Difference between revisions of "Benefit-risk assessment of food supplements"
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==Result== | ==Result== | ||
| − | + | ===The methodology for benefit-risk assessment (BRA) for plant-based food supplements (PFS) === | |
| − | * [[Margin of exposure]] (MOE) | + | |
| − | * [[Acceptable daily intake]] (ADI) | + | Most assessment methods are built on the idea of producing scientifically valid estimates about the measure of interest, such as acceptable daily intake or net health impact of consuming a PFS. The proposed method has a different starting point. It is based on the idea of a society (e.g. the EU) that needs to take actions related to a PFS. The BRA is performed to inform the society (or its representatives such as EFSA) to make wise decisions about the PFS. The decision-making process is inevitably bound to information available, information produced by an assessment, and value judgements in the society. Therefore, the BRA should try to capture also the practical needs of decision making and the values of the society. A useful BRA is much wider a thing than a net benefit estimate. |
| − | * Quantitative [[:Category:benefit-risk assessment|benefit-risk assessment]] | + | |
| + | The suggested methodology has four tiers or phases. They typically proceed from I to IV but it is also typical that tiers will be revisited based on new information occurring during the assessment. | ||
| + | |||
| + | |||
| + | |||
| + | '''Tier I: Definition of the use purpose and scope of a BRA | ||
| + | |||
| + | In the first tier, the use purpose of an assessment is defined by answering an overall question: what are the practical needs of this decision-making situation, and what information should be produced in the assessment to serve this practical need? To answer this question, several more specific sub-questions are asked: | ||
| + | # What are the research questions whose answers will bring the information needed by decision makers in this situation? Common types of questions include but are not limited to following: | ||
| + | #* Is the health claim X (e.g. improves immunity) of a PFS product Y acceptable, i.e. does it hold against observations and scientific criticism? | ||
| + | #* Is the content claim X (e.g. rich source of antioxidants) of a PFS product Y acceptable, i.e. does it hold against observations and scientific criticism? | ||
| + | #* What are the magnitudes of beneficial and harmful health effects of consuming a PFS product Y using typical doses? | ||
| + | # What are the spatial, temporal and other boundaries within which the assessment should be performed? | ||
| + | # Who are the intended users of the assessment and what is the intended use? It is especially important that the users identified actually participate in the making of the assessment, not just read a ready-made report. This is because user's needs should drive the purpose, content, and making of an assessment, and this is best ensured by active participation. | ||
| + | # Who is not allowed to participate in the assessment? The default is that anyone interested is allowed. Exceptions should be explicitly mentioned and reasons for exclusion should be given. In traditional risk assessments, it was typical that the actual user (e.g. a policy-maker) was not allowed to participate in an assessment due to a potential attempt to manipulate the assessment outcomes. In the proposed methodology, it is essential that the users participate, as was mentioned before. However, it is also essential that several other parties participate as well to identify and prevent any attempts to manipulate outcomes by users or any other group. | ||
| + | # What are the particular scenarios that are considered in the assessment (e.g. business as usual vs. targeted restrictions of use of a particular PFS)? | ||
| + | |||
| + | |||
| + | '''Tier II: Definition of the decision criteria | ||
| + | |||
| + | In the second tier, the criteria that the decision maker wants to use in the decision making process are defined. There are several ways to approach this, and again the definition is based on the practical needs of the particular situation. | ||
| + | * [[Margin of exposure]] (MOE): Based on toxicological information, a safe exposure level (NOAEL) is estimated. This level is divided by the current exposure levels. The higher the ratio (MOE), the more sure we can be that there is no hazard. | ||
| + | * [[Acceptable daily intake]] (ADI): Maximum amount of an agent, expressed on a body mass basis, to which an individual in a (sub)population may be exposed daily over its lifetime without appreciable health risk. If the actual exposure is smaller than ADI, there is no concern. | ||
| + | * Quantitative [[:Category:benefit-risk assessment|benefit-risk assessment]]: both beneficial and harmful health effects of a PFS product are quantitatively estimated. Typically, different effects are summed up using e.g. [[DALY weights|disability weights]], and decisions are made based on the net health effects. | ||
| + | * Estimation of a safe level of exposure: A PFS product may have a safe level of exposure. This means that there is a level where the exposure is high enough to cause a low probability of no benefit but low enough to cause a low probability of harm. | ||
| + | * Avoidance of harm: This is an approach where the emphasis is on harms: if exposure to a PFS product may cause harm, its use should be restricted and possible benefits are irrelevant. Only if potential harm is low, benefits are evaluated to find out whether the product can be recommended. | ||
| + | * If the question is about acceptability of a health or content claim of a PFS product, there is a need for clear criteria about what evidence is enough to accept or reject the claim. | ||
| + | |||
| + | |||
| + | '''Tier III: Information production | ||
| + | |||
| + | Tier III is about producing information needed in the decision making as described in Tiers I and II. It is useful to note that e.g. the BRAFO approach tiers all belong to Tier III. Therefore, the proposed methodology has a wider scope within the assessment-management sphere. | ||
| + | |||
| + | This tier can be clarified by listing several tasks related to information production. | ||
| + | * Collecting data | ||
| + | * Building (quantitative) models | ||
| + | * Making conclusions and writing descriptions based on tasks above. | ||
| + | * Making value judgements about e.g. the estimated outcomes of interest. | ||
| + | * Evaluating the content within the assessment: peer review, discussions, hypothesis testing. | ||
| + | |||
| + | |||
| + | '''Tier IV: Information use | ||
| + | |||
| + | Tier IV links the information production into the actual use. This tier contains the making of recommendations and conclusions based on information collected and value judgements used to interpret the information. Dissemination is a crucial part of the assessment, although it should be noted that as most interested parties are expected to participate in the whole assessment process, dissemination happens during the whole work and not just after final conclusions have been made. | ||
| + | |||
| + | Tier IV also has another important aspect: evaluation of the status of the assessment. Is the current information good enough to answer the practical needs identified in the beginning? Are the current conclusions scientifically acceptable and useful? Should more work be performed in some parts of the assessment to improve them? The evaluation of the status typically leads back to one of the previous tiers, until the practical needs have been addressed and the assessment ends. | ||
==See also== | ==See also== | ||
| Line 73: | Line 118: | ||
* [[:heande:Margin of exposure for selected food supplements|Margin of exposure for selected food supplements]] | * [[:heande:Margin of exposure for selected food supplements|Margin of exposure for selected food supplements]] | ||
* [[:heande:State of the art of environmental health assessments|State of the art of environmental health assessments]] | * [[:heande:State of the art of environmental health assessments|State of the art of environmental health assessments]] | ||
| + | |||
| + | ==Keywords== | ||
| + | |||
| + | Assessment method, plant-based food supplements, benefit-risk assessment. | ||
==References== | ==References== | ||
Revision as of 22:22, 8 December 2010
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Risk-benefit assessment for food supplements is a method about making assessments for plant-based food supplements (PFS).[1]
This page is a Plantlibra deliverable (see all). <section begin=plantlibra />
- Name: DWP5-1 Risk-benefit methodologies
- Responsible partner: THL, Jouni
- Deadline: June 2011
- Status: Scoping started
<section end=plantlibra />
Contents
Scope
What is a good method for making benefit-risk assessments for plant-based food supplements such that it has the following properties?
- The valuations and expectations are in line with what a typical user of PFS would think (i.e., if a PFS BRA and its conclusions are explained to a typical user, the user is not negatively surprised about what was done).
- It offers a clear guidance for a relevant authority to perform a PFS BRA in practice.
- It offers a clear guidance for a relevant authority to evaluate nutrition and health claims of a PFS.
- The method is coherent with the methods used for the neighbouring areas, namely foods and medicine, especially with borderline products.
How is the method validated?
Definition
Based on findings reported in the review (DWP5-1) and a preliminary conceptual workshop held
at the kick-off meeting (MWP5-1), a risk-benefit assessment methodology will be proposed and
tested in selected case-studies. The methodology, to be developed in Opasnet, should be
organized in tiers, allowing to identify risk-benefit scenarios and to address qualitatively
scenarios (e.g., through MOE, ADI) where risks or benefits are not overlapping. After
preliminary testing of the methodology on at least 5 case-studies drawn from the PlantLIBRA
list of case-studies, the report will be submitted for review to partners and to the three
advisory boards; their feedback will be discussed, aligned with outcomes of WP2 (benefits,
specifically definition of benefits and integration of various types of evidence), WP3 (risks and
new approaches for risk assessment) and WP4 (acute risks, specifically epidemiological
evidence), and integrated at the second project meeting. Uncertainty will be described and
estimated when possible. The final report will be published alongside with a generic Analytica
software tool to explore risk and benefits (DWP5-1).
Task leader: THL
PM: THL 5, Hylo 3, UMIL 0.5
A review of the concepts of validation and fit-for-purpose in the field of risk, benefit and risk-
benefit assessment will be conducted by Hylo in peer-reviewed literature and reported (DWP5-
1). Following review by partners and advisory boards, a protocol with requirements to assess
fit-for-purpose and to validate (potentially against unused data-sets) the different assessment
methodologies will be prepared using the Opasnet platform and reported by THL (MWP5-2).
Task leader: THL
PM: THL 6, Hylo 3
Safety factor thinking would lead to bizarre outcomes with benefits. For risks, the question is: "Taken into account human variability, what is a dose where we can be sure that there is no risk?" Then we apply a safety factor, e.g. divide a NOAEL with 10. But with benefits, using the same logic, we should ask: "Taken into account human variability, what is a dose where we can be sure that there is no benefit?" Although the question is logical, we have no use whatsoever for the answer. Instead, if we ask: "...what is a dose where we can be sure that there IS benefit?", then we must confess that there is no such number that we could use to multiply a dose; many compounds simply do not have any benefit, whatever the dose.
The working conclusion is that for a coherent BRA method, safety factors should not be used at all.
Result
The methodology for benefit-risk assessment (BRA) for plant-based food supplements (PFS)
Most assessment methods are built on the idea of producing scientifically valid estimates about the measure of interest, such as acceptable daily intake or net health impact of consuming a PFS. The proposed method has a different starting point. It is based on the idea of a society (e.g. the EU) that needs to take actions related to a PFS. The BRA is performed to inform the society (or its representatives such as EFSA) to make wise decisions about the PFS. The decision-making process is inevitably bound to information available, information produced by an assessment, and value judgements in the society. Therefore, the BRA should try to capture also the practical needs of decision making and the values of the society. A useful BRA is much wider a thing than a net benefit estimate.
The suggested methodology has four tiers or phases. They typically proceed from I to IV but it is also typical that tiers will be revisited based on new information occurring during the assessment.
Tier I: Definition of the use purpose and scope of a BRA
In the first tier, the use purpose of an assessment is defined by answering an overall question: what are the practical needs of this decision-making situation, and what information should be produced in the assessment to serve this practical need? To answer this question, several more specific sub-questions are asked:
- What are the research questions whose answers will bring the information needed by decision makers in this situation? Common types of questions include but are not limited to following:
- Is the health claim X (e.g. improves immunity) of a PFS product Y acceptable, i.e. does it hold against observations and scientific criticism?
- Is the content claim X (e.g. rich source of antioxidants) of a PFS product Y acceptable, i.e. does it hold against observations and scientific criticism?
- What are the magnitudes of beneficial and harmful health effects of consuming a PFS product Y using typical doses?
- What are the spatial, temporal and other boundaries within which the assessment should be performed?
- Who are the intended users of the assessment and what is the intended use? It is especially important that the users identified actually participate in the making of the assessment, not just read a ready-made report. This is because user's needs should drive the purpose, content, and making of an assessment, and this is best ensured by active participation.
- Who is not allowed to participate in the assessment? The default is that anyone interested is allowed. Exceptions should be explicitly mentioned and reasons for exclusion should be given. In traditional risk assessments, it was typical that the actual user (e.g. a policy-maker) was not allowed to participate in an assessment due to a potential attempt to manipulate the assessment outcomes. In the proposed methodology, it is essential that the users participate, as was mentioned before. However, it is also essential that several other parties participate as well to identify and prevent any attempts to manipulate outcomes by users or any other group.
- What are the particular scenarios that are considered in the assessment (e.g. business as usual vs. targeted restrictions of use of a particular PFS)?
Tier II: Definition of the decision criteria
In the second tier, the criteria that the decision maker wants to use in the decision making process are defined. There are several ways to approach this, and again the definition is based on the practical needs of the particular situation.
- Margin of exposure (MOE): Based on toxicological information, a safe exposure level (NOAEL) is estimated. This level is divided by the current exposure levels. The higher the ratio (MOE), the more sure we can be that there is no hazard.
- Acceptable daily intake (ADI): Maximum amount of an agent, expressed on a body mass basis, to which an individual in a (sub)population may be exposed daily over its lifetime without appreciable health risk. If the actual exposure is smaller than ADI, there is no concern.
- Quantitative benefit-risk assessment: both beneficial and harmful health effects of a PFS product are quantitatively estimated. Typically, different effects are summed up using e.g. disability weights, and decisions are made based on the net health effects.
- Estimation of a safe level of exposure: A PFS product may have a safe level of exposure. This means that there is a level where the exposure is high enough to cause a low probability of no benefit but low enough to cause a low probability of harm.
- Avoidance of harm: This is an approach where the emphasis is on harms: if exposure to a PFS product may cause harm, its use should be restricted and possible benefits are irrelevant. Only if potential harm is low, benefits are evaluated to find out whether the product can be recommended.
- If the question is about acceptability of a health or content claim of a PFS product, there is a need for clear criteria about what evidence is enough to accept or reject the claim.
Tier III: Information production
Tier III is about producing information needed in the decision making as described in Tiers I and II. It is useful to note that e.g. the BRAFO approach tiers all belong to Tier III. Therefore, the proposed methodology has a wider scope within the assessment-management sphere.
This tier can be clarified by listing several tasks related to information production.
- Collecting data
- Building (quantitative) models
- Making conclusions and writing descriptions based on tasks above.
- Making value judgements about e.g. the estimated outcomes of interest.
- Evaluating the content within the assessment: peer review, discussions, hypothesis testing.
Tier IV: Information use
Tier IV links the information production into the actual use. This tier contains the making of recommendations and conclusions based on information collected and value judgements used to interpret the information. Dissemination is a crucial part of the assessment, although it should be noted that as most interested parties are expected to participate in the whole assessment process, dissemination happens during the whole work and not just after final conclusions have been made.
Tier IV also has another important aspect: evaluation of the status of the assessment. Is the current information good enough to answer the practical needs identified in the beginning? Are the current conclusions scientifically acceptable and useful? Should more work be performed in some parts of the assessment to improve them? The evaluation of the status typically leads back to one of the previous tiers, until the practical needs have been addressed and the assessment ends.
See also
- Margin of exposure for selected food supplements
- State of the art of environmental health assessments
Keywords
Assessment method, plant-based food supplements, benefit-risk assessment.
References
- ↑ The research leading to these results has received funding from the European Union Seventh Framework Programme under grant agreement number 245199.
Related files
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