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For Immediate Release

 

Contact:

Cheri Jacobus, Capitol Strategies, 202 547-7358, CheriJacobus@aol.com

Sallie Bernard, Safe Minds, 970 429-1460, sbernard@safeminds.org

Major Autism and Speech/Language Disorder Organizations Release Joint Statement On The Use Of The CDC'S Vaccine Safety Datalink To Investigate Thimersosal

 Washington , DC . November 3, 2003 - A paper written by the CDC's National Immunization Program staff and published in the November 2003 Pediatrics , uses the Vaccine Safety Datalink to investigate associations between thimerosal in vaccines and neurodevelopmental disorders such as autism and speech/language delay. Examination of this paper as well as earlier versions of the study and related documents has raised concerns among the autism and speech/language delay communities over the use of the VSD by those involved in childhood immunization programs. Rules established by the CDC have made access to the VSD by independent researchers virtually impossible. In response to these events, the organizations listed below, representing families with members who have autism or a speech/language disorder, have issued the following statement:

 

Vaccine Safety is an important public health issue. The Vaccine Safety Datalink database must be made available to all qualified research scientists in a timely manner. The current practice of restricting access to the database to a limited group of possibly biased individuals is not acceptable.

 

The statement and background information can be accessed at www.safeminds.org . The supporting organizations are:

 

Autism Research Institute ( www.autism.com/ari )

Autism Society of America ( www.autism-society.org )

Cherab Foundation ( www.cherab.org )

Cure Autism Now ( www.cureautismnow.org )

Echo of Canada ( www.apraxia.ca )

Safe Minds ( www.safeminds.org )

Speechville Express ( www.speechville.com )

Unlocking Autism ( www.unlockingautism.org )

Joint Statement On The Use Of The CDC'S Vaccine Safety Datalink For Thimersosal Investigations

Autism Research Institute

Autism Society of America

Cherab Foundation

Cure Autism Now

Echo of Canada

Safe Minds

Speechville Express

Unlocking Autism

 

November 3, 2003

 

JOINT STATEMENT   Vaccine Safety is an important public health issue. The Vaccine Safety Datalink database must be made available to all qualified research scientists in a timely manner. The current practice of restricting access to the database to a limited group of possibly biased individuals is not acceptable.

BACKGROUND Findings drawn from investigations by the CDC's National Immunization program using the Vaccine Safety Datalink on thimerosal's role in Neurodevelopmental Disorders, including the study by Verstraeten et al in Pediatrics (November 2003), cannot be accepted as final. The Verstraeten et al paper may have methodological and sampling problems which limit its usefulness. The Vaccine Safety Datalink data must be opened immediately, with a fair and expedited approval process, to qualified independent researchers, in order to ensure transparency in scientific research and maintain public trust in the childhood immunization program.

 

The November issue of Pediatrics contains an article by Thomas Verstraeten and colleagues on the safety of thimerosal-containing vaccines. The study relies on the Vaccine Safety Datalink (VSD) to examine the association between exposure during infancy to the mercury preservative thimerosal and increased risk of developing a neurodevelopmental disorder (NDD). NDDs include autism, speech/language delay, attention deficit disorder, and tics. The VSD was established in 1991 to monitor possible adverse outcomes from vaccines on a post-licensing basis. The VSD relies on partnering HMOs to provide computerized health records of children enrolled in their organizations, through which health outcomes can be linked to vaccine administration. Employees of the CDC National Immunization Program (NIP), its consultants, and representatives of the HMOs have periodically issued research papers on vaccine safety using the VSD. The Verstraeten et al study is one of these papers.

 

The Verstraeten evaluation of thimerosal and NDDs began 4 years ago, in the Fall of 1999. During this time, he and his colleagues completed but never published three versions of the study plus several sub-analyses. The Pediatrics paper represents the fourth version. Each study version has produced different results, due to alterations in the study population or analytic methods used. The reasons for alterations to the original study protocol have never been fully explained. The initial version found statistically significant associations between increased thimerosal exposure and risk of an NDD diagnosis. It also found an increased relative risk of 2.48 for autism. According to the original study protocol, a risk higher than 1.5 would be considered a "plausible" association even if not statistically significant. The second version found a relative risk for autism of 1.69, while the third version did not address autism at all. While the second version detected a significantly increased risk for speech/language delay, attention deficit disorder, tics, and neurodevelopmental delays in general, the third and fourth versions dismissed all associations between thimerosal and any neurodevelopmental disorder.

 

With one recent exception, no other researchers have been allowed to access the VSD data. Current rules established by NIP make the approval process for access long and arduous. Moreover, researchers who gain access can only utilize a limited portion of the VSD data set, and their examination of the data is subject to constant monitoring by CDC staff. The single research group outside of NIP who has gained access to the VSD data for thimerosal investigation has found significant and large increases in relative risk for autism and speech/language disorder from thimerosal exposure in DTaP vaccines (study in press).

 

SITUATION Many parents have linked their child's autism or other neurodevelopmental disorder (NDD) to thimerosal in childhood vaccines. Scientific research examining such a link is being conducted. Public maintenance of trust in vaccine safety is critical for continued high childhood immunization rates. Credible research confirming or refuting an association between thimerosal and NDDs is necessary to maintain public trust in infant vaccines.

 

CONCERNS The Autism and Speech/Language Disorder Organizations have concerns about the manner in which the VSD has been used to investigate the thimerosal issue. The National Immunization Program staff and its consultants may be perceived as biased in their investigations of the issue. Lack of true open access to the VSD data by independent researchers hampers investigation and raises questions as to why such restrictions on the data are needed when transparency in research is fundamental to maintaining scientific integrity. Unless the NIP recognizes that the autism community and the public at large will only accept as valid research that is not only unbiased but is perceived to be unbiased, these constituencies will never trust health authorities regarding vaccine safety. Lack of trust puts the US childhood immunization program at risk

SUPPORTING ORGANIZATION

Autism Research Institute

Bernard Rimland, PhD

Founder and President

 

 Autism Society of America

Jeff Sell, Esq.

Board Member and Vice President

 

 Cherab Foundation

Lisa Geng

Founder and President

 

Cure Autism Now

Jonathan Shestack

Co-Founder and Board Member

 

Echo of Canada

Rhonda Jacobson Cherry

Co-Founder

 

Safe Minds

Lyn Redwood, RN

President and Co-Founder

 

Speechville Express

Gina Mikel

Co-Founder

 

Unlocking Autism

Shelley Reynolds

President

 

Contact:

Sallie Bernard, Executive Director, Safe Minds, 970 429-1460, sbernard@safeminds.org

 

 

 

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The Cherab Foundation is a world-wide nonprofit organization working to improve the communication skills and education of all children with speech and language delays and disorders. Our area of emphasis is verbal and oral apraxia, severe neurologically-based speech and language disorders that hinder children's ability to speak.

The Cherab Foundation is committed to assisting with the development of new therapeutic approaches, preventions and cures to neurologically-based speech disorders. We bring together parents and medical, research, and educational professionals. Please join us and help to give our children a smile and a voice.

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