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Improving the Presumptive Disability Decision-Making Process for Veterans (2008)

Chapter: 5 Case Studies Summary Chapter

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Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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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.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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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, legislative 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 chapter, 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.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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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 scientific 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 consequence 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 veterans 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 classification 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 depression. 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 considerations 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.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 presumption 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 illnesses 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 acknowledges that the etiology of MS is unclear and may be related to an environmental exposure received during military service. Understanding that both of these arguments have been used in the MS case is important, because the

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 association 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 discussion 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 captured 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 suggesting connections of the POW experience with certain diseases and conditions 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 established administrative standards for any new POW presumptions based on “limited/suggestive evidence” of an association of the disease with internment 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

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

country. The extensive system of veteran benefits and their liberalized rules for qualification are a manifestation of this concern. This concern is intensified 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 simplify 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. Presumptions 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 provided 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 uncertainties 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

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 presumptive 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 several 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 legislative 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.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 evidence 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 carried 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

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 probability 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 compensating particular veterans as their exposures are poorly estimated, disease outcomes lack specificity of cause, and for some rare cancers causation remains to be established. These uncertainties in large part appear responsible 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 radiation. 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-

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 epidemiologic 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 responsible risk factors, and cases caused by radiation cannot be distinguished from those caused by other factors. Additionally, for most radiation exposures 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 government 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 establish 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

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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. Foremost 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 precedence 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)

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

report (GAO, 2006a), the health of our veterans must be considered in relation to all aspects of military service. The presidential task force specifically cited the lack of exposure data to a known environmental hazard as a root cause for not being able to determine compensatory issues for our veterans (GAO, 2006a,b). While it appears that DoD is addressing the tracking and recording of the Service members’ movements to link with exposure data that have been collected, both of these issues remain concerns for the veteran. Inadequate exposure data are collected, and the ability to vector these data to location and troop movement has limited attribution of disease to exposure agents for individual veterans. Exposure assessment is the key to disability benefits for veterans. A recent report (GAO, 2004) indicates that force health protection and surveillance policy are not as good as they could be, but are improving, especially with more current deployments.

The final rule for mustard gas and lewisite (VA, 1994b), based upon the 1993 IOM report, outlined three categories of casual relationships for health consequences of exposure: indicated, suggested, and insufficient evidence of a relationship. VA acknowledged in the final rule that certain health consequences could be linked directly to mustard gas or lewisite exposure and that a second grouping of health consequences had a suggestive linkage based upon the 1993 IOM report. Although the IOM report recommended many diseases that could be associated with exposure to these agents, VA specifically eliminated several of the diseases as not being related to mustard gas or lewisite exposure. Consequently, a precedent was established by VA for causal health consequences associated with specific chemical agents as recommended by IOM. Lastly, this case study indicates an apparent lack of communication and coordination between DoD and VA regarding individual Service members and government workers involved in studies, chemical agents used in these studies, and any actual or potential exposure data for the individuals involved. This lack of coordination was emphatically pointed out in the 1993 report Veterans at Risk (IOM, 1993).

GULF WAR PRESUMPTIONS

Description

While the Gulf War presumption process was heavily influenced by the Agent Orange presumptive history, the course of the Gulf War process was different from that of its predecessor. The lengthy Agent Orange process was a culmination of interactions between veterans and their advocates, Congress, the scientific community, the work of the IOM committees, and VA. However, when Congress established the initial Gulf War presumption termed “undiagnosed illnesses,” two of the aforementioned four groups—

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

the scientific community and VA—were not involved in the decision-making process. This initial presumptive provision for “undiagnosed illnesses” by Congress was based on symptom complaints of returning Gulf War veterans and was not related to single organ systems or easily explained by a unifying exposure or mechanism. Rather, nonspecific signs and symptoms were grouped under the “undiagnosed illnesses” category for disability compensation. VA was directed by Congress to administer the program.

After the first two provisions of the Gulf War presumptions had been enacted (unexplained illnesses and chronic multisymptom illness) by Congress, Congress instructed VA to commission a scientific review examining the candidate exposures in the Gulf theater that may have contributed to the health effects experienced by veterans. These reviews were performed by IOM committees and reported in a five-volume series titled Gulf War and Health (IOM, 2000a, 2003a, 2005a, 2006, 2007). The reviews found limited evidence of linkages between veterans’ health and specific environmental exposures during deployment. The majority of the scientific findings from the IOM Gulf War committees and subsequent decisions by the VA Secretary to presumptively service connect or not service connect have not yet appeared in the Federal Register as required by statute, and VA has not yet presumptively connected any health conditions with Gulf War service.

Lessons Learned

Compensation presumptions mandated by Congress in the absence of certain scientific evidence that link Gulf War service to adverse health outcomes, while well intentioned, may have contributed to confusion and suspicion around the presumptive process. In addressing health problems in Gulf War veterans, Congress and VA faced the difficulty of providing compensation for a syndromic illness that had not been linked to specific exposures. Two approaches were followed. The earlier decision (1995), to make “presumptive” a list of conditions, signs, or symptoms clustered under the rubric of “undiagnosed illnesses” allowed medical care and other benefits to be provided to affected veterans by VA. The second approach departed from the initial symptom-based presumption model, and a 1998 act mandated as “presumptive” any additional conditions or symptoms that could be linked to “a biological, chemical, or other toxic agent, environmental or wartime hazard or preventive medicine or vaccine,” extending the possible list of potential illnesses considered presumptively linked to service in the Gulf (Persian Gulf War Veterans Act of 1998. Public Law 105-277. 105th Cong., 2d Sess. § 1602). Thus, the presumptive process for Gulf War Illnesses may have been driven by public expectations and pressure on Congress and VA to act more quickly than either Congress or VA had acted with regard to Agent Orange decisions. It was clear that Congress

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

did not want to wait very long to provide assistance to Gulf War veterans following the experience they had in establishing the Agent Orange Act.

In a politically charged and time-pressured context, decisions about qualification for the initial Gulf War presumption needed to be made, even though the base of scientific evidence was incomplete. Additionally, since Gulf War Illness comprised a symptom complex without any specific diagnostic features, a presumption was established largely in response to reports of numerous individual veterans with inexplicable symptomatology, whose health had deteriorated. Congress made a decision to accept the veteran’s self-reported symptom complaints as sufficient evidence and validation of a Gulf War service-connected illness. Congress then directed VA, through legislation, to provide service-connected benefits to veterans with qualifying health complaints.

Little consideration has been given to estimating exposures received by individual veterans and the levels of exposures, or to the potential for using such estimates, based on specific locations in theater, job title, or specific duties, in determining eligibility for a service-connected Gulf War condition. There has been a broad assumption of exposure to harmful agents that are associated with Gulf War Illness, even though the responsible exposures were uncertain. In this example, Congress directed VA to choose to include all possible claims, permitting high sensitivity (including all possible cases), but poor specificity (high false positive claims). These initial policies came from Congress and were implemented by VA with little scientific review.

In subsequent decisions related to the Gulf War, VA has engaged IOM in producing reports that VA considers in the presumptive disability decision-making process. VA has asked IOM to examine adverse health effects rather than the existing “undiagnosed illness” or “chronic diseases” provisions established by Congress with relation to Gulf War service. These reviews have been the basis for subsequent decision making by VA, which has not yet established any presumptions for the Gulf War.

A lack of exposure information has hindered evidence-based decision making. Information for retrospectively estimating troop exposures during military service has been limited by gaps in exposure information, a limitation receiving comment by IOM committees and other groups addressing service-connected disability determinations (IOM, 2000a, 2003a, 2005a). There are obvious barriers to collecting such information, including the complexity of doing so during wartime deployments. On the other hand, there has been increasing understanding of the need for exposure assessment as an element of force health protection and readiness (DoD, 1997, 2006).

This case study also points to the potential for decision making without having a sufficient evidence base to lead to unintended, adverse consequences, including erosion of public trust and confidence in the decision-

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

making process. The Committee viewed the legislated presumption for Gulf War Unexplained Illness as having some negative consequences. The decision was not evidence-based and it gave credence to the existence of a still poorly characterized and poorly investigated illness complex. Absent research, the presumption may have strengthened the belief that some candidate toxicants, or a mixture of environmental hazards known or unknown, existed in the Gulf War theater and were pervasively present at sufficient concentration to affect the thousands of veterans with symptoms of unexplained illness. Despite acknowledging preventable exposures to environmental chemicals in the Gulf War theater, after several IOM inquires into these hazards, none of the IOM committee reports (IOM, 2000a, 2003a, 2005a, 2006, 2007) has endorsed either a unifying candidate toxicant as a cause for unexplained Gulf War illness or a combination of causes as evidence for the presumptions established by Congress.

AGENT ORANGE AND PROSTATE CANCER PRESUMPTION

Description

Prostate cancer is the second most common cause of cancer deaths in U.S. men (SOURCE: http://seer.cancer.gov/csr/1975_2003/results_merged/topic_mor_trends.pdf). Although the focus of extensive research, few specific etiologic factors that explain the occurrence of the disease have been identified, other than a very strong association with age. The observational evidence available on Agent Orange and prostate cancer risk comes from epidemiological studies of herbicide and dioxin exposed groups in the general population and military personnel exposed to Agent Orange in Vietnam (see Table 6-34 in IOM, 2005b, pp. 277-280).

Beginning with the 1994 Agent Orange report, IOM committees consistently found “limited/suggestive” evidence associating prostate cancer with Agent Orange—with the results of one high-quality study indicating a positive and statistically significant association with phenoxy herbicide exposure, along with weaker evidence and less consistent findings from other studies (IOM, 1994, 1996b, 1999, 2001, 2003b, 2005b). In the populations that have been investigated with higher levels of exposure evidence, excess risk of prostate cancer has been found in some studies and not uniformly across these studies (IOM, 1994, 2005b). However, in addition to the dioxin contaminant, the chlorophenoxy herbicide is a potential causative agent. Based in part upon the IOM finding that there was “limited/suggestive” evidence for association, VA established a presumption in 1996 that provides benefits to Vietnam veterans with prostate cancer (VA, 1996).

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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Lessons Learned

In this case study, the Committee focused on the use of the scientific evidence on Agent Orange and prostate cancer in the decision to establish a presumption. The Committee assessed the relationship of the congressional language to the IOM’s criteria for classifying evidence and the use of the IOM’s evidence evaluation for prostate cancer by VA. The Agent Orange Act of 1991 (Public Law 102-4. 102nd Cong., 1st Sess. Section 2[b][3]) states that a positive association is one for which “the credible evidence of the association is equal to or outweighs the credible evidence against the association.” This statement is not necessarily equivalent to the category of “limited/suggestive” evidence for association used by IOM committees. The IOM limited/suggestive category covers a broad range of epidemiological evidence from relatively weak to strongly suggestive. In the instance of Agent Orange and prostate cancer, VA made a presumption based on the IOM’s conclusion of “limited/suggestive” evidence for association; the evidence at the time was relatively limited, but did include one study showing a statistically significant excess and a number of other studies showing positive, but weak and non-significant associations. Because the Committee did not have documentation of the rationale for VA’s decision beyond the Federal Register notice (VA, 1996), the basis for making a presumption given the particular IOM conclusion and scope of evidence was unclear to the Committee.

In reviewing evidence on Agent Orange, the 2005 IOM review considered biological and toxicological evidence when evaluating the biological plausibility of the association between prostate cancer and exposure to Agent Orange but did not integrate these other lines of evidence with epidemiological findings to come up with an overall evaluation (IOM, 2005b). In seeking to classify the strength of evidence, prior IOM committees have relied mostly on epidemiological findings, potentially leaving the resulting presumptions open to criticism for having insufficient scientific justification when viewed in a broader context. Additionally, there has been a relatively limited body of relevant toxicological literature on prostate cancer.

The criterion for reaching “limited/suggestive” evidence for association of Agent Orange used by the IOM is that the “[e]vidence is suggestive of an association between herbicides and the outcome but is limited because chance, bias, and confounding could not be ruled out with confidence. For example, at least one high-quality study shows a positive association, but the results of other studies are inconsistent” (IOM, 2005b, p. 8) The Agent Orange Committee evaluations for prostate cancer considered the totality of epidemiological evidence, but there were limitations of the exposure data available to aid in the evaluation of the studies considered. Previous Agent Orange committees also reviewed and reported on toxicological and mecha-

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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nistic information, but according to their interpretation of their charge, did not integrate this information with the epidemiological evidence to make conclusions about the overall weight of the evidence for causal association. Several studies were of worker groups and measures of exposure to either the chlorophenoxy compounds or dioxin were not available to enable comparisons across studies. Dose-response relationships could be considered for a few studies; for example, the relative risk “of prostate cancer in Ranch Hands correlated with putative exposure to Agent Orange (high 6.04 vs low 2.17 vs background 1.5; p = 0.01)” (IOM, 2005b, p. 282). The lack of accurate estimates of exposure from the military experience has limited the study of the association between prostate cancer and exposure to Agent Orange in veterans.

AGENT ORANGE AND TYPE 2 DIABETES PRESUMPTION

Description

This case study examines the 2001 decision to establish presumptive service connection for type 2 diabetes among Vietnam veterans under the Agent Orange Act (Agent Orange Act of 1991. Public Law 102-4. 102nd Cong., 1st Sess.). This case study was chosen because of several features in the events leading to the presumption and because of the implications of this presumption for VA. First, although most of the Agent Orange presumptions have been the result of the biennial IOM review of the scientific literature, the scientific evaluation that resulted in this presumption was conducted by a special IOM panel commissioned by VA specifically for this topic, out of sequence with the biennial IOM reports (IOM, 2000b). Second, after its review, this special IOM committee determined that the evidence linking Agent Orange and diabetes would justify a change from the previous category of “inadequate/insufficient” to “limited/suggestive.” Third, VA issued a presumption for type 2 diabetes on the basis of this “limited/suggestive” category of evidence, rather than the using the “sufficient evidence” standard. Finally, as a consequence of this presumption, all veterans who served in Vietnam receive compensation for their type 2 diabetes, as well as the associated complications of this morbid, chronic condition. This presumption will continue to have important financial consequences for VA as type 2 diabetes incidence generally increases with advancing age and as national rates of type 2 diabetes continue to rise in all segments of the population, fueled primarily by the high rates of obesity and inactivity.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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Lessons Learned

This case study has several features in common with some of the other case studies. As for radiation and cancer, type 2 diabetes has multiple risk factors, including age, family history, inactivity, and obesity. The extent to which Agent Orange contributes to causation of type 2 diabetes in veterans is uncertain, but likely to be relatively small compared with these other factors.

Some IOM Agent Orange reports have commented on the extent that Agent Orange exposure may contribute to diabetes rates observed among Vietnam veterans:

It must be noted, however, that these studies indicate that the increased risk, if any, from herbicide or dioxin exposure appears to be small. The known predictors of diabetes risk—family history, physical inactivity, and obesity—continue to greatly outweigh any suggested increased risk from wartime exposure to herbicides. (IOM, 2000b, pp. 3, 37)

Recognition of the relative contributions of multiple factors could be important for the identifying and compensating service-attributable type 2 diabetes that develops among aging Vietnam veterans. The IOM Agent Orange committee reports have not attempted to quantify the attributable burden of disease, although such calculations would be useful for decision making, both to understand the potential burden of disease overall and to anticipate decisions about compensation for individual veterans. An additional explicit analysis of service-attributable risk that attempts to quantify the fraction of disease risk attributable to military service might be more useful to VA and Congress when making legislative and administrative decisions based on complex scientific evidence, although it is recognized that conducting such an analysis for this case would be a challenge given the lack of adequate research in this area and the limited data on exposures to herbicides.

Analyses of high-quality data for a representative cohort of veterans could have been informative for determining the existence of an association between exposures during military service and the risk of disease or disability. A well-designed cohort study might have contributed data for evaluating the link between Agent Orange and type 2 diabetes, particularly if the design had included accurate assessments of exposure during service, evaluation of other risk factors that may have been present during service or developed subsequently (e.g., obesity), and longitudinally assessed occurrence of this disease. In fact, the Vietnam Experience Study (VES) provided an opportunity to initiate a cohort study. Continuation of the study as a cohort might have proven informative for diabetes and other potential health consequences of service in Vietnam.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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In evaluating the observational studies, specific and formal methodological protocols did not appear to be used for synthesizing findings of available studies and updating the classification of evidence as the findings of additional studies became available to successive committees. The type 2 diabetes presumption came after the 2000 IOM committee “upgraded” the assessment of the existing evidence from “inadequate/insufficient” to “limited/suggestive” category. Although new studies were considered in this reassessment, no particular study was considered as providing conclusive evidence of association between Agent Orange and type 2 diabetes. Rather, the reclassification reflected the committee’s view of the cumulative weight of the evidence. Having a more detailed evidence review algorithm and classification approach, such as IARC (IARC, 2006), could enhance the consistency of assessment of evidence across different committees.

The case study also points to a lack of transparency in the VA’s process where scientific evidence is applied to legislative and administrative decisions. The type 2 diabetes presumption signaled an important trend on the part of VA to assign presumption on the bases of “limited/suggestive” classification of the levels of evidence, rather than the highest standard of “sufficient” evidence. This decision may have been influenced by a variety of considerations beyond the scientific evidence, i.e., political, economic, and administrative factors. The interplay of these multiple factors and their relative weighting by VA were not described in any of the materials available to the Committee.

SPINA BIFIDA PROGRAM

Description

This case study examines the 1996 and 2003 decisions to grant monetary compensation and health benefits to children of Vietnam and Korean War veterans with spina bifida based on the scientific evidence suggesting an association between herbicide exposure in Vietnam and Korea and spina bifida in the children of exposed veterans. Reproductive health effects were considered by the first IOM veterans and Agent Orange report issued in 1994 (IOM, 1994). The committee concluded that male exposure to toxins could plausibly be linked to adverse developmental consequences in their offspring:

Animal and human data indicate that the exposure of the male to various toxic agents may increase the risk of the full spectrum of adverse developmental endpoints from fetal loss to cancer. (IOM, 1994, p. 595)

But the committee found the evidence to support the link between Agent Orange and a range of birth defects to be “inadequate/insufficient”

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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(IOM, 1994, p. 6). In its response to the IOM report, VA noted that although reproductive effects were considered by the IOM committee, there was no mechanism within the existing VA compensation structure to award benefits to any party other than the veteran; providing compensation to children of veterans with developmental effects attributable to Agent Orange exposure would require additional legislative action (VA, 1994c, p. 346).

Based on new research findings, in the 1996 Agent Orange report, the IOM committee assessed the evidence for the association between Agent Orange and spina bifida as “limited/suggestive” (IOM, 1996b). This reclassification was based on a re-analysis of the Ranch Hand study, in response to a critique in the IOM’s 1994 report. In addition the committee considered three other studies, each of which had potential biases that were different and therefore unlikely to be responsible for demonstrating a consistent pattern of results (IOM, 1996b).

Public Law 104-204 (Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriation Act, 1997. 104th Cong., 2d Sess.) was passed in 1996, authorizing benefits for children born to Vietnam veterans with spina bifida. Additional legislation in 2000 (Veterans Benefits and Health Care Improvement Act of 2000. Public Law 106-419 § 401. 106th Cong., 2d Sess.) established benefits to children of “women Vietnam veterans” with birth defects; this law provided benefits to children of female veterans with a broad range of defects that might be attributable to maternal exposure during Vietnam service (excluding defects that were the result of familial predisposition or the injury suffered at birth). In 2003, these benefits were extended to children of veterans of the Korean War (Veterans Benefits Act of 2003. Public Law 108-103. 108th Cong., 2d Sess.).

Lessons Learned

Apart from the programs established by legislative action described above, there continues to be no overall mechanism for compensating offspring for health consequences attributable to maternal or paternal military service. Toxic exposures that occur during military service have the potential to cause adverse developmental effects, and all of the Agent Orange reports have described the biologically plausible mechanisms for these effects in both exposed female and male veterans. Given VA’s interest in compensating veterans for adverse health effects incurred as a result of military service and the possibility that such effects may extend to the health of veterans’ offspring, the absence of a clear and consistent policy on compensating affected offspring is notable. The need for a clear policy statement will continue to grow as VA considers the health effects of mili-

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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tary service in the large population of reproductive-aged veterans and the growing number of women in the armed services.

Although the public laws providing compensation for particular categories of offspring with birth defects may have been expedient for these affected individuals, the approach of addressing the more general policy gap described above with these programs runs counter to principles of consistency and equity that should inform the approach to presumptions. Any new adverse reproductive consequences of Agent Orange exposure identified in IOM reports would again require legislative action for these specific effects in order for compensation to be granted; the administrative route that has applied to all other Agent Orange presumptions is not available for reproductive consequences of exposure at present.

It should be noted that the evidence standard for the spina bifida presumption was “limited/suggestive,” not the more rigorous “sufficient” standard (IOM, 1996b). The difficulty with using this lesser standard as the basis for presumptions has been described in other case studies related to Agent Orange and type 2 diabetes and prostate cancer.

SYNTHESIS

These case studies offer a diverse set of lessons learned and indicate elements of the current presumptive disability decision-making process for veterans that need to be addressed moving forward. The case studies show that the process has acted to serve the interests of veterans in many instances. Overall, Congress and VA have repeatedly acted to maximize the sensitivity of presumptive decisions so as to ensure that specific groups of veterans are compensated. The particular interest in caring for veterans who have experienced the hardship of being a POW, for example, has led to a range of presumptions that apply to POWs. However, in maximizing the sensitivity of presumptive decision making for particular groups of veterans, substantial numbers of false positives may have resulted, as in the examples of Agent Orange and the Gulf War. Additionally, because no systematic process for approaching presumptive decision making exists, important omissions in this coverage remain without a clear mechanism for expanding coverage, as with potential reproductive health consequences of military service for the offspring of those who serve.

The case studies illustrate the use of presumptions to cover gaps in evidence, gaps that exist in part because of lack of information on exposures received by military personnel and inadequate surveillance of veterans for the occurrence of service-related illnesses. Secrecy is a particularly troubling source of incomplete information, as illustrated by the veterans who participated in studies of mustard gas and lewisite. Research has been carried out on the health of veterans, leading to the decision, for example, on cardio-

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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vascular disease in amputees. But the research has not been systematic, and in the example of cardiovascular disease in amputees, further evidence relative to a presumption made in 1979 has not been collected. Research on radiation risks in veterans has been severely constrained by a lack of dose information, and the resulting studies have not been informative. A lack of exposure information has hindered research on other agents as well and led to a sweeping exposure presumption with regard to exposure to Agent Orange in Vietnam.

Across the case studies, the Committee believes that prior efforts did not optimally synthesize all of the evidence on the health consequences of military service. In some cases there has not been an independent body that reviews the scientific evidence and updates the medical knowledge and scientific evidence relevant for a specific presumptive decision over time. As a consequence, some presumptions appear inconsistent (as with the psychiatric illnesses) or even aberrant (as with multiple sclerosis) in the face of contemporary medical and scientific knowledge. In other cases where an independent body has reviewed the scientific evidence, the synthesis of the evidence has not always been optimally comprehensive and standardized. The inferential target in IOM reports has shifted between causation (e.g., mustard gas and lewisite, Gulf War) and association (e.g., Agent Orange), and the more recent IOM Agent Orange reports have emphasized findings of observational studies without full attention to other lines of evidence. In the Agent Orange case studies the category “limited/suggestive” for association has been used when the epidemiological evidence base was fairly weak, including only one study with statistically significant findings. In the case of type 2 diabetes, at the time of the Agent Orange and diabetes report, there were multiple studies that were all substantially limited by bias or confounding. The categorization of the evidence as “limited/suggestive” by IOM has led to presumptions on the part of VA that appear to be irreversible once made, even though scientific evidence is dynamic. Stated in another way, even if further scientific evidence were unsupportive of previous research findings and a future IOM committee were to change its classification for strength of evidence, VA may not change its presumption. The Committee notes that presumptive decisions have been made to compensate health outcomes (e.g., type 2 diabetes, prostate cancer), based on evidence characterized by IOM committees as limited/suggestive for association, well below the evidence level needed to establish causation, absent strong mechanistic understanding.

The case studies document the particular problem that arises with regard to presumptions related to common, chronic diseases with multiple causes, such as type 2 diabetes, prostate cancer, and cardiovascular disease. In seeking high sensitivity for presumptions in general, specificity is sacrificed, and the resulting number of false positives may be particularly

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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large for common conditions with multiple etiologies. These false positives are associated with large attendant costs, both financial and non-financial. Determining the degree to which the onset of a common disease with multiple etiologies may be attributable to prior military service may be particularly useful for presumptions related to such conditions, but neither the IOM committees nor VA have given full consideration to whether the attributable fraction should be estimated for veterans. Later chapters of this report discuss how the attributable fraction might be estimated for veterans, and how such estimates would benefit VA in its presumptive disability decision-making process.

In the case studies, the Committee’s analyses were based on the very general information provided by VA about its internal decision-making processes. The case studies did make clear, however, that these processes are neither fully transparent nor consistent. This was further implied by VA’s decision to withhold task force documents from the Committee’s review, considering them pre-decisional in nature. VA believes that access to predecisional documents by outside sources would stifle candid staff opinions on issues. Once IOM carries out its reviews and provides VA with reports documenting the extent of evidence available on associations, the internal processes that follow are not fully open to scrutiny. This practice could degrade the trust of veterans in the presumptive disability decision-making process and may hinder efforts to optimize the use of scientific evidence.

In its proposed approach for future decision making, the Committee offers recommendations that address the strengths and challenges highlighted by the case studies.

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VA. 1994b. Claims based on chronic effects of exposure to mustard gas or lewisite. Final Rule. Federal Register 59(159):42497-42500.

VA. 1994c. Disease not associated with exposure to certain herbicide agents. Notice. Federal Register 59(2):341-346.

VA. 1996. Diseases associated with exposure to certain herbicide agents (prostate cancer and acute and subacute peripheral neuropathy). Final rule. Federal Register 61(217):57586-57589.

VA. 2002. Possible occupational health exposures of veterans involved in Project Shad tests. Veterans Health Administration and Under Secretary for Health information letter IL10-2002-016. Washington, DC: Department of Veterans Affairs. http://www1.va.gov/shad/docs/IL_10-2002-016.pdf (accessed February 28, 2007).

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

VA. 2004. Presumptions of service connection for diseases associated with service involving detention or internment as a prisoner of war. Interim final rule. Federal Register 69(194):60083-60090.

VA. 2005. Health effects among veterans exposed to mustard and lewisite chemical warfare agents. Under Secretary for Health Information letter IL 10-2005-004. www.va.gov/environagents/docs/USHInfoLetterIL10-2005-004_March _14_2005.pfd (accessed February 27, 2007).

VA. 2006. Potential health effects among veterans involved in military chemical warfare agent experiments conducted from 1955 to 1975. Under Secretary for Health information letter IL 10-2006-010. Washington, DC: Department of Veterans Affairs. http://www1.va.gov/environagents/docs/USHInfoLetterIL10-2006-010.pdf (accessed February 28, 2007).

VA Multiple Sclerosis Study Group. 1956. Isoniazid in the treatment of multiple sclerosis: Report on VA Cooperative Study. Transactions of the American Neurological Association (81st meeting):128–131.

VA Multiple Sclerosis Study Group. 1957. Isoniazid in the treatment of multiple sclerosis: Report on Veterans Administration Cooperative Study. Journal of the American Medical Association 163(3):168-172.

Wallin, M. T., W. F. Page, and J. F. Kurtzke. 2000. Epidemiology of multiple sclerosis in U.S. veterans: 8. Long-term survival after onset of multiple sclerosis. Brain 123(Pt. 8):1677-1687.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

ANNEX 5-1
Legislative Documents Referenced for Case Studies

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

Mental Health

Veterans’ Bureau Act of 1921

PL 67-47

42 STAT. 147, 153

 

 

 

Pensions, Bonuses, and Veteran’s Relief (1949)

14 FR 571

38 CFR Part 3 Former 39 CFR 3.80, 3.86

World War Veterans’ Act, 1924

PL 68-242

43 STAT. 607, 615

 

 

 

Veterans, disability compensation, increase (1970)

PL 91-376

84 STAT. 787, 788

PL 91-376

HR 91-1166

SR 91-784

SR 91-785

Pensions, Bonuses, and Veterans’ Relief (1970)

35 FR 18280

38 CFR Part 3

Veterans Benefits; Former Prisoners of War (1981)

46 FR 57571

 

Former Prisoner of War Benefits Act of 1981

PL 97-37

95 STAT. 935, 936

PL 97-37

HR 97-28

SR 97-88

Veterans Benefits; Former Prisoners of War (1982) (final regulations)

47 FR 11655

38 CFR Part 3

Veterans’ Compensation and Program Improvements Amendments of 1984

PL 98-223

98 STAT. 37, 40

PL 98-223

HR 98-228

HR 98-425

SR 98-249

Direct Service Connection (Post-traumatic stress disorder) (1992) (proposed rule)

57 FR 34536

 

Veterans Benefits Act of 2003

PL 108-183

117 STAT. 2651

PL 108-183

HR 108-211

SR 107-86

SR 108-169

Direct Service Connection (Post-traumatic stress disorder) (1993) (final rule)

58 FR 29109

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

 

Compensation for Certain Undiagnosed Illnesses (1994) (proposed rule)

59 FR 63283

38 CFR Part 3

 

Compensation for Certain Undiagnosed Illnesses (1995) (final rule)

60 FR 6660

38 CFR Part 3

Multiple Sclerosis

Pensions, Bonuses, and Veterans’ Relief (1949)

14 FR 571

38 CFR 3.86

Pensions, Bonuses, and Veterans’ Relief (1970)

35 FR 18280

38 CFR 3.307, 3.309

Compensation and Pension Provisions of the Veterans Education and Benefits Expansion Act of 2001 (2003) (final rule)

68 FR 34539

38 CFR Parts 3 and 13

Presumptions relating to certain diseases and disabilities (2006) (38 USC § 1112)

 

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

Prisoners of War

Veterans, disability compensation, increase (1970)

PL 91-376

84 STAT. 787

PL 91-376

HR 91-1166

SR 91-784

SR 91-785

 

 

 

Former Prisoner of War Benefits Act of 1981

PL 97-37

95 STAT. 935

PL 97-37

HR 97-28

SR 97-88

 

 

 

Veterans’ Compensation and Program Improvements Amendments of 1984

PL 98-223

98 STAT. 37

PL 98-223

HR 98-228

HR 98-425

SR 98-249

 

 

 

Veterans’ Benefits Improvement and Health-Care Authorization Act of 1986

PL 99-576

100 STAT. 3248

PL 99-576

HR 99-728

HR 99-729

SR 99-494

SR 99-200

SR 99-444

 

 

 

Veterans’ Benefits and Services Act of 1988

PL 100-322

102 STAT. 487

PL 100-322

HR 100-191

HR 100-236

HR 100-578

SR 100-15

SR 100-215

 

 

 

Veterans Benefits Act of 2003

PL 108-183

117 STAT. 2651

PL 108-183

HR 108-211

SR 107-86

SR 108-169

 

 

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Amputees and Cardiovascular Disease

Veterans Disability Compensation and Survivor Benefit Act of 1976

PL 94-433

90 STAT. 1374

PL 94-433

HR 94-1270

SR 94-1226

Pension, Compensation, and Dependency and Indemnity Compensation, Proximate Results, Secondary Conditions (1979) (final regulations)

44 FR 50339

38 CFR Part 3

Radiation

Veterans’ Dioxin and Radiation Exposure Compensation Standards Act of 1984

PL 98-542

98 STAT. 2725

PL 98-542

HR 98-592

HR 98-828

SR 97-89

Guidance for the Determination and Reporting of Nuclear Radiation Dose for DoD

47 FR 21853

32 CFR Ch. 1

Radiation-Exposed Veterans Compensation Act of 1988

PL 100-321

102 STAT. 485

PL 100-321

HR 98-592

HR 100-235

SR 100-215

Participants in the Atmospheric Nuclear Test Program (1945-1962) (1982)

 

 

Radiation Exposure Compensation Act of 1990

PL 101-426

104 STAT. 920

PL 101-426

HR 101-463

SR 101-264

Guidance for the Determination and Reporting of Nuclear Radiation Dose for DoD

48 FR 10645

32 CFR Part 218

Veterans’ Benefits Programs Improvement Act of 1991

PL 102-86

105 STAT. 414

PL 102-86

HR 101-857

HR 102-130

SR 101-379

SR 102-139

Participants in the Atmospheric Nuclear Test Program (1945-1962) (1983) (final rule)

 

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

Veterans’ Radiation Exposure Amendments of 1992

PL 102-578

106 STAT. 4774

PL 102-578

HR 102-757

SR 101-379

SR 102-139

Guidance for the Determination and Reporting of Nuclear Radiation Dose for DoD

50 FR 19538

32 CFR Part 218

Veterans’ Benefits Improvements Act of 1994

PL 103-446

108 STAT. 4645

PL 103-446

HR 103-538

HR 103-668

HR 103-669

SR 103-280

SR 103-385

SR 103-386

Participants in the Atmospheric Nuclear Test Program (1945-1962) (1985) (proposed amendment of final rule)

 

 

Radiation Exposure Compensation Act Amendments of 2000

PL 106-245

114 STAT. 501

PL 106-245

HR 106-697

 

Veterans Benefit Improvements Act of 2004

PL 108-454

118 STAT. 3598

PL 108-454

HR 108-211

HR 108-572

SR 106-397

SR 108-169

Adjudication of Claims Based on Exposure to Dioxin or Ionizing Radiation (1985) (final rules)

50 FR 34452

38 CFR Parts 1 and 2

 

 

 

 

 

Claims Based on Exposure to Ionizing Radiation (1989) (final regulations)

54 FR 42802

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Claims Based on Exposure to Ionizing Radiation (1992) (proposed rule)

57 FR 10449

38 CFR Part 3

Claims Based on Exposure to Ionizing Radiation (Parathyroid Adenoma) (1992) (proposed rule)

57 FR 10853

38 CFR Part 3

Radiation Exposure Compensation Act of 1990 (1992) (proposed rule)

57 FR 40424

38 CFR Part 3

Claims Based on Exposure to Ionizing Radiation (1993) (final rule)

58 FR 16358

38 CFR Part 3

Radiation Exposure Compensation Act of 1990 (1993) (final rule)

58 FR 25564

38 CFR Part 3

Claims Based on Exposure to Ionizing Radiation (1994) (proposed rule)

59 FR 6607

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Claims Based on Exposure to Ionizing Radiation (1994) (final rule)

59 FR 45975

38 CFR Part 3

 

 

 

 

 

Claims Based on Exposure to Ionizing Radiation (Radiogenic Diseases) (1995) (final rule)

60 FR 9627

38 CFR Part 3

 

 

 

 

 

Claims Based on Exposure to Ionizing Radiation (Lymphomas other than Hodgkin’s Disease and Cancer of the Rectum) (1995) (final rule)

60 FR 53276

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Claims Based on Exposure to Ionizing Radiation (Prostate Cancer and Any Other Cancer) (1996) (proposed rule)

61 FR 50264

38 CFR Part 3

Claims Based on Exposure to Ionizing Radiation (Prostate Cancer and Any Other Cancer) (1998) (final rule)

63 FR 50993

38 CFR Part 3

The Veterans Millennium Health Care and Benefits Act (2000) (final rule)

65 FR 43699

38 CFR Part 3

Diseases Specific to Radiation-Exposed Veterans (2001) (proposed rule)

66 FR 41483

38 CFR Part 3

Diseases Specific to Radiation-Exposed Veterans (2002) (final rule)

67 FR 3612

38 CFR Part 3

Claims Based on Exposure to Ionizing Radiation (2002) (final rule)

67 FR 6870

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

Mustard Gas/Lewisite

 

 

 

 

 

Claims Based on Chronic Effects of Exposure to Mustard Gas (1992) (proposed rule)

57 FR 1699

38 CFR Part 3

 

 

 

 

 

Claims Based on Chronic Effects of Exposure to Mustard Gas (1992) (final rule)

57 FR 33875

38 CFR Part 3

 

 

 

 

 

Claims Based on Chronic Effects of Exposure to Vesicant Agents (1994) (proposed rule)

59 FR 3532

38 CFR 3.307(b)

 

 

 

 

 

Claims Based on Chronic Effects of Exposure to Mustard Gas or Lewisite (1994) (final rule)

59 FR 42497

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Gulf War

Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999

PL 105-277

112 STAT. 2681

PL 105-277

HR 105-626

SR 105-362

Compensation for Certain Undiagnosed Illnesses (1994) (proposed rule)

59 FR 63283

38 CFR Part 3

Veterans Education and Benefits Expansion Act of 2001

PL 107-103

115 STAT. 976

PL 107-103

HR 107-156

SR 107-86

SR 106-122

Compensation for Certain Undiagnosed Illnesses (1995) (final rule)

60 FR 6660

38 CFR Part 3

 

 

 

 

 

Compensation for Certain Undiagnosed Illnesses (1997) (interim rule)

62 FR 23138

38 CFR Part 3

 

 

 

 

 

Compensation for Certain Undiagnosed Illnesses (1998) (final rule)

63 FR 11122

38 CFR Part 3

 

 

 

 

 

Illnesses Not Associated with Service in the Gulf during the Gulf War (2001) (notice)

66 FR 35702

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Extension of the Presumptive Period for Compensation for Gulf War Veterans’ Undiagnosed Illnesses (2001) (interim final rule)

66 FR 56614

38 CFR Part 3

 

 

 

 

 

Extension of the Presumptive Period for Compensation for Gulf War Veterans’ Undiagnosed Illnesses (2002) (final rule)

67 FR 78979

38 CFR Part 3

 

 

 

 

 

Compensation and Pension Provisions of the Veterans Education and Benefits Expansion Act of 2001 (2003) (final rule)

68 FR 34539

38 CFR Parts 3 and 13

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Agent Orange and Prostate Cancer

Veterans’ Dioxin and Radiation Exposure Compensation Standards Act of 1984

PL 98-542 98

STAT. 2725

PL 98-542

HR 98-592

HR 98-828

SR 97-89

Adjudication of Claims based on Exposure to Dioxin or Ionizing Radiation (1985) (final rules)

50 FR 34452

38 CFR Parts 1 and 3

Agent Orange Act of 1991

PL 102-4

105 STAT. 11

PL 102-4

HR 101-672

HR 101-857

SR 100-215

SR 100-439

SR 101-82

SR 101-379

Claims Based on Service in Vietnam (1990) (proposed regulations)

55 FR 25339

38 CFR Parts 3 and 4

Veterans’ Benefits Improvements Act of 1994

PL 103-446

108 STAT. 4645

PL 103-446

HR 103-538

HR 103-668

HR 103-669

SR 103-280

SR 103-385

SR 103-386

Claims Based on Service in Vietnam (1990) (final regulations)

55 FR 43123

38 CFR Parts 3 and 4

Veterans’ Benefits Improvements Act of 1996

PL 104-275

110 STAT. 3322

PL 104-275

HR 104-649

SR 99-101

SR 100-439

SR 104-371

Claims Based on Exposure to Herbicides Containing Dioxin (Soft-Tissue Sarcomas) (1991) (proposed regulations)

56 FR 7632

38 CFR Parts 3 and 4

 

 

 

 

 

Claims Based on Exposure to Herbicides Containing Dioxin (Soft-Tissue Sarcomas) (1991) (final regulation)

56 FR 51651

38 CFR Parts 3 and 4

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Claims Based on Exposure to Herbicides Containing Dioxin (Peripheral Neuropathy/Lung Cancer) (1992) (proposed rule)

57 FR 2236

38 CFR Part 3

 

 

 

 

 

Diseases Associated with Service in the Republic of Vietnam (1992) (proposed rule)

57 FR 30707

38 CFR Part 3

 

 

 

 

 

Diseases Associated with Service in the Republic of Vietnam (1993) (final rule)

58 FR 29107

38 CFR 3.309(e)

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents (1993) (proposed rule)

58 FR 50528

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Diseases Not Associated with Exposure to Certain Herbicide Agents (1994) (notice)

59 FR 341

 

Disease Associated with Exposure to Certain Herbicide Agents (1994) (final rule)

59 FR 5106

38 CFR Part 3

Disease Associated with Exposure to Certain Herbicide Agents (Multiple Myeloma and Respiratory Cancers) (1994) (proposed rule)

59 FR 5161

38 CFR Part 3

Disease Associated with Exposure to Certain Herbicide Agents (Multiple Myeloma and Respiratory cancers) (1994) (final rule)

59 FR 29723

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Diseases Associated with Exposure to Certain Herbicide Agents (Prostate Cancer and Acute and Subacute Peripheral Neuropathy) (1996) (proposed rule)

61 FR 41368

38 CFR Part 3

 

 

 

 

 

Disease Not Associated with Exposure to Certain Herbicide Agents (1996) (notice)

61 FR 41442

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Diseases Associated with Exposure to Certain Herbicide Agents (Prostate Cancer and Acute and Subacute Peripheral Neuropathy) (1996) (final rule)

61 FR 57586

CFR Part 3

Veterans’ Benefits Improvements Act of 1996 (1997) (final rule)

62 FR 35421

38 CFR Part 3

Diseases Not Associated with Exposure to Certain Herbicide Agents (1999) (notice)

64 FR 59232

 

Diseases Not Associated with Exposure to Certain Herbicide Agents (2002) (notice)

67 FR 4 2600

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (proposed rule)

68 FR 14567

38 CFR Part 3

 

 

 

 

 

Compensation and Pension Provisions of the Veterans Education and Benefits Expansion Act of 2001 (2003) (final rule)

68 FR 34539

38 CFR Parts 3 and 13

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (final rule)

68 FR 59540

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Agent Orange and Type 2 Diabetes

Veterans’ Dioxin and Radiation Exposure Compensation Standards Act of 1984

PL 98-542

98 STAT. 2725

PL 98-542

HR 98-592

HR 98-828

SR 97-89

Adjudication of Claims based on Exposure to Dioxin or Ionizing Radiation (1985) (final rules)

50 FR 34452

38 CFR Parts 1 and 3

Agent Orange Act of 1991

PL 102-4

105 STAT. 11

PL 102-4

HR 101-672

HR 101-857

SR 100-215

SR 100-439

SR 101-82

SR 101-379

Claims based on Service in Vietnam (1990) (proposed regulation)

55 FR 25339

38 Parts 3 and 4

Veterans’ Benefits Improvements Act of 1994

PL 103-446

108 STAT.4645

PL 103-446

HR 103-538

HR 103-668

HR 103-669

SR 103-280

SR 103-385

SR 103-386

Claims based on Service in Vietnam (1990) (final regulation)

55 FR 43123

38 Parts 3 and 4

Veterans’ Benefits Improvements Act of 1996

PL 104-275

110 STAT. 3322

PL 104-275

HR 104-649

SR 99-101

SR 100-439

SR 104-371

Claims Based on Exposure to Herbicides Containing Dioxin (Soft Tissue Sarcomas) (1991) (proposed regulation)

56 FR 7632

38 Parts 3 and 4

Veterans Education and Benefits Expansion Act of 2001

PL 107-103

115 STAT. 976

PL 107-103

HR 107-156

SR 107-86

SR 106-122

 

 

 

 

 

Claims Based on Exposure to Herbicides Containing Dioxin (Soft Tissue Sarcomas) (1991) (final regulation)

56 FR 51651

38 Parts 3 and 4

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Claims Based on Exposure to Herbicides containing Dioxin (Peripheral Neuropathy/Lung Cancer) (1992) (proposed rule)

57 FR 2236

38 CFR Part 3

 

 

 

 

 

Diseases Associated with Service in the Republic of Vietnam (1992) (proposed rule)

57 FR 30707

38 CFR Part 3

 

 

 

 

 

Diseases Associated with Service in the Republic of Vietnam (1993) (final rule)

58 FR 29107

38 CFR 3.309(e)

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents (1993) (proposed rule)

58 FR 50528

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Disease Associated with Exposure to Certain Herbicide Agents (1994) (final rule)

59 FR 5106

38 CFR Part 3

Disease Associated with Exposure to Certain Herbicide Agents (Multiple Myeloma and Respiratory Cancers) (1994) (final rule)

59 FR 29723

38 CFR Part 3

Veterans’ Benefits Improvements Act of 1996 (1997) (final rule)

62 FR 35421

38 CFR Part 3

Diseases Not Associated with Exposure to Certain Herbicide Agents (1999) (notice)

64 FR 59232

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

 

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents: Type 2 Diabetes (2001) (proposed rule)

66 FR 2376

38 CFR Part 3

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents: Type 2 Diabetes (2001) (final rule)

66 FR 23166

38 CFR Part 3

 

 

 

 

 

Disease Associated with Exposure to Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (proposed rule)

68 FR 14567

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Compensation and Pension Provisions of the Veterans Education and Benefits Expansion Act of 2001 (2003) (final rule)

68 FR 34539

38 CFR Parts 3 and 13

Disease Associated with Exposure to Certain Herbicide Agents: Chronic Lymphocytic Leukemia (2003) (final rule)

68 FR 59540

38 CFR Part 3

Change of Effective Date of Rule Adding a Disease Associated with Exposure to Certain Herbicide Agents: Type 2 Diabetes (2004) (final rule)

69 FR 31882

38 CFR Part 3

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

Case Study

CONGRESS

EXECUTIVE BRANCH (DEPARTMENT OF VETERANS AFFAIRS)

Public Law Name

Public Law Statute

CIS Index

House Report

Senate Report

Rule Name

Federal Register

Code of Federal Regulations

Spina Bifida

 

 

 

 

 

Disease Not Associated with Exposure to Certain Herbicide Agents (1994) (notice)

59 FR 341

 

 

 

 

 

 

Disease Not Associated with Exposure to Certain Herbicide Agents (1996) (notice)

61 FR 41442

 

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

ANNEX 5-2

The following National Academies’ reports were evaluated by committee 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 exposure 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: Cholinesterase 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. Washington, DC: National Academy Press.

NRC. 1990. Health effects of exposure to low levels of ionizing radiation: BEIR V. Washington, DC: National Academy Press.

IOM (Institute of Medicine). 1991. Epidemiology in military and veteran populations: Proceedings of the Second Biennial Conference, March 7, 1990. 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. Washington, 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. Washington, 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 1996. 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.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

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 Academy 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 1998. 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 1985 radioepidemiological tables. Washington, DC: National Academy Press.

IOM. 2000. Veterans and Agent Orange: Herbicide/dioxin exposure and type 2 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 2000. 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 2: Insecticide and solvents. Washington, DC: The National Academies Press.

IOM. 2003. Veterans and Agent Orange: Update 2002. 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 3: Fuels, combustion products, and propellants. Washington, DC: The National Academies Press.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
×

IOM. 2005. Veterans and Agent Orange: Update 2004. 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. Washington, 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 4: Health effects of serving in the Gulf War. Washington: The National Academies Press.

IOM. 2006. Gulf War and health, volume 5: Infectious diseases. Washington, DC: The National Academies Press.

NRC. 2006. Health risks from exposure to low levels of ionizing radiation: BEIR VII Phase 2. 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. Washington, 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. 690: Adding bronchiolo-alveolar carcinoma to list of diseases presumed service connected for certain radiation-exposed veterans. Washington, DC: VA.

VA. 2000. Costing of regulation RIN 2900-AK63: Disease associated with exposure to certain herbicide agents: Type 2 diabetes. Washington, DC: VA.

VA. 2001. Costing of regulation RIN 2900-AK83: Presumption of service connection for cirrhosis of the liver in former prisoners of war. Washington, DC: VA.

VA. 2003. Costing of RIN 2900-AL55: To establish a presumption of service connection for chronic lymphocytic leukemia (CLL). Washington, DC: VA.

VA. 2004. Costing of RIN 2900-AM09: Additional presumptions for former POWs. Washington, DC: VA.

Suggested Citation:"5 Case Studies Summary Chapter." Institute of Medicine. 2008. Improving the Presumptive Disability Decision-Making Process for Veterans. Washington, DC: The National Academies Press. doi: 10.17226/11908.
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The United States has long recognized and honored the service and sacrifices of its military and veterans. Veterans who have been injured by their service (whether their injury appears during service or afterwards) are owed appropriate health care and disability compensation. For some medical conditions that develop after military service, the scientific information needed to connect the health conditions to the circumstances of service may be incomplete. When information is incomplete, Congress or the Department of Veterans Affairs (VA) may need to make a "presumption" of service connection so that a group of veterans can be appropriately compensated.

The missing information may be about the specific exposures of the veterans, or there may be incomplete scientific evidence as to whether an exposure during service causes the health condition of concern. For example, when the exposures of military personnel in Vietnam to Agent Orange could not be clearly documented, a presumption was established that all those who set foot on Vietnam soil were exposed to Agent Orange. The Institute of Medicine (IOM) Committee was charged with reviewing and describing how presumptions have been made in the past and, if needed, to make recommendations for an improved scientific framework that could be used in the future for determining if a presumption should be made. The Committee was asked to consider and describe the processes of all participants in the current presumptive disability decision-making process for veterans. The Committee was not asked to offer an opinion about past presumptive decisions or to suggest specific future presumptions.

The Committee heard from a range of groups that figure into this decision-making process, including past and present staffers from Congress, the VA, the IOM, veterans service organizations, and individual veterans. The Department of Defense (DoD) briefed the Committee about its current activities and plans to better track the exposures and health conditions of military personnel. The Committee further documented the current process by developing case studies around exposures and health conditions for which presumptions had been made. Improving the Presumptive Disability Decision-Making Process for Veterans explains recommendations made by the committee general methods by which scientists, as well as government and other organizations, evaluate scientific evidence in order to determine if a specific exposure causes a health condition.

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