MMR Vaccine, Thimerosal And Late-Onset Autism (Autistic Enterocolitis)

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Thursday, July 22, 2004 Vol. 8 No. 120

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MMR Vaccine, Thimerosal And Late-Onset Autism (Autistic Enterocolitis) -

Review Of Evidence Of Vaccine/Autism Links

Briefing Note

Thrower July 2004

[Following the executive summary is the table of contents so that the

reader can get a glimpse of the breadth of the material. The entire

document can be downloaded at http://www.sarnet.org/lib/7-04Bnote.zip It is

in zip format. Mr. Thrower has once again performed a valuable service to

the community by compiling this vast information. -editor.]

EXECUTIVE SUMMARY

This note - 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 that the MMR and thimerosal factors overlap in the cause of

late-onset degenerative autism.

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.

Its key finding is that there has not been a single credible study that canrobustly refute the claims of the parents that their children’s acquiredautism has been caused by MMR or related vaccines. Each of the studies thatseeks to “disprove†an MMR/autism link can be argued to be flawed in designor ambiguous in results. These flaws are discussed in detail in the text. 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.

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?

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 examined.

Parents who have scrutinised the studies quoted by the Department of Healthas “proof†of there being no link between MMR or thiomersal and autism havefound that such studies crumble away easily when pressed. To give just oneexample, the Finnish study by Patja, Peltola et al was very loudly heraldedat the start of 2001 by the UK Department of Health as convincing andconclusive proof that MMR was safe. After intense critical scrutiny byparents and media, by the end of 2001 the Medical Research Council wasforced to admit that Patja, Peltola et al’s original 1998 paper “did notexamine the relationship of MMR and autistic spectrum disorders.....and doesnot therefore provide useful evidence on this point.†Of the subsequentpaper by Patja, Peltola et al, the MRC admitted: “The findings need to beinterpreted with some caution, as cases of autistic spectrum disorder orbowel disorders not considered at the time attributable to MMR would notnecessarily have been reportedâ€. Quite a retreat. Yet the study stillcontinues to be regularly quoted by medical commentators and professionalsas “proof†that MMR is safe. 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 inwidespread use in 2004) could be causing acquired autism (or “autisticenterocolitisâ€) in significant numbers of children. 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 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.

Furthermore, many of the studies that suggest that there is an MMR/autismor a thimerosal/autism link are based upon the scientific analysis of datagathered from detailed individual medical examination, and upon medicalsamples taken from the children concerned. These are the studies thatactually seek to address the two key questions, “what is the damagesustained by this specific child, and what exactly precipitated the damageto this specific child?â€. A “house of cards†has thus been constructed by the UK Department ofHealth, the US Government health system and by other authorities andcommentators in the medical establishment over the past five years, withrepeated assurances being given to the public, but with these being basedupon a lop-sided, highly partisan and culpably selective gathering andinterpretation of the available evidence. 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.

Although complete and precise scientific proof of how the children have

been damaged by vaccines and become autistic is still emerging, there have

been numerous vital clues over the past six years and more - clues that

all too often have been ignored, or, worse still, have been rejected out of

hand by the authorities.

The medical establishment has repeatedly asked itself the wrong question.It has asked itself “Is MMR safe?â€, and “is thimerosal safe?â€, hoping for anaffirmative answer. In contrast, researchers and parents have asked two verydifferent questions: “What precisely is wrong with this child?â€, and “Whydid this child change from being healthy to being autistic?â€. It isanswering these latter two questions that should be the key issue. The safety trials of MMR were undoubtedly very poor. That is an established

fact. For the thimerosal issue, the picture is even more stark. The product

appears to have had no proper safety trials since its introduction about 75

years ago, and its use appears to have lacked any appropriate back-checks on

safety.

The children that have been damaged have had their lives ruined. They were

previously completely healthy. They now have seventy or eighty years of

mental handicap ahead. Whether their sacrifice is justified in the interests

of wider public health is not the point at issue. What is at issue is, what

changed for these children, through what processes, involving what

susceptibility factors and trigger factors. And how can further cases of

damage be headed-off?

This briefing note also poses a number of unanswered questions about MMR,

about thimerosal, and about the children that are believed to have been

severely damaged by vaccine administration. The damage involved is not

confined to regressive autism.

Finally, it is emphasized that this note is the result of a search of the

published (and sometimes unpublished) studies and other information. It does

not offer medical advice. Parents considering vaccinating their children

with MMR or with thimerosal-containing vaccines must form their own

conclusions as to whether to proceed, and are urged to gather the maximum

amount of hard information before making their own choice. It is hoped that

this Briefing Note offers a useful start, and is useful for journalists.

Contents

Part A: A Novel Syndrome

1. What Is Acquired Autism/Autistic Enterocolitis

2. The New Syndrome

Part B: The Costs of Autism

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 Autisticâ€7. Is Autism Increasing Due To Changes In Criteria?

8. Autistic Disorder

9. Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

10. Asperger’s11. University of Cambridge Research

12. University of Sunderland Research

13. UK National Autistic Society Estimates

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

15. Report, “Autism In Schoolsâ€, UK National Autistic Society May 200216. Is Autism Increasing? - Some Recent Official UK Pronouncements

17. Autism In The USA

18. Autism Elsewhere

Part C: MMR

19. The Introduction of MMR

20. Recognised Adverse Reactions to MMR

21. US Vaccine Adverse Events Reporting System

22. Contraindications To Receiving MMR

23. The UK Department of Health’s Position over MMR and Autism24. Single Vaccines In The UK

25. Measles In The UK

26. Promotion of MMR In The UK After The Wakefield “Early Reportâ€Controversy27. Position of the US Center For Disease Control on MMR/Autism

28. The Parents Have Seen What They’ve Seen.....Part D: The Thimerosal/Thiomersal* Issue

(*the two terms are interchangeable)

29. Thimerosal’s Possible Role30. Joint Statement by American Acad. Of Ped./Public Health Service, July

1999

31. Removal of Thimerosal

32. Waters & Kraus Press Release, 2002

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

34. UK Vaccines With Thimerosal

35. UK Medicines and Healthcare Regulatory Agency Position on Thimerosal

36. UK Joint Committee on Vaccination * Immunisation Position on Thimerosal

37. US CDC Thimerosal Studies

38. Report, “Mercury In Medicinesâ€, US Committee on Government Reform 200339. Letter to Congress by the US Office of Special Counsel, 2004

40. California Votes To Ban Thimerosal, June 2004

Part E: Reviews Questioning the Autism Epidemic

41. Paper by Fombonne, UK Medical Research Council, Pediatrics, January

2001

42. Paper by Wing, Centre for Social & Communication Disorders, London 2002

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

44. Study by Croen et al, July 2002

45. Editorial by Fombonne, Journal of the American Medical Asscn., January

2003

46. Paper by Jick et al, Boston Un. Sch of Medicine, Pharmacotherapy, Dec

2003

Part F: Evidence That Autism Increases Are Real

47. Close-Up On California

48. The MIND Study, California

49. Close-Up On New Jersey

50. Atlanta Study, 2003

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

52. Paper by F. E. Yazbak, Autism In The US - A Perspective, J of A Phs &

Surg 2003

53. Paper by F. E. Yazbak, Autism In Quebec, 2004

Part G. Studies Used To Disprove Any MMR/Thimerosal/Autism Link

54. Limitations of Epidemiology - A Preface

55. Stokes et al paper, Journal of American Medical Association (JAMA),

Oct. 1971

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

57. Paper by , et al, The Practitioner, January 1989

58. Gillberg Study, Sweden, British Journal of Psychiatry, 1991

59. Commentary by Gillberg and Heijbel, Autism, 1998

60. Letter by Fombonne, Pediatrics, March 1998

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

62. Paper By , and Farrington, Lancet, June 1999

63. Paper by & Farrington to US Government Reform Committee, April

2000

64. Patja, Peltola et al Study, Finland, Pediatric Infectious Disease

Journal Dec. 2000

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

66. Dales, Hammer and Study, JAMA, March 2001

67. De Wilde, Carey & s Study, Br. Journal of General Practice,

March 2001

68. et al study, Archive Pediatrics Adolescent Medicine, 2001

69. Further Paper by Farrington, and , Vaccine Journal, 2001

70. Fombonne & Chakrabarti Study, Pediatrics, October 2001

71. Further Paper by , et al, BMJ.com, February 2002

72. Review by and Muthu, Bazian Limited, pub British Medical Jnl

June 2002

73. Study into Childhood Gastrointestinal Disorders and Autism, August 2002

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

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

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

77. Commentary by & Bauman, Pediatrics March 2003

78 Paper, Madsen et al, Thimerosal and Autism in Denmark, Pediatrics, Sep

2003

79. Paper by Hviid, Stellfeld et al, Denmark, J of American Med Assoc Oct

2003

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

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

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

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

84. Paper by DeStefano, Yeargin-Allsopp, Boyle et al, Pediatrics, January

2004

85. Paper by et al, Aberdeen University, Neuroimage June 2004

Part H: Reviews Concluding There Is No Evidence Of A Vaccine/Autism Link

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

87. Presentation by to UK All Party Parl. Group on Primary Health

Care, 2000

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

89. Review by US Institute of Medicine, 2001

90. Review by Strauss and Bigham, Health Canada/Un. Of British Columbia,

2001

91. Elliman, Bedford and Review, Arch. of Diseases in Childhood,

Oct. 2001

92. Medical Research Council Review, July-December 2001

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

94. Review of the ish Executive MMR Expert Group, April 2002

95. Review by , Mills et al, Arch. of Pediatric & Adolescent Med.,

July 2003

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

Part J: The MMR Original Safety Trials Debate

97. Wakefield & Montgomery “Through A Glass Darkly†MMR safety-studies paper98. Dr. Fletcher Commentary, Journal of Adverse Drug Reactions, 2001

99. Dr. Dealler Commentary, Journal of Adverse Drug Reactions, 2001

100. Dr. F. Yazbak Commentary, Journal of Adverse Drug Reaction,

2001

101. The Wakefield//Shattock Rebuttals

102. The UK Department of Health’s Repudiation of “Through A Glass Darklyâ€.Part K: Studies That Point Towards The Plausibility Of Gut/Autism,

MMR/Gut/Autism, Thimerosal/Autism and Autoimmunity/Autism Links

103. Paper by & Gottshall, Applied Microbiology, May 1967

104. Paper by Eggers, Klinical Paediatrics, March 1976

105 Weizman, Weizmann, Szekely et al Study, Am. Journal of Psychiatry, Nov.

1982

106. Delgiudice-Asch and Hollander Study

107. Paper by Dr. H. Fudenberg

108. Paper by Dr. Warren

109. Warren and Singh Study, Immunogenetics, 1992

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

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

112. Oleske and Zecca paper

113. Binstock paper

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

115. Paper by , Montgomery, Pounder & Wakefield, Lancet, April

1995

116. Gupta, Aggarwal and Heads Study, Journal of Autism and Dev.

Disorders, 1996

117. Montinari, Favoino and o paper, Naples conference May 1996

118. Auwaerter and paper, Clin Immunology and Immunopath., May

1996

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

120. and Hussy Study, Journal of Infectious Diseases, June 1996

121. ez et al Study, Proceedings of National Academy of Sciences,

1997

122. Paper by Zecca, Graffino et al, Meeting of National Inst. of Health,

Sept. 1997

123. Weibel, Caserta and Study, March 1998

124. Wakefield et al “Early Reportâ€, Lancet, February 1998125. Paper by Montgomery, et al (publication date/details not yet

known)

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

127. Further Paper by Singh and Yang, Pharmaceutical Journal, October 1998

128. Uhlmann, Sheils et al Paper

129. Bitnun et al Study, Clinical Infectious Diseases Journal, October

1999

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

131. Paper by Dr. Singh to the US Committee on Government Reform, April

2000

132. O’Leary Paper Presented to US Congressional Oversight Committee,April 2000133. Kawashima, Takayuki et al Study, Digestive Diseases and Sciences,

April 2000

134. Confidential Review by Centers for Disease Control, Simpsonwood, June

2000

135. Hagenbuch, Kullak-Ublick et al Study, Journal of Pharm. Exp. Ther.,

July 2000

136. Wakefield et al Paper, American Journal of Gastroenterology,

September 2000

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

138. Furlano, et al Study, Journal of Pediatrics, 2001

139. Study by Jyonouchi, Sun and Le, J. Allergy & Clinical Immunology,

Feb. 2001

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

141. Paper by Spitzer, Aitken et al, Journal of Adverse Drug Reactions &

Tox., 2001

142. Paper by Dr. Ken Aitken to the ish Society for Autism, 2001

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

144. Paper by Dr. Buie, Oasis 2001 Conference for Autism,

Portland, US

145. Paper by Uhlmann, Wakefield, O’Leary et al, J. of Clinical Pathology,Feb. 2002146. Paper by Singh and , February 2002

147. Review by Wakefield, Pulestone, Montgomery et al, Aliment Pharm.

Ther. 2002

148. Report of Study by Comi et al, s Hopkins Hospital, Baltimore,

April 2002

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

150. Paper to 102nd GM of American Soc for Microbiology by Singh et al,

May 2002

151. Study by O’Leary et al, to be presented to Path Soc of GB and IrelandJuly 2002152. Wakefield Paper Presented to US Government Reform Committee, June

2002

153. Paper to US Government Reform Committee by Dr Krigsman, June 2002

154. Unpublished Research by Dr Shattock, University of Sunderland,

June 2002

155. Paper by Sheils, Smyth, & O’Leary, Trinity College Dublin,2002156. Paper by Dr. Vijendra Singh, Utah State University, August 2002

157. Paper by Finegold, Molitoris, Song, J. Of Clinical Infectious

Diseases, Sept 2002

158. Further paper by Jyonouchi, Sun & Itokazu, University of Minnesota,

Oct 2002

159. Paper, Treatment of Late Onset Autism, Matarazzo, Univ. of Sao o,

Nov 2002

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

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

162. Unpublished letter by Dr. Wakefield to the New Eng. J. of Medicine,

Nov 2002

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

164. Paper by Singh and Jensen, Pediatric Neurology 2003

165. Paper by Geier and Geier, Society for Experimental Biology & Medicine

2003

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

167. Further Paper by Geier and Geier, Pediatric Rehabilitation, Apr-June

2003

168. Further Paper by Geier and Geier, Journal of Am Phys and Surg, Spring

2003

169. Paper by Bradstreet, Geier, Kartzinel et al, J of Am Phy and Surg

Summer 2003

170. Letter by Geier and Geier, J of Am Physicians and Surgeons, Summer

2003

171. Paper by Via, Nguyen et al, Environmental Health Perspectives August

2003

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

173. Paper by Ashwood, Murch et al, J of Clinical Immunology, November

2003

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

175. Paper by Singh, presented to the Institute of Medicine, Washington,

Feb 2004

176. Paper by Bradstreet presented to the Inst of Medicine, Washington,

Feb 2004

177. Paper by Bradstreet, O’Leary, Sheils et al to the Inst of Medicine,Feb 2004178. Further Paper by Bradstreet, presented to the Institute of Medicine,

Feb 2004

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

2004

180. Paper by De Water, Ashwood et al, MIND Institute, U of Calif at

May 2004

181. Paper by Hornig, Chian, Lipkin et al, Molecular Psychiatry June 2004

182. Study by Waly, Olteanu, Deth et al, J of Molecular Psychiatry April

2004

183. Paper by Torrente, et al, American J of Gastroenterology,

April 2004

184. Presentation b Prof. Boyd Haley, Canada Autism Conference, April 2004

185. Paper by Bradstreet, Dahr, et al, J of Am Phy & Surg Summer

2004

Part L: Other Relevant Papers

186. US Developmental Delay Registry Report, 1994

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

188. Paper by Carbone.

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

190. Statement by Spitzer, US House of Repres. Govt Reform Committee,

April 2001

191. Statement by Dr. Jefferson, Cochrane Collaboration, Oxford, October

2002

192. Paper by Sweeten et al, Pediatrics 2003

193. Paper by Blaycock, JANA, Winter 2003

194. Paper by Singh and Rivas, Jan 2004

Part M: Future Papers Investigating A Link/Increased Prevalence

195. Fombonne et al Study, London

196. Charman et al Study, London

197. Study by Professor Hall, London

198. Study by Takahashi et al, Tokyo

199. Study by Rall, Fox Chase Cancer Center, US

200. Studies Commissioned by the US Center for Disease Control

201 UK National Institute for Biological Standards and Control Study

202. Study by University of California at into Environmental Factors

203. Study by Afzal et al, February 2003

204 . Other UK Studies funded by the Medical Research Council

205. Study by Autism Center, University of Medicine & Dentistry, New

Jersey, US

206. Study by Center for Disease Control, New Jersey, US

207. Study by Wood Medical School, New Brunswick, US

208. Survey by New Jersey Answers for Autism

209. Columbia University (Lipkin et al) Autism Birth Cohort Study

Part N: Flawed UK Regulatory and Monitoring Systems

210. Fighting Measles, Missing Autism, Overlooking Damage?

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

212. Further Statement by Dr. Jefferson, Cochrane Collaboration, Mar

2004

213. Has The UK Committee on Safety of Medicines Modified The MMR Vaccine?

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

215. The Search For Alternatives To MMR

Part P: UK and US Political Initiatives

216. UK House of Commons Health Committee, Westminster

217 UK All Party Parliamentary Group on Autism, Westminster

218. ish Parliament, Edinburgh

219. UK Liberal Democrats

220. UK Conservatives

221. US House of Representatives Government Reform Committee

Part Q: Litigation

222. UK Legal Action

223. UK Vaccine Damage Payment Scheme

224. US Vaccine Injury Compensation Scheme (VICP)

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

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

227. MMR Litigation In Ireland

228. MMR Litigation in Japan

229. Litigation Elsewhere

Part R: Some Conclusions and Some Unanswered Questions

230. Some Broad Conclusions

231. Some Unanswered Questions

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