Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects (2018) / Chapter Skim
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3 Evaluation of the Army's Causation Methodology
3 Evaluation of the Army's Causation Methodology
Pages 24-34
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From page 24... ...
The sections most relevant to the committee's charge of reviewing the approach to evaluating "agent- and outcome-specific associations" are presented in Sections 7, 8, and 9 of the Memorandum, which cover the Review and Adjudication Process, Causation Methodology, and Documentation, respectively. REVIEW AND ADJUDICATION PROCESS Section 7 of the Memorandum states that the BAP will review and adjudicate applications from veterans on the basis of previous literature reviews and case-specific reviews, including consideration of extrinsic medical evidence and records from the Army and the Department of Veterans Affairs.
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From page 25... ...
. Because the IOM Vaccine Approach was developed for the specific purpose of evaluating adverse effects of vaccines, the Memorandum indicates that the methods will be modified to suit the different test agents that the Army has to consider.
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A final consideration is whether exposure to multiple agents or mixtures of test agents occurred. The Report described several testing programs that involved tests with different types of agents.
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. Similar types of frameworks have also been developed for the purpose of informing decisions related to compensation for adverse health effects associated with specific exposures, which have applicability to the Army's need to respond to medical claims from former test subjects.
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. The IOM Agent Orange Approach was slightly modified and applied to assess potential health effects from exposures to a variety of agents used during the 1990-1991 Gulf War (IOM Gulf War Approach)
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Studies with similar strength of association and validity are given equal weight. In the IOM Agent Orange and Gulf War Approaches, a qualitative analysis and scientific judgment is used to evaluate the evidence.
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For this reason, the IOM Agent Orange and Gulf War Approaches for assessing the long-term health effects of exposures have not used case reports in their evaluations, but rather rely more on animal studies. Integration of Evidence In the IOM Agent Orange Approach (e.g., NASEM, 2016b)
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From page 31... ...
Although the committee agrees that the four categories of causality in this framework may be appropriate for the assessment of potential long-term health effects on the former test subjects, the framework is most appropriate when a large amount of human data is available, as is the case with most vaccines. This framework may not be as applicable for assessing the potential long-term health effects for the different types of agents used in the Army testing programs.
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From page 32... ...
32 FIGURE 3-1 Process of reviewing epidemiological and mechanistic evidence in the IOM Vaccine Approach.
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From page 33... ...
2016. Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis.
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From page 34... ...
2016c. Gulf War and Health: Volume 10: Update of Health Effects of Serving in the Gulf War, 2016.
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