1. DEPARTMENT OF HEALTH AND HUMAN SERVICES An Overview of the Defense Medical Surveillance System The DMSS Project Laura H. Franzke, PhD, MPH National Immunization Program NVAC, June 4 th, 2003

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES Background  CDC was charged by Congress to undertake collaborative studies regarding the safety and efficacy of the anthrax vaccine adsorbed (AVA)  NIP is working collaboratively with the DoD and FDA to investigate potential adverse events associated with AVA using the DoD’s Defense Medical Surveillance System (DMSS) database

3. DEPARTMENT OF HEALTH AND HUMAN SERVICES Purpose  To perform hypothesis testing and hypothesis generation with the DMSS  Examine the possibility that long term adverse effects are associated with AVA

4. DEPARTMENT OF HEALTH AND HUMAN SERVICES Institute of Medicine (An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, IOM of the National Academies, 2003)  “HIGH PRIORITY: Linkages of the Defense Medical Surveillance Systems and other databases for longer-term follow-up of military personnel who received AVA”

5. DEPARTMENT OF HEALTH AND HUMAN SERVICES DMSS Structure and Functional Relationships (Adapted from: AJPH, Dec 2002, Vol 92, No. 12) Personnel Data  Active Duty  Reserve Component  Active Duty Casualty  Military Entrance  Processing Stations DMSS

6. DEPARTMENT OF HEALTH AND HUMAN SERVICES DMSS Structure and Functional Relationships (Adapted from: AJPH, Dec 2002, Vol 92, No. 12) Personnel Data DMSS Medical Data  In-patient  Ambulatory  Reportable Events  Immunizations

7. DEPARTMENT OF HEALTH AND HUMAN SERVICES DMSS Structure and Functional Relationships (Adapted from: AJPH, Dec 2002, Vol 92, No. 12) DMSS Serologic Data  Serum Specimens Personnel Data Medical Data

8. DEPARTMENT OF HEALTH AND HUMAN SERVICES

9. DMSS Structure and Functional Relationships (Adapted from: AJPH, Dec 2002, Vol 92, No. 12) DMSS Personnel Data Medical Data Serologic Data Deployment Data  Deployment Rosters  Pre/Post Health Assessment  Disease & non-battle injury (aggregate)

10. DEPARTMENT OF HEALTH AND HUMAN SERVICES DMSS Structure and Functional Relationships (Adapted from: AJPH, Dec 2002, Vol 92, No. 12) MSMR Ad hoc Requests Studies/Analyses Reports Defense Medical Epidemiology Database (DMED) DMSS Personnel Data Medical Data Serologic Data Deployment Data

11. DEPARTMENT OF HEALTH AND HUMAN SERVICES Medical Surveillance Monthly Report (MSMR) DMED: Defense Medical Epidemiological Database http://amsa.army.mil

12. DEPARTMENT OF HEALTH AND HUMAN SERVICES  AMSA: Army Medical Surveillance Activity  FOH: Federal Occupational Health  VAU: Vaccine Analytic Unit  Internal Steering Committee: CDC, DoD, FDA  External Consultative Committee:  National Vaccine Advisory Committee

13. DEPARTMENT OF HEALTH AND HUMAN SERVICES DMSS Project Organizational Structure Internal Steering Committee AMSA FOH Hiring & Administrative Support Vaccine Analytic Unit (VAU) CDC/DoD/FDA DMSS IRBs DATA Outside External Consultative Committee

14. DEPARTMENT OF HEALTH AND HUMAN SERVICES Mission for the External Consultative Committee  The External Consultative Committee will act as an “Advisory” scientific committee providing expert advice regarding the development and growth for the DMSS Project.

15. DEPARTMENT OF HEALTH AND HUMAN SERVICES Roles and Responsibilities for the External Consultative Committee  Make recommendations about priority hypotheses to study  Provide advice and comment on study protocols  Periodically updated about study procedures and progress  Review results from analyses of DMSS data  Provide advice on study results manuscripts and dissemination

16. DEPARTMENT OF HEALTH AND HUMAN SERVICES External Consultative Committee  Time Commitment: 3-5 years  Meetings: Twice a year in-person (during NVAC meetings) and occasionally by teleconference  Members: Requesting approximately 5 members from NVAC  Expertise: Epidemiology, internal medicine, immunology, vaccine safety, military medicine

17. DEPARTMENT OF HEALTH AND HUMAN SERVICES Acknowledgements DOD Mark Rubertone John Grabenstein John Brundage Jeff Lange DMSS Staff CDC Ben Schwartz Mike McNeil Bruce Tierney Phil Rhodes Stacey Martin Paul Stehr-Green Betsy Cadwell Roseanne English- Bullard Kelly Bell FDA Bob Ball Dale Burwen Jane Woo FOH Wayne Grant Richard Horn AVEC