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Appendix I
Case Studies

CASE STUDY 1:
MENTAL DISORDERS’ PRESUMPTIONS

War and combat have long been considered to have acute and chronic impacts on the emotional well-being and mental health of those exposed. Indeed, of the two initial presumptive disabilities recognized in 1921, one was “neuropsychiatric disease,” a mental disorder (Veterans’ Bureau Act. 1921. Public Law 67-47. 67th Cong., 1st Sess., p. 154). The scientific understanding of mental disorders, as well as the role of war and combat in triggering them, have evolved over time. These factors have influenced the inclusion of mental disorders as presumptive disabilities among U.S. veterans. This case study is intended to review factors influencing the inclusion of various mental disorders as presumptive disabilities among U.S. veterans to date.

Scientific and Legislative History

Following World War I, two of the most common causes for hospitalizations identified among U.S. veterans were “neuropsychiatric disease” and tuberculosis. At that time, neuropsychiatric disease was considered to consist of a combination of delusions, hallucinations, and illogical thinking. Because of the lack of effective treatments at the time, neuropsychiatric disease was considered to be chronic (VA, 2006). In 1921, Senator Walsh of Massachusetts proposed an amendment to pending legislation, which was adopted and later modified, that removed the burden of proof for connecting military service and the development of a disorder from the veteran by granting presumptions of service connection for veterans diagnosed with neuropsychiatric disease or tuberculosis causing at least 10 percent disability within 2 years of military service (Veterans’ Bureau Act. 1921. Public Law 67-47. 67th Cong., 1st Sess., p. 154). In support of these presumptions, Senator Walsh stated that

It is very apparent to me that this wave of tuberculosis and of nervous and mental disease that has taken such a deadly hold and grip of late upon our ex-servicemen must have been contracted in the service. I feel, therefore, that we ought not continue this requirement of endless affidavits, necessarily involving long delay, in demonstrating the fact that their illness is of service origin.

(61 Cong. Rec. 4105 [daily ed. July 20, 1921], as referenced in VA, 1993a, p. 8)



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Appendix I Case Studies CASE STUDY 1: MENTAL DISORDERS’ PRESUMPTIONS War and combat have long been considered to have acute and chronic impacts on the emo- tional well-being and mental health of those exposed. Indeed, of the two initial presumptive dis- abilities recognized in 1921, one was “neuropsychiatric disease,” a mental disorder (Veterans’ Bureau Act. 1921. Public Law 67-47. 67th Cong., 1st Sess., p. 154). The scientific understanding of mental disorders, as well as the role of war and combat in triggering them, have evolved over time. These factors have influenced the inclusion of mental disorders as presumptive disabilities among U.S. veterans. This case study is intended to review factors influencing the inclusion of various mental disorders as presumptive disabilities among U.S. veterans to date. Scientific and Legislative History Following World War I, two of the most common causes for hospitalizations identified among U.S. veterans were “neuropsychiatric disease” and tuberculosis. At that time, neuropsy- chiatric disease was considered to consist of a combination of delusions, hallucinations, and il- logical thinking. Because of the lack of effective treatments at the time, neuropsychiatric disease was considered to be chronic (VA, 2006). In 1921, Senator Walsh of Massachusetts proposed an amendment to pending legislation, which was adopted and later modified, that removed the bur- den of proof for connecting military service and the development of a disorder from the veteran by granting presumptions of service connection for veterans diagnosed with neuropsychiatric disease or tuberculosis causing at least 10 percent disability within 2 years of military service (Veterans’ Bureau Act. 1921. Public Law 67-47. 67th Cong., 1st Sess., p. 154). In support of these presumptions, Senator Walsh stated that It is very apparent to me that this wave of tuberculosis and of nervous and mental disease that has taken such a deadly hold and grip of late upon our ex-servicemen must have been contracted in the service. I feel, therefore, that we ought not continue this requirement of endless affidavits, necessarily involving long delay, in demonstrating the fact that their illness is of service origin. (61 Cong. Rec. 4105 [daily ed. July 20, 1921], as referenced in VA, 1993a, p. 8) I-1

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I-2 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS To emphasize the difficulty in particular for veterans with neuropsychiatric disease he added that I think really that the most human feature of this amendment is the assistance it will render to those afflicted with nervous and mental disease in obtaining their compensation. When it is considered that the most important proof, the essential proof, to establish a claim for compen- sation must come from the man himself, and when it is realized that he is mentally afflicted and therefore can not, for instance, file affidavits from officers and servicemen with whom he served—since memory is usually defective and he can not remember whom his officers or comrades were—it becomes apparent how important is the change made by the bill. (61 Cong. Rec. 4105 [daily ed. July 20, 1921], as referenced in VA, 1993a, p. 9) At the time the legislation was enacted in 1921, there were few scientific studies to support or refute these assertions, and a flood of demands for presumptions for other disorders and for enhancement of those already approved followed soon thereafter. By early 1923, the 2-year period from the time of discharge within which the neuropsychiat- ric disorder had to manifest itself was extended to 3 years despite administration objections that the extension was not supported by scientific evidence (VA, 1993a, p. 12). Later that same year veterans groups, including the Disabled American Veterans, the Veterans for Foreign Wars, and the American Legion, began calling to extend the period from 3 to 5 years. The lack of scientific evidence to justify the extension was noted by Dr. Earl Holt of the Veterans Bureau. In testimony to Congress, Dr. Holt stated that available statistics showed that neuropsychiatric disorder was just as common among the civilian population as among the military population, and that the ex- tension of presumptions was unwarranted due to uncertainty over the causes of psychiatric dis- abilities arising after service (VA, 1993a, p. 14). In response to the Depression, the Economy Act of 1933 eliminated all benefits based on presumptive service connection. In its place the Presi- dent was given broad authority to prescribe rules concerning eligibility for disability compensa- tion including “the nature and extent of proofs, and presumptions” (emphasis added) for various classes of veterans (Economy Act of 1933 ch. 3 § 4, 48 Stat. at 9, as referenced in VA, 1993a, p. 17). Following strong protests from World War I veterans, Congress subsequently moved to reen- act presumptive service-connection conditions. President Roosevelt vetoed the legislation stating that he thought the Economy Act had settled the issue that a service-connected disability was a “question of fact rather than a question of law” in which each individual case would be “consid- ered on its merits” rather than by legislative dicta which, contrary to fact, provide that thousands of individual cases of sickness that commenced 4, 5, or 6 years after the termination of the war were caused by war services. (VA, 1993a, p. 19) Congress overrode the veto, and the measure was enacted into law (Independent Offices Ap- propriations Act. 1935. Public Law 141. 73rd Cong., 2d Sess.). The tension between those intent on being inclusive and generous in presumptive benefits to veterans and those wanting presump- tions to be more firmly grounded by evidence of causation continues today. The pertinent provisions of that 1935 Act are now found in 38 USC § 1702, “Presumption Relating to Psychosis,” and provide that eligible veterans who developed an active psychosis

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APPENDIX I I-3 within 2 years of military discharge “shall be deemed to have incurred such a disability in the active military, naval, or air service.” That language has remained essentially unchanged except for the expansion of eligibility for veterans of subsequent periods of military conflict up to and including those serving in today’s current war. The Committee was unable to obtain information as to how many veterans rated for mental disabilities have been service connected by use of the presumption set forth in section 1702. Additional legislation concerning psychiatric presumptions has been confined to former pris- oners of war (POWs). These psychiatric presumptions were the result of strong concern about the well-being of a group of veterans who suffered extreme privations and of POW studies un- dertaken to ascertain the effect of their captivity. Psychiatric disorders, by their very nature, have created challenges for decision making on presumptions. For many of these disorders, symptoms can only be obtained by self-reporting methods, making it more difficult to distinguish those who truly exhibit symptoms and those who do not. Many early studies focused on excessive hospitalizations for mental disorders among veterans and associations of these disorders with military service rather than causation (Beebe, 1975; Cohen and Cooper, 1954). In addition, as the medical community’s understanding of mental disorders has evolved over time so have the definitions of various mental disorders. Congress, the Department of Veterans Affairs (VA), the National Academy of Sciences (NAS), and a large collection of veterans groups and scientists have all been involved in questions re- lated to presumptions and psychiatric disorders in veterans. The first legislation to create statutory presumptions specifically applicable to POWs was en- acted in 1970 (Veterans Disability Compensation Increase Act. 1970. Public Law 91-376. 91st Cong., 2d Sess.). Under Public Law 91-376, psychosis was to be considered a service-connected disability provided it became manifest within 2 years of separation from service in the military. In justifying the statutory presumptions, the accompanying report said that because of the condi- tions of captivity and the “kinds of long-range harm that may have been caused,” it was “some- times difficult for a former prisoner of war to establish some time after completion of military service” that a disability is related to military service (U.S. Congress, House of Representatives, Committee on Veterans’ Affairs, 1970, p. 7). From October 1972 through August 1976, VA issued a number of program guides with re- spect to Public Law 91-376. These guides were characterized as suggestions for the guidance of personnel in the handling of disability claims filed by former POWs. The program guides in- structed that in light of the “frequent paucity of records” in POW claims, special attention should be given to POW experiences in determining the relationship of the disability to service (VA, 1980, p. 118). The duration and circumstances of imprisonment were to be associated with perti- nent medical principles in making determinations. The burden of proof as to the occurrence of a POW episode was shifted from the claimant to the government. The “unusual hardship and isolation from society” resulting from POW life meant that an “extended period of readjustment to ordinary conditions of life is essential.” Claims for individual unemployability (IU) were to receive liberal construction, and if the threshold disability percentage for the IU benefit was not met, the claim was to be submitted to the VA central office for further consideration. Finally, it was emphasized that presumptions were rebuttable only where there was “affirmative evidence to the contrary” (VA, 1980, p. 119). In 1975, the second phase of the Follow-Up Studies of World War II and Korean War Pris- oners, entitled Morbidity, Disability, and Maladjustment, was issued (Beebe, 1975). Its author, Gilbert W. Beebe, observed at the outset that studies of the long-term effects of catastrophic

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I-4 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS stress are “difficult to make and the frequently multidimensional character of such stress severely limits inferences about the etiologic role of specific components, such as malnutrition, social iso- lation, sensory deprivation, physical punishment, compulsory reeducation, and the like.” He fur- ther noted that recent studies of survivors of World War II German concentration camps pro- vided useful information on a persistent defective state marked by “severe permanent psychiatric residuals and by nonspecific somatic symptoms” (Beebe, 1975, pp. 400-401). Beebe’s findings were that morbidity, some types of maladjustment, and disability were ele- vated in POWs relative to controls especially for Pacific theater veterans. Beebe stated that the “most remarkable and long-lasting differentials” were seen in hospitalization for psychoneurosis and for psychosis (schizophrenia). Data obtained supported a finding that many Pacific theater and Korean War POWs had “permanent psychologic impairments.” Beebe also noted that Euro- pean theater POWs did not go “unscathed” with respect to psychoneurosis hospitalization (Beebe, 1975, p. 421). In the Veterans Disability Compensation and Survivor Benefits Act of 1978 (Public Law 95- 479. 95th Cong., 2d Sess.), Congress included provisions requiring VA to carry out a “compre- hensive study on the compensation awarded to, and the health-care needs of” former POWs. The results of the study were to include such administrative and legislative recommendations as “may be necessary to assure that former prisoners of war receive compensation and health-care bene- fits for all disabilities which may reasonably be attributed to their internment” (Public Law 95- 479, sec. 305; emphasis added). The legislative history indicates that the study was prompted by questions about the adequacy of repatriation examinations and by concerns that health conditions that may have appeared minor at the time were becoming progressively more debilitating. It also cited Beebe’s 1975 follow-up study for the proposition that POWs had excess morbidity, and many were suffering from what was termed a “POW syndrome” (VA, 1993a, p. 51). As VA was preparing its study, the third phase of the follow-up studies entitled Mortality to January 1, 1976, authored by Robert J. Keehn (1980), was issued. That study continued to find increased risks of mortality among World War II Pacific theater and Korean War POWs, though the excess diminished over time. For Pacific theater veterans the principal cause for the mortality increase was tuberculosis and trauma, while for former Korean War POWs it was trauma. In de- scribing this trauma, the report found that for Pacific theater POWs suicide was responsible for two-thirds and accidents one-third of the excess deaths (Keehn, 1980). The study also reported that anxiety neurosis accounted for 12.7 percent of all service-connected conditions for former POWs, compared to a rate of approximately 4 percent for all veterans receiving compensation. Given a consistent finding of persistent psychologic impairment and reported problems of ad- justment to civilian life, the report concluded that The finding of increased mortality due to trauma, both accidental (including cases of masked suicide) and suicide, in former prisoners of war is not surprising. Increased feel- ings of frustration, anger, and tension lead to impatience and impulsive actions that are likely to contribute to both the risk and severity of accidental and self-inflicted injury. (Keehn, 1980, p. 209) Shortly thereafter VA delivered its Study of Former Prisoners of War (VA, 1980) to Con- gress as required by Public Law 95-479. The principal finding that VA stated was “essential to the entire study” was that

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APPENDIX I I-5 [T]he POW experience—characterized by starvation diet, poor quality or nonexistent medical care, “death marches,” executions, and tortures—has historically been an ex- tremely harsh and brutal experience. (VA, 1980, p. 161) Concerning the quality of POW repatriation procedures, exams, and resultant medical re- cords, the study found that the prescribed procedures were generally well designed and reflected “state-of-the art medical knowledge and technique at the time they were designed,” which “if followed would have provided former POWs with adequate records” (VA, 1980, p. 71). Exami- nation of VA claims folders, however, found that less than 20 percent of European theater POWs who filed disability claims had evidence of a repatriation examination. For Pacific theater and Korean War veterans, records of repatriation examinations were located in 60 percent and 85 percent of their files, respectively. In those cases where records were located, VA reviewer phy- sicians judged 67 percent of World War II and 85 percent of Korean War POW repatriation ex- ams as “providing a good or adequate basis for evaluating physical or psychiatric conditions.” The limitations were that over half of the examinations contained either no medical history or poor history of health status prior to capture. In addition, about one-third of the examinations had “inadequate evaluations of the POW’s mental status and psychiatric conditions” (VA, 1980, p. 72). The “most remarkable finding” of the study, according to VA, was that anxiety neurosis was “the most prevalent service-connected condition of the former POWs under study, from the time of their repatriation to the present.” Anxiety neurosis accounted for 12.7 percent of all service- connected conditions of former POWs, which was three times the rate of all veterans receiving compensation (VA, 1980, p. 95). VA stated that The significance of this disability relative to veterans controls remains regardless of the length of internment. This is especially apparent among former European theater POWs, in which those POWs interned less as well as more than 6 months exhibit significantly higher rates of anxiety neurosis compared to other service-connected World War II veterans. (VA, 1980, p. 95) The study had also required VA to analyze procedures used to determine eligibility for bene- fits with a particular emphasis on the statutory and regulatory provisions unique to POWs. VA concluded that Former POWs generally have received special consideration in keeping with statutory and procedural provisions in terms of medical evaluations and disability compensation. Limitations in knowledge as to the long-term effects of the stresses and deprivations ex- perienced by prisoners of war is a major obstacle for decision makers. (VA, 1980, p. 128) VA also reported that over the years it had changed its approach to the adjudication of POW claims by gradually developing flexibility in such areas as substantiation of claims in the absence of medical records for periods of internment and in the presumption of service incur- rence for certain disabilities. This changed approach reflected the “evolution of the law,” and the degree of flexibility roughly coincided with “advancements in medical knowledge” con- cerning the serious effects of imprisonment on health (VA, 1980, p. 121).

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I-6 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS The literature review of health problems of former POWs, a fourth requirement of the study, included eyewitness accounts of disabilities during captivity, epidemiologic follow-up studies, analysis of concentration camp populations, and discussions of former POW family and social problems. VA said that its review showed that the higher rate of health problems ex- perienced were “related to the malnutrition, torture, climatic exposure, and other deprivations of internment.” The epidemiologic follow-up studies indicated that “residuals of these and other disabilities have persisted until the present time.” According to VA, it was particularly noteworthy that the psychological problems of former POWs, especially those of World War II, “closely resemble[d]” those of concentration camp survivors of the same period (VA, 1980, p. 154). The K-Z syndrome, as discussed in Beebe’s 1975 report, included the symptoms: General anxiety and nervousness, “startle” reaction, insomnia and nightmares, phobias, psychosomatic complaints, memory lapses, moodiness, inferiority complex, obsession with the past, depression, apathy, and survivor guilt. (VA, 1980, p. 154) The psychological literature on K-Z syndrome and what VA termed “other forms of psy- chic stress” revealed a significantly higher amount of family and social maladjustment as evi- denced by inadequate functioning in father and parent roles, and higher rates of unemployment and disability compensation among POWs (VA, 1980, p. 154). Two major legislative recommendations were contained in the study submitted to Congress. First, VA recommended that the law be amended to authorize eligibility for VA health care to former POWs for any disease or neuropsychiatric disability. VA observed that studies by the National Research Council (NRC) and NAS showed former POWs generally had higher mor- tality and morbidity rates and that this was reflected in their higher rates of service-connected disabilities. Yet, despite the special consideration given to POW claims, their adjudication was complicated by the frequent absence of medical information at the time of repatriation and by the fact that “medical science cannot, at this time, conclusively determine on an individual ba- sis the origins of some disabilities particularly prevalent among former POWs” (emphasis added). Authorizing comprehensive VA inpatient and outpatient medical care for any disease or neuropsychiatric condition “would remove access barriers to VA medical care for those for- mer POWs currently classified in a lower than 50 percent service-connected priority category” (VA, 1980, pp. 163-164). The second legislative recommendation was to modify the existing statutory presumption of service connection for psychosis. VA proposed to “eliminate the requirement that psychoses suffered by POWs must become manifest within 2 years following service separation before the rebuttable presumption of service connection arises” (VA, 1980, p. 164). VA said that its literature review indicated that psychosis related to the POW experience “frequently appears years after service, not just immediately after separation,” citing NAS/NRC follow-up studies published between 1946 and 1980 in support thereof (VA, 1980, p. 164). VA also reported that it was undertaking several administrative actions as a result of its study. First, forthcoming guidelines on “post-traumatic stress neurosis” would have “explicit reference to former POWs as well as other combat veterans.” Post-traumatic stress neurosis was a term scheduled on October 1, 1980, to become part of VA’s official diagnostic classifica- tion system to describe this anxiety neurosis. The guidelines would “specifically be used to di- agnose, treat, and rate former POWs with anxiety neurosis or similar neurotic disorders” (em- phasis added). VA said this change was justified because former POWs had experienced a wide

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APPENDIX I I-7 range of psychological problems. In addition, anxiety neurosis had been the most prevalent dis- ability among former POWs according to NRC epidemiologic studies and VA compensation data. VA also added that an analysis comparing anxiety neurosis and length of internment demonstrated that it remained a “statistically significant service-connected disability among former POWs regardless of the amount of time in prison camp” (VA, 1980, pp. 165-166; em- phasis added). VA announced that it would adopt a standardized protocol for disability compensation ex- aminations for all former POWs similar to that developed by the military for former Vietnam POWs (VA, 1980). Congressional hearings followed the receipt of VA’s study of POWs in both 1980 and 1981. Legislation was reported in June 1981 and enacted into law on August 14 as the Former Prisoner of War Benefits Act of 1981 (Public Law 97-37. 97th Cong., 1st Sess.). Among its provisions, the requirement that psychosis manifests itself within 2 years of separation of ser- vice in order to qualify for a service-connection presumption was deleted as recommended by VA. An additional presumption termed any of the anxiety states was added to the statute. As noted in House testimony, “. . . psychosis related to the POW experience frequently appears years after service, and not just immediately after separation. This is understandable in view of the psychological torture and ‘brainwashing’ to which these POWs were subjected” (U.S. Con- gress, House of Representatives, Committee on Veterans’ Affairs, 1981, p. 6). Three additional presumptions for POWs were added between 1984 and 1988. The first, in the Veterans’ Compensation and Program Improvements Amendments of 1984 (Public Law 98-223. 98th Cong., 2d Sess.) added “dysthymic disorder” to the list of disabilities developing any time after a POW’s separation from service for which a presumption of service connection would apply. Senator Alan K. Simpson, chairman of the Senate Committee on Veterans Af- fairs, termed the inclusion a clarification of the original intent of the Former Prisoner of War Benefits Act of 1981. Speaking on the floor of the Senate during consideration of the measure he said that The complexity of anxiety states, anxiety neuroses, posttraumatic stress disorder, and dysthymic disorders and their associated and sometimes interrelated diagnoses inadver- tently resulted in a lack of clarity regarding the granting of service connection for depression. (VA, 1993a, p. 55) Further explanation was contained in the committee’s report accompanying the measure that states that at the time the Senate reached agreement with the House on the 1981 Act: [The Senate] was not aware that there would be cases in which former POWS suffering from nonpsychotic depressive disorders would not be diagnosed as suffering from post- traumatic stress disorder and therefore not adjudged under VA guidelines to be service- connected disabled. . . . The committee intends that this addition would correct the inad- vertent oversight in the original legislation and establish a presumption for a mental dis- order that is linked in scientific literature to the POW experience. (VA, 1993a, pp. 55-56) Since the late 1980s, a number of well-designed studies have supported increased psychiatric morbidity among former POWs as well as among other veterans experiencing combat. In 1988,

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I-8 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS results from the Vietnam Experience Study (VES) conducted by the Centers for Disease Control and Prevention (CDC) were released. The VES selected a random sample of Army personnel discharged between 1965 and 1971. Those who served a single tour in Vietnam (n = 9,324) were compared to a random sample of Army personnel discharged during the same period and who served a single tour of duty elsewhere (n = 8,989). Veterans who were alive at the time of study completed a telephone interview, in-person psychological examinations, and assessments for re- productive outcomes (CDC, 1988, p. 2702). The VES found that Vietnam veterans had a 45 percent excess of deaths in the first 5 years after discharge in comparison to non-Vietnam veterans. These deaths were largely due to motor vehicle accidents, suicides, and homicides. After the initial 5-year period, the death rates among the two groups of veterans remained approximately the same. Nevertheless, Vietnam veterans were more likely to meet diagnostic criteria for alcohol abuse or dependence, generalized anxiety disorder, and depression. Among Vietnam veterans, 14.7 percent met criteria for posttraumatic stress disorder (PTSD) previously in life and 2.2 percent met criteria for PTSD during the month prior to the examination (CDC, 1988, p. 2705). Though a constellation of psychiatric symptoms among this Vietnam group was similar to studies previously conducted on World War II POWs, this study was significant in the fact that the veterans enrolled in this study were selected due to their combat theater rather than their POW status. Several studies published in 1991 examined chronic depression among former POWs. Eng- dahl et al. (1991) found that long-term chronic depressive symptomatology persisted over 40 years and was elevated among POWs of all theaters when compared to control groups. Age, edu- cation, medical symptoms during captivity, and level of social support were found to be related to later levels of adjustment. A second, longitudinal study published the same year by Page et al. (1991) elaborated on previous research to show that not only was depressive symptomatology highly elevated in World War II and Korean War POWs, but it was elevated to the point where these populations closely resembled a clinical population of recovering depressives. Two major conclusions from this longitudinal study were that treatment during captivity is statistically linked with depressive symptoms, and that differences in these symptoms were attributable to captivity-related treatment, even when age at capture and education level were considered. Conducting a 40-year follow-up of U.S. World War II and Korean War former POWs, Eng- dahl and Page et al. (1991) measured captivity trauma variables and individual protective vari- ables (i.e., age, education, medical symptoms during captivity, social support) to compare with current depressive symptoms. Although depressive symptoms persisted more than 40 years with the knowledge that PTSD and generalized anxiety disorders are known to occur with elevated frequency in POW populations, the degrees of individual protective variables were related to levels of adjustment. This study made a case for the need to examine former POWs that adjusted well in order to understand both the role of specific protective variables and posttrauma adjust- ment and resiliency. Page’s (1991) work continued with respect to the validity and reliability of some of the work cited above. Despite the heavy reliance on survey data, a noticeable shortage of reports on the effects of nonresponse bias on the measurement of depression existed. Longitudinal data pre- sented opportunities for different types of nonresponse bias, but these data could also be useful in modeling for bias because of previously collected data. Page found that a predictive model shows nonresponse bias on the reporting of depressive symptoms among former World War II and Korean War POWs to be small.

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APPENDIX I I-9 In 1992, the Institute of Medicine (IOM) produced a report entitled The Health of Former Prisoners of War. This longitudinal study focused on morbidity and was initiated in 1986 and built on the earlier work of Cohen and Cooper (1954), Nefzger (1970), and Keehn (1980), which has been previously discussed. Veterans were invited to a medical center to undergo the VA pro- tocol exam, which included a comprehensive physical and psychiatric examination. In addition, a face-to-face psychiatric interview and a battery of psychological tests were administered. A cau- tion was provided at the outset of the report that due to low response rates there could be “no confidence . . . that the group of respondents accurately reflects the composition of all former POWs” (IOM, 1992, p. 4). Nevertheless, the results were presented as descriptive data that con- stituted the largest national collection of POW examinations ever gathered and analyzed. Some of the findings confirmed earlier studies while other findings were suggestive and served the purpose of generating more definitive research studies. The report urged a “maximum of reason- able caution in (the) interpretation” of the results (IOM, 1992, p. 5). The report brought attention to the high prevalence of a number of medical conditions for POWs as compared to the controls, especially with regard to psychiatric illness. Prevalence rates for over 20 different medical condi- tions were discussed, with key results including the following: • Pacific theater POWs had higher prevalence rates of PTSD, ulcer, schizophrenia, and generalized anxiety than European theater and Korean War POWs. • Visual symptoms were associated with higher prevalence rates of cerebrovascular disease, ulcers, asthma, and PTSD. • Korean War POWs showed higher prevalence rates for schizophrenia. (IOM, 1992, pp. 6-11) The IOM report stated that many of the organ-specific findings were familiar and that the increased prevalence of depressive disorders, PTSD, and generalized anxiety among POWs was not unexpected. To better understand the characteristics that affect POWs’ reintegration into civilian life, Engdahl et al. published a report in 1993 that investigated long-term responses to captivity trauma among former POWs. Engdahl et al. reported that symptoms at 20 years following re- lease were related to those at 40 years following release. Many factors known to affect POWs’ long-term adjustment were not included in the study (e.g., combat exposure, postwar social support). This was due in part to their statistical infrequency or skewed nature (i.e., family his- tory of mental illness, marital status at capture, military rank at capture). Trauma response was found to be determined by an interaction of characteristics of the individual and characteristics of the trauma, not primarily one over the other. The authors suggested that trauma response, from an evolutionary standpoint, may be better understood as adaptive due to its persistent na- ture. As previously discussed, Congress has delegated to the VA Secretary the general authority to prescribe “all rules and regulations . . . with respect to the nature and extent of proof and evi- dence and the method of taking and furnishing them in order to establish the right to benefits un- der such laws” (38 USC § 501[a]). Pursuant to that authority, VA published evidentiary pre- sumptions with respect to establishing PTSD claims in 1993 (VA, 1993b). The regulation initially observes that service connection for PTSD requires “medical evidence establishing a clear diagnosis of the condition, credible supporting evidence that the claimed in-service stressor actually occurred, and a link, establishing by medical evidence, between current symptomatology and the claimed in-service stressor” (VA, 1993b, p. 3). The regulation provided that

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I-10 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS If the claimed stressor is related to combat, service department evidence that the veteran engaged in combat or that the veteran was awarded the Purple Heart, Combat Infantry- man Badge, or similar combat citation will be accepted, in the absence of evidence to the contrary, as conclusive evidence of the claimed in-service stressor. (VA, 1993b, pp. 3-4; emphasis added) In addition, the regulation provided that status as a POW would similarly be regarded as evi- dence of an in-service stressor. PTSD continued to gain great attention. Page et al. (1997) examined the literature on PTSD in POWs and compared lifetime PTSD prevalence among POWs and control subjects. After a follow-up period of 40 years, differences in prevalence rates existed between POWs and control subjects for depressive disorders as well as generalized anxiety. All groups of POWs shared nearly the same lifetime and current PTSD rates. Among World War II POWs, however, roughly half of the POWs who once suffered from PTSD were not currently diagnosed with that condi- tion, suggesting the possible presence of chronic, stable PTSD in the other half of the POWs evaluated. However, the authors stated that this may be explained by the symptoms causing less stress on the first group of individuals. The authors suggested that those with higher distress lev- els should be evaluated for secondary symptoms of PTSD, such as depression. They concluded that Sensitivity toward older war veterans is vital. An awareness that their PTSD may have gone unnoticed by other health-care professionals for decades should encourage direct clinical inquiries about possible PTSD symptoms. We strongly recommend a structured interview. . . . PTSD symptoms have been all too common, yet undiagnosed among older war veterans, especially POWs. (Page et al., 1997, p. 157; emphasis added) Work on PTSD continued into the new millennium when World War II and the Korean War POW interviews were examined for two separate index measures at two points in time—1965 and 1990. Results from Gold et al. (2000) supported previous research highlighting the severe psychological consequences of POW status 40-50 years following captivity. Trauma severity during captivity was found to be the best predictor of current PTSD symptomatology. The Veterans Benefits Act of 2003 (Public Law 108-183. 108th Cong., 1st Sess.) included provisions that removed the 30-day minimum confinement requirement for 5 of the 16 POW pre- sumptive conditions. Included in those 5, for which no minimum confinement was required, were (a) psychosis, (b) any of the anxiety states, and (c) dysthymic disorder (or depressive neu- rosis). In justifying the change, a Senate committee report on a similar bill observed that POWs were often treated brutally and, even if treated humanely, often suffered extreme mental anguish. Thus, the “30-day minimum requirement for purposes of presumptive service connection may be too restrictive for certain conditions” (U.S. Congress, Senate, Committee on Veterans’ Affairs, 2003, p. 10). Lessons Learned Presumptive decisions for mental disorders have been established for veterans who are for- mer POWs and for veterans who developed chronic mental problems during or shortly after mili- tary service. The subjective nature and self-reporting aspects of mental disorders have made it

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APPENDIX I I-11 more difficult to determine the mental disorders that should be presumptively service connected. Although legislation has been informed by the scientific evidence available at the time (Beebe, 1975; CDC, 1988; Cohen and Cooper, 1954; Engdahl and Page, 1991; Keehn, 1980; Nefgzer, 1970; Page et al., 1997), the scientific evidence has been limited by inconsistency surrounding the disorders that have been included in the research. For example, if the limited and suggestive evidence led to presumptive decisions for PTSD, dysthymic disorders, and any anxiety state among former POWs, then there does not appear to be a clear basis for excluding other mental disorders with equal or stronger evidence of connection to being a POW, such as major depres- sion or substance abuse. The presumptive decisions with regard to these mental disorders dem- onstrate that these decisions have been influenced not only by the evidence, but also by political and social considerations that apply to these veterans and the specific mental disorders they manifest. The need to develop stronger evidence and consistency with regard to these disorders is great, particularly in light of evidence of high rates of disorders among military personnel cur- rently assigned to Iraq. This case study illustrates the need for a process that can continually carry out research while updating the scientific evidence used in presumptive disability decision making. Improved future studies will be aided by pre- and postdeployment mental health as- sessments of Service members and more thorough assessment and documentation of exposures while deployed. This information will facilitate a deeper understanding of the relationship be- tween military service and the subsequent development of mental health disorders. References Beebe, G. W. 1975. Follow-up studies of World War II and Korean War prisoners: Morbidity, disability, and maladjustments. American Journal of Epidemiology 101(5):400-422. CDC (Centers for Disease Control). 1988. Vietnam experience study—psychosocial characteristics. Jour- nal of the American Medical Association 259(18):2701-2707. Cohen, B. M., and M. Z. Cooper. 1954. A follow-up study of World War II prisoners of war. Washington, DC: Government Printing Office. Engdahl, B. E., and W. F. Page. 1991. Psychological effects of military captivity. In Epidemiology in military and veteran populations. Proceedings of the Second Biennial Conference, March 7, 1990. Washington, DC: National Academy Press. Pp. 49-66. Engdahl, B. E., W. F. Page, and T. W. Miller. 1991. Age, education, maltreatment, and social support as predictors of chronic depression in former prisoners of war. Social Psychiatry and Psychiatric Epidemi- ology 26(2):63-67. Engdahl, B. E., A. R. Harkness, R. E. Eberly, W. F. Page, and J. Bielinski. 1993. Structural models of cap- tivity trauma, resilience, and trauma response among former prisoners of war 20 to 40 years after re- lease. Social Psychiatry and Psychiatric Epidemiology 28(3):109-115. Gold, P. B., B. E. Engdahl, R. E. Eberly, R. J. Blake, W. F. Page, and B. C. Frueh. 2000. Trauma exposure, resilience, social support, and PTSD construct validity among former prisoners of war. Social Psychia- try and Psychiatric Epidemiology 35(1):36-42. IOM (Institute of Medicine). 1992. The health of former prisoners of war: Results from the medical ex- amination survey of former POWs of World War II and the Korean Conflict. Washington, DC: Na- tional Academy Press. Keehn, R. J. 1980. Follow-up studies of World War II and Korean Conflict prisoners: Mortality to Janu- ary 1, 1976. American Journal of Epidemiology 111(2):194-211. Nefzger, M. D. 1970. Follow-up studies of World War II and Korean War prisoners: Study plan and mor- tality findings. American Journal of Epidemiology 91(2):123-138. Page, W. F. 1991. Using longitudinal data to estimate non-response bias. Social Psychiatry and Psychiat- ric Epidemiology 26:127-131.

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I-108 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS bases for this estimate are not described, the multiple possible complications associated with type 2 diabetes suggests that this average payment would likely increase over time for a given veteran with type 2 diabetes. Estimated administrative costs for type 2 diabetes from 2001 through 2005 were $62 million with estimated benefit costs of $3.3 billion during that same time period. VA estimated that there would be 20,399 new type 2 diabetes awards in the first year and 179,000 over the next 5 years. The estimates did not include retroactive payments (McLenachen, 2005). Today, the most frequent service-connected disability for which Vietnam veterans are receiving compensation is type 2 diabetes (VBA, 2006). “At the end of fiscal year 2006, nearly 248,000 veterans were service connected for diabetes. More than 215,000 of these awards were based upon herbicide exposure in Vietnam. As veterans with diabetes reach and move past the 10-year point since initial diagnosis, additional secondary conditions tend to manifest. VA has started to see increasingly complex medical cases resulting in neuropathies, vision problems, cardiovascu- lar problems, and other issues directly related to diabetes” (VA, 2007, pp. 6B-13). Lessons Learned This case study offers several lessons that are relevant when considering strategies for im- proving the current system of presumptions. These lessons relate to the role of Congress in issu- ing the Agent Orange Act of 1991 (Public Law 102-4. 102nd Cong., 1st Sess.), VA in their use of scientific evidence to both convene the special IOM committee on type 2 diabetes (IOM, 2000) and eventually issue a presumption related to type 2 diabetes, and IOM in its evaluation and presentation of the body of evidence for the relationship between Agent Orange and type 2 diabetes. 18 17 16 15 Population) 14 13 12 11 Rate (per 1,000 10 9 8 7 6 5 4 3 2 1 18–44 45–64 65–79 0 1997 1998 1999 2000 2001 2002 20 Year FIGURE I-8 Annual incidence of diagnosed type 2 diabetes per 1,000 population aged 18-79 years, by age, United States, 1997-2004. SOURCE: See http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm.

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APPENDIX I I-109 Congress In describing the type of relationship between dioxin and health outcomes necessary for a presumption, Congress used the language both of “association” as well as “causation” in the Agent Orange Act of 1991 (Public Law 102-4. 102nd Cong., 1st Sess., Sec. 2[b][3]) (see Chapter 4). Association appears to be the standard set for VA: An association between the occurrence of a disease in humans and exposure to an herbi- cide agent shall be considered to be positive for the purposes of this section if the credible evidence for the association is equal to or outweighs the credible evidence against the as- sociation. (Agent Orange Act of 1991. Public Law 102-4. 102nd Cong., 1st Sess.) However, the congressional language regarding “Scientific Determinations Concerning Dis- eases” includes evidence related to causation (Agent Orange Act of 1991. Public Law 102-4. 102nd Cong., 1st Sess., Sec. 3[d]): 1. whether a statistical association with herbicide exposure exists, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiologic methods used to detect the association; 2. the increased risk of disease among those exposed to herbicides during service in the Republic of Vietnam during the Vietnam era; and 3. whether there exists a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and disease. (emphasis added) This inconsistency in the congressional language may have allowed considerable differences in interpretation of whether scientific evidence exists for the basis for a presumption. The diffi- culties that result from this lack of clarity in the Agent Orange Act of 1991 (Public Law 102-4. 102nd Cong., 1st Sess.) may have been particularly problematic for type 2 diabetes for which some evidence for association is present, but limited by chance, bias, or confounding. In addition to the more general confusion between “association” and “causation” in the Agent Orange Act described above, the second standard set for IOM by this act—evaluating evi- dence for the increased risk of disease among those exposed to herbicides during service in the Republic of Vietnam during the Vietnam era—is particularly vague. Nearly all of the Agent Or- ange reports issued by IOM (1994, 1996, 1999, 2000, 2001, 2003, 2005) comment on the chal- lenge of addressing this second charge, noting that the lack of exposure data on Vietnam veterans made the task difficult to fulfill. The intent of Congress in this second charge is unclear, particu- larly as the lack of exposure data for Vietnam veterans was well known at the time of the Agent Orange Act. VA In justifying its decision to convene a special IOM panel to evaluate the evidence related to Agent Orange and type 2 diabetes, VA may have overstated the findings of the report that prompted this action. Based on the Federal Register, VA summarized the report by NIOSH on occupational exposure to dioxin as

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I-110 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS . . . a report that detects an association, though not a strong association, between type 2 diabetes and dioxin exposure. The study does suggest a dose-response relationship be- cause of excess cases of type 2 diabetes found in workers having the highest serum-lipid levels of dioxin. (VA, 2001a, p. 2378) By contrast, the authors of the NIOSH report summarized their findings in this way: Overall, the prevalence of diabetes mellitus was not significantly different between the workers and referents. Also, there was not a significant positive trend between prevalence of diabetes and increasing serum TCDD concentration. However, diabetes was found in six of 10 (60%) workers with current serum TCDD concentrations > 1500 pg/g lipid. (Calvert et al., 1999, p. 270) Because this study was the primary justification for the special IOM committee, an under- standing of VA’s interpretation of the study results is essential. No additional information re- garding how new studies come to the attention of VA or the criteria for evaluating new studies and using these to inform the charge to IOM were made available to the Committee. In the debate regarding this presumption, VA dismissed the link between national increases in type 2 diabetes rates related to obesity and the calls for more studies that control for the back- ground high rates of obesity, noting that the IOM “adequately took into consideration the rela- tionship between obesity and type 2 diabetes” (VA, 2001b, p. 23167). This statement appears to conflict with the IOM reports, as the IOM type 2 diabetes report stated that “the known predic- tors of diabetes risk—family history, physical inactivity, and obesity—continue to greatly out- weigh any suggested increased risk from wartime exposure to herbicides” (IOM, 2000, pp. 3, 37). VA noted that the requirement of timely action on the part of VA imposed by the Agent Or- ange Act prevented consideration of additional studies; although action is required within 60 days of the finding of a “positive association” on the part of the VA Secretary, it is notable that this VA finding was based on the lesser “limited/suggestive” categorization of evidence in the IOM report. VA’s cost projections for the type 2 diabetes presumption were likely underestimates. VA failed to consider the likely rise in type 2 diabetes prevalence in the aging veteran population and national trends suggesting increasing rates of type 2 diabetes in all age groups. Furthermore, as type 2 diabetes has many known complications that are also highly morbid, it is likely that the average percentage of service-connected disability for veterans with type 2 diabetes will continue to increase over time. Overall, the Committee found that VA’s process for using IOM reports to inform presump- tive decisions has not been transparent. The diabetes presumption signaled an important trend on the part of VA to assign presumption on the basis of “limited/suggestive” classification of the levels of evidence. This decision could have been influenced by a variety of considerations be- yond scientific ones, such as political, economic, and administrative factors. The interplay of these multiple factors and their relative weighting by VA are not easily characterized because of the lack of transparency in the VA process for using scientific evidence to arrive at the final de- cision of issuing a presumption. This attempt by the Committee to carry out at a balanced critique of the various parties in the Agent Orange and type 2 diabetes presumption is limited by the availability of information from VA on this subject.

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APPENDIX I I-111 IOM All of the IOM committees reviewing the type 2 diabetes evidence did not consider the re- sults of the Vietnam Experience Study. This CDC study is one of the few large studies compar- ing the health of Vietnam veterans to other veterans of the same age who did not serve in Viet- nam. The Vietnam-enlisted veterans surveyed in the Vietnam Experience Study did not have an increased risk of self-reported type 2 diabetes compared with other Vietnam-era veterans. In the subsample of participants that underwent blood test evaluation, Vietnam veterans also did not show higher rates of abnormal blood glucose concentrations compared with their Vietnam-era counterparts, although the geometric mean of their fasting serum glucose was slightly (and sig- nificantly) higher. The IOM committee did not appear to have an explicit and formal methodological protocol for synthesizing evidence and for updating the classification of evidence based on new studies. The IOM type 2 diabetes committee “upgraded” their assessment of the existing literature from “inadequate/insufficient” (studies of insufficient quality, consistency, or statistical power to per- mit conclusion) to “limited/suggestive” (studies 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). The committee’s conclu- sion was not reached because of a single high-quality study that provided evidence of a conclu- sive association between Agent Orange and type 2 diabetes. Rather, the reclassification resulted from the committee’s view of the cumulative weight of the evidence from several smaller stud- ies, each limited in varying ways so that overall chance, bias, and confounding could not be ruled out with confidence and some studies differed in the direction of the association found (i.e., posi- tive or negative). The IOM report emphasized a particular feature of outcome ascertainment in type 2 diabetes research that may have led to overinterpretation of the conclusions of their report. The IOM committee concluded that “[p]ositive associations are reported in many mortality studies, which may underestimate the incidence of diabetes” (IOM, 2000, pp. 2, 36; emphasis added). The committee correctly pointed out that death certificates routinely underestimate death rates attrib- utable to type 2 diabetes. Because type 2 diabetes is not typically fatal, complications of type 2 diabetes are more likely to be listed as a cause of death rather than type 2 diabetes itself, and con- tributory factors (such as type 2 diabetes) are not routinely listed on death certificates. However, these features would only be expected to underestimate type 2 diabetes mortality generally and should not lead to differential outcome ascertainment based on exposure status. Although the strength of association between dioxin exposure and type 2 diabetes would likely be unaffected by overall underreporting of type 2 diabetes on death certificates, the VA summary of the IOM findings appeared to suggest that the associations observed in these mortality studies be given additional weight because the type 2 diabetes mortality associated with dioxin exposure is under- estimated. Although determining the extent of type 2 diabetes risk that might be attributable to military service was not explicitly part of their charge, several of the committee reports address this issue and implicitly suggest that this fraction is likely to be small: It must be noted, however, that these studies indicate that the increased risk, if any, posed by herbicide or TCDD exposure appears to be small. The known predictors of diabetes

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I-112 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS risk—family history, physical inactivity, and obesity—continue to greatly outweigh any suggested increased risk from wartime exposure to herbicides. (IOM, 2000, pp. 3, 37) A more explicit evaluation of attributable fraction might have been useful to policy makers considering this presumption by placing the scientific evidence on the link between TCDD and diabetes in context of overall diabetes risks, although determining the magnitude of this attribut- able fraction would remain difficult in the absence of accurate exposure data. General The Agent Orange and type 2 diabetes case study illustrates the challenge—both for scien- tists and policy makers—of evaluating evidence for an association between exposure and subse- quent disease when accurate exposure data are lacking. This challenge is particularly striking for a disease like diabetes where multiple factors often contribute to the onset of disease, and the other known risk factors (e.g., genetics, obesity) are common in the general population. In this context, the contribution of exposures incurred during prior military service to overall disease risk is likely to be small as acknowledged in the IOM reports. In the absence of accurate expo- sure data, determining whether this small increased risk of disease is present and further quanti- fying the magnitude of this risk is difficult. Faced with this challenge of identifying a possible small increased risk of disease without ac- curate exposure data, it appears that policy makers have adopted an approach in the diabetes pre- sumption that minimizes the possibility of denying service connection to a veteran whose type 2 diabetes may have been caused by Agent Orange (maximizing sensitivity). The implicit assump- tion in the type 2 diabetes presumption is if any possibility exists, no matter how small, that a veteran may have been exposed to any amount of Agent Orange (presumption of exposure), and any possibility exists, no matter how small, that Agent Orange may have contributed even the smallest incremental increased risk of type 2 diabetes (presumption of association), service con- nection should be granted. High-quality data for a cohort of veterans are essential for improving this process. Ideally such data would include (1) more accurate assessments of exposure during service; (2) evalua- tion of other risk factors that may have been present during service or have developed after ser- vice before the onset of disease; and (3) longitudinal assessments for evaluation of diseases that may have long latency periods. The type 2 diabetes case study highlights the potential value of such an ongoing cohort study and the missed opportunities when such studies are not continued. The VES was the largest study of a representative group of Vietnam veterans exploring whether Vietnam service was associated with a variety of disease outcomes. Although this study did not include an assessment of exposures, the variety of measurements included after military service did provide some ability to address multiple other risk factors that might confound the associa- tion observed between military service and type 2 diabetes. Extension of the VES as a cohort study might have provided an opportunity to determine whether the observed increase in mean glucose levels signaled future type 2 diabetes risk, whether this risk was independent of other risk factors present among Vietnam veterans, and what fraction of type 2 diabetes risk is attribut- able to military service.

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APPENDIX I I-113 References ADA (American Diabetes Association). 1997. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 20(7):1183-1197. ADA. 2003. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care 26(11):3160-3167. ADA. 2007. Diagnosis and classification of diabetes mellitus. Diabetes Care 30(Suppl 1):S42-S47. AFHS (Air Force Health Study). 2000. An epidemiologic investigation of health effects in Air Force per- sonnel following exposure to herbicides. 1997 follow-up examination results. Reston, VA: Science Application International Corporation. Doc. F41624-96-C1012. Alberti, K. G., and P. Z. Zimmet. 1998. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabetic Medicine 15(7):539-553. Bertazzi, P. A., I. Bernucci, G. Brambilla, D. Consonni, and A. C. Pesatori. 1998. The Seveso studies on early and long-term effects of dioxin exposure: A review. Environmental Health Perspectives 106(Suppl 2):625-633. Calvert, G. M., M. H. Sweeney, J. Deddens, and D. K. Wall. 1999. Evaluation of diabetes mellitus, serum glucose, and thyroid function among United States workers exposed to 2,3,7,8-tetrachlorodibenzo-p- dioxin. Occupational and Environmental Medicine 56(4):270-276. CDC (Centers for Disease Control and Prevention). 1989a. Health status of Vietnam veterans. Synopsis. Vol. 1. Atlanta, GA: CDC. http://www.cdc.gov/nceh/veterans/default1c.htm (accessed June 7, 2007). CDC. 1989b. Health status of Vietnam veterans. Telephone interview. Vol. 2. Atlanta, GA: CDC. http://www.cdc.gov/nceh/veterans/default1c.htm (accessed June 7, 2007). CDC. 1989c. Health status of Vietnam veterans. Medical examination. Vol. 3. Atlanta, GA: CDC. http://www.cdc.gov/nceh/veterans/default1c.htm (accessed June 7, 2007). CDC. 2005. National diabetes fact sheet. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf (accessed March 7, 2007). CDVA (Commonwealth Department of Veterans’ Affairs). 1998. Morbidity of Vietnam veterans: A study of the health of Australia’s Vietnam veteran community. Male Vietnam veterans survey and commu- nity comparison outcomes. Vol. 1. Canberra, Australia: Department of Veterans’ Affairs. Cook, R. R., G. G. Bond, R. A. Olson, and M. G. Ott. 1987. Update of the mortality experience of work- ers exposed to chlorinated dioxins. Chemosphere 16(8-9):2111-2116. Gregg, E. W., Y. J. Cheng, B. L. Cadwell, G. Imperatore, D. E. Williams, K. M. Flegal, K. M. V. Narayan, and D. F. Williamson. 2005. Secular trends in cardiovascular disease risk factors according to body mass index in U.S. adults. Journal of the American Medical Association 293(15):1868-1874. Henneberger, P. K., B. G. Ferris, Jr., and R. R. Monson. 1989. Mortality among pulp and paper workers in Berlin, New Hampshire. British Journal of Industrial Medicine 46(9):658-664. Henriksen, G. L., N. S. Ketchum, J. E. Michalek, and J. A. Swaby. 1997. Serum dioxin and diabetes mel- litus in veterans of Operation Ranch Hand. Epidemiology 8(3):252-258. IOM (Institute of Medicine). 1994. Veterans and Agent Orange: Health effects of herbicides used in Viet- nam. Washington, DC: National Academy Press. IOM. 1996. Veterans and Agent Orange: Update 1996. Washington, DC: National Academy Press. IOM. 1999. Veterans and Agent Orange: Update 1998. 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. Veterans and Agent Orange: Update 2000. Washington, DC: National Academy Press. IOM. 2003. Veterans and Agent Orange: Update 2002. Washington, DC: The National Academies Press. IOM. 2005. Veterans and Agent Orange: Update 2004. Washington, DC: The National Academies Press. Longnecker, M. P., and J. E. Michalek. 2000. Serum dioxin levels in relation to diabetes mellitus among Air Force veterans with background levels of exposure. Epidemiology 11(1):44-48. May, G. 1982. Tetrachlorodibenzodioxin: A survey of subjects ten years after exposure. British Journal of Industrial Medicine 39(2):128-135.

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I-114 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS McLenachen, D. 2005. Presumptive service connection in the VBA. Paper presented to Veterans Disabil- ity Benefits Commission. Washington, DC. Michalek, J. E., N. S. Ketchum, and R. C. Tripathi. 2003. Diabetes mellitus and 2,3,7,8- tetrachlorodibenzo-p-dioxin elimination in veterans of Operation Ranch Hand. Journal of Toxicology and Environmental Health, Part A 66(3):211-221. Moses, M., R. Lilis, K. D. Crow, J. Thornton, A. Fischbein, H. A. Anderson, and I. J. Selikoff. 1984. Health status of workers with past exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin in the manufacture of 2,4,5-trichlorophenoxyacetic acid: Comparison of findings with and without chloracne. American Journal of Industrial Medicine 5(3):161-182. Pazderova-Vejlupkova, J., E. Lukas, M. Nemcova, J. Pickova, and L. Jirasek. 1981. The development and prognosis of chronic intoxication by tetrachlorodibenzo-p-dioxin in men. Archives of Environmental Health 36(1):5-11. Pesatori, A. C., C. Zocchetti, S. Guercilena, D. Consonni, D. Turrini, and P. A. Bertazzi. 1998. Dioxin exposure and nonmalignant health effects: A mortality study. Occupational and Environmental Medi- cine 55(2):126-131. Steenland, K., L. Piacitelli, J. Deddens, M. Fingerhut, and L. I. Chang. 1999. Cancer, heart disease, and diabetes in workers exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin. Journal of the National Cancer Institute 91(9):779-786. Steenland, K., G. Calvert, N. Ketchum, and J. Michalek. 2001. Dioxin and diabetes mellitus: An analysis of combined NIOSH and Ranch Hand data. Occupational and Environmental Medicine 58(10):641- 648. Sweeney, M. H., R. W. Hornung, D. K. Wall, M. A. Fingerhut, and W. E. Halperin. 1992. Diabetes and serum glucose levels in TCDD-exposed workers. Abstract of a paper presented at the 12th Interna- tional Symposium on Chlorinated Dioxins (Dioxin ‘92), Tampere, Finland, August 24-28. Sweeney, M. H., G. Calvert, G. A. Egeland, M. A. Fingerhut, W. E. Halperin, and L. A. Piacitelli. 1996. Review and update of the results of the NIOSH medical study of workers exposed to chemicals con- taminated with 2,3,7,8-tetrachlorodibenzodioxin. Paper presented at the symposium, Dioxin Exposure and Human Health—An Update, Berlin, Germany, June 17. Sweeney, M. H., G. Calvert, G. A. Egeland, M. A. Fingerhut, W. E. Halperin, and L. A. Piacitelli. 1997. Review and update of the results of the NIOSH medical study of workers exposed to chemicals con- taminated with 2,3,7,8-tetrachlorodibenzodioxin. Teratogenesis, Carcinogenesis, and Mutagenesis 17(4-5):241-247. VA (Department of Veterans Affairs). 2000. Costing of regulation RIN 2900-AK63—Disease associated with exposure to certain herbicide agents: Type 2 diabetes. Washington, DC: Office of Resource Management, Department of Veterans Affairs. VA. 2001a. Disease associated with exposure to certain herbicide agents: Type 2 diabetes. Proposed rule. Federal Register 66(8):2376-2380. VA. 2001b. Disease associated with exposure to certain herbicide agents: Type 2 diabetes. Rules and regulations. Federal Register 66(89):23166-23169. VA. 2007. National Cemetery Administration. Benefits Programs, and Departmental Administration, Congressional Submission, FY 2008. Vol. 2. http://www.va.gov/budget/summary/VolumeIINationalCemeteryAdministrationBenefitsProgramsand DepartmentalAdmin.pdf (accessed June 6, 2007). VBA (Veterans Benefits Administration). 2006. Annual benefits report. Fiscal year 2005. Washington, DC: VBA. Vena, J., P. Boffetta, H. Becher, T. Benn, H. B. Bueno de Mesquita, D. Coggon, D. Colin, D. Flesch- Janys, L. Green, T. Kauppinen, M. Littorin, E. Lynge, J. D. Mathews, M. Neuberger, N. Pearce, A. C. Pesatori, R. Saracci, K. Steenland, and M. Kogevinas. 1998. Exposure to dioxin and nonneoplastic mortality in the expanded IARC international cohort study of phenoxy herbicide and chlorophenol production workers and sprayers. Environmental Health Perspectives 106(Suppl 2):645-653.

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APPENDIX I I-115 Von Benner, A., L. Edler, K. Mayer, and A. Zober. 1994. Dioxin investigation program of the chemical industry professional association. Arbeitsmedizin Sozialmedizin Praventivmedizin 29(1):11-16. Zober, A., M. G. Ott, and P. Messerer. 1994. Morbidity follow up study of BASF employees exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) after a 1953 chemical reactor incident. Occupational and Environmental Medicine 51:479-486. CASE STUDY 10: SPINA BIFIDA PROGRAM 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, respectively. These decisions were based on scientific evidence for an association between Agent Orange and this developmental abnormality. This case study illustrates the issues surrounding compensation for reproductive health effects related to exposures incurred during military service. As spina bi- fida is a condition that affects the children of veterans, it is not a presumptive decision for veter- ans; however, the children of Vietnam and Korean War veterans are covered by a VA program. Reproductive Effects of Military Service Two categories of reproductive effects for exposures to toxic agents have been considered by the IOM committees charged with evaluating the evidence for adverse health effects associated with Agent Orange. The first category relates to the reproductive health of the exposed men and women and includes conditions that affect fertility and impaired ability to conceive and/or to bear live children. The second category relates to developmental effects in the offspring of ex- posed individuals, including birth defects, growth retardation, and childhood cancers. Exposure to certain toxic agents has long been accepted as leading to developmental abnormalities in the offspring of women. However, the role of paternal exposures in the etiology of developmental outcomes has been more challenging to understand. The Agent Orange reports review the bio- logical plausibility for paternal exposure leading to developmental abnormalities and generally find evidence from both animal and human studies to support the potential for male-mediated developmental toxicity (IOM, 1994, 1996). The Need for a Spina Bifida Program The preceding case studies examine presumptions which serve to fill important evidentiary gaps (either gaps for exposure or gaps for association). The program related to spina bifida de- parts from this pattern in important ways. Strictly speaking, the program for spina bifida is not based on a presumption; however, the program operates in a similar manner as those based on presumptions in the type of evidence that a veteran (and their offspring) is required to produce to claim compensation. The reason for the program for spina bifida is that the existing compensa- tion structure within the Department of Veterans Affairs (VA) does not provide a mechanism for compensating an individual other than the veteran; that is, children with developmental conse- quences of toxic exposures incurred by the veteran cannot be compensated by existing VA mechanisms for presumptions. This program creates a specific exception, allowing for compen- sation for one type of developmental effect (i.e., spina bifida) in specific populations (i.e., chil- dren of Vietnam and Korea veterans). Therefore, this program exists to fill a gap in legal author- ity and policy rather than a gap in evidence. It is important to note that this narrowly tailored program for spina bifida does not address the more general ongoing policy concern that VA is not able to compensate the adverse health

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I-116 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS consequences to offspring of veterans due to exposures they may have incurred during military service. Through the presumptive process, VA can only compensate a veteran. A Brief History of the Spina Bifida Program Reproductive health effects were evaluated by the first IOM Agent Orange committee (IOM, 1994). The Committee concluded that male exposure to toxins could plausibly be linked to ad- verse developmental consequences in their offspring, stating that The 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) However, the committee found the evidence in support of an association between Agent Orange and a range of birth defects to be “inadequate/insufficient” (IOM, 1994, p. 6). In VA’s Federal Register response to the consideration of developmental toxicities associated with Agent Orange exposure, VA noted that 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 vet- erans with developmental effects attributable to Agent Orange exposure would require additional legislative action (VA, 1994, p. 346). In the 1996 Agent Orange report (IOM, 1996), the committee included a specific evaluation of the evidence for the association between Agent Orange and spina bifida as “lim- ited/suggestive.” This classification of the strength of evidence was based on the review of three studies in Vietnam veterans that, although limited in their ability to completely control the ef- fects of bias, were deemed by the committee to be of high quality and demonstrate a consistent pattern of results (IOM, 1996). The three studies are summarized as follows. The CDC VES surveyed Vietnam and non-Vietnam veterans and found that Vietnam veter- ans were more likely to report central nervous system defects in their offspring than non- Vietnam veterans (OR 2.3; 95% CI 1.2-4.5) (CDC, 1989, p. 23). A substudy that attempted to validate these findings with birth records failed to confirm the results, but the substudy was lim- ited by differential participation between Vietnam and non-Vietnam veterans and by the diffi- culty in validating negative responses (CDC, 1988). The CDC Birth Defects Study was a case-control study utilizing a population-based birth de- fects registry in the Atlanta, Georgia area (Erickson et al., 1984a,b). Service in Vietnam was not associated with risk of spina bifida among the offspring of veterans; however, when an exposure opportunity index was used (based on interviews that evaluated which types of activities the vet- eran engaged in during military service), those veterans with the highest estimated level of expo- sure to Agent Orange had the highest risk of having children with spina bifida (OR 2.7; 95% CI 1.2-6.2) (Erickson et al., 1984a,b, as referenced in IOM, 1996, p. 9). This study was limited by the low response rates among both cases and controls and the lag between the birth of the off- spring and exposure assessment. The Ranch Hand study of Air Force personnel involved in herbicide spraying found excess cases of neural tube defects among offspring of the Ranch Hands, with two cases of spina bifida occurring among those with the highest level of exposure, and one case of spina bifida and one of anencephaly occurring among the low-exposure group. No cases of neural tube defects were observed in the nonexposed group (P = .04) (IOM, 1996, p. 9; Wolfe et al., 1995).

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APPENDIX I I-117 In 1996, VA noted the findings in the IOM report and again stated that providing compensa- tion to anyone other than the veteran would require enabling legislation by Congress (VA, 1996). 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 and authorized benefits for children born to Vietnam veterans with spina bifida. Additional legis- lation in 2000 established benefits for “children of women Vietnam veterans with certain birth defects” (Veterans Benefits and Healthcare Improvement Act of 2000. Public Law 106-419 § 401. 106th Cong., 2d Sess.). This law provided benefits to children of female veterans that cov- ered a broad range of defects potentially attributable to maternal exposure during Vietnam ser- vice; however, the law excluded defects that were the result of familial predisposition or of in- jury 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 With the exceptions of the legislative actions to establish the spina bifida program as well as the program for the children of female Vietnam veterans, there continues to be no overall mechanism for compensating the offspring of veterans for health consequences attributable to maternal and paternal exposures incurred during military service. Toxic exposures that occur during military service have the potential to cause adverse developmental effects, and each of the IOM Agent Orange reports (IOM, 1994, 1996, 1999, 2001, 2003, 2005) has described biologi- cally plausible mechanisms for these effects in the offspring of 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 veter- ans’ offspring, the absence of a clear and consistent mechanism and policy on compensating po- tentially affected offspring is notable. The need for a clear policy statement will continue to grow as VA considers the health effects of military service in the large population of reproductive- aged female and male veterans, especially with the growing number of women who serve in the military. 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 VA programs runs counter to principles of consistency and equity that should inform the approach for presumptions. Any new adverse reproductive consequences of Agent Orange exposure identified in the IOM reports would again require legislative action for these specific effects in order for compensation to be granted to the offspring of veterans; the administrative route that has applied to all other Agent Orange pre- sumptions is not available for reproductive consequences of exposure at present. It is worthy of note that the evidence standard for establishing the program for spina bifida was “limited/suggestive evidence of an association” not the more rigorous “sufficient” classifica- tion. The challenges in using this lower evidence classification as the basis for VA’s presump- tions have been described in case studies related to Agent Orange and prostate cancer and type 2 diabetes. References CDC (Centers for Disease Control and Prevention). 1988. Health status of Vietnam veterans: Reproduc- tive outcomes and child health. Vol. 3. Journal of the American Medical Association 259(18):2715- 2719.

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I-118 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS CDC. 1989. Health status of Vietnam veterans: Reproductive outcomes and child health. Vol. 5. Atlanta, GA: Centers for Disease Control. http://www.cdc.gov/nceh/veterans/default1c.htm (accessed July 1, 2007). Erickson, J. D., J. Mulinare, P. W. McClain, T. G. Fitch, L. M. James, A. B. McClearn, and M. J. Adams, Jr. 1984a. Vietnam veterans’ risks for fathering babies with birth defects. Atlanta, GA: Centers for Disease Control. Erickson, J. D., J. Mulinare, P. W. McClain, T. G. Fitch, L. M. James, A. B. McClearn, and M. J. Adams, Jr. 1984b. Vietnam veterans’ risks for fathering babies with birth defects. Journal of the American Medical Association 252(7):903-912. IOM (Institute of Medicine). 1994. Veterans and Agent Orange: Health effects of herbicides used in Viet- nam. Washington, DC: National Academy Press. IOM. 1996. Veterans and Agent Orange: Update 1996. Washington, DC: National Academy Press. IOM. 1999. Veterans and Agent Orange: Update 1998. Washington, DC: National Academy Press. IOM. 2001. Veterans and Agent Orange: Update 2000. Washington, DC: National Academy Press. IOM. 2003. Veterans and Agent Orange: Update 2002. Washington, DC: The National Academies Press. IOM. 2005. Veterans and Agent Orange: Update 2004. Washington, DC: The National Academies Press. VA (Department of Veterans Affairs). 1994. Disease not associated with exposure to certain herbicide agents. Notice. Federal Register 59(2):341-346. VA. 1996. Disease not associated with exposure to certain herbicide agents. Federal Register 61(154):41442-41449. Wolfe, W. H., J. E. Michalek, J. C. Miner, A. J. Rahe, C. A. Moore, L. L. Needham, and D. G. Patterson, Jr. 1995. Paternal serum dioxin and reproductive outcomes among veterans of Operation Ranch Hand. Epidemiology 6(1):17-22.