Should direct-to-consumer personalized genomic medicine remain unregulated?: A rebuttal of the defenses

Perspectives in Biology and Medicine

Volumn 55, Issue 2, 2012, Pages 250-265

  Valles, Sean A ^a  

^a MICHIGAN STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONSUMER; ETHICS; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; HUMAN; HUMAN GENOME; LEGAL ASPECT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PATIENT RIGHT; PERSONALIZED MEDICINE; POSTAL MAIL; PREDICTIVE VALUE; RISK FACTOR; UNITED STATES; UTILIZATION REVIEW;

CONSUMER SATISFACTION; GENETIC TESTING; GENOME, HUMAN; HUMANS; INDIVIDUALIZED MEDICINE; PATIENT RIGHTS; POSTAL SERVICE; PREDICTIVE VALUE OF TESTS; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84861145759     PISSN: 00315982     EISSN: None     Source Type: Journal    
DOI: 10.1353/pbm.2012.0019     Document Type: Article

References (40)

1. Andrews, N. J. 2010. Incidence of variant Creutzfeldt-Jakob disease diagnoses and deaths in the UK, January 1994-December 2009. National Cretuzfeldt-Jakob Disease Research & Surveillance Unit. Western General Hospital, Edinburgh. http://www.cjd.ed.ac.uk/cjdq64.pdf.
2. Andrews, N. J. 2011. Incidence of variant Creutzfeldt-Jakob disease diagnoses and deaths in the UK, January 1994-December 2010. National Cretuzfeldt-Jakob Disease Research & Surveillance Unit. Western General Hospital, Edinburgh. http://www.cjd.ed.ac.uk/cjdq68.pdf.
3. Bloss, C. S., N. J. Schork, and E. J. Topol. 2011a. Direct-to-consumer genomewide profiling. N Eng J Med 364(21):2075.
4. Bloss, C. S., N. J. Schork, and E. J. Topol. 2011b. Effect of direct-to-consumer genomewide profiling to assess disease risk. N Eng J Med 364(6):524-34.
5. Burke, W., A.M. Laberge, and N. Press. 2010.Debating clinical utility. Public Health Genomics 13(4):215-23.
6. Central Intelligence Agency (CIA). 2012. India. https://http://www.cia.gov/library/publications/the-world-factbook/geos/in.html.
7. Chung, C. C., and S. J. Chanock. 2011. Current status of genome-wide association studies in cancer. Hum Genet 130(1):59-78.
8. Del Tredici, A. L., and K. D. Becker. 2011. Personal genetic testing can motivate behavioral change. In Pathway Genomics Newsroom. http://blog.pathway.com/personal-genetic-testing-can-motivate-behavioral-change/.
9. Eckman, M. H., et al. 2009. Cost-effectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation. Ann Intern Med 150(2): 73-83.
10. GenePlanet. 2012a. Our values. http://www.geneplanet.com/about_geneplanet/our_values.
11. GenePlanet. 2012b. Traits and talents. http://www.geneplanet.com/presentation/traits_and_talents.
12. Grosse, S.D., and M. J. Khoury. 2006.What is the clinical utility of genetic testing? Genet Med 8(7):448-50.
13. Grosse, S.D., et al. 2009. Personal utility and genomic information: Look before you leap. Genet Med 11(8):575-76.
14. Haga, S. B., M. J. Khoury, and W. Burke. 2003. Genomic profiling to promote a healthy lifestyle: Not ready for prime time. Nat Genet 34(4):347-50.
15. Hunter, D. J., M. J. Khoury, and J.M. Drazen. 2008. Letting the genome out of the bottle: Will we get our wish? N Eng J Med 358(2):105-7.
16. James, K. M., et al. 2011. Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic. Mayo Clin Proc 86(10):933-40.
17. Kauppi, K., et al. 2011. KIBRA polymorphism is related to enhanced memory and elevated hippocampal processing. J Neurosci 31(40):14218-22.
18. Khoury, M. J., et al. 2007.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 9(10):665-74.
19. Khoury, M. J., et al. 2008.The evidence dilemma in genomic medicine. Health Aff (Millwood) 27(6):1600-1611.
20. Klugman, S., and S. J. Gross. 2010. Ashkenazi Jewish screening in the twenty-first century. Obstet Gynecol Clin North Am 37(1):37-46.
21. MacArthur, D. 2011a. Snippets from day one of the FDA meeting on consumer genetics. In Genetic future. Wired.com, Condé Nast Digital. http://www.wired.com/wiredscience/2011/03/snippets-from-day-one-of-the-fda-meeting-on-consumer-genetics/.
22. MacArthur, D. 2011b. Yet another trial by press release for personal genomics. In Genetic future. Wired.com, Condé Nast Digital. www.wired.com/wiredscience/2011/05/yet-another-trial-by-press-release-for-personal-genomics/.
23. Nature Biotechnology. 2011. Testing times for gene test regulators. Editorial. Nat Biotechnol 29(2):90.
24. Ng, P. C., et al. 2009.An agenda for personalized medicine. Nature 461(7265):724-26.
25. Offit, K. 2011. Personalized medicine: New genomics, old lessons. Hum Genet 130(1):3-14.
26. Papassotiropoulos, A., et al. 2006. Common KIBRA alleles are associated with human memory performance. Science 314(5798):475-78.
27. Patch, C., and B. Prainsack. 2011. Regulating genomic information needs: New approaches. Progress Educational Trust. http://www.bionews.org.uk/page_91963.asp.
28. Plebani, M., and G. Lippi. 2011.Direct-to-consumer genomewide profiling. N Eng J Med 364(21):2074-75.
29. Prainsack, B., et al. 2008.Misdirected precaution. Nature 456(7218):34-35.
30. Ransohoff, D. F., and M. J. Khoury. 2010. Personal genomics: Information can be harmful. Eur J Clin Invest 40(1):64-68.
31. Scripps Translational Science Institute. 2011. Scripps genomic health initiative. http://www.stsiweb.org/index.php/translational_research/research_highlights/consumer_genomics/.
32. 23and Me. 2012a. Leprosy susceptibility. https://http://www.23andme.com/health/leprosy-susceptibility/.
33. 23andMe. 2012b. Memory. https://http://www.23andme.com/you/journal/pre_memory/overview/.
34. van Ommen, G. B., and M. C. Cornel. 2008. Recreational genomics? Dreams and fears on genetic susceptibility screening. Eur J Hum Genet 16(4):403-4.
35. Wadelius, M., et al. 2009. The largest prospective warfarin-treated cohort supports genetic forecasting. Blood 113(4):784-92.
36. Wagner, J.K. 2010.Understanding FDA regulation of DTC genetic tests within the context of administrative law. Am J Hum Genet 87(4):451-56.
37. Wersching, H., et al. 2011. Impact of common KIBRA allele on human cognitive functions. Neuropsychopharmacology 36(6):1296-1304.
38. World Health Organization (WHO). 2010. Leprosy. http://www.who.int/mediacentre/factsheets/fs101/en/.
39. World Health Organization (WHO). 2011. Leprosy update, 2011. Wkly Epidemiol Rec 86(36):389-400.
40. Zhang, H., et al. 2009. Cognitive flexibility is associated with KIBRA variant and modulated by recent tobacco use. Neuropsychopharmacology 34(12):2508-16.