DECIDING TO TAKE a step into the unknown, particularly when it involves a decision that might have implications for health, almost invariably involves the weighing up of risks and benefi ts. A person with a heart condition, for example, may think carefully before travelling to an exotic destination, if it involves a long and potentially stressful fl ight. Food contains many benefi cial ingredients, but can also contain potentially harmful substances. Potential benefi t and harm can be present even in the same ingredient. For example, vitamins and minerals are necessary micronutrients but excessive levels could result in adverse effects. Many other examples can be mentioned e.g. fatty fi sh may reduce the risk of heart disease but can contain contaminants, fruits and vegetables are good for health but can contain pesticides, phytosterols lower blood cholesterol but a potential negative effect of the lowering of blood beta-carotene levels is still debated. Therefore, food and food ingredients can be both benefi cial and adverse In the case of food, it is usually the case in Europe that information on risks and benefi ts is presented separately. This approach can be unhelpful, because it leaves consumers, and those responsible for advising consumers, uncertain as to where the balance lies between potentially positive and negative effects. At worst, it could lead to dietary choices or recommendations with unexpected and unwanted consequences. This is the issue that the QALIBRA project (‘Quality of Life - Integrated Benefi t and Risk Analysis’) is aiming to address. Ideally, information on risks and benefi ts need to be combined to indicate the overall effects of particular dietary choices, and provide an assessment of the resulting impact on health. With this in mind, the key aim of QALIBRA, which began in 2006, is to develop improved approaches for the assessment and communication of the impact of dietary choices on health, and to present the methodology as web-enabled software (www.qalibra.eu). QALIBRA coordinator Helga Gunnlaugsdottir says: “In retrospect, the objectives we set for the project were very challenging”. They included: • Developing a generalised modular approach to risk-benefi t analysis using menus of doseresponse and valuation functions • Implementing the risk-benefi t analysis methods developed in web-enabled software that is available for use by all stakeholders via an integrated website, with different components adapted to different user groups • Developing targeted risk communication strategies for integrated risk-benefi t analysis, adapted to the needs of different stakeholders, and developing and testing programmes and materials for dissemination • Using the methods and software developed to carry out comprehensive risk-benefi t analyses for selected food groups including oily fi sh and functional foods, for selected EU populations, and using the results to evaluate and improve the QALIBRA approaches “As the project developed”, explains Helga, “it became clear that making the QALIBRA software available to non-specialists could generate misleading results and cause unnecessary alarm, because risk-benefi t modelling requires high levels of expertise and very careful interpretation. Both our own advisory panel and the European Commission’s reviewers advised us to modify this part of the project, and focus instead on generating reliable information that could subsequently be communicated to consumers.” In another change, the consortium decided that as other software packages (e.g. Proast) already provide menus of dose-response models, it would be more effi cient to equip the QALIBRA tool with a fl exible interface to accept input from any model, rather than duplicate the existing functions. The QALIBRA project was organised in seven work packages. The fi rst worked on the development of an overall framework for riskbenefi t analysis, using common currencies such as Disability-Adjusted Life Years (DALYs) to quantify the balance of risk and benefi t, and providing the option to quantify uncertainty in every element of the calculation. Work package two focussed on implementing the QALIBRA methods as web-enabled software, and conducting detailed testing with end-users to make it as user-friendly as possible. Work package three investigated challenges and solutions for communicating and disseminating risk benefi t information. The fourth and fi fth work packages developed foodrelated case studies to test the applicability of the QALIBRA methodology and software. The fi rst case study was about oily fi sh, while the second concentrated on a functional food, i.e. margarine enriched with phytosterolesters. To start with the second case study, the literature search revealed a convincing serum cholesterol lowering effect of margarines enriched with phytosterolesters. As we know from drug trials that the lowering of cholesterol levels is associated with a lower incidence rate for heart diseases we assumed that this would also account for the enriched margarines. For the negative effect, the literature was less pronounced. We decided to take the lowering of beta-carotene levels as an example. This meant that we had to work with many uncertainties and assumptions in order to calculate a potential negative health effect i.e. an increase in the incidence of night blindness. The results show that the positive effect outweighs by far the negative effect. The first case study on oily fi sh also included an extensive literature search on positive and negative health effects. Many studies have described health effects of oily fi sh but for many effects there is still no absolute proof. The results show the positive effects taken on board (fatal heart diseases and stroke) again outweigh the effects of the contaminants included in QALIBRA (dioxins, methylmercury). The case studies helped us to build the tool but should be expanded more deliberately in new projects. The sixth and seventh work packages provided management and coordinated interactions with other EU projects. As part of this, QALIBRA has been cooperating with another EU project in the same call, BENERIS (www.beneris.eu). Both projects deal with risks and benefi ts of food, using complementary methods and approaches. QALIBRA and BENERIS held joint meetings to share ideas, approaches and results, and developed a common dissemination strategy. In addition, QALIBRA formed a very productive relationship with another EU project, BRAFO, which is coordinated by ILSIEurope (www.ilsi.org/Europe/Pages/BRAFO. aspx). Helga says: “BRAFO is developing a tiered framework for risk-benefi t assessment, and the QALIBRA methods and software fi t very well with the higher tiers”. A joint workshop was held in September 2009 to explore the applicability of the QALIBRA tool to a range of case studies being undertaken by BRAFO. At a subsequent BRAFO meeting in October, Ib Knudsen President of ILSI-Europe reported back on the joint workshop, saying “The QALIBRA model and software was very impressive in practical use when demonstrated at the workshop.” further he said “It will be important to run educational courses to make scientists in the fi eld familiar with and confi dent with the use of the QALIBRA model on practical cases in order to ensure that the QALIBRA model will become commonly used, further development and attract refi nements as it deserves.” As the project draws to a close the QALIBRA software will be made available for wider use. It is intended for use primarily by health assessors in food authorities and the food industry, providing them, their decision-makers and the public with better information on the overall health impacts of different foods, or of foods produced by different methods. It is expected that this will: • Provide decision-makers with a better basis for policy and regulatory decisions and contribute to improving the safety and health benefi ts of the food chain • Help consumers to make better-informed dietary choices • Contribute to reinforcing competitiveness of European food industries by providing companies with better information on the overall health impacts of different foods and production practices. This will help them to compete more effectively by meeting consumer demands for healthy foods.
|Period||1 Jan 2009|