Vaccine Science is Not Settled: A Critical Review of the Literature

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A White Paper by Brian S. Hooker, PhD, PE,
and the Alliance for Natural Health USA

Purpose

Since the modern inception of public mistrust in vaccines in the late 1990s, in the wake of a since-retracted study published in The Lancet by Andrew Wakefield in 1998,[1] a handful of sporadic and hastily completed epidemiological studies have been used by the media and various government agencies as evidence that vaccines are safe. As Mark Twain quipped, “Facts are stubborn, but statistics are more pliable.” There are many ways in which data is chosen, manipulated, and compared, and the average person with only a basic knowledge of statistical methods must take the word of the author that the results are “proof.” Important policy decisions and laws are being made, and public debate is being suppressed, based on the unexamined assumption that the science on vaccine safety has been settled. The Alliance for Natural Health USA (ANH-USA) and Dr. Brian Hooker have teamed up to rigorously scrutinize twelve of the papers most often cited as proof positive that vaccines are safe. Each review presents the study’s overview and findings, along with an analysis of the findings, and a final statement of the authors’ conflicts of interest.

Summary of Findings

Generally speaking, each study was conducted by researchers connected to government immunization offices or drug companies, thereby giving them a vested interest to “prove” that vaccines are universally safe. Other problems were identified: poor sample choice, data inconsistencies, unproven assumptions, subjective dismissals of data contrary to conclusions, faulty comparisons, unreliable methods, and unsupported conclusions. Given these flaws, one cannot take this research as proof positive that vaccines are as universally safe for children as pharmaceutical companies and government agencies claim. We do not posit that vaccines are a cause of autism—but we point out that these studies cannot allay all concerns, given the following issues.
No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study (1998)[2]
Authors:
Peltola H, Patja A, Leinikki P, Valle M, Davidkin I, Paunio M.

Study overview: This study was conducted in response to a previous study conducted by Andrew Wakefield et al. in 1998 which suggested a link between the measles, mumps, and rubella vaccine, and chronic inflammatory bowel disease related to autism.[3] Peltola et al. reviewed data from the US Vaccine Adverse Event Reporting System (VAERS) to claim that GI symptoms were rare after the measles, mumps, and rubella (MMR) vaccine. Their findings come from data that showed 31 individuals complaining of gastrointestinal symptoms after receiving the MMR vaccine out of 3 million vaccines administered in the years studied. This study is often cited as evidence that the MMR vaccine is safe.

Study’s flaws: The VAERS database is a federally funded surveillance system based on self-reporting, meaning that only those with the wherewithal to report their adverse event will do so.[4] The VAERS system itself states: “‘Underreporting’ is one of the main limitations of passive surveillance systems, including VAERS. The term ‘underreporting’ refers to the fact that VAERS receives reports for only a small fraction of actual adverse events.”[5] By VAERS’ own accounts, many more than 31 may have experienced symptoms without reporting them. This type of study is inherently limited by relying solely on VAERS data. It cannot rule out that a larger population experienced GI systems after receiving the vaccine, nor can it rule out that a specific subpopulation could be vulnerable to the MMR vaccine, similar to the children evaluated in the 1998 Lancet study.

Conflicts of interest: This study was funded by Merck, which makes the current formulation (MMR-II) of the measles, mumps, and rubella vaccine, and stands to profit from results that disprove any dangers.

 

A population-based study of measles, mumps, and rubella vaccination and autism (2002)[6]
Authors:
Madsen KM, Hviid A., Vestergaard M., Schendel D, Wohlfahrt J, Thorsen, P.

Study overview: Admitting that previous studies disproving the link between MMR vaccine and autism were limited by design, and responding to the World Health Organization’s call for further study, the authors sought a larger data sample to increase the statistical analysis capabilities. They conducted a retrospective study on children born in Denmark between 1991 and 1998, after the MMR vaccine was approved for use in Denmark in 1987. They compared the cohort of unvaccinated children to the nearly half a million children who received the vaccine, and found an insignificant relative risk of autism and autism spectrum disorders in the vaccinated population.

Study’s flaws: The data presented by the researchers in their findings is inconsistent, calling into question their entire methodology. Table 1 reports 269 vaccinated children with autistic disorder and 47 unvaccinated children with autistic disorder. Table 2 reports 263 vaccinated children with autistic disorder and 53 unvaccinated children with autistic disorder. Using one set of numbers instead of the other changes the results from slightly less than a relative risk of 1 to slightly more, when the vaccinated cohort is compared to the unvaccinated. That their findings are based on inconsistent data should be enough for credible reporting on vaccinations to not cite the study. Also, the authors themselves admit that this type of study does not rule out that a subpopulation could be vulnerable to the MMR vaccine as presented in the 1998 Lancet study.

Conflicts of interest: This study was funded by the National Immunization Program (NIP) at the US Centers for Disease Control and Prevention (CDC), which had a vested financial interest in increased uptake of the MMR vaccine, as it directly bought the vaccine from Merck and distributed it for reimbursement to the states’ public health departments. Also, one of the co-authors of the study, Dr. Diana Schendel, was a CDC employee at the time of publication. In addition, three of the co-authors (Dr. Mads Melbye, Mr. Jan Wohlfahrt, and Mr. Anders Hviid) were employees of Staten Serum Institut, a for-profit company that manufactures and distributes vaccines in Denmark.

 

Do children who become autistic consult more often after MMR vaccination? (2001)[7]
Authors:
DeWilde S, Carey IM, Richards N, Hilton SR, Cook DG

Study overview: The researchers posited that if the MMR vaccine was causing autism, then children with symptoms would have a significant increase in general practitioner doctor visits post-immunization. Data from England during the years 1989–2000 was used to compare visits to the primary care provider of autistic children versus visits by non-autistic children within six months of receiving the MMR vaccine. They found no significant increase in doctor visits within this six-month time period.

Study’s flaws: The premise of this paper is based on the assumption that if the MMR causes autism, then the number of general practitioner visits would increase for autistic children after the administration of their first MMR vaccine. This does not take into account the total number of practitioner visits, which would include specialist visits. It stands to reason that most general practitioners would not see autistic children at a greater frequency but instead would make referrals to specialists, such as behaviorists, neurologists and gastroenterologists, who would be sought out to attend to the symptoms of an adverse reaction. The data also does not show how many children may have sought treatment for their symptoms outside of the narrow 6-month window studied. Finally, there were no autism specialists among the authors who could speak to how and when autism presents and is diagnosed.

Conflicts of interest: DG Cook, one of the paper’s authors, worked as a professor in the Department of Public Health Sciences at St. George’s Hospital Medical School. Public health practitioners are generally trained to accept vaccination policies without question and would not serve as objective researchers.

 

Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study (2002)[8]
Authors:
Taylor B, Miller E, Lingam R, Andrews N, Simmons A, Stowe J.

Study overview: This paper focused on autism cases identified in five districts of London, England, for children born nine years prior to and nine years after the introduction of the MMR vaccine in the UK in 1988. The authors hypothesized that if autism were related to the MMR vaccine, then there would be a corresponding increase in the number of autism cases after 1988 as well as rising rates of regressive autism (in which a child with typical developmental levels suddenly begins to lose speech and social skills and is subsequently diagnosed with autism). Additionally, the researchers sought to determine if the MMR vaccine was linked to increased incidence of bowel disorders among children with autism, perhaps indicating a “new variant” form of autism. The authors concluded that there was no “new variant” form of autism characterized by regressive autism and bowel disorders, and further, that there was no link between the MMR vaccine and autism.

Study’s flaws: The authors claim that there is no statistical evidence of any link between the MMR vaccine and autism, yet the raw data suggests otherwise. Consider their report of the number of children whose parents reported symptoms: only 29% of parents reported an incidence of autism, regressive autism, or bowel disorder before the child was vaccinated, as opposed to 58% of parents who reported symptoms after the vaccine. Only 13% of reported cases occurred in unvaccinated children. The authors caution in their conclusion that some parents may have changed the age at which they noticed symptoms after the Wakefield study made news, but this is complete conjecture on their part, and certainly does not explain such a large differential. Their own data suggests that more children overall were “regressing” after the MMR vaccine rather than before.

Conflicts of interest: Two of the study’s authors, Nick Andrews and Elizabeth Miller, are a part of the UK’s immunization division in the Public Health Laboratory Service, Communicable Disease Surveillance Center. This particular division is in charge of immunization uptake in the UK as well as vaccine safety.

 

No evidence for a new variant of measles-mumps-rubella-induced autism (2001)[9]
Authors:
Fombonne E, Chakrabarti S.

Study overview: This study sought evidence of a new form of autism characterized by developmental regression (in which children who seemed to be achieving developmental milestones began losing ground and were subsequently diagnosed with some form of autism) and bowel disorders in children, as posited by the Wakefield study. The authors contended that if such a new form existed, then they should find statistical evidence in at least one of the following ways:

  • there should be a higher incidence of this type of disorder in the general population;
  • first parental concern should be closer to mean vaccination age in vaccinated vs. unvaccinated children;
  • there should be an increase in regression of autistic children in vaccinated vs. unvaccinated children;
  • autistic children with regression would be clustered around age at vaccination;
  • autistic children with regression would have distinct symptoms with similar severity; or
  • regression autism would be associated with gastrointestinal and/or bowel disorders.

The authors used three sample sets to identify statistical relationships between the administration of the MMR vaccine and evidence of any of the above listed indicators. The first sample was a purposive sample comprised of children who had been identified with pervasive developmental disorders through a UK survey in Staffordshire. The sample consisted of 96 children who were born between 1992 and 1995, all but one of whom had received the MMR vaccine. The second sample was a convenience sample, in which the subjects volunteered or were chosen to take part in the study, specifically culled from the practice of the paper’s first author, Dr. Eric Fombonne. This sample was also comprised of children who received the MMR vaccine after 1988 (when the MMR vaccine was introduced), including 68 children born between 1987 and 1996 who had a confirmed diagnosis of Pervasive Developmental Disorder (PDD). The third sample was also a convenience sample, of 99 individuals with autism who were born before the introduction of the MMR vaccine.

The authors claim that their analysis found no statistical evidence to support any of the above claims, thereby establishing there was no new form of autism and no link to the MMR vaccine.

Study’s flaws: Comparing purposive samples to convenience samples is not a valid research method and therefore should not be relied upon to make inferences regarding the MMR vaccine and autism. The authors also do not list the source of the third convenience study, further calling into question the validity of the sample.

Conflicts of interest: After this paper was published, lead author Dr. Fombonne violated scientific ethics at his post at Montreal Children’s Hospital and McGill University when he improperly used samples derived from autistic children for another study unauthorized by their parents. Dr. Fombonne has also testified as an expert witness for vaccine manufacturers and against families with reportedly vaccine-injured children, both in civil courts and the National Vaccine Injury Compensation Program for the US.

 

Time trends in autism and in MMR immunization coverage in California (2001)[10]
Authors:
Dales L, Hammer SJ, Smith NJ

Study overview: The goal of the study was to find a correlation between increased autism rates and increased MMR vaccination rates in the general population. The authors used an ecological study, which looks at the whole population for incidences of a disease rather than examining individual cases of autism. The data came from the state of California between 1980 and 1994, using kindergarten enrollment to determine the number of children vaccinated between 17 and 24 months of age, and comparing it to the number of children born during these years who received services from the California Department of Developmental Services after an autism diagnosis. Their analysis shows that while autism rates in California increased in this time period by 373% (from 44 cases per 100,000 live births to 208 cases per 100,000 live births), the relative uptake of the MMR vaccine by 24 months increased by only 14%, leading to their claim that the rise in autism rates cannot be account for by the relative rise in MMR vaccinations.

Study’s flaws: A relationship between the MMR vaccine and autism cannot be ruled out at an individual level based on this comparison of overall rates alone. Increases in the use of the developmental centers may be bolstered, as the authors acknowledged, by increased availability of the centers and increased public awareness of autism. Further, in a rebuttal, Edwards and Baltzan remapped the data and found that the age at immunization was actually trending younger than 17 months between 1981 and 1993,[11] and that the original comparison plots were vertically compressed—and once adjusted actually suggest a correlation, if not a causation.

Conflicts of interest: The lead author of this publication, Dr. Loring Dales, was the head of the immunization branch of the California Department of Health Services at the time of publication of this paper. Dr. Dales then had a responsibility to maintain vaccine uptake (including the MMR vaccine) in the state of California.

 

Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis (2001)[12]
Authors: Kaye JA, del Mar Melero-Montes M, Jick H.

Study’s overview: This study was a time trend analysis, where researchers look to see if one variable increases or decreases in tandem with another factor over a period of time. The researchers looked at the rate of increase of autism diagnoses among children between 1988 and 1999, and then specifically looked at boys born between 1988 and 1993, and the rate of MMR vaccine administration (uptake) during the same time periods. The authors claimed that there was no correlation despite a marked increase in autism incidence with time, because trends in MMR uptake remained unchanged.

Study flaws: Instead of defining autism incidence based on when the child was born, the study authors instead defined autism incidence based on diagnosis rate during diagnosis year, with the denominator corrected for age of diagnosis. This method gives a bias towards autism diagnosed at younger ages and is not a true measure of autism incidence. Therefore, this section of the analysis is essentially meaningless in determining true autism incidence versus MMR uptake. The rate of MMR uptake remained steady at over 95% throughout the birth cohorts while the autism incidence (as measured by the researchers) increased sevenfold. MMR uptake could not possibly proportionally increase as it was already a high 95%, so this type of temporal study sheds no light—it was de facto “proof” by design.

Conflicts of interest: The authors of this paper were residents at the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine. This program is supported in part by grants from AstraZeneca, Berlex Laboratories, Boehringer Ingelheim Pharmaceuticals, Boots Healthcare International, Bristol-Myers Squibb Pharmaceutical Research Institute, GlaxoSmithKline, Hoffmann-La Roche, Janssen Pharmaceutica Products, RW Johnson Pharmaceutical Research Institute, McNeil Consumer Products, and Novartis Farmaceutica. Funding for their residency program is directly tied to those profiting from the vaccine companies their claims protect.

 

MMR and autism: further evidence against a causal association (2001)[13]
Authors:
Farrington CP, Miller E, Taylor B. 

Study overview: The authors of this study investigated time trends of autism diagnoses in a case series involving 357 UK children diagnosed with autism. They looked at temporal relationships, that is, how much time elapsed between administration of the MMR vaccine and a subsequent autism diagnosis. Farrington et al. looked at two different time spans—36 months and 60 months, respectively—between the MMR vaccine and the first reported parental concern, as a previous study had only looked for a closer temporal relationship. Additionally they looked at 24 months as an interval between the MMR vaccine and onset of regressive autism. They claim their results showed no correlation as the incidence of autism increased while the MMR uptake remained steady. Importantly, the World Health Organization has used these findings to support their immunization policy.[14]

Study’s flaws: Despite the authors’ claims, the data presented as evidence in the paper instead seems to actually confirm a temporal relationship between the MMR vaccine and the age of first diagnosis. This is best shown using their own data charts. Figure 1 includes the age of first diagnosis for 64 unvaccinated children with autism and shows significantly more “scatter,” as compared to Figure 2, for 231 children receiving a single dose of the MMR vaccine, where diagnoses tend to cluster between 0 and 30 months post-vaccination.

 

Fig. 1. Distribution of age at autism diagnosis (in months) of 64 unvaccinated children with autism.

fig1 fig2 fig3

Fig. 2. Distribution of (top) age at autism diagnosis and (bottom) age at vaccination (in months), of 231 children with autism who received a single dose of MMR vaccine.

fig2

Figure 3, of 62 children receiving two doses of the MMR vaccine, also shows clustering between 0 and 30 months after administration of the first vaccine.

fig3

Fig. 3. Distribution of (top) age at autism diagnosis and (bottom) ages at vaccination (in months) of 62 children with autism who received two doses of MMR vaccine.

 

The study authors blame this phenomenon on time trends where cases post-MMR vaccine tend to be newer and cases without the MMR vaccine tend to be older, because newer cases would be subject to earlier diagnosis and screening. This statement is completely unsubstantiated in the paper, however, and does little to counter the clear clustering of autism diagnoses after vaccination.

Conflicts of interest: One of the authors, Dr. Elizabeth Miller, was a chief official at the Immunization Division of the UK’s Public Health Laboratory Service (PHLS) and possessed an institutional conflict of interest, given the PHLS’s stake in maintaining high vaccination rates in the UK.

 

Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association (1999)[15]
Authors:
Taylor B, Miller E, Farrington CP, et al.

Study overview: This study provided a comparison of autism rates before and after the introduction of the MMR vaccine in the UK in 1988. Data showed a sharp increase in autism incidence in the early 1990s but did not appear to correlate with MMR vaccine uptake, which plateaued soon after introduction. According to the study authors, although most evidence did not show a temporal relationship between MMR vaccine timing and “autism onset,” there is compelling data for the age of first parental concern clustering between 0 and 6 months of administration of the MMR. The authors dismiss this finding by arguing that parents chose an age of first concern of 18 months simply because it was a round number.

Study’s flaws: The claim that parents chose an age of concern of 18 months because it was a “round number” is unsubstantiated and therefore not a valid explanation for the cluster of data that shows otherwise. Data findings should not be subjectively dismissed at the convenience of the researchers.

Conflicts of interest: Two of the study authors (Dr. Elizabeth Miller and Ms. Pauline Waight) are from the UK’s Immunisation Division, Public Health Laboratory Service Communicable Disease Surveillance Centre, which reflects institutional conflict of interest as this particular agency is responsible for increasing vaccine uptake within the UK population.

 

Neurologic disorders after measles, mumps, rubella vaccination (2002) [16]
Authors:
Makela A, Nuorti JP, Peltola H.

Study overview: This study used hospital records to determine if there was a relationship between when the MMR vaccination and hospitalizations of children for three different diagnoses: encephalitis (within three months of MMR vaccine); aseptic meningitis (within three months of vaccination); and autism (throughout time period of analysis, which was 1982–86). Data was taken from hospital records in Finland. The authors claim that no temporal relationship exists between the MMR vaccine and any of the three diagnoses, including autism in a hospital setting. They report there was no clustering of hospitalizations for autism at any intervals following immunization.

Study’s flaws: This study actually clearly shows that peak rates of autism diagnoses occurred after the MMR vaccine was administered, especially in the 0 to 6 month window following vaccination. Additionally, the data is based on autism “hospitalization” visits, which is likely an under-ascertainment of actual autism cases, given that many cases are diagnosed in an outpatient setting.[17] Also, diagnoses in a hospital setting do not reflect the actual onset of symptoms, including regression, and the authors of this paper directly admit that this is a flaw in their analysis.

Conflicts of interest: Major MMR and MMR-II manufacturer Merck funded this study, and held a worldwide monopoly on these vaccines during the time of the research.

 

Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations (2006)[18]
Authors:
Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D.

Study overview: This study focused on ecological methods—looking at the whole population for incidences of a disease rather than examining individual cases of autism—based on a population of students in a large school district in Montreal, Canada. The authors looked at the increases in developmental disorders which were identified in children by schools’ special needs teams, and compared them to (a) estimates of exposure to thimerosal (ethylmercury), which was phased out during the study, over the same time period, and (b) to changes in the MMR vaccination trends, including a switch to a two-dose MMR schedule during the study period. The authors concluded that there was no relationship between thimerosal exposure and increased developmental disorders. Further, they claimed that while the vaccination rate experienced a dip during the study period, there was no corresponding decrease in developmental disorders and also that there was no change in developmental disorders associated with the subsequent increase to a two-dose schedule.

Study’s flaws: The school district represented in this study accounts for only 14% of the total school population in Montreal but has the highest rates of pervasive developmental disorder (PDD, aka autism) diagnosis in the five total districts, and in some cases PDD rates were three times higher within this district. Also, the claim that the thimerosal exposure in the Canadian vaccine schedule starting in 1996 was “nil” is false. At this point in time, the thimerosal free HepB formulation had not yet been introduced (not until 2001) and the thimerosal containing “Penta” vaccine was administered, leading to a cumulative maximum dosage of 137.5 micrograms mercury. Essentially, this fact, along with the lack of actual vaccine records for cohort members, renders any time trend comparison between autism/ASD/PDD prevalence and thimerosal exposure useless.

Also, regarding the MMR vaccine uptake, the study authors use uptake as a metric of vaccine coverage, which was not done for the thimerosal analysis. The authors do not accurately reflect the effect of the introduction of two doses of the vaccine in 1996, which would essentially double the viral load administered to each individual. Finally, the errors associated with autism/ASD/PDD diagnoses essentially obviate any true indication of an upward trend, given that there is significant overlap in the 95% CI range at each year reported, including the endpoints of 1987 and 1998.

Conflicts of Interest: The lead author of this study, Dr. Eric Fombonne, has significant conflicts of interest, as he has many times represented vaccine manufacturers as an expert witness in thimerosal litigation, opposing the families of vaccine injured children.

 

Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta (2004)
Authors:
DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C.

Study’s overview: The authors were looking for an association between the increased rates of autism in children and the MMR vaccine, both among the general population and in sub-groups of children. Researchers compared the vaccination schedules of autistic children from the general population to a control group of school-matched children who did not have autism. This study focused on children enrolled in public school within five districts in metropolitan Atlanta who received their first MMR vaccine at different time intervals. Autism cases were matched with three controls based on gender, birth year, and school of enrollment for a total sample of 2448 individuals. The researchers concluded that similar proportions of case children (those with autism) and control children (school-matched subjects) were vaccinated according to the recommended schedule and likewise with any of the subgroups also studied. One sub-group, boys ages 3 to 5 enrolled in special education services, had a rate of immunization earlier than their school-matched controls. However, the authors argue that this subgroup would have had the earlier immunization as a requirement for receiving school-based services and thus dismiss it as insignificant.

Study’s flaws: The study actually showed statistically significant relationships between autism incidence and MMR timing for all individuals considered in the study (OR: 1.49, 95% CI: 1.04–2.14) with a stronger association for males only (OR: 1.67, 95% CI: 1:10–2.53) for those individuals who received their first MMR vaccine prior to 36 months of age, with a reference of those individuals who received their MMR vaccine after 36 months of age. This is quite a compelling relationship, though the authors dismiss the effect, stating that children with autism would be enrolled in special education services which would require earlier vaccination with the MMR. This statement makes no sense, in light of the fact that the relationship is observed to come exclusively from boys in the cohort and not girls (no statistically significant relationship is seen when considering girls separately). There is no reason to assume that boys enrolled in special education services would receive earlier MMR vaccines than girls enrolled in the same programs.

Conflicts of interest: Two of these individuals were employees of the National Immunization Program of the US Centers for Disease Control and Prevention (CDC), which is charged to increase immunization rates in the US in order to prevent outbreaks of infectious diseases. Thus there was a propensity against finding a causal relationship between vaccines and vaccine adverse events, which is demonstrated clearly in the text of the paper by the authors’ faulty explanation when statistically significant relationships are observed. Dr. William Thompson, co-author of the paper and lead statistician with the CDC, has recently (August 2014) come forth with evidence of fraud committed specifically regarding this paper, and has launched a complaint against his co-authors regarding both the outcomes and the interpretations of the results of this study.

 

Conclusion
Studies undertaken by researchers with a vested interest either in immunization uptake or vaccine manufacture should be subjected to greater scrutiny. While the goal should always be the eradication of disease, both the profit motive and bureaucracy impede the necessary safeguards to public health. While the majority of a population may suffer no ill effects from vaccines, subgroups of the population may be at risk. After the public started questioning the safety of vaccines in the late nineties, public health agencies and drug manufacturers were quick to produce more than a dozen studies “proving” the safety of vaccines. Applying scientific scrutiny to some of these studies shows that they do not, beyond dispute, prove that vaccines are safe. Further independent, open-minded study is needed to prove the safety of vaccines for all subgroups of the population.

 

[1] Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637 41.

 

Dr. Wakefield, together with twelve other colleagues, published a paper in the famed British journal The Lancet—a case study of twelve young patients who presented with a new type of bowel disorder, all of whom had autism and developmental delays. Parents reported that each of these children regressed into their condition after receiving the MMR vaccine (for measles, mumps, and rubella). It is important to note that this paper neither confirmed nor denied a connection between regressive autism and the MMR vaccine. However, it did indicate that it was an area worthy of further study.

 

[2] Peltola H, Patja A, Leinikki P, Valle M, Davidkin I, Paunio M. No evidence for measles, mumps, and rubella vaccine–associated inflammatory bowel disease or autism in a 14-year prospective study. Lancet 1998; 351:1327–8.

[3] Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637 41.

[4] https://vaers.hhs.gov/data/index

[5] Ibid.

[6] Madsen KM, Hviid A, Vestergaard M, et al. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 2002; 347:1477–82.

[7] DeWilde S, Carey IM, Richards N, Hilton SR, Cook DG. Do children who become autistic consult more often after MMR vaccination? Br J Gen Pract 2001; 51:226–7.

[8] Taylor B, Miller E, Lingam R, Andrews N, Simmons A, Stowe J. Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study. BMJ 2002; 324: 393–6.

[9] Fombonne E, Chakrabarti S. No evidence for a new variant of measles, mumps, rubella–induced autism. Pediatrics 2001; 108:e58.

[10] Dales L, Hammer SJ, Smith NJ. Time trends in autism and in MMR immunization coverage in California. JAMA 2001; 285:1183–5.

[11] Michael Edwardes, PhD; Marc Baltzan, MD, FRCPC. MMR Immunization and Autism. JAMA June 13, 2001. http://jama.jamanetwork.com/issue.aspx?journalid=67&issueid=4787

[12] Kaye JA, del Mar Melero-Montes M, Jick H. Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis. BMJ 2001; 322:460–3.

[13] Farrington CP, Miller E, Taylor B. MMR and autism: further evidence against a causal association. Vaccine 2001; 19:3632–5.

[14] http://apps.who.int/iris/bitstream/10665/107553/1/e82636.pdf.

[15] Taylor B, Miller E, Farrington CP, et al. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999; 353:2026–9.

[16] Makela A, Nuorti JP, Peltola H. Neurologic disorders after measles, mumps, rubella vaccination. Pediatrics 2002; 110:957–63.

[17] Madsen K, Lauritsen M,Pedersen C, Thorsen P, Plesner A, Andersen P, Mortensen P. Thimerosal and occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics 2003; 112:604-606.

[18] Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D. Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations. Pediatrics 2006; 118:e139–50.

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  • Martha

    I am very confused by the existence of this white paper, but only for its assumption that correlation shows cause, which every scientist worth any statistical salts knows cannot be done. Absolutely NONE of the reviewed studies even looked at vaccines as a CAUSE, since NONE were experimental. Experimentation is the very foundation of the scientific method. They were all OBSERVATIONAL, or just covered the very first step in the scientific method. Of course direct experiments of vaccines on humans is unacceptable. But, without good clinical experimentation, isn’t that what approval of these vaccines for use has accomplished, in fact?

    This white paper usually concludes that all of these studies had methodological problems. But that is the very nature of observational research. Assumptions about what kind of “controls” should be imposed on the data to be “observed” are usually the reason why observational studies offer very little that can be used to make policy decisions. The researchers seem to assume that the same controls can be applied to ANY observational study, constituting considerable hubris, if not scientific incompetency. That is why it is so ridiculous to conclude that “the science is settled” when no science was done at all.

    • denise0513

      Unfortunately, the entire public IS the experimentation and the children are paying a very high price for greed.

    • lifebiomedguru

      Unless and until vaccines are studied with randomized prospective trials with proper controls, no study conducted amounts to what Karl Popper called a “critical test” of the hypothesis. The studies to date do not routinely provide evidence that they were sufficiently large (in terms of sample size, # patients involved) to reject the null hypothesis if it were true. That needs to change – ALL studies on autism causality and correlation of outcome with treatments and exposures should be required to publish power curves that show 1-beta, the probability of rejecting the null hypothesis (no association) if it were true, assuming low percentages of autism (0.5%, 1%, 2%) reflecting the rate distributions currently observed. Hooker has done a service to the scientific community to point out the methodological flaws and limitations of the studies he has canvassed, as well as to point to the serious conflicts of interest, which appear to cause no concern to the publishing journals, to Universities that employ individuals w/serious COIs, nor to funding agencies. COIs are killing science. #curesvsprofits

      • Unless and until vaccines are studied with randomized prospective trials
        with proper controls, no study conducted amounts to what Karl Popper
        called a “critical test” of the hypothesis.

        You are suggesting an unethical study which would place children at risk. You claim to know better but do you? Furthermore, I notice that Mr. Hooker has failed to leave out several more recent and powerful studies which fail to find an association between MMR and autism. He also has a creative definition of conflict of interest. One which he would also have if he applied his same criteria.

        • Trevor

          … “You are suggesting an unethical study which would place children at risk. You claim to know better but do you?”

          The idea that a prospective controlled study is unethical, is the circular reasoning that veils the bias of pro-vaccinators.

          A prospective study (comparing a large vaccinated group with a control group i.e. a non-vaccinated group) is only considered unethical because there is an assumption that the unvaccinated are being placed at risk, the unvaccinated are considered to be unprotected.

          Additionally whatever the safety issues of the vaccine are, the unvaccinated are also assumed to be at a greater disadvantage than the vaccinated group. The assumption also that the vaccinated are necessarily protected. This assumption that you are necessarily placing unvaccinated children at more risk than the vaccinated is of course nonsense, unless you know that from a prospective trial.

          Firstly every living being has an immune system and has a degree of protection, (an unvaccinated person is not an unprotected person). A prospective study would be determining how much a pharmaceutical product can enhance that immune system, if at all. Vaccines are commercial products based on outdated models of the immune system, it is not a foregone conclusion that they necessarily work in real disease situations.

          Secondly if the vaccine is not safe i.e. it creates more problems than it is solving, then it is the vaccinated that are disadvantaged, and therefore the children at greater risk are the vaccinated not the unvaccinated.

          Pharmaceutical companies use circular reasoning to avoid conducting prospective trials, the very trials that would really tell us what vaccines are doing … this is also a view held by those in vaccine research read Tom Jefferson (head of Vaccine Division Cochrane database) on the ethics of not conducting controlled vaccine trials.

          • The idea that a prospective controlled study is unethical, is the circular reasoning that veils the bias of pro-vaccinators.

            But that is not what Mr. Lyons-Weiler proposed. He stated also randomised “with proper controls” which would place children randomly into either an unvaccinated group or an unvaccinated group. No anti-vaxx nor pro-vaxx parent would consent to that and nor should they, it’s unethical.

            A prospective study (comparing a large vaccinated group with a control
            group i.e. a non-vaccinated group) is only considered unethical because
            there is an assumption that the unvaccinated are being placed at risk,
            the unvaccinated are considered to be unprotected.

            That’s partially correct. It’s not an assumption, it’s based on evidence and it doesn’t matter what a parent believes. There would be undue pressure on the unvaccinated to remain in that group which is also unethical.

            Firstly every living being has an immune system and has a degree of
            protection, (an unvaccinated person is not an unprotected person). A
            prospective study would be determining how much a pharmaceutical product
            can enhance that immune system, if at all. Vaccines are commercial
            products based on outdated models of the immune system, it is not a
            foregone conclusion that they necessarily work in real disease
            situations.

            That’s a naturalistic fallacy, furthermore, not everyone has a fully functioning immune system. It is also false to state that only “enhancement of the immune system would be determined”. That’s based upon erroneous assumptions about how vaccines work; there would also be the problem of children getting VPDs whether you want to believe that or not. Vaccines don’t get licensed unless they work; the nuance lies within the actual efficacy with some being better than others. I’m afraid your statement about “outed models of the immune system” is embedded in a belief system which was derived from self-appointed superiority and scientific ignorance.

            Pharmaceutical companies use circular reasoning to avoid conducting
            prospective trials, the very trials that would really tell us what
            vaccines are doing … this is also a view held by those in vaccine
            research read Tom Jefferson (head of Vaccine Division Cochrane database)
            on the ethics of not conducting controlled vaccine trials.

            Firstly, most vaccine studies are not conducted by pharmaceutical companies nor even funded by them. Secondly, it’s not within the purview of pharmaceutical companies to deviate from ethical standards set forth by many conventions and declarations. There is nothing wrong with conducting a retrospective study but it wouldn’t be quite as rigorous. But more importantly, what would the study design be? What are you looking for? What are the differences in groups you expect? Based upon answering those questions, what would your statistical power be? It’s easy to talk about and demand such things but who among you has ever done the heavy-lifting and answered those questions?

          • Trevor

            You consider people’s natural immunity to disease without vaccines a naturalistic fallacy …

            You don’t understand basic microbiology … e.g. most people harbour microbes that are capable of becoming invasive and causing illnesses such as meningitis. Most people are not vaccinated against these illnesses and most people do not contract these illnesses … what is protecting them?

            From 1850 to 1950 in the UK most of the vaccinated illnesses declined in mortality by 95% before vaccines were given: Scarlet fever, with the largest associated infant mortality declined to zero with no vaccine ever being produced – data from UK Office of National Statistics … do you consider all of that a naturalistic fallacy?

            The attached is a packet insert for a flu vaccine, which says: … there have been no controlled trials adequately demonstrating a decrease in influenza after vaccinating with that vaccine.

            http://uploads.disquscdn.com/images/dfe08a3c0651a10cbf9996e9ef604af02455933b3253e0f527c3891b97aca106.jpg

            So what evidence had been used to get that vaccine to market? … I can tell you it is serological evidence which means that without studies comparing vaccinated and non-vaccinated in real disease situations nobody can possibly know what benefit that vaccine is in real life.

            Hence the statement in the British Medical Journal 28/10/06- “The inception of a vaccination campaign seems to preclude the assessment of a vaccine through placebo controlled randomised trials on ethical grounds. Far from being unethical, however, such trials are desperately needed and we should invest in them without delay”. Tom Jefferson – Head of Vaccine Division, Cochrane Collaboration.

            You say my statement that vaccines are based on outdated models of the immune system … “is embedded in a belief system which was derived from self-appointed superiority and scientific ignorance” … the following statement was made by Antonio Coutinho, Director of Immunology Research at institutes in France (CNRS) and Portugal (IGC), states that:

            “Most vaccines used today are of the ‘conventional’ type, many of which were discovered when we had; little knowledge of immunology, and absolutely no information on the cells and molecules of the immune system.” …
            European Molecular Biology Organisation (EMBO) Reports (2003)

            You believe that pharmaceutical companies don’t do the research to get their vaccines to market or fund them … who on earth pays for that research?? A useful book for those interested … ‘The Truth About the Drug Companies’ by Marcia Angell MD former editor in Chief at The New England Journal of Medicine and a member of Harvard Medical School’s Department of Social Medicine. Shows pretty clearly how the pharmaceutical industry funds research.

          • Trevor, I had a lengthy reply but it won’t get approved. I removed a link so we’ll see if that goes through.

          • p { margin-bottom: 0.1in; line-height: 120%; }

            You don’t understand basic microbiology

            Heh, this is going to be more fun
            than I thought.

            e.g. most people harbour
            microbes that are capable of becoming invasive and causing illnesses
            such as meningitis. Most people are not vaccinated against these
            illnesses and most people do not contract these illnesses … what is
            protecting them?

            You can’t compare
            opportunistic pathogens and/or transient colonisers to other
            pathogens with such a blanket statement. Let’s take Hib for example;
            yes children over the age of two rarely experience pathogenesis.
            Since you think I know nothing of microbiology, why don’t you tell me
            why that is.

            From 1850 to 1950 in the UK
            most of the vaccinated illnesses declined in mortality by 95% before
            vaccines were given: Scarlet fever, with the largest associated
            infant mortality declined to zero with no vaccine ever being produced
            – data from UK Office of National Statistics … do you consider all
            of that a naturalistic fallacy?

            Disease
            mortality, not morbidity in general. As for
            Scarlet fever, you are leaving some rather large gaps in information
            and geography. Mortality never declined to zero and the disease
            pattern had numerous pandemics and nadirs throughout history. Prior
            to antibiotics, sanitation and improved living conditions attributed
            to the decrease in mortality but even then some pandemics (not just
            the UK) saw upwards of 30% mortality. The pathogen itself has evolved
            too. It’s not the naturalistic fallacy by the by but what you stated
            earlier is.

            The attached is a packet
            insert for a flu vaccine, which says: … there have been no
            controlled trials adequately demonstrating a decrease in influenza
            after vaccinating with that vaccine.

            That’s
            just for that particular vaccine, Flulaval but there have been
            placebo-controlled RCTs of other flu vaccines, this is just one:

            http://bitDOTly/2aMyja4 Subsequent vaccines are tested for
            non-inferiority.

            So what evidence had
            been used to get that vaccine to market? … I can tell you it is
            serological evidence which means that without studies comparing
            vaccinated and non-vaccinated in real disease situations nobody can
            possibly know what benefit that vaccine is in real
            life.

            Not exactly true now is it? What
            is true is that yes, there are situations, particularly with flu jabs
            that serological proxies are inadequate but when you have a dramatic
            decrease in morbidity and mortality of a VPD e.g. measles, mumps,
            rubella, Hib then sufficient data are obtained to estimate the
            effectiveness, not just efficacy of a vaccine.

            Hence
            the statement in the British Medical Journal 28/10/06- “The
            inception of a vaccination campaign seems to preclude the assessment
            of a vaccine through placebo controlled randomised trials on ethical
            grounds. Far from being unethical, however, such trials are
            desperately needed and we should invest in them without delay”. Tom
            Jefferson – Head of Vaccine Division, Cochrane
            Collaboration.

            That statement was
            specifically referring to influenza vaccines, not other vaccines.
            Given the current state of influenza vaccines, I’m not entirely in
            disagreement with Dr. Jefferson on that one. However it is highly
            disingenuous to try and apply a single statement to global vaccine
            programmes.

            “Most vaccines used today
            are of the ‘conventional’ type, many of which were discovered
            when we had; little knowledge of immunology, and absolutely no
            information on the cells and molecules of the immune
            system.”

            Way to cherry-pick. Perhaps
            some readers would like to read the entire opinion piece, yes it’s an
            opinion piece lamenting the stall in vaccine technology for
            non-pathogenic diseases and treatments for immunological diseases.
            But he never questions the efficacy, success and utility of vaccines,
            in fact he attributes the decline in VPDs to
            vaccines.

            You believe that
            pharmaceutical companies don’t do the research to get their vaccines
            to market or fund them … who on earth pays for that
            research??

            Of course pharma pays for pre-licensure clinical trials but that
            is a drop in the bucket and not as comprehensive as post-licensure
            research which they do not contribute to hardly at all. That is
            the research that Mr. Hooker et al. tries to vilify and badly
            critiques. But he doesn’t have the qualifications nor
            experience to do so let alone produce his own badly-conducted,
            COI-riddled studies. Has he declared that he lost his NVICP
            case? Has he posted the link to it which clearly demonstrates
            his narrative has been sorely misleading.

          • Trevor

            You don’t answer the point … mortality diminished and morbidity over time 1850 to 1950 with vaccinated infectious illnesses, these are not opportunistic pathogens or transient colonisers (which are no less severe when pathological) … I asked you what was that due to. It is due to natural immunity and not vaccine immunity … it is clearly not a naturalistic fallacy as you stated. Vaccines need to be tested against that natural immunity, unvaccinated people are not unprotected … controlled studies are needed, as it is highly conceivable that vaccines could make things worse.

            Yes Tom Jefferson talks of influenza but that is true of all vaccines, vaccines are not licensed from controlled trials testing for their ability to reduce actual illness … and there a ways to do them and reasons to do them, (retrospectively and prospectively) given that there are many individual people and communities that choose not to vaccinate.

            I’m not implying what Coutinho believes outside of the specific point I mentioned, (in fact, better he is pro-vaccine) … I am merely showing you that someone at the head of an immunology institute (or two) acknowledges that most vaccines are based on old concepts of immunity … something that you said was based on “a belief system which was derived from self-appointed superiority and scientific ignorance” … do you believe that is based on scientific ignorance ??? You have difficulty focusing on what I am talking about and instead you try and swing into another area.

            Again here you’re shifting … you initially say … “Firstly, most vaccine studies are not conducted by pharmaceutical companies nor even funded by them”. Now you’re saying “Of course pharma pays for pre-licensure clinical trials” (and of course other pre-licensure studies). So contrary to what you were saying before, pharmaceuticals do fund research to get a vaccine to market … post-licensure is what many people criticise … you now say that’s the bulk of the vaccine research, based on what and what budget figures do you have comparing to pre-licensure? Pre-licensure research takes a massive budget.

          • You don’t answer the point … mortality diminished and morbidity over
            time 1850 to 1950 with vaccinated infectious illnesses, these are not
            opportunistic pathogens or transient colonisers (which are no less
            severe when pathological) …

            This is simply incorrect, or what I could make of this sentence since it doesn’t follow well. Disease mortality for some VPDs did decline prior to the introduction of the vaccine but not morbidity. Your example of Scarlet Fever was demonstrably false as mortality didn’t decrease to zero as you stated and was in fact alarmingly high during some pandemics during that time frame.

            I asked you what was that due to. It is due to natural immunity and not
            vaccine immunity … it is clearly not a naturalistic fallacy as you
            stated.

            That is also not entirely true. Here is your statement: “e.g. most people harbour microbes that are capable of becoming invasive and causing illnesses such as meningitis. Most people are not vaccinated against these illnesses and most people do not contract these illnesses … what is protecting them?”

            You seem to be confusing different concepts. Transient colonisers like Hib and N. meningitidis do cause disease and they are also great at evading host immune responses. I turned your question back on you because you didn’t acknowledge the pathogenesis of these types of organisms. Infants do not respond well at all to polysaccharide-capsulated bacteria such as the aforementioned. And the latter still causes pathogenesis in adults so I don’t know where you are getting that we have this great natural immunity, not only that but it is short-lived even when we do experience disease and develop humoural immunity. As for others like measles, mumps and rubella we had to get those diseases in order to develop immunity. Not a good trade-off given the risk of disease v. vaccination. To believe that natural immunity is developed without disease or is superior is absolutely a naturalistic fallacy.

            Vaccines need to be tested against that natural immunity, unvaccinated
            people are not unprotected … controlled studies are needed, as it is
            highly conceivable that vaccines could make things worse.

            New vaccines are tested in real life e.g. HIV. Whatever do you mean by, “tested against that natural immunity”? If someone has a sufficient titre against a particular pathogen then they are presumed immune whether by vaccination or wild-type. Surely you aren’t suggesting that we take a group of people who received MMR and a group who were not vaccinated and expose them to the diseases. Even with clarification of this what are your endpoints of interest?

            Yes Tom Jefferson talks of influenza but that is true of all vaccines,
            vaccines are not licensed from controlled trials testing for their
            ability to reduce actual illness … and there a ways to do them and
            reasons to do them, (retrospectively and prospectively) given that there
            are many individual people and communities that choose not to
            vaccinate.

            Um no, you can’t take a quote from Dr. Jefferson explicitly referring to influenza vaccines and extrapolate that to all vaccines. Please give me an example sans influenza of a vaccine on the childhood schedule that hasn’t “reduced actual illness”. Heck even influenza vaccines work in particular conditions. As I explained a prospective trial is unethical besides you haven’t even done the basic work to frame your study design such as endpoints, effect measure and statistical power. Why don’t you do that first because I assure you, others have.

            I’m not implying what Coutinho believes outside of the specific point I
            mentioned, (in fact, better he is pro-vaccine) … I am merely showing
            you that someone at the head of an immunology institute (or two)
            acknowledges that most vaccines are based on old concepts of immunity

            Not really, your word was “outdated” and you used the quote to present a concept that he was excoriating vaccines when nothing like that was ever presented. Vaccine platforms should always be examined and improved with current technology and they are but most current vaccines work exceptionally well and have an excellent safety profile no matter what you believe. Not perfect but show me what is.

            … something that you said was based on “a belief system which was
            derived from self-appointed superiority and scientific ignorance” … do
            you believe that is based on scientific ignorance ??? You have
            difficulty focusing on what I am talking about and instead you try and
            swing into another area.

            The idea that vaccines are inherently bad is based on self-appointed superiority and scientific ignorance. You can’t even give me a frame-work for a study design that would appease you and isn’t unethical but won’t accept vaccines without any idea of vaccinology, immunology and epidemiology.

            Again here you’re shifting … you initially say … “Firstly, most
            vaccine studies are not conducted by pharmaceutical companies nor even
            funded by them”. Now you’re saying “Of course pharma pays for
            pre-licensure clinical trials and of course other pre-licensure
            studies”. So contrary to what you were saying before, pharmaceuticals do
            fund research to get a vaccine to market … post-licensure is what
            many people criticise … you now say that’s the bulk of the vaccine
            research, based on what and what budget figures do you have comparing to
            pre-licensure? Pre-licensure research takes a massive budget.

            That’s not shifting, it’s absolutely correct. The vast majority of safety and efficacy/effectiveness studies take place post-licensure when sufficient numbers of doses have been administered to evaluate. Pre-licensure is very limited in scope. Take a gander at PubMed and it should be obvious that funding by pharma is paltry compared to government, foundation and academic sources. Of course I don’t have exact numbers, simply knowing what studies and clinical trials cost.

          • Steve Smith

            Pardon me for my naivety, but to me we obviously have a natural immunity.

            That natural immunity has within it a susceptibility to some pathogens due to hereditary factors for example.

            What never seems to be acknowledged in discussions re vaccinations is that any vaccination at any point in life is an invasion of ones immunity by gross methodology eg injection. This violates a persons susceptibility. It is an abuse of human rights.

            Once the vaccination has entered the human system who knows in what way the immune system is compromised. Other kinds of illness can result thereafter surely.

            There is no overall perspective on the threat of unnatural vaccinations on human health. The arguments for vaccinations are thus all piecemeal discourse.

            To me vaccinations are abhorrent in the way we cluelessly inflict them without any idea of consequences on human health in a broad sense

          • Loni Hull

            Trevor has eaten you alive. Face your defeat and walk away, or join us in asking for reform of industry/government collusion and poor vaccine trials. Your choice.

          • Trevor has eaten you alive.

            Sure if you say so. But where I’m from argument from assertion and scientific ignorance don’t make for good polemics.

            Face your defeat and walk away, or join us in asking for reform of
            industry/government collusion and poor (or non-existent) vaccine trials.
            Your choice.

            Whatever Darth Vader.

          • Which government?

          • tonibark

            Hi Trevor, who are you. love to connect. twitter @doctorsensation

        • tonibark

          again science mom, “attributable risk” has only ONE definition, the rest is noise. to assume a prospective study would be unethical implies you already believe one outcome. The same was said about aggressive breast cancer tx including bone marrow transplants and full mastectomies for all patients, until the study was done. It was then found more patients were dying of unnecessary treatments. Retrospective studies could also be done as there are tens of thousands if not hundreds, of unvaccinated children

          • again science mom, “attributable risk” has only ONE definition, the rest
            is noise. to assume a prospective study would be unethical implies you
            already believe one outcome.

            That’s quite false. A prospective study with vaxxed v. unvaxxed is unethical for the reasons I listed. Given you are challenging the ethics of this why don’t you explain why it wouldn’t be unethical and name an IRB that would approve this and why.

            The same was said about aggressive breast cancer tx including bone
            marrow transplants and full mastectomies for all patients, until the
            study was done. It was then found more patients were dying of
            unnecessary treatments.

            Citation please. But medical science is always evolving. Just because you believe that vaccines cause a litany of diseases doesn’t make it so. Numerous hypotheses have been tested and fail to demonstrate any association between some diseases/disorders and vaccines. Why aren’t any of your sympathetic researchers studying this?

            Retrospective studies could also be done as there are tens of thousands if not hundreds, of unvaccinated children

            And I’ll ask the same question. What are your endpoints? Effect measure? Length of study? Sample power? What are the differences that you would accept?

          • “to assume a prospective study would be unethical implies you already believe one outcome.”

            Yes, that is true but you have the reasoning *backwards*. In order for a potential prospective study to be ethical, there has to be genuine *scientific* uncertainty about which group is more likely to be harmed.

            However..let’s ignore the Nuremberg Code and the Belmont Report and the like for the moment.

            Scientist A: Already believes that vaccines help children thus believes that the unvaccinated group is being unnecessarily and unethically exposed to potential for VPDs and thus it’s unethical because the unvaccinated kids are clearly going to be harmed.

            Scientist B: Already believes that vaccines hurt children and thus believes that the vaccinated group is being unnecessarily and unethically exposed to the potential for catastrophic vaccine injuries and thus it’s unethical because the vaccinated kids are clearly going to be harmed.

            Do you see how it’s going to be unethical from both scientist A’s perspective and scientist B’s perspective even though they believe in two different outcomes?

            As for retrospective studies, that’s already been done.

            http://uploads.disquscdn.com/images/14faaaf7812c84d485f88446ac4a367898b311461151558b514840a13b3ba1e4.png

      • EpiRen

        How about BS Hooker’s previous COI of having litigation before the vaccine court and the necessity of him to prove that vaccines cause autism in order to receive a pay out from the vaccine compensation fund?

        • Correct argument. Hookers standards regarding COI are so broad as to encompass himself and other vaccine critical researchers.

          Vaccines definitely cause autism and there are severe propblems with the MMR-autism studies. But vaccine critics rely far too much on the “COI gambit” or “appeal to COI”.

          The main problem with the MMR-autism studies is healthy user bias. This single source of selection bias explains pretty much all the negative results. There is no need to make arguments based on COI or corruption.

        • tonibark

          you don’t get paid by the court by proving anything. one gets paid for their time if a consultant whether the case wins or loses.

  • Lucifa Crowley

    I would just like to ask one question of the studies done also. Has any of the doctors or scientests bothered to look at the links between the vaccines-autism and whether the affected were negative or positive blood types. Are there any higher instances among negative blood groups????

    • EpiRen

      You do know that “negative” is not negative but, rather, just the absence of an antigen on the cell surface, right? It’s the so-called “Rh factor” or — as we who studied blood banking know it as — antigen D. What makes you think the presence or absence of this one antigen is more predictive than the presence or absence of all the other blood group antigens? (HINT: There’s more than A and B antigens, and O is simply the absence of A and B.)

      • Bruce Stewart

        Maybe a simple yes or no would be good. Since antigens and the immune system work together there may be a correlation. Is it possible that different antigen profiles may react differently to a vaccine?

        • That is not how it works.

        • EpiRen

          That’s not how the ABO blood group system works. That’s not how any of this works. My God, man. Really?

          • Bruce Stewart

            You’re such an egotist. Who do you work for and what is your stake in this?

  • Ted Fogarty

    Thank you Dr. Hooker for this analysis. When billions of dollars and prized seats of academia as well as public health positions are on the line, it is pretty clear objectivity is subverted. Obfuscation of safety problems of vaccines or other pharmaceuticals through science is a refined art now. Our citizenry is repeatedly collectively abused by the collusion of government and industry.

    • LexRex Mann

      Very well-said

  • Lord Windemere

    Courtrooms do not even expect people to incriminate themselves. What makes anyone think that drug companies would?

  • EpiRen

    This is rich. BS Hooker, who published several papers of his own without disclosing his conflict of interest (his now defunct litigation before the vaccine court), and whose epidemiological and biostatistical knowledge is — in my opinion — the worst I’ve seen from a so-called professional, now has the “tanates” to criticize other studies. Did BS Hooker do this as part of the course in epidemiology and biostatistics he should be taking? Because I’d give him a C- for this.

    • Gr8freedomfan

      Isn’t it funny how you are using the name EpiRen. Is this a left hand slap to all the people who developed deadly food allergies and now are paying $500 and up for an EpiPen?! Go away professional Troll! You are totally discredited.

  • This article relies on an unreasonably broad scope of conflicts of interest. So research by anyone with past or present career in the public health field should be rejected as conflicted?

    Research by anyone with any past support from the vaccine industry or litigants should be rejected as conflicted?

    This is absurd. This is far too restrictive. Scientists on both sides of this issue must be able to obtain funding from somewhere.

    What happens if the tables are turned? Then, it could be argued that anyone affected by vaccine injury cannot be objective. This is not reasonable argumentation.

    Quote:
    “DG Cook, one of the paper’s authors, worked as a professor in the Department of Public Health Sciences at St. George’s Hospital Medical School. Public health practitioners are generally trained to accept vaccination policies without question and would not serve as objective researchers.”

    Also, this article does not mention healthy user bias, which is the real problem with the MMR-autism studies. HUB explains almost all the wrong results because its a systematic bias that affects the uptake of MMR.

    HUB will affect many of the studies here, such as Farrington 2001 and DeWilde 2001.

    For example farrington 2001 states:

    “For the 357 cases with autism diagnosis (core and atypical), the observation periods had median 89 months, maximum 191; the oldest age at diagnosis was 180 months; 64 cases did not receive any MMR”

    Thats a lot of children that did not receive MMR (64/357). Why so many? Could it be because the children were rendered autistic by prior aluminum-containing vaccines, and then parents refused to give the MMR to an already-damaged child? These subjects must be removed from the analysis.

    So, HUB affects many different types of MMR-autism studies to conceal the association.

    Vaccine reform activists must do better than this. This article is not persuasive.

    • Cuool

      What’s “not persuasive” or “absurd” is your comment because it lacks a reasonably broad scope.

      The medical business has long denied that conflicts-of-interests has any significant impact on their research findings and outcomes. Yet, studies regarding this issue show otherwise. This is the first huge clue that no one should trust mainstream medical research: they will ignore solid facts if they interfere with their self-serving interests. The same denial can be found in the finance business. I’ve seen a Harvard official deny this solid fact.

      Furthermore, frequently conflicts-of-interests are carefully hidden in study papers and other documents, lied about or left out entirely – the fraudulent mammogram business, among others, is a good example of that (see “The Mammogram Myth” by Rolf Hefti). If vested interests has little significance why does the medical business with its well paid hired “scientists” habitually resort to such criminal activities?

      Instead of providing value your comment obfuscates one of the arguably major problems in mainstream “science” today. In that sense, unfortunately, your comment is inadvertently what the corrupt medical business has been engaging in as a matter of routine for decades: the denial and distortion of the true facts.

      • I agree completely that medical science is corrupt. it is extremely corrupt.

        But it is not always corrupt. Vaccine critics use the corruption gambit excessively, sometimes when there is no evidence of corruption. The result is an unpersuasive message.

        • tonibark

          the only true test would be of those exposed to those unexposed
          attributable risk has only one definition, everything else is noise

  • Bruce Stewart

    This may be slightly off topic but a friend of mine took his baby in for a 2 month check-up and vaccinations several years ago. I’m not sure how many vaccines that was then but today it would be about 6 according to the CDC. The baby died that night from what the doctor diagnosed as SIDS. I say vaccination reaction!

    • disqus_NQYEqMEsI6

      U.S. has the highest rate of “SIDS” of any industrialized nation in the world. We also have the highest number of childhood vaccinations, and we are the only country that gives a vaccine on the day of birth. Of course most SIDS cases are actually unreported vaccine reactions.

      • AutismDadd

        I wonder what South Korea’s is, they have a heavy schedule and 1 in 34 autism rate.

    • JJKA13

      @Bruce It was shown in the cotwatch study thirty years ago, and corroborated currently by pediatric RNs, that vaccines severely affect respiration, the original study showing a reduction in breathing of up to 95% – obviously potentially catastrophic, particularly if the baby is face down, on any surface.

    • AutismDadd

      Like autism, SIDS is one they strongly deny. They want us to accept the SAFE and EFFECTIVE slogan, and agencies like the National Vaccine Injury Compensation Plan, narrowly defines vaccine injury to eliminate both autism and SIDS.

    • tonibark

      many, it is what fueled the birth of the vaccine court in the first place

    • AutismDadd

      Agreed. The coincidence explanation is no longer believable.

  • Hydra Viridis

    Having said that in Table 2 the risks are adjusted for other factors, I do not really understand how you estimated the risks given the data in Madsen et al. [6]: crude risk estimates (as Odds Ratios) are 1.20 and 1.09, both greater than 1 and both non-significant (p = 0.23 and p = 0.57 respectively). Furthermore looking at the point estimate of the risk without taking into account either the level of significance or the confidence interval (CI) is just wrong and misleading.
    It doesn’t matter whether the risk is greater o lower than 1: as long as the lower and upper limits of the CI are lower and greater than 1 respectively, the estimated risk values are just a matter of chance.
    I see an utterly confused attempt to speak statistics without the most elementary knowledge of the basics.

  • Paul Opheim

    A smoking gun which usually/most often goes un-analyzed are the adjuvants put in the vaccines to stimulate an immune response. The ones disclosed are often highly neuroendocrine disrupting. The ones not disclosed are even more problematic. What needs to be looked at asap is to whether or not, how or not they can adversely decrease neuronal pruning which normally takes place. I posit the adjuvants are at the heart of the vaccine-autism link.

  • Lindaxox

    With your criteria and protocols no drug or pesticide could ever be deemed unsafe and that is your point. Muddy the situation to the point that nothing is clear and the paid science and lobbyists and salesmen and profits just carry on.
    By the same measures vaccines can never be sited as “safe and effective”

    • Truth4All

      They do love to pontificate don’t they? And they have their comments on a loop.
      Isn’t is cute the way they upvote each other? Your reply is astute and correct. These people are a real piece of work and are a THREAT to our freedom to choose our own method of Health Care. This is their goal. Pathetic is all their blather and they are the disease.
      It is documented the vaccinated children have greater risk for ear infections and subsequent experimentation of ear tube insertion surgery. Fodder for the pediatric surgeons. No one is going to shoot us up with monkey virus, aluminum, mercury, aborted fetal cells… the things that we know of, at least.
      In 2012, in Nashville, TN, a number of patients were infected by fungal meningitis with injections of steroids into backs of people with back pain.
      We will not take anything from them ever again.

  • metanoic

    All of this would be fixed if the manufacturers were held legally and financially responsible for their products. It’s really that simple. Disband the vaccine injury court and compensation program, remove immunity granted to the manufacturers and allow people to bring civil cases for damages.

    • How about we hold them legally and financially responsible and also have a court that’s easier than even civil court with table injuries? That’d solve it.

      Great.

      • How about we make the pharmaceutical companies pay liability costs in advance on every sale of every vaccine dose, regardless of whether it ever causes an injury?

  • openmindedguy

    This should be shared and spread wide. Esp. the “conflict of interest” parts of each study examined is very telling.

  • Selena Roberts

    I don’t get it. Isn’t the author of this paper a conflict of interest? It’s not mentioned that the reanalysis of Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta (2004) that Hooker did was retracted due to serious concerns about the validity of its conclusions. And it’s it odd that Wakefield’s study is mentioned at all, listed as [1], but no conflicts of interest identified? If one is writing a paper about critical flaws and conflicts of interest and then include Wakefield’s retracted 1998 paper, you sort of loose your validity with any of it.

  • luvnnana

    It seems to me that it would be simple to encourage parents of children, who are vaccinating according to schedule, and those who had not had any type of shot by parental choice, including shots while the mother was pregnant, (If i had a choice in making a study, to also exclude children who had a vitamin K shot ) All babies with good APGAR scores at birth. Then follow them though the years of their childhood, including in the data all of the childhood illnesses that are suffered in both groups as well as things like neurological issues, autism, bowel disease etc.
    Yes it would be a long study, but seems to me we are experimenting right now with the vaccine schedule, on millions of kids, because we honestly do know for certain that all vaccines aren’t safe for 100% of the children receiving them (and we have no protocol to ensure the baby/child we are vaccinating isn’t going to be one of the “few” that will have a reaction).

  • FallsAngel

    Hooker had a case before the Vaccine Court when he did the research. Is that not enough of a conflict for you?

    • AutismDadd

      Its not as good as CDC owning 56 patents for vaccines and vaccine components, AND being involved in safety and usage of vaccines…just sayin!

  • Mike Stevens

    Are you for real, Mr Hooker? Just dipping into your “analysis” revealed this gem (among many others):
    “Conflicts of interest: DG Cook, one of the paper’s authors, worked as a professor in the Department of Public Health Sciences at St. George’s Hospital Medical School. Public health practitioners are generally trained to accept vaccination policies without question and would not serve as objective researchers.”

    Seriously? …You want your medical science to come from the shelf-stacker at Macy’s, rather than from the experts in the relevant field?

  • How does the UK health system work? Explain this for your readers.