Ethicolegal Aspects of Cancer Genetics

Chapter
Part of the Cancer Treatment and Research book series (CTAR, volume 155)

Abstract

In the wake of efficacious preventive interventions based on hereditary cancer risk assessment, a number of ethical and legal challenges have emerged. These include issues such as appropriate testing of children and embryos, the “duty to warn” relatives about familial risk, reproductive genetic testing, the risk of genetic discrimination, and equitable access to testing. These and other issues will be discussed within the framework of a bioethical model, with reference to recent case law.

References

  1. 1.
    American Society of Clinical Oncology (1996) Statement of the American Society of Clinical Oncology: genetic testing for cancer susceptibility. J Clin Oncol 14:1730–1736Google Scholar
  2. 2.
    American Society of Clinical Oncology (2003) American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility. J Clin Oncol 21:2397–2406CrossRefGoogle Scholar
  3. 3.
    Green MJ, Botkin JR (2003) “Genetic exceptionalism” in medicine: clarifying the differences between genetic and nongenetic tests. Ann Intern Med 138:571–575PubMedGoogle Scholar
  4. 4.
    American Medical Association Opinions on social policy issues, 1/4/05 update. http://www.ama-assn.org/ama/pub/category/8295.html. Accessed 1/5/2007
  5. 5.
    United States Department of Health and Human Services Office for human research protection (OHRP) policy guidance [by topics], 12/28/06 update. http://www.hhs.gov/ohrp/policy/index.html. Accessed 5/07/09
  6. 6.
    The National Women’s Health Information Center (1996) Position paper: hereditary susceptibility testing for breast cancer, March 1996, 5/7/02 update. http://www.4woman.gov/napbc/catalog.wci/napbc/hspospap.htm. Accessed 1/5/07
  7. 7.
    National Information Resource on Ethics and Human Genetics 3/06 update. http://bioethics.georgetown.edu/nirehg/. Accessed 4/18/09
  8. 8.
    Genetics & Public Policy Center http://www.dnapolicy.org/. Accessed 5/07/09
  9. 9.
    Offit K (1998) Chapter 10 In: Clinical cancer genetics: risk management and counseling. Wiley, New YorkGoogle Scholar
  10. 10.
    Beauchamp TL, Childress JF (1994) Principles of biomedical ethics. Oxford University Press, New YorkGoogle Scholar
  11. 11.
    Hall MA, Rich SS (2000) Laws restricting health insurers’ use of genetic information: impact on genetic discrimination. Am J Hum Genet 66:293–307PubMedCrossRefGoogle Scholar
  12. 12.
    Harris M, Winship I, Spriggs M (2005) Controversies and ethical issues in cancer-genetics clinics. Lancet Oncol 6:301–310PubMedCrossRefGoogle Scholar
  13. 13.
    Hall MA, McEwen JE, Barton JC et al (2005) Concerns in a primary care population about genetic discrimination by insurers. Genet Med 7:311–316PubMedCrossRefGoogle Scholar
  14. 14.
    McEwen JE, McCarty K, Reilly PR (1992) A survey of state insurance commissioners concerning genetic testing and life insurance. Am J Hum Genet 51:785–792PubMedGoogle Scholar
  15. 15.
    Norman-Bloodsaw v. Lawrence Berkeley Laboratory 135 F.3d 1260, 1269 (9th Cir. 1998)Google Scholar
  16. 16.
    The U.S. Equal Employment Opportunity Commission (EEOC) The Americans with disabilities act of 1990, Title I and V. US Code 12111–12201. http://www.eeoc.gov/policy/ada.html. Accessed 5/07/09
  17. 17.
    The U.S. Equal Employment Opportunity Commission (EEOC) Compliance manual, vol. 2, section 902, order 9 15.002, 902–945, 6/06 update. http://www.eeoc.gov/policy/ada.html. Accessed 5/07/09
  18. 18.
    Patient Privacy Rights. http://www.patientprivacyrights.org/site/PageServer. Accessed 5/07/09
  19. 19.
    65 Fed. Reg. 82,467Google Scholar
  20. 20.
    Clinton WJ (2000) Executive Order 13145 of February 8, 2000: to prohibit discrimination in federal employment based on genetic information. Fed Regist 65:6877–6880PubMedGoogle Scholar
  21. 21.
    Genetic Information Nondiscrimination Act (GINA) of 2008. Information for researchers and health care professionals. http://www.genome.gov/24519851. Accessed 4/18/09
  22. 22.
    Lapham EV, Kozma C, Weiss JO (1996) Genetic discrimination: perspectives of consumers. Science 274:621–624PubMedCrossRefGoogle Scholar
  23. 23.
    Statement of Commissioner Paul Steven Miller, U.S. Equal Employment Opportunity Commission (20 July 2000). “Genetic information in the workplace.” Before the Committee on Health, Education, Labor and Pensions, U.S. SenateGoogle Scholar
  24. 24.
    Kauff ND, Mitra N, Robson ME et al (2005) Risk of ovarian cancer in BRCA1 and BRCA2 mutation-negative hereditary breast cancer families. J Natl Cancer Inst 97:1382–1384PubMedCrossRefGoogle Scholar
  25. 25.
    Katskee v. Blue Cross/Blue Shield. Nebraska (1994) 515 N.W.2d 645Google Scholar
  26. 26.
    Centers for Disease Control and Prevention (CDC) (2004) Genetic testing for breast and ovarian cancer susceptibility: evaluating direct-to-consumer marketing–Atlanta, Denver, Raleigh-Durham, and Seattle, 2003. MMWR 53:603–606Google Scholar
  27. 27.
    Hogarth S, Javitt G, Melzer D (2008) The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 9:161–182PubMedCrossRefGoogle Scholar
  28. 28.
    Hudson KL, Murphy JA, Kaufman DJ et al (2006) Oversight of US genetic testing laboratories. Nat Biotechnol 24:1083–1090PubMedCrossRefGoogle Scholar
  29. 29.
    Hudson K (2006). Testimony before the United States senate special committee on aging “at home DNA tests: marketing scam or medical breakthrough?” 27 July 2006. http://www.dnapolicy.org/resources/Testimony_of_Kathy_Hudson_Senate_Aging_7-27-06.pdf. Accessed 12/01/2006
  30. 30.
    Burke W, Petersen G, Lynch P et al (1997) Recommendations for follow-up care of individuals with an inherited predisposition to cancer. I. Hereditary nonpolyposis colon cancer. Cancer Genetics Studies Consortium. JAMA 277:915–919; Burke W, Daly M, Garber J, et al (1997) Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. Cancer Genetics Studies Consortium. JAMA 277:997–1003PubMedCrossRefGoogle Scholar
  31. 31.
    Offit K, Garber J, Grady M et al (2004) American society of clinical oncology curriculum: cancer genetics and cancer predisposition testing, 2nd edn. ASCO Publishing, Alexandria, VAGoogle Scholar
  32. 32.
    Robson M, Offit K (2007) Management of women at hereditary risk for breast cancer. N Engl J Med 357:154–162PubMedCrossRefGoogle Scholar
  33. 33.
    Kauff ND, Satagopan JM, Robson ME et al (2002) Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 346:1609–1615PubMedCrossRefGoogle Scholar
  34. 34.
    Garber J, Offit K (2005) Hereditary cancer predisposition syndromes. J Clin Oncol 23:276–292PubMedCrossRefGoogle Scholar
  35. 35.
    Offit K, Groeger E, Turner S et al (2004) The “duty to warn” a patient’s family members about hereditary disease risks. JAMA 292:1469–1473PubMedCrossRefGoogle Scholar
  36. 36.
    Burke T, Rosenbaum S (2005) Molloy v Meier and the expanding standard of medical care: implications for public health policy and practice. Public Health Rep 120:209–210PubMedGoogle Scholar
  37. 37.
    Andrews LB (1994) Assessing genetic risks: implications for health and social policy. National Academy Press, Washington, DCGoogle Scholar
  38. 38.
    Reilly PR, Boshar MF, Holtzman SH (1997) Ethical issues in genetic research: disclosure and informed consent. Nat Genet 15:16–20PubMedCrossRefGoogle Scholar
  39. 39.
    Miletich S, Armstrong K, Mayo J (2006) Life or death question, but debate was hidden for years. Seattle Times, 19 Oct 2006Google Scholar
  40. 40.
    Carstairs VDL, Morris R (1991) Deprivation and health in Scotland. Aberdeen. Aberdeen University Press, AberdeenGoogle Scholar
  41. 41.
    Halbert CH, Kessler L, Stopfer JE et al (2006) Low rates of acceptance of BRCA1 and BRCA2 test results among African American women at increased risk for hereditary breast-ovarian cancer. Genet Med 8:576–582PubMedCrossRefGoogle Scholar
  42. 42.
    Halbert CH, Kessler LJ, Mitchell E (2005) Genetic testing for inherited breast cancer risk in African Americans. Cancer Invest 23:285–295PubMedCrossRefGoogle Scholar
  43. 43.
    Collins SR, Davis K, Doty MM et al (2006) Gaps in health insurance: an all-American problem: findings from the commonwealth fund biennial health insurance survey, April 2006. http://www.commonwealthfund.org/usr_doc/Collins_gapshltins_920.pdf. Accessed 4/29/09
  44. 44.
    Doty MM, Holmgren AL (2006) Health care disconnect: gaps in coverage and care for minority adults. Findings from the commonwealth fund biennial health insurance survey (2005). Issue Brief (Commonwealth Fund) 21:1–12Google Scholar
  45. 45.
    AMA Opinions on social policy issues, E-2.138, Genetic Testing of ChildrenGoogle Scholar
  46. 46.
    American Society of Human Genetics Board of Directors, American College of Medical Genetics Board of Directors (1995) Points to consider: ethical, legal, and psychosocial implications of genetic testing in children and adolescents. Am J Hum Genet 57:1233–1241Google Scholar
  47. 47.
    National Society of Genetic Counselors Position Statement: Prenatal And Childhood Testing For Adult-Onset Disorders, adopted 2005. http://www.nsgc.org/about/position.cfm#Prenatal_two. Accessed 5/07/09
  48. 48.
    Rhodes R (2006) Why test children for adult-onset genetic diseases? Mt Sinai J Med 73:609–616PubMedGoogle Scholar
  49. 49.
    Cauffman E, Steinberg L (2000) (Im)maturity of judgment in adolescence: why adolescents may be less culpable than adults. Behav Sci Law 18:741–760PubMedCrossRefGoogle Scholar
  50. 50.
    Offit K, Kohut K, Clagett B et al (2006) Cancer genetic testing and assisted reproduction. J Clin Oncol 24:1–8CrossRefGoogle Scholar
  51. 51.
    The Council on Ethical and Judicial Affairs, American Medical Association (1994) Ethical issues related to prenatal genetic testing. Arch Fam Med 3:633–642CrossRefGoogle Scholar
  52. 52.
    Ethics Committee of the American Society of Reproductive Medicine (2004) Sex selection and preimplantation genetic diagnosis. Fertil Steril 82:S245–S248Google Scholar
  53. 53.
    British Medical Association. Preimplantation genetic diagnosis with tissue typing, 10/99 update.http://www.bma.org.uk/ap.nsf/AttachmentsByTitle/PDFEthicsBrief68/$FILE/EthicsBrief68.pdf. Accessed 12/03/06
  54. 54.
    Thornhill AR, de Die-Smulders CE, Geraedts JP et al (2005) ESHRE PGD consortium ‘best practice guidelines for clinical preimplantation genetic diagnosis (PGD) and preimplantation genetic screening (PGS)’. Hum Reprod 20:35–48PubMedCrossRefGoogle Scholar
  55. 55.
    Danish Council of Ethics. Microinsemination and pre-implantation genetic diagnosis (PGD): resume of recommendations, 3/05 update. http://www.etiskraad.dk/sw1771.asp. Accessed 5/07/09
  56. 56.
    The President’s Council on Bioethics. Reproduction and responsibility: the regulation of new biotechnologies, 3/04 update. Accessed 12/03/06Google Scholar
  57. 57.
    Offit K, Sagi M, Hurley K (2006) Preimplantation genetic diagnosis for cancer syndromes: a new challenge for preventive medicine. JAMA 296:2727–2730PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Clinical Genetics Service, Memorial Sloan-Kettering Cancer CenterNew YorkUSA

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