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5 Looking to the Future Process for DRI Development: Session 4
Pages 123-150

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From page 123...
... examined some considerations in specifying "new" nutrient substances for DRI study. Discussions open to all audience members were held after each presentation, and a panel discussion in which panel members reflected on what they had heard about DRI development during the workshop closed the session.
From page 124...
... A second conceptual evolution was the move from basing recommendations on observations of usual food intake to using the emerging scientific knowledge of the needs for essential nutrients and energy to provide specific nutrient recommendations. From 1941 -- when the Roosevelt administration asked the National Research Council (NRC)
From page 125...
... recommended that the public and professionals look to the IOM report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989b) for more information about dietary intakes as they relate to chronic disease prevention.
From page 126...
... Some factors important to the DRIs of the future are described briefly below. Scientific progress will further our approaches, methodologies, and insights: • Undoubtedly scientific progress will move us from the consideration of single nutrients to patterns of nutrients or food intake, especially for chronic disease endpoints.
From page 127...
... It also puts more responsibility on the IOM in terms of communication within the risk analysis paradigm, com munication with the sponsors, and communication with the scientific community. Implications The issues raised about DRI development offer direction for the kinds of information needed and identify the steps to be taken to improve future DRIs.
From page 128...
... Dr. Woteki suggested that the decisions about the nature of questions to be directed to study committees are an enormous and complex responsibility that, under the risk analysis paradigm, includes input from sponsors of the DRI process.
From page 129...
... The reasons for this are unclear because the narratives in their reports are not explicit. For vitamin B6, in North America, the tolerable upper intake level (UL)
From page 130...
... Apparently the research gaps identified by study committees were often compiled
From page 131...
... An overall effort at transparency would have called attention to this approach and perhaps improved it, making it more deliberative. Configuration of Study Committees Finally, improved transparency has the potential to ameliorate the nearly inevitable problems associated with configuring study committees.
From page 132...
... Russell, a clear problem formulation step or an indication of the uses of the needed reference values, particularly regarding the intended population, would have helped to enhance clarity. She then asked about the composition and functioning of study committees, suggesting there were two models.
From page 133...
... Nature of Consensus Report Development and Opportunities for Input Reports produced by consensus committees tackle major health issues, such as DRIs, obesity prevention, overhaul of the Food and Drug Administration's drug review system, medical errors, and health literacy. As the backbone of the Academies' activities, the committee studies are the most visible.
From page 134...
... The committee deliberates in closed sessions to allow its members to debate ideas without fear of outside influence and to change their minds as they consider evidence, which is all part of the process. Written materials given to the committee from the outside are put in Report Released Committee Meetings, Information Report Committee Gathering, Deliberations, Review Study Selection and and Dissemination Defined and Drafting Approval Report Approval Dissemination Planning FIGURE 5-1  Opportunities for input into the consensus study process.
From page 135...
... Input can be provided through a variety of mechanisms, and within the procedures, there is room for creativity and flexibility. Open Discussion An audience member suggested another option in addition to the use of IOM study committees as the source of scientific reviews to inform DRI development.
From page 136...
... Her personal experience in government suggested that when the Dietary Guidelines for Americans committees had access to science reviews prepared by the IOM or in some cases NIH, the model for the development of guidance worked well. However, when this scientific input was lacking, the government advisory committees for the dietary guidelines experienced many more challenges.
From page 137...
... We will have the opportunity to put more experts on the study committee who are familiar with the specific nutrients and their research areas, as well as additional specialists, such as biostatisticians, who could not be included on previous study committees. This will facilitate more fruitful deliberations.
From page 138...
... Suttie said this could be examined in the future. Another participant noted that the existing reference values lose credibility as medical societies and other organizations offer different recommended intakes, presumably based on newer data.
From page 139...
... Threshold Considerations The first task related to the use of research to inform public policy is whether there are enough research data to even begin. In the field of nutrition, there are often not enough data because of insufficient investment in the basic or clinical nutritional sciences to provide the groundwork for these considerations.
From page 140...
... . our purposes, it is important to note that the most definitive studies are randomized controlled clinical trials (buttressed by basic nutritional science)
From page 141...
... , decreased total cancer mortality by 13 percent, and de creased total gastric cancer mortality by 21 percent (Blot et al., 1993)
From page 142...
... Complicating the issue further was the observation that what benefited overall mortality, total cancer mortality, and stomach cancer mortality appeared to be detrimental against esophageal cancer mortality. This indicates that the overall effect must be considered if assessing the effects of nutrients on a population at large or major subgroups of the population.
From page 143...
... To underscore the importance of "getting the science right," we need only turn to a recent article in the New York Times Magazine written by a respected science reporter. It was entitled "Why can't we trust much of what we hear about diet, health and behavior-related diseases?
From page 144...
... He emphasized that a true disease endpoint must be identified, covering multiple categories of disease over a sufficient period of time and taking into account individual variability. A participant asked about an approach for food components such as macronutrients that cannot easily be studied in randomized clinical trials or similar types of research.
From page 145...
... It was noted that the way in which the scientific concepts are "put together" in the DRI reports is essential to stakeholder understanding -- and acceptance -- of the process and the reference values and the process used to create them. The process must be clear, transparent, and understood by stakeholders, or the credibility will suffer.
From page 146...
... Finally, she suggested that changes in the food supply should be taken into consideration and we should ensure the availability of high-quality food composition databases as well as relevant expertise within DRI study committees.
From page 147...
... Research Priorities A question was asked about approaches for setting priorities given that the study committees had identified research gaps. A panelist suggested it would be useful to identify a coalition of stakeholders who would specify the top five research priorities based on the existing IOM effort to synthesize the research gaps.
From page 148...
... For the DRI project, a small percentage of support was obtained from the Dietary Reference Intakes Private Foundation Fund and the Dietary Reference Intakes Corporate Donors' Fund. International Collaboration An audience member noted that the European Food Safety Authority (EFSA)
From page 149...
... Dr. Habicht responded that "false" AIs appear to DRI users to have been based on the well-established approach of deriving a recommended intake using a population intake level.
From page 150...
... Such studies outline the physiology involved, and offer a direction for focused human research. He underscored that animal data are not used to extrapolate values for humans, but rather provide information for designing the needed human clinical trials.


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