceeding.25 The Program’s special masters conducted hearings

on six “test cases” and concluded in each that the claimants had not proven a causal link

between the vaccine and autism.26 The U.S. Court of Federal Claims and the U.S. Court

of Appeals for the Federal Circuit upheld the decisions that were appealed.27

Neither the judicial decisions, the ethics findings, nor The Lancet’s retraction

appear to have shaken the Wakefield faithful. Immediately following the GMC’s ethical

decision, the National Autism Association announced on its website, “Parents of children

22 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified

at scattered sections of U.S.C. tit. 42). 23 42 U.S.C. § 300aa-11(a)(2)(A).

No person may bring a civil action for damages in an amount greater than

$1,000 . . . against a vaccine administrator or a manufacturer in a State or

Federal court for damages arising from a vaccine-related injury . . . unless a

petition has been filed, in accordance with section 300aa-16 of this title . . .

Id. The covered vaccines are: diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT, or Td),

measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis B, Hib,

varicella, rotavirus, and pneumococcal conjugate vaccines. Id. § 300aa-14(a). 24 Id. § 300aa-11(a)(1). 25 Autism General Order #1, In re Claims for Vaccine Injuries Resulting in Autism Spectrum

Disorder or a Similar Neurodevelopmental Disorder; Various Petitioners v. Sec'y of Health &

Human Servs., Autism Master File, 2002 Fed. Cl. 2002 WL 31696785, *1, available at

http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf

(asserting it is in the best interests of the court and the petitioners involved to consolidate the

cases because of the amount of claims and gravity of the medical issue). 26 Autism Update, In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a

Similar Neurodevelopmental Disorder; Various Petitioners v. Sec'y of Health & Human Servs.,

Autism Master File, at 2-3, 2011 Fed. Cl., available at http://www.uscfc.uscourts.gov/sites/

default/files/autism/Autism+General+Order1.pdf. Although the test cases do not constitute

precedent, similar cases presenting the same theory of causation will likely be decided the same

way without new evidence. Id. at 3. 27 See generally Cedillo v. Sec’y of Health and Human Servs., 617 F.3d 1328 (Fed. Cir. 2010)

(finding the evidence presented by the petitioners to be unreliable); Hazlehurst v. Sec’y of Health

and Human Servs., 604 F.3d 1343 (Fed. Cir. 2010) (determining the Special Master made no error

in considering the evidence presented and holding there was no causal link).

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with autism around the world are calling the findings against Dr. Andrew Wakefield in

the U.K.’s General Medical Council unjust and a threat to researchers investigating

autism as a medical condition . . . Bravo to Dr. Andrew Wakefield.”28 A visitor to the

Age of Autism website posted this in response to The Lancet’s retraction: “[T]hose who

will stand behind Wakefield . . . will remain standing proudly with integrity, truth, and

honor . . . the [L]ancet will slide into a pool of ignorant denial . . . along with all their lies

and cover ups [sic].”29 As recently as September 5, 2011, Age of Autism posted on its

website, “The allegations against Wakefield remain grotesquely flawed.”30 Perhaps most

dramatically, the director of an autism advocacy group urged in a book published in the

summer of 2011 that the world will place Wakefield’s name among “human rights

dissidents” like Nelson Mandela.31 Moreover, as of January 2012, the online “We

Support Andy Wakefield” petition bore 3,858 signatures.32

Wakefield, who practiced what the British Medical Journal has termed “Piltdown

medicine,”33 is still seen as a defender of human rights: “Before long, the world will

28 PRESS RELEASE, NATIONAL AUTISM ASSOCIATION, PARENTS OF CHILDREN WITH AUTISM

CALL DECISION IN WAKEFIELD TRIAL A THREAT TO MEDICAL INTEGRITY (Jan. 28, 2010),

available at http://www.nationalautismassociation.org/press012810.php. 29 Candace, Comment to The Lancet Retraction, AGE OF AUTISM (Feb. 2, 2010, 2:37 PM),

http://www.ageofautism.com/2010/02/the-lancet-retraction/comments/page/3/#comments. 30 John Stone, MMR, the Murdochs and British Medical Journal: Questions Unanswered as Editor Godlee

Plans Washington Triumph, AGE OF AUTISM, (Sept. 5, 2001, 12:01 AM), http://www.ageof

autism.com/2011/09/mmr-the-murdochs-and-british-medical-journal-questions-unanswered-as-

editor-godlee-plans-washington-.html. The Age of Autism is a website for “those who believe

autism is an environmentally induced illness that it is treatable, and that children can recover.” A

Letter from the Editor, AGE OF AUTISM, http://www.ageofautism.com/a-welcome-from-dan-

olmste.html (last visited Nov. 13, 2011). 31 Mary Holland, Who is Doctor Andrew Wakefield?, in VACCINE EPIDEMIC: HOW CORPORATE

GREED, BIASED SCIENCE, AND COERCIVE GOVERNMENT THREATEN OUR HUMAN RIGHTS,

OUR HEALTH, AND OUR CHILDREN 223, 229 (2011). Mary Holland, Esq. is a founding board

member and managing director of the Elizabeth Birth Center for Autism Law & Advocacy.

Board Members, ELIZABETH BIRT CENTER FOR AUTISM LAW & ADVOCACY, http://www.

ebcala.org/about/board-members (last visited Jan. 8, 2012). Holland is also a founding board

member of the Center for Personal Rights and a member of the Coalition for Vaccine Safety’s

Steering Committee. The Board, CENTER FOR PERSONAL RIGHTS, http://www.centerforpersonal

rights.org/index.php?option=com_content&view=article&id=5&Itemid=66 (last visited Jan. 8,

2012). 32 WE SUPPORT DR. ANDREW WAKEFIELD, http://www.wesupportandywakefield.com/ (last

visited Jan. 8, 2012). 33 Brian Deer, Piltdown Medicine: The Missing Link Between MMR and Autism, BMJ GROUP BLOGS

(Jan. 6, 2011), http://blogs.bmj.com/bmj/2011/01/06/brian-deer-piltdown-medicine-the-miss

ing-link-between-mmr-and-autism/. Brian Deer, who investigated Dr. Wakefield’s research and

reported his findings in a series appearing in the British Medical Journal, compared Wakefield’s

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likely recognize that it was Dr. Wakefield, not his detractors, who stood up for the

practice of medicine and the pursuit of science.”34

Why is it that those who were swayed by a single study of twelve subjects

cannot be “un-swayed” by dozens of studies of thousands of subjects? Is it simply, as

Paul Offit, author of Autism’s False Prophets: Bad Science, Risky Medicine and the Search for a

Cure, has opined that “while it’s very easy to scare people, it’s very hard to unscare

them”?35 Or is it that Wakefield gives parents sufficient “enthusiasm and superstition”

to resist the pull of science?36

This article attempts to explain why many participants in the MMR-autism

debate have refused to accept the greater weight of the scientific evidence. Part I briefly

reviews autism prevalence over time. Part II examines the findings of the Wakefield

ethics hearings and describes the beliefs of those who, despite the ethics hearings’

findings, remain unshakably committed to Wakefield and his work. Part III presents the

theory of cultural cognition, which posits that people are psychologically disposed to

believe what, given their cultural background, they deem honorable and to reject what

they deem to be dishonorable to reject. That part concludes with the observation that

the context of the MMR-autism debate made for the perfect cultural storm in which a

group of “hierarchical individualists” were unlikely ever to reject the findings of an “in-

group” messenger. As one participant in the debate has put it, “Well, I personally feel

that vaccines are implicated in the increase in autism. And frankly, the [criticism of] Dr.

Wakefield’s study doesn’t really alter my beliefs one way or the other.”37 Part IV

concludes this article with some observations about how science might coexist with

research to Piltdown man – a paleontological hoax, lasting over 40 years in which fossilized

fragments were claimed to be the “missing link” between man and ape. Id. See generally Brian

Deer, How the Case Against the MMR Vaccine Was Fixed, 342 BRIT. MED. J. 77 (2011); Brian Deer,

How the Vaccine Crisis Was Meant to Make Money, 342 BRIT. MED. J. 136 (2011); Brian Deer, The

Lancet’s Two Days to Bury Bad News, 342 BRIT. MED. J. 200 (2011) (criticizing Wakefield’s claims

about the MMR vaccine). 34 Holland, supra note 31, at 229. 35 Sharon Begley, Anatomy of a Scare, NEWSWEEK, Mar. 2, 2009, at 42, 47, available at http://

www.thedailybeast.com/newsweek/2009/02/20/anatomy-of-a-scare.html; see also PAUL OFFIT,

AUTISM’S FALSE PROPHETS: BAD SCIENCE, RISKY MEDICINE, AND THE SEARCH FOR A CURE

(2008) (presenting a history of autism research to separate legitimate facts about autism from

“bad science” that consistently misleads the general public). Offit argues that despite what many

people believe, vaccines are not the cause of autism. Offit, supra, at xxvii. 36 SMITH, supra note 1, at Vol. 1, 203. 37 British Medical Journal Finds Autism Study a Fraud; Focus: Constitution; Gulf Oil Spill Blame, CNN

NEWSROOM, (January 6, 2011, 12:01 PM), http://www.cnnstudentnews.cnn.com/TRAN

SCRIPTS/1101/06/cnr.04.html.

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enthusiasm, if not superstition, within the community concerned with the MMR-autism

debate.

I. Autism Through the Years

A. Diagnosis

Swiss psychiatrist Eugen Bleuler coined the word “autism” in 1911 to describe

the unrealistic thought processes that occur in dreams and fantasies. 38 The word

“autism” derives from the Greek word “autos” meaning “self.”39 Bleuler considered

reality-based thoughts the norm and unrealistic, self-reflecting thoughts more refined.40

But, he also used “autism” to describe the thoughts of patients suffering from

schizophrenia.41

Leo Kanner, who founded the world’s first child psychiatry program at Johns

Hopkins and authored Child Psychiatry42 — the first text on the subject43 — published the

first description of autism in his 1943 article, “Autistic Disturbances of Affective

Contact.”44 He presented two case studies of “children whose condition differs so

markedly and uniquely from anything reported so far, that each case merits – and, I

hope, will eventually receive – a detailed consideration of its fascinating peculiarities.”45

Nearly four decades elapsed after Kanner’s seminal article before the word

38 ADAM FEINSTEIN, A HISTORY OF AUTISM: CONVERSATIONS WITH THE PIONEERS 5-6 (2010)

(explaining that Dr. Bleuler distinguished the difference between logical or realistic thinking and

autistic thinking). 39 Id. at 5. 40 Id. at 6. Bleuler believed that autistic thinking was normal thinking for both children and

adults. Id. This was evident to Bleuler from dreams and pretend play of the non-autistic and the

fantasies and delusions of the schizophrenic. Id. 41 Id. Bleuler originally included autism as one of what he called the “four schizophrenias,” which

included: associated disturbance, affective disturbance, ambivalence, and autism. Id. 42 LEO KANNER, CHILD PSYCHIATRY (1935). 43 See Medicine: The Child Is Father, TIME, July 25, 1960, at 78, (outlining Kanner’s revolutionary

work and early achievements in the area of child psychiatry). 44 See generally Leo Kanner, Autistic Disturbances of Affective Contact, 2 NERVOUS CHILD 217-50

(1943), available at http://www.neurodiversity.com/library_kanner_1943.html. There is some

debate regarding whether Kanner’s work was original or whether he borrowed from the work of

Hans Asperger. See FEINSTEIN, supra note 38, at 11. For an example of Asperger’s work, see

Hans Asperger, Autistic Psychopathy in CHILDHOOD (1944), reprinted in AUTISM AND ASPERGER

SYNDROME 37 (Uta Frith ed., Uta Frith trans., 1991) (originally published in German). 45 Kanner, supra note 44, at 217.

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“autism” entered the primary diagnostic instrument for the mental health profession, the

Diagnostic and Statistical Manual of Mental Disorders (“DSM”).46 The first articulation of

DSM was published in 1952, is the result of the efforts of the New York Academy of

Medicine in the late 1920s to lead the medical community out of diagnostic “chaos

towards a nationally accepted standard nomenclature of disease.”47 Perhaps because the

drafting committee did not include child and adolescent psychiatrists, the manual did

not include a diagnosis of autism.48 Rather, the closest diagnosis listed in this first

rendition of DSM-I was “Schizophrenic reaction, childhood type.”49

Beginning in 1968, with the crafting of DSM-II, the American Psychiatric

Association, drafters of the manual, began to make “progress in the classification of

childhood and adolescent disorders.”50 The DSM-II drafters added a note observing

that the “Schizophrenia, childhood type” disorder might include symptoms of “autistic,

atypical and withdrawn behavior.”51

The first two iterations of DSM reflected the views of the dominant

psychoanalytic and sociological thought of the time and “conceived of symptoms as

reflections of broad underlying dynamic conditions or as reactions to difficult life

problems.”52 DSM-III, on the other hand, bore the evidence of a revolution in the

psychiatric profession in the 1970s that transformed disorder classification from “broad,

etiologically defined entities that were continuous with normality to symptom-based,

categorical diseases.”53 As a result, where DSM-I and DSM-II avoided “elaborate

classification schemes, because overt symptoms did not reveal disease entities,” DSM-III

reflected psychiatry’s attempt to “reorganize[] itself from a discipline where diagnosis

played a marginal role to one where it became the basis of the specialty.”54 One of these

diagnoses contained the first listing for autism: “Diagnostic Criteria for Infantile

46 See Mina K. Dulcan, Classification of Psychiatric Disorders, in DULCAN’S TEXTBOOK OF CHILD AND

ADOLESCENT PSYCHIATRY, 61, 61 (Mina K. Dulcan ed., 2010). 47 See generally AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL

DISORDERS v (1952) [hereinafter DSM-I]. 48 Dulcan., supra note 46, at 62. 49 Id.; DSM-I, supra note 47, at 28 (diagnosis 000-x28). 50 Dulcan, supra note 46, at 62; see AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL

MANUAL OF MENTAL DISORDERS (2d ed. 1968) [hereinafter DSM-II], available at http://libweb.

uoregon.edu/index/cms-filesystem-action/guides/english/dsm.pdf. 51 DSM-II, supra note 50, at 35 (disorder 295.8). 52 Rick Mayes & Allan V. Horwitz, DSM-III and the Revolution in the Classification of Mental Illness, 41

J. HIST. BEHAV. SCI. 249, 249 (2005). 53 Id. See generally AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL MANUAL OF

MENTAL DISORDERS (3d ed. 1980) [hereinafter DSM-III]. 54 Mayes & Horwitz, supra note 52, at 250.

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Autism.”55 The criteria include “[o]nset before 30 months of age” and “[p]ervasive lack

of responsiveness to other people.”56

The move toward categorization reached its zenith in 1994 with the publication

of DSM-IV.57 The manual introduced five related disorders:58 autistic disorder,59

Asperger’s Disorder,60 Rett’s Disorder,61 Childhood Disintegrative Disorder,62 and

Pervasive Developmental Disorder Not Otherwise Specified (“PDD-NOS”).63 These

five disorders are usually grouped together under the heading of autism spectrum

disorders (“ASD”). The National Institute of Mental Health summarizes ASD

disorders:

All children with ASD demonstrate deficits in 1) social interaction, 2)

verbal and nonverbal communication, and 3) repetitive behaviors or

interests. In addition, they will often have unusual responses to sensory

experiences, such as certain sounds or the way objects look. Each of

these symptoms runs the gamut from mild to severe.64

55 DSM-III, supra note 53, at 89. 56 Id. 57 See generally AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL

DISORDERS IV (1994) [hereinafter DSM-IV]. 58 See id. at 65-78. See generally NAT’L INST. OF MENTAL HEALTH, AUTISM SPECTRUM

DISORDERS: PERVASIVE DEVELOPMENTAL DISORDERS (2008), available at http://cpancf.com/

pdf/nimhautismspectrumdisorders.pdf (hereinafter NIMH) (discussing prevalence, types,

symptoms, diagnoses, and treatment of autism spectrum disorders). 59 Peter E. Tanguay, Autism Spectrum Disorders, in DULCAN’S TEXTBOOK OF CHILD AND

ADOLESCENT PSYCHIATRY, 174, 174 (Mina K. Dulcan ed., 2010) (“[A]utism is defined by the

presence of severe and pervasive impairments in reciprocal social interaction and in verbal and

nonverbal communication skills.”). 60 Id. “The criteria for Asperger’s disorder are identical to those for autistic disorder . . . with the

exception that there is no clinically significant delay in cognitive development or in the

development of age appropriate self-help skills, and no significant delay in language

development.” Id. at 177. 61 NIMH, supra note 58, at 4. “Rett syndrome is relatively rare, affecting almost exclusively

females, one out of 10,000 to 15,000. After a period of normal development, sometime between

6 and 18 months, autism-like symptoms begin to appear.” Id. 62 Id. “The diagnosis requires extensive and pronounced losses involving motor, language, and

social skills. CDD is also accompanied by loss of bowel and bladder control and oftentimes

seizures and a very low IQ.” Id. (citations omitted). 63 Id. This diagnosis is used when there are autistic-like symptoms, “but the criteria for any of the

more specific pervasive developmental disorders (PDD) are not met.” Id. at 2. 64 NIMH, supra note 58, at 5.

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The American Psychiatric Association (“APA”) is currently at work on DSM-

V.65 The organization is supervising field trials of the manual and will accept a third

round of comments in spring 2012.66 The APA expects to release the final version in

May 2013.67 This fifth incarnation will conflate the four autism-related disorders into a

single diagnostic category of “Autism Spectrum Disorders.”68 “The recommendation of

a new category of autism spectrum disorders reflects recognition by the work group that

the symptoms of these disorders represent a continuum from mild to severe, rather than

being distinct disorders.”69 An ASD diagnosis requires the finding of deficits in “social

interaction and communication” and “the presence of repetitive behaviors and fixated

interests and behaviors.”70

65 DSM-5: The Future of Psychiatric Diagnosis, AMERICAN PSYCHIATRIC ASS’N, http://www.dsm5.

org/Pages/Default.aspx (last visited Jan. 7, 2012). 66 Id. 67 DSM-5 Timeline, AMERICAN PSYCHIATRIC ASSOCIATION, http://www.dsm5.org/about/Pages/

Timeline.aspx (last visited Jan. 3, 2012). 68 DSM-5 Proposed Revisions Include New Category of Autism Spectrum Disorders, AMERICAN

PSYCHIATRIC ASSOCIATION (Feb. 10, 2010, 12:01 AM), http://www.dsm5.org/Newsroom/

Documents/Autism%20Release%20FINAL%202.05.pdf. 69 Id. (quoting Edwin Cook, M.D, a member of the DSM-5 Neurodevelopmental Disorders Work

Group). 70 Id.; see A 09 Autism Spectrum Disorder, AMERICAN PSYCHIATRIC ASS’N, http://www.dsm5.org/

proposedrevision/pages/proposedrevision.aspx?rid=94 (last updated Jan. 26, 2011). The

proposed revision provides:

Autism Spectrum Disorder. Must meet criteria A, B, C, and D:

A. Persistent deficits in social communication and social interaction across

contexts, not accounted for by general developmental delays, and manifest by

all 3 of the following:

1. Deficits in social-emotional reciprocity; ranging from abnormal

social approach and failure of normal back and forth conversation

through reduced sharing of interests, emotions, and affect and

response to total lack of initiation of social interaction,

2. Deficits in nonverbal communicative behaviors used for social

interaction; ranging from poorly integrated-verbal and nonverbal

communication, through abnormalities in eye contact and body-

language, or deficits in understanding and use of nonverbal

communication, to total lack of facial expression or gestures.

3. Deficits in developing and maintaining relationships, appropriate

to developmental level (beyond those with caregivers); ranging from

difficulties adjusting behavior to suit different social contexts through

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B. Prevalence

In 2005, the journal Pediatrics published one of the first reports of autism

prevalence in the U.S.71 The article drew conclusions from data collected by the U.S.

Department of Education, Office of Special Education Programs (“OSEP”).72 OSEP

tabulates state-supplied data regarding children enrolled in state special education

programs.73 Since 1992, OSEP has mandated that all states report the number of

children in special education programs who have been diagnosed with autism.74 These

data, the “only available source for national [autism] prevalence estimates,” allow for the

difficulties in sharing imaginative play and in making friends to an

apparent absence of interest in people

B. Restricted, repetitive patterns of behavior, interests, or activities as

manifested by at least two of the following:

1. Stereotyped or repetitive speech, motor movements, or use of

objects; (such as simple motor stereotypies, echolalia, repetitive use

of objects, or idiosyncratic phrases).

2. Excessive adherence to routines, ritualized patterns of verbal or

nonverbal behavior, or excessive resistance to change; (such as

motoric rituals, insistence on same route or food, repetitive

questioning or extreme distress at small changes).

3. Highly restricted, fixated interests that are abnormal in intensity

or focus; (such as strong attachment to or preoccupation with

unusual objects, excessively circumscribed or perseverative interests).

4. Hyper-or hypo-reactivity to sensory input or unusual interest in

sensory aspects of environment; (such as apparent indifference to

pain/heat/cold, adverse response to specific sounds or textures,

excessive smelling or touching of objects, fascination with lights or

spinning objects).

C. Symptoms must be present in early childhood (but may not become fully

manifest until social demands exceed limited capacities)

D. Symptoms together limit and impair everyday functioning.

Id.

71 Craig J. Newschaffer et al., National Autism Prevalence Trends From United States Special Education

Data, 115 PEDIATRICS e277, e277 (2005), available at http://pediatrics.aappublications.org/

content/115/3/e277.full.pdf. 72 Id. 73 Id. 74 Id.

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computation of prevalence rates over time among school-aged children.75 From 1994

through 2004, autism prevalence rates for children between the ages of six and twenty-

one years increased by an average of more than twenty percent annually.76 The data for

children aged three to five years, tabulated from 2000 through 2004, revealed a similar,

though less dramatic, trend.77

The authors noted that some researchers had theorized that the relatively recent

identification of the autism disorder may have resulted in the reclassification of some

mental health disorders to autism, producing a falsely elevated number of new autism

cases.78 “Because there was no indication of decreases in one or another of these

categories concomitant with, and of similar magnitude to, increases in autism

classification prevalence,” the authors rejected a finding of “diagnostic shifting.”79

The Autism and Developmental Disabilities Monitoring (“ADDM”) Network

of the Centers for Disease Control (“CDC”) has published two reports on ASD

prevalence. 80 These studies reported prevalence findings in eight year old children, the

point of “‘peak prevalence,’ or the age at which most children [with ASD] have been

identified. . . .”81 The 2007 report, tabulating 2002 data, found ASD prevalence to range

from one in 300 to one in 100, and average one in 150 children.82

75 See id. at e277, e280. 76 Newschaffer et al., supra note 71, as reflected in online presentation of data here: http://

www.taap.info/Gallup%202005.pdf. 77 Id. 78 Newschaffer et al., supra note 71, at e280 (noting possible “diagnostic shifting” from mental

retardation and speech and language impairment to autism). 79 Id. (discussing why diagnostic shifting theories are not supported by data to explain the

increase of autism cases). 80 See OFFICE OF AUTISM RESEARCH COORDINATION, U.S. DEP’T OF HEALTH AND HUMAN

SERVICES, REPORT TO CONGRESS ON ACTIVITIES RELATED TO AUTISM SPECTRUM DISORDER

AND OTHER DEVELOPMENTAL DISABILITIES UNDER THE COMBATING AUTISM ACT OF 2006 (FY

2006–FY 2009), 37-8 (Dec. 2010, Updated Apr. 2011), available at http://iacc.hhs.gov/

reports/reports-to-congress/FY2006-2009/caa-full-report-2006-2009.pdf [hereinafter REPORT

TO CONGRESS] (citing two reports of ASD prevalence). 81 Id. at 39. 82 Id. at 37; see CATHERINE RICE, CENTERS FOR DISEASE CONTROL AND PREVENTION, Prevalence

of Autism Spectrum Disorders - Autism and Developmental Disabilities Monitoring Network, 14 sites, United

States, 2002, 56 MORBIDITY & MORTALITY WKLY. REP. 12 (2007), available at http://www.

cdc.gov/mmwr/preview/mmwrhtml/ss5601a2.htm [hereinafter RICE, 2002]. The study

tabulated data from fourteen sites:

In this study, six ADDM sites (Arizona, Georgia, Maryland, New Jersey, South

Carolina, and West Virginia) reported the prevalence for children who were

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The second report, reporting on 2006 data and published in 2009, found an

increased prevalence of approximately one in 110 children.83 This represented an

average increase in prevalence of ASD from 2002 to 2006 of fifty-seven percent.84 This

report also revealed that prevalence for boys was 14.5 per 1,000 compared with 3.2 per

1,000 girls.85

The 2009 report concluded with the observation that, “[a]lthough improved

ascertainment accounts for some of the prevalence increases . . . a true increase in the

risk for children to develop [autism] symptoms cannot be ruled out.”86

The 2005 report in Pediatrics sampled only those children in special education

programs while both ADDM studies sampled a modest number of sites across the

country.87 In the summer of 2011, researchers from Yale and George Washington

Universities published a study designed to augment the available evidence of ASD

prevalence by sampling an entire population of elementary school children.88 Since

2001, in response to the recommendation of the U.S. Centers for Disease Control,

South Korea has required the MMR vaccine as a condition to children enrolling in

school, resulting in a ninety-nine percent vaccination rate.89 The researchers obtained

eight years old in 2000 (born in 1992). An additional eight sites (Alabama,

Arkansas, Colorado, Missouri, North Carolina, Pennsylvania, Utah, and

Wisconsin) participated in the second study year, determining the prevalence

for children who were eight years old in 2002 (born in 1994).

REPORT TO CONGRESS, supra note 80, at 37. 83 See CATHERINE RICE, CENTERS FOR DISEASE CONTROL AND PREVENTION, Prevalence of Autism

Spectrum Disorders - Autism and Developmental Disabilities Monitoring Network, United States, 2006, 58

MORBIDITY AND MORTALITY WKLY. REP. SURVEILLANCE SUMMARIES 1 (2009), available at

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5810a1.htm [hereinafter RICE, 2006]. This

study tabulated data from eleven sites around the country: Alabama, Arizona, Colorado, Florida,

Georgia, Maryland, Missouri, North Carolina, Pennsylvania, South Carolina, and Wisconsin. Id. 84 Id. 85 Id. 86 Id. 87 See Newschaffer et al., supra note 71, at e277; REPORT TO CONGRESS, supra note 80, at 11;

RICE, 2002, supra note 82 (study utilizing data from states across the country including: Arizona,

Georgia, Maryland, New Jersey, South Carolina, West Virginia, Alabama, Arkansas, Colorado,

Missouri, North Carolina, Pennsylvania, Utah, and Wisconsin). 88 Young Shin Kim et al., Prevalence of Autism Spectrum Disorders in a Total Population Sample, 168 AM.

J. PSYCHIATRY 904, 905-07 (2011). The study ran from 2005-2009 in a suburb of Seoul, South

Korea, and included 33 schools with 36,592 students. Id. at 905. 89 Centers for Disease Control, Elimination of Measles – South Korea, 2001 – 2006 ,56 MORBIDITY

AND MORTALITY WKLY. REP. 304, 304-07 (April 6, 2007), available at http://www.

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data on all seven to twelve year olds in a South Korean community.90 They obtained

information from both a group exhibiting a high probability of ASD, the “special

education schools,” and a low probability, the “regular schools.”91 The researchers

screened children and offered a questionnaire to parents of children who screened

positive.92

The study revealed ASD prevalence rates of 2.64 percent in the total

population, with 1.89 percent in the general-population group and 0.75 percent in the

high-probability group.93 The male to female ratios were 5.1 to 1 in the high probability

population and 2.5 to 1 in the general population.94

As the researchers noted, “There is a striking difference between our estimated

prevalence of 2.64% for any ASD and previously reported estimates ranging from 0.6%

to 1.8%.”95 But, they concluded that their use of “gold standard” diagnostic tools and

careful examination of the data rendered their results valid, and would strengthen the

design of future prevalence studies.96

These reports present the questions whether ASD is increasing or whether only

its diagnosis is increasing. At the very least, we now know that ASD affects a significant

portion of the population: “Autism now affects more American children than childhood

cancer, diabetes and AIDS combined.”97 As journalist Robert MacNeil has observed,

cdc.gov/mmwr/preview/mmwrhtml/mm5613a3.htm. 90 Kim et al., supra note 88, at 905. 91 Id. Of the students issued questionnaires, 103 students from the special education schools

returned information and 23,234 student from regular schools returned forms. Id. at 907. The

responses from the special education schools included 82 percent boys, while the regular schools

included only 52 percent boys. Id. 92 Kim et al., supra note 88, at 905. 93 Id. at 908. The study noted a significant difference in prevalence rates from this group and

prevalence rates previously reported through other studies at 0.6 percent and 1.8 percent. Id. 94 Id. at 907. The high-probability group studied included children who were enrolled in the

Disability Registry or special education schools and those in regular schools with psychiatric or

psychological service use. Id. The general-population sample included children in regular schools

without psychiatric or psychological service use. Id. at 909. 95 Kim et al., supra note 88, at 908. The research team went on to note possible cultural

variations for reported statistics as contributing to possible report bias, and that the “less than

optimal participation rate” in the general-population research sample of 63 percent is another

possible factor which limited the statistical applicability of the data. Id. A response rate

approaching 80 percent is the preferred practice in epidemiological studies to limit the impact of

reporting bias on data. Id. 96 Id. at 908-10. 97 PBS Newshour: Autism Now: Exploring the 'Phenomenal' Increase in U.S. Prevalence, (PBS television

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“[A] majority of . . . researchers . . . believe that wider diagnosis explains only part of the

increase in autism numbers.”98 Whether further explanation lies in environmental

causes, infectious agents, or nutritional factors remains a mystery.99 As one researcher

put it, unraveling that mystery will take further research, including a peak into the human

genome:

There are a variety of factors that could be influencing development,

and they may play a role at different points in development. But I think

multiple factors contribute not just across the population but within

any one individual. So when I say that I think autism is multifactorial in

its causation, I think that applies to even at the individual level so that it

might take two or three susceptibility genes combined with two or

three environmental factors at critical junctures.100

Might one of those environmental factors be the childhood MMR vaccine?

II. Andrew Wakefield, MD

A. An Anatomy of a Scientific Fraud

The GMC’s Fitness to Practice Panel convened on July 16, 2007 to consider

Wakefield’s “conduct, duties and responsibilities” in conducting the study that resulted

in The Lancet publication.101 The Panel, comprising three physicians and two lay people,

met for a total of 148 days over a two and a half year period and considered the

testimony of three dozen witnesses.102

broadcast Apr. 19, 2011), available at http://www.pbs.org/newshour/bb/health/jan-june11/

autism2preval_04-19.html. 98 Id. 99 Id. 100 Id. (quoting statement by Dr. Irva Hertz-Piccotto of the University of California, Davis during

interview with Robert MacNeil). 101 GEN. MED. COUNCIL, supra note 18, at 1-3. The Panel also considered the conduct of

Professors John Walker Smith and Simon Murch, the two co-authors who had not renounced the

study. Id. The Panel focused exclusively on ethical inquiries and did not consider “whether there

is or might be any link between the MMR vaccination and autism. Id. at 2. When the panel

considered the conduct of John Walker and Simon Murch it was a stated goal to take into

account the particular circumstances that each professor faced at the “material times” to the

relevant conduct and avoid making judgments with the benefit of hindsight. Id. Among the

stated “conduct, duties and responsibilities” that the panel considered was the duty to conduct

research within ethical constraints. Id. at 3. 102 Id. at 2.

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The Panel found a number of aspects of Wakefield’s conduct to be unethical.

First, the Panel focused on conflicts of interest. Wakefield initiated his study after being

retained by a law firm that represented parents alleging that the MMR vaccine had

caused autism in their children.103 Wakefield accepted approximately $750,000 in

compensation from the law firm without disclosing to The Lancet either the payment or

its source, a “legal aid board” designed to underwrite access for the poor to legal

services.104 In addition, some nine months before The Lancet published his paper,

Wakefield filed a patent application on a single measles vaccine that could find success

in the market place only if parents chose not to inoculate their children with the MMR

vaccine.105

The Panel also commented on Wakefield’s selection process for study subjects.

The subjects were neither randomly selected nor were they, as Wakefield, claimed, “self

referred.”106 Rather, most of the families were recruited through an anti-MMR campaign

and most were clients of the plaintiffs’ law firm that had retained Wakefield.107

The conduct of the study, itself, also troubled the Panel. Wakefield and his

coworkers administered a number of invasive procedures upon the study subjects,

including anesthesia, radioactive beverages, x-rays, ileocolonoscopies, lumbar punctures,

MRIs, and EEGs.108 Because the subjects had not presented appropriate symptoms, the

procedures were not clinically indicated.109 Rather, Wakefield had subjected the children

103 GEN. MED. COUNCIL, supra note 18, at 4. 104 Brian Deer, Exposed: Andrew Wakefield and the MMR-autism fraud, BRIANDEER.COM, http://

briandeer.com/mmr/lancet-summary.htm (last visited Jan. 5, 2012) (stating that the amount

billed by Wakefield was “£435,643 (then about $750,000 US)”). The U.K. legal aid fund was the

source of the funds the law firm used to compensate Wakefield. Id. The U.K. legal aid fund is

“run by the government to give poorer people access to justice.” Id.; see also GEN. MED.

COUNCIL, supra note 18, at 4-7. 105 See Deer, supra note 104 (referencing the patent found during an investigation conducted by

The Sunday Times); GEN. MED. COUNCIL, supra note 18, at 49-50 (outlining findings as to

Wakefield’s conflict of interest concerning the patent and the article). 106 See GEN. MED. COUNCIL, supra note 18, at 103-05 (explaining the Panel’s conclusion that the

children in the study were not “self-referred”). 107 Deer, supra note 104. The majority of the children involved in the study “had been pre-

selected through MMR campaign groups . . . most of their parents were clients and contacts of

the lawyer.” Id.; see also GEN. MED. COUNCIL, supra note 18, at 103-105. 108 Deer, supra note 104; see also GEN. MED. COUNCIL, supra note 18, (describing eleven out of the

twelve children’s individual circumstances and the Panel’s findings). 109 GEN. MED. COUNCIL, supra note 18, at 11-42. The Panel found that the lumbar puncture that

was administered was not clinically indicated for Children 3, 9 and 12. Id. In addition, the Panel

found that Dr. Wakefield’s conduct was contrary to the clinical interests of ten of the twelve

children. Id.

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“to a programme of investigations for research purposes without having Ethics

Committee approval for such research.”110 In addition, Wakefield falsely reported to The

Lancet that he had presented this regimen to the hospital ethics committee.111 Moreover,

to obtain “control” blood samples, Wakefield turned to the children who attended his

son’s birthday party.112 There, without proper informed consent or parents’

authorization, he obtained blood samples from the attendees and “as a reward at the end

of the party the children who had given blood all received £5.”113 Compounding the

ethical violation, at a conference in California, Wakefield publicly referred to the event in

“humorous terms” and expressed “an intention to obtain research samples in similar

circumstances in the future.”114

In sum, the Panel found Wakefield’s conduct to be “dishonest . . . irresponsible

. . . [and] misleading.”115 The GMC then reviewed the Panel’s findings and characterized

Wakefield’s conduct:

The Panel made findings of transgressions in many aspects of Dr

Wakefield’s research. It made findings of dishonesty in regard to his

writing of a scientific paper . . . [and] in respect of the [Legal Aid

Board] funds secured for research . . . Furthermore he was in breach of

his duty to manage finances as well as to account for funds that he did

not need to the donor of those funds. In causing blood samples to be

taken from children at a birthday party, he callously disregarded the

pain and distress young children might suffer and behaved in a way

which brought the profession into disrepute.116

The appropriate penalty, concluded the GMC, was that Wakefield’s name be

stricken from the Medical Register, precluding him from practicing medicine in the

110 Id. at 13, 16, 18, 24, 25, 31. The Panel made this finding for Children 1-6 and 9. Id. Children

8 and 12 were also found to have undergone investigation for Wakefield’s research without the

Ethics Committee’s approval. Id. at 34-35, 37. 111 Deer, supra note 104. Dr. Wakefield made this false report in order to satisfy The Lancet’s

patient-protection requirements. Id. 112 GEN. MED. COUNCIL, supra note 18, at 54. 113 Id. The Panel found that Dr. Wakefield’s was unethical and that he “. . . abused [his] position

of trust as a medical practitioner.” Id. at 55. 114 GEN. MED. COUNCIL, supra note 18, at 54. 115 Id. at 44. 116 GEN. MED. COUNCIL, DETERMINATION ON SERIOUS PROFESSIONAL MISCONDUCT (SPM)

AND SANCTION 8, available at http://www.gmc-uk.org/Wakefield_SPM_and_SANCTION.pdf

_32595267.pdf.

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U.K.117

Upon reading the Fitness to Practise Panel’s conclusions, The Lancet retracted

Wakefield’s paper.118 The Journal found particularly damning the false claims that

“children were ‘consecutively referred’ and that investigations were ‘approved’ by the

local ethics committee.”119

Following The Lancet’s retraction, the British Medical Journal took the

extraordinary step of publishing an editorial entitled, “Wakefield’s Article Linking MMR

Vaccine and Autism Was Fraudulent.”120 In that piece, the journal’s editors observed

that Wakefield’s article was “fatally flawed both scientifically and ethically” and “was in

fact an elaborate fraud.”121 The authors characterized Wakefield’s conduct in the

starkest of terms: “Is it possible that he was wrong, but not dishonest: that he was so

incompetent that he was unable to fairly describe the project, or to report even one of

the 12 children’s cases accurately? No.”122

The British Medical Journal editors pointed to the efforts of journalist Brian Deer

in uncovering “the extent of Wakefield’s fraud.”123 Through a series of articles for

London’s Sunday Times, Deer discovered fraud in each of the twelve cases reported in

The Lancet paper.124 Indeed, “in no single case could the medical records be fully

117 Id. at 9. Doctors who are not registered with the General Medical Counsel may not practice in

the U.K. See THE MEDICAL REGISTER, GENERAL MEDICAL COUNCIL, http://www.gmc-

uk.org/doctors/medical_register.asp (last visited January 28, 2012). 118 The Editors of the Lancet, Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and

pervasive developmental disorder in children, 375 THE LANCET 455, 455, available at

http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673610601754.pdf?id=4d037fefc

b72946c:-2bdd2a5a:1352ff74261:26311327952419579. 119 Id. 120 Godlee et al., supra note 21, at 64. 121 Id. at 64. Critics to the vaccine scare quickly pointed out the faults in Wakefield’s paper,

including the lack of experimental controls, and that it relied on the beliefs and memory of

parents. Id. The paper was finally retracted twelve years later. Id. 122 Id. at 65 (explaining that Wakefield’s paper was fraudulent, that he put in a great deal of effort

to obtain the results he wanted, and his paper was full of misreporting). 123 Godlee et al., supra note 21, at 64. Seven years after first looking into the connection of the

MMR vaccine and autism, Deer illustrated Wakefield’s fraud. Id. Deer used interviews,

documents, and data that were made public at the General Medical Council hearings to show that

Wakefield altered many facts about the patients’ medical histories in order to support Wakefield’s

claim that he identified a new syndrome. Id. 124 Godlee et al., supra note 21, at 65; Brian Deer, Exposed: Andrew Wakefield and the MMR-Autism

Fraud, BRIANDEER.COM, http://briandeer.com/mmr/lancet-summary.htm, (last visited Jan. 7,

2012) (summarizing Deer’s articles). Deer’s first investigation into Wakefield’s paper was

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reconciled with the descriptions, diagnoses, or histories published in [The Lancet].”125

Although Deer and the GMC had unmasked the fraud, repairing the damage will take

some time:

Meanwhile the damage to public health continues, fuelled by

unbalanced media reporting and an ineffective response from

government, researchers, journals, and the medical profession.

Although vaccination rates in the United Kingdom have recovered

slightly from their 80% low in 2003-4, they are still below the 95% level

recommended by the World Health Organization to ensure herd

immunity. In 2008, for the first time in 14 years, measles was declared

endemic in England and Wales. Hundreds of thousands of children in

the UK are currently unprotected as a result of the scare, and the battle

to restore parents’ trust in the vaccine is ongoing.126

Because “[t]o conclude that [a child’s] condition was the result of his MMR

vaccine, an objective observer would have [had] to emulate Lewis Carroll’s White Queen

and be able to believe 6 impossible (or at least highly improbable) things before

breakfast,” one might expect that the revelation of fraud inexorably would lead

Wakefield’s followers to reject his claims.127

B. The Unshakably Faithful

1. The Followers

In November 2011, the National Autism Association (“NAA”) held its annual

National Autism Conference, which it billed as featuring “the world’s leading experts on

autism.”128 The autism expert who gave the keynote address was none other than

published in 2004 and it set forth the possibility of fraud, unethical treatment of children, and a

conflict of interest, since Wakefield was involved in a lawsuit against the manufacturers of the

MMR vaccine. Godlee et al., supra note 21, at 65. 125 Godlee et al., supra note 21, at 65. Deer compared the children’s medical records with what

Wakefield published by focusing on whether the research was true and found evidence of

numerous falsifications. Id. The General Medical Council built on Deer’s findings and launched

its own investigation that centered on whether Wakefield’s research was ethical. Id. 126 Id. at 65 (citations omitted) (describing the ramifications of Wakefield’s findings). 127 Snyder ex rel. Snyder v. Sec’y of Dept. of Health and Human Servs., No. 01-162V, 2009 WL

332044 (Fed. Cl. Feb. 12, 2009). Parents alleged their son contracted autism and chronic

gastrointestinal dysfunction through the use of vaccines. Id. 128 See NATIONAL AUTISM CONFERENCE, NATIONAL AUTISM CONFERENCE PROGRAM GUIDE 3

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Andrew Wakefield.129 NAA’s biography for Wakefield omits any reference to the

retraction of The Lancet paper, the GMC’s findings of fraud, or his loss of his medical

license.”130 Furthermore, in its presentation of causes of autism, NAA’s website

contains an “MMR” page that presents Wakefield’s research as if it remains to this day

unimpeachable;

Dr. Andrew Wakefield first cautioned parents of the potential link

between autism and the MMR vaccine in 1998. He raised fears that the

MMR vaccination could trigger bowel disorders in susceptible children.

His studies have shown the presence of persistent measles virus in

children with ileocolonic lymphonodular hyperplasia, which was shown

repeatedly in children with developmental disorders. Dr. Wakefield’s

work confirmed an association between the presence of measles virus

and gut pathology in children.131

The NAA has been unwavering in its support of Wakefield. In the hours

following the GMC’s striking of his name from the list of those licensed to practice

medicine in the U.K., the NAA issued a press release defending Wakefield and asserting

that the GMC’s actions were but an attempt to suppress “science linking vaccines and

autism . . . at the expense of children’s health.”132 Moreover, NAA is one of the

organizations that sponsors an online “We Support Andrew Wakefield” petition that

(2011), available at http://nationalautismconference.org/2011/FINAL%20GUIDE%20BOOK.

pdf (giving details of the National Autism Conference); see also NATIONAL AUTISM ASSOCIATION,

http://www.nationalautismassociation.org/index.php (last visited Jan. 7, 2012) (describing the

NAA). 129 See Conference Schedule, NATIONAL AUTISM CONFERENCE, http://nationalautismconference.

org/fullschedule.htm (last visited Jan. 7, 2012) (noting that Wakefield was the featured speaker on

the evening of the conference’s last full day, Saturday, November 12). 130 See Speaker Bios and Presentations, NATIONAL AUTISM CONFERENCE (2011), available at

http://nationalautismconference.org/speakerbios.htm#wakefield (last visited January 30, 2012)

(outlining Wakefield’s credentials). “Dr. Wakefield is an academic gastroenterologist. Trained as

a GI surgeon and experimental gastroenterologist in London and Toronto. Published widely on

inflammatory bowel disease and latterly, autism and its links to intestinal disease. [sic]” Id. 131 What Causes Autism, NATIONAL AUTISM ASSOCIATION, http://www.nationalautism

association.org/mmr.php (last visited Jan. 7, 2012). 132 See Press Release, National Autism Association, National Autism Association Says GMC

Actions Against Wakefield Show Lack of Scientific Integrity (May 24, 2010), available at

http://www.nationalautismassociation.org/press052410.php (standing behind Dr. Wakefield and

quoting the board chair, Lori McIlwain as saying, “The message is clear, scientists who dare to

question the safety of vaccines do so at the risk of their careers.”).

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declares, among other things, that Wakefield “is a man of honesty, integrity, courage,

and proven commitment to children and the public health” and that his “research is

rigorous, replicated, biologically valid, clinically evidenced, corroborated by published,

peer-reviewed research in an abundance of scientific disciplines, and consistent with

children’s medical problems.”133

Some advocates of the link between MMR vaccine and autism did change

position in light of revelations about Wakefield’s study. For example, Alison Singer, a

senior executive of Autism Speaks, resigned from the group in January 2009 and urged it

to use its resources to look elsewhere for answers because “looking where we know the

answer isn’t is one less dollar we have to spend where we might find new answers. The

fact is that vaccines save lives; they don’t cause autism.”134 In response, Autism Speaks

dropped its opposition to the MMR vaccine and urged parents to vaccinate their

children.135 In addition, the organization embraced an August 2011 Institute of

Medicine (“IOM”) report136 that rejected any link between the MMR vaccine and

autism.137

The IOM report, the largest study of its kind ever undertaken, endeavored “to

133 WE SUPPORT DR. ANDREW WAKEFIELD, http://www.wesupportandywakefield.com (last

visited Jan. 9, 2012). This website was created in order to show support for Dr. Wakefield as well

as inform the public about Dr. Wakefield’s mission and the controversy surrounding it. Id.

There are also several other organizations that support Dr. Wakefield such as Autism One,

Autism Research Institute, Generation Rescue, SafeMinds, Schafer Autism Report, Talk About

Curing Autism, and Unlocking Autism. Id. 134 Richard Luscombe, Charity Chief Quits Over Autism Row, THE OBSERVER, Jan. 24, 2009,

http://www.guardian.co.uk/lifeandstyle/2009/jan/25/autism-mmr-vaccine. 135 AUTISM SPEAKS, Information About Vaccines and Autism, http://www.autismspeaks.org/science/

policy-statements/information-about-vaccines-and-autism (last visited Jan. 9, 2012).

Many studies have been conducted to determine if a link exists between

vaccination and increased prevalence of autism, with particular attention to the

measles-mumps-rubella (MMR) vaccine and those containing thimerosal.

These studies have not found a link between vaccines and autism. We strongly

encourage parents to have their children vaccinated.

Id. 136 INSTITUTE OF MEDICINE, ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY 25-

26 (Kathleen Stratton et al., eds., 2011), available at http://www.nap.edu/catalog.php?

record_id=13164 (discussing the various diseases children were at risk of being infected with due

to the unavailability of vaccines). 137 Geraldine Dawson, Ph.D., Message from the Chief Science Officer regarding the Institute of Medicine’s

report on Adverse Effects of Vaccines, AUTISM SPEAKS OFFICIAL BLOG (August 26, 2011)

http://blog.autismspeaks.org/tag/national-academy-of-sciences.

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assess dispassionately the scientific evidence” concerning the safety of a number of

vaccines, including MMR.138 The investigating committee examined both

epidemiological data regarding the link between the MMR vaccine and autism and the

mechanistic evidence, both clinical and biological, explaining the medical mechanism

that might enable the vaccine to catalyze the development of autism.139

In examining the epidemiological evidence, the committee considered twenty-

two studies published between 1999 and 2010.140 Winnowing the studies to those

exhibiting sufficient “validity and precision,” the committee concluded with a “high

degree of confidence” that the epidemiologic evidence did not support a claim of a

causal relationship between the MMR vaccine and autism.141

The committee was able to find only four mechanistic studies examining the

relationship between the vaccine and autism.142 Three of those studies demonstrated

only that some children were diagnosed with autism after receiving a vaccine, but

provided no evidence that the vaccine caused the onset of autism.143 Only a single study

provided any evidence of a biological mechanism by which the vaccine might trigger

autism, but in that study, the vaccinated child did not develop autism.144 As a result, the

committee concluded that “mechanistic evidence regarding an association between

MMR vaccine and autism as lacking.”145

Coming on the heels of the Wakefield ethics investigation and The Lancet

retraction, one might have expected the IOM report to put an end to suspicions about

the relationship between the MMR vaccine and autism. But, that was not to be. Age of

138 INSTITUTE OF MEDICINE, supra note 136, at ix. 139 Id. at 35.

Two streams of evidence from the peer-reviewed literature support the

committee’s causality conclusions: (1) epidemiologic evidence derived from

studies of populations (most often based on observational designs but

randomized trials when available), and (2) clinical and biological (mechanistic)

evidence derived primarily from studies in animals and individual humans or

small groups.

Id. 140 Id. at 112-14. 141 Id. at 114. 142 Id. at 114. One of the studies was Wakefield’s Lancet paper. Id. 143 INSTITUTE OF MEDICINE, supra note 136, at 114-15. More specifically, those studies “did not

provide evidence beyond temporality.” Id. 144 Id. at 115. Initially, this fact was unreported. Id. 145 Id. The publications did not contribute to the weight of mechanistic evidence. Id.

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Autism, a group critical of the vaccine and supportive of Andrew Wakefield, rejected the

study, largely because it “was paid for by the Department of Health and Human

Services, the government agency which is also a defendant against the vaccine-injured in

the government’s vaccine court.”146 Age of Autism warned that parents “should still be

concerned.”147

Age of Autism is not the lone, remaining skeptic. Perhaps the most notorious

among skeptics is model and actress, Jenny McCarthy.148 She rejected the Wakefield

ethics investigation as “dubious . . . allegations”149 and added in a Huffington Post op-ed

piece, “I have never met stronger women than the moms of children with autism. Last

week, this hoopla [about the GMC’s Wakefield investigation] made us a little stronger,

and even more determined to fight for the truth about what’s happening to our kids.”150

In her foreword to Wakefield’s 2010 book, Callous Disregard: Autism and Vaccines: The

Truth Behind a Tragedy, McCarthy elevated the man to heroic status: “For hundreds of

thousands of parents around the world, myself included, Andy Wakefield is a symbol of

strength and conviction that all parents of children with autism can use to fight for truth

and the best lives possible for their kids.”151

McCarthy is not the only celebrity supporting Wakefield. Recently, actor Chuck

Norris published a commentary in which he declared that the “link between vaccines

and autism” is a “biological certainty.”152 Given that certainty, the appropriate parental

146 New IOM Report on Vaccine Adverse Effects Shows Alarming Lack of Good Science SafeMinds Notes:

Parents Should Still be Concerned, AGE OF AUTISM (Aug. 26, 2011, 5:46 AM), http://www

.ageofautism.com/2011/08/new-iom-report-on-vaccine-adverse-effects-shows-alarming-lack-of-

good-science-safeminds-notes-parent.html [hereinafter NEW IOM REPORT]; see also John Stone,

Desperate British Medical Journal Editor Godlee Turns on Wakefield’s Co-authors, AGE OF AUTISM (Nov.

10, 2011, 12:01 AM), http://www.ageofautism.com/dr-andrew-wakefield/page/2/. 147 See NEW IOM REPORT, supra note 146. 148 See Jenny McCarthy, THE INTERNET MOVIE DATABASE , http://www.imdb.com/name/

nm0000189/ (last visited Jan. 31, 2012); see also JENNY MCCARTHY BODY COUNT,

http://jennymccarthybodycount.com (last visited Jan. 31, 2012) (publicizing Jenny McCarthy’s

beliefs about the relationship between vaccines and autism diagnosis); GENERATION RESCUE |

JENNY MCCARTHY’S AUTISM ORGANIZATION, http://www.generationrescue.org/ (last visited

Jan. 31, 2012) (promoting Jenny McCarthy’s charity organization, Generation Rescue, dedicated

to supporting the recovery of children with autism). 149 Jenny McCarthy, In the Vaccine-Autism Debate, What Can Parents Believe?, THE HUFFINGTON

POST (Jan. 10, 2011, 3:14 PM), http://www.huffingtonpost.com/jenny-mccarthy/vaccine-

autism-debate_b_806857.html. 150 Id. 151 ANDREW J. WAKEFIELD, CALLOUS DISREGARD: AUTISM AND VACCINES: THE TRUTH

BEHIND A TRAGEDY iv (2010). 152 Chuck Norris, Link Between Autism, Vaccines ‘Biological Certainty’, WORLD NEWS DAILY (Nov. 4,

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response is clear: “It is your health, and they are your children, entrusted to you by God,

so be bold in ensuring their safety and welfare. You still have the constitutional right to

refuse any health care you deem unnecessary.”153

2. The Pace “Study”

In May 2011, the Pace Environmental Law Review published an article with no

apparent relationship to environmental law: Unanswered Questions from the Vaccine Injury

Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury (“Pace

study”).154 The authors reviewed all cases from the Vaccine Injury Compensation

Program (“VICP”) of the U.S. Court of Federal Claim that resulted in a compensatory

award, either by judgment or settlement.155 To identify court awards for vaccine-caused

autism, the authors and their research assistants searched for evidence that the

compensated child suffered “autism or autism-like symptoms.”156 To identify settlement

awards granted for vaccine-caused autism, they conducted telephone interviews of the

families, asking an adult in the household whether the child who received the award had

“autism” or “autism-like symptoms.”157 The authors found eighty-three cases of

“confirmed autism” among the 2,621 compensated vaccine injury claims.158 The authors

concluded that “autism is often associated with vaccine-induced brain damage.”159 At a

news conference conducted in front of the U.S. Court of Federal Claims in Washington,

D.C., the lead author, Mary Holland, stated, “[w]e think this is the tip of the iceberg.”160

Although not disclosed in the article’s authors’ footnote, all three authors sit on

the board of an organization that alleges a link between vaccines and autism.161

2011, 11:33 AM), http://www.wnd.com/index.php?fa=PAGE.view&pageId=364073. 153 Id. 154 Mary Holland et al., Unanswered Questions from the Vaccine Injury Compensation Program: A Review of

Compensated Cases of Vaccine-Induced Brain Injury, 28 PACE ENVTL. L. REV. 480, 482 (2011). 155 Id. at 480-83. For an explanation of the VICP, see supra notes 22-27 and accompanying text. 156 Holland et al., supra note 154, at 503. The research assistants were Pace Law School students.

Id. 157 Id. at 512-13 (discussing settled cases procedure). 158 Id. at 522, 527. Twenty-one of them were decided cases and sixty-two were settled cases. Id.

at 504, 512. 159 Id. at 531. 160 83 Cases of Autism Associated with Childhood Vaccine Just “Tip of the Iceberg”, HEALTH IMPACT

NEWS (May 10, 2011), http://healthimpactnews.com/2011/83-cases-of-autism-associated-with-

childhood-vaccine-just-tip-of-the-iceberg/. 161 Holland et al., supra note 154, at 408 n.a1. All three are board members of the Elizabeth Birt

Center for Autism Law and Advocacy. Board Members, ELIZABETH BIRT CENTER FOR AUTISM

LAW AND ADVOCACY, http://www.ebcala.org/about/board-members (last visited Jan. 31, 2012).

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Moreover, prior to the article’s publication, two of the authors had publicly rejected the

GMC’s ethics findings and had professed steadfast support for Wakefield and his work.

Mary Holland, for example, wrote a chapter entitled Who is Doctor Andrew Wakefield? that

appeared in the book Vaccine Epidemic.162 Wakefield, she wrote, is a “human rights

dissident” “who should be compared with Nelson Mandela.163 She added that the GMC

hearings were but the modern equivalent of the traveling medicine shows of yore,

engineered to punish Wakefield “for his temerity to caution the public about vaccine

risks and to urge them to use their own judgment.”164

The front page of that organization’s website features a link entitled, “FOX News: Law School

Links Autism, Vaccines in Report,” that sends to visitor to an archived broadcast of Fox News in

which one of the authors speaks about “the link between vaccines and autism.” News Video: Law

School Links Autism, Vaccines in Report, ELIZABETH BIRT CENTER FOR AUTISM LAW AND

ADVOCACY (May 10, 2011), http://www.ebcala.org/areas-of-law/vaccine-law/law-school-links-

autism-vaccines-in-report. Mary Holland is also a board member of the Center for Personal

Rights and the Coalition for Vaccine Safety. The Board, CENTER FOR PERSONAL RIGHTS,

http://www.centerforpersonalrights.org/index.php?option=com_content&view=article&id=5&

Itemid=66 (last visited Jan. 31, 2012). The organization is dedicated to “individual vaccination

choice, parental consent to vaccination for children, and freedom to make health care decisions

for ourselves and our families.” Id. 162 Mary Holland, Who is Doctor Andrew Wakefield?, in VACCINE EPIDEMIC: HOW CORPORATE

GREED, BIASED SCIENCE, AND COERCIVE GOVERNMENT THREATEN OUR HUMAN RIGHTS,

OUR HEALTH, AND OUR CHILDREN 223 (Louise Kuo Habakus & Mary Holland eds., 2011),

available at http://vaccineepidemic.com/images/vech25.pdf. 163 Id. at 229.

Dr. Wakefield has joined in a long, honorable tradition of dissidents in science

and human rights. The world has benefitted profoundly from other

courageous dissidents in science—Galileo, who argued that the sun is the

center of the universe; Semmelweis, who reasoned that doctors must wash

their hands to prevent transmission of infection . . . . In due course, the world

has paid tribute to human rights dissidents, as well—Nelson Mandela moved

from prison in South Africa under apartheid to become its most beloved

President; . . . . Before long, the world will likely recognize that it was Dr.

Wakefield, not his detractors, who stood up for the practice of medicine and

the pursuit of science.

Id. 164 Id. at 228.

Dr. Wakefield was, and remains, a dissident from medical orthodoxy. The

medical establishment subjected him to a modern-day medical show trial for

his dissent. Dr. Wakefield’s research raised fundamental doubts about the

safety of vaccines and the etiology of autism. Dr. Wakefield was punished for

his temerity to caution the public about vaccine risks and to urge them to use

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Co-author Louis Conte was more emphatic in his defense of Wakefield.

Nothing, he stated in an interview on CNN following the GMC’s findings, could shake

his beliefs about the link between vaccines and autism:

Well, I personally feel that vaccines are implicated in the increase in

autism. And frankly, the [criticism of] Dr. Wakefield’s study doesn’t

really alter my beliefs one way or the other. Parents who were

observing their children regressing into autism after vaccination before

Dr. Wakefield came on the scene. So, whatever occurs with his study is

not necessarily anything that influences my opinions on the matter.165

Conte had also signed the “We Support Doctor Andrew Wakefield” petition by

which he declared Wakefield “a man of honesty [and] integrity” whose “research is

rigorous, replicated, biologically valid, clinically evidenced, corroborated by published,

peer-reviewed research.”166

The very design of the Pace study was also compromised. There were no health

care professionals or epidemiologists involved in study design, evaluation of the records,

training of the law students who did the research, or interpretation of results.167

Moreover, those results prove little. The authors report that they discovered twenty-one

cases among the court decisions with “language that strongly suggests autistic

features.”168 But, of those twenty-one, five do not do not refer to the compensated

child as having “autism,” “autistic” tendencies or behavior, or “PDD.”169 In many of

their own judgment. Dr. Wakefield was punished for upholding vaccination choice.

Id. (emphasis in original). In the traveling medicine shows of the nineteenth century, those selling

patent “medicines” attracted customers by presenting their wares in as entertaining a fashion as

possible. See Dr. Wilson’s Memory Elixir: Old-Time Traveling Medicine Show, DR. WILSON’S MEMORY

ELIXIR MEDICINE SHOW, http://www.memoryelixir.com/history.html (last visited Jan. 31,

2012). 165 CNN NEWSROOM, supra note 37. 166 WE SUPPORT DR. ANDREW WAKEFIELD, http://www.wesupportandywakefield.com/ (last

visited Jan. 31, 2012). 167 Holland et al., supra note 154, at 503-04. 168 Id. at 504. The authors and the law students “created a database of VICP published decisions

that used relevant terms related to autism.” Id. The article, however, did not list what the

“relevant terms” were. See id. 169 See Holland et al., supra note 154 at 505-510 (cases 1, 5, 8, 9 and 14). A diagnosis of autism

requires findings of findings of “qualitative impairment in social interaction,” “qualitative

impairments in communication,” and “restricted repetitive and stereotyped patterns of behavior,

interests and activities.” DSM-IV, supra note 57, at 70-71 (Diagnostic Criteria for 299.00 Autistic

Disorder); see infra notes 170-178 and accompanying text. The information that the authors

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the other cases, the authors present language taken from a court summary of the

claimants’ arguments. For example, regarding Case 2, the authors cite the following as

evidence that the claimant was autistic: “Petitioners further maintain that the injuries

resulted in . . . moderate autistic characteristics.”170 Similarly, regarding Case 17, the

authors assert that the claimants “allege Sarah developed autism. . .”171

Purporting to show a case possibly compensating autism, the authors also cite a

case of a girl with Rett’s syndrome, which is genetically determined and could not be

caused by vaccines.172 Another case was of a boy with tuberous sclerosis, another

genetic disorder that also could not be caused by vaccines.173 Most of the remaining

cases received the diagnosis of “autism or “autism-like” symptoms from the authors and

the law students reviewing the records, none of whom received training from mental

health professionals.174 Consider this case in which the researchers identified “autism-

like” symptoms:

Jennifer is a severely mentally retarded individual with hyperactive and

destructive behaviors . . . Her social functioning is extremely

inappropriate: she is belligerent and sometimes aggressive; . . . she . . .

practices self stimulating behavior; and she repeatedly bites her hand . .

. She presents a danger to herself and to family members.175

The current iteration of the Diagnostic and Statistical Manual of Mental Disorders,

DSM-IV, requires for a diagnosis of autism findings of “qualitative impairment in social

interaction,” “qualitative impairments in communication,” and “restricted repetitive and

stereotyped patterns of behavior, interests and activities.”176 The quoted language does

not mention communication impairment. Moreover, autistic social impairment involves

present about cases 1, 5, 8, and 14 contain no such findings. 170 Id. at 505. 171 Id. at 509. 172 See id. at 507 (case 9). See generally Rett syndrome, PUBMED HEALTH, http://www.ncbi.nlm.nih.

gov/pubmedhealth/PMH0002503/ (last reviewed Nov. 12, 2010) (“Rett syndrome occurs almost

exclusively in girls and may be misdiagnosed as autism or cerebral palsy. Studies have linked

many Rett syndrome cases to a defect in the methl-CpG-binding protein 2 (MeCP2) gene. This

gene is on the X chromosome.”). 173 See Holland et al., supra note 154, at 505-10 (case 13). See generally Tuberous Sclerosis, PUBMED

HEALTH, http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001791/ (last reviewed Sept. 10,

2010) (“Tuberous sclerosis is inherited. Changes (mutations) in two genes, TSC1 and TSC2, are

responsible for most cases of the condition.”). 174 See Holland et al., supra note 154, at 504-11. 175 See id. at 504-12 (case 5). 176 DSM-IV, supra note 57, at 70-71 (Diagnostic Criteria for 299.00 Autistic Disorder).

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limitations in nonverbal behaviors “such as eye-to-eye gaze, facial expression, body

posture,” “failure to develop peer relationships,” and “lack of social or emotional

reciprocity,” such as not engaging in social play or games.177 This subject’s only

apparent social impairment is that she is “belligerent and sometimes aggressive.”178

The authors’ presentations regarding settled cases contain similar inaccuracies.

Seven of the identified claimants received their diagnoses from “[t]hird party medical,

educational or court records confirming autistic disorder.”179 In none of these cases did

the court find that the vaccine caused the autism or autism-like symptoms.180 Indeed, as

in the following quoted language, in several of the cases, the authors quote language

indicating that the diagnosing physician explicitly concluded that the vaccine at issue did

not cause the autism:

[R]espondent’s report . . . suggests vaguely . . . that Kenny’s problems

‘can be attributed in part to other causes such as a family history of

epilepsy, autism and tonsillar hypotrophy.’ . . . Dr. Spiro did not even

purport to know what did cause Kenny’s seizure disorder, his basic

point was that in his view the DPT did not cause it.181

In the other examples, the court found the symptoms “not related” to, “totally

unrelated” to, and “irrelevant” to the award granted.182 Yet, the authors cite these

examples as evidence of a link between vaccines and autism.

In conducting the study for the law review article, the authors also violated a

basic tenet of research ethics. Research involving human subjects conducted at an

institution that receives federal financial support must be approved by an institutional

review board (“IRB”).183 Research with human subjects occurs when researchers obtain

177 Id. 178 Holland et al., supra note 154, at 504 (case 5). 179 Id. at 515-21. 180 See Holland et al., supra note 154, at 515-21. 181 Id. at 505 (case 4). 182 Id. at 506-509 (cases 7, 12, and 16). 183 45 C.F.R § 46.101(a) (2011). The IRB regulations appear in 45 C.F.R. § 46.101-505 (2011) and

are “[o]ften referred to as the ‘Common Rule.’” Office for Human Research Protections (OHRP), U.S.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, http://www.hhs.gov/ohrp/policy/

common.html (last visited Jan. 31, 2012). The Common Rule has been adopted by the

Department of Agriculture, Department of Energy, National Aeronautics and Space

Administration, Department of Commerce, Consumer Product Safety Commission, International

Development Cooperation Agency, Agency for International Development, Department of

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“[d]ata through intervention or interaction with the individual” or obtain “[i]dentifiable

private information” about an individual.184 The authors conducted human research

when they obtained information about settled cases by telephoning the homes of the

claimants and speaking with parents or “caregivers” and compiling data that included

parent and guardian names and occupations and the child’s age and living situation.185

Pace University, which sponsored the research, receives federal funds and maintains an

IRB.186 The authors, however, did not, however, obtain permission from the IRB to

conduct their research.187

Finally, the study, even accepting its results, does not offer evidence to support

its conclusion that “autism is often associated with vaccine-induced brain damage.”188

The eighty-three cases that the authors identified comprise 3.7 percent of the 2,621

compensated vaccine injury claims.189 The authors did not identify these 3.7 percent by

in-person diagnosis by mental health care professionals, but relied on their own abilities

and those of the law students that assisted. The results, then, might be akin to the

screening conducted by teachers and parents in other studies.190

Housing and Urban Development, Department of Justice, Department of Defense, Department

of Education, Department of Veterans Affairs, Environmental Protection Agency, National

Science Foundation, and Department of Transportation. Id. The regulations mandate IRB

approval of human subject research that is “conducted, supported or otherwise subject to

regulation by any federal department or agency which takes appropriate administrative action to

make the policy applicable to such research.” 45 C.F.R. § 46.101(a). As a result, research

involving human subjects conducted by any institution that receives federal financial support

must be approved by an appropriate IRB. See David A. Hyman, Institutional Review Boards: Is This

the Least Worst We Can Do?, 101 NW. U. L. REV. 749, 750-52 (2007). 184 45 C.F.R. § 46.102(f) (2011). 185 See Holland et al., supra note 154, at 524-26 (questioning family caregivers about the current

condition of the child and how the vaccine injury impacted his or her family). 186 See Pace University Institutional Review Board (IRB), PACE UNIVERSITY IN THE CITY OF NEW

YORK AND WESTCHESTER COUNTY, http://www.pace.edu/provost/information-faculty-0/pace-

university-institutional-review-board-irb-0 (last visited Jan. 7, 2012) (explaining that the IRB was

created to protect both the rights and privacy of human research participants in any research

conducted by the Pace University community, including those outside individuals who wish to

conduct research using the Pace University facilities). 187 See Unanswered Questions from Pace law Journal Study: Ethical Standards for Research on Human

Subjects, AUTISM NEWS BEAT (May 20, 2011), http://autism-news-beat.com/archives/1671

(explaining that the IRB, established to protect the rights and interests of human subjects, was

not consulted prior to conducting research and that this requirement is a well established ethical

standard in the scientific community). 188 See Holland et al., supra note 154, at 531. 189 See id. at 527. 190 See, e.g., Kim et al., supra note 88, at 907.

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Consider, for example, the recent study of the population of seven to twelve

year olds in a South Korean community.191 Parents and teachers screened children by

use of an “Autism Spectrum Screening Questionnaire”192 similar to the questionnaire

that the Pace study authors employed.193 The screening diagnosed seven percent of the

population with autism spectrum disorders.194

The South Korean full population study found twice the screened prevalence

that the Pace study authors found among the compensated cases. Certainly, the Pace

authors are wrong in claiming to have found that autism is correlated with vaccine.

Indeed, if the study proved anything it was that the VICP compensated pool does not

exhibit higher rates of autism than does the general public. This did not, however, stop

them from claiming to have viewed but the tip of an iceberg of autism cases among the

vaccinated and calling for a Congressional investigation.195 As Louis Conte, one of the

co-authors, had earlier observed, research discoveries are “not anything that influences

[their] opinions on the matter” of the link between vaccines and autism.196

III. Cultural Cognition, Science, and Superstition and Enthusiasm

A. The Culture of “The Vaccine Liberation Army”197

How might one parent transfer “two lollipops and a wet rag and spit” across the

country to another parent who has purchased them?198 “Tuck [them] inside a zip lock

baggy and then put the baggy in the envelope :) Don’t put anything identifying it as

191 See id. at 905. In this study, parents and teachers conducted the autism screening. Id. 192 Id. at 905. Stage 1 used systematic multi-informant screening with the Autism Spectrum

Screening Questionnaire (“ASSQ”), a 27-item questionnaire assessing social interactions,

communication problems, and restricted and repetitive behaviors. Id. All parents were asked to

complete the ASSQ; additionally, teachers were asked to complete the ASSQ for all children who

had any ASD characteristics, as described in educational sessions led by the research team. Id. 193 See Holland et al., supra note 154, at 514. The Pace study used “The Social Communication

Questionnaire,” (“SCQ”) which is a screening measure very similar to the ASSQ used in the

South Korean study. Id. 194 Kim et al., supra note 88, at 3. Seven percent “screened positive”. Id. 195 See Holland et al., supra note 154, at 530; 83 Cases of Autism Associated with Childhood Vaccine Just

“Tip of the Iceberg,” HEALTH IMPACT NEWS, http://healthimpactnews.com/2011/83-cases-of-

autism-associated-with-childhood-vaccine-just-tip-of-the-iceberg/ (last visited Nov. 29, 2011). 196 CNN NEWSROOM, supra note 37. 197 The Vaccine Liberation Army, http://vaccineliberationarmy.com/ (last visited Jan. 31, 2011). 198 Morgan Loew, CBS 5 Investigates Mail Order Diseases, http://www.kpho.com/story/15896021/

cbs-5-investigates-mail-order-diseases (last updated Nov. 14, 2011, 12:45 PM).

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pox.”199 The asking price for such a parcel is fifty dollars.200

The “pox” refers to the chickenpox, which is caused by the varicella-zoster

virus.201 Parents opposed to vaccinating their children arrange natural vaccination “pox

parties” with a child who is suffering from the ailment.202 If a child with the illness

cannot be found, other parents will mail a “pox package” containing lollipops and other

items coated in the saliva of a pox-inflicted child.203

Some parents oppose the chickenpox vaccine merely because it is one vaccine

too many and for an ailment that rarely presents a serious threat to health.204 But, for

many parents it is but one component of a “war” against a “vaccine culture.”205

Consider, for example, the raison d’être of the Facebook group called Proud Parents of

Unvaccinated Children: “For people, parents and family and friends of unvaccinated

Children and adults! A place for Parents of vaccinated children to learn the truth, reverse

and prevent future damage from vaccines!”206 The group’s founder, Robert Schecter,

contends that public health officials who urge the vaccination of children are but

“paternalistic do-gooders” who “get satisfaction out of what they [falsely] believe to be

helping people.”207

Schecter has stated his views in more militant terms elsewhere. He also runs the

Facebook page for another anti-vaccine group, The Vaccine Machine.208 That group states

199 Id. 200 Erik Schelzig, Prosecutor to parents: Mailing chickenpox illegal, THE WASHINGTON TIMES (Nov. 6,

2011) http://www.washingtontimes.com/news/2011/nov/6/prosecutor-to-parents-mailing-chic

kenpox-is-illega/. “One of the Facebook postings from Wendy Werkit of Nashville offered a

‘fresh batch of pox in Nashville shipping of suckers, spit and Q-tips available tomorrow 50

dollars via PayPal.’” Id. Sending diseased substances through the mails is a violation of federal

law. Id. 201 Loew, supra note 198; see also Chickenpox, Varicella; Chicken pox, PUBMED HEALTH,

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002559/ (last visited Jan. 31, 2012). 202 Schelzig, supra note 200. 203 Id. 204 PUBMED HEALTH, supra note 201. Chickenpox can lead to other, more serious ailments such

as encephalitis, Reye’s syndrome, Myocarditis and Pneumonia. Id. 205 See STD Shot Stuck in Center of U.S. Culture War, MSNBC.COM, http://www.msnbc.msn.

com/id/18769275/ns/health-cancer/t/std-shot-stuck-center-us-culture-war/#.TtKEmByfvvJ

(last updated May 20, 2007, 7:23 PM). 206 Proud Parents of Unvaccinated Children, FACEBOOK, http://www.facebook.com/pages/Proud-

Parents-Of-Unvaccinated-Children/302370145808 (last visited Jan. 4, 2012). 207 See Brian Wheeler, Why Do Parents Buy Chickenpox Lollies?, BBC NEWS MAGAZINE,

http://www.bbc.co.uk/news/magazine-15647434 (last updated Nov. 10, 2011 09:05 ET). 208 The Vaccine Machine, FACEBOOK, http://www.facebook.com/TheVaccineMachine?sk=info,

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its agenda in starker terms: “The Vaccine Machine refers to the vested interests in

medicine, industry and government dedicated to vaccinating our children by any means

necessary. We stand in opposition to that machine.”209 Schecter’s related website states

as it goal the “[u]nplugging [of] America from the Vaccination Matrix.”210 Vaccine

opponents will accomplish that because, even though the “establishment and their

media dupes have the force of the state behind them . . . it is we who have the

intellectual basis to defend current exemptions and to someday overturn the very idea of

a vaccination mandate from which those exemptions must be sought.”211

In a recent interview on BBC radio, Schecter conceded that a number of

diseases have “disappeared” as a result of vaccines and that they might well return if a

sufficient number of people refuse to be vaccinated.212 True to his libertarian

philosophy, Schecter stated that he owed no “responsibility to other children” who

might contract illnesses because of his refusal to vaccinate his own children.213

Some communities have been able to approach Schecter’s vaccine-free goal.

The schools associated with the Waldorf educational philosophy may provide the best

example. The system was the brainchild of Hungarian philosopher Rudolf Steiner, who

lived from 1861 to 1925.214 The Waldorf/Steiner educational philosophy derived from a

notion of individual rights:

We are convinced that the mainspring of social life and health lies in

the spiritual nature of man. Our complex and difficult civilization

requires a fuller and freer inflow of the basic spiritual impulses. Such

inflow can only take place through the individual human beings who

are born into the world and unfold their faculties within it. Education

in the widest sense of the word must open out the way. True

education, therefore, whether of the child, the adolescent, or the adult,

presupposes the deepest reverence and respect for the freedom of the

human spirit in every individual.215

(last visited Jan. 31, 2012). 209 Id. 210 Id. 211 Id. 212 Up All Night (BBC Radio 5 live broadcast Nov. 11, 2011). 213 Id.; Wheeler, supra note 207 (describing himself as a libertarian). 214 John Paull, Rudolf Steiner and the Oxford Conference: The Birth of Waldorf Education in Britain, 3 EUR.

J. EDUC. STUDIES 53, 53-54 (2011), available at http://orgprints.org/18835/1/Paull2011Oxford

EJES.pdf. 215 Id. at 60.

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That emphasis on individual rights is inconsistent with reliance on vaccination

to escape from disease.216 As a result, Waldorf schools boast a “strong cultural anti-

immunization preference among thought-leaders” in its community.217

Waldorf is the “largest independent school movement in the world,” boasting

over 1,000 schools and 2,000 “early childhood centres” throughout sixty countries.218

The result of its libertarian position on children immunization can be dramatic. The

children at the Waldorf school in the San Francisco Bay area, for example, have an

immunization rate of 23 percent compared with the 97 in the surrounding county.219

Children from that school may, as one observer has worried, “emerge from their school

to infect infants, immunocompromised adults, and people whose vaccinations didn’t

take or have waned, with potentially fatal diseases.”220 But, those like The Vaccine

Machine’s Robert Schecter will be untroubled because they own no “responsibility to

other children.”221

The anti-vaccine community has begun to join ranks. The Vaccine Machine

recently announced that it has “just begun teaming up with the good folks” at Operation

Rescue.222 Celebrity Jenny McCarthy, who founded Operation Rescue, has characterized the

216 OPENWALDORF, Health and Safety, http://www.openwaldorf.com/health.html (last visited Jan.

31, 2012).

We also understand why, among the best minds of our period, there exists a

kind of aversion to vaccination . . . This would constitute the indispensable

counterpart without which we are performing only half our task. We are

merely accomplishing something to which the person in question will himself

have to produce a counterpart in a later incarnation. If we destroy the

susceptibility to smallpox, we are concentrating only on the external side of

karmic activity.

Id. (quoting Rudolf Steiner, Lecture: Karma of the Higher Beings, RUDOLF STEINER ARCHIVE,

http://wn.rsarchive.org/Lectures/ManfKarma/19100525p01.html (last visited Jan. 31, 2012)). 217 OPEN WALDORF, supra note 216, Health and Safety, http://www.openwaldorf.com/health.html

(last visited Jan. 6, 2012) (setting forth Waldorf’s approach to health and safety). 218 Paull, supra note 214, at 63 (citations omitted). 219 See Megan McArdle, A Shocking Chart on Vaccination, THE ATLANTIC (Oct. 31, 2011),

http://www.theatlantic.com/life/archive/2011/10/a-shocking-chart-on-vaccination/247651/. 220 Id. 221 See Robert Schecter, Dr. Wendy’s Washington, THE VACCINE MACHINE (May 17, 2011),

http://www.thevaccinemachine.com/2011/05/dr-wendys-washington.html (last visited Jan. 6,

2012) (stating that parents have the responsibility to protect their children and not the children of

others). 222 See Robert Schecter, The Vaccine Machine @ Generation Rescue, THE VACCINE MACHINE,

http://www.thevaccinemachine.com/p/vaccine-machine-generation-rescue.html (last visited Jan.

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GMC’s investigation into Andrew Wakefield’s MMR-autism study as “dubious . . .

allegations.”223 Moreover, to this day she maintains that “Andy Wakefield is a symbol of

strength and conviction.”224

B. The Cultural Dimensions of the Controversy

1. Cultural Cognition

The debate concerning the link between the MMR vaccine and autism is not

unique in presenting a controversy in which public opinion has not followed scientific

consensus. Debates concerning climate change and the safety of nuclear power plants,

for example, “have featured intense political contestation over empirical issues on which

technical experts largely agree.”225 In recent years, Dan Kahan and his co-authors have

explored the utility of the theory of the cultural cognition of risk in explaining the

disconnect between scientific and public opinion.226

The theory of cultural cognition “refers to the tendency of individuals to fit

their perceptions of risk and related factual beliefs to their shared moral evaluations of

putatively dangerous activities.”227 The theory posits that people are psychologically

predisposed to believe what, given their culture, they deem honorable and to reject what

they deem to be dishonorable.228

The theory offers a number of postulates to explain why psychological

31, 2012) (announcing that Vaccine Machine and Generation Rescue are teaming up to bring

parents vaccine-related information). 223 McCarthy, supra note 149. 224 WAKEFIELD, supra note 151. 225 Dan Kahan et al., Cultural Cognition of Scientific Consensus 1 (J. Risk Research, Yale Law School,

Public Law Working Paper No. 205, 2011), available at http://papers.ssrn.com/sol3/papers.cfm?

abstract_id=1549444. 226 See, e.g., id. (recognizing the political sphere’s impact on the public’s opinion of climate

change). See generally Dan M. Kahan, Cultural Cognition as a Conception of the Cultural Theory of Risk

(Handbook of Risk Theory, Yale Law School, Public Law Working Paper No. 222, 2008) available

at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1123807 (exploring the theory of

cultural cognition in which individuals’ feelings on particular societal dangers reflect and reinforce

their prior commitment to other societal norms); Dan Kahan & Donald Braman, More Statistics,

Less Persuasion: A Cultural Theory of Gun-Risk Perceptions, 151 U. PA. L. REV. 1291 (2003)

(recognizing individuals’ opinions on gun control are largely derived from their cultural

worldviews). 227 Kahan et al., supra note 225, at 2. 228 Id.

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predisposition might impact the perception of scientific evidence. First, people might

simply selectively recall opinions supportive of their world views and repress contrary

opinions.229 Similarly, they might “impute expert knowledge and trustworthiness” to

messengers whom they perceive as sharing their views.230 Finally, predisposition might

affect research.231 Certainly, we can imagine people combing the internet and choosing

to land only on sources that support conclusions that they have already deemed

acceptable. As a result, the authors posit the theory, “scientific consensus cannot be

expected to counteract the polarizing effects of cultural cognition because apprehension

of it will necessarily occur through the same social psychological mechanisms that shape

individuals’ perceptions of every other manner of fact.”232

In Cultural Cognition of Scientific Consensus, Dan Kahan, Hank Jenkins-Smith, and

Donald Braman tested this hypothesis in a national sample of 1,500 adults.233 The

authors first assessed the subjects’ cultural worldviews in two categories. The hierarchy-

egalitarianism measure, or “hierarchy” scale, gauged attitudes about whether society

should attempt to remedy “social orderings” based on gender, race, and class.234 The

individualism-communitarianism measure, or “individualism” scale, assessed attitudes

about whether society should be structured to minimize interference with individual

liberties or to maximize the collective welfare.235 The authors then compared worldview

measures with the subjects’ opinions on whether “most expert scientists agree” or

disagree with statements about climate change, the safety of nuclear power, and gun

control.236

229 Id. at 4. 230 Id. 231 Id. at 5. 232 Id. at 5-6. 233 Kahan et al., supra note 225, at 6. 234 Id. at 7. The study asked participants to indicate on a six-point scale the extent to which they

agreed or disagreed with statements such as, “Society as a whole has become too soft and

feminine” and “We need to dramatically reduce inequalities between the rich and the poor,

whites and people of color, and men and women.” Id. at 7, 37-38. 235 Id. at 7. To assess placement on the “individualism” scale, participants were asked to indicate

on a six-point scale the extent to which they agreed or disagreed with statements such as, “The

government interferes far too much in our everyday lives” and “The government should do more

to advance society’s goals, even if that means limiting the freedom and choices of individuals.”

Id. 236 Id. at 7-8. Subjects were asked to evaluate whether experts are in agreement that “global

temperatures are increasing,” “human activity is causing global warming,” “radioactive wastes

from nuclear power can be safely disposed of in deep underground storage facilities,” and

“permitting adults without criminal records or histories of mental illness to carry concealed

handguns in public decreases violent crime.” Id. at 8.

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The study confirmed the hypothesis that people of different cultural outlooks

reached different conclusions about scientific consensus.237 Those with hierarchical and

individualistic perspectives disagreed with those with egalitarian and communitarian

perspectives about both scientific opinion and about the qualifications of fictional

“experts.” 238 “[B]ecause of culturally biased information search and culturally biased

assimilation, [a person] is likely to attend to the information in a way that reinforces her

prior beliefs and affective orientation.”239

Kahan and some colleagues also tested the cultural cognition thesis in a study of

attitudes about mandating that teenage girls receive the vaccine for human-

papillomavirus (“HPV”), the sexually transmitted virus that causes cervical cancer.240 In

2006, the national Advisory Committee on Immunization Practices (“ACIP”)

recommended routine vaccination for girls between ages of eleven and twelve.241 The

prospect of including the HPV vaccine among those required to attend public schools

has generated controversy.242 Proponents have argued that a mandatory HPV vaccine

will save many lives.243 Opponents have countered with reference to concerns about the

237 Id. at 27. 238 Id. at 27. 239 Kahan et al., supra note 225, at 29 (internal citations omitted). 240 Dan M. Kahan et al., Who Fears the HPV Vaccine, Who Doesn’t, and Why? An Experimental Study

of the Mechanisms of Cultural Cognition, 34 LAW & HUMAN BEHAVIOR 501, 513 (2010), available at

http://ssrn.com/abstract=1160654 [hereinafter Kahan et al. HPV]; see also HPV Vaccine

Information for Young Women - Fact Sheet, CENTERS FOR DISEASE CONTROL AND PREVENTION,

http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine-young-women.htm, (last updated Sept.

15, 2011) (discussing the pros and cons of the HPV vaccine and why it may be important for

women to be vaccinated). 241 HPV Vaccine: State Legislation and Statutes, NCSL, http://www.ncsl.org/default.aspx?tabid=

14381 (last updated Jan. 2012). 242 See id. See generally Trip Gabriel, In Republican Race, a Heated Battle Over the HPV Vaccine, N.Y.

TIMES, Sept. 13, 2011 at A16, available at http://www.nytimes.com/2011/09/14/us/politics/r

epublican-candidates-battle-over-hpv-vaccine.html. The governor of Texas, Rick Perry, came

under fire for a regulation in Texas requiring that the HPV vaccine be administered to adolescent

women. Id. The regulation, which was signed into law in 2007 by Perry, was controversial and

some speculated that the requirement was simply another case of a political favor to Perry’s

former chief of staff who worked for the pharmaceutical manufacturer Merck. Id. 243 NCSL, supra note 241. See also Cheryl A. Vamos, Robert J. McDermott, & Ellen M. Daley, The

HPV Vaccine: Framing the Arguments FOR and AGAINST Mandatory Vaccination of All Middle School

Girls, 78 J. SCHOOL HEALTH 302, 305-06 (2008) available at http://onlinelibrary.wiley.com/doi/

10.1111/j.1746-1561.2008.00306.x/full (arguing that the HPV vaccine is 100 percent effective in

preventing four of the HPV strains that are known to cause 70 percent of all cervical cancers).

Proponents of the vaccine also conclude that requiring the vaccine can save health care dollars

that would be subsequently dedicated to testing for and treating HPV once contracted. See id. at

306.

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vaccine’s safety and “moral objections related to a vaccine mandate for a sexually

transmitted disease.”244

The authors hypothesized that those embracing hierarchical and individualistic

worldviews would tend to oppose mandatory HPV vaccination both because the vaccine

might encourage sexual behavior and because a mandate would preclude individual

choice.245 Similarly, those embracing egalitarian and communitarian worldviews would

favor a mandate as expressing tolerance for a non-traditional norm and because it would

support the common good.246

The authors again first assessed the subjects’ cultural worldviews on the

hierarchy and individualism scales.247 They then assessed subjects’ views on mandatory

HPV vaccine by asking them to agree or disagree with assertions like, “It is important to

devise public health policies to reduce the spread of HPV,” and, “Universal vaccination

of girls for HPV will lead girls to become more sexually active.”248 In addition, the

authors identified attitudes toward fictional scientists offering opening opinions on the

risks and benefits of the vaccine.249

The results again revealed a relationship between worldview and beliefs about

the vaccine and the messengers conveying information about it:

[P]olarization grows where culturally diverse subjects see the argument

they are disposed to accept being made by the advocate whose values

they share, and the argument they are predisposed to reject being made

by the advocate whose values they repudiate. In contrast, when

subjects see the argument they are disposed to reject being made by the

244 NCSL, supra note 241. In 2007, the governor of Texas issued an executive order mandating

vaccination, but the Texas legislature overrode the order. Id. See also Katrina Trinko, How Many

States Have Mandated HPV Vaccines?, NATIONAL REV. (Sep. 16, 2011, 4:26 PM),

http://www.nationalreview.com/corner/277496/how-many-states-have-mandated-hpv-

vaccines-katrina-trinko. To date, only two places have mandated the vaccine: Virginia and

Washington, DC. Id. 245 Kahan et al. HPV, supra note 240, at 504. 246 Id. 247 Id. at 505. The two scales were “Hierarchy-Egalitarianism” (“hierarchy”), which consisted of

12 items, and “Individualism-Communitarianism” (“individualism”), which consisted 18 items,

and both scales assess worldviews based on responses of ‘strongly disagree,’ ‘disagree,’ ‘agree,’

and ‘strongly agree’ to statements. Id. 248 See Kahan et al. HPV, supra note 240, at 505. The order in which the statements were

presented was random. Id. 249 See id. at 505-07.

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advocate whose values they share, and the argument they are

predisposed to accept being made by the advocate whose values they

repudiate, polarization shrinks to the point of disappearing.250

In sum, the results confirmed “that disagreements about the risks and benefits

of HPV vaccination are shaped by cultural values, which exert their influence through

the biased assimilation of information and through attributions of information-source

credibility.”251

2. Anti-Vaccine Culture and Views on the Causes of Autism and Safety of the MMR

Vaccine

The cultural cognition literature provides a framework by which to evaluate the

MMR vaccine critics’ refusal to accept scientific consensus. Kahan and his colleagues

have demonstrated that worldview predicts judgments about the credibility of scientific

information.252 We know the judgment of the Wakefield faithful that, contrary to

scientific consensus, the MMR vaccine causes autism.253 Given this, if we can identify

the worldviews of the Wakefield faithful, we may be able to offer an explanation.

Recall that Kahan and his colleagues discerned position on the hierarchy scale

by assessing whether subjects preferred society stratified according to immutable,

individual characteristic such as “gender, ethnicity, and class.”254 Among others, the

authors posed this statement to study subjects: “A lot of problems in our society today

come from the decline in the traditional family, where the man works and the woman

stays home.”255 Agreement signifies a hierarchical worldview.256

The anti-vaccine community embraces a hierarchical worldview, and especially

the concept of “traditional family values,”257 which emphasize gender-based, family

250 Id. at 511 (emphasis in original). 251 Id. at 512. 252 See supra notes 225-251 and accompanying text (analyzing and supporting the hypothesis that

people of different cultural outlooks reach different conclusions about scientific consensus). 253 See supra notes 128-153 and accompanying text (describing Wakefield’s followers). 254 Kahan et al., supra note 225, at 8. 255 Id. at 11. 256 Id. 257 See, e.g., Rachel Chen, HPV Vaccination: Understanding the Controversy, 6 YALE J.L. & MED 26, 26-

27, (2010) available at http://www.yalemedlaw.com/2010/02/hpv-vaccination-understanding-the-

controversy/. The advocacy group, Focus on the Family, opposes mandatory HPV vaccination

because “such a requirement constitutes an attempt by the secular state to force a child to

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roles.258 Consider, for example, the counsel of actor Chuck Norris, one of the leaders of

“a celebrity-driven campaign against vaccines” that legitimized Wakefield’s discredited

views and “kept them in the public eye” in the U.S.259 Norris has argued that the decline

of traditional family values is one of the major problems contributing to America’s

“downward spiral.”260 As evidence of the diminution of these values, Norris observes

that nearly two-thirds of children in the country under the age of five “are in some form

of day care every week, living life apart from their parents.” 261 Women’s forsaking their

traditional roles has also contributed to America’s moral decline: “Nearly half of

America’s labor force is women and of course many of these women are mothers.”262

The cultural cognition theory’s second scale, the individualism assessment,

gauges attitudes about individual rights versus governmental obligations. Kahan and his

co-authors determined this measure by posing competing statements to subjects: “The

government interferes far too much in our everyday lives” and “the government should

do more to advance society’s goals, even if that means limiting the freedom and choices

of individuals.”263 Agreement with the first statement signifies an individualistic

worldview while agreement with the second signifies a communitarian view.264

The objection to governmental intervention in individual choice lies at the heart

of the vaccine opposition. These parents dispute “what they see as the dictatorial nature

of the US vaccine programme, which, they argue, leaves them little choice over what is

being put into their children’s bodies.”265 Advocates of this worldview find particularly

troubling any communitarian notion that values the group over the rights of the

individual. Indeed, they find “Phrases like, ‘needs of the population at large,’ ‘cost-

benefits analysis,’ and ‘all that matters is that its victims number significantly fewer than

those of the diseases vaccinations are designed to prevent’ . . . really frightening.”266

undergo an intervention that may be irreconcilable with her family’s religious values and beliefs.”

Id. at 26. 258 See, e.g., Ali Gunes, From Mother-Care to Father-Care: The Split-Up of The Traditional Heterosexual

Family Relationship and Destruction of Patriarchal Man’s Image and Identity in Nick Hornby’s About a Boy,

3 SKASE J. OF LITERARY STUD. 59, 59- 61 (2011), available at http://www.skase.sk/Volumes/

JLS03/pdf_doc/04.pdf (discussing “traditional family values”). 259 Wheeler, supra note 207. 260 CHUCK NORRIS, BLACK BELT PATRIOTISM: HOW TO REAWAKEN AMERICA 21 (2010). 261 Id. 262 Id. 263 Kahan et al., supra note 225, at 7. 264 Id. 265 Wheeler, supra note 207. 266 Anne Dachel, New York Times Reviews The Greater Good Movie Tells Vaccine-Injured Children to

Drop Dead, AGE OF AUTISM, http://www.ageofautism.com/2011/11/new-york-times-reviews-

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Robert Schecter, founder of the Facebook group Proud Parents of Unvaccinated Children and

the website The Vaccine Machine has put this most simply: he believes that he owes no

“responsibility to other children.”267

The cultural cognition thesis would have predicted that the Wakefield Faithful

would find the MMR vaccine troubling. Because they embrace the combination of

hierarchical and individualistic worldviews, these “hierarchical individualists” tend to

“perceive greater risks and smaller benefits” in the vaccine.268 In addition, the Wakefield

faithful’s alarm about the governmental intrusion represented by a mandatory vaccine

would unsurprisingly inspire them to be all the more critical of the vaccine.269

Another variable is at play here. As recognized by the cultural cognition

theorists, people tend to believe “sources with whom they have some ‘in group’

connection, and to deny the same to ‘out group’ information sources.”270 This “cultural

affinity” or “cultural difference” either accentuates or mutes a listener’s response to the

information source.271

Wakefield probably could not be more “in” the anti-vaccine group. He is

“dissident from medical orthodoxy” and had the courage to stand up for his patients,

“the practice of medicine and the pursuit of science.”272 As Jenny McCarthy put it,

“Andy Wakefield is a symbol of strength and conviction that all parents of children with

autism can use to fight for truth and the best lives possible for their kids.”273 He is a

“hero” to those standing with him outside the walls of medical orthodoxy.274

the-greater-good-movie-tells-vaccine-injured-children-to-drop-dead.html (last visited Jan. 31,

2012). 267 Schecter, supra note 221. 268 Kahan et al., supra note 225, at 8, 10 (using the cultural cognition thesis to examine subjects’

views on the HPV vaccine). Cultural worldviews that are based on individualism and hierarchical

values would predispose an individual to see more risks with the vaccine and fewer benefits. Id.

at 8. 269 See id. (hypothesizing that individualism would “dispose individuals to see more risk” with a

mandatory vaccine “because mandatory vaccination intrudes on individual decision-making.”) 270 Id. at 9. Individuals generally assess the strength of an argument based on judgments about

credibility. Id. Qualities of credibility are more readily attributed to sources with which

individuals have an “‘in-group’ connection.” Id. 271 See id. (hypothesizing that the strength of arguments for and against mandatory HPV

vaccinations would vary according to source affinity). 272 See Holland, supra note 31; Kahan et al., supra note 225, at 9. 273 Wakefield, supra note 151, at iv. 274 See, e.g., Our Hero Dr. Andrew Wakefield on the TODAY Show, THE VACCINE LIBERATION ARMY,

http://vaccineliberationarmy.com/our-hero-dr-andrew-wakefield-on-the-today-show-2/

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Wakefield’s critics, as part of the vaccine “establishment” probably could not be

more “out” of the anti-vaccine group.275 Indeed, Wakefield’s supporters characterize his

critics as a component in a “vaccine machine” comprising “pharmaceutical companies,

public health agencies, medical organizations and the government.”276 Those “fountains

of misinformation” conspired to discredit Wakefield.277

The context of the MMR-autism debate provided the setting for a perfect

cultural storm: an “in-group” messenger presenting alarming information to a group of

“hierarchical individualists” who simply could not credit his critics. As one of the

authors of the Pace “study” put it, “Well, I personally feel that vaccines are implicated in

the increase in autism. And frankly, the [criticism of] Dr. Wakefield’s study doesn’t

really alter my beliefs one way or the other.”278

IV. Conclusion

On November 21, 2011, the New York Times conducted an online, “Armchair

Ethicist” discussion of this question: “Is it ethical for pediatricians to refuse routine care

to families that do not immunize their children?279 The editor asked, “Will the whole

thing devolve into yet another online debate on vaccination, and how society should

handle the families . . . who (without medical necessity) skip the shots?”280 She

predicted, “Yes, yes it will.”281

(last visited Jan. 31, 2012) (discussing the website’s support for Dr. Wakefield while also

providing current information and developments concerning Dr. Wakefield and his research). 275 See Holland, supra note 31, at 229. “The medical establishment subjected [Wakefield] to a

modern-day medical show trial for his dissent.” Id. 276 Robert Schecter, FAQs, THE VACCINE MACHINE, http://www.thevaccinemachine.com

/p/faqs.html (last visited Jan. 8, 2012). This quote was a response to a question on the blog

inquiring about the author’s opposition towards vaccines. Id. 277 Media, the Medical Establishment, and Big Pharma start up new round of Andrew Wakefield Bashing,

MEASLES INITIATIVE, http://www.measlesintiative.org/88-media-the-medical-establishment-and

-big-pharma-start-up-new-round-of-andrew-wakefield-bashing.html (last visited Jan. 31, 2012).

“What a combo . . . Drug Companies, Doctors, and the Media. Three fountains of

misinformation that just won’t stop with this 1998 study that struck a nerve.” Id. 278 CNN NEWSROOM, supra note 37. 279 Ariel Kaminer, Armchair Ethicist, Flu Season Edition, N.Y. TIMES (Nov. 21, 2011, 11:04 AM),

http://6thfloor.blogs.nytimes.com/2011/11/21/armchair-ethicist-flu-season-edition/?hp. 280 Karin J. Dell’Antonia, Is It O.K. for Doctors to Turn Away Unvaccinated Kids?, N.Y. TIMES (Nov.

21, 2011, 12:07 PM), http://parenting.blogs.nytimes.com/2011/11/21/is-it-o-k-for-doctors-

turn-away-unvaccinated-kids/. 281 Id.

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The two hundred forty-eight comments posted over four hours replicated in the

written equivalent of time lapse photography the entire spectrum of the vaccine

debate.282 Parents opposed to vaccination wrote of medical coercion,283 parents who

vaccinate their children complained about the non-vaccinators who pose a risk to the

community,284 and pediatricians voiced frustration over the failure to vaccinate

children.285 One comment succinctly summarized the culture gap between those who

do and do not vaccinate their children: “I am a person who does not vaccinate her kids

. . . I wonder how we can get better at coexisting OR we can choose not to be friends

with someone whose values are so diametrically opposed to our own. That’s okay

too.”286

The writer has cause to worry. That the debaters embrace “diametrically

opposed” worldviews does present a barrier to useful discourse. But, in the words of

the cultural cognition scholars, it “does not imply, however, that there is no prospect for

rational public deliberations informed.”287 But, to be effective, “communicators must

attend to the cultural meaning as well as the scientific content of information.”288

The cultural cognition scholars have proposed several methods for attending to

the cultural meaning of communications. First, communicators might employ “identity

affirmation” by which they craft a missive in language that supports the listener’s

cultural identity.289 Vaccine supporters have historically accused the anti-vaccine group

282 Dell’Antonia, supra note 280. The Times allowed comments from 1:00 PM to 5:00 PM. Id. 283 See Kaminer, supra note 279. One commentator opposed to forced vaccinations stated,

“[p]arents should be allowed to make their own health decisions for their children and not be

forced into submitting to whatever passes for the conventional medical wisdom of the day, even

when such conventional wisdom is cloaked in the lofty mantle of ‘public health.’” Id. 284 Id. A commentator concerned about risk to the community stated, “I’d be afraid to send my

kid to a pediatrician who spent a lot of time around kids who hadn’t been immunized. I almost

died from measles as a child. I wouldn’t wish what mothers went through back then during a

measles epidemic on any parent today.” See id. 285 See Kaminer, supra note 279. One physician stated, “While it [sic] exasperating for physicians

to be in this situation—especially since the primary driver for avoiding immunizations was the

fraudulent data published about the link to Autism—we are obliged to provide care.” See id.

Other pediatricians reported that they refuse to serve the unvaccinated: “I am a partner in a

practice in Kansas City, MO that does not allow non-immunizers. We have a strict policy—no

refusers and no alternative schedules. All immunizations must be on-time and per the CDC

schedule.” See id. 286 Dell’Antonia, supra note 280, at 1. 287 Kahan et al.., supra note 225, at 30. 288 See id. at 30. 289 Id.

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of putting their own children at risk and neglecting to consider the public good. Vaccine

supporters might find their message more acceptable if they emphasized that choosing

to be vaccinated liberates one from fear of disease.

Cultural cognition scholars also recommend “pluralistic advocacy” by which

speakers “of diverse values on both sides of the debate” present scientific

information.290 In the vaccine context, finding speakers outside of the “vaccine

machine,” such as parents of children with autism, might be particularly helpful.

Finally, the theorists suggest “narrative framing” that emphasizes the context

that presents an issue before an appropriate moral backdrop.291 Here, references to

impending changes to the U.S. health care system might prove effective. The

governmental participation signaled by the Patient Protection and Affordable Care

Act292 is certainly inconsistent with an individualistic worldview. Indeed, opponents

have characterized the legislation as an affront to personal liberty.293 A vaccine would

assist an individual in maintaining health and avoiding that governmental intrusion.

In order to bring effective communication that closes the culture gap, we might

have to rely on the natural reach of disease to fuse public and scientific consensus. In

England in 1772, the Rev. Edward Massey presented to his congregation a sermon

entitled, “The Dangerous and Sinful Practice of Inoculation.”294 Disease, he contended,

was heaven sent and any attempt to prevent God’s will by vaccination was “a diabolical

operation.”295 Massey represented a well-established tradition religious opposition to

vaccination that spread to the New World, too.296 That opposition finally withered

during Canada’s smallpox outbreak of 1885 when Protestants, who had embraced

vaccination, survived the disease while Catholics, who had avoided the diabolical, did

290 See id. at 31. 291 Id. 292 Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, 124 Stat.119

amended by Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat.

1029. 293 See, e.g., Robert Moffit, Obamacare and the Individual Mandate: Violating Personal Liberty and

Federalism, THE HERITAGE FOUNDATION (Jan. 18, 2011), http://thf_media.s3.amazonaws.com/

2011/pdf/wm3103.pdf. 294 ANDREW D. WHITE, Theological Opposition to Inoculation, Vaccination, and the Use of Anaesthetics, in

A HISTORY OF THE WARFARE OF SCIENCE WITH THEOLOGY IN CHRISTENDOM 339, 339-47 (The

Free Press 1965) (1896), available at http://abob.libs.uga.edu/bobk/whitem10.html. 295 Id. at 339. 296 Id. at 340-41.

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not.297 One can only hope that it will not take a disease outbreak and a differential

survival rate to convince modern day skeptics to embrace vaccination.

297 Id. at 343-44.