S

S.F.T.A.H. Society For The Autistically Handicapped.

Vaccines. FACT SHEET

MMR Vaccine, Thimerosal and Regressive or Late Onset Autism

(“Autistic Enterocolitis”)

A Review of the Evidence for a Link Between Vaccination and Regressive Autism

July 2005

David Thrower,

49, Ackers Road,

Stockton Heath,

Warrington, England

email david.throwerwarrington@ntlworld.com

Contents

Executive Summary

Part A: A Novel Syndrome

1. What Is Acquired Autism/Autistic Enterocolitis

2. The New Syndrome

Part B: The Scale of the Autism Problem

3. The Financial Costs - Autism Is Costing The Taxpayer £$Billions

4. Overall Cost Estimates

5. Failure to Monitor Increases In UK Autism Numbers

6. “Now Almost Everyone Knows Someone Who’s Autistic”

7. Is Autism Increasing Due To Changes In Criteria?

8. Autistic Disorder

9. Pervasive Developmental Disorder Not Otherwise Specified

10. Asperger’s

11. Paper by Mark Blaxill, June 2001

12. University of Cambridge Research

13. University of Sunderland Research

14. UK National Autistic Society Estimates

15. Report by Fiona Loynes, UK All Party Parliamentary Group, Dec. 2001

16. Report, “Autism In Schools”, UK National Autistic Society May 2002

17. Autism in Scottish Schools

18. Is Autism Increasing? - Some Official UK Pronouncements

19. Autism In The USA

20. The US Amish Community

21. Autism Elsewhere

Part C: MMR

22. The Introduction of MMR

23. Recognised Adverse Reactions to MMR

24. US Vaccine Adverse Events Reporting System (VAERS)

25. Contraindications To Receiving MMR

26. The UK Department of Health’s Position over MMR and Autism

27. Single Vaccines In The UK

28. Measles In The UK and US

29. Promotion of MMR In The UK After Wakefield “Early Report”

30. Position of the US Centers For Disease Control on MMR/Autism

31. The Parents Have Seen What They’ve Seen.....

Part D: The Thimerosal/Thiomersal* Issue

(*the two terms are interchangeable)

32. Thimerosal’s Possible Role

33. Joint Statement by American Acad. Of Ped./PH Service, July 1999

34. Removal of Thimerosal

35. Interview With Neal Halsey, Johns Hopkins University, Nov 2002

36. Waters & Kraus Press Release, 2002

37. Statement by Safe Minds group, US

38. US Use of Thimerosal - Statement by Dr. Geier, 2004

39. Thimerosal’s Use in the US

40. UK Vaccines With Thimerosal

41. UK Med. and Healthcare Regulatory Agency Position on Thimerosal

42. UK Joint C’ttee on Vaccin & Immunisation Position on Thimerosal

43. UK Department of Health’s Position on Thimerosal

44. US CDC Thimerosal Studies

45. Report, “Mercury In Medicines”, US C’ttee on Govt. Reform 2003

46. Letter to Congress by the US Office of Special Counsel, 2004

47. California Votes To Ban Thimerosal, June 2004

48. US CDC’s Current Position on Thimerosal

49. Memo by Merck

Part E: Evidence That Autism Increases Are Real

50. Paper by Mark Blaxill, The Rising Incidence of Autism

51. Close-Up On California

52. The MIND Study, California

53. Close-Up On New Jersey

54. Atlanta Study, 2003

55. Paper by Gurney, Fritz et al, Trends on ASD In Minnesota, 2003

56. Paper by Yazbak, Autism In The US, J of A Phs & Surg 2003

57. Paper by Yazbak, Autism In Quebec, 2004

Part F: Reviews Questioning the Autism Epidemic

58. Paper by Fombonne, UK Med Research Council, Pediatrics, Jan 2001

59. Paper by Wing, Centre for Social & Commun. Disorders, London 2002

60. Position of Dr. B. S. Siegal, University of California, 2002

61. Study by Croen et al, July 2002

62. Editorial by Fombonne, J of the American Medical Asscn., January 2003

63. Paper by Jick et al, Boston Un Sch of Med, Pharmacotherapy, Dec 2003

64. Study by Smeeth, Fombonne et al, November 2004

65. Study by Barbarisi et al, January 2005

Part G: The MMR Original Safety Trials Debate

66. Wakefield & Montgomery “Through A Glass Darkly” (MMR safety)

67. Dr. Peter Fletcher Commentary, J of Adverse Drug Reactions, 2001

68. Dr. Stephen Dealler Commentary, J. of Adverse Drug Reactions, 2001

69. Dr. F. E. Yazbak Commentary, J of Adverse Drug Reaction, 2001

70. The Wakefield/Watson/Shattock Rebuttals

71. The UK Dept of Health’s Repudiation of “Through A Glass Darkly”.

Part H: Studies and Papers That Point Towards The Plausibility Of Gut/Autism, MMR/Gut/Autism, Thimerosal/Autism and Autoimmunity/Autism Links

72. Paper by Nelson & Gottshall, Applied Microbiology, May 1967

73. Paper by Eggers, Klinical Paediatrics, March 1976

74 Weizman, Weizmann et al Study, Am. J of Psychiatry, Nov. 1982

75. Delgiudice-Asch and Hollander Study

76. Paper by Dr. H. Fudenberg

77. Paper by Dr. Reed Warren

78. Warren and Singh Study, Immunogenetics, 1992

79. Singh, Warren, Odell, Warren and Cole Paper, March 1993

80. Singh, Warren, Odell et al Study, Brain Behaviour, March 1993

81. Oleske and Zecca paper

82. Binstock paper

83. Anne-Marie Plesner Letter, Lancet, February 1995

84. Paper by Thompson, Montgomery et al, Lancet, April 1995

85. Gupta, Aggarwal & Heads Study, J of Autism and Dev Disorders, 1996

86. Montinari, Favoino and Roberto paper, Naples conference May 1996

87. Auwaerter & Griffin paper, Clin Immunol & Immunopath, May 1996

88. Cook, Courchesne et al Paper, Molecular Psychiatry, May 1996

89. Griffin and Hussy Study, Journal of Infectious Diseases, June 1996

90. Martinez et al Study, Proceedings of National Acad of Sciences, 1997

91. Paper by Zecca, Graffino et al, Meeting of Nat Inst of Health, Sept. 1997

92. Weibel, Caserta and Evans Study, March 1998

93. Wakefield et al “Early Report”, Lancet, February 1998

94. Paper by Montgomery, Morris et al (pub. date/details not yet known)

95. Sabra, Bellanti and Colon letter, Lancet, July 1998

96. Further Paper by Singh and Yang, Pharmaceutical Jnl, October 1998

97. Uhlmann, Sheils et al Paper

98. Bitnun et al Study, Clinical Infectious Diseases Journal, October 1999

99. Paper by Horvath, Papadimitriou et al, Journal of Pediatrics Nov 1999

100. Paper by Singh to the US Committee on Govt Reform, April 2000

101. O’Leary Paper Presented to Congressional Oversight C’ttee, April 2000

102. Kawashima, Takayuki et al Study, Digestive Dis and Sciences, Apr 2000

103. Confidential Review, US CDC, Simpsonwood, June 2000

104. Hagenbuch, Kullak-Ublick et al Study, J of Pharm Exp Ther, July 2000

105. Wakefield et al Paper, American J. of Gastroenterology, September 2000

106. Statement by Professor Walter O. Spitzer, December 2000

107. Furlano, Anthony et al Study, Journal of Pediatrics, 2001

108. Paper by Enayati et al, Medical Hypotheses, 2001

109. Study by Jyonouchi, Sun and Le, J. of Allergy & Clin. Immun., Feb. 2001

110. Study by Jyonouchi, Sun and Le, J of Neuroimmunology, 2001

111. Paper by Spitzer, Aitken et al, J of Adverse Drug Reactions & Tox., 2001

112. Study by Holmes, Cave et al, June 2001

113. Paper by Blaxill, Institute of Medicine, July 2001

114. Paper by Dr. Ken Aitken to the Scottish Society for Autism, 2001

115. Paper by Imani and Kehoe, Clinical Immunology, September 2001

116. Paper by Redwood, Bernard et al, Neurotoxicology, October 2001

117. Paper by Buie, Oasis 2001 Conference for Autism, Portland, US

118. Paper by Uhlmann, Wakefield et al, J. of Clinical Pathology, Feb. 2002

119. Paper by Singh and Nelson, February 2002

120. Review by Wakefield, Pulestone et al, Aliment Pharm. Ther. 2002

121. Report of Study, Comi et al, Johns Hopkins Hosp, Baltimore, Apr 2002

122. Paper by Torrente, Ashwood, Day et al, Lancet, May 2002.

123. Paper to 102nd GM of Am. Soc for Microbiology, Singh et al, May 2002

124. Study by O’Leary et al to Path Soc of GB and Ireland July 2002

125. Wakefield Paper Presented to US Govt Reform Committee, June 2002

126. Paper to US Government Reform C’ttee by Dr Krigsman, June 2002

127. Unpublished Research by Shattock, Un. of Sunderland, June 2002

128. Paper by Sheils, Smyth, Martin & O’Leary, Trinity Coll Dublin, 2002

129. Paper by Dr. Vijendra Singh, Utah State University, August 2002

130. Paper by Finegold, Molitoris, Song, J. Of Clin. Infect. Dis., Sept 2002

131. Further paper, Jyonouchi, Sun & Itokazu, Un. of Minnesota, Oct 2002

132. Paper, Treat. of Late Onset Autism, Matarazzo, U.S-Paulo, Nov 2002

133. Paper by Makani, Gollapudi et al, Genes & Immunity, 2002

134. Paper by Westphal, Asgari et al, Arch of Toxicology, August 2002

135. Unpublished letter by Wakefield to New Eng. J. of Medicine, Nov 2002

136. Study by Croonenberghs et al, University of Antwerp, December 2002

137. Paper by Holmes, Blaxill & Haley, Internat J of Toxicology 2003

138. Paper by Singh and Jensen, Pediatric Neurology 2003

139. Paper by Geier & Geier, Soc. for Experimental Biology & Med. 2003

140. Study by Geier and Geier, International Pediatrics, May 2003

141. Further Paper by Geier & Geier, Ped. Rehabilitation, Apr-June 2003

142. Further Paper by Geier & Geier, J of Am Phys and Surg, Spring 2003

143. Paper by Blaxill, Redwood & Bernard, Safe Minds

144. Paper by Bradstreet, Geier et al, J of Am Phy and Surg Summer 2003

145. Letter by Geier & Geier, J of Am Phys. & Surgeons, Summer 2003

146. Paper by Baskin, Ngo et al, Toxicology Science Aug 2003

147. Paper by Via, Nguyen et al, Envir. Health Perspectives August 2003

148. Paper by Sweeten, Bowyer et al, Pediatrics, November 2003

149. Paper by Ashwood, Murch et al, J of Clinical Immunology, Nov 2003

150. Study by Ueha-Ashibishi, Oyama et al, Toxicology, Jan 2004

151. Paper by Jyonouchi, Geng et al, Jan 2004

152. Paper by Singh, presented to the Inst. of Med, Washington, Feb 2004

153. Paper by Bradstreet, Inst of Medicine, Washington, Feb 2004

154. Paper by Bradstreet, O’Leary et al, Inst of Medicine, Feb 2004

155. Further Paper by Bradstreet, Institute of Medicine, Feb 2004

156. Presentation by Geier and Geier to the Institute of Medicine, Feb 2004

157. Letter by Geier, Genetic Centers of Am, to Pediatrics, March 2004

158. Paper by De Water, Ahwood et al, MIND Instit, California, May 2004

159. Study by Deth et al, Journal of Molecular Psychiatry, Apr 2004

160. Paper by Torrente, Anthony et al, Am. J of Gastroenterology, Apr 2004

161. Presentation by Prof. Boyd Haley, Canada Autism Conference, Apr 2004

162. Paper by Bradstreet Dahr et al, J of Am Phys & Surg, Summer 2004

163. Paper by Deth, Health & Wellness Committee, Sept 2004

164. Paper by Hornig, Chian, Lipkin et al, Mol Psychiatry June 2004

165. Paper by Wakefield et al, J of Clinical Immunology, November 2004

166. Paper by Slikker et al, Neurotoxicology, December 2004

167. Paper by the Environmental Working Group on Mercury, Dec 2004

168. Paper by Havarinasab et al, Toxicology & App Pharmacology, 2005

169. Paper by Burbacher et al, Environmental Health Perspectives, 2005

170. Press Report, Los Angeles Times, February 2005

171. Study by Palmer & Miller, Health and Place journal, March 2005

172. Paper by Jyonouchi, Geng et al, Neuropsychobiology, February 2005

Part J: Other Relevant Papers

173. US Developmental Delay Registry Report, 1994

174. Stratton et al Study, National Academy Press, 1994

175. Paper by Carbone.

176. Iizuka, Saito et al Study, Gut, May 2001 (Mumps Study)

177. Statement by Spitzer, US Govt Reform Committee, April 2001

178. Statement by Dr. Jefferson, Cochrane Collaboration, Oxford, Oct 2002

179. Paper by Sweeten et al, Pediatrics 2003

180. Paper by Blaycock, JANA, Winter 2003

181. Paper by Singh and Rivas, Jan 2004

182. Paper by Richler, Luyster et al, Univ of Michigan Aut Center, 2004

Part K. Studies Seeking To Disprove Any MMR/Thimerosal/Autism Link

183. Limitations of Epidemiology - A Preface

184. Stokes et al paper, J of American Medical Assoc. (JAMA), Oct. 1971

185. Study by Peltola and Heinonen, Lancet, April 1986

186. Paper by Miller, Miller et al, The Practitioner, January 1989

187 Gillberg Study, Sweden, British Journal of Psychiatry, 1991

188 Commentary by Gillberg and Heijbel, Autism, 1998

189. Letter by Fombonne, Pediatrics, March 1998

190. UK Committee on Safety of Medicines Study, June 1999

191. Paper By Taylor, Miller and Farrington, Lancet, June 1999

192. Paper by Miller & Farrington to US Govt Reform Committee, Apr 2000

193. Patja, Peltola et al Study, Finland, Pediat. Infect Disease J. Dec. 2000

194 Kaye, Melero-Montez and Jick Study, British Medical Journal, 2000

195. Dales, Hammer and Smith Study, JAMA, March 2001

196. De Wilde, Carey & Richards Study, Br. J. of General Practice, Mar 2001

197. Davis et al study, Archive Pediatrics Adolescent Medicine, 2001

198. Further Paper by Farrington, Miller and Taylor, Vaccine Journal, 2001

199. Fombonne & Chakrabarti Study, Pediatrics, October 2001

200. Further Paper by Taylor, Miller et al, BMJ.com, February 2002

201. Review by Donald and Muthu, Bazian Ltd, British Medical J. June 2002

202. Study into Childhood Gastrointestinal Disorders and Autism, Aug 2002

203. Madsen et al, Population-Based study, MMR/Autism, Denmark, Nov 2002

204. Study on Mercury by Pichichero, Lancet, November 2002

205. Study by Makela et al, Finland, Pediatrics November 2002

206. Commentary by Nelson & Bauman, Pediatrics March 2003

207. Paper, Madsen et al, Thimerosal/Aut in Denmark, Pediatrics, Sep 2003

208. Paper by Hviid, Stellfeld et al, Denmark, J of Amer. Med Assoc Oct 2003

209. Paper by Miller, Taylor et al, Archives of Diseases in Childhood 2003

210. Paper by Taylor et al, Archives of Diseases in Childhood, 2003

211. Article by Verstraeten et al, Pediatrics, Nov 2003

212. Paper by Stehr-Green et al, American J of Preventative Medicine 2003

213. Paper by DeStefano, Yeargin-Allsopp et al, Pediatrics, January 2004

214. Paper by Williams et al, Aberdeen University, Neuroimage June 2004

215. Paper by Smeeth, Cook, Fombonne et al, Lancet, September 2004

216. Paper by Heron, Golding et al, Pediatrics, September 2004.

217. Paper by Barbaresi et al, Arch of Ped & Adolescent Medicine, Jan 2005

218. Paper by Honda & Rutter, J of Child Psychol & Psychiatry, March 2005

219. Study by Seagroatt, British Med Journal, May 2005

Part L: Reviews Claiming There Is No Evidence Of A Vaccine/Autism Link

220. Medical Research Council Ad-Hoc Review, March 1998

221. Presentation by Miller, UK All-Party Parl. Gp on Primary Health, 2000

222. Medical Research Council Sub-Committee Report, March 2000

223. Review by US Institute of Medicine, 2001

224. Review by Strauss & Bigham, Health Canada/Un Of Br Columbia, 2001

225. Elliman, Bedford & Miller Review, Arch. of Dis. in Childhood, Oct. 2001

226. Medical Research Council Review, July-December 2001

227. Further Review by US Institute of Medicine, February 2002

228. Review of the Scottish Executive MMR Expert Group, April 2002

229. Review by Wilson et al, Arch. of Ped. & Adol Med., July 2003

230. Review by US Institute of Medicine, Washington, February 2004

Part M: Flawed UK Regulatory, Safety and Monitoring Systems

231. Fighting Measles, Missing Autism, Overlooking Damage?

232. Has the UK Medicines Control Agency Missed the Syndrome?

233. Further Statement by Dr Jefferson, Cochrane Collaboration, Mar 2004

234. Has The UK C’ttee on Safety of Medicines Modified MMR Vaccine?

235. UK Department of Health Re-Launch of MMR, January 2001

236. The Search For Alternatives To MMR

237. Full Removal of Thimerosal from Childhood Vaccines

Part N: UK and US National Political Initiatives

238. UK House of Commons Health Committee, Westminster

239 UK All Party Parliamentary Group on Autism, Westminster

240. Scottish Parliament, Edinburgh

241. UK Liberal Democrats

242. UK Conservatives

243. US House of Representatives C’ttee on Government Reform

244. Commentary by Congressman David Weldon, February 2005

Part P: Compensation and Litigation

245. UK Legal Action

246. UK Vaccine Damage Payment Scheme

247. US Vaccine Injury Compensation Scheme (VICP)

248. Families Taking Legal Action in the US over Thimerosal and Autism

249. US Government Attempts To Block The Thimerosal/Autism Litigation

250. MMR Litigation In Ireland

251. MMR Litigation in Japan

252. Litigation Elsewhere

Part Q: Some Conclusions and Some Unanswered Questions

253. Some Broad Conclusions

254. Some Unanswered Questions

EXECUTIVE SUMMARY

Ÿ This comprehensive review - which has been put together by the parent of a child who became autistic after immunisation - sets out the concerns of parents whose children have degenerated into an acquired-autistic state after MMR or other vaccines, and attempts to summarize the debate over thimerosal (or thiomersal) preservative used in vaccines other than MMR, and to highlight possible links between this mercury-based preservative and autism. It is possible, and increasingly likely, that the MMR and thimerosal factors overlap in the cause of late-onset degenerative autism.

Ÿ These are immense and complex subjects. This briefing does not attempt to cover every single piece of the available scientific literature for or against an MMR/autism or thimerosal/autism link, but it reviews about one hundred of the most recent, most pivotal, or most frequently-quoted studies and papers.

Ÿ Its key finding is that there has not been a single credible study that can robustly refute the claims of the parents that their children’s acquired autism has been caused by MMR or related measles-containing vaccines, or thimerosal-containing vaccines.

Ÿ The concept of vaccination is not the issue. No attempt is made here to criticize the principle of vaccination. It has been argued that vaccines have saved millions of lives, and continue to do so, particularly in the developing world.

Ÿ The issue here is, have a small minority of children been damaged by vaccines, in a way that has yet to be fully understood? Specifically, is a subset of the autism spectrum causally linked to certain types of vaccine, or vaccine ingredients? These are the questions that are addressed.

Ÿ This document is in no way an “anti-vaccine” tirade. But if there is a problem, even for a small sub-set of children, it must be investigated, and its consequences faced up to. We do not shrug-off air travel fatalities, or deaths of passengers traveling by rail. Yet possible vaccine damage seems to have been largely ignored in the past, and the issue of safety treated as a taboo subject. Vaccine safety monitoring, and even the wider issue of drug and pharmaceuticals safety, has been in need of major reform, for many years.

Ÿ Each of the studies that seeks to “disprove” an MMR/autism link or a thimerosal/autism link can be argued to be flawed in design or ambiguous in results. These flaws are discussed in detail in the text.

Ÿ It also notes that all but one of the studies that seek to disprove an MMR/autism or a thimerosal/autism link did not look at the actual children themselves, but rather were based upon statistical analyses of the medical records of the wider population. Such epidemiological studies are not appropriate to the identification of relatively-rare adverse outcomes, and have indeed been criticized by professional statisticians.

Ÿ Such studies also fail to address the problem - what was it that damaged the specific children that became autistic after MMR or thimerosal-containing vaccines?

Ÿ The one MMR study that has both claimed there is no MMR/autism link and also actually looked at information extracted from the medical records of a sub-set of UK damaged children was unable to prove or refute the suggested association with MMR on the basis of the information available - although it went on, despite this, to insist that MMR was safe. And - note - this was still not a clinical study. No children were actually clinically examined.

Ÿ Parents who have scrutinised the studies quoted by the Department of Health as “proof” of there being no link between MMR or thiomersal and autism have found that such studies crumble away easily when pressed. To give just one example, the Finnish study by Patja, Peltola et al was very loudly heralded at the start of 2001 by the UK Department of Health as convincing and conclusive proof that MMR was safe. After intense critical scrutiny by parents and media, by the end of 2001 the Medical Research Council was forced to admit that Patja, Peltola et al’s original 1998 paper “did not examine the relationship of MMR and autistic spectrum disorders.....and does not therefore provide useful evidence on this point.” Of the subsequent paper by Patja, Peltola et al, the MRC admitted: “The findings need to be interpreted with some caution, as cases of autistic spectrum disorder or bowel disorders not considered at the time attributable to MMR would not necessarily have been reported”. Quite a retreat. Yet the study still continues to be regularly quoted by medical commentators and professionals as “proof” that MMR is safe.

Ÿ In contrast, the parents find that there is a considerable, and growing, number of studies that suggest that MMR and/or thimerosal preservative (routinely used in very many vaccines until very recently, and still in widespread use in 2005) could be causing acquired autism (or “autistic enterocolitis”) in significant numbers of children.

Ÿ Contrary to the claims of the authorities, particularly in the UK, not all of these studies originate from only one group of researchers (the former Wakefield team at the Royal Free Hospital London, and then Dr. Wakefield since his departure), as has sometimes been inaccurately asserted by those who defend MMR. The studies that point to a link have involved a growing number of research teams, in several countries. Other studies, whilst not specifically targeting MMR or thimerosal-containing vaccines, offer further clues as to what may be happening, and are consistent with an MMR and/or thimerosal involvement, implicating vaccines.

Ÿ Furthermore, many of the studies that suggest that there is an MMR/autism or a thimerosal/autism link are based upon the scientific analysis of data gathered from detailed individual medical examination, and upon medical samples taken from the children concerned. These are the studies that actually seek to address the two key questions, “what is the damage sustained by this specific child, and what exactly precipitated the damage to this specific child?”.

Ÿ A “house of cards” has thus been constructed by the UK Department of Health, the US Government health system and by other authorities and commentators in the medical establishment over the past five years, with repeated assurances being given to the public, but with these being based upon a lop-sided, highly partisan and culpably selective gathering and interpretation of the available evidence.

Ÿ This briefing note also finds that there are other related concerns - from the regulatory bodies themselves - about the risk of permanent developmental damage from thimerosal-containing (or thiomersal-containing) vaccines, though it is not yet completely understood as to how these problems are directly interlinked biologically to the MMR/autism problems (we are told that MMR in itself does not contain thimerosal). Class-action lawsuits are now under way in the US (see later sections) over thimerosal/thiomersal and autism, just as they have been (or still are) in the UK and Ireland over MMR and autism.