Epidemiological Autism Studies: Why parents of children with autism are so upset!

The Peltola Studies were funded in part by Merck & Co

The Taylor Studies were commissioned by the Medicines Control Agency of the UK Department of Health.

The Kaye Study had no specific funding. James A Kaye is an epidemiologist at the Boston Collaborative Drug Surveillance Program, which is supported in part by grants from AstraZeneca, Berlex Laboratories, Boehringer Ingelheim Pharmaceuticals, Boots Healthcare International, Bristol-Myers Squibb Pharmaceutical Research Institute, GlaxoWellcome, Hoffmann-La Roche, Janssen Pharmaceutica Products, R W Johnson Pharmaceutical Research Institute; McNeil Consumer Products, and Novartis Farmaceutica.

The Dales Study: Loring Dales works for the California Department of Health Services.

The Meldgaard Madsen Study, the just-released study from Denmark, was co-funded by the National Alliance for Autism Research (NAAR) and the Centers for Disease Control and Prevention (CDC)

The above “feel-good studies” about the safety of the MMR vaccine have enchanted the vaccine authorities. CDC’s Chen described the Peltola publication and Taylor’s first study in superlative terms, the British vaccine hierarchy assured everyone that the MMR is safe and the vaccine supporters on both sides of the Atlantic thought the Kaye and Dales studies were wonderful. Dales applauded the Danes and Taylor applauded himself by stating that his second paper was the “final” word.

Not surprisingly, the earlier studies failed to fully reassure the public that the MMR is totally safe. They also failed to convince the parents of affected children that the MMR had no role in the present autism epidemic. The impact of the latest study from Denmark, which “provides strong evidence against the hypothesis that MMR vaccination causes autism”, has yet to be felt, but it is likely that interested parties will be commissioning and financing more “final” studies in the future.

The parents who have watched their normal children sink into autism shortly after MMR vaccination do not believe that it is “just a coincidence”. Specific pathological findings in the gut, evidence of vaccine-strain measles, elevated IAG / urinary polypeptides levels, and positive Myelin Basic Protein antibody tests are impressive objective findings. Claiming that they mean nothing because of data no one can check, or conclusions proved erroneous with time, only adds insult to injury.

Honest, unbiased, and scientific studies, which actually LOOK at the children, and the biological, cellular, molecular, toxic and immune aspects of their medical illness, are urgently needed. Talking to parents is also a great idea! Now, that kind of research will be well worth the money.
F. Edward Yazbak, MD, FAAP, TL Autism Research, Falmouth, Massachusetts.

Addendum:
I wrote Epidemiological Autism Studies: Or why parents of children with autism are so upset, because I was thoroughly disturbed that yet another “computer study”, this time from Denmark, had just been published (N Engl J Med 2002;347:1477-82) instead of a decent clinical research study with “real patients”, and objective investigations of all predisposing factors and specific pathology. Unlike the parents who want to find out what has caused their children’s regressive autism, the CDC hierarchy is only interested in proving that MMR vaccination does NOT contribute to autism. The good people at CDC must have been confident that the Danish study would “clear” the MMR even before they decided to co-fund it. They would have never gambled federal funds to support a study, which could have possibly indicted the triple vaccine, given their vehement support of it and its ‘safety’.

The results of the study by Meldgaard Madsen and Co will be thoroughly critiqued by others, as they should be. This commentary is about a statement in the beginning of the second paragraph of the publication: “Studies designed to evaluate the suggested link between MMR vaccination and autism do not support an association, but the evidence is weak and based on case-series, cross-sectional and ecological studies. No studies have had sufficient statistical power to detect an association, and none had a population-based cohort design. 10-16”

The listed references 10 to16 are:
10. 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.
11. Kaye JA, del Mar Meleno-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
12. Dales L, Hammer SJ, Smith NJ. Time trends in autism and in MMR immunization coverage in California. JAMA 2001;285:1183-5
13. Fombonne E, Chakzbarti S. No evidence for a new variant of measles-mumps-rubella -induced autism. Pediatrics 2001;108:991.abstract
14. Patja A, Davidkin I, Kurki T, Kallio MJ, Valle M, Peltola H. Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up.
Pediatr Infect Dis J 2000;19:1127-34
15. 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
16. Taylor B, Miller E, Lingram L, 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

Since 1998, noted statisticians and world-renowned epidemiologists have criticized the methodology and the findings of the above-listed studies; however, the CDC, the vaccine authorities in the UK, and the pro-vaccine lobbies have always insisted that they were all, well designed, reliable and totally convincing. Pediatricians thought that parents who dared mention an autism-vaccine connection after all this evidence were trouble-makers and I was wished a happy retirement.

And now, a study co-funded by the CDC, tells us that the critics were right and that indeed ”No studies have had sufficient statistical power to detect an association…”
Following this logic, it is obvious that the above listed studies could not have disproved an MMR-autism connection either.

The parents of children with autism are better informed now.
They know that peer-review does not guarantee quality and that bigger is not necessarily better: After all, Leo Kanner’s original study only included 11 subjects.
They know that the message of Andrew Wakefield’s first report, on the clinical peculiarities in twelve medically ill children, is still alive and well.
They know that the authors of the listed epidemiological studies knew what they were supposed to prove and went out to prove it, while Wakefield first examined children, and when he discovered unusual findings, reported them, in order to invite more research.
They know that he was maligned and forced to resign because of his views and that he was only trying to save children, while his opponents were just protecting a product.
They know that buzzwords are freely used in scientific papers, that pages full of statistics can be a smoke screen and that graphs can be compressed with a computer mouse.
They also know that if they are unable to understand a study, it is because this is precisely what the author wishes.

What parents really need are studies about autoimmunity, mercury, and why their affected children have evidence of vaccine-strain measles in their body. It is unlikely the CDC will fund such studies.

F. Edwards Yazbak, MD, FAAP, Falmouth, Massachusetts
TLAutStudy@aol.com

November 19, 2002

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