Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL, Phase 2 (2010) / Chapter Skim
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BACKGROUND AND INTRODUCTION
BACKGROUND AND INTRODUCTION
Pages 5-15
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Technical Input on the National Institutes of Health's Draft Supplemental Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report (2007)
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5 NRC. Technical Input on Any Additional Studies to Assess Risk Associated with Operation of the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report (2008)
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Following each meeting with the BRP , the NRC Committee in closed session will prepare brief letter reports on the preliminary results of the supplementary risk analyses, focusing on whether the analyses are scientifically and technically sound in general and whether they address the public health concerns previously raised by the NRC in its review of the July 2007 DSRASSA. These letter reports will be made available to the public.
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The results of modeling are only as good as the quality of the modeling inputs, and the problemof limited data should be addressed in narrative, with supporting scientific rationale for its interpretation, as part of a comprehensive qualitative analysis for the 13 pathogens. Instead, NIH and its contractors used a modified Delphi process to gather expert opinions that were then used as a substitute for data for modeling.
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Use of a Delphi Process to Generate Dose-Response Relationships The committee is very concerned about the method by which dose-response assessment -- a critical element of risk assessment for prediction of human infection, morbidity, and mortality -- is being handled in the contractor analyses. The committee was informed that NIH elected to use a "modified Delphi method" to generate dose response estimates due to the absence of human data for predicting infections.
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As one example already mentioned above, it is inadequate to consider that the uncertainty in the dose-response relationship could be represented as a question of which of the eight Delphi process experts is correct, when another possibility is that none of the curves developed from the three points elicited from each expert provide the true human dose-response curve. Nor is it adequate to state that the results of fitting models to three median point estimates from 8 experts for 13 pathogens "tracked the literature" when the referenced studies represent an incomplete understanding of the available literature.
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Such transfers can lead to diverse outcomes, for example, no secondary transfer in a recent case of tularemia in Maryland, but transfers producing secondary infections from laboratories studying more highly contagious pathogens. Scenarios for infection outside leading to secondary transmissions should be considered in addition to the centrifuge example, particularly where there are documented case studies of LAIs.
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. V ulnerable Populations The September 2010 presentations indicated that the Tetra Tech team had identified the vulnerable or sensitive groups as "those 5 years of age or younger, those 65 years of age or older, those with diabetes mellitus, those with HIV/AIDS, and those who are pregnant." The report from the modified Delphi process with the expert panel listed the median percentage increases in vulnerability to disease and death among these five groups.
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The South Boston and Roxbury neighborhoods that are potentially affected by the NEIDL facility have been identified as environmental justice communities and a vulnerable population analysis should take that into consideration. These communities suffer from higher rates of several chronic diseases, including asthma, which is not one of the higher risk factors presented, and have a much greater population density (see discussion below on dispersal modeling)
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They may also provide ground truth examples for how potential time of exposure to a pathogen compares to time of recognition of an LAI, secondary transmission of the disease, and the effectiveness of treatment. There are a number of well-documented accounts of recent LAIs that could be used in the development of brief case studies to illustrate more clearly the effect of infected laboratory workers on community health.
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The committee intended that this first tier of qualitative analyses would then be supplemented by second tier quantitative analysis for a subset of agents as necessary for decision making. However, instead of beginning with a first tier qualitative analysis of both direct and indirect scientific evidence to bound the analysis for the 13 pathogens, a modified Delphi process was used to gather expert opinions on multiple unknown parameters.
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