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    The current case-control study of birth defects and childhood cancer should be completed, given the effort already invested, despite severely limited statistical power. To the extent that simple categories of exposure will be used in the final analysis, the rationale for waiting for complex water modeling to be completed is unclear. A broader consideration of health effects would be needed to provide scientific evidence to answer questions regarding the possible effects of water-supply contamination. However, some information on the population that completes the health survey would be available. Cases are confirmed birth defects diagnosed by the age of 5 years or childhood cancers diagnosed by the age of 20 years. The study methods used in the two analyses will be presented here first, followed by the results of each. Even with the uncertainty about the total number of cases that will eventually be included in the analysis and even under the more optimistic scenario, statistical power is low.

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    Thus far, the research on the Camp Lejeune population has been limited with respect to the scope of health outcomes considered and the quality of exposure assessment. Historical contaminant-exposure estimates are difficult to construct and might be impossible to quantify with any confidence in the absence of contaminant measurements taken during the period of concern, no matter how elaborate the water models are. The housing records, which contained dates of residence, were used to estimate the dates when the mother resided in base housing units. Infants whose mothers were transferred or moved away from Camp Lejeune before giving birth were not included. That population did not include births to mothers who resided on the base during pregnancy but were no longer residents of Onslow County at the time of delivery. The review concluded that previous studies supported evaluation of a variety of health effects, predominantly cancers, in future studies at Camp Lejeune. Those are reasonable strategies but are of unknown feasibility. Even if all the information on the population, exposure, and health outcomes could be obtained, consideration should be given to whether the cost and time required to conduct more definitive studies justify the likely delay in or distraction from resolving the public-health concerns and the controversy that has developed around the issue. SGA, defined as below the 10th percentile of weight for gestational age, was calculated by using published sex-specific growth curves for white newborns in California Williams et al. It is not clear that the cancer-incidence study or the health survey would be successful; success in the former would be contingent on the cooperation of many cancer registries, and success of the latter on generating an adequate response. Other limitations in exposure classification in these studies are more difficult to correct. Reanalyses should include development of a detailed written analysis plan for example, Sheppard ATSDR has proposed to use water-system modeling as a way to improve the quantification of exposure. In spite of the reported difference, the birth-weight results were said to show no association, because the magnitude of the difference was viewed as clinically negligible. One major problem is that the number of people available for the study may be too small to generate statistically meaningful results related to rare outcomes of greatest interest such as kidney cancer. Fourth, exposure was determined exclusively by place of residence, excluding workplace and other locations in which exposure may have occurred. Specific subgroups showed statistically significant effects, but no formal hypothesis test for the presence of interaction between subgroups defined by maternal age or history of fetal loss was mentioned. No risk of any of the outcomes was found in the temporarily exposed population with a maximum exposure duration of 12 days. Realistic estimates of the time required to conduct the study are needed, particularly in light of the long history of concerns regarding contaminated water and health at Camp Lejeune. Controls will be randomly selected from all other births included in the survey to attain a target of 10 controls for each case. Given the lack of information on which wells were used to supply water on any particular day, the quality of exposure estimates based on water-system modeling is highly uncertain, especially for the quantification of PCE and TCE concentrations over the short periods of interest for the study of birth defects. With those concerns layered on the previously noted problems regarding the accuracy of exposure assessment, it is not clear what the scientific value of additional studies would be. The same recommendations noted for the study of preterm birth and fetal growth apply here as well, including careful planning of analytic methods and full documentation. Another major limitation of the study is the inadequate statistical power to detect associations in a plausible range. The statistical power to compare groups of interest across the array of outcomes of interest was not provided.

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