Summary

More than 5,800 military personnel, mostly Navy personnel and Marines, participated in a series of tests of U.S. warship vulnerability to biological and chemical warfare agents, Project SHAD (Shipboard Hazard and Defense), in the period 1962–1973. Only some of the involved military personnel were aware of these tests at the time. Many of these tests used simulants, substances with the physical properties of a chemical or biological warfare agent, thought at the time to have been harmless. After the tests were conducted, the results were reported in classified documents.

The existence of these tests did not come to light until many decades later. In September 2000, at the request of the Department of Veterans Affairs (VA), the Department of Defense (DoD) undertook the task to provide data related to Project SHAD to the VA and others. As a result of their investigations, the DoD publicly released information about the Project SHAD tests and assembled a list of Project SHAD participants. In September 2002, the Institute of Medicine (IOM) agreed to undertake a scientific study, funded by the VA, of potential long-term health effects of participation in Project SHAD.

Beginning with a list of Project SHAD participants provided by the DoD, IOM staff went back to military unit records to assemble as complete a list of Project SHAD participants as possible. IOM staff also assembled a list of comparable nonparticipant controls, and mounted a health survey of general content, with the assistance of SRBI of Silver Spring, Maryland, who conducted the telephone interviews. IOM staff met with Project SHAD personnel and with the representatives of various veteran service organizations (VSOs), eliciting their help with the design and conduct of the health survey. Mortality data were also collected from various records sources. Throughout the study, IOM staff drew upon the advice of an expert panel, headed by Dr. Daniel Freeman. The study was reviewed and approved by the National Academies Human Subjects Research Committee.

In reviewing the Project SHAD fact sheets, IOM staff realized that the Project SHAD participants could be broken down into four broad groups, based on their potential exposures. Group A consisted of more than 3,000 participants whose potential exposure was limited to one of two agents: Bacillus globigii (BG) or methylacetoacetate (MAA). Indeed, there was a natural pattern of exposures that enabled one to make independent statistical estimates of the health effects of BG and MAA. Group B consisted of some 850 participants whose only potential exposure was to trioctyl phosphate (TEHP or TOF). Group B was unusual in that there were a relatively large number of Marine participants, and it was also unusual in that there were individual dose estimates for a large proportion of these Marine participants. Group C consisted of around 720 participants who were in tests where active agents were used. Finally, Group D consisted of roughly 850 subjects potentially exposed to simulants who were not in



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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Summary More than 5,800 military personnel, mostly Navy personnel and Marines, participated in a series of tests of U.S. warship vulnerability to biological and chemical warfare agents, Project SHAD (Shipboard Hazard and Defense), in the period 1962–1973. Only some of the involved military personnel were aware of these tests at the time. Many of these tests used simulants, substances with the physical properties of a chemical or biological warfare agent, thought at the time to have been harmless. After the tests were conducted, the results were reported in classified documents. The existence of these tests did not come to light until many decades later. In September 2000, at the request of the Department of Veterans Affairs (VA), the Department of Defense (DoD) undertook the task to provide data related to Project SHAD to the VA and others. As a result of their investigations, the DoD publicly released information about the Project SHAD tests and assembled a list of Project SHAD participants. In September 2002, the Institute of Medicine (IOM) agreed to undertake a scientific study, funded by the VA, of potential long-term health effects of participation in Project SHAD. Beginning with a list of Project SHAD participants provided by the DoD, IOM staff went back to military unit records to assemble as complete a list of Project SHAD participants as possible. IOM staff also assembled a list of comparable nonparticipant controls, and mounted a health survey of general content, with the assistance of SRBI of Silver Spring, Maryland, who conducted the telephone interviews. IOM staff met with Project SHAD personnel and with the representatives of various veteran service organizations (VSOs), eliciting their help with the design and conduct of the health survey. Mortality data were also collected from various records sources. Throughout the study, IOM staff drew upon the advice of an expert panel, headed by Dr. Daniel Freeman. The study was reviewed and approved by the National Academies Human Subjects Research Committee. In reviewing the Project SHAD fact sheets, IOM staff realized that the Project SHAD participants could be broken down into four broad groups, based on their potential exposures. Group A consisted of more than 3,000 participants whose potential exposure was limited to one of two agents: Bacillus globigii (BG) or methylacetoacetate (MAA). Indeed, there was a natural pattern of exposures that enabled one to make independent statistical estimates of the health effects of BG and MAA. Group B consisted of some 850 participants whose only potential exposure was to trioctyl phosphate (TEHP or TOF). Group B was unusual in that there were a relatively large number of Marine participants, and it was also unusual in that there were individual dose estimates for a large proportion of these Marine participants. Group C consisted of around 720 participants who were in tests where active agents were used. Finally, Group D consisted of roughly 850 subjects potentially exposed to simulants who were not in

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) groups A, B, or C, that is, they were not solely exposed to BG, MAA, or TOF, nor were they potentially exposed to any active chemical or biological warfare agents. Control groups were assembled for each of the four exposure groups, and most analyses were exposure-group specific. Of the nearly 12,500 Navy and Marine study subjects, roughly 9,600 were assumed to be alive (i.e., no evidence of death from available records sources) and eligible to be surveyed. We received mail questionnaire or telephone interview responses from 60.8 percent of Project SHAD participants and 46.6 percent of controls. The primary study outcome was the SF-36 assessment of general health, particularly the two summary scores, physical component summary (PCS) and mental component summary (MCS). We also asked for a history of medical conditions and present symptoms. Questionnaire items to determine somatization symptoms and neuropsychological problems were included, as well as items on postservice hospitalization and birth defects. In general, there was no difference in all-cause mortality between Project SHAD participants and nonparticipant controls, although participants statistically had a significantly higher risk of death due to heart disease. However, the lack of cardiovascular risk factor data as well as any explanation as to biological plausibility makes this latter difference difficult to interpret. Participants also reported statistically significantly worse health than controls, but no consistent, specific, clinically significant patterns of ill health were found. Both PCS and MCS of the SF-36 were significantly lower among participants than controls, but these differences were mostly small in magnitude. Group C, the only group with potential exposure to active chemical or biological agents, reported the smallest SF-36 differences. There were small but statistically significant increases in self-reported memory and attention problems as well as somatization scores. Project SHAD participants reported higher levels of neurodegenerative medical conditions, but most of these were of an unspecified nature. Participants also reported nearly uniformly higher rates of symptoms, including a specific symptom (earlobe pain) without an apparent medical basis, thus raising the question of reporting bias. There were no significant differences in self-reported hospitalization, and in one group (group D), participants reported a higher rate of birth defects than controls; however, this significant difference can be attributed to an unusually low control rate rather than a high rate among participants. While we have found no clear evidence of specific health effects that are associated with Project SHAD participation, we must remark that this does not constitute clear evidence of a lack of health effects. Although the sample seems large, some of the exposure groups are indeed rather moderate in size, and the lack of specific a priori hypotheses of health effects becomes a real limitation. If there were, for example, very specific, targeted effects on a particular organ system, but with a relatively low prevalence, our relatively coarse grouping of health outcomes might well have missed finding such a specific effect. Although the focus of our study was on the potential health effects of participation in Project SHAD, we found some evidence of ill health among the group B Marines in this study, as compared to Navy group B participants. They had significantly higher mortality than Navy personnel, adjusting for age, participation status, race, and pay grade, as well as significantly lower PCS and MCS scores, with a large (more than 9-point) difference in MCS scores. Although these latter findings are not related to the original charge of the study, to examine the effects of Project SHAD participation per se, they may warrant some further investigations.