Vaccine Safety Datalink

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The Vaccine Safety Datalink Project (VSD) was established in the United States, in 1990, by the Centers for Disease Control and Prevention (CDC) for the study of adverse side effects of vaccines.

Four large health maintenance organizations, including Kaiser Permanente, were initially recruited to provide the CDC with medical data on vaccination histories, health outcomes, and subject characteristics. The VSD database comprises data compiled from surveillance on more than seven million Americans, including about 500,000 children from birth through age six years (2% of the U.S. population in this age group).

The VSD data sharing program is now being administered by the National Center for Health Statistics' Research Data Center. The data sharing guidelines have been revised to include comments from interested groups as well as recommendations from the Institute of Medicine (IOM).

1 No evidence of harm reported
2 Crisis of vaccine safety confidence
3 Access to database
4 See also
5 External links

[edit] No evidence of harm reported

The CDC has spent four years analyzing data from children who received varying amounts of thimerosal from vaccines. The study was revised several times before being published by the IOM in November, 2003. Early drafts, discussed at the 2000 Simpsonwood CDC conference, showed highly elevated, statistically significant increased risks for autism and other disorders among the kids receiving the most mercury. The CDC indicates it has examined the data exhaustively, and pronounced that it found "no evidence of harm."

[edit] Crisis of vaccine safety confidence

The issue of whether mercury in vaccines can cause autism in children has been at the heart of the vaccine controversy that has escalated in recent years, as more biological evidence has surfaced suggesting a possible link. The possibility that vaccines have contributed to the striking rise in autistic spectrum diagnoses has led to concerns of a possible autism epidemic. The data compiled by the VSD could resolve this debate within weeks, but access has been denied to independent researchers, on the grounds that confidential data might be misused. But rules established by the CDC have made access to the VSD by independent researchers virtually impossible.[1]

According to autism activist Barbara Loe Fisher, "There is a long history of denial by government health officials that vaccines cause brain injury, immune system dysfunction and death as evidenced by congressional testimony and public statements by federal health officials."

[edit] Access to database

Advocacy groups, including Safe Minds, A-CHAMP and the National Vaccine Information Center, have staged protests, circulated petitions, lobbied congressional representatives in Washington, D.C., and waged media campaigns for the purpose of securing access to the VSD project database by independent researchers.[2]

Only two outside researchers, Mark Geier and David Geier, have thus far gained access to the raw data. They faced formidable obstacles before being allowed into the CDC computer center, and then resistance from staff and software malfunctions once inside. Nevertheless, they reportedly found highly elevated risks for autism among children in the highest mercury exposure group. The Geiers study on the VSD, "A two-phased population epidemiological study of the safety of thimerosal-containing vaccines: a follow-up analysis" was published in the Medical Science Monitor in 2004 volume 11(4):CR160-CR170. [3]

The National Immunization Program later alleged that "In summary, during the first visit the researchers conducted unapproved analysis on their datasets and on the second visit attempted to carry out unapproved analyses but did not complete this attempt. This analysis, had it been completed, could have increased the risk of a confidentiality breach. Before leaving, the researchers renamed files for removal which were not allowed to be removed. Had it gone undetected, this would have constituted a breach of the rules about confidentiality."[4] Upon further review it was determined by the CDC and the IRBs of the HMOs that there was no violation and the Geiers have again been granted access to the Vaccine Safety Datalink.

The National Academies has circulated a position paper to government health agencies, stating "Two new oversight groups are needed to ensure that the policies and procedures of the Vaccine Safety Datalink (VSD) and its data sharing program -- which is intended to give researchers access to patient data that will help them study vaccine safety issues -- are implemented as fairly and openly as possible."[5]

[edit] See also

Controversies in autism

[edit] External links

CDC.gov - 'Vaccine Safety Data-Sharing Process', Centers for Disease Control
ImmunizationInfo.org - 'Vaccine Safety: Vaccine Safety Datalink', National Network for Immunization Information
JPandS.org (pdf) - : 'Thimerosal in Childhood Vaccines, Neurodevelopment Disorders and Heart Disease in the United States' Mark Geier and David Geier Journal of American Physicians and Surgeons, Vol 8, No 1, Spring, 2003
JPandS.org (pdf) - 'A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders', Jeff Bradstreet, M.D., David A. Geier, B.A., Jerold J. Kartzinel, M.D., James B. Adams, Ph.D, Mark R. Geier, M.D., Ph.D. Journal of American Physicians and Surgeons, Vol 8, No 3, Summer, 2003
NationalAcademies.org - 'Independent Oversight of Vaccine Safety Data Program Needed To Ensure Greater Transparency and Enhance Public Trust', National Academies (February 17, 2005)
TheCre.com - /Why Won't the CDC Allow Access to the Vaccine Safety Datalink? Memo to CDC: We're not getting our money's worth', David Kirby (May 23, 2005)
UniversityOfHealth.net - 'Institute of Medicine Report Stuns Scientific Community and Parents: Report Says No Evidence Mercury In Vaccines Related To Epidemic Levels of Autism' (May 20, 2004)
WHO.int (pdf) - 'The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA', R.T. Chen, F. DeStefano, R.L. Davis, L.A. Jackson, R.S. Thompson, J.P. Mullooly, S.B. Black, H.R. Shinefield, C.M. Vadheim, J.I. Ward, S.M. Marcy & the Vaccine Safety Datalink Team, World Health Organization