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A peer-reviewed research letter by Children’s Health Defense (CHD) scientists — published this month in Integrative Medicine: A Clinician’s Journal — calls into question a 2002 study cited by health officials as “strong evidence” that there is no link between the MMR vaccine and autism.
The findings in the decades-old study “do not support rejecting the causal link” between the measles-mumps-rubella (MMR) vaccine and autism, Karl Jablonowski, Ph.D., and Brian Hooker, Ph.D., said after reanalyzing the 2002 New England Journal of Medicine (NEJM) study.
Jablonowski and Hooker called for the NEJM study to be replicated after correcting for errors, which they said included problems with measures of certainty, contradictions in numbers presented in the study’s tables and a flaw in the method used to determine risk.
Jablonowski, CHD’s senior research scientist, said the simple and glaring errors ought to be addressed:
“A landmark publication in one of the most prestigious medical journals in the world — whose erroneous conclusions have been reverberated through news outlets and doctors’ offices alike for the last 23 years — is shown to be invalid by the most basic form of arithmetic.
“The problem is not that we were sold $69 billion a year in vaccines based on faulty analyses that riddled our children with toxins and left them with chronic and debilitating diseases, if not death. The problem is that we bought it.”
The NEJM paper by Madsen et al. is one of the key studies cited by vaccine advocates to dispel the “myth” that there may be a link between the MMR vaccine and autism.
When Madsen et al. conducted the study 23 years ago, evidence was mounting of a possible link between the MMR vaccine and autism. The widespread use of the MMR vaccine coincided with an increase in autism rates in California, and a growing number of case reports that indicated some children regressed into autism following the shots.
However, large studies on a possible association hadn’t been done.
Madsen and colleagues analyzed data from 537,303 children in the Danish healthcare system between 1991 and 1998, comparing outcomes among vaccinated and unvaccinated children.
They reported that the risk of autism was the same in both groups and there was no association between a child’s age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autism.
The authors concluded their study strongly supported an argument against a link.
‘Strong evidence’ of the need for more evidence
In April, U.S. Health Secretary Robert F. Kennedy Jr. launched an investigation into the root causes of autism.
Kennedy’s detractors in mainstream media cite epidemiological studies like Madsen’s as “proof” that Kennedy is pushing a “discredited” and “debunked” theory about a possible link between vaccines and autism.
“Madsen has become a cornerstone publication that forms the basis of the claim that vaccines do not cause autism,” Jablonowski and Hooker wrote.
However, it’s not possible to replicate the NEJM study’s findings because the raw data the researchers used are not available to other researchers, they said.
The Madsen study used 95% confidence intervals, which refer to a range of values within which one can be confident there is no connection between autism and the shot.
Jablonowski and Hooker said the range of the 95% confidence intervals should be narrower to constitute strong evidence. They said the study results, as presented, show that “the authors are 95% confident that recipients of the MMR vaccine are anywhere from 47% less likely to 24% more likely to be harmed by autistic disorder.”
“This is ‘strong evidence’ of the need for more evidence,” they wrote.
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‘The numbers literally don’t add up’
Jablonowski and Hooker also cited problems with how the NEJM study authors conducted their statistical adjustment, which is the method scientists use to correct data to account for biases, confounding factors or limitations in the data.
They said that the authors didn’t share their detailed model for statistical adjustment, which would have been appropriate given that the adjustment changed the safety signal to its opposite — from leaning toward harm to leaning toward protection. Adjusting for different variables could have shown a different outcome.
The study’s authors “are confused” about the size of the vaccinated and unvaccinated cohorts, Jablonowski and Hooker said. The number of vaccinated versus unvaccinated individuals with autistic disorder and other autism spectrum disorders varies between tables. This discrepancy significantly affects the interpretation of the results.
For example, reanalyzing unadjusted data from one of their tables indicated with 90% confidence that children who receive an MMR vaccination have an 18% greater incidence of autistic disorder or other autism spectrum disorders.
Hooker said:
“The original Madsen paper is foundational to the pharmaceutical industry canard that ‘vaccines don’t cause autism.’ However, the numbers literally don’t add up. Based on this and myriad other issues with this foundation, the question of vaccines and autism desperately needs to be put back on the table.”
Jablonowski and Hooker said the Danish researchers had access to some of the highest-quality data possible for conducting such an analysis.
At the time of the study, Denmark had a population-wide standardized autism screening program and a population-wide healthcare surveillance program. The study was also done at the beginning of the explosion in autism rates, when fewer vaccines were recommended to children and when there were fewer other possible toxic exposures.
The raw data ought to be made available for analysis to all researchers so the study can be replicated, Jablonowski and Hooker said.
Related articles in The Defender
- Pulling Back the Curtain’: NIH Will Use Medicaid, Medicare Records to Study Autism
- NIH to Use Health Records From Public, Private Databases to Study Autism
- RFK Jr. Launches ‘Massive Testing and Research’ Into Autism Epidemic
- What Most Autism Research Gets Wrong — and Why That Might Change
- 1 in 31 Kids Had Autism in 2022 — Up From 1 in 36 in 2020
