Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects (2018) / Chapter Skim
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From page 1... ...
The tests investigated the immediate or short-term health effects from acute exposure to understand vulnerabilities to attack. Whether the exposures could have resulted in longterm health consequences to the test subjects has been assessed periodically, and the Army is required to notify subjects of information relating to potential health effects associated with exposure to the test agents.
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The only information provided about the literature searches and screening in the Report was the date range of the searches, so the committee was unable to determine whether the scope of the searches was adequately comprehensive or whether the most relevant references were selected for the analyses. The Report provided short summaries of the evidence without critical evaluation of the individual studies or any substantive synthesis of the collective evidence to explain how an agent was judged to have adequate or inadequate evidence of long-term health effects.
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However, the approach as designed is most appropriate when a large amount of human evidence-based data is available, as is the case with vaccines, which could limit its applicability for assessing the potential long-term health effects from the different types of test agents used in the Army testing programs. Therefore, the committee questions whether the IOM Vaccine Approach, beyond the categories of causality, is the most suitable for the Army's purposes.
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These factors include whether the test subject's exposure was of sufficient magnitude to produce the alleged medical condition, whether the exposure was temporally related to the onset of the alleged medical condition, whether alternate causes of the medical condition can be ruled out, and whether there is coherence and consistency in the evidence. The Army has noted that information on individual test subjects, such as exposures they experienced and potential confounders, are unlikely to be available, and this will limit the ability of the BAP to draw definitive conclusions with respect to specific causation.
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STRATEGY FOR EVALUATING POTENTIAL LONG-TERM HEALTH EFFECTS IN ARMY TEST SUBJECTS The committee's proposed strategy for evaluating potential long-term health effects in Army test subjects is outlined in Figures S-1 and S-2. This strategy is based on best practices in hazard identification and systematic review, which the Army can tailor to its needs.
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6 Evaluating Long-Term Health Effects in Army Test Subjects Step 1: Agent prioritization Step 2: GO to Step 6: Problem formulation Authoritative hazard assessment available Step 3: Literature search and screening STOP Insufficient evidence for Step 4: hazard ID Data analysis and synthesis Step 5: Evidence integration Step 6: Hazard ID conclusions FIGURE S-1 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances.
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From page 7... ...
, and strength of association FIGURE S-2 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances. Abbreviations: ACGIH, American Conference of Governmental Industrial Hygienists; ATSDR, Agency for Toxic Substances and Disease Registry; EPA, U.S.
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