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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
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1

Introduction

In the 1960s the U.S. military carried out a series of tests to evaluate the vulnerabilities of U.S. Navy ships to chemical and biological warfare agents. Termed Project SHAD (Shipboard Hazard and Defense), this effort was a component of Project 112, a larger program that included both land- and sea-based testing as part of a chemical and biological warfare readiness effort by the Department of Defense (DoD) and the military services. Approximately 5,900 military servicemen, primarily from the Navy and Marine Corps, are reported to have been included in Project SHAD testing.

In the 1990s some veterans who participated in the SHAD tests expressed concerns to the Department of Veterans Affairs (VA) that they were experiencing health problems that might be the result of exposures in the testing. Congress and VA requested information from DoD to clarify what substances veterans may have been exposed to and when the tests had taken place. At the time they were conducted, virtually all aspects of the Project 112/SHAD tests were assigned a security classification of Secret or Top Secret, but in 2002 DoD publicly released fact sheets that described each test, identified the participating military units, and named the agents, simulants, decontaminants, and tracers used (DoD, 2015). Some of the fact sheets were revised in 2003 as DoD corrected or supplemented the initial documents.

The health concerns of the SHAD veterans also led to a 2002 request from VA to the Institute of Medicine (IOM) to carry out an epidemiological study of the health of SHAD veterans and a comparison population of veterans who had served on similar ships or in similar units during the same time period. The results of the study, published in 2007 (IOM, 2007) and referred to in the remainder of this report as the SHAD I study, were complex, but did not show clear relationships between participation in the SHAD tests and adverse long-term health effects. Questions about the SHAD I study from veterans and from Congressmen Mike Thompson and Dennis Rehberg about certain aspects of the study resulted in the IOM conducting some additional analyses and preparing a short follow-up publication in 2008 (IOM, 2008).

The SHAD I study examined both the mortality experience of SHAD veterans and the health status of the surviving veterans. Data on health status were collected through a survey of the members of the study population who were assumed to be alive at the time of the study. Responses were received from 61 percent of the SHAD veterans and 47 percent of the comparison population surviving at the time of the study. The modest size of the study population and the level of response to the survey meant that the findings in the SHAD I study could not be considered conclusive because uncommon or subtle health effects would be difficult

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

to discern. Furthermore, the SHAD I study had little basis for assessing the potential impact of differences among SHAD veterans in their levels of possible exposure to the agents used in the tests.

Continuing concerns about potential health effects from exposures during SHAD testing and an interest in further evaluation of the health of this population led to a request in the Caregivers and Veterans Omnibus Health Services Act of 2010 (PL 111-163) for an expanded IOM study of the SHAD test participant and comparison populations. This study, carried out by the Committee on Shipboard Hazard and Defense (SHAD) II between June 2011 and October 2015 is the subject of this report. The new study expanded on the previous IOM work by making use of additional years of health care experience, including an analysis of data from Medicare, which captures most health care encounters for people who have attained the age of 65.1

In finding no overall differences in all-cause mortality between SHAD participants and comparison groups, the SHAD II analysis agreed with the results of the previous IOM study. However, it differed in that, with an additional 7 years of follow up, it did not find an elevation in heart disease mortality except in one of the exposure groups examined. The SHAD II analysis found no clear differences in degree of illness between SHAD participants and the comparison group. This result was consistent with the absence of differences in self-reported hospitalizations noted in SHAD I, but not in accord with the SHAD I survey responses that indicated overall worse health among SHAD veterans.

This report provides background on Project SHAD testing, describes the study population and the health outcomes data used in the new analysis, and presents the findings of the analysis.

STUDY CHARGE AND COMMITTEE ACTIVITIES

The IOM Committee on Shipboard Hazard and Defense (SHAD) II was charged with conducting a new epidemiological study of the potential long-term health effects of participation in the SHAD testing. The study charge appears in Box 1-1.

In carrying out its work, the committee held five in-person meetings and numerous meetings via conference call. Two meetings included public sessions at which SHAD veterans described to the committee their experiences during the tests and responded to questions. Panels represented veterans from several specific tests, and a group of veterans who had served as part of the Project SHAD Technical Staff (PSTS) also shared some of their experiences and perspectives with the IOM committee. Agendas listing the participants in these meetings can be found in Appendix B. Additional discussion of the input provided at these meetings appears in Chapter 2.

The committee oversaw a search of the scientific literature to identify reports published in 2000 or later that might update information on the potential health effects from exposure to the agents, simulants, decontaminants, and tracers2 used in the tests. Committee members also discussed findings from their review of the redacted technical reports describing the tests and planned elements of study design.

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1 As of December 31, 2011, the end of the follow-up period for this study, 83 percent of SHAD test participants assumed alive were 65 years of age or older.

2 The literature review included all of the substances reported to have been used in the tests to allow for the possibility that substances previously thought to be harmless (e.g., simulants and tracers) may subsequently have been found to have health risks.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

APPROACH TO THE STUDY

The committee’s interest was in evaluating whether the long-term health of SHAD veterans has been adversely affected by their exposures during SHAD testing. The committee uses “long-term” to mean persisting or recurring conditions as well as those appearing several years or more after exposure. The committee evaluated the causes of SHAD veterans’ deaths since the 1960s and the diagnoses assigned at hospital and outpatient visits in data from the VA health system and from Medicare from 1999 through 2011. The analysis included two approaches. One focused on testing hypotheses about specific exposures and health outcomes that the committee concluded were suggested by a review of the scientific literature. The other exploratory approach was based on testing the more general hypothesis that the health or mortality experience of the population of SHAD veterans (or certain subgroups) differed from that of the veterans in the comparison population.

Specifically, the committee sought to address the following questions:

Research Question 1: Is participation in SHAD tests that used certain agents, simulants, tracers, or decontaminants associated with differences in long-term health effects?

Objective 1: Test the hypotheses that exposure to specific agents is associated with greater incidence of specific health effects (e.g., Coxiella burnetii and endocarditis; sarin and neurological effects).

Objective 2: Test the hypotheses that exposure to specific agents is associated with greater mortality from specific causes (e.g., C. burnetii and endocarditis; betapropiolactone and cancers).

Research Question 2: How does the health of Project SHAD participants compare with that of a comparison population of veterans who served on similar ships or in similar units that did not participate in the SHAD tests?

Objective 1: Compare, as appropriate, the cumulative incidence or prevalence of specified chronic conditions and cancers between participants and controls using VA and Centers for Medicare & Medicaid Services inpatient and outpatient data

Objective 2: Compare the mortality experience of participant and control populations using vital status information from VA, the National Death Index, and state vital records offices.

The SHAD testing involved use of active chemical and biological agents, simulants, tracers, and decontaminants (see Box 1-2).3 Active chemical and biological agents were potential weapons and known to be debilitating or even fatal in the short term. Simulants were substances that shared certain chemical or biological characteristics of the active agents but were considered at the time to be relatively safe to use. For example, Bacillus globigii (BG) has been used for

______________

3 The following substances were included in the SHAD I review but were not included in the update of literature for this study: bis-hydrogen phosphite and phosphorus-32. These tracers were disseminated with VX over a barge in the Flower Drum II test. No personnel have been identified as participants in this test.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

BOX 1-2
Agents, Simulants, Tracers, and Decontaminants Reported by DoD to Be Used in SHAD Testing

Active Agents

Biological

Coxiella burnetii

Pasteurella tularensis (Francisella tularensis)

Staphylococcal enterotoxin type B, or SEB

Chemical

Sarin

VX

Simulants

Biological

Bacillus globigii or BG

Escherichia coli or E. coli

Serratia marcescens or SM

Chemicalaa

Diethylphthlate

Methyl acetoacetate or MAA

Sulfur dioxide

Trioctyl phosphate, or (tris(2-ethylhexyl) phosphate) or TOF or TEHP

Tracers

Calcofluor

Diethylphthlate mixed with 0.1 percent of fluorescent dye DF-504

Uranine or sodium flourescein

Zinc cadmium sulfide

Decontaminants

Betapropiolactone

Calcium hypochlorite

many years as a simulant for the aerosol behavior of the active biological agent Bacillus anthracis, which causes the disease anthrax. Tracers were substances used to track the movement of test agents or simulants.

To test the hypotheses generated by a review of published literature (Research Question 1), the committee looked at those SHAD participants with exposure to particular agents and compared their experience of specific health effects with the unexposed comparison group. For its broader analysis (Research Question 2), the committee compared health outcomes in the participant group with those of service members from similar vessels and units. Additional analyses considered the potential effects of differences in exposures to types of agents (e.g., any biological agent, any chemical agent) and in numbers of exposures based on numbers of tests and trials within tests.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

The comparison population was made up of the crews of Navy vessels identified to be as similar as possible to those participating in the Project SHAD tests. Similarly, the comparison population of Marines was men in units comparable to those that participated in the SHAD tests. Identification of the comparison ships and Marine units is described in greater detail in Chapters 2 and 3. All of the study participants and comparison population were men.

CHALLENGES FOR THE STUDY

Several of the challenges involved in carrying out this study are typical of studies to examine the potential health effects from past occupational exposures. For example, the SHAD tests took place in the 1960s and were not intended to study the health of the participants. However, occupational health researchers often have to turn to decades-old records that may be incomplete and are not designed for use in estimating a workplace exposure. Other challenges are specific to the unusual circumstances of the Project SHAD testing.

The committee reviewed the information available from both DoD fact sheets and the publicly available portions of the reports written for each of the 21 SHAD tests. All of the study participants had in common their participation in at least one of the Project SHAD test trials, but it became clear to the committee that several subgroups could be defined on the basis of the particular agents, simulants, tracers, or decontaminants that had been used in the specific tests. One subgroup of particular interest was the crews of five light tug boats that had a role in the only SHAD tests reported to have used active biological warfare agents in addition to the simulants used in many of the other tests. Rosters for the crews of these small vessels were not archived as crew rosters were for most Navy ships. Although the tugs participated in six tests, crew members have been identified as a group in conjunction with only one test in January 1965. Moreover, it was not possible to identify comparable ships that could contribute crew members to the comparison population. Identification of members of the PSTS was also limited to a single document from January 1965.

The men who served on the USS George Eastman were also of special interest because this test ship was the only manned vessel reported to be involved in trials using active chemical warfare agents in addition to simulants. Focused analysis for each of these subgroups was a challenge because of the relatively small numbers of people involved in each group. Chapter 3 discusses analytical issues further.

Ideally, studies to assess whether environmental or occupational exposures are associated with adverse health effects are able to incorporate quantitative information about the amount of exposure each member of the study population received. The concentration of a substance in each subject’s blood or urine might be used, for example. Often, however, studies must rely on indirect indicators of exposure such as the concentration of a substance in the air where a subject worked and the amount of time (e.g., days, months, years) the subject worked there. For this study, the committee’s assessment of the exposures received by participants in the SHAD tests was constrained by the limits of the available documentation. Information on the concentrations of test agents, simulants, tracers, and decontaminants used in the tests largely remains classified. To the committee’s knowledge, no biological samples were collected from the participants that could be used to measure individuals’ internal dose of specific substances used in the tests. In a few tests, contact with these substances was assessed using mouth washes, nasal swabs, or clothing patches. For two tests, such information was available in a qualitative form (e.g., high, medium, low exposure) that was not sufficient to aid the analysis. Although the SHAD tests

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

generally used air samplers placed in various locations of a ship to measure the presence and concentration of a test substance, the data that were collected are among those that remain classified. Moreover, no information was available to show the location of individual crew members during a test, making the sampler data unhelpful in confidently distinguishing potential exposure levels among crew members.

The IOM requested declassification of additional material pertaining to the tests and exposures, including data on particle size, air sampler locations and sampler results, and movie films of some of the tests. A preliminary DoD review resulted in the conclusion that additional material for only one test was appropriate for declassification. Material on the other tests was not considered suitable for declassification because of its potential to reveal ship vulnerabilities to chemical or biological agents. At the time this report was written, no additional materials had been declassified and provided to the committee.

TOPICS BEYOND THE SCOPE OF THE STUDY

Some topics were considered beyond the scope of the study. For the SHAD I study, the IOM staff made a detailed review of Navy quarterly unit rosters and daily personnel diaries and of Marine Corps monthly personnel rosters and company diaries as part of a validation of the study participants identified by DoD as being present during the time of the SHAD tests. In that review of archival materials, the IOM identified several additional likely SHAD test participants and provided these names to DoD to augment its database. Since that time and as described by Government Accountability Office (GAO) reports (2004, 2008), contractors working on behalf of DoD have continued searching records to identify veterans potentially involved in Project SHAD and other chemical and biological warfare testing.

Consistent with the charge for the current study to use the same population of test participants and the same comparison population as in the first study, the IOM did not repeat its independent review of personnel diaries and quarterly reports. However, the IOM did receive an updated listing of SHAD participants from DoD, in order to use the most recent roster of participants. Thus, the analysis for the current report included any additional test participants who had been identified in the years since the first IOM study was concluded. As described in Chapter 3, nine additional test participants were identified through this update.

Several veterans who had served as members of the PSTS reported that they had been administered vaccines against certain biological warfare agents such as those that cause tularemia (P/F tularensis) and Q fever (C. burnetii). They noted that the vaccinations had been recorded on lists that did not become part of their permanent medical records or personnel folders. Because information linking specific vaccinations to specific individuals was not available, the committee could not include the vaccinations as separate exposure factors in the study. However, and as noted in the data and methods chapter, the tug and PSTS group was considered to have several unique exposures that should be taken into account in their analysis as a special subgroup.

Several SHAD veterans have also expressed concerns about the potential for exposure to radiation from their service because two of the ships used in SHAD had also been used to monitor nuclear tests conducted in the Pacific Ocean in the 1950s (Naval History and Heritage Command, 2015a,b). The two ships were the USS George Eastman, which served as a target

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

vessel in six SHAD tests, and the USS Granville S. Hall, which served as a laboratory ship for many SHAD tests.4 In addition, tug crews who participated in the 1965 SHAD test Shady Grove spent some time on Johnston Atoll, which had been used for nuclear testing in 1962 (Personal communication, J. Alderson, U.S. Navy Reserve (Ret.), January 22, 2013). Radiation was not specifically a SHAD-related exposure, but various factors noted in Chapter 3 resulted in these groups receiving special analytical consideration.

As has been noted, Project SHAD was part of a larger testing program designated Project 112. Because the charge to the committee was to study SHAD exposures and use the same participant and comparison populations as in the previous IOM study, the committee did not attempt to include participants in the other Project 112 tests that took place between December 1962 and May 1974 (see DoD, 2015).

Veterans and others have raised questions about the ethics and legality of the SHAD testing (described further in Chapter 2). While many issues attend consideration of Project SHAD, this committee was not charged with reviewing the merits of the program. The focus was on the scientific question of whether test participation is associated with adverse long-term health effects.

THE COMMITTEE’S REPORT

This report reviews the information available on the individual Project SHAD tests and the agents, simulants, tracers, and decontaminants used in them for an analysis of the association between participation in the tests or specific exposures in the tests and long-term health effects. Specifically, Chapter 2 provides background on the SHAD tests, previous studies of SHAD veterans, and some of the concerns and input SHAD veterans shared with the committee in its public workshops. Chapter 3 describes the rationale for the committee’s approach to and design for the study. Chapter 4 presents results of the analysis of the mortality data, and Chapter 5 focuses on the analysis of morbidity data. Chapter 6 provides a discussion of the findings from the analysis and their implications, and notes the strengths and weaknesses of the study. Included as appendixes are biographical sketches of committee members (Appendix A), agendas for the committee’s public sessions (Appendix B), information from the review of recent literature on each of the test substances (Appendix C), additional information on data and methods used for analysis (Appendix D), units participating in Project SHAD tests and units selected as comparisons (Appendix E), and diagnostic codes used to define health outcomes (Appendix F).

REFERENCES

DoD (Department of Defense). 2015. Project 112/SHAD fact sheets. http://www.health.mil/MilitaryHealth-Topics/Health-Readiness/Environmental-Exposures/Project-112-SHAD/Fact-Sheets (accessed October 1, 2015).

GAO (General Accounting Office). 2004. Chemical and biological defense: DoD needs to continue to collect and provide information on tests and potentially exposed personnel. GAO-04-410. Washington, DC: General Accounting Office.

______________

4 There was an anecdotal report that at least one ship set off a radiation alarm in a Hawaiian harbor (Morris, 2004, Tab 6).

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×

GAO (Government Accountability Office). 2008. Chemical and biological defense: DoD and VA need to improve efforts to identify and notify individuals potentially exposed during chemical and biological tests. GAO-08-366. Washington, DC: Government Accountability Office.

IOM (Institute of Medicine). 2007. Long-term health effects of participation in Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press.

IOM. 2008. Response to 15 February 2008 letter from Congressmen Mike Thompson and Dennis Rehberg. Letter from Frederick J. Erdtmann, Director, Medical Follow-up Agency, Institute of Medicine. http://iom.nationalacademies.org/~/media/Files/Report%20Files/2007/Long-Term-Health-Effects-of-Participation-in-Project-SHAD-Shipboard-Hazard-and-Defense/SHAD%20Response%20Letter.pdf (accessed January 7, 2014).

Morris, D. D. 2004. The Department of Defense identification of participants and exposures in Projects 112 and Shipboard Hazard and Defense. M.P.H. thesis, Morris, Dee Dodson: George Washington University.

Naval History and Heritage Command. 2015a. George Eastman. http://www.history.navy.mil/research/histories/ship-histories/danfs/g/george-eastman.html (accessed October 15, 2015).

Naval History and Heritage Command. 2015b. Granville S. Hall (YAG-40). http://www.history.navy.mil/research/histories/ship-histories/danfs/g/granville-s-hall-yag-40.html (accessed October 15, 2015).

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 11
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 12
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 13
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 14
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 15
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 16
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
Page 17
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Assessing Health Outcomes Among Veterans of Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press. doi: 10.17226/21846.
×
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Between 1963 and 1969, the U.S. military carried out a series of tests, termed Project SHAD (Shipboard Hazard and Defense), to evaluate the vulnerabilities of U.S. Navy ships to chemical and biological warfare agents. These tests involved use of active chemical and biological agents, stimulants, tracers, and decontaminants. Approximately 5,900 military personnel, primarily from the Navy and Marine Corps, are reported to have been included in Project SHAD testing.

In the 1990s some veterans who participated in the SHAD tests expressed concerns to the Department of Veterans Affairs (VA) that they were experiencing health problems that might be the result of exposures in the testing. These concerns led to a 2002 request from VA to the Institute of Medicine (IOM) to carry out an epidemiological study of the health of SHAD veterans and a comparison population of veterans who had served on similar ships or in similar units during the same time period. In response to continuing concerns, Congress in 2010 requested an additional IOM study. This second study expands on the previous IOM work by making use of additional years of follow up and some analysis of diagnostic data from Medicare and the VA health care system.

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