Search results for 'vaccinated unvaccinated'

Studies on the autism-vaccine hypothesis

15 Apr

Below is a collection of studies which the American Academy of Pediatrics put together on the autism/vaccine question. Why bring this up now? Because with the indictment of Poul Thorsen, I’ve read a number of comments where people are claiming that he worked on the study that debunked the connection. Hardly. Going through these quickly, I find 2 articles that Poul Thorsen worked on (the two Madsen studies). No one has made a credible claim that even the studies Mr. Thorsen worked on are tainted.

The comparison to Andrew Wakefield has already been made. Mr. Wakefield promoted the idea that the MMR vaccine caused autism, and was later was found guilty of a number of ethical lapses in his research efforts. The major difference between Wakefield and Thorsen is this: Wakefield was wrong. His assertion that the MMR was related to autism causation when he stated: “…but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.” It was a statement not even supported by his own paper (even if it hadn’t been based on fraudulent research), much less has ever been supported by research by any other team. By contrast, the work that Mr. Thorsen worked on has been replicated.

Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study
Budzyn D, et al. The Pediatric Infectious Disease Journal. Vol. 29, No. 5, May 2010
Researchers in Poland compared vaccination history and autism diagnosis in 96 children with autism, ages 2 to 15, as well as 192 children in a control group. For children diagnosed before a diagnosis of autism, the autism risk was lower in children who received MMR vaccine than in nonvaccinated children. A similar result was achieved for the single-antigen measles vaccine.
AUTHOR CONCLUSION: The study provides evidence against the association of autism with either MMR or a single measles vaccine.
http://www.ncbi.nlm.nih.gov/pubmed/19952979

Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study
Hornig M et al., PLoS ONE 2008, 3(9): e3140 doi:10.1371/journal.pone.0003140
Researchers looked for measles virus in the guts of 25 children with both autism and gastrointestinal disorders, and another 13 children with the same gastrointestinal disorders but no autism. The virus was detected in one child from each group.
AUTHOR CONCLUSION: This study provides strong evidence against association of autism with persistent measles virus RNA in the gastrointestinal tract or with measles, mumps and rubella (MMR) vaccine exposure.
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140

Measles Vaccination and Antibody Response in Autism Spectrum Disorders
Baird G et al., Archives of Disease in Childhood 2008; 93(10):832-7
Case-control study of 98 vaccinated children aged 10-12 years in the UK with autism spectrum disorder (ASD) and two control groups of similar age: 52 children with special educational needs but no ASD and 90 children in the typically developing group. No difference was found between cases and controls for measles antibody response. There was no dose-response relationship between autism symptoms and antibody concentrations.
AUTHOR CONCLUSION: No association between measles vaccination and ASD was shown.
http://tinyurl.com/dn6yy8

MMR-Vaccine and Regression in Autism Spectrum Disorders: Negative Results Presented from Japan
Uchiyama T et al. Journal of Autism and Developmental Disorders, 2007; 37(2):210-7
Study of 904 patients with Autism Spectrum Disorders (ASD). During the period of measles, mumps and rubella vaccine (MMR) usage, no significant difference was found in the incidence of regression between MMR-vaccinated children and nonvaccinated children. Among the proportion and incidence of regression across the three MMR-program-related periods (before, during and after MMR usage), no significant difference was found between those who had received MMR and those who had not. Moreover, the incidence of regression did not change significantly across the three periods.
AUTHOR CONCLUSION: The data do not support an association between MMR and autism.
http://tinyurl.com/6c6o4r

No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells from Children with Autism Spectrum Disorder
D’Souza Y et al. Pediatrics 2006; 118(4):1664-75
Peripheral blood mononuclear cells were isolated from 54 children with Autism Spectrum Disorders (ASD) and 34 developmentally normal children, and up to 4 realtime polymerase chain reaction assays and 2 nested polymerase chain reaction assays were performed. No sample from either ASD or control groups was found to contain nucleic acids from any measles virus gene. In the nested polymerase chain reaction and in-house assays, none of the samples yielded positive results. Furthermore, there was no difference in anti-measles antibody titers between the autism and control groups.
AUTHOR CONCLUSION: There is no evidence of measles virus persistence in the peripheral blood mononuclear cells of children with ASD.
http://tinyurl.com/dcb79o

Immunizations and Autism: A Review of the Literature
Doja A, Roberts W. The Canadian Journal of Neurological Sciences 2006; 33(4):341-6
Literature review found very few studies supporting an association between vaccines and autism, with the overwhelming majority showing no causal association between the measles, mumps and rubella (MMR) vaccine and autism. The vaccine preservative thimerosal has alternatively been hypothesized to have a possible causal role in autism. No convincing evidence was found to support an association between the vaccine preservative thimerosal and autism, nor for the use of chelation therapy in autism.
AUTHOR CONCLUSION: With decreasing uptake of immunizations in children and the inevitable occurrence of measles outbreaks, it is important that clinicians be aware of the literature concerning vaccinations and autism so that they may have informed discussions with parents and caregivers.
http://tinyurl.com/ddnqq7

Pervasive Developmental Disorders in Montreal and Quebec, Canada: Prevalence and Links with Immunizations
Fombonne E et al. Pediatrics. 2006; 118(1):e139-50
Study of thimerosal and measles, mumps and rubella (MMR) vaccine uptake in 28,000 Canadian children born between 1987 and 1998, of whom 180 were identified with a pervasive developmental disorder.
AUTHOR CONCLUSION: The data rule out an association between pervasive developmental disorder and either high levels of ethyl mercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose MMR vaccinations.
http://tinyurl.com/5c27nu

Is there a ‘regressive phenotype’ of Autism Spectrum Disorder associated with the measles mumps-rubella vaccine? ACPEA Study
Richler et al. Journal of Autism and Developmental Disorders. 2006
A multi-site study of 351 children with Autism Spectrum Disorders (ASD) and 31 typically developing children used caregiver interviews to describe the children’s early acquisition and loss of social-communication milestones. For the majority of children with ASD who had experienced a regression, pre-loss development was clearly atypical.
AUTHOR CONCLUSION: No evidence that onset of autistic symptoms or of regression was related to measles, mumps and rubella vaccination.
http://tinyurl.com/66gtk2

Relationship between MMR Vaccine and Autism
Klein KC, Diehl EB. The Annals of Pharmacotherapy. 2004; 38(7-8):1297-300
Ten articles that specifically evaluated the possible relationship between the measles, mumps and rubella (MMR) vaccine and autism were identified. Review articles, commentaries, and evaluations of a link between gastrointestinal symptoms in autistic children and MMR immunization were excluded.
AUTHOR CONCLUSION: Based upon the current literature, it appears that there is no relationship between MMR vaccination and the development of autism.
http://tinyurl.com/chdjrk

Immunization Safety Review: Vaccines and Autism
Institute of Medicine, The National Academies Press: 2004
The IOM’s Committee on Immunization Safety Review was convened in the fall of 2000 to provide an independent review of increasingly prominent vaccine safety concerns. The 15 committee members with expertise in pediatrics, internal medicine, immunology, neurology, infectious diseases, epidemiology, biostatistics, public health, risk perception, decision analysis, nursing, genetics, ethics and health communications analyzed over 200 relevant studies.
AUTHOR CONCLUSION: The committee rejected a causal relationship between the MMR vaccine and autism as well as a causal relationship between thimerosal containing vaccines and autism.
http://books.nap.edu/catalog.php?record_id=10997#description

No effect of MMR withdrawal on the incidence of autism: a total population study
Honda H et al, Journal of Child Psychology and Psychiatry 2005 June; 46(6):572-9
Study examined incidence of Autism Spectrum Disorders (ASD) to age 7 for children born between 1988 and 1996 in Yokohama, Japan. The measles, mumps and rubella (MMR) vaccination rate in Yokohama declined significantly in the birth cohorts of years 1988-92, and no MMR vaccines were administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age 7 increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.
AUTHOR CONCLUSION: MMR vaccination is not likely to be a main cause of ASD, and cannot explain the rise over time in the incidence of ASD. Withdrawal of MMR in countries where it is still being used cannot be expected to lead to a reduction in the incidence of ASD.
http://tinyurl.com/d8f3lg

No evidence for links between autism, MMR and measles virus
Chen W et al, Psychological Medicine 2004 April;34(3):543-53
Study compared 2,407 persons with autism born between 1959 and 1993; to 4,640 Down syndrome subjects born between 1966 and 1993.
AUTHOR CONCLUSION: No increased risk of autism was found following exposures to wild measles and vaccinations with monovalent measles, and Urabe or Jeryl-Lynn variants of measles, mumps and rubella (MMR) vaccine.
http://tinyurl.com/5msou2

Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta
DeStefano F et al. Pediatrics 2004; 113(2): 259-66
Study compared ages at first measles, mumps and rubella (MMR) vaccination between children with autism and children who did not have autism in the total population and in selected subgroups, including children with regression in development.
AUTHOR CONCLUSION: Similar proportions of case and control children were vaccinated by the recommended age or shortly after (ie, before 18 months) and before the age by which atypical development is usually recognized in children with autism (ie, 24 months).
http://pediatrics.aappublications.org/cgi/content/abstract/113/2/259

MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study
Smeeth L et al. Lancet 2004; 364(9438):963-9
Matched case-control of 1,295 people born in 1973 or later who had first recorded diagnosis of pervasive developmental disorder while registered with a contributing general practice between 1987 and 2001. Controls (4,469) were matched on age, sex and general practice. 1,010 cases (78.1%) had measles, mumps and rubella (MMR) vaccination recorded before diagnosis, compared with 3,671 controls (82.1%) before the age at which their matched case was diagnosed,
AUTHOR CONCLUSION: Data suggest that MMR vaccination is not associated with an increased risk of pervasive developmental disorders.
http://tinyurl.com/8wlhfj

Prevalence of Autism and Parentally Reported Triggers in a North East London Population
Lingam R et al. Archives of Disease in Childhood. 2003; 88(8):666-70
Study of reported age of onset of Autism Spectrum Disorder (ASD) among 567 children in northeast London born between 1979 and 1998. The age at diagnosis of ASD was estimated to have decreased per five-year period since 1983, by 8.7% for childhood autism and by 11.0% for atypical autism.
AUTHOR CONCLUSION: The data suggest that a rise in autism prevalence was likely due to factors such as increased recognition, a greater willingness on the part of educators and families to accept the diagnostic label, and better recording systems. The proportion of parents attributing their child’s autism to MMR appears to have increased since August 1997.
http://adc.bmj.com/cgi/content/abstract/88/8/666

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism
Madsen KM et al. New England Journal of Medicine. 2002; 347(19):1477-82
Compared relative risk of Autism Spectrum Disorder (ASD) in children vaccinated with measles, mumps and rubella (MMR) vaccine and unvaccinated children born in Denmark between 1991 and 1998. Of the 537,303 children in the cohort, 82% had received the MMR vaccine. Researchers identified 316 children with a diagnosis of autism and 422 with a diagnosis of other ASDs. There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autism.
AUTHOR CONCLUSION: This study provides strong evidence against the hypothesis that MMR vaccination causes autism.
http://tinyurl.com/5eob5k

Neurologic Disorders after Measles-Mumps-Rubella Vaccination
Makela A et al. Pediatrics. 2002; 110:957-63
Study of 535,544 1- to 7-year-old children who were vaccinated between November 1982 and June 1986 in Finland.
AUTHOR CONCLUSION: Data do not support an association between measles, mumps and rubella (MMR) vaccination and encephalitis, aseptic meningitis or autism.
http://tinyurl.com/6ybfjr

Relation of Childhood Gastrointestinal Disorders to Autism: Nested Case Control Study Using Data from the UK General Practice Research Database
Black C et al. British Medical Journal. 2002; 325:419-21
Nested case control study of 96 children diagnosed with autism and 449 controls. The estimated odds ratio for a history of gastrointestinal disorders among children with autism compared with children without autism was 1.0 (95% confidence interval 0.5 to 2.2).
AUTHOR CONCLUSION: No evidence was found that children with autism were more likely than children without autism to have had defined gastrointestinal disorders at any time before their diagnosis of autism.
http://tinyurl.com/csudoy

Measles, Mumps, and Rubella Vaccination and Bowel Problems or Developmental Regression in Children with Autism: Population Study
Taylor B et al. British Medical Journal. 2002; 324(7334):393-6
Population study of 278 children with core autism and 195 with atypical autism, born between 1979 and 1998. The proportion of children with developmental regression (25% overall) or bowel symptoms (17%) did not change significantly during the 20 years from 1979, a period which included the introduction of measles, mumps and rubella (MMR) vaccination in October 1988.
AUTHOR CONCLUSION: Data provide no support for an MMR associated “new variant” form of autism with developmental regression and bowel problems, and further evidence against involvement of MMR vaccine in the initiation of autism.
http://tinyurl.com/6oqsfc

No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism
Fombonne E et al. Pediatrics. 2001;108(4):E58
Study compared 96 children with a pervasive developmental disorder (PDD) born between 1992 and 1995 and who had received the measles, mumps and rubella (MMR) vaccine, to PDD patients who did not receive MMR.
AUTHOR CONCLUSION: No evidence was found to support a distinct syndrome of MMR-induced autism or of “autistic enterocolitis.” These results add to the largescale epidemiologic studies that all failed to support an association between MMR and autism at population level. These findings do not argue for changes in current immunization programs and recommendations.
http://tinyurl.com/5adckj

Measles-Mumps-Rubella and Other Measles-Containing Vaccines Do Not Increase the Risk for Inflammatory Bowel Disease: A Case-Control Study from the Vaccine Safety Datalink Project
Davis RL et al. Archives of Pediatric and Adolescent Medicine. 2001;155(3):354-9
A case control study of 155 persons with inflammatory bowel disease with up to five controls each. Neither past vaccination nor age at vaccination with other MCV was associated with increased risk for Crohn’s disease, ulcerative colitis, or IBD. Risk for Crohn’s disease, ulcerative colitis, or IBD was not elevated in the time immediately following vaccination with either vaccine.
AUTHOR CONCLUSION: Vaccination with MMR or other MCV, or the timing of vaccination early in life, did not increase the risk for IBD.
http://archpedi.ama-assn.org/cgi/content/abstract/155/3/354

Time Trends in Autism and in MMR Immunization Coverage in California
Dales L et al. Journal of the American Medical Association. 2001; 285(9):1183-5
Scientists looked for correlation between increases in the rate of autism diagnoses and increases in the rate of measles, mumps and rubella (MMR) vaccination in children born between 1980 and 1994.
AUTHOR CONCLUSION: These data do not suggest an association between MMR immunization among young children and an increase in autism occurrence.
http://jama.ama-assn.org/cgi/content/abstract/285/9/1183

MMR and autism: further evidence against a causal association
Farrington CP, et al. Vaccine. 2001; Jun 14; 19(27):3632-5
Data from an earlier measles, mumps and rubella (MMR) vaccine study (Taylor et al, 2000) were reanalyzed to test a second hypothesis.
AUTHOR CONCLUSION: Results provide further evidence against a causal association between MMR vaccination and autism.
http://tinyurl.com/5lb3w7

Mumps, Measles, and Rubella Vaccine and the Incidence of Autism Recorded by General Practitioners: A Time Trend Analysis
Kaye JA et al. British Medical Journal. 2001; 322:460-63
Study compared prevalence of measles, mumps and rubella (MMR) vaccination among children in the United Kingdom to rising prevalence of autism diagnoses for children.
AUTHOR CONCLUSION: The data provide evidence that no correlation exists between the prevalence of MMR vaccination and the rapid increase in the risk of autism over time.
http://www.bmj.com/cgi/content/full/322/7284/460

Further Evidence of the Absence of Measles Virus Genome Sequence in Full Thickness Intestinal Specimens from Patients with Crohn’s Disease
Afzal MA, et al. Journal of Medical Virology. 2000; 62(3):377-82
Study of specimens of macroscopically inflamed and normal intestine along with mesenteric lymph nodes from patients with Crohn’s disease. None of the samples examined gave any evidence of the persistence of measles virus in the intestine of Crohn’s disease patients.
AUTHOR CONCLUSION: The study supports previous findings produced by this laboratory and others using highly sensitive measles virus specific PCR diagnostic technology.
http://tinyurl.com/aoec5b

Absence of Detectable Measles Virus Genome Sequence in Inflammatory Bowel Disease Tissues and Peripheral Blood Lymphocytes
Afzal MA et al. Journal of Medical Virology. 1998; 55(3):243-9
Study looked for measles virus in 93 colonoscopic biopsies and 31 peripheral blood lymphocyte preparations, examined and obtained from patients with inflammatory bowel disease (IBD) and noninflammatory controls.
AUTHOR CONCLUSION: Measles virus was not detected using this method.
http://www.ncbi.nlm.nih.gov/pubmed/9624614

Autism and Measles, Mumps, and Rubella Vaccine: No Epidemiological Evidence for a Causal Association
Taylor B et al. Lancet. 1999;353 (9169):2026-9
Researchers looked for a change in trend in incidence or age at diagnosis associated with the introduction of measles, mumps and rubella (MMR) vaccination to the United Kingdom in 1988. The study identified 498 cases of autism (261 of core autism, 166 of atypical autism, and 71 of Asperger syndrome) in children born in the UK since 1979. There was a steady increase in cases by year of birth with no sudden “step-up” or change in the trend line after the introduction of MMR vaccination. There was no difference in age at diagnosis between the cases vaccinated before or after 18 months of age and those never vaccinated. There was no temporal association between onset of autism within 1 or 2 years after vaccination with MMR. Developmental regression was not clustered in the months after vaccination.
AUTHOR CONCLUSION: Data do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in this large regional sample.
http://tinyurl.com/5bgvwg

No Evidence for Measles, Mumps, and Rubella Vaccine-Associated Inflammatory Bowel Disease or Autism in a 14-year Prospective Study
Peltola H et al. Lancet. 1998; 351:1327-8
Prospective study of 3 million adverse events in temporal relation to MMR vaccine. A form was filled and posted to the data collectors, followed by another form with further information 2-3 weeks later. Researchers traced subjects who developed gastrointestinal symptoms or signs lasting 24 hours or more at any time after MMR vaccination (apart from within the first hour). Researchers also checked hospital and health center records or interviewed the local public-health nurses.
AUTHOR CONCLUSION: Over a decade’s effort to detect all severe adverse events associated with MMR vaccine could find no data supporting the hypothesis that it would cause pervasive developmental disorder or inflammatory bowel disease.
http://www.freenetpages.co.uk/hp/gingernut/lancet/Finland%20May%201998.pdf

Exposure to Measles in Utero and Crohn’s Disease: Danish Register Study
Nielsen LL et al. British Medical Journal. 1998; 316(7126):196-7
Investigators identified 472 women aged 15 to 43 years who had been admitted with measles between 1915 and 1966. Thirty-three were pregnant: 11 developed measles during the first trimester, 9 during the second, 6 during the third, and 9 had exanthema less than 14 days after delivery. Of the 26 offspring identified (including one set of twins), four died, one in infancy. The diagnoses of the other three, who died as adults, did not suggest inflammatory bowel disease. Among individuals still alive (median age 51.4 (36-79) years) none were registered as having Crohn’s disease or inflammatory bowel disease.
AUTHOR CONCLUSION: Exposure to measles in utero does not seem to be strongly associated with the development of Crohn’s disease later in life.
http://www.bmj.com/cgi/content/short/316/7126/196

U.S. Court of Federal Claims decision in Omnibus Autism Proceeding
On Feb. 12, 2009, the “vaccine court” ruled in three test cases on the theory that MMR vaccine and the vaccine preservative thimerosal are linked to autism. The court found the scientific evidence is overwhelmingly contrary to this theory.
http://www.uscfc.uscourts.gov/node/5026

Studies looking at thimerosal:

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism
Price C et al., Pediatrics. Vol. 126 No. 4 October 2010, pp. 656-664
Researchers reviewed managed care organization records and conducted interviews with the parents of 256 children who were verified to have ASD according to a standardized personal evaluation. Children with ASD were further categorized as having autistic disorder or ASD with regression. Another 752 children without autism, matched to the ASD children by birth year, gender and managed care organization, were also studied. For none of the autism outcomes was prenatal or early life receipt of thimerosal-containing vaccines and immunoglobulins significantly greater among children with ASD than among children without ASD.
AUTHOR CONCLUSION: These results add to the evidence that thimerosal containing vaccines do not increase the risk of autism.
http://pediatrics.aappublications.org/cgi/content/full/126/4/656

Continuing increases in autism reported to California’s developmental services system: mercury in retrograde
Schechter and Grether, 2008, Archives of General Psychiatry. 65(1):19-24
Study analyzed autism client data from the California Department of Developmental Services between 1995 and 2007. Even though thimerosal was absent from scheduled childhood vaccines after 2002, cases of autism continued to climb quarter by quarter.
AUTHOR CONCLUSION: The California DDS data do not show any recent decrease in autism in California despite the exclusion of more than trace levels of thimerosal from nearly all childhood vaccines. The data do not support the hypothesis that exposure to thimerosal during childhood is a primary cause of autism.
http://www.ncbi.nlm.nih.gov/pubmed/18180424

Mercury Levels in Newborns and Infants After Receipt of Thimerosal-Containing Vaccines
Pichichero, et al., Pediatrics. Vol. 121 No. 2, 2008, pp. e208-e214
Study assessed blood mercury levels of 216 healthy children prior to immunization with thimerosal-containing vaccines, and 12 hours to 30 days after. The blood mercury half-life was calculated to be 3.7 days and returned to prevaccination levels by day 30.
AUTHOR CONCLUSION: The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines in infants is substantially shorter than that of oral methyl mercury in adults. Increased mercury levels were detected in stools after vaccination, suggesting that the gastrointestinal tract is involved in ethyl mercury elimination. Because of the differing pharmacokinetics of ethyl and methyl mercury, exposure guidelines based on oral methyl mercury in adults may not be accurate for risk assessments in children who receive thimerosal-containing vaccines.
http://pediatrics.aappublications.org/cgi/content/full/121/2/e208

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
Thompson, et al. 2007, New England Journal of Medicine. 357:1281-1292
Study compared early exposure to thimerosal-containing vaccines to 42 neuropsychological outcomes in 1,047 children between the ages of 7 and 10 years. Exposure to mercury from thimerosal was determined from computerized immunization records, medical records, personal immunization records and parent interviews.
AUTHOR CONCLUSION: The study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.
http://tinyurl.com/5ndvpe

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations
Fombonne, et al., Pediatrics. Vol. 118 No. 1, 2006, pp. e139-e150
Quantified thimerosal and measles, mumps rubella (MMR) vaccine uptake in 28,000 Canadian children born between 1987 and 1998, of whom180 were identified with a pervasive developmental disorder.
AUTHOR CONCLUSION: The data rule out an association between pervasive developmental disorder and either high levels of ethyl mercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measlesmumps-rubella vaccinations.
http://tinyurl.com/5c27nu

Immunization Safety Review: Vaccines and Autism
Institute of Medicine, The National Academies Press: 2004
The IOM’s Committee on Immunization Safety Review was convened in the fall of 2000 to provide an independent review of increasingly prominent vaccine safety concerns. The 15 committee members with expertise in pediatrics, internal medicine, immunology, neurology, infectious diseases, epidemiology, biostatistics, public health, risk perception, decision analysis, nursing, genetics, ethics and health communications analyzed over 200 relevant studies.
AUTHOR CONCLUSION: The committee rejected a causal relationship between the MMR vaccine and autism as well as a causal relationship between thimerosal containing vaccines and autism.
http://books.nap.edu/catalog.php?record_id=10997#description

Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Andrews N et al., Pediatrics. Vol. 114 No. 3, 2004, pp. 584-591
Study analyzed thimerosal exposure and possible development delays in 109,863 children born in the United Kingdom from 1988-97. Exposure was defined according to the number of DTP/DT doses received by 3 and 4 months of age and also the cumulative age-specific DTP/DT exposure by 6 months.
AUTHOR CONCLUSION: With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.
http://tinyurl.com/7rvj6m

Autism and thimerosal-containing vaccines: Lack of consistent evidence for an association
Stehr-Green P et al., American Journal of Preventive Medicine. 2003; 25(2):101-6
Study compared the prevalence/incidence of autism in California, Sweden and Denmark from the mid-80s to the late 90s with average exposures to thimerosal containing vaccines. In all three countries, the incidence and prevalence of Autism Spectrum Disorders began to rise in the 1985-1989 period, and the rate of increase accelerated in the early 1990s.
AUTHOR CONCLUSION: The data is not consistent with the hypothesis that increased exposure to thimerosal-containing vaccines is responsible for the apparent increase in the rates of autism in young children being observed worldwide.
http://www.ncbi.nlm.nih.gov/pubmed/12880876

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data
Madsen et al., Pediatrics; Vol. 112 No. 3, 2003, pp. 604-606
Analyzed data from the Danish Psychiatric Central Research Register recording all psychiatric admissions since 1971, and all outpatient contacts in psychiatric departments in Denmark since 1995. There was no trend toward an increase in the incidence of autism during that period when thimerosal was used in Denmark, up through 1990. From 1991 until 2000 the incidence increased and continued to rise after the removal of thimerosal from vaccines, including increases among children born after the discontinuation of thimerosal.
AUTHOR CONCLUSION: The discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. The data do not support a correlation between thimerosal-containing vaccines and the incidence of autism.
http://tinyurl.com/5omq4u

Association Between Thimerosal-Containing Vaccine and Autism
Hviid et al., Journal of the American Medical Association, 2003; 290(13):1763-6
Study of 467,000 children born in Denmark between 1990 and 1996 compared children who were vaccinated with a thimerosal-containing vaccine to children who received a thimerosal-free formulation of the same vaccine. The risk of autism and other autism spectrum disorders did not differ significantly between children vaccinated with thimerosal-containing vaccine and children vaccinated with thimerosal-free vaccine.
AUTHOR CONCLUSION: The results do not support a causal relationship between childhood vaccination with thimerosal-containing vaccines and development of autistic-spectrum disorders.
http://tinyurl.com/5rtzjd


Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Heron et al., Pediatrics. Vol. 114 No. 3, 2004, pp. 577-583
The researchers monitored the thimerosal exposure of more than 14,000 children born in the UK between 1991 and 1992. The age at which doses of thimerosal-containing vaccines were administered was recorded, and measures of mercury exposure by 3, 4 and 6 months of age were calculated and compared with measures of childhood cognitive and behavioral development covering from 6 to 91 months of age.
AUTHOR CONCLUSION: No convincing evidence was found that early exposure to thimerosal had any deleterious effect on neurologic or psychological outcome.
http://pediatrics.aappublications.org/cgi/content/abstract/114/3/577

Additional studies looking at vaccine safety:

On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes
Smith M and Woods C, Pediatrics. Vol. 125 No. 6 June 2010, pp. 1134-1141

The study of data on more than 1,000 children born between 1993 and 1997 looked at their vaccination schedules up to 1 year of age, and studied their performance 7 to 10 years later on 42 different neuropsychological outcomes. Timely vaccination was associated with better performance on numerous outcomes. The less-vaccinated children did not do significantly better on any of the outcomes.
AUTHOR CONCLUSION: This comparison of children vaccinated on time with children whose vaccinations were delayed or incomplete found no benefit in delaying immunizations during the first year of life. For parents who are concerned that children receive too many vaccines too soon, these data may provide reassurance that timely vaccination during infancy has no adverse effect on long-term neuropsychological outcomes.
http://pediatrics.aappublications.org/cgi/content/abstract/125/6/1134

Measles in Minnesota: more cases and a visitor

26 Mar

We recently discussed here on LeftBRainRightBrain the measles outbreak in Minneapolis. Since then the number hospitalized has continued to rise. There are now six kids who have been hospitalized. As of March 23rd (two days ago) there were 11 cases of measles total. Why bring this up on an autism-focus blog? Because the outbreak has ties to the autism communities. One of the questions that has arisen in recent years is whether there are more autistic children amongst the Somalis in Minneapolis than amongst other groups. In response to the news that a larger fraction of young Somaili children were in the autism classes, Generation Rescue reached out to the Somali community. Andrew Wakefield reached out to the Somali community. Fear of autism appears to be behind a possible low vaccination rate amongst Somali children. And, now, Somali children have higher incidence of measles in this outbreak.

According to the MDH: “Four of the cases were too young to receive vaccine, five were of age but were not vaccinated, and two have unknown vaccine status”. Of those unvaccinated, I believe at least three were from the Somali community.

In response to the measles outbreak, Andrew Wakefield is once again speaking with the Somali community there. In Anti-vaccine doctor meets with Somalis, the Minneapolis Star Tribune reports:

Dr. Andrew Wakefield, a controversial British doctor whose research purported to link vaccines to autism, met privately with a gathering of Somali parents in Minneapolis on Wednesday night.

and,

Wakefield, who arrived amid the city’s first measles outbreak in years, declined to answer questions about the purpose of his visit. Reporters were barred from the meeting, which was described as a “support group” for parents of autistic children.

I find this closed door discussion more than a bit ironic. Calls for transparency abound when people are inquiring about the government’s actions. But Mr. Wakefield declined to even comment for the press, much less allow access to his meeting.

The Minnesota department of Public Health has translated their measles fact sheet into Somali.

It was noted that Mr. Wakefield has discussed a study on the Somali autism prevalence question:

Patti Carroll, an organizer of Wednesday’s meeting at the Safari restaurant, said that Wakefield is helping to build support for a study about rising autism rates in the Somali community.

What wasn’t mentioned is that the National Institute of Mental Health, the Centers for Disease Control and Autism Speaks are already starting a project to study the question.

I can’t help but think back to one of the Jenny McCarthy interviews a few years back. She made a comment that maybe people will have to start dying of vaccine preventable diseases before people take her seriously. My guess is that she wasn’t expecting outbreaks that could be so directly tied to her, her organization (Generation Rescue) and one of her mentors (Andrew Wakefield).

David Kirby shows he’s been out of the loop

19 Mar

David Kirby is back on the Huffington Post blogging about vaccines and autism in a piece titled CDC to Study Vaccines and Autism.

The CDC move comes one month after the federal government’s leading autism body, the Interagency Autism Coordinating Committee (IACC) announced a shift in research priorities toward environmental triggers for autism, which the IACC said could include toxins, biological agents and “adverse events following immunization.”

In case we didn’t read that paragraph, he repeats himself later:

Meanwhile, the IACC has signaled a major shift in research priorities into the causes of autism, moving away from purely genetic studies in favor of investigating the interaction between genes and environmental factors, which it said could include toxins, biological agents and vaccines.

What shift? Funding levels for environmental causation and gene-environment interactions have outpaced funding for purely genetic research for the past few years.

Mr. Kirby, I’d like to say you’d know that if you read LeftBrainRightBrain instead of the blogs and websites which claim to be asking for more research into environmental research. But I have to ask, are you really out of the loop, or does it just make a better story to claim these fake “shifts”?

Here are a few posts you might want to read, Mr. Kirby:

US proposes $154M in new autism research projects

US plan for autism research: focus on environmental causation re-emphasized

Here’s one from over a year ago:

IACC calls for $175 million in autism and the environment research

Is his post a misconception because he’s been out of the loop on another book project? No. Here’s Mr. Kirby’s introductory paragraph:

The Centers for Disease Control and Prevention wants to study autism as a possible clinical outcome of immunization, as part of its newly adopted 5-year research agenda for vaccine safety, the agency said on its website.

Take a look at the CDC research agenda that Mr. Kirby links to. It includes:

In 2004, the IOM concluded that the evidence “favors rejection of a causal relationship” between MMR vaccine and autism and thimerosal-containing vaccines and autism (IOM, 2004).
• VSD has completed a thimerosal and autism case-control study. The chief goal was to determine if exposure to thimerosal in infancy (through 7 months of age) or in-utero is related to development of autism. A secondary objective was to evaluate whether exposure to thimerosal in infancy is related to a subclass of autism predominately associated with regression. The manuscript Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism (Pediatrics) by Price CS et al. showed that prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk for Autistic Spectrum Disorders (Price CS et al, Pediatrics 2010).
• CDC funded a study in Italy comparing children who previously received thimerosal-containing or non-thimerosal-containing DTaP vaccines (Tozzi AE, 2009).
• A VSD study was completed on early thimerosal exposure and neuropsychological outcomes at 7 to 10 years (Thompson WW et al, 2007). Another study using the public dataset was published (Smith MJ, WoodsCR. Pediatrics 2010).

So, the CDC has already been studying autism as a possible outcome of vaccines. In fact, they’ve already completed it and published it: “VSD has completed a thimerosal and autism case-control study.”

And let’s not forget all the other studies of the past 10 years on MMR, and those on thimerosal. We won’t. Apparently David Kirby has. It’s “new” that the CDC would consider vaccines and autism.

And, noting that the IACC federal autism panel “suggested several studies including vaccinated versus unvaccinated children to determine if there are differences in health outcomes,” the CDC said it will convene an “external expert committee to offer guidance on the feasibility of conducting such studies and additional studies related to the immunization schedule, including studies that may indicate if multiple vaccinations increase risk for immune system disorders.”

Germany has already done one of those studies. Kev discussed it here on LeftBrainRightBrain just recently as Vaccinated Children Not at Higher Risk of Infections or Allergic Diseases, Study Suggests. The results were that people are better off vaccinated. Fewer infectious disease. No increased risk of asthma or other problems (the study size, with about 18,000 people, was too small to study autism).

Sorry if I appear to have little patience for David Kirby. It’s true. I don’t have much patience for him. He’s framed his piece in a manner which misleads. And he has no excuse.

Minneapolis reports three more measles cases

18 Mar

In Minneapolis reports three more measles cases, the Minneapolis Star Tribune discusses, well, three more measles cases in the city. Why bring this up here?

Three more children under the age of five have developed cases of measles in Minneapolis, state health officials reported Thursday, including two Somali children who were not vaccinated because of fears about the vaccine safety.

Four children have been infected. Three were hospitalized. At least two unvaccinated out of fear.

Three more children under the age of five have developed cases of measles in Minneapolis, state health officials reported Thursday, including two Somali children who were not vaccinated because of fears about the vaccine safety.

Officials said that the vaccination rate has dropped in Minnesota’s Somali community, largely because of misconceptions about the vaccine safety. Concerns about a possible link between the vaccine and autism have spread in the Somali community, as well as other communities, in spite of medical reports debunking the connection.

“Contrary to misinformation that may still be circulating, the measles vaccine is safe and effective,” said Dr. Edward Ehlinger, Minnesota Commissioner of Health. “Without it, the risk of disease is real. Children can die from measles.”

The previous case, reported March 5, involved a child under a year old who was too young to be vaccinated. Officials said they did not know whether the fourth child had been vaccinated.

I can already write the responses:
“Better measles than autism” (as though this were a real choice. MMR doesn’t increase the risk of autism)
“If they offered a safe measles vaccine, this wouldn’t have happened” (as though the MMR causes autism, making it “unsafe”)
“look at all the reports in VAERS of death/injury/etc” (as though every report in VAERS is an event caused by vaccines)
“but vaccines don’t work anyway”

I could go on with the responses, but why? They are as obvious as they are lame.

(edit to add–I missed on obvious one that has already been made: “4 cases=outbreak?”. That one just boggles the mind. How many should there be before we take action? If these were demonstrated cases of vaccines causing autism, the answer would be no more. But, hey, it’s just a life-threatening disease in children, one under a year old. I guess that “immature immune system” we hear vaccine skeptics claim is just fine at fighting a full on infection. Just not a vaccine.)

How the Lancet reviewed the 1998 Wakefield Lancet paper

28 Jan

A recent discussion here on LeftBrainRightBrain involved the peer review process and, in specific, how the 1998 Lancet paper by Wakefield and coworkers was reviewed. As I prepared a response I saw that (a) the response was getting long and (b) this gives a discussion of the peer review process in general, which could be of interest to some readers. So I decided to blog yet again about Mr. Wakefield. So, with apologies to those who have tired of Andrew Wakefied:

Here is Richard Horton being questioned about the general process of peer review of papers for The Lancet (from Day 16 of the GMC hearing). Note that it was typical for 3 referees to be engaged. It has been reported that the Wakefield Lancet paper used 6 reviewers. If so, it is very interesting. Why would the Lancet have gone after extra reviewers?

Lower down, you will find a discussion of the process involved in the Wakefield et al. Lancet paper.

Q Once that process is complete, they have seen the paper and written reports on it, what happens next?
A Those reports back in 1997 would have been sent in my mail, collated by the editor and, when all the reports were available, then he or she would present the paper plus the peer review comments at the Thursday afternoon editorial meeting and the debate would ensue.

Q Is it customary for people who have reviewed the paper to say critical things as well as positive things?
A Extremely, yes, very much so.

Q How do you handle those as far as the authors of the paper are concerned?
A We have two separate components. They say things that they are happy to be transmitted to the authors and they also provide confidential comments that they say they report to the editors, which often presents us with a tricky situation because they are frequently very polite to authors and somewhat less polite when they are discussing a paper in front of us privately.

Q On those parts that they are happy to have relayed to the authors, do you discuss any criticisms that have been made?
A On the Thursday afternoon meetings?

Q Or at all?
A We certainly debate all the pros and cons of the paper at the manuscript meeting and make a decision then whether we are going to reject the paper, seek further opinion or open negotiations with the authors.

Q Will there be, at that state, any general discussion about other matters which might be relevant to publication?
A Certainly we will be discussing whether the paper has aspects of it that might cause controversy and should be considered in judging a paper, whether there are any conflicts of interest that should be taken into account in considering the paper or any other aspects of the work that might have cause for concern.

Q At the end of that meeting, do you then make a final decision as to whether you are going to reject the paper or admit it for publication?
A Three options: either to reject, to open negotiations or to seek further opinion.

Q Can you tell us what open negotiations means?
A That means that if there are questions raised by one or more of the peer reviewers that we think require explanation or further elucidation in a revised manuscript by the authors, then we will go back to the authors and say please can you take a look at your paper, in the light of these reviewers’ comments, and make the necessary adjustments. They hopefully will take account of those questions, submit a revised version of the paper and then we go back into a Thursday afternoon discussion to decide whether that is acceptable or not.

Q The third option you said was to seek a further opinion. Is that over and above the peer reviews you have already had done?
A Yes, that is right. Particularly I would say now that is quite a common option but back in 1997 it was less common.

And here is a discussion of the Wakefield et al. 1998 Lancet paper:

Q Do you have any recollection or are you assuming that it would have been the norm as far as the number of others who were concerned?
A Yes, it would have been the norm to have sent it to three external advisers and a statistical reviewer.

Q Do you have any recollection of the nature of the reviews that were received?
A From what I can recall, there were two aspects that were most important. The first was that all of the reviewers remarked on the original nature of the description of the syndrome and felt that this was something that merited consideration for a general medical journal but there was concern about the reporting of the parents’ testimony relating to a possible temporal link with MMR vaccine.

Q We have the log book for when the paper was first discussed. I think it is right, I should say, so the Panel is clear, the actual reviews are no longer available?
A I am afraid that is so.

Q We do have the log book. If you look in the same volume, page 637, we see, in the middle of the page, the left-hand number is a manuscript number, is that correct?
A Correct. That would have meant it was submitted in November, so the first two digits reflect the month, then the next set of digits the simple sequence with which it was entered up by our office.

Q We are about ten figures down at 11096 “new GI syndrome in children”, is that correct?
A Correct, and JB refers to John Bignall under “Ed”.

Q What is the last column?
A The last column is about the decision about the paper. You can see we received two papers: one describing a new G I syndrome in children, and then a second attempting to define the cause of that syndrome. Both papers were taken through peer review by Dr Bignall. The first one, PP means put points, so a set of manuscript reviewer points were put to the authors, and the second paper was rejected after peer review.

Q As far as the title “A new G I syndrome in children” was that of any legal relevance, the title you have given it there?
A This has been a source of much discussion in the past eight or nine years. Many people have focused on the fact or asked the question was The Lancet in some way supporting the linking of MMR vaccination with this syndrome. From our point of view, when we first received the paper, the parental testimony was actually incidental. The central thrust of the paper was this new syndrome. This is not an uncommon kind of report. If you read any text book of epidemiology, the very first description of any new syndrome often comes with either a case report or a case series. If you go back and look in history at, for example, the first reports of HIV and Aids, the first reports of variant CJD, they all began with a simple case series very much like this one. Then it is quite typical for the investigators to ask, and it is their obligation to ask, the families or the patients “Do you have any thoughts yourself about any behaviours or activities you might have done that might have precipitated this syndrome?” For example, if you go back and look at the first reported series of Aids or variant CJD you see questions like that raised and the answers are very speculative. In this case, again, the answers were very speculative. Eight of the 12 families put potential temporal link with MMR vaccination was made. That was very much supplemental to the major theme of the paper which was this new syndrome.

Q Before I turn you to another page, I just wanted to complete things. As far as the second paper, which you rejected, was concerned, did that come from the same research group?
A It did come from the same research group although I cannot recall, and I do not have a record, of exactly what the authorship of that paper was. I do not recollect.

Q Can you help us as to its nature at all?
A From what I can remember, this was a laboratory study trying to identify what the possible cause of the new syndrome was. From what I can remember, this was an attempt to try to isolate a component of the MMR vaccine with this syndrome.

Q Without that paper, the paper with which we are concerned, the 11096 paper made only the temporal link, is that correct, with the MMR vaccine?
A That is exactly right. Not only did it only make the temporal link but it was made very clear in that paper that such a temporal link was not a proof of association, moreover that there was no published evidence to support any association between the vaccine and the new syndrome.

Q If you turn back to the paper, page 783 and go on to 787, the discussion session, we see, in the left-hand column:

“We did not prove an association between measles, mumps and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue.

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 UK in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps and rubella vaccine.”

Then it goes on to the possibilities of a pre-disposition. Do you recall if that paper was, so far as you can remember, in the original submission, the paper originally submitted?
A Those sentences? I certainly remember that “we did not prove an association”, that sentence, was in the final accepted manuscript, yes.

Q When the paper was submitted to you and considered at the manuscript meeting and logged as we have seen with PP beside it, were various amendments then made to the paper in agreement with the authors?
A Yes, that is absolutely routine practice in peer review. Often quite substantial change to papers are made.

Q Then ultimately a decision has to be taken as to whether to publish with those amendments in place, is that correct?
A Correct.

Q If we go back to page 645 we see, the fourth entry down on that page, 11096, now called “new syndrome in children”, is that correct?
A Correct.

Q We see the editor initials JB and then “accepted as ER”, although it is cut off, is that right?
A Yes. ER stands for early report.

Q Rather than asking you to explain that, I would like to go back to look at a description which is given in a editorial which deals with writing for The Lancet, page 615, on the left-hand side, half-way down the page:

“Early reports may simply be preliminary, the first results from a study, whereas subsequent analysis is planned, for example, of an incidental interesting observation from a study set up with another purpose or they may be early in the sense of being well short of changing clinical practice. These papers will tend to be shorter than articles.”

Does that broadly sum up what is meant by early report?
A Yes. What we were trying to do then – and I should say we have dropped the section Early Reports in more recent years – was to offer the opportunity for researchers to identify something at a very early stage before we were absolutely cast solid certain that what was being reported was totally factual. It gave the opportunity for new ideas, for innovation, to be included in the medical literature which we thought was an extremely important function of a medical journal.

Q This report was categorised as an early report and indeed it appears at the top of the actual paper. Can you help us as to which category it fell into? We see here two categories: the first results from a study where a subsequent analysis is planned, or an incidental interesting observation from a study set up with another purpose. Did you have any need to analyse?
A You are very generous in crediting our categorisation in precise terms. The way we felt about early reports was: is this a preliminary observation; is this raising something that is completely original that requires more in-depth investigation to confirm whether it is absolutely true or not. What we were trying to do in instructions to authors, because you can never cover every eventuality in written guidelines, the closest it would come to would be may be early in the sense of being well short of changing clinical practice.

Q I think it is right that when it was actually published it was published with a commentary.
A Yes. There were several mechanisms that we tried to focus on for making sure that when this paper was published it would not cause an adverse public health impact: one was obviously the statement that was obvious already in the paper about no proof of causation or association; a second was making sure that this paper was identified as an early report; but third, and possibly most importantly, we wanted to have external respected experts in measles eradication and control to offer their view. For us the comments that we published was vital in trying to set the context, which was essentially look at this paper with an open mind but please remember that measles vaccination has saved many hundreds of thousands of children’s lives and in considering this first report do not let it have an adverse effect on measles vaccination.

Q Can I ask you, first of all, how common was it at that the time for you to commission this commentary? You commissioned this commentary, is that correct?
A Yes.

Q How common was it for you to commission a commentary to go with a paper that was being published?
A Not uncommon if we were concerned about the interpretation of a paper but much less common than it is today. I would say today in almost every case a research paper will have a comment running with it.

Q Is the comment sought from somebody wholly independent from The Lancet and the researchers?
A Independent of The Lancet certainly. It is very hard sometimes to have people who are completely independent of the investigators. They are often experts in the field and fields, even globally, are often quite small. They will almost certainly be aware of the research or be aware of the investigators. They may even know the investigators very well professionally but we hope they will give an independent judgment about the quality and meaning of the paper, yes.

Q Your commissioning of it in the context of this paper. You have told us that as far as you were concerned, the reference to the link with MMR was relatively tentatively expressed. Did you nonetheless have concerns about the impact it might have?
A We did have concerns. These concerns were raised by the reviewers of the paper and they were also raised by my colleagues and myself in discussion of the paper on a Thursday afternoon. It was clear that if we were going to move ahead and publish this paper, we had two options: either we erased or asked the authors to erase the parental testimony about the possible temporal association with MMR vaccine or, if we were going to publish, we keep that in, but we give as much context as we possibly can.

Q If we could look at the commentary at page 788, it was commissioned from Robert Chen and Frank DeStefano, who work at the Vaccine Safety and Development Activity National Immunisation Program in Atlanta, Georgia. Is that correct?
A Correct. I think just to clarify, the Centre for Disease Control and Prevention is an internationally recognised centre for public health, based, as it is, in the United States, but with very strong global recognition.

Q If you do not mind bearing with me for a moment, just so the Panel can see what this is about – I am not going to read the whole of this, but if we can just run through it – we can see it says:

“Although immunisations rank among the most important public health measures, no vaccine is perfectly safe. Because vaccines are given to millions of healthy people, usually infants, extremely high standards for vaccine safety are demanded. It is therefore important to examine, critically and with an open mind, the report by Andrew Wakefield and colleagues of several children whose chronic bowel and behavioural abnormalities were linked by their parents and physicians to measles, mumps and rubella (MMR) vaccination.”

Then it sets out the various ways that adverse events of a vaccine can be said to be caused:

“ .. if it is associated with a specific laboratory finding and a specific clinical syndrome or both. Alternatively, a clinical or epidemiological study is needed to find out whether the rate of a given syndrome in vaccinated individuals exceeds that expected among unvaccinated controls. Such studies require acquisition of data in an unbiased way. Because of the inherent methodological limitations of epidemiological studies, biological plausibility, consistency, strength and specificity of association must also be considered in inferring causation. How well then do the features of the association reported by Wakefield and colleagues fit with causality?”

Then they point out:

“First, hundreds of millions of people worldwide … have received measles-containing vaccine without developing either chronic bowel or behavioural problems sine the mid-1960s. This finding provides important negative evidence as well as an appropriate framework for the assessment of [the paper].”

It goes on:

“Is the syndrome reported today clinically unique? Ileal lymphoid hyperplasia is non-specific. Autism was known well before MMR vaccine became available. Are there unique laboratory features, including detection of vaccine viruses in clinical specimens where they would not be expected? Although Wakefield has reported the detection of these viruses in patients with inflammatory bowel disease (IBD), other investigators, using more sensitive and specific assays, have not been able to reproduce these findings.”

Then it refers to a negative report which was actually in the same copy of The Lancet. It goes on:

“There is no report of detection of vaccine viruses in the bowel, brain or other tissue of the patients … ”

Then they look at the epidemiological questions:

“Is there selection bias? The Wakefield report is based on cases referred to a group known to be specially interested in studying the relation of MMR vaccine with IBD, rather than a population-based study. A first dose of MMR is given to about 600,000 children every year in the UK, most during the second year of life, the time when autism first becomes manifest. Not surprisingly, therefore, some cases will follow MMR vaccination. Biased case-ascertainment, as in this study, will exaggerate the association.”

Then it says:

“Was there recall bias. It is usually difficult to date precisely the onset of a syndrome such as autism. Parents and others may attempt to relate its onset to an unusual event such as coincidental postvaccinal reaction. The clearest example of such an association was the link between infantile spasms and pertussis vaccine;”

That is, the whooping cough vaccine –

“ … the vaccine tends to unmask rather than cause the syndrome.

There are other reasons for doubt about the association reported by Wakefield and colleagues. They suggest that MMR immunisation may lead to IBD, which results in malabsorption, consequent neurological damage, and ‘autism’. However, behavioural changes preceded bowel symptoms in almost all their reported cases.”

They go on to say:

“Vaccine-safety concerns gain prominence whenever the incidence of vaccine-preventable diseases falls to negligible levels and when the number of vaccine adverse events, whether true reactions or those coincidental to the vaccination but falsely attributed to it … rises as a consequence of high vaccine coverage. False attribution usually occurs because many developmental abnormalities first manifest in the early years of life, which is also when several vaccines – which can cause crying, fever, and, occasionally, febrile seizures – are given.”

Then it underlines the need for effective and credible systems for the detection of vaccine associated adverse events and it ends, you may think, rather prophetically, by saying:

“Without such a system, vaccine-safety concerns such as that reported by Wakefield and colleagues may snowball into societal tragedies when the media and the public confuse association with causality and shun immunisation. This painful history was shared by the UK (among others) over pertussis in the 1970s after another similar case series was widely publicised, and it is likely to be repeated all too easily over MMR. This would be tragic because passion would then conquer reason and the facts again in the UK.”

You published that commentary in those terms, Dr Horton. Did you feel that that was a responsible way forward, given the concerns which you have expressed?
A At the time, most certainly we did.

Q As far as you were concerned, did it highlight the criticisms which could be made in relation to the paper which you were publishing?
A It highlighted the criticisms that, as I recall, were made at the peer review stage, the concerns about possible bias. It highlighted what we were most anxious about, which was any adverse effect which might follow on MMR vaccination, but it also, fairly, we thought at the time, said, “Treat this study with an open mind.”

Q Did the paper in fact result in a very significant amount of correspondence to The Lancet?
A I think you might say that!

Q You say it in that tone of voice. Tones of voice do not always come over in the transcript. Are you suggesting that it was exceptional?
A Well, remember the context. The context was that when the paper was published, it was not published in a medical journal; it was launched, I think would be an appropriate word, at a press conference where other statements were made which were radically different from the statements made in the paper.

Q As far as the press conference is concerned, I think it is right that you did not attend. Is that correct?
A That is correct.

Q But Dr Bignall, the editor directly involved, did attend.
A That is correct.

Q You obviously cannot tell us anything about the press conference, because you were not present, but what I would like you to deal with is this. Did The Lancet have anything to do with the arranging of that?
A No, it did not, sadly.

Q How usual is it as an occurrence for there to be a press briefing or conference prior to the publication of a scientific paper?
A It is not common, but it is increasingly so, because often institutions, funding bodies and authors themselves want to make a splash of their paper to get more publicity for it, especially if it has something important to say. That can be for wholly good reasons. If there is a concern about the efficacy of a treatment or the adverse effect of a treatment, then it is very important that that gets wide publicity.

Q We have in the bundle an example of some of the correspondence which was generated. If you go to page 818, please – I am not going to take you through all that correspondence, Dr Horton, because I am going to invite the Panel to take some time at the end of your evidence to read the documents which we are producing – but just dealing with it very briefly, from page 818, this is the March edition of The Lancet, the paper having been published in February, we see the first letter, for instance, from the Programme on Immunisation of the World Health Organisation, the second one is from the Department of Public Health at Barnsley Health Authority. Then we have a letter which seems to come from a personal address and then at page 819 one from the Scottish Centre for Infection and Environmental Health. Going over to page 820, one from the Institute of Child Health. Would it be fair for me to summarise it by saying that those letters were mainly concerned with concerns as to the public health implications of the paper?
A Oh, absolutely.

Q We see underneath that on page 821 a reply by Dr Wakefield. Again, would it be the norm for you to give publication room to the author of a paper, if that paper has been the subject of significant criticism?
A Yes, indeed. We would consider it a fair way to conduct the debate that there would be responses, but in the same issue allow the original author to respond or in this case, as you can see, the authors divided in their responses.

Q We see, as you say, one from Dr Wakefield and then one from Professor Murch,
Dr Thomson and Professor Walker-Smith. At the end, we see also your own reply:

“The Lancet has been quick to criticise scientific and journalistic exuberance about the release of data that might unduly aggravate public concern. By contrast with these past episodes and with the implied criticism in the letters we publish this week, the paper by Andrew Wakefield and colleagues is an example of how researchers, editors and those concerned with the public’s health can work together to present new evidence in a scientifically balanced and careful way. Wakefield et al informed the UK Department of Health of their findings in 1997 and supplied them with a final copy of their Lancet paper in advance of publication.”

You then say, “(Wakefield A.J, personal communication)” So this arose as a result of information which Dr Wakefield gave to you. Is that right?
A That is right, yes.

Q You say, “There are at least four parts to this story.”
A I should just say, I do not have the second page of that. It goes on.

Q I think that is the end of your reply in relation to the correspondence.
A I think I probably would have gone on to explain what the four parts of the story were. Otherwise it would have been an extremely negligent reply on my part.

Andrew Wakefield: the last gasps of a desperate man?

7 Jan

In his interview on Anderson Cooper 360 last night, Andrew Wakefield made some amazing claims against Brian Deer, claiming Brian Deer is part of some vast conspiracy. He wants to distance himself from the word, but that’s what he’s claiming with phrases like “He’s a hit man, he’s been brought in to take me down”, “It’s a ruthless pragmatic attempt…” “Who’s paying this man, I don’t know” and a claim that Mr. Deer is paid by the Association of British Pharmaceutical Industries.

Anderson Cooper has Brian Deer on tonight:

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=health/2011/01/07/ac.autism.brian.deer.cnn

Brian Deer throws down the gauntlet and challenges Andrew Wakefield to sue him. Wakefield has already brought forth one case against Mr. Deer–and he forced to pay Brian Deer’s legal fees. Mr. Wakefield brought forth a lengthy complaint to the UK’s press complaints commission, only to abandon it without attempting to prosecute the complaint.

He also goes through a number of Mr. Wakefield’s attacks and shows that they are false.

Here’s the transcript from the Brian Deer interview:

(BEGIN VIDEOTAPE)

COOPER: Brian, overall, Wakefield is denying all of — all of the — the evidence that you have put forward in — in this — in this “British Medical Journal” report. What do you make of his — his — his defense?

BRIAN DEER, INVESTIGATIVE JOURNALIST, “THE SUNDAY TIMES OF LONDON”: Well, two things.

One, what else can he do, where else can he go but to deny it, and to make up even more tall stories about me, suggesting that somehow I’m in cahoots with the drug industry or governments or whoever else. He’s been at that one for years.

Secondly, these revelations are not just my revelations. They have been checked, exhaustively, by editors of “The British Medical Journal,” who have peer-reviewed it, who have gone back into the data individually and checked back and forth to have been sure that what I have said is accurate. So, it’s not just me.

So, I think it’s just the — the last gasps of a desperate man, really.

COOPER: I want to go over some specific things, because I think it’s important to be very specific with these allegations and with his response.

I asked Andrew Wakefield last night to respond to your report and the — the “British Medical Journal” report, which calls his study — quote — “an elaborate fraud.”

Here’s what he said.

(BEGIN VIDEO CLIP) WAKEFIELD: I have read his multiple allegations on many occasions.

He is a hit man. He’s been brought in to take me down because they are very, very concerned about the adverse reactions to vaccines that are occurring in children.

COOPER: Wait a minute, sir. Let me just stop you right there.

(CROSSTALK)

COOPER: You say he’s a hit man and he’s been brought in by “they.” Who is “they”? Who is he a hit man for?

(CROSSTALK)

COOPER: This is an independent journalist who’s won many awards.

(CROSSTALK)

WAKEFIELD: Yes, he’s…

(LAUGHTER)

WAKEFIELD: And he’s — you know, who brought this man in? Who is paying this man? I don’t know. But I do know for sure that he’s not a journalist like you are.

(END VIDEO CLIP)

COOPER: Wakefield went on to claim later in the interview that you’re being paid by the Association of British Pharmaceutical Industries.

Are you?

(LAUGHTER)

DEER: No, I’m not. I have been paid by “The Sunday Times of London.”

COOPER: Have you ever been paid by — by — by them?

(CROSSTALK)

DEER: Never, never once. I can’t even remember the last time I ever spoke to them.

I think I did have a — I did have an interview with some people who did some work for them several years ago. That’s about the closest I have ever got to the pharmaceutical industry.

In fact, one of the awards I received, the citation was that I was probably the only journalist in Britain who investigates the drug industry. So, I don’t think that one goes very far.

COOPER: What initially sparked your interest in investigating Wakefield?

DEER: Well, it was just an absolute routine assignment.

There was a television program that had been paid for by American interest to be broadcast in the U.K., and I was just assigned to do a — do a piece on it. And it started out like that.

And we asked Dr. Wakefield for an interview. And, almost immediately, within a matter of hours, complaints were being made against me to my editors by Dr. Wakefield’s personal publicist.

COOPER: When was that that you started doing these investigations?

DEER: Oh, this was in October, November 2003…

COOPER: OK, because…

DEER: … a long time ago now.

COOPER: … as you know, James Murdoch, the owner of — of your employer, “The London Times,” joined the board of GlaxoSmithKline, which is a manufacturer of MMR. He joined that board in 2009.

DEER: Yes.

(CROSSTALK)

COOPER: Some people have brought that up as a — as a conflict of interest.

DEER: No, it’s absurd, absolutely absurd.

In fact, it’s interesting that, in the last 24 hours, the only American network to have shown no interest whatsoever in the “BMJ”‘s revelations has been the FOX network…

COOPER: I asked Wake…

DEER: The only — they’re the only people.

COOPER: I asked Wakefield to respond to your reporting that — that — that states that medical records of all of the 12 cases that he initially cited in his “Lancet” paper back in 1998, that — that none of them were accurate, fully accurate.

I want to you listen to what he said.

(BEGIN VIDEO CLIP)

WAKEFIELD: That is false. He has not interviewed the parents. That is absolutely not true.

(CROSSTALK)

COOPER: So, you’re saying the parents — no parents say that what — that what you have said about their children’s medical histories is false?

WAKEFIELD: No, they don’t. What I have said and what has been reported in that paper by me and my colleagues is exactly what we saw.

(CROSSTALK)

(END VIDEO CLIP)

COOPER: Did you speak to any of the parents from the 12 cases?

DEER: I personally interviewed one, two, three families of the 12. Somebody else — two others were interviewed on my behalf by other journalists. So, that’s five of the 12.

Oh, no, actually, I interview — and I have had conversations with another, so quite a substantial number…

(CROSSTALK)

COOPER: So, you’re basically saying he falsified or — or got wrong all of the medical history, one way or another?

DEER: I — I — I showed the “Lancet” paper that Wakefield published to a father of a child in California who is child number 11 of this series of 12, and he looked at the paper, and he just looked at what it said about his own child, and he said, “That’s not true.” And that was one of the parents of one of these children in the paper.

But I think Dr. Wakefield has a — has a solution here. These revelations have been published in the U.K. jurisdiction, which is the most onerous libel jurisdiction in the world. Dr. Wakefield should sue, because, if what Dr. Wakefield is saying is true, then he would have an easy case for libel against “The British Medical Journal,” against “The Sunday Times of London,” against me personally.

If what he is saying is true, then he must be the victim of the most sustained campaign of malicious libel that has ever been inflicted on any individual in history.

COOPER: And that’s what he’s saying he is.

(CROSSTALK)

DEER: Well, you know, he has a remedy, doesn’t he?

But the reason he doesn’t take this remedy — in fact, he tried to take this remedy once before, when the doctors’ Medical Protection Society was funding him to sue me, sue the television company, sue “The Sunday Times.” And what happened at the end? He discontinued his action, and he sent me a check. I actually received a check from his lawyers to pay my legal costs.

Dr. Wakefield has a remedy. The trouble is, he can’t take that remedy, because he’s a fraudster. And, after all these years, he’s finally been nailed. We have been able to, over the years, produce the evidence that he was being paid by lawyers. We were able to show that he received three-quarters-of-a-million U.S. dollars.

Next week, we’re going to itemize in “The BMJ” his business interests and the extraordinary sums of money he intended to make from his own vaccine, from diagnostic kits, and from all kinds of other weird products he was going to sell off the back of his scare.

Dr. Wakefield did this for the money. And, finally, he’s been nailed as a cheat and a fraudster, and not just in a sort of academic vanity sense, but in an area of where children’s lives have been put at risk, and, even more importantly, in a funny way, where parents of children with autism have been left to blame themselves, thinking it was their own fault for vaccinating their child that their child has gone on to develop autism.

These are forgotten victims of Dr. Wakefield, and these are people ultimately that Dr. Wakefield preys upon.

COOPER: You know, it’s interesting, because I have gotten a lot of e-mails from parents who don’t — who still believe in Wakefield or believe the research, and are angry at — at, you know, our reporting on this, angry, certainly, at your reporting on this. I’m sure you have heard from them many times over the years.

DEER: Oh, yes.

COOPER: And it is heartbreaking, because there is no answer for what is causing autism. And, clearly, there have been problems with vaccines in the past.

What do you — what do you tell parents? What do you say to them?

DEER: Well, I say to — I say to parents when I talk to them — and, you know, you discuss these things with them, and I will tell you, the killer question to ask these parents, if you get an even conversation with them, is to say, do you blame yourself?

And they do. And I have had parents absolutely break down in tears, blaming themselves, thinking it was their fault for vaccinating their child.

Now, what Dr. Wakefield is able to do is to take that energy of guilt and self-blame, which is quite understandable, but is quite wrong, take that, exploit it, turn it into money, turn it into a business. And that’s what he’s done. And he’s having a wonderful time in Jamaica. I saw you interviewed him in Jamaica. Very nice.

COOPER: Wakefield claims that — that his findings have been independently replicated. Is that true?

DEER: That’s completely false.

COOPER: I mean, he said they have been replicated in five countries around the world. That was news to me.

DEER: Completely false. That’s absolutely, completely false. What he does is what he’s been doing in front of these parents over many years. He takes tangential pieces of research that don’t really relate to what he’s saying and represent them as somehow endorsing what he said.

One of the papers in fact which he cites absolutely, explicitly denies that anything like what he suggests has been found.

COOPER: He — he also…

DEER: He just makes it up.

COOPER: He also claims that — that he wasn’t making a connection between vaccines and — and — and autism, that — that it was parents who — who started making that, that the purpose of the study wasn’t to look at possible associations between MMR vaccinations and autism, but that association came from parents.

DEER: No, he just makes it up.

Those parents were selected by him and the lawyer and the campaign groups — actually, a campaign group organized by a mother who doesn’t have a child with autism, does have a grievously disabled child who I saw in a CNN bulletin just 10 minutes ago.

These people together selected a group of parents who blamed MMR and brought them to the hospital for them to make that allegation. That’s one of the key ways in which this research was rigged. He knew who these parents were. He would telephone them at their homes, invite them to the hospital, bring them in and get them to make the allegations to other doctors.

COOPER: What has angered you most or surprised you most in the years now since 2003 that you have been looking into and investigating this?

DEER: What has angered or surprised me most?

I think what has angered me most is the — is the distraction away from the real needs of children with developmental disorders and the real needs of families who are looking after them, because, very often, the families of children, particularly the ones that Wakefield preys on, are people who are just desperate for answers.

Some of them are financially quite challenged as well. Many of them are — are — are terrified about what’s going to happen to their children in the future. And it’s really shocked me that somebody would really prey upon the vulnerable.

It’s almost as though, if you’re vulnerable, you get picked on. It’s almost as — it’s almost an animal thing that — that people prey on these — these really unfortunate families who have got a — who have got issues.

And I — I just think it’s a shame that the energy that has gone into this anti-vaccine campaign hasn’t gone into a campaign for better services for people with disabilities, more research to get to the bottom of these kind of problems. I think it’s a great tragedy, great diversion of resources.

COOPER: Brian Deer, I appreciate your reporting and I appreciate you talking about it. Thank you.

DEER: Thank you.

(END VIDEOTAPE)

COOPER: He said a great diversion of resources for a mysterious and terrifying threat and one that is growing.

I want to show you the numbers that explain the fear. According to the Centers for Disease Control, on average, an estimated one in 110 kids in the United States have an autism spectrum disorder. That’s just under 1 percent, according to the most recent data from 2006.

The number of cases has been growing since 2002. There’s no doubt about it. Now, the rate varies among states, and it’s important to point out that autism spectrum disorder includes a — a range of developmental disabilities,with the most severe being autism.

There have also been changes in how diagnoses are made. And that may explain some of the increase, but not all of it, according to experts. Something else you should know, boys are four to five times more likely than girls to develop an autism spectrum disorder.

And while there’s no known cause yet, clues are emerging. It’s estimated that about 10 percent of kids with autism spectrum disorders have a genetic and neurologic or metabolic disorder, such as fragile X or Down syndrome.

Autism spectrum disorder is obviously an incredibly heartbreaking diagnosis for parents. It’s also extremely costly for both the families and the health care system. According to a recent study, the estimated lifetime cost to care for someone with an autism spectrum disorder is $3.2 million.

Let us know what you think. Join the live chat right now at AC360.com.

We will continue to follow the controversy.

One problem I have seen with this media frenzy over the Wakefield fraud story is that they (the media) are falling into the old traps of false balance, faux controversy, and “he-said, she said” reporting. The question isn’t whether Mr. Wakefield is guilty of misconduct. The GMC has already ruled on that. Mr. Wakefield is not “the accused” but “the guilty”.

CNN has allowed people like Andrew Wakefield and JB Handley a platform to make mostly statements which, at the initial airing, are unchallenged, and unsupported accusations. These people have much experience with handling the media and have been able to avoid the topic of of Mr. Wakefield’s fraud and his proven ethical violations. I appreciate that Anderson Cooper has gone back to do some fact checking, but the damage is already done at that point.

Here is a segment where Anderson Cooper does some fact checking on Mr. Wakefield’s claims and accusations:

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=health/2011/01/06/ac.kth.autism.debate.cnn

Anderson Cooper made an attempt to verify the claims Andrew Wakefield made. Andrew Wakefield claimed that regression followed shortly after MMR vaccination. This has never been replicated. The studies that Mr. Wakefield attempts to use as support do not support that claim. The one attempt to actually replicate the claim, the Hornig study, found there was no association between gastrointestinal symptoms, regression and the MMR.

Anderson Cooper says that the studies Mr. Wakefield cites are “beside the point”. He says that the studies found an association between GI complaints and autism…which isn’t really the case.

Mr. Wakefield and his supporters try to claim, repeatedly, that Mr. Wakefield did not suggest that MMR and autism are linked. Interestingly, his own publisher in a statement to Anderson Cooper says the opposite.

“Yesterday, ‘The British Medical Journal’ published an article deeming the research printed over a decade ago by Dr. Andrew Wakefield suggesting a connection between autism and vaccines fraudulent. Wakefield stands strong in asserting that the allegations of ‘BMJ’ journalist Brian Deer are entirely false.”

Here’s the transcript of that section:

We begin, though, as always, “Keeping Them Honest.”

Tonight, the emotional and bitter debate over childhood vaccines and autism is louder than ever, if that’s even possible. Tonight, supporters of Andrew Wakefield, a discredited doctor who’s now accused of outright fraud by “The British Medical Journal,” “BMJ,” are standing by their man. To them, he remains a hero and a victim.

Wakefield is the lead author of the 1998 study that triggered a worldwide scare over childhood vaccines. It suggested vaccines given to kids may cause autism. His study, which looked at just 12 children, has been discredited. And last year, “The Lancet,” the journal that originally published it back in 1998, they retracted the study over concerns about its methods and ethics, as well as financial conflicts of the interests — on interests on the part of Wakefield.

Months later, Wakefield actually lost his license. It was taken away, his medical license, in the U.K. And now an award-winning investigative journalist, Brian Deer, has uncovered evidence he says proves Wakefield deliberately faked his study. Deer lays out his case in a series of articles that began running last in the “BMJ” last night. In a moment, you are going to hear directly from Mr. Deer. He will respond to attacks that Andrew Wakefield made last night in an exclusive right here on 360.

Things got pretty heated. He denied point-blank every accusation laid out by Mr. Deer. Take a look.

(BEGIN VIDEO CLIP)

ANDREW WAKEFIELD, AUTHORED RETRACTED AUTISM STUDY: He is a hit man. He’s been brought in to take me down.

COOPER: Wait a minute, sir. Let me just stop you right there.

(CROSSTALK)

COOPER: You say he’s a hit man and he’s been brought in by “they.” Who is “they”? Who is he a hit man for?

WAKEFIELD: Who brought this man in? Who is paying this man? I don’t know.

COOPER: You’re basically saying this is a — some sort of conspiracy against you. Is that — is that your argument?

WAKEFIELD: Conspiracy is your word.

What this is, is a ruthless, pragmatic attempt to crush any investigation…

COOPER: Well…

WAKEFIELD: Because the truth is in that book.

(CROSSTALK)

COOPER: However, I have read Brian Deer’s report, which is incredibly extensive. Sir, I’m not here to let you pitch your book. I’m here to have you answer questions.

(CROSSTALK)

WAKEFIELD: If you read the record that I have set out in the book, you will see the truth. You will see a detailed…

(CROSSTALK)

COOPER: But, sir, if you’re lying, then your book is also a lie. If your study is a lie, your book is a lie.

WAKEFIELD: The book is not a lie.

I suggest you do your investigation properly before making such allegations.

(END VIDEO CLIP)

COOPER: Well, we believe in facts here at 360, so, today, we followed up on some of the claims that Mr. Wakefield made last night. If we got something wrong, we would want to set the record straight, obviously.

One point Wakefield was adamant about was that other researchers have reproduced his study’s findings.

(BEGIN VIDEO CLIP)

COOPER: You have been offered the chance to replicate your study, and you have never taken — taken anybody up on that. You have had plenty of opportunity to replicate your study.

(CROSSTALK)

WAKEFIELD: You just accused me of giving you a falsehood. I’m telling you that this work has been replicated in five countries around the world.

(CROSSTALK)

COOPER: Then why has it been completely discredited by — by — by public health officials around the world?

WAKEFIELD: I suggest you do your investigation properly before making such allegations.

OK, if you look up the name Gonzalez, if you look up the name Balzola and Krigsman, you will see that the work has been replicated independently by other doctors around the world. They fail to mention that in these allegations. And Deer has failed to mention that at any time. Is that honest?

(END VIDEO CLIP)

COOPER: Well, today, we tracked down three of those studies and spoke to experts about all five that Wakefield kept citing.

And what we found is, they’re basically beside the point. They looked at gastrointestinal problems in children with autism, and nothing else. Like Wakefield, they found an association between gastrointestinal problems and autism, but they say nothing at all about a connection between autism and vaccines. So his suggestion of any such link remains his alone.

Now, a lot of parents have stopped vaccinating their kids because of Mr. Wakefield’s study. There have been deadly outbreaks of infectious diseases like measles and whooping cough as a result.

I asked Wakefield about that.

(BEGIN VIDEO CLIP)

COOPER: Sir, what’s also growing in number is the number of children who have died because they haven’t been vaccinated. Do you feel any sense of responsibility for that?

WAKEFIELD: I have never said not vaccinate. I have offered, I have suggested that children have the option of single vaccines.

(END VIDEO CLIP)

COOPER: Now, what he means by that is giving kids separate vaccines for measles, mumps and rubella, rather than a three-in-one combination vaccine.

Parents in the U.S. can choose which type their kids get. We checked out the rest of his claim. And it’s true. We found no instance of him saying do not vaccinate, period.

In 2003, Wakefield told “The Sunday Herald” newspaper: “I think parents are well-informed. They are not inherently anti-vaccine, nor are we. We have advocated throughout that children continued to be protected, but, in the light of this evidence, there’s a question mark. And while that question mark exist, parents must have the choice over how they protect their children.”

That’s what he said. But, at the same time, Wakefield is the undisputed champion of the anti-vaccination movement. And the people in this movement commonly cite his research as the reason for not vaccinating their kids.

Wakefield has never stood up to put a stop to this movement. In fact, the forward of his book, the book he kept trying to promote last night, is written by Jenny McCarthy, a vocal autism activist who believes her son’s autism was caused by vaccines.

She writes: “Unfortunately, it appears that a product intended for good, vaccines, also has a dark side, which is the ability to do harm in certain children. This ability to do harm has unfortunately increased quite a bit in the last few decades because children today receive so many more shots than when — than when most parents were kids.”

McCarthy also writes that Andrew Wakefield — quote — “listened to parents who reported two things: Their children with autism were suffering from severe bowel pain, and the children regressed into autism after vaccination. He listened. He studied. And they published what he learned.”

So, even if Wakefield hasn’t said do not vaccinate in so many words, he has certainly fueled the fear and distrust of vaccines. Wakefield’s publisher released a statement today on his behalf, and its headline reads — quote — “Vaccines Continue to Ruin Some Children’s Lives While Mainstream Medical Community and Big Drug Companies Refuse to Respond to the Series Medical Concerns of Worried Parents.”

The release goes on to say: “Yesterday, ‘The British Medical Journal’ published an article deeming the research printed over a decade ago by Dr. Andrew Wakefield suggesting a connection between autism and vaccines fraudulent. Wakefield stands strong in asserting that the allegations of ‘BMJ’ journalist Brian Deer are entirely false.”

So, the release itself describes Wakefield’s research as — quote — “suggesting a connection between autism and vaccines.”

And that’s exactly why his study, which the “BMJ” now says is flat-out fraudulent, has become such a powerful piece of the autism- vaccine controversy.

Want to show you something else. This is from the study itself, the one that’s been debunked. It’s a table listing autism diagnoses in one column and then the vaccines the kids in the study received. The table also shows when the kids got the vaccines.

To an average parent, with no scientific background, that would look pretty scary, if it were true. You can see how many parents desperate for an answer might latch on to that data.

But, after seven years of investigating, Brian Deer says he’s proved the data was faked. Here’s what told me about when we talked earlier.

In the end, this is probably the last major spike of news attention for Andrew Wakefield. Sure, in his new role as spokesperson for a consortium of vaccines-cause-autism organizations, he will get in the news again. And there will be at least one more BMJ article. But, what else is there? His research efforts even before he was let go by Thoughtful House were unimpressive to say the least (remember the Monkey study that used 2 controls and claimed that unvaccinated infant monkey brians shouldn’t grow, but the vaccinated ones should?). Perhaps he will be a study author on the Generation Rescue “vaccinated/unvaccinated” study. Even that won’t gain him the notoriety of his Lancet paper. With the paper debunked, his ethical violations in pursuing that paper and others proven by the GMC hearing and, now, the entire effort described as fraudulent, what’s left? Not much.

Deadly Choices: The myth of the mild disease

29 Dec

I’ve started reading Deadly Choices and goodness me its a breath of fresh air in terms of factual analysis and also writing skill. The last autism book I read was Age of Autism so you’ll appreciate how great the difference is.

I’ll be blogging about Deadly Choices a fair bit I guess and I guess Sullivan will too (after all he is Bonnie Offit) and in this first blog post I want to discuss why the idea that certain illnesses are perceived (and indeed promoted) by the anti-vaccine lobby as mild and therefore of no risk – just another excuse to stick us all with another needle containing who knows what!!

The book Deadly Choices, makes this point crystal clear in the Introduction. Regarding a Hib outbreak in Minnesota:

[parents]…were afraid that vaccines contained dangerous additives, or that children received too many vaccines too soon; or that vaccines caused autism

…

…one mother reconsidered her decision: ” the doctor looked at me and said, ‘Your son is going to die, he doesn’t have much time.’ Honestly, I never really understood how severe the risk [was] that we put our son at.”

Deadly choices indeed.

And what about mumps? In 2009, an outbreak caused by an unvaccinated traveller coming back from England caused a chain reaction that infected over 1500 people in 8 months. The end result?

When it was over, mumps was found to have caused pancreatitis, meningitis, deafness, facial paralysis or inflammation of the ovaries in sixty-five people, nineteen were hospitalised.

Hib and mumps are just two of the diseases previously easily controlled by vaccines that are now becoming rampant again due to poor vaccination rates and the fact that such deadly and crippling diseases are now just a plane ride away.

Don’t Take the Risk: Get the Facts on SafeMinds

1 Dec

No matter what your position is on SafeMinds, I bet you found that title somewhat overly sensational. You may have thought that there was a not-so-hidden message in it. I’d love to know what your initial reaction was. Think it over before going on.

Here is one of the banner icons from the SafeMinds website. “Don’t Take The Risk” (big letters) above “Get the Facts on the Flu Vaccine” (smaller letters, below). What message does this send?

So, once again I’ll ask you to think about your initial reaction to the title of this blog post. If you found it sensational, if you found it leading, what do you think about the SafeMinds banner?

That banner is from the site you go to if you follow their advice to get more information at “safemindsflu.org”. You may recall that SafeMinds was collecting donations to fund the placement of their advertisement about flu vaccines, an ad that asked you to go to safemindsflu.org. As it turns out that fundraising effort was at least partially for naught. You can read about it in Orac’s Something to be thankful for: No anti-vaccine propaganda with my Harry Potter, or at skepchick’s Let’s all go to the movies and save ourselves some lives.

As you might guess from Autism News Beat’s, AMC says no to shouting fire in a crowded theater, AMC movie theaters decided that they would pass on the opportunity to show the SafeMinds advertisements.

Why? Well, according to a comment left on the AMC community discussion forum by an AMC employee:

Ryan Noonan, Official Rep, replied 12 hours ago
Thank you for your feedback.

I understand there’s a lot of passion on both sides of this issue, however, as an entertainment company, AMC feels our movie screens are not the proper forum for this debate.

Quite right: public service announcements aren’t for the promotion of a debate. As if to prove AMC’s decision correct, the forum then devolved into the usual debate on mercury in vaccines, with much of the usual misinformation and, as Mr. Noonan notes, name-calling:

Thank you all for taking the time to post. As I have addressed, AMC Theatres have not and will not be airing any spot about this topic. While we appreciate the feedback received, we consider this matter closed.

Per Get Satisfaction’s community guidelines, discussion about topics unrelated to AMC Theatres, as well as name calling are against Get Satisfaction’s community guidelines. Despite numerous requests to refrain from debating issues not related to AMC Theatres, there continues to be discussion and debate about vaccination. Because this is not the proper forum for this debate, I am deleting this thread, as well as any subsequent discussion about this topic in this community.

The advertisement was to put both SafeMinds and their position in the public eye. Those who wanted to could then read more on the SafeMindsFlu.org website. Here is an example of what you will find there. Under the heading “If You Are Pregnant or Have Small Children . . .”

Look at the evidence and decide if you consider the influenza virus a true threat to your family. Also consider the evidence regarding, the effectiveness of the flu vaccine in actually preventing influenza.

If you do decide to vaccinate, insist on mercury–free influenza vaccines for yourself and your children.

Do not combine the flu vaccine with other vaccines.

Do not let yourself be pressured into receiving a vaccine that you don’t want; insist that your doctor or pharmacist find you a mercury-free vaccine

Let’s look at those points.

1) “Look at the evidence and decide if you consider the influenza virus a true threat to your family.” Well, unless you are immune to influenza, then, yes, it is a threat to your family. The question is how much of a threat, not whether it is a threat. The second part is valid, consider the effectiveness of the vaccine. I would add, consider that any medical procedure, including vaccines, carries some risk.

2) “If you do decide to vaccinate, insist on mercury–free influenza vaccines for yourself and your children.” Sounds like they’ve made up your mind for you on the mercury discussion.

3) “Do not combine the flu vaccine with other vaccines.” Why would that be? Especially, why would that be from the position of mercury exposure? If, as SafeMinds claims, this discussion is about reducing the exposure to mercury, why avoid, say, a mercury free flu shot in combination with a mercury free measles/mumps/rubella shot?

4) “Do not let yourself be pressured into receiving a vaccine that you don’t want; insist that your doctor or pharmacist find you a mercury-free vaccine “. But do let yourself get pressured by SafeMinds, as they have already made up your mind that you must have mercury-free vaccines.

SafeMinds goes on:

All vaccines pose some risk, with or without mercury content. However, the influenza vaccine is of great concern, as many brands contain high levels of mercury. SafeMinds recommends that consumers read package inserts for any vaccine prior to immunization.

No idea given as to what constitutes a “high level” of mercury. Given that SafeMinds bills themselves as an autism organization, one would assume that flu vaccines have a low level of mercury. Why? Because the level of mercury in a flu vaccine doesn’t cause autism. (It is worth noting that no level of mercury exposure has been shown to cause autism).

There are valid questions that should be raised about any medical procedure, vaccines included. One reason why SafeMinds gathers so much criticism is that they do not act as a vaccine safety organization. Instead, they are an organization which uses vaccine safety information and questions.

SafeMinds cites studies in Pediatrics, some authored by employees of the CDC or vaccine manufacturors to support some of their claims that the influenza vaccine may not be effective in pregnant women and their infants. Those familiar with SafeMinds will find this ironic as any of those affiliations appear to be a basis to immediately disregard any paper that goes against the SafeMinds positions.

Another example of the methods used by SafeMinds which are deservedly criticized is their approach to the issue of the flu-mist vaccine. They give citations which conclude that the flumist vaccine (which is thimerosal free) is more effective than the injected vaccine. However, SafeMinds stops short of a clear statement such as, “Ask for the nasal spray version of the vaccine”. Why? They have no problem making a clear decision for their readers in regards to avoiding mercury. Why not recommend a vaccine that they claim is safer and more effective? Why not recommend a vaccine? Many critical readers would question whether SafeMinds is, as they would like to say, an organization promoting safer vaccines or if they are, instead, an organization which can not bring itself to recommend a vaccine because they will not support a vaccination.

Can you “get the facts” from SafeMinds? Well, you won’t get all the facts in any place as there is so much material. But, one paper I couldn’t find on the SafeMinds website was this very recent one:

Eick, A., et al, Maternal influenza vaccination and effect on influenza virus infection in young infants.

Here’s the abstract:

Objective To assess the effect of seasonal influenza vaccination during pregnancy on laboratory-confirmed influenza in infants to 6 months of age.

Design Nonrandomized, prospective, observational cohort study.

Setting Navajo and White Mountain Apache Indian reservations, including 6 hospitals on the Navajo reservation and 1 on the White Mountain Apache reservation.

Participants A total of 1169 mother-infant pairs with mothers who delivered an infant during 1 of 3 influenza seasons.

Main Exposure Maternal seasonal influenza vaccination.

Main Outcome Measures In infants, laboratory-confirmed influenza, influenzalike illness (ILI), ILI hospitalization, and influenza hemagglutinin inhibition antibody titers.

Results A total of 1160 mother-infant pairs had serum collected and were included in the analysis. Among infants, 193 (17%) had an ILI hospitalization, 412 (36%) had only an ILI outpatient visit, and 555 (48%) had no ILI episodes. The ILI incidence rate was 7.2 and 6.7 per 1000 person-days for infants born to unvaccinated and vaccinated women, respectively. There was a 41% reduction in the risk of laboratory-confirmed influenza virus infection (relative risk, 0.59; 95% confidence interval, 0.37-0.93) and a 39% reduction in the risk of ILI hospitalization (relative risk, 0.61; 95% confidence interval, 0.45-0.84) for infants born to influenza-vaccinated women compared with infants born to unvaccinated mothers. Infants born to influenza-vaccinated women had significantly higher hemagglutinin inhibition antibody titers at birth and at 2 to 3 months of age than infants of unvaccinated mothers for all 8 influenza virus strains investigated.

Conclusions Maternal influenza vaccination was significantly associated with reduced risk of influenza virus infection and hospitalization for an ILI up to 6 months of age and increased influenza antibody titers in infants through 2 to 3 months of age.

So, vaccinating a pregnant mother reduces the risk of the infant getting the flu (and getting hospitalized as a result). That is contrary to the message I see coming from SafeMinds. They do host another, older study that showed no statistically significant difference in children of vaccinated or unvaccinated mothers. Will they update their webpage to include this new study?

SafeMinds does bring up some valid questions on vaccine safety. And, contrary to how they like to present the discussion, vaccines (and all medical procedures) are not above challenge. However, they tend to use safety questions more as a tool rather than as honest discussion points. Perhaps I missed it, but can you find them bringing up these questions? How can we make influenza vaccines more effective? Isn’t that a laudable goal? Isn’t a universal influenza vaccine be a good goal, rather than the current method of trying to guess which specific strains will be in circulation for the upcoming season? Why haven’t simple safety improvements been made sooner. Changes such as the move to cell-based cultures over egg based cultures which run the risk of allergic reactions. Note that a new flu vaccine plant was being built in the US which would make the move to cell based cultured vaccines. Instead they concentrate on mercury and autism–mercury being the most thoroughly studied vaccine ingredient when it comes to autism (as in, multiple studies, large studies, good studies, have failed to find a link).

Callous Disregard: “That Paper”

16 Nov

We recently discussed here on LeftBrainRightBrain some sections of the transcripts from the GMC fitness to practice hearing that was held for Andrew Wakefield. I’ve recently added Mr. Wakefield’s book, Callous Disregard to my reading mix. Frequent visitors to LeftBreainRightBrain may have noticed that my blogging output has dropped. There is just so much, so much, to respond to in that book that it has become difficult to find good and somewhat brief examples of the misinformation that Mr. Wakefield is attempting.

As you can see, even this example isn’t so brief. But it does show a clear example of Mr. Wakefield’s methods, past and present.

Mr. Wakefield likes to use citations. They look good and, if you don’t look closely, they make it seem like he has data to back up his claims. Catherina at JustTheVax blogged that Andrew Wakefield uses references to support his ideas, but if you follow those references you get a very different story. Catherina’s example showed that Mr. Wakefield claimed that his work has been replicated by others when, in fact, his references showed nothing of the sort. No surprise: he does this again in his book. The citations don’t prove his point. Much to the contrary, in fact.

Following that sleight of hand, as I followed some of his references and checked with the GMC hearing transcirpts I kept finding more and more examples of exactly why he lost his license to practice medicine.

For example:

1) Mr. Wakefield knew full well that many of the parents of the children being seen at the Royal Free were on the road to litigation. Not only that, but Mr. Wakefield’s stated goal was “…to make sure that their legal cases are presented in the best possible light”.

2) Mr. Wakefield did not make his activities with the legal aid board public. He informed one of his authors, but there isn’t evidence he informed the other 11. If he knew it was important to inform one author, why leave the rest in the dark about his activities?

3) Mr. Wakefield claims that a news story made his activities public. The news story never mentions his name. In fact, it tends to prove just what Mr. Wakefield denies. The news article states that the study at the Royal Free was being organised by silicitors.

Orac over at Respectful Insolence would call “Callous Disregard” a “target rich environment”. At some point, when every page, every sentence, every reference has a high probability of being false, it becomes something worse. I have to pull in a popular culture reference–the Princess Bride–as this is what comes to mind as I read “Callous Disregard”: it is a land war in Asia.

This comes to mind because I am bogged down and it is only chapter 1.

Chapter 1 of his book is entitled “That Paper” and focuses on the 1998 article in the Lancet. Mr. Wakefield published essentially the same discussion of “That Paper” in the magazine The Autism File.

Let’s just pick a couple of the so-called “myths”, shall we? From Callous Disregard:

My involvement as a medical expert was kept “secret”[14].

False– at least one year before publication, I informed my senior coathors[15], the head of the department, the dean of the medical school[16], and the CEO of the hospital. This fact was also reported in the national press 15 months prior to publication.

He informed his “senior” coathors? Why not everyone? Let’s take a look at citation 15, shall we?

[15] Correspondence between Dr. Wakefield and Professor Waker-Smith, February 3, 1997 and February 20, 1997.

Do you know based on that what letters he is talking about? They are in the transcripts for the GMC hearing, and they are in the press complaints commission (PCC) complaint that Mr. Wakefield filed (is he actually moving on that at all, by the way? It seems to be hanging for a long time with no activity).

The letters are reproduced below.

Note a few things here. This is in February 1997. That’s a year before the Lancet study was published. Mr. Wakefield’s letter is not to his “senior coauthors”, plural, but to one coauthor. He had 13 authors. So were eleven co-authors left in the dark? Why only let one author know?

Also note that the children in the Lancet study had already been seen at the Royal Free. Child 1 was admitted in July 1996. Mr. Wakefield had seen the children and he knew that many were pursuing claims. Mr. Wakefield felt it his duty to “…make sure their legal cases are presented in the best possible light”.

That is a very clear conflict of interest.

Here is the letter:

“Dear John

re: Enterocolitis and regressive autism

Further to our meeting on Tuesday 21 January, I thought it important to write to you to clarify my role in the legal issues. I fully appreciate your desire not to become involved in the legal aspect of these cases, but I feel that it is important to express the reasons that I do feel obliged to become involved.

The future for the children with whom we are dealing is very bleak indeed. Not only are the provisions for these children within the community inadequate at present, but looking ahead to the future, there will come a time when the parents of these children die, and the patients, as chronically disabled adults, left to fend for themselves in an extremely hostile world. Were there any long-term institutions left for such children, then that is where they would end up. Since these hospitals are being closed on an almost weekly basis around the country, these hopeless individuals will be left to ‘care in the community’. One does not like to imagine how it will all end. Maybe their only hope is in people taking the possible organic basis of their disease seriously enough to investigate it and institute the appropriate therapies where possible.

Vaccination is designed to protect the majority, and it does so at the expense of a minority of individuals who suffer adverse consequences. Although the case against MMR is far from proven it is one that we are obliged to investigate in view of the consistent history given by these patients’ parents and by the observations made in the United States. If this disease is caused by the MMR vaccination, then these children are the few unfortunates that have been sacrificed to protect the majority of children in this country. If this is the case, our society has an absolute obligation to compensate and care for those who have been damaged by the vaccine for the greater good. This is an inescapable moral imperative and is the principal reason that I have decided to become involved in helping these children pursue their claims. I have considered this issue in great depth and, whilst it may not be the wish of others within the group to become involved, it falls to me to make sure that their legal cases are presented in the best possible light. Fortunately, this is entirely consistent with best clinical practice which, I believe, you are providing for these children. I felt it important, however, to let you know of my feelings on this, and the position that I feel I am obliged to adopt to support these children. Without our help, I genuinely believe that the medical profession would otherwise put them to one side, as it appears to have done in many cases already. My present fears for these children are much less than the horrible imaginings if they do not receive the appropriate help that is due to them at this stage. However, I am an optimist, and I believe that this project will turn out to be both enlightening and rewarding for all those who have been involved, and I am most grateful for your help and encouragement.

Kindest regards & best wishes,

Yours sincerely”

Here is Prof. Walker-Smith’s response. Note this sentence (with emphasis added): “It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest.”

“Dear Andy

Re: Enterocolitis and Regressive Autism

Many thanks for your letter of 3 February concerning the legal issues. I can exactly understand your position and I can appreciate the compassionate human side of your argument.

My position as with measles, MMR and Crohn’s disease is that the link with MMR is so far unproven. It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest. I myself simply will not appear in court on this issue.

I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation.

I am very excited by this work and it is very worthwhile. Simon Murch and I met today and have drawn up a draft for patient selection for your comment please.

I also feel that Dr Harvey’s contribution to the study should now be concluded and Dr Andrew Lloyd-Evans asked to join us. Do you agree with this?

With Kind Regards
Yours sincerely”

Prof. Walker-Smith made a very good comment here: I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation.

Another “myth” which Mr. Wakefield chose to address:

Children were litigants[19].

False–at the time of their referral to the Royal Free, the time material to their inclusion in The Lancet paper, none of the children were litigants.

I don’t know what definition of “litigant” Mr. Wakefield is using, but “nearly all” of the parents were involved in preparing legal action, according to Dr. Walker-Smith. Also, Mr. Wakefield was working to “…make sure their legal cases are presented in the best possible light”.

Mr. Wakefield can define terms and redefine the English language however he wishes. I deserved to hear that the parents were pursuing legal action and I deserved to hear that Mr. Wakefield was working to help those families in their cause.

Let’s go back to another statement by Mr. Wakefield.

This fact [Mr. Wakefield’s involvement as a medical expert] was also reported in the national press 15 months prior to publication[17].

As evidence of this He cites this article in the Independent. The article doesn’t mention Andrew Wakefield at all, much less mention his side job as a paid expert for the MMR litigation:

The article [17] can be found on Brian Deer’s website. I copy it here, but will replace it with a link should he make that request.

Law: A shot in the dark; The complications from vaccine damage seem to multiply in the courtroom, writes Grania Langdon-Down

The Independent (Law, Page 25) November 27 1996

Rosemary Kessick has watched her son William deteriorate from a bright, active toddler to a destructive eight-year-old who cannot talk, play or feed himself and who lives in a frantic, rushed world of his own. She blames the MMR (measles, mumps and rubella) vaccine for the devastating changes in William, now diagnosed as autistic and suffering from a debilitating inflammatory bowel disorder which can leave him screaming with pain.

William is one of 10 children taking part in a pilot study at the Royal Free Hospital in London, which is investigating possible links between the measles vaccine with the bowel disorder Crohn’s Disease, and with autism. The study is being organised by Norfolk solicitors Dawbarns, one of two firms awarded a contract in 1994 to co-ordinate claims resulting from the MMR vaccine.

Mrs Kessick, 42, had to give up her job as a business manager to look after William, the middle of her three children. William joined the other 300-plus children bringing claims through Dawbarns only in February, because the doctors she saw during her traumatic search for answers dismissed her fears about the vaccine out of hand.

“Within weeks of the vaccination, his development slowed down, then it stopped and then he regressed. Seeing what has happened to him has broken our hearts. It means so much to finally be listened to and to find people to stand up and say the safety of these vaccines must be investigated,” she says.

Concern about vaccination has resurfaced with the Government’s campaign to introduce a new MMR booster for all four-year-olds. Most of those children will have had their first MMR at about 15 months.

The Department of Health dismisses suggested links with autism and Crohn’s disease as the work of just one researcher, and argues that children are at far greater risk from measles than from the vaccine. The latest campaign, launched on the advice of an independent committee of doctors, was needed to stop the build-up of unvaccinated children, which would inevitably lead to new outbreaks of measles.

Dawbarns partner Richard Barr is co-ordinating the families’ claims. Depending on the results of the scientific study and counsel’s advice, he intends taking on the vaccine manufacturers using the Consumer Protection Act, 1987.

The Act was introduced to offer a system for dealing with no-fault liability without the need to prove negligence, and was intended to help cases such as those involving vaccine damage.

However, critics argue that it has not been widely used because of the extensive defences offered to manufacturers. These include the “development risks” defence which says manufacturers will not be liable if, with reasonably diligent research, they would not have been able to find the fault that is now causing the problem.

The development risks defence is being challenged in the European Court as being outside the terms of the European Directive on consumer protection legislation, because it effectively incorporates negligence back into the strict liability provision.

Mr Barr also intends to pursue the medical negligence aspect but, to date, there has never been a successful compensation claim for vaccine damage under negligence laws.

Mr Barr said: “The whole field of vaccine litigation was brought to a shuddering halt by the High Court judgement in Loveday and Renton in 1988, which involved the whooping cough vaccine.

“The case centres on whether the vaccine caused brain damage, but it went horribly wrong and the outcome was the judge concluded it did not. The case was based mainly on expert opinion rather than scientific evidence and the manufacturers were able to marshal massive resources to defeat the plaintiff’s experts. We will have to try to make sure we do not fall into the same traps.”

One result of the Loveday case was that the Legal Aid Board applied the result to all vaccine damage cases and generally refused to grant aid.

Mr Barr said: “For a year, we were without legal aid but we battled on until we were eventually granted it to pursue the possibility of bringing cases under the Consumer Protection Act.

“The benefit is you do not have to prove negligence – you simply have to prove the vaccine caused the damage and that it is an unsafe product. We will also have a strong argument that parents were given no, or insufficient, information or warnings about the possible risks of the vaccine to be able to give informed consent to its use.

“I am sure the manufacturers will try to discount any causal link between the vaccine and the damage suffered by the children. They will also argue that the benefits of being immunised far outweigh the risks from the vaccine. But we will argue that the dangers of these childhood disease have been exaggerated to terrorise parents into vaccinating their children.

“I also do not think the ‘development risk’ defence is a runner, because we would argue the mechanisms of how the damage is caused have been known since the Sixties when the measles vaccine was first being tested.”

He said another line of attack would be to focus on clusters of similar side-effects associated with particular batches of vaccine, although the main thrust remained against the vaccine as a whole.

Mr Barr, who refused to let his children be vaccinated, said their research was being helped by having an in-house scientist working on the cases. Kirsten Limb initially came to them as a client after her daughter was left severely disabled through medical negligence.

Jack Rabinowicz, a partner at Teacher Stern Selby, has been involved in vaccine damage cases for a decade and is chairman of the solicitors’ steering group dealing with whooping cough claims.

He was pessimistic about the likely success of cases brought against the vaccine rather than a specific “bad batch”.

“My view is that you have to show a child was damaged by vaccine from a bad batch, as happened in a case in Ireland in 1994 which resulted in more than pounds 2m compensation. The court found in favour of the claimant after hearing that the vaccine had failed internal toxicity tests but was still put on the market.

“A full frontal attack against the vaccine itself is much more difficult. The steering group is waiting for advice from counsel and, if it is reasonably optimistic, will issue writs early next year. They will involve product liability claims against manufacturers over specific ‘hot lots’ of the vaccine and medical negligence claims against individual doctors who ignored the contraindicational warnings about having the vaccinations.”

He said the cases were at the frontiers of medicine and law and the Legal Aid Board was rightly worried about committing public money unwisely. “There have been a number of disastrous product liability cases and these will be David against Goliath because the manufacturers and doctors have unlimited resources to fight their corner.

“I think the only thing that will change the situation is if Richard Barr and I get our cases off the ground and the manufacturers and doctors scream merry hell at the prospect of paying millions in compensation and put pressure on the government of whatever hue to provide state aid.”

The only help currently offered by the government is through the Vaccine Damage Pay Unit. Since it was set up in 1979, it has received 3,749 claims and made 883 awards. However, these have been capped at pounds 30,000 since 1991, and apply only if a child is 60 per cent disabled.

Mr Rabinowicz said: “If these children were birth victims they would receive about 2m each. These vaccine-damaged children would be looking probably for upwards of pounds 1m.”

There is no reference to Andrew Wakefield in the above article. The reference to the study at the Royal Free is this paragraph:

William is one of 10 children taking part in a pilot study at the Royal Free Hospital in London, which is investigating possible links between the measles vaccine with the bowel disorder Crohn’s Disease, and with autism. The study is being organised by Norfolk solicitors Dawbarns, one of two firms awarded a contract in 1994 to co-ordinate claims resulting from the MMR vaccine.

“The study is being organised by Norfolk solicitors Dawbarns….”

So, an article which Mr. Wakefield cites in his defense states that there is a study ongoing, organised by solicitors, on the link between mealses vaccine, bowel disorder and autism.

Keep that in mind when you read this other so-called “myth”:

Children were “sourced” by lawyers to sue vaccine manufacturers.

False– children were referred, evalueated and investigated on the basis of their clinical symptoms alone, following referral from the child’s physician[18]

I’ve only covered some of the “myths”, and that is only part of chapter 1 of “Callous Disregard”. There are 13 chapters, an afterword and an epilogue. There are hundreds upon hundreds of pages of GMC testimony.

It is a land war in Asia. I don’t plan to drag myself or LBRB through it all. My hat is off to the people who sat through the entire GMC hearing, read and reread the transcripts and boiled it down to a decision, only to have Mr. Wakefield attempt to rewrite history, complete with citations.

Safeminds comments on the latest thimerosal-autism study

21 Sep

SafeMinds is an organization which has long promoted the idea that thimerosal caused an autism epidemic. They may be the single greatest force that got the idea into the public’s eye, and got research funding focused on looking at the question.

SafeMinds has shown themselves to be very resistant to the very research they called for. Studies which show a lack of association between thimerosal containing vaccines (TCV’s) and autism are always rejected by SafeMinds. They are not alone in this, groups such as Generation Rescue and the National Autism Association (NAA) have also refused to accept the science.

So it was with no surprise that I read that SafeMinds had issued a statement against the study. The statement starts by pointing out that the study was funded and performed by those with conflicts–the CDC, Abt (an organization which does contract research for groups including the CDC), and HMO’s “which receive substantial funding from vaccine manufacturers to conduct vaccine licensing research”.

If we can’t use the HMO’s to work on such project, that sort of takes away the VSD as a tool. It certainly takes away the opportunity to do anything more than passive surveillance of the VSD data. One of the strengths of the Price study was the effort to do more than just review the medical charts. They worked with the children, both cases and controls, to verify that the autism counts were accurate. I bring this up because groups like SafeMinds frequently request access to VSD data.

SafeMinds also discusses the study methodology:

The study sample did not allow an examination of an exposed versus an unexposed group, or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates.

There is much wrong with the above statement. Let’s start with where they are close to correct. The study sample did not allow for a direct comparison (with good statistics) of exposed vs. unexposed. This is true. This is because there are few unexposed kids (unexposed=no thimerosal exposure in this study. Unexposed does not mean no vaccines). If you look at exhibit 9.1.4 from the technical reports by Abt associates (the detailed reports on the study), you will see about 20-30 “unexposed” children. I.e. children with no thimerosal exposure. Of those, about 3-4 (out of 1,000) had no HiB, HepB or DTP vaccine vaccine at all (MMR isn’t listed as it is not a source of thimerosal). This is in line with estimates by the CDC of how many children are unvaccinated (typically about 0.4%). (as an aside–this points out how difficult it would be to do a good study of vaccinated vs. unvaccinated children using the VSD. Seriously, with 99.6% of kids receiving at least one vaccine, you would need a huge number of kids to get the number of unvaccinated needed for good statistics).

Here is that exhibit, with the no-exposure kids circled. (click to enlarge)

It would appear to this reader that the issue of unexposed vs. exposed isn’t so much one of “study design” as the limitations of the VSD itself. There just aren’t that many autistic kids to make a good statistical comparison of unexposed vs. exposed populations.

And, it should be noted, an unexposed vs. exposed comparison wasn’t the purpose of this study. One big question posed by SafeMinds and later picked up by groups such as Generation Rescue was simple: did the increase in thimerosal exposure from vaccines in the 1990’s result in an “epidemic” of autism? This is the question this study addressed.

I am at a loss as to why SafeMinds wrote this: “….or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates”. Contrary to SafeMinds’ assertion, there is a large variation on thimerosal exposure in the study subjects. One of the surprising facts from this study was the number of children receiving thimerosal-free vaccines. This, together with variations in the number of vaccines administered, led to a much larger distribution in thimerosal exposures than one would expect based on the vaccine schedule alone.

Thus, the study was not on “timing” at all. It was, as advertised, on variation of exposure of thimerosal. The question is (at least to me), does the range of exposure amount to significant number of kids having “low” levels of exposure by SafeMinds’ definition?

The answer, it turns out, is yes.

Safeminds has the following statement on their website:

[Autism] remained rare (1 in 10,000) until the rapid escalation of vaccines beginning in the late 1980’s (from 10 shots of 7 antigens in 1983 to 36 shots of 15 antigens). Vaccines are a likely candidate to explain some, if not most of the rise in autism cases and possibly other chronic childhood disorders linked to immune system malfunction.

In one of the seminal papers on the thimerosal was co-written by SafeMinds founder Lyn Redwood Autism: a novel form of mercury
poisoning. In it, the authors state:

The discovery and rise in prevalence of ASD mirrors the introduction and spread of TMS in vaccines. Autism was first described in 1943 among children born in the 1930s (123). Thimerosal was first introduced into vaccines in the 1930s (7). In studies conducted prior to 1970, autism prevalence was estimated, at 1 in 2000; in studies from 1970 to 1990 it averaged 1 in 1000 (124). This was a period of increased vaccination rates of the TMS containing DPT vaccines among children in the developed world. In the early 1990s, the prevalence of autism was found to be 1 in 500 (125), and in 2000 the CDC found 1 in 150 children affected in one community, which was consistent with reports from other areas in the country (126). In the late 1980s and early 1990s, two new TMS vaccines, the HIB and Hepatitis B, were added to the recommended schedule (7).

I know I am spending a lot of time on this point, but it is important. The idea that there is a dose-response relationship between thimerosal and the presumed risk of autism is fundamental to the arguments made by groups like SafeMinds.

A sister organization to SafeMinds, Generation Rescue, says the same thing. In their take, “This is the schedule from 1983. If it worked for kids then, why doesn’t it work for kids now?”. Generation Rescue leader and spokesperson Jenny McCarthy wrote in her book, Healing and Preventing Autism: A Complete Guide, “In 1983, we had 10 shots on the vaccine schedule and autism was one in 10,000. Today there are 36 given and autism is nearing one in 100”. I.e. if we go back to the 1983 vaccine schedule, autism rates should drop to 1 in 10,000.

The 1983 schedule, as graphically presented in expensive full page newspaper ads by Generation Rescue, included 4 DPT shots (yes, the old whole cell pertussis vaccine). Each of those shots included 25 micrograms of mercury.

It strikes this reader that the thimerosal exposure from 4 DPT shots, the amount in the 1983 schedule that supposedly only resulted in 1 in 10,000 kids having autism, should be a “low” exposure amount. If groups are going to point to 1983 as a safer schedule and point to the increases in thimerosal exposure in the 1990’s as the major sign of the “epidemic”, we should be able to take their word that the levels in 1983 were somehow safer.

Let’s look at that figure from the Price study again, shall we? I will highlight how many kids have “low exposure” (i.e. comparable to the 1983 vaccine schedule) to thimerosal. Again, click to enlarge if you wish.

By my eye, something approaching 50% of the kids in the study received the thimerosal exposure of the 1983 schedule. Certainly more than 25%. Those highlighted in red have the same thimerosal exposure as kids did in 1983, so they should have the same autism prevalence that SafeMinds and Generation Rescue claim for that time period: 1 in 10,000.

If that group has a prevalence of 1 in 10,000–or even anything significantly lower than the prevalence of those with higher thimerosal exposure– this study would have found it.

In other words, a thimerosal-induced epidemic of autism didn’t happen. Even using the logic that SafeMinds used to hypothesize it in the first place:that, somehow, the thimerosal exposures in 1983 resulted in a low autism prevalence.

Yes, this is far from rigorous. But, so is the logic that claims that increased thimerosal exposure led to an autism epidemic.

If we read further into the SafeMinds response, we see some of the confusion:

The study sample did not allow an examination of an exposed versus an unexposed group, or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates. There were virtually no subjects who were unvaccinated and few who were truly less vaccinated; rather, the low exposed group was mostly just late relative to the higher exposed group, ie, those vaccinating on time.

SafeMinds seems to be assuming this is a study on the number of vaccines, not the amount of thimerosal. They also don’t appear to have read the study thoroughly enough to note that, yes, there is a large fraction who were “less vaccinated” and, more importantly to this study, a large fraction who had lower thimerosal exposures. As noted above, the low thimerosal exposures result from the fact that many of the children received thimerosal free vaccines.

It is unfortunate that SafeMinds (and other groups like them) can not adapt to science as it comes out. Science which clearly shows that many of their hypotheses were wrong.

The Respectful Insolence blog also discusses some of the failings of the SafeMinds response.

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