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The CDC and Denmark: The Love Fest That Fizzled

 

F. Edward Yazbak MD

 

I first described the warm and fuzzy relationship between the Centers for Disease Control and Prevention (CDC) and Danish Research in 2005.[1] At the time, I never thought that this “liaison” with Denmark would last so long or that it would end up costing the CDC (and the US taxpayers) so dearly.[2]  

When I asked why certain people in high places at the CDC thought that Danish Research was so wonderful, I was told that it was because Denmark had a unique “REGISTRY” of longitudinal statistics and medical information. Apparently, the United States desperately needed such valuable information from a country with a population of around 5 million.[3]

***

It became quickly evident that the most visible CDC envoy to collect and report “Danish Research” was Dianna E Schendel PhD[4], a distinguished scientist and epidemiologist.  

The most visible “liaison facilitator” representing the Danish side of that unique scientific undertaking until recently was Poul Thorsen MD, PhD, a psychiatrist turned epidemiologist.

In 2002, Drs. Schendel and Thorsen co-authored a study with K M Madsen and other Danish researchers titled “A population-based study of measles, mumps, and rubella vaccination and autism”.[5]

The study was “supported by grants from the Danish National Research Foundation; the National Vaccine Program Office and National Immunization Program, Centers for Disease Control and Prevention; and the National Alliance for Autism Research.”

I have no idea why the “Danish National Research Foundation” would want to invest a single Danish Kroner on a study from Denmark about MMR vaccination not causing “Regressive Autism”. On the other hand, when it is the CDC’s National Immunization Program and not the CDC’s Developmental Disabilities Branch that funds a study that claims to prove that the MMR vaccine was not responsible for the increasing rates of autism in Denmark, then one must seriously wonder what the good people in Atlanta really expected as return on their investment.  

Thanks to a memorable publicity campaign, the Madsen study quickly became the absolute proof against any MMR-Autism connection. To this day in fact, the “November 2002 study by CDC and the Danish Medical Research Council that followed more than 500,000 children over 7 years and found no association between MMR vaccination and autism” is still listed chronologically first under “MMR Vaccine Safety Research.”[6]

What was truly incredible was the fact that the scientific world believed that the Danish study findings were rock-solid because the study was “population-based” and had examined a cohort of 537,303 children representing 2,129,864 person-years. In fact a quick look at Table 2 of the publication easily revealed that the “Big Danish Study” only included 316 children with autism and 422 children with autism spectrum disorders born from January 1991 through December 1998, a minute number of cases, when compared to the numbers we were reporting in the United States at the time.   

The “Big Study” obviously needed a response.[7]

***

Drs. Schendel and Thorsen also published another study in 2002 titled “Public health issues related to infection in pregnancy and cerebral palsy”.[8] Their co-author in that study, Dr. Anne Schuchat, is presently the Assistant Surgeon General, United States Public Health Service and the Acting Director of the Center for Global Health at the CDC.

The Schendel-Thorsen duo’s first research adventure “Identification of biological/biochemical marker(s) for preterm delivery”[9] was published in 2001 and had nothing to do with autism

In 2003, Drs. Schendel and Thorsen cooperated with Cauci et al to publish “Determination of immunoglobulin A against Gardnerella vaginalis hemolysin, sialidase, and prolidase activities in vaginal fluid: implications for adverse pregnancy outcomes.”[10]

Interestingly, for some reason or another, they did not join Hviid, Stelfelld et al in their well-advertised and orchestrated 2003 “Thimerosal-Autism Danish Study”[11] published in JAMA and titled “Association between thimerosal-containing vaccine and autism.

In 2004, the Schendel-Thorsen Duo joined Vestergaard, Hviid, Madsen et al and published another Danish MMR-related paper titled “MMR vaccination and febrile seizures: Evaluation of susceptible subgroups and long-term prognosis.”[12] Having reassured the world about MMR not causing Autism the Danish team and its US guest, also decided to relieve any concerns over the febrile seizures that followed MMR vaccination, a minor adverse event when compared to regressive autism.

That relatively inconsequential publication is still given a big play on pro-vaccination websites.[13]

***

On April 13, 2011, The United States Attorney’s Office, Northern District of Georgia issued a Press release [14] titled

AUTISM RESEARCHER INDICTED FOR STEALING GRANT MONEY”

The Press Release went on:

Thorsen Allegedly Absconded With Over $1 Million

ATLANTA, GA - POUL THORSEN, 49, of Denmark, has been indicted by a federal grand jury on charges of wire fraud and money laundering based on a scheme to steal grant money the CDC had awarded to governmental agencies in Denmark for autism research.

The Press Release ended with the important reminder that “the indictment contains only allegations. A defendant is presumed innocent of the charges and it will be the government's burden to prove a defendant's guilt beyond a reasonable doubt at trial.”

It is equally imperative to remind everyone that no one at the CDC whether mentioned or unmentioned in this report, has ever been suspected of any financial irregularity related to Dr. Thorsen’s issues.   

Commenting on the Thorsen affair, Attorney Robert Kennedy Jr.[15] stated that the Danish psychiatrist had vanished along with almost $2 million that he had supposedly spent on research.” For most of us, there is obviously a difference between “over $1 million” and “almost $2 million” but so far, those who know exactly the $ amount are not talking and chances are they never will.

***

For the sake of time, I can simply say that a PubMed search on September 10, 2013 revealed that Drs. Schendel and Thorson co-authored with others 36 publications in all,  including four in 2007, six in 2008, three in 2009, seven in 2010, two in 2011 (February and December), one in October 2012 and one in January 2013.

A PubMed search on the same day revealed 90 publications authored or co-authored by Dr. Thorsen. These included since April 2011, when he was indicted, five publications in 2011, four in 2012 and five in 2013, the last one in June. The last two and half years clearly show how talented the Danish psychiatrist turned epidemiologist has become. In addition to autism publications, Dr. Thorsen wrote papers on infertility, cerebral palsy, retinopathy of prematurity, blood stream infections, serum interlukin-17, cytokenes, amniotic fluid chemokenes and cervical ultrasound elastography.  A few of the recent publications were from Denmark but some were clearly published in the United States.

One must wonder, however, how much Dr. Thorsen actually contributed to those studies since he was indicted and if indeed, according to the Inspector General of HHS, Thorsen is currently in Denmark and is awaiting extradition to the United States.”[16]

Dr. Schendel’s PubMed search revealed 234 publications including 13 in 2013 some of which still originating at the “Section of Epidemiology, Department of Public Health, University of Aarhus, Denmark” with no mention of the CDC.

***

The DSM-5 Connection

According to the Chair and Vice-Chair of the DSM-5 Task Force: “When the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) was released at the American Psychiatric Association’s Annual Meeting in May 2013, it marked the end of more than a decade’s journey in revising the criteria for the diagnosis and classification of mental disorders”.[17]

The DSM-5 Table of Contents[18], lists all the Neuro-Developmental Disorders, discussed in the new Manual including “Autism Spectrum Disorder”[19], that I urge anyone interested in autism to read and keep for future reference.

According to the American Psychiatric Association DSM-5 Development, both Drs. Schendel and Thorsen were part of the DSM-5 panel discussing “International Cultural, and Gender considerations in the diagnosis of Autistic Spectrum Disorders” at the Autism and Other Pervasive Developmental Disorders Conference (February 3-5, 2008)[20] 

During his DSM-5 collaboration, Dr. Thorsen listed his position as Adjunct Associate Professor, Department of Epidemiology and Biostatistics, School of Public Health, Drexel University. His related Biosketch[21] read as follows:

Dr. Thorsen has since his first project, initiated in 1987 as a medical doctoral student, managed a considerable number of studies on autism, national as well as international. Dr. Thorsen finished his training as MD 1989 and during a period of 3 years thereafter completed his internship. His research career was initiated in 1992 and he worked on the Danish National Birth Cohort first time 1996; was visiting scientist at the Centers for Disease Control and Prevention, Atlanta, GA, USA (CDC) 1997-2000; was Associate Professor, Department of Epidemiology, School of Public Health, University of Aarhus, Denmark, 2000-2008; Research Professor at Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, USA, 2008-2009, and associate at the Department of Epidemiology, Johns Hopkins University, Baltimore, USA, since 1999. Further, during the period 1998-2005 Dr. Thorsen has been a March of Dimes, PERI grantee, and for the period 1999-2008 Dr. Thorsen was appointed principal investigator on the “Epidemiologic studies of reproductive and developmental outcome – Denmark” from CDC. Dr. Thorsen is author or co-author of more than 90 scientific articles and book chapters. During the period 2000-2008 Dr. Thorsen established the research group, “North Atlantic Neuro-epidemiology Alliances” (NANEA) originally initiated through research on Cerebral Palsy in 1999-2000. NANEA’s main research areas are: a) autism, b) cerebral palsy c) neuropsychological development, d) preterm birth, e) Down syndrome, and f) Hearing loss. At present, the research network comprises more than 30 persons who are affiliated with the above areas of research (a-f).

If my calculations are right, Dr. Thorsen was 30 years old in 1992 when he started his research career and 35 years old when the CDC grabbed him to make him a visiting scientist because there was absolutely no one like him in the United States.

The Danish expert requested a leave of absence from the DSM-5 Panel effective March 16, 2010.[22] It is unlikely that we will ever know who recommended him to the DSM-5 Task Force. What is known is that the new DSM-5 manual contains changes in the diagnostic criteria of Autism /ASD.  

***

The CDC National Center on Birth Defects and Developmental Disabilities very prominently lists its research every year. Its “Autism Spectrum Disorder Scientific Articles of 2010”[23] included three out of eight publications co-authored by Dr. Thorsen.

In 2011, that list[24] included a study co-authored by Dr. Thorsen and published in June 2011 in the British Medical Journal, shortly after the doctor had been indicted in the United States. The publication, titled “Risk of autism spectrum disorders in children born after assisted conception: a population-based follow-up study”[25], was co-authored by Dr. Schendel and originated from the “Institute of Public Health, at the Department of Epidemiology, University of Aarhus, Aarhus C, Denmark.”

The results of the study were as follows:

33,139 (5.6%) of all children born in Denmark in 1995-2003 resulted from assisted conception, 225 of whom (0.68%) had a diagnosis of ASD. Of the 555,828 children born in this period after natural conception, 3394 (0.61%) had a diagnosis of ASD. The follow-up time was 4-13 years (median 9 years). In crude analyses, children born after assisted conception had an increased risk of a diagnosis of ASD: crude hazard rate ratio (HRR) 1.25 (95% CI 1.09 to 1.43). In analyses adjusting for maternal age, educational level, parity, smoking, birth weight and multiplicity, the risk disappeared: adjusted HRR 1.13. (95% CI 0.97 to 1.31). However, subgroup analyses that suggest possible associations in women who received follicle stimulating hormone indicate the need for further study.

Under Discussion, the authors stated: “This population-based follow-up study found no risk of ASD in children born after assisted conception.”

Wisely someone added the following footnote to the article: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.”[26]

***

The CDC’s web site on Developmental Disabilities[27] explains the reason for its completed Danish Liaison as follows:

The CDC–Denmark Program (Project Completed)

The CDC–Denmark Program was set up to look at many public health issues. The program highlighted the work done using Danish national public health data systems. The Danish data systems include more than 200 long-term disease and administrative registries. These systems are linked with one another. Thus, they can be used to make data sets with information on very large numbers of people. These data sets cover long periods of time. Therefore, they can be used to look at health trends and disease traits. They also can be used to study some less common risk factors or diseases in detail.

The CDC also published a one page summary about its wonderful relationship with Danish researchers.[28]

Lastly, the CDC National Center on Birth Defects and Developmental Disabilities has published the list of the 24 or so “Developmental Disabilities Scientific Articles”[29] that our taxes bought us.

***  

Even though I am aware of the statement by the US Attorney, Northern District of Georgia that the CDC awarded over $11 million to two governmental agencies in Denmark to study the relationship between autism and exposure to vaccines, between cerebral palsy and infection during pregnancy, and between childhood development and fetal alcohol exposure”, I am afraid that the final cost of our Danish Affair may be substantially higher.  

Will we ever know the exact dollar amount? I doubt it. I guess we will have to wait and see.

I also somewhat doubt that Dr. Thorsen will ever come back to Atlanta or that anyone at the CDC would really want him to come back.  

The fact is that even without a population-based study of Denmark and of the United States Penitentiary in South East Atlanta, GA I can safely say that the good doctor is much better off staying in Denmark “awaiting extradition to the United States”.

 

F Edward Yazbak MD
Falmouth, Massachusetts 02540
 

9-17-2013

 

[5] Madsen KM, Hviid A, Vestergaard M, Schendel DE, Wohlfart J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 2002; 347:1477-1482.

[8] Schendel DE, Schuchat A, Thorsen P. Public health issues related to infection in pregnancy and cerebral palsy. Mental Retardation and Developmental Disabilities Research Reviews 2002; 8:39-45.

[9] Thorsen P, Schendel D, Deshpande AD, Vogel I, Dudley DJ, Olsen J. identification of biological/biochemical marker(s) for preterm delivery. Paediatric and Perinatal Epidemiology 2001; 15(suppl):90-103.

[10] Cauci S, Thorsen P, Schendel DE, Bremmelgaard A, Viglino P, Quadrifoglio F, Guaschino S. Determination of immunoglobulin A against Gardnerella vaginalis hemolysin, sialidase, and prolidase activities in vaginal fluid: implications for adverse pregnancy outcomes. J Clin Microbiol 2003; 41:435-438.

[11] Hviid A, Stellfeld M, Wohlfahrt J, Melbye M. Association between thimerosal-containing vaccine and autism. JAMA. 2003 Oct 1;290(13):1763-6.

[12] Vestergaard M, Hviid A, Madsen KM, Wohlfahrt J, Thorsen P, Schendel D, Melbye M, Olsen J. MMR vaccination and febrile seizures: evaluation of susceptible subgroups and long-term prognosis. JAMA 2004; 292: 351-357.

[25] Hvidtjørn DGrove JSchendel DSchieve LASværke CErnst EThorsen P. Risk of autism spectrum disorders in children born after assisted conception: a population-based follow-up study. Epidemiol Community Health. 2011 Jun;65(6):497-502. doi: 10.1136/jech.2009.093823. Epub 2010 Jun 27

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