[Government agencies including the NIH and CDC are conspiring with seemingly reputable publications like PEDIATRICS to push junk science.  They hope to bury evidence of the dangers of vaccines.  At the same time they have waged a misinformation campaign in making claims that skyrocketing Autism/ASD rates are due to better diagnostics.  Dr. Ed Yazbak of our scientific board debunks their efforts with two fantastic articles that expose the government's lies and vindicate vaccine rights activists.  Vaccine Autoimmune Project for Research and Education (VAP)  ]

The Unconvincing Thimerosal Epidemiological Studies: How and Why They Were Produced, Published and Protected

by F. Edward Yazbak, MD, FAAP

 http://www.vaproject.org/yazbak/Unconvincing-Thimerosal-Studies-20080902.htm

Like everyone else in the United States who has been touched by autism, I watched the Larry King Show on Wednesday April 3, 2008 and …like everyone else I could not believe my eyes and ears. Jenny McCarthy, bless her heart, was simply dynamite. I was glued to my recliner for the duration except when I got up to vote on the CNN question:

“Do you think vaccines cause or contribute to autism?”

I personally not only “think” but I am positively certain that vaccinations contribute to autistic regression in some predisposed children, like my oldest grandson.  

I know that my big boy regressed after his first MMR vaccination, improved for a while and regressed again, much more seriously, following his second MMR. The Institute of Medicine (IOM) and U.S. Courts have accepted this sequence known as “Challenge-Dechallenge-Rechallenge” as evidence of causation. [1]

My grandson was carefully and fully worked-up at the Royal Free Hospital in London and found to have:

I was contacted over the last ten years by a number of MDs, PhDs, and scientists who were just as positive as I was that their child or grandchild had regressed following one or more vaccinations.

Just to clarify my personal position relative to pediatric vaccination:

Representing the American Academy of Pediatrics (AAP) on the April 3rd Larry King show were Drs. Tayloe and Karp who strongly supported all present vaccination initiatives and were genuinely convinced that vaccines had nothing to do with autism. Dr. Tayloe is President–Elect of the AAP.

As I expected, Dr. Karp brought up some recent California research showing that autism increased while the use of thimerosal decreased and Dr. Tayloe alluded to “14 studies” that he thought proved that thimerosal and vaccines did not cause autism. Jenny McCarthy brought them right back to reality with a little board that showed the old short list of pediatric vaccines on the left and the present much larger (and still growing) list on the right.

Although my primary interest has always been the MMR-autism connection, I have become informed about thimerosal and actively participated in efforts to convince the Rhode Island and Massachusetts state legislatures to remove it from vaccines. I have also followed with great interest the research that has been going on nationwide.    

I do believe that:

Since we started removing the mercury “preservative” from vaccines in 1999, we have added to the recommended pediatric primary vaccination series 3 doses of a 7-valent pneumococcal vaccine, 3 doses of a pentavalent vaccine (DTaP+IPV+HepB) and 3 doses of a new rotavirus vaccine that “may” prevent diarrhea caused by that virus.

The simultaneous administration of a dose of HIB, pneumococcal and pentavalent vaccines means the injection of 1,200 mcg of Aluminum salts in a few seconds at 2, 4 and 6 months of age. Chapter 21 of the US Code of Federal Regulations [610.15(a)] limits the amount of aluminum in biological products, including vaccines, to 0.85 mg/dose [3] and the new FDA limit for aluminum exposure from parenteral nutrition is <5 µg/kg/d. [4]      

It was very obvious to anyone watching the Larry King show, that Drs. Karp and Taloe truly believed that reliable epidemiological studies had ruled out a vaccine-autism connection …forever. Like most other pediatricians who read PEDIATRICS, JAMA and the NEJM, they believed what they read, particularly after they heard that the IOM Immunization Safety Review Committee gave those studies its seal of approval on February 9, 2004 and certainly after IOM president Dr. Harvey V. Fineberg [5] stated on Meet the Press:

These studies were carried out in the United States, in Great Britain, in Denmark and Sweden. These studies covered hundreds of thousands of individuals, children, in these populations. They compared systematically in different ways whether you received vaccine with no thimerosal, with some thimerosal, with more thimerosal, and they looked at the relationship of those experiences with the development of autism. Uniformly, the best of those studies all show no association between receiving vaccine of different amounts with thimerosal or without and the development of autism. It was the absence of that association which was the main reason for reaching the conclusion that the evidence points to no association between vaccines and autism.

A few years ago, the CDC decided that it was time to administer the “Coup de Grace” to the preposterous idea that vaccines somehow caused certain children to regress into autistic states. The IOM Immunization Safety Review Committee would have to meet in February 2004 and conclude, once and for all, that neither mercury-containing vaccines nor live virus vaccines caused autistic regression.   

The CDC had a problem: A few months before the planned meeting, it had no Thimerosal studies that could convincingly deny a mercury-autism connection and some had to be created easily, inexpensively and …in a hurry.

The Up and Down studies (as I like to call them) were the answer. Because Thimerosal was not the only cause of autism/ASD, all the chosen friendly researchers needed to do was to show that these awful and terrible conditions increased (UP) when the thimerosal content in pediatric vaccines decreased (DOWN). Obviously if the number of pediatric vaccines happened to increase at the same time,  then the results would be even more convincing - a welcome bonus.

The CDC made its wishes known and studies were created.

For the researchers, whether local or foreign, this was truly a dream come true:

With all these incentives, four Up and Down studies were published in the second half of 2003 … just in time for the IOM meeting . To the best of my knowledge, there had never been an Up and Down Thimerosal article prior to June 2003.

As February 2004 approached, Representative Dave Weldon, begged CDC Director  Gerberding and friends to delay the IOM Immunization Safety Review Committee meeting because solid clinical and animal thimerosal studies were underway. His request was flatly turned down and on February 9, 2004, Marie McCormick gaveled her committee to order. She knew she had the four late-2003 papers to “prove” that mercury in vaccine did not cause autism. For extra insurance, she allowed Britain’s Elizabeth Miller (Liz as she is known at the CDC) to present raw data from a British study: data that had not yet been peer-reviewed and would only be published, in the fall of 2004… by a “friend”… of course!

Based mostly on those studies, the Committee decided that the evidence was so strong against a thimerosal-autism connection that further autism research should be directed elsewhere. The Committee did the same with the MMR vaccine: After a short session, it anointed certain epidemiological studies, ignored reasonable contrary arguments and decreed that MMR vaccination never caused autism and ...future research should focus on other causes.

For the parents and grandparents of affected children, February 9, 2004 will forever be remembered as “ The Autism Day of Infamy”.

*****

The 2008 California Thimerosal study

The 2008 Up and Down study from California that Dr. Karp mentioned to Larry King received some national and international attention, but probably less than the authors (and the CDC) expected. For a careful review, please see: “SafeMinds Critique of Schechter & Grether Paper on California’s Autism DDS Data and Thimerosal Exposure”. [6]

The article titled “Continuing Increases in Autism Reported to California's Developmental Services System: Mercury in Retrograde” by Robert Schechter, MD, MSc and Judith K. Grether, PhD was published in the January 2008 issue of The Archives of General Psychiatry, an American Medical Association publication with a readership of around 30,000 psychiatrists. I do not know how many U.S. psychiatrists are really interested in thimerosal but I suspect that there are not too many. In fact, the Department of Justice (DOJ) went out of the Country to find a psychiatrist willing to testify on thimerosal, MMR and autism. That French psychiatrist, Dr. Eric Fombonne, presently Professor of Psychiatry at McGill University, wrote an accompanying commentary to the Schecter and Grether article with the poetic title “Thimerosal Disappears but Autism Remains”

The authors of the articles disclosed no financial conflicts of interest. Dr. Schecter is employed in the Immunization Branch of the California Department of Public Health and Dr. Grether works in the California Center for Autism and Developmental Disabilities Research and Epidemiology, Environmental Health Investigations Branch. I must confess that it was nice to know that at least in California the center for autism research is part of the Environmental Health Investigations Branch. May be there is hope…after all! 

The authors stated in the opening paragraph of their abstract.

Context: …The exclusion of thimerosal from childhood vaccines in the United States was accelerated from 1999 to 2001. The Immunization Safety Review Committee of the Institute of Medicine has recommended surveillance of trends in autism as exposure to thimerosal during early childhood has decreased.

In fact, the removal of Thimerosal from childhood vaccines started in the United States in 1999 and only after a lot of pressure. If it had started before that, then it could have accelerated in 1999. In addition, it is not clear what the authors meant by “accelerated from 1999 to 2001”.

Did they really mean to say that starting in 2001 the exclusion of thimerosal was supposed to decelerate?

Is that really what they meant?

The following sentence concerning the Immunization Safety Review Committee of the Institute of Medicine also seems problematic. In 2004, Chairperson Marie McCormick and members of the “Committee” told the world that they were so convinced that Thimerosal did not cause autistic regression that further autism research should be directed elsewhere. If that was so and if everyone was absolutely sure that Thimerosal was safe and wonderful, then why would the committee have recommended the “surveillance of trends in autism as exposure to thimerosal decreased”?

It would be nice to hear Dr. Marie McCormick’s comment on that at a congressional hearing and under oath.

Under “Results” Drs. Schecter and Grether reported that

“The estimated prevalence of autism for children at each year of age from 3 to 12 years increased throughout the study period. The estimated prevalence of DDS clients aged 3 to 5 years with autism increased for each quarter from January 1995 through March 2007. Since 2004, the absolute increase and the rate of increase in DDS clients aged 3 to 5 years with autism were higher than those in DDS clients of the same ages with any eligible condition including autism.”

One must wonder how the authors could report such a prolonged calamity and only be interested in proving that it was not related to Thimerosal. Didn’t they get just a little curious about what could have perpetuated the alarming increases in the prevalence of Type I autism among 3 to 5- year-old California children through forty-nine consecutive quarters - if it was not the Thimerosal?

*****

The 2003 California - Sweden - Denmark Thimerosal study

The CDC rush-order studies had included another study from California:  “Autism and thimerosal-containing vaccines: lack of consistent evidence for an association” by Stehr-Green, Tull, Stellfeld, Mortenson, and Simpson. The study, funded by the CDC, compared what happened in California, Sweden and Denmark. This was probably the study that IOM president Harvey Fineberg mentioned on Meet the Press.

“In all three countries, the incidence and prevalence of autism-like disorders began to rise in the 1985-1989 period, and the rate of increase accelerated in the early 1990s. However, in contrast to the situation in the United States, where the average Thimerosal dose from vaccines increased throughout the 1990s, Thimerosal exposures from vaccines in both Sweden and Denmark-already low throughout the 1970s and 1980s-began to decrease in the late 1980s and were eliminated in the early 1990s.”

The authors of the 2003 California study were all internationally renowned.

Dr. Stehr-Green had been a CDC consultant, Dr. Simpson a CDC employee and Dr. Stellfeld was still at the Danish Statens Serum Institut (SSI).

According to its mission statement, “Statens Serum Institut is a public enterprise operating as a market-oriented production and service enterprise.”  In 2007, its “revenue rose considerably to DKK 1,128m.” [7] Vaccine sales have always constituted a major source of income; in 2002, over 80% of SSI profits came from vaccines. [8]

The Stehr-Green article was published in the American Journal of Preventive Medicine, a journal that “…publishes articles in the areas of prevention research, teaching, practice and policy”. The audience was described as “Practitioners, Researchers, Teachers, Students and Policy Makers in preventive medicine and public health. [9]

Because the pediatric vaccination schedules were so different in California, it would have been interesting to actually compare the increase in the prevalence of ASD in California with that of Denmark and Sweden.  

*****

The British Thimerosal study

The British research raw data presented by Dr. Elizabeth Miller and accepted at the February 9, 2004 IOM meeting was finally published in the September 2004 issue of PEDIATRICS, the journal of the American Academy of Pediatrics under the title “Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association”. The publication by Andrews, Miller, Grant, Stowe, Osborne and Taylor made a moderate splash in the U.S. but went almost unnoticed in the U.K.

The editor of PEDIATRICS refused to publish any criticism of the study in the printed journal. Two electronic responses were allowed; the second only questioned why the first one was never answered by the authors.

There were several problems with that research and publication that should have been noticed by the editor and the reviewers: 

In their exuberance, the authors even reported that regarding “general developmental disorders, unspecified developmental delay, and ADD, there was an apparent protective effect from increasing thimerosal exposure.”

I did not even attempt to request the actual statistical data of this study. In the past, independent U.S. investigators never had much luck accessing such data or reviewing them. In April 2000, Brent Taylor, a co-author of this study, was invited to testify at a hearing of the House Committee on Government Reform. At that hearing, Chairman Dan Burton (R-IN) asked him to produce the data that were the basis of his studies and his criticism of the Wakefield research. Taylor flatly refused citing confidentiality. Later, Congressman Burton made the same request in a personal letter to Prime Minister Tony Blair, also without success.

Taylor had previously refused to honor two requests by Dr. Bernard Rimland and two by Dr. Jane Orient of the American Association of Physicians and Surgeons.  

At an AAP conference on June 13, 2000, Brent Taylor was asked again to show his data confidentially and privately to the Institute of Medicine… and again he refused.

A more detailed review of the Andrews’ study by John Stone and his comprehensive investigation of the thimerosal issue in the United Kingdom are available on this web site: “How PEDIATRICS validated erroneous British Mercury Data” [9]

*****

In their recent publication, Drs. Schecter and Grether referenced several epidemiological studies but singled out two they apparently felt were strongest: 

I will discuss both but will also review the just as problematic 2003 Danish Thimerosal study by Madsen, a larger and more substantial review than Hviid’s.

The Hviid Thimerosal study

Association between thimerosal-containing vaccine and autism.
Hviid A, Stellfeld M, Wohlfahrt J, Melbye M.
JAMA. 2003 Oct 1;290(13):1

During 2 986 654 person-years, we identified 440 autism cases and 787 cases of other autistic-spectrum disorders. The risk of autism and other autistic-spectrum disorders did not differ significantly between children vaccinated with thimerosal-containing vaccine and children vaccinated with thimerosal-free vaccine (RR, 0.85 [95% confidence interval [CI], 0.60-1.20] for autism; RR, 1.12 [95% CI, 0.88-1.43] for other autistic-spectrum disorders). Furthermore, we found no evidence of a dose-response association (increase in RR per 25 microg of ethylmercury, 0.98 [95% CI, 0.90-1.06] for autism and 1.03 [95% CI, 0.98-1.09] for other autistic-spectrum disorders).

Just eleven months before the Hviid study was published, Madsen et Al published an MMR-related study in the New England Journal of Medicine. That study was co-authored by Hviid and compared the prevalence of autism and ASD among MMR-vaccinated and unvaccinated Danish cohorts. The study “A population-based study of measles, mumps, and rubella vaccination and autism” is still often referred to as the “Big MMR study from Denmark”.

Of the 537,303 children in the cohort (representing 2,129,864 person-years), 440,655 (82.0 percent) had received the MMR vaccine. We identified 316 children with a diagnosis of autistic disorder and 422 with a diagnosis of other autistic-spectrum disorders. After adjustment for potential confounders, the relative risk of autistic disorder in the group of vaccinated children, as compared with the unvaccinated group, was 0.92 (95 percent confidence interval, 0.68 to 1.24), and the relative risk of another autistic-spectrum disorder was 0.83 (95 percent confidence interval, 0.65 to 1.07). There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autistic disorder.

The two studies used data from the Danish Civil Registration System, which assigns a unique identification number to every live-born infant and new resident in Denmark.

Superlative figures such as 537,303 and 2,129,864 are always very intimidating and they are meant to be. Their purpose is often to hide the small size of the study samples.

As clearly evident in the table below, those highly advertised Danish studies included less than 65 cases of autism a year – in fact less than the number of new cases of autism added by the California Department of Developmental Services each week.

The findings of the two studies, Madsen’s MMR study (November 2002) and Hviid’s Thimerosal study (October 2003) are quite revealing when they are compared.

To the best of my knowledge, this is the first time a side-by-side comparison of the studies has been published. It shows that the most official and supposedly most accurate Danish autism numbers and statistics are small and variable, year-to-year.

The MMR study by Madsen, Hviid et al. (on the left) was co-authored by a CDC epidemiologist and co-funded by the CDC’s Vaccine Immunization Program and …an autism organization.

It is evident that “peer-review” of the data could have been more careful.   

But then, what was the IOM Immunization Safety Review Committee’s excuse?

For a committee supposed to be the “Court of Last Resort”, the failure to do this simple comparison is inexcusable. If the committee members had detected this flagrant weakness in the data, they would have had to reject both studies and indeed all Danish studies that used that data. They still can and they probably should.

The two Danish populations, from the same registry and organization, were so different in two consecutive years (1999 and 2000) that no intelligent conclusions could or should have been drawn.

There are two little-known facts that illustrate the solid post publication “protection” that was provided to the CDC-funded Madsen MMR study (NEJM, November 7, 2002). Samy Suissa PhD, James McGill Professor and Director, Department of Epidemiology and Biostatistics, McGill University and Division of Clinical Epidemiology, Royal Victoria Hospital, Montreal wrote to the editor of the New England Journal of Medicine within 4 days of the publication of the article seriously criticizing the paper’s statistical findings and calculations. His letter was never published.  

A few months later, Dr. Gary Goldman and I wrote a review using the same Danish data, that clearly showed that the prevalence of autism/ASD increased after the introduction of MMR vaccination in Denmark and before thimerosal had been removed from all pediatric vaccines. We submitted our paper to the NEJM and the editor refused to publish it outright. As a Massachusetts physician and because the journal is owned by the Massachusetts Medical Society, I wrote to the editor and asked him to reconsider. He did not even bother to respond. Our article was later published in the Journal of American Physicians and Surgeons to whose editor we remain most grateful.

See “An Investigation of the Association between MMR Vaccination and Autism in Denmark” [10]

*****

The Fombonne study

Pervasive developmental disorders in Montreal, Quebec, Canada:
prevalence and links with immunizations
Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D.
Pediatrics. 2006 Jul;118(1):e139-50

METHODS: We surveyed 27749 children born from 1987 to 1998 attending 55 schools from the largest Anglophone school board... The cumulative exposure by age 2 years to thimerosal was calculated for 1987-1998 birth cohorts. Ethylmercury exposure ranged from medium (100-125 microg) from 1987 to 1991 to high (200-225 microg) from 1992 to 1995 to nil from 1996 onwards when thimerosal was entirely discontinued. Measles-mumps-rubella coverage for each birth cohort was estimated through surveys of vaccination rates. The immunization schedule included a measles-mumps-rubella single dose at 12 months of age up to 1995, and a second measles-mumps-rubella dose at 18 months of age was added on after 1996.

RESULTS: We found 180 children (82.8% males) with a pervasive developmental disorder diagnosis who attended the surveyed schools, yielding a prevalence for pervasive developmental disorder of 64.9 per 10000… A statistically significant linear increase in pervasive developmental disorder prevalence was noted during the study period. The prevalence of pervasive developmental disorder in thimerosal-free birth cohorts was significantly higher than that in thimerosal-exposed cohorts (82.7 of 10000 vs 59.5 of 10000). Using logistic regression models of the prevalence data, we found no significant effect of thimerosal exposure used either as a continuous or a categorical variable. Thus, thimerosal exposure was unrelated to the increasing trend in pervasive developmental disorder prevalence... Measles-mumps-rubella vaccination coverage averaged 93% during the study interval with a statistically significant decreasing trend from 96.1% in the older birth cohorts (1988-89) to approximately 92.4% in younger birth cohorts (1996-1998). Thus, pervasive developmental disorder rates significantly increased when measles-mumps-rubella vaccination uptake rates significantly decreased… Thus, no relationship was found between pervasive developmental disorder rates and 1- or 2-dose measles-mumps-rubella immunization schedule.

CONCLUSIONS: The prevalence of pervasive developmental disorder in Montreal was high, increasing in recent birth cohorts as found in most countries. Factors accounting for the increase include a broadening of diagnostic concepts and criteria, increased awareness and, therefore, better identification of children with pervasive developmental disorders in communities and epidemiologic surveys, and improved access to services. The findings ruled out an association between pervasive developmental disorder and either high levels of ethylmercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measles-mumps-rubella vaccinations.

The following statement accompanied the publication:

“In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001.  Since June 2004, Dr. Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation. None of his research has ever been funded by the industry.”

It is not clear how Dr. Fombonne was recognized as an expert witness in U.S. thimerosal litigation in 2004 when his Montreal study, published in July 2006, was his first thimerosal-related publication.  

Review of the study findings:   

Under “methods”, the authors stated: “We surveyed 27749 children born from 1987 to 1998 attending 55 schools from the largest Anglophone school board”. In reality, only around 14% of all Montreal students attended schools in the Lester B. Pearson School Board (LBPSB) where the study was conducted, while 13% attended schools in “English Montreal School Board”, the only other Anglophone school board in Montreal. So if indeed LBPSB was the “largest” Anglophone school board, it was certainly not by much.

The authors wrote: “Children could not be individually assessed for diagnostic confirmation”, without explaining why. The five authors not only “could” have but certainly “should” have assessed a representative sample of the 180 students and their records, just to make sure that they really had PDD.

The five authors also chose not to examine any of the vaccination records

Strangely the editor of PEDIATRICS did not find fault with a study on autism and vaccines in which the authors had not checked the validity of the diagnosis or the list and mercury content of the vaccines.

One must also wonder to what extent the authors “surveyed” the 27749 unaffected children when they did not even look at a single PDD record.

 The native language in Montreal is French (42%), Non-English (36%) and English (22%) and the children who attend schools in the two Anglophone boards are all from that smallest English group.  The majority (51.1%) of Montreal students in 2005 were either
        A. Immigrants with immigrant parents (17%),
        B. Born in the Province of Quebec with immigrant parents (23.6%)
        C: Born in the Province of Quebec with one immigrant parent (10.5%).

Adopted and Immigrant children, those who are born to foreign-born parents and those who have incomplete or no vaccination records are routinely revaccinated before being assigned to French schools.

The mercury content of pediatric vaccines in Montreal was not “nil from 1996 onwards”:
        -Some pediatric vaccines contained thimerosal well into 1997-1998
        -Thimerosal-free hepatitis B vaccine was only licensed in Canada in 2001
        -Thimerosal-free RhoGAM was not available prior to 2001
        -The pediatric Influenza vaccines (age 6-23 m) used in Canada contain mercury

The following is one of the official vaccination records we reviewed.

The child, an adopted boy with PDD, was born in a South American Country on September 2, 1997. He has been in Montreal since the age of 3 months. 

Total mercury content of vaccines received after 1996: 81.75 mcg.

The following table shows the situation in a French school for special needs.
[Figures compiled and published by J. Bonnefil]

There were 185 students aged 4-13 years in that school during school year 2001-2002.  Fifty-six (56) students were on the autism spectrum.  

*Haitian children and those whose mothers came from near-eastern and far-eastern countries were almost invariably re-vaccinated.

One does not need an epidemiological study to demonstrate that there were proportionately more diagnosed cases of ASD among revaccinated Montreal school children.      

When David Ayoub MD critically examined Fombonne’s Thimerosal claims and discovered the above facts (and many more), he reported them in a letter to the editor of PEDIATRICS. In return, he received a “form” e-mail stating that his letter could not be published because of lack of space. Later, a friend who inquired was told that that Dr. Ayoub’s letter was not published because “Dr. Fombonne did not wish to answer it.”

When I started examining the MMR-related portion of the “Montreal” study, the following statement intrigued me: “Data an MMR uptake for the study were available through the Direction de Santé Publique de la Capitale Nationale” (N. Bouliane, BN, MSc - 2005)”. In the Province of Quebec, “La Capitale Nationale” is Quebec City.  Dr. Fombonne also stated “These data were routinely collected in the region of Québec among 5-year-old children attending kindergarten during the years 1993-2004 (i.e. for birth cohorts from 1988 – 1998)”.

It is impossible to know how many readers were tempted to think that the data were from the Province of Quebec where Montreal is located when in fact, the MMR statistics had nothing to do with the city of Montreal or the Province; they were those of the City of Quebec, located 265 km (156.6 miles) and almost three hours away by car for most of us, and perhaps two hours for Canadian drivers.

I called Ms. Bouliane and she confirmed that the MMR vaccination rates data that were provided to Dr. Fombonne were from the Quebec City area but refused to release them to me because they were “administrative information” and “only intended for research”.

A Canadian parent requested and promptly received written confirmation through the Canadian Freedom of Information Act: The data given to Dr. Fombonne were indeed from Quebec City and vicinity.   

Meanwhile I had reviewed four Montreal area studies and they revealed that MMR vaccination rates had actually increased during that study period.

The details of what happened next and my first and last run-in with the editor of PEDIATRICS can be found in “A Tale of Two Cities: Flawed Epidemiology” [12]               

I was first told, like Dr. Ayoub, that there was no space to publish my letter. I called the editor’s secretary and she confirmed that the real reason was that Dr. Fombonne did not wish to answer my letter. I told her that I had been a fellow of the Academy since 1963, nine years longer than the editor and that this was my FIRST letter to him and … that he should personally insist that Dr. Fombonne respond to me.

That is when the nice young lady asked me if I wanted to talk to the editor and I said I would love to and she connected us.

On the editor’s suggestion, I resubmitted a shorter version of the letter.

Two weeks later I received another rejection.

Obviously my “MMR agenda” had nothing to do with what I wrote and my letter had nothing to do with MMR causing regressive autism. I only wrote that it was strange and unacceptable to relate Montreal’s PDD cases to Quebec City’s MMR vaccination rates also noting that Montreal’s MMR vaccination rates were actually increasing during the study period.

As to the editor’s beliefs, they were totally irrelevant to the subject at hand.

The unfortunate fact was that by publishing Dr. Fombonne’s allegation: “Thus, pervasive developmental disorder rates significantly increased when measles-mumps-rubella vaccination uptake rates significantly decreased” the editor of PEDIATRICS helped propagate to 65,000 pediatricians (including Larry King’s guests) a fallacy. The absolute and incontestable truth was that in Montreal pervasive developmental disorder rates significantly increased when measles-mumps-rubella vaccination uptake rates also significantly increased.

That fact could not be denied by Dr. Fombonne or by the editor of PEDIATRICS but unfortunately… I had no way to tell my fellow pediatricians worldwide.

Something else was bothering me … apart from Dr. Fombonne referring to me as “this person”. The style of Dr. Fombonne’s note suggested that this was the first time he had heard about my letter to the editor.

Now things were really getting interesting!

I decided to look at all Dr. Fombonne’s publications in PEDIATRICS. There was not a single letter to the editor published in response to any of them.

A 2001 article by Dr. Fombonne reported to the huge pediatric readership of the Journal (including Drs. Tayloe and Karp) the results of a study he had conducted in the United Kingdom.  That publication titled “No evidence for a new variant of measles-mumps-rubella-induced autism” was evidently intended to rebuke research by Andrew Wakefield.

The editor and his peer reviewers should have been more careful with that study too.

If they had, they would have saved themselves the embarrassment of having Demichelli, Jefferson et al comment in the well-known Cochrane Review: “The numbers and possible impact of biases in this study is so high that interpretation of the results is impossible.” [12]

*****

The Madsen Mercury Study

Thimerosal and the occurrence of autism:
negative ecological evidence from Danish population-based data.
Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P,
Plesner AM, Andersen PH, Mortensen PB.
Pediatrics. 2003 Sep;112(3 Pt 1):604-6.

PATIENTS: All children between 2 and 10 years old who were diagnosed with autism during the period from 1971-2000.
OUTCOME MEASURES: Annual and age-specific incidence for first day of first recorded admission with a diagnosis of autism in children between 2 and 10 years old.
RESULTS: A total of 956 children with a male-to-female ratio of 3.5:1 had been diagnosed with autism during the period from 1971-2000. There was no trend toward an increase in the incidence of autism during that period when thimerosal was used in Denmark, up through 1990. From 1991 until 2000 the incidence increased and continued to rise after the removal of thimerosal from vaccines, including increases among children born after the discontinuation of thimerosal.
CONCLUSIONS: The discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. Our ecological data do not support a correlation between thimerosal-containing vaccines and the incidence of autism.

This most comprehensive Danish study looked at a total of 956 children diagnosed with autism over 29 years - around 32 children a year. Just for comparison, California added 832 children with Type I autism to its social services system during the first quarter of 2003.

As mentioned earlier, there is no possible comparison between U.S. and Danish pediatric vaccination practices.  

Madsen stated in his paper: "From 1991 until 2000 the incidence increased and continued to rise after the removal of thimerosal from vaccines, including increases among children born after the discontinuation of thimerosal."

In a November 13, 2002 e-mail obtained through FOIA and addressed to Dr. Madsen and to a CDC epidemiologist, the first co-author of the study Dr. Marlene B. Lauritsen wrote: “But the incidence and prevalence are still decreasing in 2001".

The authors had a problem for which there was only one solution: They had to exclude the 2001 statistics and cut-off the study at 29 years. After all, the “still decreasing rates” could not be mentioned when the propaganda machine was about to proclaim that the incidence of autism had “increased and continued to increase” after the removal of Thimerosal from pediatric vaccines.  

Because time was running out, someone really important needed to lean on some editor and get the Madsen article published in 2003 in order to help Dr. Marie McCormick and her Immunization Safety Review Committee.  

An Assistant Surgeon General, the Director of the CDC’s National Center on Birth Defects and Developmental Disabilities, was the natural choice. On December 10, 2002 he mailed a long "personal" letter, also obtained through FOIA, to the editor of PEDIATRICS: “I am writing in support of an expedited review and consideration of the enclosed manuscript that examines the association between thimerosal, an ethyl mercury containing preservative and autism. As you may know, there has been considerable interest by parents, clinicians, educators, and policy makers for an explanation of the marked increase in the rate of autism."

The letter ended: “I feel this is a very important study that deserves thoughtful consideration by the Journal. Its findings provide one strong piece of evidence that thimerosal is not causally linked to autism. Thank you for your consideration,
Sincerely…”

Obviously if an Assistant Surgeon General stated that the Danish findings provided strong evidence that thimerosal did not cause autism, then the editor had to publish them and send them to 65,000 pediatricians… in a hurry.  

While the letter did not surprise me at all, the reference to “thimerosal, an ethyl mercury containing preservative” certainly seemed strange… to say the least.

On December 13, 2002, just three days after the CDC request, a CDC epidemiologist contacted Dr. Madsen and others by e-mail (also obtained through FOIA). She wrote: “We are having persistent questions from one of the congressional offices about data on the prevalence of autism in Denmark…I keep telling them that the information has been submitted for publication… But they have now asked if we can tell them the subject matter of the paper. So what do you feel about this… Don’t feel like you have to say yes to this request – no pressure at all…Again, absolutely no pressure to comply. And we wanted to get your permission before we say anything. Have a good weekend.”

A Dr. Thorsen, who was copied, answered within 26 minutes: “Thank you for your note. I suggest that you refer to Marlene B Lauritsen or Proben Bo Mortenson and they could recommend the very persistent person to contact the Editor of "Pediatrics".

On December 16, 2002 Dr. Madsen agreed with the plan to “refer to Marlene”.

Well! Well! A U.S. Congressman inquires what an upcoming Danish paper is all about; a paper that was completed and submitted for publication and a CDC employee, who knows the answer, refuses to tell him and then …calls her Danish friends to inform them …that they don’t have to answer him either. The Congressman is then referred to the editor of PEDIATRICS, who just had his arm twisted to accept the manuscript.  

Did that really happen?

Absolutely!

In a paper titled “How Mercury Was Absolved: Creativity, Collusion and Censorship”. Mr. Jeff Trelka systematically dissected the Madsen thimerosal study and discussed in great detail all its problems and shortcomings. He also described in his brilliant and very unique style all the related “protective interventions” and his own experience with the editor of PEDIATRICS.  His masterful review is a must read …in its entirety. [13]  

On April 13, 2004, Mr. Trelka wrote to the editor outlining his major criticisms of the Danish paper. Once again, the letter could not be printed and the editor wrote back on June 9, 2004: “A major review carried out by the US Institute of Medicine published last month (May 2004) found no evidence that thimerosal was linked to autism. Similarly, investigations by the UK Committee on Safety of Medicine, Europe's Agency for the Evaluation of Medicinal Products and the World Health Organization concluded the preservative was safe.  I consider this issue closed.”

With this understated pronouncement (he could have added “By the power vested in me…), the editor had anointed as a Gospel’s truth a committee report that was largely based on the particular flawed study, the criticism of which he was refusing to publish.

Isn’t that precious?    

 The Madsen publication was quoted in seventeen subsequent studies and innumerable news items. There were no published letters to the editor.  

* * * * *

So:

Q. Are some epidemiological studies worthwhile?
A. Certainly
Q. Were the Up and Down Thimerosal–Autism epidemiological studies worthwhile?
A. Apparently not
Q. When it comes to autism and mercury, are well-done clinical and animal studies always better than epidemiological mumbo-jumbo?
A. Absolutely
Q. Did the IOM Immunization Safety Review Committee ultimately help the children of the United States by its February 9, 2004 conclusions?
A. Unfortunately not
Q. Should pediatricians be given both sides of complex scientific issues and be allowed to decide for themselves?
A. Hopefully 

* * * * *

References:

 F. Edward Yazbak, MD, FAAP

Falmouth, Massachusetts

E-mail: tlautstudy@aol.com

 © 2008 Vaccine Autoimmune Project (VAP)