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Scientific Evidence for Personalized Nutrition: Ethical Implications of Methodological Limitations

Scientific Evidence for Personalized Nutrition: Ethical Implications of Methodological Limitations. A. Cecile J.W. Janssens, PhD Research Professor of Epidemiology Department of Epidemiology @cecilejanssens. Same presentation 10 years ago. Different companies, same issues ….

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Scientific Evidence for Personalized Nutrition: Ethical Implications of Methodological Limitations

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  1. Scientific Evidence for Personalized Nutrition: Ethical Implications of Methodological Limitations A. Cecile J.W. Janssens, PhD Research Professor of Epidemiology Department of Epidemiology @cecilejanssens

  2. Same presentation 10 years ago

  3. Different companies, same issues …

  4. Lack of scientific evidence

  5. Not informing major risks still issue Informing participants should also include impact of tested genes on other diseases Commentary reports about two studies: • Testing APOE gene to tailor recommendations saturated fat intake • Forgot to disclose major risk of Alzheimer’s disease Information: ethical issues around informed consent, privacy, and data sharing (not discussed today)

  6. v

  7. What professionals say: limited evidence 2014 2013

  8. What companies claim

  9. What their disclaimers reveal …

  10. … and the Terms of Service Allows applications to be of poor quality and lack scientific basis, and their recommendations to be irrelevant and totally wrong

  11. Ethical principles Medicine Marketing (AMA) Ethical norms: Do no harm Foster trust in marketing Embrace ethical values: Respect, Honesty, Responsibility, Transparency, Fairness, Citizenship • Autonomy • Beneficence • Nonmaleficence • Justice

  12. Beneficence Intent of doing good, includes • Developing and maintaining skills and knowledge, and continually update • Consider individual circumstances of all patients • Is commercial offer in interest of customers or company? • Insufficient evidence: • Many statistically significant gene-diet-outcome associations, some replicated • No studies that show how/whether diet can ‘compensate’ unfavorable genetic effects on diet

  13. USPSTF Analytic Framework Glucose test Diet/exercise Obese individuals Pre-diabetes Weight loss Reduced diabetes, CVD, mortality Figure taken from Melnyk et al. Pediatrics 2012;130:e399-e407

  14. USPSTF Analytic Framework DNA testing + survey + lab Personalized nutrition Healthy consumers Personal profiles ??? Figure taken from Melnyk et al. Pediatrics 2012;130:e399-e407

  15. Autonomy • Consumer should decide themselves whether testing is useful for them  personal utility  Needs information to make informed decision Yet, • Companies use proprietary algorithms to create personalized recommendations • Consumers and scientists have no insight in validity • Proprietary ‘algorithms’ suggest advanced processing of data, but may well hide lack of knowledge

  16. Proprietary algorithms: how advanced? SNP with small effect SNP with small effect SNP with small effect Other lab/lifestyle … Algorithm Personalized diet SNP with small effect SNP with small effect SNP with small effect Other lab/lifestyle … Simple rule Simple rule Simple rule Simple rule … Recommendation Recommendation Recommendation Recommendation … Personalized combination

  17. Companies may still do same as 10 years ago Arkadianos et al Nutrition Journal 2007

  18. Companies can be transparent about lack of scientific evidence, open about algorithms, and still have a market and a future

  19. Onward • Better and more relevant scientific studies • More respectful conversation with consumers • Genetically personalized nutrition recommendations is still premature, largely lacking appropriate scientific basis • Just say it 2005

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