Personalized medicine and genome-based treatments: Why personalized medicine ≠ individualized treatments

Clinical Ethics

Volumn 9, Issue 4, 2014, Pages 135-144

  Nicholls, S G ^a   Wilson, B J ^a   Castle, D ^b   Etchegary, H ^c   Carroll, J C ^d  

^a UNIVERSITY OF OTTAWA   (Canada)

^b UNIVERSITY OF VICTORIA   (Canada)

^c MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

Author keywords

Genetic reductionism; Genomics; Personalized medicine; Utility; Validity

Indexed keywords

EID: 84923196743     PISSN: 14777509     EISSN: 1758101X     Source Type: Journal    
DOI: 10.1177/1477750914558556     Document Type: Article

References (69)

1. Burton H, Cole T and Lucassen AM. Genomic medicine: challenges and opportunities for physicians. Clin Med 2012; 12: 416-419.
2. Berg JS, Khoury MJ and Evans JP. Deploying whole genome sequencing in clinical practice and public health: Meeting the challenge one bin at a time. Genet Med 2011; 13: 499-504.
3. Auffray C, Caulfield T, Khoury MJ, et al. Genome Medicine: past, present and future. Genome Med 2011; 3: 6.
4. Roberts R. Personalized medicine: a reality within this decade. J Cardiovasc Transl Res 2008; 1: 11-16.
5. Department of Health. Our Inheritance, Our Future. London: Department of Health, 2003.
6. http://www.hopkinsmedicine.org/geneticmedicine/news/ NewsletterStories/2009_03/2009_03_feature.html (accessed 16 November 2011).
7. Fraga MF, Ballestar E, Paz MF, et al. Epigenetic differences arise during the lifetime of monozygotic twins. Proc Natl Acad Sci USA 2005; 102: 10604-10609.
8. Mill J, Dempster E, Caspi A, et al. Evidence for monozygotic twin (MZ) discordance in methylation level at two CpG sites in the promoter region of the catechol-Omethyltransferase (COMT) gene. Am J Med Genet Part B 2006; 141B: 421-425.
9. Kaminsky ZA, Tang T, Wang SC, et al. DNA methylation profiles in monozygotic and dizygotic twins. Nat Genet 2009; 41: 240-245.
10. Chadwick R. Ethical issues in personalized medicine. Drug Discov Today Therap Strat 2013; in press, DOI: 10.1016/j.ddstr.2013.05.001.
11. Miller HI. Personalized medicine may be good for patients but bad for drug companies' bottom line, http://www.forbes.com/sites/henrymiller/2013/09/25/personalized- medicine-may-be-good-for-patients-but-badfor- drug-companies-bottom-line/ (2013, accessed 9 December 2013).
12. Ginsburg GS and Voora D. The long and winding road to warfarin pharmacogenetic testing. J Am Coll Cardiol 2010; 55: 2813-2815.
13. Ginsburg GS and Willard HF. Genomic and personalized medicine: foundations and applications. Transl Res 2009; 154: 277-287.
14. Dancey JE, Bedard PL, Onetto N, et al. The genetic basis for cancer treatment decisions. Cell 2012; 148: 409-420.
15. Hedgecoe A. 'At the point at which you can do something about it, then it becomes more relevant': informed consent in the pharmacogenetic clinic. Soc Sci Med 2005; 61: 1201-1210.
16. Khoury MJ, Gwinn M, Yoon PW, et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genet Med 2007; 9: 665-674.
17. Trusheim MR, Berndt ER and Douglas FL. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat Rev Drug Discov 2007; 6: 287-293.
18. Juurlink DN, Gomes T, Guttmann A, et al. Postpartum maternal codeine therapy and the risk of adverse neonatal outcomes: a retrospective cohort study. Clin Toxicol (Phila) 2012; 50: 390-395.
19. Koren G, Cairns J, Chitayat D, et al. Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed mother. Lancet 2006; 368: 704.
20. Madadi P, Moretti M, Djokanovic N, et al. Guidelines for maternal codeine use during breastfeeding. Can Fam Physician 2009; 55: 1077-1078.
21. Haga SB, Khoury MJ and Burke W. Genomic profiling to promote a healthy lifestyle: not ready for prime time. Nat Genet 2003; 34: 347-350.
22. Green RC, Berg JS, Grody WW, et al. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 2013; 15(7): 565-574.
23. Feero WG. Clinical application of whole-genome sequencing. Proceed with care. JAMA 2014; 311: 1017-1019.
24. Dewey FE, Grove ME, Pan C, et al. Clinical interpretation and implications of whole-genome sequencing. JAMA 2014; 311: 1035.
25. Haga SB. Ethical issues of predictive genetic testing for diabetes. J Diabetes Sci Technol 2009; 3: 781-788.
26. Li C. Personalized medicine - the promised land: are we there yet? Clin Genet 2011; 79: 403-412.
27. Bell CJ, Dinwiddie DL, Miller NA, et al. Carrier testing for severe childhood recessive diseases by next-generation sequencing. Sci Transl Med 2011; 3: 65ra64.
28. Cutting GR and Sosnay PR. CFTR2-A research and clinical practice tool. In: Plenary session given at the 25th Annual North American Cystic Fibrosis Conference, Anaheim, California, 3-5 November 2011. http:// www.cff.org/research/NACFC/index.cfm?dspPrintReady ¼Y (accessed 25 November 2011).
29. Yong E. Whole-genome growing pains, http://www.thescientist. com/?articles.view/articleNo/39400/title/Whole- Genome-Growing-Pains/ (2014, accessed 17 March 2014).
30. Mardis ER. The $1,000 genome, the $100,000 analysis? Genome Med 2010; 2: 84.
31. Goldberger JJ and Buxton AE. Personalized medicine vs guideline-based medicine. JAMA 2013; 309: 2559-2560.
32. Prasad V and Ioannidis JPA. Evidence-based deimplementation for contradicted, unproven, and aspiring healthcare practices. Implement Sci 2013; 9: 1.
33. Schmedders M, van Aken J, Feuerstein G, et al. Individualized pharmacogenetic therapy: a critical analysis. Community Genet 2003; 6: 114-119.
34. Sankar P and Kahn J. BiDil: race medicine or race marketing? Health Aff (Millwood) 2005; Jul-Dec: 455-463.
35. Woodcock J. The prospects for "personalized medicine" in drug development and drug therapy. Clin Pharmacol Ther 2007; 81: 164-169.
36. Honig P and Lalonde R. The economics of drug development: a grim reality and a role for clinical pharmacology. Clin Pharmacol Ther 2010; 87: 247-251.
37. Cohen D and Raftery J. Paying twice: questions over high cost of cystic fibrosis drug developed with charitable funding. BMJ 2014; 348: g1445.
38. O'Sullivan BP, Orenstein DM and Milla CE. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013; 121: 4439-4442.
39. North of England Specialised Commissioning Group. Clinical Commissioning Policy: Ivacaftor for Cystic Fibrosis. Yorkshire and Humber: NHS Commissioning Board, 2013, NHSCB/A01/P/b.
40. Caulfield T, Evans J, McGuire A, et al. Reflections on the cost of "low-cost" whole genome sequencing: framing the health policy debate. PLoS Biol 2013; 11: e1001699.
41. http://cadth.ca/en/products/cdr/cdr-overview (accessed 1 October 2012).
42. Rose N. Personalized medicine: Promises, problems and perils of a new paradigm for healthcare. Procedia Soc Behav Sci 2013; 77: 341-352.
43. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359: 1757-1765.
44. National Institute for Health and Clinical Excellence. Final Appraisal Determination. Cetuximab (Monotherapy or Combination Chemotherapy), Bevacizumab (in Combination with Non-oxaliplatin Chemotherapy) and Panitumumab (Monotherapy) for the Treatment of Metastatic Colorectal Cancer after First-Line Chemotherapy (Review of Technology Appraisal 150 and Part Review of Technology Appraisal Guidance 118). London, UK: National Institute for Health and Clinical Excellence, 2011.
45. Miller HI. Personalized medicine may be good for patients but bad for drug companies' bottom line, http://www.forbes.com/sites/henrymiller/2013/09/25/ personalized-medicine-may-be-good-for-patients-butbad- for-drug-companies-bottom-line/ (2013, accessed 3 October 2013).
46. Sankar P. Genetic privacy. Annu Rev Med 2003; 54: 393-407.
47. Petersen A. The genetic conception of health: is it as radical as claimed? Health (London) 2006; 10: 481-500.
48. President's Council of Advisors on Science and Technology. Priorities for Personalized Medicine. Publisher is: President's Council of Advisors on Science and Technology. Washington, DC, 2008.
49. Offit K. Personalized medicine: new genomics, old lessons. Hum Genet 2011; 130: 3-14.
50. Burke W and Psaty BM. Personalized medicine in the era of genomics. JAMA 2007; 298: 1682-1684.
51. Feero WG, Bigley MB and Brinner KM. New standards and enhanced utility for family health history information in the electronic health record: an update from the American Health Information Community's Family Health History Multi-Stakeholder Workgroup. J Am Med Inform Assoc 2008; 15: 723-728.
52. Flockhart DA, O'Kane D, Williams MS, et al. Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin. Genet Med 2008; 10: 139-150.
53. Conti R, Veenstra DL, Armstrong K, et al. Personalized medicine and genomics: challenges and opportunities in assessing effectiveness, cost-effectiveness, and future research priorities. Med Decis Making 2010; 30: 328-340.
54. Furie B. Do pharmacogenetics have a role in the dosing of vitamin K antagonists? N Engl J Med 2013; 369: 2345-2346.
55. Pirmohamed M, Burnside G, Eriksson N, et al. A randomized trial of genotype-guided dosing of warfarin. N Engl J Med 2013; 369: 2294-2303.
56. Bungard TJ, Ghali WA, McAlister FA, et al. The relative importance of barriers to the prescription of warfarin for nonvalvular atrial fibrillation. Can J Cardiol 2003; 19: 280-284.
57. Ingelgå rd A, Hollowell J, Reddy P, et al. What are the barriers to warfarin use in atrial fibrillation?: Development of a questionnaire. J Thromb Thrombolysis 2006; 21: 257-265.
58. Gattellari M, Worthington J, Zwar N, et al. Barriers to the use of anticoagulation for nonvalvular atrial fibrillation: a representative survey of Australian family physicians. Stroke 2008; 39: 227-230.
59. Cardoso J, Boer J, Morreau H, et al. Expression and genomic profiling of colorectal cancer. Biochim Biophys Acta 2007; 1775: 103-137.
60. Canadian Cancer Society. Canadian Cancer Statistics 2011. Toronto, ON: Canadian Cancer Society, 2011.
61. Hawken SJ, Greenwood CM, Hudson TJ, et al. The utility and predictive value of combinations of low penetrance genes for screening and risk prediction of colorectal cancer. Hum Genet 2010; 128: 89-101.
62. Dunlop MG, Tenesa A, Farrington SM, et al. Cumulative impact of common genetic variants and other risk factors on colorectal cancer risk in 42 103 individuals. Gut 2012; 62: 871-881.
63. Zanke BW, Greenwood CM, Rangrej J, et al. Genomewide association scan identifies a colorectal cancer susceptibility locus on chromosome 8q24. Nat Genet 2007; 39: 989-994.
64. Tenesa A and Dunlop MG. New insights into the aetiology of colorectal cancer from genome-wide association studies. Nat Rev Genet 2009; 10: 353-358.
65. de Jong AE, Hendriks YM, Kleibeuker JH, et al. Decrease in mortality in Lynch syndrome families because of surveillance. Gastroenterology 2006; 130: 665-671.
66. Walsh JME and Terdiman JP. Colorectal cancer. Scientific review. JAMA 2003; 289: 1288-1296.
67. Khoury MJ, Yang Q, Gwinn M, et al. An epidemiologic assessment of genomic profiling for measuring susceptibility to common diseases and targeting interventions. Genet Med 2004; 6: 38-47.
68. Simani NJ, Tomaszewski M and Schunkert H. The personal genome - the future of personalised medicine? Lancet 2010; 375: 1497-1498.
69. Schleidgen S, Klinger C, Bertram T, et al. What is personalized medicine: sharpening a vague term based on a systematic review. BMC Med Ethics 2013; 14: 55.