Veterans and Agent Orange Update 2012 (2014) / Chapter Skim
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6 Epidemiologic Studies: Background on Multiply Referenced Populations
6 Epidemiologic Studies: Background on Multiply Referenced Populations
Pages 145-270
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From page 145... ...
One-time reports on given study populations that addressed only single health outcomes are not discussed in this chapter. In drawing its conclusions, the committee synthesized the evidence from studies that have gathered data and published results over an extended period of time, taking into account the interdependence among related studies.
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According to the policy established by the Agent Orange Act of 1991, studies of Vietnam veterans are presumed to involve relevant exposure, as are studies of workers at a particular plant during a period when it is known to have been producing phenoxy herbicides or other chemicals recognized as having been contaminated with TCDD. In Update 2010, the committee undertook a major change in the formatting of the tables of cumulative results on the health outcomes that was aimed at making relationships among publications more evident for its own deliberations and for the reader.
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The section "Occupational Studies" covers studies of workers other than Vietnam veterans exposed occupationally to the COIs, including production workers, agriculture and forestry workers (including herbicide and pesticide applicators) , and paper and pulp workers.
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Again, there is no specific information on exposure to the COIs. US Air Force Health Study Although no new reports from the Air Force Health Study (AFHS)
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(1995) developed several indexes of herbicide exposure of members of the Ranch Hand cohort and tried to relate them to the measurements of serum TCDD from 1987 to 1992.
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Identical study population counts vary Force Health Study. on occasion within and across cycle what was known to AFHS investigatorsbe considered NOTE: Flowchart numbers reflect reports.
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. Ranch Hands were divided into three categories on the basis of their potential exposure: • Low potential.
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have been deemed not useful for the purposes of the VAO reviews because of the prevalence or cross-sectional nature of the data on only those in the cohort who were still alive and participated in a particular examination. Blood samples for determination of serum TCDD concentrations were drawn at the periodic examinations conducted in 1982 from 36 Ranch Hands (Pirkle et al., 1989)
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. All the VAO updates -- Veterans and Agent Orange: Herbicide/Dioxin Exposure and Type 2 Diabetes (IOM, 2000)
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. The availability of serum TCDD concentrations in a subset of this cohort of Vietnam veterans has made its findings particularly useful in appraising possible associations with various health outcomes.
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Veterans who reported spraying herbicides had significantly higher TCDD serum concentrations than did Vietnam veterans and other veterans who did not report herbicide spraying. The final analysis compared Vietnam-veteran sprayers with Vietnam-veteran nonsprayers in the entire study population.
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A comparison group consisted of female veterans who were identified through the same process as the female Vietnam veterans but had not served in Vietnam during their military service. Demographic information and information on overseas tours of duty, unit assignments, jobs, and principal duties were abstracted from military records.
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Cypel and Kang (2008) conducted a mortality study of female Vietnam veterans and compared their mortality with that in a control group of women who were in military service but did not participate in the Vietnam War.
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Additional information was extracted on veterans who served in SEA, including the first and last dates of service in SEA, the military unit, and the country where the veteran served. For the final sample of 52,253 Army and Marine Corps veterans, cause of death was ascertained from death certificates or Department of Defense Report of Casualty forms for 51,421 men, including 24,235 who served in Vietnam and 26,685 men who did not serve in SEA; 501 deaths were excluded from the final analyses because service in SEA was in a country other than Vietnam or the location of military service was unknown.
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, a computer database containing health information on Vietnam veterans who voluntarily undergo examinations in a VA hospital. The AOR was set up in 1978 to monitor Vietnam veterans' health complaints or problems that could be related to Agent Orange exposure during military service in Vietnam.
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VAO and Update 1998 discuss them in detail; most did not deal with exposure to Agent Orange, and exposure to "combat" was evaluated as the risk factor of interest. US Centers for Disease Control and Prevention Studies Surveys of US Vietnam veterans who were not part of the Operation Ranch Hand or ACC groups indicated that 25–55% believed that they were exposed to herbicides (CDC, 1989a; Erickson et al., 1984a,b; Stellman and Stellman, 1986)
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to test the validity of the various indirect methods used to estimate exposure of ground troops to Agent Orange in Vietnam. The study measured serum TCDD in a nonrandom sample of Vietnam veterans and in Vietnam-era veterans who did not serve in Vietnam (CDC, 1988a)
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The serum TCDD measurements in Vietnam veterans also suggested that exposure to TCDD in Vietnam was substantially lower, on the average, than that of persons exposed as a result of the industrial explosion in Seveso or that of the heavily exposed occupational workers who have been the focus of many of the studies evaluated by the present committee. The assessment of average exposure does not preclude heavy exposure of subgroups of Vietnam veterans.
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(2008) examined the association between Agent Orange and prostate cancer in all Vietnam-era veterans using the VA health system in northern California; the reliability of this study of about 13,000 men is limited by its reliance on self-reported exposure status and the exclusion of prostate cases diagnosed before 1998, when computerized records became available.
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. The reversal of the conclusion on this matter by the committee for Update 2000 is discussed in Veterans and Agent Orange: Herbicide/Dioxin Esposure and Acute Myelogenous Leukemia in the Children of Vietnam Veterans (IOM, 2002)
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. Adjusting for maternal age, infant sex, multiple births, and father's place of birth, conditional logistic regression was used to compare the Vietnam veterans (National Service or regular Army)
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Instead of 180 samples in each of the final exposure categories, the pooled analysis produced only three samples in each category. The lipid-adjusted serum TCDD concentrations in the 12 pooled samples from Vietnam veterans ranged from 0.25 to 1.2 pg/g, whereas the single sample from the non-Vietnam veterans contained 0.3 pg/g.
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in Korean Vietnam veterans who were exposed to Agent Orange during the Vietnam War. OCCUPATIONAL STUDIES Several occupational groups in the United States and elsewhere have been exposed to the COIs.
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Other occupationally exposed groups included were pulp and paper workers exposed to dioxins through bleaching processes that use chlorinated compounds, and sawmill workers exposed to chlorinated dioxins that can be contaminants of chlorophenates used as wood preservatives. Studies of Herbicide Production Workers International Agency for Research on Cancer Phenoxy Herbicide Cohort A multisite study by IARC involved 18,390 production workers and phenoxy herbicide sprayers working in 10 countries (Saracci et al., 1991)
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and four plants in Germany. The 21,863 male and female workers exposed to phenoxy herbicides or chlorophenols were classified in three categories of exposure to TCDD or higher-chlorinated dioxins: those exposed (13,831)
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Dutch production workers The two Dutch subcohorts of the IARC cohort consist of 2,106 male workers employed in two manufacturing factories producing and formulating chlorophenoxy herbicides: 2,4,5-T in factory A during 1955–1985 and 2-methyl-4-chlorophenoxyacetic acid (MCPA) , 2-(2-methyl4-chlorophenoxy)
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The log-linear TCDD model was applied to the workers in factory A only and to the entire cohort, including workers from factory B, who had been exposed only to phenoxy herbicides as confirmed by the serum samples from the 86 factory B subjects who had only background concentrations of TCDD. Saberi Hosnijeh et al.
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. All the plants were involved in production of phenoxy herbicides or chlorophenols.
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(1997) examined cancer incidence and mortality in workers exposed to TCDD after the accident or during reactor cleanup, maintenance, or demolition.
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(2009c) described the group's serum TCDD concentrations overall, and Burns et al.
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, presumably because these participants are relatively young. The inclusion of the incremental participants might dilute the power of the study to detect effects of TCDD exposure on health outcomes that require a long latent period; participants who have not yet "matured" through the latent period might be contributing noise rather than signal to the analyses.
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(2004) studied three birth outcomes -- birth weight, preterm delivery, and birth defects -- in offspring of the cohort members by comparing serum TCDD concentrations with those in a reference population.
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(2011) have reported on cancer incidence in 2,4-D production workers in the Dow Midland plant.
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Cancer incidence was ascertained from the Michigan statewide cancer registry and data linked to Arizona and Ohio, states where cohort members might reside. Three nested cohorts were used for statistical analyses to address potential problems with data that were missing because of migration outside the three states with data linkage.
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(2009b) conducted a mortality study of the Dow PCP production workers with the accrual of years at risk starting at the beginning of 1940.
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The authors used their data to estimate worker exposure at the time of exposure termination by using several pharmacokinetic models. They concluded that their findings were consistent with those of other studies that reported high serum dioxin concentrations in chlorophenol workers after occupational exposure.
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Previous VAO committees concluded that there were methodologic problems of selection bias; lack of control for confounding by educational achievement, tobacco use, or alcohol use; the use of self-reported symptoms; and the lack of an objective measure of exposure. In 2004, Pelclová and colleagues (2007)
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. Rather than measuring serum dioxin, both studies inferred dioxin exposure of individual workers on the basis of dioxin concentrations in air and estimated exposures to polycyclic aromatic hydrocarbons by analyzing two urinary metabolites: 1-hydroxypyrene and 2-naphthol.
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(2009) studied serum dioxin concentrations in 94 former sawmill workers in New Zealand who were classified as exposed (71)
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. The congener profiles in serum were consistent with those in PCP solutions, and dioxin concentrations increased with both employment duration and estimated exposure intensity.
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Weighting factors for key exposure variables were developed from the literature on pesticide exposure. This quantitative approach has the potential to improve the accuracy of exposure classification for the cohort but has not yet been used in published epidemiologic studies.
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, prostate cancer incidence (Alavanja et al., 2003, 2005) , lung cancer incidence (Alavanja et al., 2004)
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Risk estimates were calculated by using unconditional logistic regression for various exposures and controlling for age, smoking, and diabetes. Hoppin et al.
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based on intensity-weighted lifetime days of exposure were used for other chemicals, including 2,4-D, 2,4,5-T, and 2,4,5-TP. Unconditional logistic regression was used to estimate the association between melanoma and exposure with adjustment for age, sex, and other variables "as indicated" (apparently selection through an unspecified variable selection procedure)
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and on cancer incidence
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The final study sample consisted of 776 prostate-cancer cases diagnosed in 1993–2004 and 1,444 controls. Although the primary focus of this substudy was on the interaction between pesticide exposure and genetic markers (how pesticide exposure modified the association between genetic markers and prostate cancer)
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(2011) reported on an updated version of an estimation algorithm for pesticide exposure intensity, developed previously in Dosemeci et al.
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Vital status and cancer incidence were ascertained through a probabilistic record linkage to the California Cancer Registry for the period 1988–2001. Mills and Yang (2007)
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(2008) examined occupational exposures and birth defects in the offspring of OFFHS participants.
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Studies have been conducted in forestry workers potentially exposed to the types of herbicides used in Vietnam. A cohort mortality study examined men employed by a Canadian public utility (Green, 1987, 1991)
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The utility of the findings was limited by their being largely unanalyzed products of linking the country's cancer registry with census records to garner information on recent occupation. Dutch Herbicide-User Studies A Dutch study of forestry workers exposed to 2,4,5-T investigated the prevalence of acne and hepatic dysfunction (van Houdt et al., 1983)
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studied cancer incidence and overall mortality through 1970– 1978 in 1,658 male agricultural plant-protection workers in the former German Democratic Republic who spent a portion of at least 5 years in 1948–1972 applying pesticides. Unlike most of the many pesticides thought to have contributed to the exposure of these workers, the phenoxy herbicides were available for use throughout this period.
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(2005) evaluated a study population that included herbicide production workers and was a subcohort of the IARC cohort.
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Because the systematic followup studies that have been conducted on the Seveso population and the numerous analyses of the large database generated by the continuing US National Health and Nutrition Examination Survey (NHANES) have contributed so prominently to the evidence base considered by VAO committees, this section opens with discussions of these two study populations.
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have not changed the exposure-assessment approach. A number of studies of the Seveso population have used lipid-adjusted serum TCDD concentrations as the primary exposure metric (Baccarelli et al., 2002; Eskenazi et al., 2002a,b, 2003a, 2004; Landi et al., 2003)
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In addition to a 2-year prospective controlled study of workers potentially exposed to TCDD during cleanup of the most highly contaminated areas after the accident (Assennato et al., 1989a) , studies have examined specific health effects associated with TCDD exposure in Seveso residents -- chloracne, birth defects, and spontaneous abortion -- and crude birth and death rates (Bisanti et al., 1980)
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. Mothers' serum TCDD concentrations were measured by using serum samples collected in 1976–1977 and kept frozen since and extrapolated to the time of conception.
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was undertaken to evaluate the association between individual serum TCDD concentrations and reproductive effects in women who resided in Seveso at the time of the 1976 accident. From a pool of 1,271 eligible women who were between infancy and 40 years old at the time of the accident, who had resided in Zone A or B, and for whom adequate serum remained from the samples collected shortly after the explosion, 981 were enrolled in the study group in 1996–1998.
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. It was a small cohort, so the analyses that could be conducted were curtailed, but the availability of serum TCDD concentrations measured from blood samples gathered fairly soon after the single-substance accident (which minimizes uncertainty about what exposure had been experienced and reduces the need for back-extrapolation)
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Initial serum TCDD concentrations at the time of the accident were measured in stored samples from 444 participants (431 collected in 1976–1977 and 13 collected in 1978–1981)
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A rich variety of data -- demographic and socioeconomic data; dietary information; medical, dental, and physiologic assessments; and serum concentrations of persistent organic pollutants (POPs) , including specific congeners of dioxins, furans, and PCBs -- are collected through in-person interviews, health examinations, and blood samples obtained from a nationally representative sample of adults and children in the noninstitutionalized US population.
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Logistic regression was used to derive adjusted ORs, which were stratified by sex and adjusted for age, race or ethnicity, poverty–income ratio, BMI, cigarette-smoking (never, former, or current) , cotinine, alcohol consumption, and leisure-time physical activity (vigorous, moderate, or none)
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(2011) examined the association between urinary arsenic and hypertension and blood pressure in NHANES 2003–2008 participants (4,167)
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(2011) extended the 2010 report by considering the effect of PCBs on the entire range of continuous blood pressure and by investigating 5 PCB groups and 33 individual PCB congeners.
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is a longitudinal birth-cohort study investigating the effect of in utero and postnatal environmental exposures on the health of children who live in the Salinas Valley of Monterey County, California. The study enrolled 601 pregnant women from September 1999 to November 2000 in six prenatal clinics in the largely agricultural Salinas area.
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(2006) measured serum dioxin in New York sport fishermen as part of a study of thyroid function.
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In 2001, the study collected health and exposure histories and measured serum concentrations of 17 PCDD and PCDF congeners in 47 potentially exposed people who were selected nonsystematically from among former workers, their families, and residents. Logistic regression was used to predict the prevalence of health outcomes from TEQs with adjustment for age, race, sex, BMI, tobacco and alcohol use, and worker status.
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participated in a substudy of fish consumption and life habit and provided blood samples that were analyzed for nutrients and environmental contaminants, including dioxins and PCBs. The substudy found higher fish consumption and higher serum dioxins and PCBs in fishermen and their wives than in the general population studied in the 2000 health survey.
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TCDD concentrations in cow's milk measured on three farms near the incinerator were well below the EU guideline of 6 ng/kg of fat, but the concentrations were highest on the farm closest to the incinerator. Floret et al.
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(2010) examined the same population with a case-control study in 2001–2003, comparing 304 infants who had urinary tract birth defects with a random sample of 226 population controls that were frequency-matched for infant sex and year and district of birth.
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Participants were classified as exposed or nonexposed; those exposed were further classified into above or below the median. Multiple logistic regression was used to estimate the association between dioxin exposure and urinary tract birth defects, with adjustment for stratification variables (child's sex and year and district of birth)
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had their dioxin concentrations measured and participated in the mother–child study. Maternal serum concentrations of contaminants were assessed, converted into TEQs, and extrapolated to the time of delivery.
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(2001) presented rudimentary comparisons of cancer incidence and mortality and reproductive outcomes with regional and national rates; residence in the city of Chapaevsk was used as a surrogate for exposure, and no attempt was made to create exposure categories based on factors that might have influenced the degree of TCDD exposure.
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included 989, and 725 were in the prospective analysis. The additional value of POPs on top of standard risk factors was evaluated with the C-statistic and the net reclassification index and the improved discrimination index.
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Ordinal logistic regression was used to model the ordinal outcome of number of involved arteries. A Bonferroni adjustment for multiple testing was applied.
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and who were 30–45 years old. The study aimed to investigate associations between PCDD and PCDF exposure and continuous measures of CVD within 10 years as measured by the Framingham risk score, a formula for combining established risk factors into a single number.
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(2006) examined the association between PCDDs, PCDFs, and PCBs measured in the placenta samples and estrogens and metabolites measured in mothers' blood samples by using Pearson correlations, linear and quadratic regressions, and multivariate regression analyses.
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Marked increases in TCDD concentrations and TEQs were found in ducks, chickens, and fish, but not in pork or beef. The study concluded that food appeared to be responsible for the increase in TCDD in residents of Bien Hoa City even though the original Agent Orange contamination occurred 30–40 years before sampling.
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; neuropsychologic effects in Germany (Peper et al., 1993) ; mortality and cancer incidence in two cohorts of Swedish fishermen whose primary exposure route was assumed to be diet (Svensson et al., 1995)
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. Residents near a rural incinerator had significantly higher serum dioxin concentrations than did a control group (38 vs 24 TEQ pg/g of lipid)
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Any subject who reported at least 10 hours of pesticide exposure per year was asked to complete a telephone questionnaire on the details of pesticide exposure; in addition, 15% of the remaining subjects were randomly selected to answer the telephone survey. Conditional logistic regression stratified on age and province and adjusted for all covariates found to be associated with the outcome at the 0.05 level of significance was used to estimate ORs for specific active ingredients, including dicamba and the phenoxy herbicides 2,4-D, Mecoprop, MCPA, and diclofopmethyl.
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Upper Midwest Health Study The Upper Midwest Health Study (UMHS) was initiated by NIOSH as a population-based case-control study of cancer risk in a nonmetropolitan Midwestern US population.
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(2012) has reported findings from new analyses of the UMHS sample that incorporated more detailed exposure information that was not used in previous analyses, including years of use and estimated cumulative exposures to categories of pesticides, including phenoxy herbicides, and use of specific agents, including 2,4-D and dicamba.
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; STS and malignant lymphomas in the Victorian Cancer Registry of Australia (Smith and Christophers, 1992) ; oral-cancer risk in occupationally exposed workers in Sweden (Schildt et al., 1999)
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; birth defects in offspring of agriculture workers (Nurminen et al., 1994) ; mortality from neurodegenerative diseases associated with occupational risk factors (Schulte et al., 1996)
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No specific COIs were reported beyond the broad category "herbicide." Unconditional logistic regression was used to estimate the association between PD and exposure, with adjustment for age, sex, and smoking. Firestone et al.
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2005b. Cancer Incidence in Australian Vietnam Veteran Study 2005.
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2003. Use of agricultural pesticides and pros tate cancer risk in the Agricultural Health Study cohort.
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2005. Cancer incidence in the Agricultural Health Study.
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American Journal of Industrial Medicine 16:119–125. ATSDR (Agency for Toxic Substances and Disease Registry)
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1996. Cancer mortality in German male workers exposed to phenoxy herbicides and dioxins.
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2011. Impact of pesticide exposure misclassification on estimates of relative risks in the Agricultural Health Study.
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American Journal of Industrial Medicine 23:289–300. Bullman TA, Kang HK.
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2005. Gliomas and farm pesticide exposure in women: The Upper Midwest Health Study.
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2008. Agent Orange exposure, Vietnam War veterans, and the risk of prostate cancer.
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2011. An updated algorithm for estimation of pesticide exposure intensity in the Agricultural Health Study.
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British Journal of Industrial Medicine 48:173–178. Collins JJ, Strauss ME, Levinskas GJ, Conner PR.
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2008. Hearing loss among licensed pesticide applicators in the Agricultural Health Study.
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2005. Pesticide use and breast cancer risk among farmers' wives in the Agricultural Health Study.
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2006. Pesticide exposure and timing of menopause: The Agricultural Health Study.
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2004. Cancer risk and parental pesticide application in children of Agricultural Health Study participants.
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1986. Final Report: A Case-Control Mortality Study on the Association of Soft Tissue Sarcomas, Non-Hodgkin's Lymphomas, and Other Selected Cancers and Vietnam Military Service in Pennsylvania Males.
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American Journal of Industrial Medicine 3:247–257.
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2006a. Pesticides as sociated with wheeze among commercial pesticide applicators in the Agricultural Health Study.
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American Journal of Industrial Medicine 50(12)
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2007b. Pesticide exposure and self-reported Parkinson's disease in the Agricultural Health Study.
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2001. A study on the correlation between catego rizations of the individual exposure levels to Agent Orange and serum dioxin levels among the Korean Vietnam veterans.
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1992. Cancer mortality from soft-tissue sarcoma and malignant lymphomas in an international cohort of workers exposed to chlorophenoxy herbicides and chlorophenols.
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2007b. Association between serum concentrations of persistent organic pollutants and insulin resistance among nondiabetic adults: Results from the National Health and Nutrition Examination Survey 1999–2002.
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2007. Pesticide use and colorectal cancer risk in the Agricultural Health Study.
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1999b. Serum dioxin and immunologic response in veterans of Operation Ranch Hand.
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2008. Incident diabetes and pesticide exposure among licensed pesticide applicators: Agricultural Health Study, 1993–2003.
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2006. Association between Agent Orange and birth defects: Systematic review and meta-analysis.
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1996b. The Australian Vietnam Veterans Health Study: II.
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2012. Determinants of high pesticide exposure events in the Agricultural Health Cohort Study from enrollment (1993–1997)
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1989. Estimates of the half-life of 2,3,7,8-tetrachlorodibenzo-p-dioxin in Vietnam veterans of Operation Ranch Hand.
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2007. Pesticide exposure and self-reported gestational diabetes mellitus in the Agricultural Health Study.
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2006. Cancer incidence among pesticide applicators exposed to dicamba in the Agricultural Health Study.
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American Journal of Industrial Medicine 9:305–321. Stellman SD, Stellman JM, Sommer JF Jr.
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. American Journal of Industrial Medicine 23:845–858.
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1997. The Agricultural Health Study: Factors affecting completion and return of self-administered questionnaires in a large prospective cohort study of pesticide applicators.
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2007. Chronic bronchitis among nonsmoking farm women in the Agricultural Health Study.
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2002. Serum dioxin concentrations and breast cancer risk in the Seveso Women's Health Study.
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1995. Paternal serum dioxin and reproductive outcomes among veterans of Operation Ranch Hand.
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2012. The Upper Midwest Health Study: A case-control study of pesticide applicators and risk of glioma.
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