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5
Case Studies Summary Chapter

INTRODUCTION

In addressing its charge with regard to characterizing Congress’ and the Department of Veterans Affairs’ (VA’s) presumptive disability decision-making process for veterans, the Committee completed the set of case studies around specific exposures and illnesses listed in Table 5-1. The Committee determined that a thorough evaluation of selected case studies would capture past practices of all participants involved in the presumptive disability decision-making process for veterans—Congress, VA, the National Academies’ (Institute of Medicine [IOM] and National Research Council [NRC]), stakeholders, and the courts—and provide a basis for making sound and practical recommendations for the future of this process. The complete, specific case studies are found in Appendix I.

The case studies were selected to reflect the range of presumptive decisions established by Congress and VA, as they made decisions using evidence ranging from abundant and quite conclusive in the case of radiation to much more limited in cases such as Agent Orange and prostate cancer. The examples were also chosen to illustrate approaches taken by IOM and NRC committees in evaluating evidence related to presumptions. In the case studies, the Committee focused on examining the evidence foundation available for evaluation by Congress, the IOM or NRC, and VA; the approaches taken for reviewing the evidence; the schema used to classify the level of evidence for causation; and the translation of the scientific evidence through the conclusions of the IOM and NRC committees into a decision by VA. The case studies also provided insights into principles embedded in the presumptive disability decision-making process.



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5 Case Studies Summary Chapter INTRODUCTION In addressing its charge with regard to characterizing Congress’ and the Department of Veterans Affairs’ (VA’s) presumptive disability decision- making process for veterans, the Committee completed the set of case studies around specific exposures and illnesses listed in Table 5-1. The Committee determined that a thorough evaluation of selected case studies would capture past practices of all participants involved in the presump- tive disability decision-making process for veterans—Congress, VA, the National Academies’ (Institute of Medicine [IOM] and National Research Council [NRC]), stakeholders, and the courts—and provide a basis for making sound and practical recommendations for the future of this process. The complete, specific case studies are found in Appendix I. The case studies were selected to reflect the range of presumptive deci- sions established by Congress and VA, as they made decisions using evi- dence ranging from abundant and quite conclusive in the case of radiation to much more limited in cases such as Agent Orange and prostate cancer. The examples were also chosen to illustrate approaches taken by IOM and NRC committees in evaluating evidence related to presumptions. In the case studies, the Committee focused on examining the evidence founda- tion available for evaluation by Congress, the IOM or NRC, and VA; the approaches taken for reviewing the evidence; the schema used to classify the level of evidence for causation; and the translation of the scientific evidence through the conclusions of the IOM and NRC committees into a decision by VA. The case studies also provided insights into principles embedded in the presumptive disability decision-making process. 83

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS TABLE 5-1 List of Case Studies (in chronological order of when presumptions were established by Congress or VA) Mental Disorders’ Presumptions Multiple Sclerosis Presumption Prisoners of War (POWs) Presumptions Amputees and Cardiovascular Disease Presumption Radiation Presumptions Mustard Gas and Lewisite Presumptions Gulf War Presumptions Agent Orange and Prostate Cancer Presumption Agent Orange and Type 2 Diabetes Presumption Spina Bifida Program* *Because spina bifida is a condition that affects the children of veterans, it is not a presumptive decision for veterans; however, the children of Vietnam and Korean War veterans are covered by a VA program. The case studies were based on detailed review of public laws, legisla- tive background, research reports, National Academies’ IOM and NRC committees’ reports, and VA materials. However, as described in Chapter 1, the case studies were limited by VA’s response to the Committee’s request for information, documents, and responses to the Committee’s written questions. The case studies synthesize a large body of information. This body of information is summarized in Annex 5-1 at the end of this chap- ter, and the full case study series is in Appendix I. Additional materials on individual case studies and cost estimates are also referenced at the end of this chapter in Annexes 5-2 and 5-3. This chapter synthesizes the “lessons learned” from each of the case studies. We begin by summarizing each of the case studies and the particular lessons learned and then look across the case studies as a group for more general conclusions. The case studies are presented in chronological order as to when presumptions were established by Congress or VA. In drawing out these lessons as a basis for moving forward, the Committee’s commentary should not be construed as a critique of past activities and processes of Congress, VA, and National Academies’ IOM and NRC committees. This Committee recognizes that these activities took place over decades during which scientific research and evidence review processes were evolving and that tremendous efforts from all participants in the process went into producing all of the work that we summarize as follows.

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 CASE STUDIES SUMMARY CHAPTER MENTAL DISORDERS’ PRESUMPTIONS Description There have been two major types of presumptive disabilities for mental disorders among U.S. veterans: those presumed to be chronic and those among POWs. The diversity of these disorders has posed a challenge. The presumptive disabilities assigned to posttraumatic stress disorder (PTSD), depression, and any anxiety state for POWs are well grounded in the scien- tific literature (Beebe, 1975; CDC, 1988; Cohen and Cooper, 1954; Engdahl and Page, 1991; Keehn, 1980; Nefgzer, 1970; Page et al., 1997). The presumptive disability category for psychosis among veterans has a more limited base of evidence (Beebe, 1975; Keehn, 1980) and appears a conse- quence of its initial inclusion as a presumptive disability when presumptions first began in 1921. At that time, the disorder (then called neuropsychiatric disease) had no treatment and was considered to be chronic. Lessons Learned Presumptive decisions for mental disorders have been made for vet- erans who are former POWs and veterans who developed chronic mental problems during or shortly after military service. Although legislation has been informed by the scientific evidence available at the time, the scientific evidence in some instances has been limited and with inconsistency around the disorders included. For example, if the strength of evidence classifica- tion of limited/suggestive evidence led to presumptive decisions for PTSD, dysthymia, and any anxiety state among former POWs, then there does not appear to be a clear basis for excluding other mental disorders with equal or stronger evidence of connection to being a POW, such as major depres- sion. The presumptive decisions established with regard to the previously mentioned mental disorders make clear that these decisions have been influenced by not only scientific evidence but by political and social consid- erations that apply to these veterans (e.g., POWs) and the specific mental disorders they may manifest. The need to develop a stronger evidence base and consistent evaluation of the evidence base with regard to these mental disorders is great, particularly in light of the anticipated high rates of mental disorders among military personnel assigned to and returning from Iraq and Afghanistan. This case study also illustrates the need for a process to continually carry out research and update the scientific evidence base for presumptions.

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6 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS MULTIPLE SCLEROSIS PRESUMPTION Description This case study examines the 1962 decision to grant compensation for service-connected disability to veterans diagnosed with multiple sclerosis (MS) within 7 years of their separation from the military. This presump- tion stems from the VA’s interest in compensating disease and disability that has its onset during military service. Veterans with one of a defined list of chronic diseases may also be compensated if these are diagnosed within 1 year of separation from the military. The rationale here is that these diseases are sufficiently insidious and the diagnosis sufficiently challenging so as to make it impossible to conclude with certainty that the true disease onset did not occur during the period of military service. Multiple sclerosis was eventually singled out from the other chronic ill- nesses and the period of diagnosis extended from 1 year (Veterans’ Chronic and Tropical Diseases Act of 1948. Public Law 80-748. 80th Cong., 2d Sess.; VA, 1949), to 2 (Act of October 12, 1951. ch. 499, 65 Stat. 421 as cited in VA, 1993), to 3 years (Act of August 25, 1959. Public Law 86- 187. 86th Cong., 1st. Sess. as cited in VA, 1993), and eventually to 7 years (Veterans’ Disability Compensation Increase Act of 1962. Public Law 87- 645. 87th Cong., 2d Sess. as cited in VA, 1993) following separation from military service. The rationale for this extension was the growing scientific evidence (much of it generated by VA researchers studying veterans) of the long delay between the onset of MS symptoms and eventual diagnosis, as well as the possibility that environmental factors may play a role in the etiology of MS. However, these studies also failed to find evidence that military service contributes to MS risk, and veterans do not appear to have higher rates of MS than the general population (Berkowitz and Santangelo, 1999; Kurtzke and Page, 1997; Kurtzke et al., 1979, 1985, 1992; Norman et al., 1983; Page et al., 1993, 1995; VA Multiple Sclerosis Study Group, 1956, 1957; Wallin et al., 2000). Lessons Learned The rationale for the MS presumption reflects two lines of reasoning used in making presumptions. The first reflects the possibility that MS diagnosed after separation from the military may, in fact, have been present during military service, and therefore subject to the same compensation rules as other direct service-connection disabilities. The second acknowl- edges that the etiology of MS is unclear and may be related to an environ- mental exposure received during military service. Understanding that both of these arguments have been used in the MS case is important, because the

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 CASE STUDIES SUMMARY CHAPTER evidence required to support each is very different. In the first case, timing is the standard (specifically the possibility of disease onset during military service), and evidence for association between an exposure and outcome is not required. By contrast, in the second case, evidence from some associa- tion between exposure during service and future disease is necessary. Congress did not call for a systematic review of the scientific literature on this topic; such a review might have allowed for more evidentiary discus- sion of the premise behind this presumption and the type of evidence that might be necessary to support it. PRISONERS OF WAR PRESUMPTIONS Description Disability presumptions concerning American veterans who were cap- tured and interned as POWs almost uniformly developed as a result of congressional initiatives prompted by concerns over the harsh treatment that POWs had endured and practical difficulties that they might encounter in establishing entitlement to benefits. Concerned that World War II POWs might lack official medical records and have difficulties establishing the conditions of their internment, Congress first instructed VA to give special consideration and apply liberal evidentiary standards to POWs’ claims. As details of the harsh nature of the POW experience became more widely known, and as members received complaints from some former POWs having difficulties establishing disability benefit claims, Congress began to enact statutory presumptions for certain nutritionally related conditions and mental illness. Studies of mortality and morbidity among POWs sug- gesting connections of the POW experience with certain diseases and con- ditions also served as impetus for additional legislation, notwithstanding scientific limitations noted in those studies (Keehn, 1980; Nefzger, 1970; Page and Miller, 2000; Page and Ostfeld, 1994; Page and Tanner, 2000; VA, 1993). Over the course of more than 50 years, certain preconditions that had to be met before a presumption could attach, such as length or internment or the time period in which a condition must first be manifested, were progressively liberalized or eliminated by statute. In 2004 VA estab- lished administrative standards for any new POW presumptions based on “limited/suggestive evidence” of an association of the disease with intern- ment provided that it was “biologically plausible” (VA, 2004). Lessons Learned Americans and their elected representatives have long been concerned with the welfare of those who protected, defended, and sacrificed for their

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS country. The extensive system of veteran benefits and their liberalized rules for qualification are a manifestation of this concern. This concern is inten- sified when those veterans seeking assistance are viewed as having been subjected to extraordinary stresses and sacrifices, as have POWs. As VA declared in its 1980 study, the POW experience was an “extremely harsh and brutal experience,” “. . . characterized by starvation, diet, poor quality or nonexistent medical care, ‘death marches,’ executions, and torture” (VA, 1980, p. 4). Given this context, the creation of certain presumptions with respect to disabilities claimed to be connected with a veteran’s experience as a POW reflects long established concern for their welfare. These presumptions sim- plify adjudication for otherwise difficult cases because of the lack of specific evidence on exposures and the complexity of the health consequences of having been a POW. A difficult burden of proof for the veteran and VA is removed by a presumption. Presumptions have been particularly helpful in assessing POW claims for which information about individual conditions of internment and complete medical records were frequently unavailable. Pre- sumptions have enabled greater consistency in decision making for POWs; a previous lack of consistency generated much discontent by veterans who strongly communicated their concerns to elected representatives. Research has been carried out on the health of former POWs (Beebe, 1975; Brass and Page, 1996; Cohen and Cooper, 1954; IOM, 1992; Keehn, 1980; Nefzger, 1970; Page and Brass, 2001; Page et al., 1991, 1997; VA, 1980). The studies, which date back to the early 1950s, have slowly pro- vided evidence on the POW experience, particularly about malnutrition, stress, and the psychological consequences. At the same time, evidence relevant to particular presumptions was sometimes limited by coming from a single study with a small sample size. Consequently, interpretations of most studies acknowledged the uncertain- ties of findings and urged caution at drawing unwarranted inferences. As described by one author, the mixture and interdependence of various factors of the POW experience and the variation of their relative intensities “from time to time, from place to place, and from man to man,” have “limit[ed] the scope and specificity of the inferences that may be drawn statistically” (Nefzger, 1970, p. 124). Given the suggestive but scientifically uncertain results of many studies, not surprisingly policy makers frequently decided to create service-connected presumptions when faced with the pressing claims of genuinely sick and disabled former POWs. As one author observed of his 1992 study of POWs, the “descriptive” data obtained had “uses beyond the scientific,” specifically in the “discussion of military service-connected disabilities.” He added, “[d]espite the fact that sound inferences about the group of all former POWs cannot be drawn from the exam data in this report, policymakers

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 CASE STUDIES SUMMARY CHAPTER who must deal with such issues should be able to review this descriptive information” (IOM, 1992, p. 5; emphasis added). VA in its 2004 Guidelines for POW Presumptions responds to uncertainty; while expressing an intent to base its determinations on “sound scientific and medical evidence,” it adopts a standard of “limited/suggestive evidence” of an association for former POWs and adds the additional caveat that “fairness to former POWs requires that VA fully evaluate the available data and not accord undue significance to the fact that such data are comparatively limited by the small size of the affected population” (VA, 2004, p. 60085). The POW case study illustrates how uncertainties of the available scientific information have been relatively weighted against other driving factors for compensating POWs. Over time, the requirement that a pre- sumptive decision be “based on sound scientific and medical evidence” has increasing been overshadowed by these other considerations, reflecting the determination to assure that compensation for former POWs has maximum sensitivity. AMPUTEES AND CARDIOVASCULAR DISEASE PRESUMPTION Description This case study examines the 1979 presumption of service connection for cardiovascular disease that develops in veterans with certain types of service-related amputations. This case study was chosen to illustrate sev- eral important features. First, in contrast to many presumptions that exist because of the difficulty establishing exposure status among veterans, this presumption applies to a defined group of veterans for whom exposure (i.e., amputation) is not in question. Controversy regarding whether amputation was linked to cardiovascular disease prevented this complication from being compensated through standard individual claims and therefore necessitated the presumption. Second, this presumption was put in place through legisla- tive action on the part of Congress, not administratively by VA, as is the case with many of the other presumptions. Third, the scientific basis for this presumption is a single Medical Follow-Up Agency (MFUA) study of World War II amputees and their mortality from cardiovascular disease (Hrubec and Ryder, 1980). During the more than 30 years of follow-up of the study population, 922 proximal amputees died; 714.1 deaths were expected based on the general U.S. male death rate. Compared with distal amputees and those with disfigurement, proximal amputees had a higher risk of all-cause mortality, diabetes, and cardiovascular disease, particularly atherosclerotic (ischemic) heart disease.

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0 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS Lessons Learned The lessons from this case study center around the type of evidence necessary to put a presumption in place, specifically what level of evi- dence should be required for a presumption; how the scientific base of evidence is updated based on new studies; how to evaluate evidence regarding exposures, outcomes, and potential mediators; and what types of evidence might make the scientific basis for a presumption more robust. This presumption was put into place largely on the basis of one study and further studies on cardiovascular disease in amputees have not been car- ried out, even though the occurrence, management, and natural history of cardiovascular diseases have changed substantially in the subsequent three decades. In the decades since the presumption was implemented, many aspects of cardiovascular disease have changed; incidence rates have dropped, as has mortality; new preventive approaches are available, and treatments are increasingly effective. However, further studies have not been carried out on cardiovascular disease in subsequent cohorts of amputees, nor were data systems put in place to carry out surveillance for changing disease risks in the amputees. Special populations, such as the amputees, could be closely tracked through registries (i.e., specific cohort studies) to make certain that previous scientific observations hold and to assess if the establishment of additional presumptions is needed. RADIATION PRESUMPTIONS Description The radiation case study is concerned with the experience of the “atomic veterans” who were exposed to ionizing radiation, mainly through participation in nuclear weapons tests. In this case study, unlike most of the others, there is an abundant literature—some relating to dose-response relationships in general populations, some specific to veterans—upon which to base compensation policy (CIRRPC, 1988; IARC, 2000; IOM, 1996a, 2002; Lagakos and Mosteller, 1986; Lubin and Steindorf, 1995; NRC, 1980, 1984, 2003, 2005, 2006; Podgor, 2007; Prentice et al., 1983; RECAC, 1996; UNSCEAR, 2000). In general, most veterans for whom exposure estimates are available appear to have had relatively low doses, and a summary of the epidemiologic evidence suggests that the majority of cancers in this group were not caused by radiation. Despite this, there remain numerous uncertainties, particularly with respect to estimation of an individual’s exposures and with respect to the risk for specific rare cancers. These uncertainties in large part are responsible for the shift in emphasis from individual dose-based criteria for compensation in the

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1 CASE STUDIES SUMMARY CHAPTER Veterans’ Dioxin and Radiation Exposure Compensation Standards Act of 1984 (Public Law 98-542. 98th Cong., 2d Sess.) to the establishment of presumptions in the Radiation-Exposed Veterans Compensation Act of 1988 (Public Law 100-321. 100th Cong., 2d Sess.), illustrating the need for presumptions even in this relatively data-rich situation. It also illustrates that epidemiologic studies of veterans themselves can be less informative than other nonmilitary populations because of such issues as limited sample size, inadequate length of follow-up, low doses, poor dosimetry, other potential biases, and difficulties in teasing out the effects of modifiers such as smoking. Finally, the radiation story illustrates the practical difficulties posed by the secrecy under which these nuclear weapons test operations were conducted, posing difficulties both for researchers and for individual veterans seeking to document their claims. Lessons Learned For radiation exposure, in contrast to the factors considered in the other case studies, epidemiological evidence on risks is abundant and the dose-response relationships for cancer have been described with reasonable precision from such major studies as that of the atomic bomb survivors. Epidemiological studies have been carried out on radiation-exposed veterans specifically. General models have been developed for quantifying the prob- ability of causation, given the level of exposure. Additionally, there is a substantial body of research on mechanisms by which radiation causes cancer. Nonetheless, uncertainties remain in extending this evidence to com- pensating particular veterans as their exposures are poorly estimated, dis- ease outcomes lack specificity of cause, and for some rare cancers causation remains to be established. These uncertainties in large part appear respon- sible for the shift in emphasis from individual probability of causation (PC)-based criteria for compensation in the Veterans’ Dioxin and Radiation Exposure Compensation Standards Act of 1984 (Public Law 98-542. 98th Cong., 2d Sess.) to the establishment of presumptions in the Radiation- Exposed Veterans Compensation Act of 1988 (Public Law 100-321. 100th Cong., 2d Sess.). Still unresolved is whether, in light of the uncertainties about site-specific risk, perhaps all cancers in radiation-exposed veterans should be treated as presumptively caused by radiation, at least absent very convincing evidence that the specific cancer is not caused by radia- tion. Arguably, the only site that might be excluded on this basis would be chronic lymphatic leukemia. While the Committee has called for research and surveillance on the health of veterans, the studies of radiation effects in veteran populations have proven of limited utility, in part because of the relatively small num-

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS ber of excess cancers expected in the available cohorts and, importantly, because individual exposures were not tracked in a systematic manner. As a result an opportunity to carefully characterize radiation-related cancer risks among veterans may have been missed. Fortunately, there has long been a strong body of evidence from other populations, so that the weak evidence provided by the studies of veterans has not been construed as a basis for holding back on presumptions for radiation. The availability of strong epi- demiologic data has made possible the construction of quantitative models to guide compensation policy for radiation-exposed veterans, which has often not been possible for other exposures. These models have not been used to quantify the burden of radiation-caused cancer among veterans. Specificity is an issue in compensation of cancers in radiation-exposed individuals. Many cancers caused by radiation also have many other respon- sible risk factors, and cases caused by radiation cannot be distinguished from those caused by other factors. Additionally, for most radiation expo- sures received during military service, the probability of causation is low. In the example of smoking, which interacts with radiation for lung cancer, evidence-based policies can be developed based on an understanding of the joint effects of radiation and smoking. Potentially, if data are available, similar models could be developed for the interaction of radiation with other agents. Ultimately, much of the force behind the movement for compensation for the atomic veterans came from the fact that the government deliberately exposed them to harm, while having at least some knowledge of the risks involved at the time. Furthermore, the risks were often denied by govern- ment officials, both at the time of exposure when military personnel were not properly informed and later when diseases were manifest and attempts at redress were dismissed. On this basis, veterans consider that the case for their claims for compensation is enhanced by the culpability of the government. MUSTARD GAS AND LEWISITE PRESUMPTIONS Description This case study examines the 1992 and 1994 decisions by VA to estab- lish presumptive service connection for health outcomes related to mustard gas and lewisite exposures among World War II veterans. This case study, the first involving a congressional request for the IOM to develop a report, raises a series of still persistent issues. With the recognition that some World War II veterans had been exposed to mustard gas during laboratory studies, VA in 1992 proposed a presumptive service-connection decision covering this exposure (VA, 1992a). The presumption was based on four primary

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 CASE STUDIES SUMMARY CHAPTER factors: (1) the studies were classified, (2) participants were directed not to discuss their participation in the studies, (3) their medical records were sparse, and (4) no long term follow-up was conducted or provided for the participants (VA, 1992a). VA issued a final rule in July 1992 (VA, 1992b). As a result of public comment to the proposed rule as found in the final rule (VA, 1992a,b), VA contracted with IOM to write a report on the health effects of exposure to mustard gas and lewisite. In early 1994, VA revised the presumption based on the IOM study, Veterans at Risk: The Health Effects of Mustard Gas and Lewisite (IOM, 1993), and issued a proposed rule (VA, 1994a). The second presumptive service-connection rule was issued in August 1994. This rule amended the original proposal by (1) adding more diseases to the original list of diseases, (2) adding the compound lewisite to the rule, (3) adding veterans who might have been exposed during World War I and in studies after the end of World War II, and (4) clarifying the extent of exposure (VA, 1994b). Lessons Learned A number of concerns are raised by this presumptive decision. Fore- most is the unresolved problem raised by secrecy surrounding military/ governmental studies involving exposure of military personnel to warfare agents that may have immediate or delayed effects on their health (IOM, 1993). Classifying warfare studies based on national security is necessary in many cases. However, this classification can lead to concerns about health that might not be resolved for decades. In the case of mustard and lewisite agents, national security took prece- dence over the long-term health risks to the study participants. Participants in these studies maintained their secrecy oaths for decades even though they developed health problems consequent to their exposures. As health consequences emerged there were problems in finding information about exposure to mustard gas or lewisite in their medical records. Consequently, health-care providers could not provide appropriately targeted screening and care and long-term medical follow-up was not provided to the study participants. A third area of concern is that this classification precluded health-care providers from being aware that symptoms of mustard gas or lewisite exposure might be exhibited by patients. As a result, the health-care providers did not look for these occupationally related symptoms (IOM, 1993). The consequences of secreting information were partially recognized in several Information Letters from the VA Under Secretary for Health (VA, 2002, 2005, 2006). As indicated in the Presidential Task Force 2003 report (President’s Task Force to Improve Health Care Delivery for Our Nation’s Veterans, 2003) and a recent Government Accountability Office (GAO)

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Diseases 61 FR CFR Part 3 Associated with 57586 Exposure to Certain Herbicide Agents (Prostate Cancer and Acute and Subacute Peripheral Neuropathy) (1996) (final rule) Veterans’ Benefits 62 FR 38 CFR Improvements Act 35421 Part 3 of 1996 (1997) (final rule) Diseases Not 64 FR Associated with 59232 Exposure to Certain Herbicide Agents (1999) (notice) Diseases Not 67 FR 4 Associated with 2600 Exposure to Certain Herbicide Agents (2002) (notice) 1 continued

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ANNEX 5-1 Continued 16 EXECUTIVE BRANCH (DEPARTMENT CONGRESS OF VETERANS AFFAIRS) Code of Public Law Public Law House Senate Federal Federal Case Study Name Statute CIS Index Report Report Rule Name Register Regulations Agent Disease Associated 68 FR 38 CFR Orange with Exposure to 14567 Part 3 and Certain Herbicide Prostate Agents: Chronic Cancer Lymphocytic (continued) Leukemia (2003) (proposed rule) Compensation and 68 FR 38 CFR Pension Provisions 34539 Parts 3 and of the Veterans 13 Education and Benefits Expansion Act of 2001 (2003) (final rule) Disease Associated 68 FR 38 CFR with Exposure to 59540 Part 3 Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (final rule) Agent Veterans’ Dioxin PL 98-542 PL 98-542 HR 98-592 SR 97-89 Adjudication of 50 FR 38 CFR Orange and Radiation 98 STAT. 2725 HR 98-828 Claims based 34452 Parts 1 and Type 2 Exposure on Exposure to and 3

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Agent Veterans’ Dioxin PL 98-542 PL 98-542 HR 98-592 SR 97-89 Adjudication of 50 FR 38 CFR Orange and Radiation 98 STAT. 2725 HR 98-828 Claims based 34452 Parts 1 and Type 2 Exposure on Exposure to and 3 Diabetes Compensation Dioxin or Ionizing Standards Act of Radiation (1985) 1984 (final rules) Agent Orange PL 102-4 PL 102-4 HR 101-672 SR 100-215 Claims based on 55 FR 38 Parts 3 Act of 1991 105 STAT. 11 HR 101-857 SR 100-439 Service in Vietnam 25339 and 4 SR 101-82 (1990) (proposed SR 101-379 regulation) Veterans’ PL 103-446 PL 103-446 HR 103-538 SR 103-280 Claims based on 55 FR 38 Parts 3 Benefits 108 STAT. HR 103-668 SR 103-385 Service in Vietnam 43123 and 4 Improvements 4645 HR 103-669 SR 103-386 (1990) (final Act of 1994 regulation) Veterans’ PL 104-275 PL 104-275 HR 104-649 SR 99-101 Claims Based 56 FR 38 Parts 3 Benefits 110 STAT. SR 100-439 on Exposure 7632 and 4 Improvements 3322 SR 104-371 to Herbicides Act of 1996 Containing Veterans PL 107-103 PL 107-103 HR 107-156 SR 107-86 Dioxin (Soft Education 115 STAT. 976 SR 106-122 Tissue Sarcomas) and Benefits (1991) (proposed Expansion Act regulation) of 2001 Claims Based 56 FR 38 Parts 3 on Exposure 51651 and 4 to Herbicides Containing Dioxin (Soft Tissue Sarcomas) (1991) (final regulation) 1 continued

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ANNEX 5-1 Continued 1 EXECUTIVE BRANCH (DEPARTMENT CONGRESS OF VETERANS AFFAIRS) Code of Public Law Public Law House Senate Federal Federal Case Study Name Statute CIS Index Report Report Rule Name Register Regulations Agent Claims Based 57 FR 38 CFR Orange on Exposure 2236 Part 3 and Type 2 to Herbicides Diabetes containing Dioxin (continued) (Peripheral Neuropathy/Lung Cancer) (1992) (proposed rule) Diseases 57 FR 38 CFR Associated with 30707 Part 3 Service in the Republic of Vietnam (1992) (proposed rule) Diseases 58 FR 38 CFR Associated with 29107 3.309(e) Service in the Republic of Vietnam (1993) (final rule) Disease Associated 58 FR 38 CFR with Exposure to 50528 Part 3 Certain Herbicide Agents (1993) (proposed rule) Disease 59 FR 38 CFR Associated with 5106 Part 3 Exposure to

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with Exposure to 50528 Part 3 Certain Herbicide Agents (1993) (proposed rule) Disease 59 FR 38 CFR Associated with 5106 Part 3 Exposure to Certain Herbicide Agents (1994) (final rule) Disease 59 FR 38 CFR Associated with 29723 Part 3 Exposure to Certain Herbicide Agents (Multiple Myeloma and Respiratory Cancers) (1994) (final rule) Veterans’ Benefits 62 FR 38 CFR Improvements Act 35421 Part 3 of 1996 (1997) (final rule) Diseases Not 64 FR Associated with 59232 Exposure to Certain Herbicide Agents (1999) (notice) 1 continued

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ANNEX 5-1 Continued 10 EXECUTIVE BRANCH (DEPARTMENT CONGRESS OF VETERANS AFFAIRS) Code of Public Law Public Law House Senate Federal Federal Case Study Name Statute CIS Index Report Report Rule Name Register Regulations Agent Disease 66 FR 38 CFR Orange Associated with 2376 Part 3 and Type 2 Exposure to Diabetes Certain Herbicide (continued) Agents: Type 2 Diabetes (2001) (proposed rule) Disease Associated 66 FR 38 CFR with Exposure to 23166 Part 3 Certain Herbicide Agents: Type 2 Diabetes (2001) (final rule) Disease Associated 68 FR 38 CFR with Exposure to 14567 Part 3 Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (proposed rule) Compensation and 68 FR 38 CFR Pension Provisions 34539 Parts 3 and of the Veterans 13

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Compensation and 68 FR 38 CFR Pension Provisions 34539 Parts 3 and of the Veterans 13 Education and Benefits Expansion Act of 2001 (2003) (final rule) Disease Associated 68 FR 38 CFR with Exposure to 59540 Part 3 Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (final rule) Change of 69 FR 38 CFR Effective Date of 31882 Part 3 Rule Adding a Disease Associated with Exposure to Certain Herbicide Agents: Type 2 Diabetes (2004) (final rule) 11 continued

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ANNEX 5-1 Continued 1 EXECUTIVE BRANCH (DEPARTMENT CONGRESS OF VETERANS AFFAIRS) Code of Public Law Public Law House Senate Federal Federal Case Study Name Statute CIS Index Report Report Rule Name Register Regulations Spina Disease Not 59 FR 341 Bifida Associated with Exposure to Certain Herbicide Agents (1994) (notice) Disease Not 61 FR Associated with 41442 Exposure to Certain Herbicide Agents (1996) (notice)

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1 CASE STUDIES SUMMARY CHAPTER ANNEX 5-2 The following National Academies’ reports were evaluated by commit- tee members for inclusion in the individual case studies (see Appendix I). The reports appear below in chronological order: NRC (National Research Council). 1982. Possible long-term health effects of short-term ex- posure to chemical agents. Vol. 1. Washington, DC: National Academy Press. NRC. 1984. Assigned share for radiation as a cause of cancer: Review of radioepidemiological tables, assigning probabilities of causation. Washington, DC: National Academy Press. NRC. 1984. Possible long-term health effects of short-term exposure to chemical agents: Cho- linesterase reactivators, psychochemicals and irritants and vesicants. Vol. 2. Washington, DC: National Academy Press. NRC. 1985. Mortality of nuclear weapons test participants. Washington, DC: National Academy Press. NRC. 1985. Possible long-term health effects of short-term exposure to chemical agents: Final report. Current health status of test subjects. Vol. 3. Washington, DC: National Academy Press. NRC. 1988. Overview. In Health risks of radon and other alpha-emitters: BEIR IV. Wash- ington, DC: National Academy Press. NRC. 1990. Health effects of exposure to low levels of ionizing radiation: BEIR V. Washing- ton, DC: National Academy Press. IOM (Institute of Medicine). 1991. Epidemiology in military and veteran populations: Pro- ceedings of the Second Biennial Conference, March , 10. Washington, DC: National Academy Press. IOM. 1992. The health of former prisoners of war. Washington, DC: National Academy Press. IOM. 1993. Veterans at risk: The health effects of mustard gas and lewisite. Washington, DC: National Academy Press. IOM. 1994. Health effects of herbicides used in Vietnam. Washington, DC: National Academy Press. IOM. 1994. Veterans and Agent Orange: Health effects of herbicides used in Vietnam. Wash- ington, DC: National Academy Press. IOM. 1995. Health consequences of service during the Persian Gulf War: Initial findings and recommendations for immediate action. Washington, DC: National Academy Press. IOM. 1995. Recommendations for research on the health of military women: Bibliographies. Washington, DC: National Academy Press. IOM. 1995. A review of the dosimetry data available in the Nuclear Test Personnel Review (NTPR) Program. Washington, DC: National Academy Press. IOM. 1996. Health consequences of service during the Persian Gulf War: Recommendations for research and information systems. Washington, DC: National Academy Press. IOM. 1996. Interactions of drugs, biologics, and chemicals in U.S. military forces. Wash- ington, DC: National Academy Press. IOM. 1996. Mortality of veteran participants in the Crossroads nuclear test. Washington, DC: National Academy Press. IOM. 1996. Veterans and Agent Orange: Update 16. Washington, DC: National Academy Press. IOM. 1997. Characterizing exposure of veterans to Agent Orange and other herbicides used in Vietnam: Scientific considerations regarding a request for proposals for research. Washington, DC: National Academy Press.

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1 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS IOM. 1997. An evaluation of radiation exposure guidance for military operations: Interim Report. Washington, DC: National Academy Press. IOM. 1998. Adequacy of the VA Persian Gulf registry and uniform case assessment protocol. Washington, DC: National Academy Press. IOM. 1998. Assessing readiness in military women: The relationship of body, composition, nutrition, and health. Washington, DC: National Academy Press. IOM. 1998. Measuring the health of Persian Gulf veterans: Workshop summary. Washington, DC: National Academy Press. IOM. 1999. Gulf War veterans: Measuring health. Washington, DC: National Academy Press. NRC. 1999. Health effects of exposure to radon: BEIR VI. Washington, DC: National Acad- emy Press. IOM. 1999. Potential radiation exposure in military operations: Protecting the soldier before, during, and after. Washington, DC: National Academy Press. IOM. 1999. Veterans and Agent Orange: Update 1. Washington, DC: National Academy Press. IOM. 2000. The Five Series Study: Mortality of military participants in U.S. nuclear weapons tests. Washington, DC: National Academy Press. IOM. 2000. Gulf War and health, volume 1: Depleted uranium, pyridostigmine bromide, sarin, vaccines. Washington, DC: National Academy Press. NRC. 2000. A review of the draft report of the NCI-CDC working group to revise the 1 radioepidemiological tables. Washington, DC: National Academy Press. IOM. 2000. Veterans and Agent Orange: Herbicide/dioxin exposure and type  diabetes. Washington, DC: National Academy Press. IOM. 2001. Gulf War veterans: Treating symptoms and syndromes. Washington, DC: National Academy Press. IOM. 2001. Veterans and Agent Orange: Update 000. Washington, DC: National Academy Press. IOM. 2002. Veterans and Agent Orange: Herbicide/dioxin exposure and acute myelogenous leukemia in the children of Vietnam veterans. Washington, DC: National Academy Press. IOM. 2003. Characterizing exposure of veterans to Agent Orange and other herbicides used in Vietnam: Interim findings and recommendations. Washington, DC: The National Academies Press. IOM. 2003. Characterizing exposure of veterans to Agent Orange and other herbicides used in Vietnam: Final report. Washington, DC: The National Academies Press. IOM. 2003. Gulf War and health, volume : Insecticide and solvents. Washington, DC: The National Academies Press. IOM. 2003. Veterans and Agent Orange: Update 00. Washington, DC: The National Academies Press. NRC. 2003. A review of the dose reconstruction program of the Defense Threat Reduction Agency. Washington, DC: The National Academies Press. IOM. 2004. Gulf War and health: Updated literature review of sarin. Washington, DC: The National Academies Press IOM. 2004. Veterans and Agent Orange: Length of presumptive period for association between exposure and respiratory cancer. Washington, DC: The National Academies Press. NRC. 2004. Review of the Army’s technical guides on assessing and managing chemical hazards to deployed personnel. Washington, DC: The National Academies Press. IOM. 2005. Gulf War and health, volume : Fuels, combustion products, and propellants. Washington, DC: The National Academies Press.

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1 CASE STUDIES SUMMARY CHAPTER IOM. 2005. Veterans and Agent Orange: Update 00. Washington, DC: The National Academies Press. NRC. 2005. Assessment of the scientific information for the Radiation Exposure Screening and Education Program. Washington, DC: The National Academies Press. IOM. 2006. Amyotrophic lateral sclerosis in veterans: Review of scientific literature. Wash- ington, DC: The National Academies Press. IOM. 2006. Disposition of the Air Force Health Study. Washington, DC: The National Academies Press. IOM. 2006. Gulf War and health, volume : Health effects of serving in the Gulf War. Wash- ington: The National Academies Press. IOM. 2006. Gulf War and health, volume : Infectious diseases. Washington, DC: The National Academies Press. NRC. 2006. Health risks from exposure to low levels of ionizing radiation: BEIR VII Phase . Washington, DC: The National Academies Press. IOM. 2006. Posttraumatic stress disorder: Diagnosis and assessment. Washington, DC: The National Academies Press. NRC. 2006. Toxicity testing for assessment of environmental agents interim report. Wash- ington, DC: The National Academies Press. ANNEX 5-3 The VA provided the Committee with the following cost estimates (in chronological order): VA (Department of Veterans Affairs). 1988. Cost estimate of Agent Orange legislation: Non- Hodgkin’s lymphoma. Washington, DC: VA. VA. 1996. Cost estimate for regulation on claims based on exposure to herbicides: Estimated benefit and administrative costs. Adding prostate cancer and peripheral neuropathy to list of diseases for which VA will provide presumptive service connection based on herbicide exposure. Washington, DC: VA. VA. 1996. Memorandum: Costing for regulation on claims based on exposure to herbicides. Washington, DC: VA. VA. 1999. Costing of H.R. 60: Adding bronchiolo-alveolar carcinoma to list of diseases pre- sumed service connected for certain radiation-exposed veterans. Washington, DC: VA. VA. 2000. Costing of regulation RIN 00-AK6: Disease associated with exposure to certain herbicide agents: Type  diabetes. Washington, DC: VA. VA. 2001. Costing of regulation RIN 00-AK: Presumption of service connection for cirrhosis of the liver in former prisoners of war. Washington, DC: VA. VA. 2003. Costing of RIN 00-AL: To establish a presumption of service connection for chronic lymphocytic leukemia (CLL). Washington, DC: VA. VA. 2004. Costing of RIN 00-AM0: Additional presumptions for former POWs. Wash- ington, DC: VA.