Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects (2018) / Chapter Skim
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2 Evaluation of the Report
2 Evaluation of the Report
Pages 11-23
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From page 11... ...
PERFORMANCE WORK STATEMENT The contract for the Report was for a literature review and assessment of potential long-term health effects from more than 100 agents the Army tested on human subjects. Three objectives were specified: (1)
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The reason that omission of the literature strategies and screening criteria from the Report is problematic is described in the section below on Best Practices in Hazard Identification. Evaluation of Information The contractor was asked to describe the potential long-term health effects from the test agents.
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Furthermore, as noted earlier in reference to the conclusions in Table 18, simply classifying the evidence as high, medium, or low for an agent without reference to specific health effects is not useful. Other Observations on the Report The contract for the Report specifies that long-term health effects are to be the focus of the literature review and analysis.
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From page 14... ...
The hazard identification frameworks for noncancer health effects used by EPA, NTP, and the IOM also consider human, animal, and mechanistic evidence; however, in contrast to the cancer hazard identifications, mechanistic data are largely used to support classifications on the basis of human and animal data. The methods used to determine causality in noncancer hazard identification vary slightly between organizations; the IOM methods (e.g., IOM, 2000, 2012; NASEM, 2016)
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EXAMPLES OF MISSED STUDIES AND HEALTH EFFECTS Although the committee did not evaluate the completeness of the literature search for all test agents reviewed in the Report, committee members with subjectmatter expertise had concerns that key studies were missing for a subset of test agents, specifically cyanide, the organophosphates sarin and diisopropylfluorophosphate (DFP) , and sulfur mustard.
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Nonetheless, the results of this exercise raise questions regarding the completeness of the literature search. The committee's review of missed studies raised concerns that the Report may have also missed long-term health effects associated with specific test agents, as exemplified in Table 2-2 for cyanide, sarin, and sulfur mustard.
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From page 17... ...
TABLE 2-1 Examples of References Missing from the Report Test Agent Health Effect Missing References Cyanide Neurological impairment: memory deficits, Baud et al.
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The Report did not provide the necessary documentation and analysis to address the performance requirements of the contract and did not follow standard best practices in performing literature reviews in support of hazard identification. The major concerns include failure to document the literature search and screening strategies; inadequate evaluation and synthesis of the literature to explain how an agent was judged to have evidence of long-term health effects; and insufficient information to understand how strength-of-association determinations were made.
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2011. Delayed toxic effects of sulfur mustard on respiratory tract of Iranian veterans.
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2008. Parkinsonism and cognitive impairment following chronic exposure to potassium cyanide.
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2016. Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Med ications and Substances: Literature Review and Analysis.
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2016. Repeated low-dose organophosphate DFP expo sure leads to the development of depression and cognitive impairment in a rat model of Gulf War Illness.
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Delayed cyanide induced dystonia.
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