2
Investigating the Potential Health Effects from Participation in Project SHAD

To conduct a reasonable study of the effects of participation in Project SHAD (Shipboard Hazard and Defense), we needed to come to some understanding of potential health effects of such participation. The starting point for this effort was the information published by the Department of Defense (DoD) in its fact sheets. We then did our own literature review, including commissioning a series of papers on the potential health effects of various agents used in Project SHAD. In addition, at the second meeting of the expert panel (described below), we heard from various sources, including former Project SHAD participants. Further, at the strong urging of the expert panel, a review of Project SHAD classified documents was made by an expert panel member and a Medical Follow-Up Agency (MFUA) staff member with the proper clearances. Finally, MFUA study staff attended Project SHAD “reunion meetings” in Kansas City and Seattle to talk to former Project SHAD participants about the conduct of the study and to hear about their health concerns. Many health concerns centered around current medical conditions of shipmates, and we were given a health questionnaire that was being administered to Project SHAD participants. We included many of the items in this questionnaire in our own health questionnaire.

LITERATURE REVIEW

Normally, a literature review would include articles on the precise topic under question, here the health of former participants in Project SHAD. However, we were unable to identify any articles on this topic. Falling back to long-term health studies of veterans potentially exposed to the agents and simulants used during Project SHAD added little.

Two studies have been published on the long-term health of volunteers who participated in experimental studies of the effects of controlled exposure to various warfare agents. The earlier report looked at the experience of all identifiable study subjects, while the later report focused more specifically on subjects experimentally exposed to anticholinesterase agents, such as sarin. The first report concluded that there were no important health effects (BOTEHH, 1985), while the second report found only two statistically significant differences: volunteers exposed to anticholinesterase agents reported significantly fewer attention problems than subjects exposed to other chemical agents and reported significantly more sleep problems than subjects exposed to no chemical agents (Page, 2003).

Although there was little literature on health effects in military veterans, we felt that a more general review of relevant toxicological literature was in order. We thus contracted with the Center for Research Information



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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) 2 Investigating the Potential Health Effects from Participation in Project SHAD To conduct a reasonable study of the effects of participation in Project SHAD (Shipboard Hazard and Defense), we needed to come to some understanding of potential health effects of such participation. The starting point for this effort was the information published by the Department of Defense (DoD) in its fact sheets. We then did our own literature review, including commissioning a series of papers on the potential health effects of various agents used in Project SHAD. In addition, at the second meeting of the expert panel (described below), we heard from various sources, including former Project SHAD participants. Further, at the strong urging of the expert panel, a review of Project SHAD classified documents was made by an expert panel member and a Medical Follow-Up Agency (MFUA) staff member with the proper clearances. Finally, MFUA study staff attended Project SHAD “reunion meetings” in Kansas City and Seattle to talk to former Project SHAD participants about the conduct of the study and to hear about their health concerns. Many health concerns centered around current medical conditions of shipmates, and we were given a health questionnaire that was being administered to Project SHAD participants. We included many of the items in this questionnaire in our own health questionnaire. LITERATURE REVIEW Normally, a literature review would include articles on the precise topic under question, here the health of former participants in Project SHAD. However, we were unable to identify any articles on this topic. Falling back to long-term health studies of veterans potentially exposed to the agents and simulants used during Project SHAD added little. Two studies have been published on the long-term health of volunteers who participated in experimental studies of the effects of controlled exposure to various warfare agents. The earlier report looked at the experience of all identifiable study subjects, while the later report focused more specifically on subjects experimentally exposed to anticholinesterase agents, such as sarin. The first report concluded that there were no important health effects (BOTEHH, 1985), while the second report found only two statistically significant differences: volunteers exposed to anticholinesterase agents reported significantly fewer attention problems than subjects exposed to other chemical agents and reported significantly more sleep problems than subjects exposed to no chemical agents (Page, 2003). Although there was little literature on health effects in military veterans, we felt that a more general review of relevant toxicological literature was in order. We thus contracted with the Center for Research Information

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) (CRI, Inc.), in Silver Spring, Maryland, to do a series of literature reviews. Appendix A contains the executive summaries of the literature review on the agents used in Project SHAD, and the full reports can be found on the study’s website (IOM, 2006). PUBLIC MEETINGS In addition to examining the DoD fact sheets and commissioning a series of toxicological reviews, we wanted to hear from Project SHAD participants about the kinds of things they had done in Project SHAD, their possible exposures, and their thoughts about potential health effects. At the second meeting of the expert panel, held on March 21, 2003, we therefore invited a number of guests to testify in an open meeting. The expert panel and MFUA staff heard from three panels. The first panel contained Dr. Mark Brown of the Department of Veterans Affairs (VA) and Dr. Michael Kilpatrick and Ms. Dee Morris of the DoD. The second panel consisted of Dr. J. Clifton Spendlove, former Plans and Operations Officer of Project SHAD. The third panel consisted of veteran participants in Project SHAD as well as a representative from a veterans service organization: Mr. Rick Weidman, Vietnam Veterans of America; Mr. Jack Alderson, Project SHAD participant; Mr. Robert Bates, Project SHAD participant; Mr. Jim Druckemiller, Project SHAD participant; and Mr. Norman LaChapelle, Project SHAD participant. Material from these presentations is available on the study website (IOM, 2006). REVIEW OF CLASSIFIED MATERIAL To expedite making the information about Project SHAD public, the DoD investigation team requested declassification of only those portions of the documents it collected that were necessary to identify test participants and prepare the test fact sheets. This practice led to repeated veteran accusations that vital health-related information was not being made available. To counter this accusation, and at the expert panel’s urging, the DoD made its classified Project SHAD collection available for review by the Institute of Medicine (IOM). In February 2005, an expert panel member and a MFUA staff member with security clearances reviewed all the documents that the DoD had used for the Project SHAD investigation. They found little additional information to inform the study and requested that only two additional pages be declassified. On February 10, 2006, two members of the SHAD team, one advisory panel member (Don Burke), and one staff member (Rick Erdtmann), visited the DoD deployment office, which serves as the repository for Project SHAD’s classified documents. The documents were reviewed by the two visitors to clarify questions or concerns expressed by the Project SHAD advisory panel. Their report was handwritten and reviewed by members of the DoD security office staff prior to being physically removed from the premises. The staff indicated that the summary was unclassified in its entirety. The following conclusions were reached: Reasons for maintaining classification of the Project SHAD documents were apparent. Test plans had scientific protocols well conceived to answer important questions with clear statements of test objectives using reasonable methods. Some test documentation was not available in the files. There was no human health data noted in the reports; some testing did involve use of human data to judge adequacy of protective masks or to estimate relative exposure levels. We saw no lists with individual names except for DTC-69-10, the VX simulant (trioctyl phosphate) where various clothes and respiratory devices were worn by participating marines. We saw no reference to human illness attributable to test agents in the reports. No new agents were identified in the reports from those previously provided.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Levels of the test agents could not be assigned to individuals exposed with the following exceptions: Two studies used nasopharangeal swabs to evaluate exposure levels or effectiveness of masks while using the Bacillus globigii simulant agent. One study of trioctyl phosphate listed, by name, relative levels of exposure. Animal studies were used in live agent testing. Results could not be used to directly judge risk to test participants. There were no reports of environmental exposure suggesting untoward effects by test agents. There were no vaccines for participants mentioned in the reports. Nothing we saw in the reports would inform changes to the Project SHAD study design. REFERENCES BOTEHH (Board on Toxicology and Environmental Health Hazards), Committee on Toxicology. 1985. Possible long-term health effects of short-term exposure to chemical agents. Washington, DC: National Academy Press. Page, W. F. 2003. Long-term health effects of exposure to sarin and other anticholinesterase chemical warfare agents. Military Medicine 168:239-245. IOM (Institute of Medicine). 2006. Long-term health effects of participation in Project SHAD. http://www.iom.edu/CMS/3795/4909.aspx (accessed November 28, 2006).