Appendix F
Summary of Public Submissions

The committee has received numerous public submissions and comments via e-mail, fax, and mail since the announcement of its first meeting in August 2004. The submissions were reviewed by the committee to inform its recommendations for this report.

All information reviewed by the committee and cited in this report are available—in the form in which they were reviewed—through the public-access files of the National Academies. Information about this process and access to these documents can be obtained at 202-334-3543 or www.national-academies.org/publicaccess.

Below is a list as of February 11, 2005, of the public submissions received, divided into three categories.

1) Personal Statements

The committee received many statements from the public that described their views on the Vaccine Safety Datalink data sharing program and the release of preliminary findings from the VSD. The committee also received personal statements about vaccines and autism in general:

  • Barile, D. Data Base. September 1, 2004.

  • Bono, L. and Bono, S. (National Autism Association). Submitted Testimony. October 21, 2004.

  • Brasher, A. Thimerosal. August 31, 2004.

  • Brown, W. Vaccine Safety Datalink. September 2, 2004.

  • Buckley, P. Vaccine Data Base. September 1, 2004.



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Vaccine Safety Research, Data Access, and Public Trust Appendix F Summary of Public Submissions The committee has received numerous public submissions and comments via e-mail, fax, and mail since the announcement of its first meeting in August 2004. The submissions were reviewed by the committee to inform its recommendations for this report. All information reviewed by the committee and cited in this report are available—in the form in which they were reviewed—through the public-access files of the National Academies. Information about this process and access to these documents can be obtained at 202-334-3543 or www.national-academies.org/publicaccess. Below is a list as of February 11, 2005, of the public submissions received, divided into three categories. 1) Personal Statements The committee received many statements from the public that described their views on the Vaccine Safety Datalink data sharing program and the release of preliminary findings from the VSD. The committee also received personal statements about vaccines and autism in general: Barile, D. Data Base. September 1, 2004. Bono, L. and Bono, S. (National Autism Association). Submitted Testimony. October 21, 2004. Brasher, A. Thimerosal. August 31, 2004. Brown, W. Vaccine Safety Datalink. September 2, 2004. Buckley, P. Vaccine Data Base. September 1, 2004.

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Vaccine Safety Research, Data Access, and Public Trust Conrick, T. To IOM Committee on Review of NIP’s Research Procedures and Data Sharing Program. September 3, 2004. Cook, B, and Cook, L. Vaccine Safety Datalink. September 2, 2004. Dakdouk, D. Vaccine Safety Datalink. September 1, 2004. Dannemann, E. (Director, National Caalition of Organized Women). Letter submitted to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 23, 2004. Dannemann, E. (Director, National Caalition of Organized Women). Letter with multiple attachments: Comments on Data Sharing. August 27, 2004. Dannemann, E. (Director, National Caalition of Organized Women) Statement for IOM Hearing 8/23/04 on Vaccine Safety Datalink Access to Public, by A. Gore. August 27, 2004. Davidson, L. To IOM Committee on Review of NIP’s Research Procedures and Data Sharing Program. September 16, 2004. Dease, B. IOM Meeting. September 1, 2004. Fisher, B.L. (National Vaccine Information Center). Statement to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 23, 2004. Greenwood, J. Autism. December 16, 2004. Greenwood, J. VSD. August 31, 2004. Hale, E. Sharing info. September 2, 2004. Hanus, L. Letter to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 23, 2004. Kalika, D. and Kalika, E. Vaccine Safety Datalink. August 31, 2004. Kanji, S. VSD Data Access. August 31, 2004. King, P. A Poisoned Child’s Cry. August 23, 2004. Krumenacker, J. Review of NIP’s Research Procedures and Data Sharing Program met last week to discuss future handling of the Vaccine Safety Datalink. August 31, 2004. Lathrop, H. Regarding data sharing. August 20, 2004. Maniotis, R. Letter to Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 23, 2004. McCandless, J. Letter to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 19, 2004. McCandless, J. A physician shares a letter from a parent to the IOM. August 29, 2004. McCandless, J. McC to IOM. August 31, 2004. McDonald, M.E. Comments—Access to VSD September 1, 2004. Meleck, M. VSD. September 1, 2004. Mumper, E. Letter to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. August 23, 2004.

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Vaccine Safety Research, Data Access, and Public Trust National Vaccine Information Center (NVIC), submitted by B.L. Fischer. Petition. October 21, 2004. Phipps, S. IOM Input. August 31, 2004. Piselli, J. and Piselli, P. Autism. September 6, 2004. Piselli, J. and Piselli, P. VSD Access. September 12, 2004. Ranieri, S. Comments on data sharing on vaccines. September 24, 2004. Rankin, D. We had a perfectly normal grandson. August 31, 2004. Thompson, J. Please release the VSD information. September 2, 2004. vanDoorn, C. Access to VSD. September 2, 2004. VanHaaften, J. Comments on data sharing on vaccines. August 19, 2004. Vernetti, S. VSD Comments. August 31, 2004. Weed, L. VSD. September 14, 2004. Weinmaster, L. VSD. September 1, 2004. 2) Questions to Consider Several people e-mailed questions to the committee for them to consider while reviewing its charge, and making its recommendations. They included: Bernard, S. Enayati, A. Krakow, R. Peterson, M. Wax, M. 3) Documents for Review The committee received many published and unpublished documents: ACIP Charter. (Submitted by M. Wharton, October 2004) Amendment of Solicitation/Modification of Contract between NIP and HMOs involved in the VSD Data Sharing Program dated February 2003 – October 2004 (Submitted by NIP, 2004) Award/Contract 200-2002-00732, Effective Date 09/20/2002 (Submitted by NIP, 2004) Clarification of the draft VSD data sharing guidelines (Submitted by J. Madans and K. Harris at NIP, February 2005) Clarification of your presentation to the IOM on October 21, 2004:

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Vaccine Safety Research, Data Access, and Public Trust Responses to your questions (Submitted by F. DeStefano via P. Harvey on February 10, 2005) Cochlear Implant Recipients may be at Greater Risk for Meningitis by FDA, 2002. (Submitted by S. Gardner on October 21, 2004) Correspondence between W. Broom and M. Geier dated November 2002–September 2004. (Submitted by NIP, 2004) Confidentiality Security Statement, Vaccine Safety Datalink Project (VSD). (Submitted by NIP, October 2004) Current Legislative Authorities Pamphlet, 2000. (Submitted by the National Center for Health Statistics (NCHS) on committee site visit to NCHS on September 22, 2004) Evidence of Harm—Book Cover only by Kirby D. (Submitted by L. and S. Bono, October 2004) FDA Public Health Web Notification: Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent by FDA, 2003. (Submitted by S. Gardner on October 21, 2004) FDA Public Health Web Notification: Risk of Bacterial Meningitis in Children with Cochlear Implants by FDA, 2003. (Submitted by S. Gardner on October 21, 2004) FDA Public Health Web Notification: Updated Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent by FDA, 2003. (Submitted by S. Gardner on October 21, 2004) Genetic Disclosure Project. (Submitted by M. Gordon on October 15, 2004) Guidelines for Data Sharing Proposals from External Researchers: Vaccine Safety Datalink (VSD) Project—Version #A, 2002. (Submitted by NIP on committee site visit to NIP on September 7, 2004) Guidelines for Data Sharing Proposals from External Researchers: Vaccine Safety Datalink (VSD) Project—Version #B, 2003. (Submitted by NIP on committee site visit to NIP on September 7, 2004) It just won’t go away. E-mail to Davis R, DeStefano from Verstraeten T, 1999. (Submitted by M. Geier on October 21, 2004) J & J stent linked to more than 60 deaths by Kerber R, (Boston Globe Staff), 2003. (Submitted by S. Gardner on October 21, 2004) Letter to John Bailar and Committee on Review of NIP’s Research Procedures and Data Sharing Program by D. Weldon. (Submitted by Congressman Dave Weldon on September 13, 2004) NCHS Research Data Center Pamphlet, 2001. (Submitted by NCHS on committee site visit to NIP on September 22, 2004) NCHS Staff manual on Confidentiality, 2004. (Submitted by NCHS on committee site visit to NIP on September 7, 2004)

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Vaccine Safety Research, Data Access, and Public Trust Press Packet (Folder) by SafeMinds, National Autism Association, Moms Against Mercury, Nomercury.org, BC&A International, Unlocking Autism, Coalition for Mercury Free Drugs, Autism Autoimmunity Project. (Joint Statement: Submitted to the Committee on Review of NIP’s Research Procedures and Data Sharing Program on August 23, 2004) Professional paper by Russell Blaylock, MD. (Submitted by L.J. O’Brien, September 1, 2004) Responses to questions raised by the IOM Committee on the Review of NIP VSD Data Sharing Program, with attachments A-E. (Submitted by NIP on October 4, 2004) Summary Statistics—Thimerosal Study: Attachment #1 by D. Weldon. (Submitted by Congressman Dave Weldon on September 17, 2004) TrialTech Visit as Technical Monitor to the NCHS RDC, by Adelman T, Shabe P, 2004. (Submitted by National Immunization Program [NIP], November 2004) Vaccine Safety Datalink Project, Confidentiality Assurance Statement. (Submitted by NIP on October 6, 2004) VSD Contract with attachment A-J. (Submitted by NIP on October 6, 2004) Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases by Verstraeton et al., 2003. (Submitted by Congressman Dave Weldon on September 17, 2004) Judgement Under Uncertainty: Suspending the Use of Rotavirus Vaccine by M. Wharton (CDC), 2000. (Submitted by M. Wharton on October 21, 2004) Mothering Magazine. No. 125. (Submitted by L. Sykes on August 23, 2004) Guidelines for Archival Datasets and Documentation from Completed Vaccines Safety Datalink (VSD) Studies; Draft 4.0. (Submitted by NIP November 2004) General Description. (Submitted by J. Madans on August 20, 2004) Procedures for Use of the RDC. (Submitted by J. Madans on August 20, 2004) Progressive Convergence. Do Not Vaccinate Your Child Without Due Diligence. Find Out About Mercury in Their Vaccinations. (Submitted by Progressive Convergence on August 24, 2004) Thimerosal paper in Frank DeStefano’s presentation in October. (Submitted by P. Harvey on December 9, 2004) Letter to F. Pavley by J. McCandless. (Submitted by J. McCandless on August 13, 2004)