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Vaccine Safety Research, Data Access, and Public Trust
a similar study be done in the United Kingdom with the General Practice Research Database. In July 2001, the researchers presented updated preliminary findings to the Institute of Medicine Committee on Immunization Safety Review (Verstraeten, 2001). The updated results were fairly similar to those of earlier analyses; there were still some indications of association with speech or language delay and perhaps with attention problems (DeStefano, 2004).
The principal researcher on the thimerosal study left CDC in July 2001, but in December 2000, before he left, he wrote a first draft of a manuscript on the study and submitted it for CDC clearance (DeStefano, 2004). Because many of the researchers had moved on to other studies, it took over a year for the manuscript to be completed. Additional follow-up data became available, and improved ideas for addressing concerns about healthcare-seeking bias emerged (DeStefano, 2004).
In October 2002, the revised manuscript was submitted for CDC clearance. It was cleared by December 2002.3 The manuscript was also submitted to the first journal for publication in that month. In May 2003, it was accepted by the second journal it was submitted to (Pediatrics), pending revision. The researchers revised it and resubmitted it in June. It was accepted in July, and published in November 2003 (DeStefano, 2004; Verstraeten et al., 2003a).
VACCINE SAFETY DATALINK RESEARCH PLAN
The VSD is the only population-based resource in the nation that has sufficient sample size to address possible concerns about rare adverse effects of vaccines. The VSD is an important national resource. As a resource, however, rather than a study, its value depends primarily on the nature and extent of its use. The investigators who have conducted studies with it have been almost exclusively those who are also responsible for its funding, creation, development, or maintenance. Within that community of researchers, opportunities to propose and lead studies have been created and prioritized, systems for conducting studies have been developed, and funding has been allocated.
For researchers outside the VSD research network, the opportunities and support for use of this resource have been, at best, unclear and narrow. Similarly, there appear to be few opportunities for individuals or parties outside of the NIP or the VSD MCOs to have direct input into research priorities and the allocation of resources. Finally, the public has not been routinely informed about the status and ultimate findings of research efforts undertaken with the VSD.
Personal communication, F. DeStefano, NIP, February 10, 2005.