Regulatory and ethical challenges of personalized medicine

Personalized Medicine

Volumn 7, Issue 5, 2010, Pages 465-468

  Torr Brown, Sheryl R ^a  

^a Spirals Translational Sciences   (United States)

Author keywords

commercial testing; ethics; FDA; genes; genetic testing; genetics; personalized medicine; regulation; regulatory

Indexed keywords

ABACAVIR; APOLIPOPROTEIN E; BRCA1 PROTEIN; DNA; HLA B57 ANTIGEN;

ALZHEIMER DISEASE; DRUG HYPERSENSITIVITY; DRUG METABOLISM; EDITORIAL; GENE MUTATION; GENETIC SCREENING; GENOME ANALYSIS; HUMAN; HUNTINGTON CHOREA; MEDICAL ETHICS; MEDICAL RESEARCH; MOLECULAR GENETICS; PRIORITY JOURNAL; SINGLE NUCLEOTIDE POLYMORPHISM;

EID: 77957606846     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.10.49     Document Type: Editorial

References (20)

1. West M, Ginsburg GS, Huang AT, Nevins JR: Embracing the complexity of genomic data for personalized medicine. Genome Res. 16, 559-566 (2006).
2. Hansson MG: Taking the patient's side: the ethics of pharmacogenetics. Per. Med. 7(1), 75-85 (2006).
3. Santos L: Genetic research in native communities. Prog. Community Health Partnersh. 2(4), 321-327 (2008).
4. Beskow LM, Burke W: Offering individual genetic research results: context matters. Sci. Transl. Med. 2(38), 38-20 (2010).
5. Kohane IS, Taylor PL: Multidimensional results reporting to participants in genomics studies. Sci. Transl. Med. 2(37), 37cm19 (2010).
6. Hamburg M: Bringing home the genome: the US FDA's role in realizing personalized medicine. Per. Med. 7(3), 239-242 (2010).
7. Gusella JF, Wexlar NS, Conneally PM et al.: A polymorphic DNA marker genetically linked to Huntingdon's disease. Nature 306, (1983).
8. Green RC, Roberts JS, Cupples LA et al.: Disclosure of APOE genotype for risk of Alzheimer's disease. N. Engl. J. Med. 361, 245-254 (2009).
9. Freedman AN, Wideroff L, Olson L et al.: US physicians' attitudes toward genetic testing for cancer susceptibility. Am. J. Med. Genetics 120 A (1), 63-71 (2003). (Pubitemid 37063834)
10. Gessen M: Blood matters. In: Inherited Illness to Designer Babies, How the World and I Found Ourselves in the Future of the Gene. Harcourt Press Publishers, USA (2008).
11. Thompson D, Easton DF: The breast cancer linkage consortium: cancer incidence in BRCA1 mutation carriers. J. Natl. Cancer Inst. 94(18), 1358-1365 (2002).
12. Kadouri L, Hubert A, Rotenberg Y et al.: Cancer risks in carriers of the BRCA1/2 Ashkenazi founder mutations. J. Med. Genet. 44(7), 467-471 (2007). (Pubitemid 47056875)
13. Roses AD: Genome-wide screening for drug discovery and companion diagnostics. Expert Opin. Drug Discov. 2(4), 489-501 (2007). (Pubitemid 47073074)
14. Moridani M, Maitland-van der Zee AH, Sasaki H, McKinnon R, Fleckenstein L, Shah VP: Medicine: methods, regulatory, and clinical applications. AAPSJ. 11(2), 214-216 (2009)
15. Woodcock J: The human genome and translational research: how much evidence is enough? Health Aff (Millwood) 27, 1616-1618 (2008).
16. Zineh I, Lesko LJ: Pharmacogenetics in medicine: barriers, critical factors and a framework for dialogue. Per. Med. 6(4), 359-361 (2009).
17. *5701 screening for hypersensitivity to abacavir. N. Engl. J. Med. 358, 568-579 (2008).
18. Tutton R, Smart A, Martin PA, Ashcroft R, Ellison GTH: Genotyping the future: scientists' expectations about race/ethnicity after BiDil. J. Law Med. Ethics 36(3), 464-470 (2008).
19. Duster T: Medicalisation of race. Lancet 369, 702-704 (2007). (Pubitemid 46281317)
20. Wadman M: 'Drug targeting: is race enough?' Nature 435, 1008-1009 (2005).