Disposition of the

1

• Disposition of the
• Air Force Health Study
• Michael A. Stoto, PhD
• Institute of Medicine
• April 14, 2005

2
Disclaimers

• I chair the official advisory committee in my
  personal capacity
• Not a RAND project
• Some information from AFHS
• Opinions are my own, based on following the study
  closely for a decade
• Not Air Force, RHAC, RAND, or NAS/IOM

3
Outline

• AFHS as a national resource to study
• Agent Orange and Vietnam herbicides
• Dioxin
• Veterans and occupational health issues
• Aging
• Chronic disease risks
• Other environmental health issues
• Disposition options and issues

4
AFHS Purpose

• Congressional and Presidential mandate
• To conduct a 20-year prospective epidemiological
  study of herbicide exposure and health,
  mortality, and reproductive outcomes in veterans
  of Operation Ranch Hand

5
Study Design

• Index group Ranch Hand veterans (N1,208)
• Control population Air Force veterans of
  Southeast Asia (N19,080)
• Examined controls matched on age, race, military
  occupation (N1,668)

6
Study Design (Continued)

• Multiple endpoints
• Mortality, morbidity, reproductive outcomes
• Repeated physical examinations, interviews and
  mortality assessments, plus
• Biological samples
• Medical records
• Military and civilian employment history
• Herbicide and dioxin exposure based on military
  records, military occupation, serum dioxin
  measurement

7
Morbidity Endpoints

• General Health
• Cancer
• Neurological
• Psychological
• Gastrointestinal
• Dermatological

• Endocrinological
• Immunological
• Pulmonary
• Cardiovascular
• Renal

8
Study Schedule
1960 1970 1980
1990 2000 2010
Exposure period
Protocol Development
Physical Examination
9
Median serum dioxin levels in selected
populations
157
355
4540
16,600
0
20
40
60
80
100
1000
10,000
Serum dioxin (ppt)
10
Numbers of Veterans Physically Examined
Year Ranch Hand Comparison Total
1982 1985 1987 1992 1997 2002 1,045 1,016 995 952 869 777 1,224 1,293 1,299 1,281 1,252 1,174 2,269 2,309 2,294 2,233 2,121 1,951
11
Study Materials
12
Knowledgeable Staff
13
Research Results
14
Study Disposition

• Veterans Benefits Act of 2003 (PL108-183) NAS
  study to address (among others)
• Potential value of extending the study
• Scientific merit of retaining and maintaining
  medical records, specimens, other data
• Obstacles to retaining materials
• Advisability and cost of making specimens
  available to independent researchers

15
Extending the Study

• Due to age and number of remaining participants,
  value of extending the study to do more physical
  examinations is not clear
• Consider
• Value of completing research in progress
• Monitoring mortality

16
Retaining and Maintaining Materials

• Not the original goal, but the result is a
• Longitudinal study of males with very detailed
  information on a variety of occupational and
  other health risks and outcomes
• Clear value of retaining and maintaining
  materials to study
• Health effects of herbicides/dioxin in veterans
• Other aspects of military health and
  environmental and occupational exposures
• Chronic disease risks
• Normal aging

17
Consent to Use Records and Materials
Response Comparison N () Ranch Hand N () Total N ()
AO Health AO only Do not use Other Total 1,138 (96.9) 23 (2.0) 11 (0.9) 2 (0.2) 1,174 731 (94.1) 32 (4.1) 11 (1.4) 3 (0.4) 777 1,869 (95.8) 55 (2.8) 22 (1.1) 5 (0.3) 1,951
18
Making Data and Materials Available to Researchers

• Separately consider
• A. Logistics and costs of maintenance of
  materials
• B. Costs of further research using these
  materials
• If data and material were available to
  researchers, NIH and other research funders could
  support research using it through established
  programs