Decision-making in the nutrition sciencesa critical analysis of scientific evidence for assessing health claims

  1. Bautista Bengoetxea, Juan
  2. Todt, Oliver
Revista:
Manuscrito: revista internacional de filosofía

ISSN: 0100-6045

Any de publicació: 2021

Títol de l'exemplar: jul./set.

Volum: 44

Número: 3

Pàgines: 42-69

Tipus: Article

DOI: 10.1590/0100-6045.2021.V44N3.JB DIALNET GOOGLE SCHOLAR lock_openAccés obert editor

Altres publicacions en: Manuscrito: revista internacional de filosofía

Objectius de Desenvolupament Sostenible

Resum

In this paper we present an analysis of the role of randomized controlled trials (RCTs) in the regulation of health claims (claims about additional health benefits provided by foods). Currently there is a line of thought in the nutrition sciences and in regulation that data from RCTs may be able to minimize, or even make superfluous, the role played by expert knowledge in decision making. We analyze the limitations of, as well as the possible intervention of expert judgment in RCTs in pharmacology and nutrition. As a result of our analysis, we argue that both RCTs and expert knowledge are necessary for data generation in health claim regulation. We argue that as far as data generation is concerned, nutrition is more complex than pharmacology, implying that RCTs are more difficult to effectively design and execute. What the latter means is that in nutrition and health claim regulation, expert knowledge is even more important than in pharmacology.

Referències bibliogràfiques

  • ACHINSTEIN, P. The Book of Evidence. Oxford: Oxford University Press, 2001.
  • AGARWAL, S., HORDVIK, S., MORAR, S. “Nutritional claims for functional foods and supplements”. Toxicology, 221, pp. 44-49, 2006.
  • AGGETT, P., ANTOINE, J.-M., DE VRIES, J., GALLAGHER, A., HENDRIKS, H., KOZIANOWSKI, G., MEIJER, G., RICHARDSON, D., RONDEAU, V., TWEEDIE, G., WELCH, R. (ILSI), “Beyond PASSCLAIM - Guidance to substantiate health claims on foods”. ILSI Europe Report Series, pp. 1-24, 2010.
  • ASP, N.-G., BRYNGELSSON, S. “Health claims in Europe: new legislation and PASSCLAIM for substantiation”. Journal of Nutrition, 138, pp. 1210S-1215S, 2008.
  • BLUMBERG, J., HEANEY, R.P., HUNCHAREK, M., SCHOLL, T., STAMPFER, M., VIETH, R., WEAVER, C.M., ZEISEL, S.H. “Evidence-based criteria in the nutritional context”. Nutrition Reviews, 68, pp. 478-484, 2010.
  • BOWEN, S., ZWI, A.B. “Pathways to ‘Evidence-Informed’ Policy and Practice: A Framework for Action”. PloS Medicine, 2, pp. 0600-0605, 2005.
  • CARTWRIGHT, N. “What are randomised controlled trials good for?”. Philosophical Studies, 147, pp. 59-70, 2010.
  • CARTWRIGHT, N. Evidence: For Policy, and Wheresoever Rigor is a Must. London: LSE, 2015.
  • CARTWRIGHT, N., HARDIE, J. Evidence-Based Policy: A Practical Guide to Doing It Better. Oxford: Oxford University Press , 2012.
  • DE BOER, A., VOS, E., BAST, A. “Implementation of the nutrition and health claim regulation - The case of antioxidants”. Regulatory Toxicology and Pharmacology, 68, pp. 475-487, 2014.
  • DOUGLAS, H. “The Irreducible Complexity of Objectivity”. Synthese 138, pp. 453-473, 2004.
  • EFSA. Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (Revision 1). EFSA Journal, 9, 2170, pp.1-36, 2011.
  • EUROPEAN PARLIAMENT AND COUNCIL. 2006. Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the European Union L.404: 9-25.
  • EU, 2002. “Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.” Chapter 11 ‘General Food Law’, Article 6 ‘Risk analysis’ and article 14 ‘Food safety requirements’. Official Journal of the European Communities (1.2.2002), L31, 34 pp. (Available at: Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002R0178&from=en Accessed on May 9th, 2020).
  • GARZA, C., STOVER, P.J., OHLHORST, S.D., FIELD, M.S., STEINBROOK, R., ROWE, S., WOTEKI, C., CAMPBELL, E. “Best practices in nutrition science to earn and keep the public’s trust”. The American Journal of Clinical Nutrition, 109, pp. 225-243, 2019.
  • GOODMAN, K. Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science. Cambridge: Cambridge University Press, 2003.
  • HACKING, I. Representing and Intervening. Cambridge: Cambridge University Press , 1983.
  • HAYWARD, R.A., KRUMHOLZ, H.M. “Three reasons to abandon low-density lipoprotein targets”. Circulation, 5, pp. 2-5, 2012.
  • HEANEY, R.P. “Nutrients, Endpoints, and the Problem of Proof”. The Journal of Nutrition, 138, pp. 1591-1595, 2008.
  • HENDRICKX, K. “Rivaling evidence-bases and politics in regulatory science”. Food, Science & Law, 4, 2013 [ Food, Science & Law, 4, 2013. Available at: http://hdl.handle.net/2268/162196. Access in: 29 may. 2021.
  • HSIANG-K., C., SZU-T., C., MILLSTEIN, R.L. Mechanisms and Causality in Biology and Economics. Dordrecht, Springer, 2013.
  • ILLARI, P., RUSSO, F. Causality: Philosophical Theory Meets Scientific Practice. Oxford: Oxford University Press , 2014.
  • JACOBS, D.R., TAPSELL, L.C. “Food synergy: the key to a healthy diet”. Proceeding of the Nutrition Society, 72, pp. 200-206, 2013.
  • JIMÉNEZ-BUEDO, M., MILLER, L.M. “Why a Trade-Off? The Relationship between the External and Internal Validity of Experiments”. Theoria 69, pp. 301-321, 2010.
  • JUKOLA, S. “On the evidentiary standards for nutrition advice”. Studies in History and Philosophy of Biological and Biomedical Sciences 73, pp. 1-9, 2019.
  • KOSKINEN, I. “Defending a risk account of scientific objectivity”. The British Journal for the Philosophy of Science, 71, pp. 1187-1207, 2020.
  • LÄHTEENMÄKI, L. “Claiming health in food products”. Food Quality and Preference, 27, pp. 196-201, 2013.
  • LAWRENCE, G.D. “Dietary fats and health: dietary recommendations in the context of scientific evidence”. Advances in Nutrition, 4, pp. 294-302, 2013.
  • LUJÁN, J.L., TODT, O. “Evidence based methodology: a naturalistic analysis of epistemic policies in regulatory science”. European Journal for Philosophy of Science 11, pp. 26-44, 2021.
  • NEALE, E.P., TAPSELL, L.C. “Perspective: The Evidence-Based Framework in Nutrition and Dietetics: Implementation, Challenges, and Future Directions”. Advances in Nutrition, 10, pp. 1-8, 2019.
  • NHCR-Regulation (EC). 2006. No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (17 pp.) Available at: http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924. Accessed on December 2nd, 2020).
  • PAPINEAU, D. “The Virtues of Randomization”. The British Journal for the Philosophy of Science, 45, pp. 437-450, 1994.
  • PASSCLAIM, “Process for the Assessment of Scientific Support for Claims on Foods: Consensus on Criteria”. European Journal of Nutrition, 44, §§ I/1-I/2, 2005.
  • REISS, J. “A pragmatist theory of evidence”. Philosophy of Science, 82, pp. 341-362, 2015.
  • RIETJENS, I., ALINK, G. “Future of toxicology-low-dose toxicology and risk- benefit analysis”. Chemical Research in Toxicology, 19, pp. 977-981, 2006.
  • RUBIN, D.B. “Estimating Causal Effects of Treatments in Randomized and Nonrandomized Studies”. Journal of Educational Psychology, 66, pp. 688-701, 1974.
  • SACKETT, D.L., ROSENBERG, W.M.C., GRAY, J.A.M., HAYNES, R.B., RICHARDSON, W.S. “Evidence based medicine: what it is and what it isn't”. British Medical Journal, 312, pp. 71-72, 1996.
  • SCHWINGSHACKL, L., KNÜPPEL, S., SCHWEDHELM, C., HOFFMAN, G., MISSBACH, B., STELMACH-MARDAS, M., DIETRICH, S., EICHELMANN, F., KONTOPANTEILS, E., IQBAL, K. “Perspective: NutriGrade: a scoring system to assess and judge the meta-evidence of randomized controlled trials and cohort studies in nutrition research”. Advances in Nutrition, 7, pp. 994-1004, 2016.
  • STEGENGA, J. “Measuring effectiveness”. Studies in History and Philosophy of Biological and Biomedical Sciences, 54, pp. 62-71, 2015.
  • STEEL, D. Philosophy and the precautionary principle: Science, evidence, and environmental policy. Cambridge: Cambridge University Press , 2015.
  • TAPSELL, L.C. “Evidence for health claims: a perspective from the Australia-New Zealand region,” The Journal of Nutrition, 138, pp. S1206-S1209, 2008.
  • TEIRA, D. “On the impartiality of British trials”. Studies in History and Philosophy of Biological and Biomedical Sciences, 44, pp. 412-418, 2013.
  • TEIRA, D., REISS, J. “Causality, Impartiality and Evidence-Based Policy”. In C. Hsiang-K., C. Szu-T. and R. L. Millstein (Eds.) (2013), p. 207-224.
  • TRUSSWELL, S. “Levels and kinds of evidence for public-health nutrition”. The Lancet, 357, pp. 1061-1062, 2001.
  • URBACH, P. “Randomization and the design of experiments”. Philosophy of Science, 52, pp. 256-273, 1985.
  • VAN BAALEN, S., BOON, M. “An epistemological shift: from evidence-based medicine to epistemological responsibility”. Journal of Evaluation in Clinical Practice, 21, pp. 433-439, 2015.
  • WORRALL, J. “Evidence: philosophy of science meets medicine”. Journal of Evaluation in Clinical Practice, 16, pp. 356-362, 2010.
  • ZEISS, R., VAN EGMOND, S. “Dissolving Decision Making? Models and Their Roles in Decision-Making Processes and Policy at Large”. Science in Context, 27, pp. 631-657, 2014.
Fuente de los datos: Dialnet