Seeking genomic knowledge: The case for clinical restraint

Hastings Law Journal

Volumn 64, Issue 6, 2013, Pages 1649-1663

  Burke, Wylie ^a   Trinidad, Susan Brown ^a   Clayton, Ellen Wright ^b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b VANDERBILT UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84885202597     PISSN: 00178322     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (63)

1. See generally Geoffrey S. Ginsburg & Huntington F. Willard, Genomic and Personalized Medicine: Foundations and Applications, 154 TRANSLATIONAL RES. 277 (2009);
2. Teri A. Manolio et al., Implementing Genomic Medicine in the Clinic: The Future is Here, 15 GENETICS IN MED. 1, 3 (2013).
3. see also Bryce A. Schuler et al., Using Whole Exome Sequencing to Walk from Clinical Practice to Research and Back Again, 127 CIRCULATION 968, 968 (2013).
4. See generally Isaac S. Kohane et al., Taxonomizing, Sizing, and Overcoming the Incidentalome, 14 GENETICS IN MED. 399 (2012).
5. COMM. ON QUALITY OF HEALTH CARE IN AM., INST, OF MED., CROSSING THE QUALITY CHASM: A NEW HEALTH SYSTEM FOR THE 2IST CENTURY 1-3 (2001).
6. See generally INST, OF MED., BEST CARE AT LOWER COST: THE PATH TO CONTINUOUSLY LEARNING HEALTH CARE IN AMERICA 1 (2011).
7. Haidong Wang et al., Age-Specific and Sex-Specific Mortality in 187 Countries, 1070-2010: A Systematic Analysis for the Global Burden of Disease Study 2010, 380 LANCET 2071, at 2082, 2086 (2012).
8. See COMM. ON QUALITY OF HEALTH CARE IN AM., supra note 5, at 1.
9. See STEPHEN K. HEFFLER et al., CTRS. FOR MEDICARE & MEDICAID SERVS., THE LONG-TERM PROJECTION ASSUMPTIONS FOR MEDICARE AND AGGREGATE NATIONAL HEALTH EXPENDITURES 22-23 (2012).
10. See, e.g., Massachusetts State Budget, MASS. BUDGET & POL'Y CTR., http://www.massbudget.org/browser/index.php (last visited July 30, 2013).
11. Patient Protection and Affordable Care Act of 2010, Pub. L. No. III-48, 124 Stat. 119.
12. Kathleen M. Giacomini et al., Pharamcogenomics and Patient Care: One Size Does Not Fit All, SCI. TRANSLATIONAL MED., Sept. 2012, at 1.
13. See generally Ken Dutton-Regester & Nicholas K. Hayward, Reviewing the Somatic Genetics of Melanoma: From Current to Future Analytical Approaches, 25 PIGMENT CELL & MELANOMA RES. 144 (2012);
14. Levi. A Garraway & José Baselga, Whole-Genome Sequencing and Cancer Therapy: Is Too Much Ever Enough?, CANCER DISCOVERY, Sept. 2012, at 766.
15. Schildcrout et al., Optimizing Drug Outcomes Through Pharmacogenetics: A Case for Preemptive Genotyping, 92 CLINICAL PHARMACOLOGY & THERAPEUTICS 235 (2012).
16. See generally Jonathan S. Berg et al., Deploying Whole Genome Sequencing in Clinical Practice and Public Health: Meeting the Challenge One Bin at a Time, 13 GENETICS IN MED. 499 (2011);
17. See A Brief Guide to 'Genomics, NAT'L HUMAN GENOME RESEARCH INST. (Oct. 19, 2011), http://www.genome.gov/18016863;
18. Euan A. Ashley et al., Clinical Assessment Incorporating a Personal Genome, 375 LANCET 1525, 1526 (2010).
19. Jennifer J. Johnston et al., Secondary Variants in Individuals Undergoing Exome Sequencing: Screening of 572 Individual Identifies High-Penetrance Mutations in Cancer-Susceptibility Genes, 91 AM. J. HUM. GENETICS 97, 97 (2012).
20. See, e.g., Edison T. Liu, HUGO President Reports from the HUGO Symposium on Genomics and Ethics, Law and Society 2009, HUGO MATTERS: THE OFFICIAL BLOG OF THE HUMAN GENOME ORG. (Nov. 2, 2009), http://www.hugo-international.org/blog/? p=86.
21. David Wheeler et al., The Complete Genome of an Individual by Massively Parallel DNA Sequencing, 452 NATURE 872, 874 (2008).
22. Katrina M. Dipple & Edward R. B. McCabe, Phenotypes of Patients with "Simple" Mendelian Disorders Are Complex Traits: Thresholds, Modifiers, and Systems Dynamics, 66 AM. J. HUM. GENETICS 1729, 1731, 1733 (2000).
23. See generally Ernest Beutler, Discrepancies Between Genotype and Phenotype in Hematology: An Important Frontier, 98 BLOOD 2597 (2001).
24. See generally Nilanjan Chatterjee et al., Projecting the Performance of Risk Prediction Based on Polygenic Analyses of Genome-Wide Association Studies, 45 NATURE GENETICS 400 (2013);
25. Muin Khoury et al., How Can Polygenic Inheritance Be Used in Population Screening for Common Diseases?, GENETICS IN MED., Feb. 2013, at 1;
26. Callum J. Bell et al., Carrier Testing for Severe Childhood Recessive Diseases by Next-Generation Sequencing, SCI. TRANSLATIONAL MED., Jan. 2011, at 1, 11;
27. See generally Misha Angrist, Only Connect: Personal Genomics and the Future of American Medicine, 14 MOLECULAR DIAGNOSIS & THERAPY 67, 68-69 (2010) (discussing the need for further interpretation of variations).
28. See generally Abby G. Ershow, Environmental Influences on Development of Type 2 Diabetes and Obesity: Challenges in Personalizing Prevention and Management, 3 J. DIABETES SCI. &TECH. 727 (2009);
29. J. J. Reilly & J. Kelly, Long-Term Impact of Overweight and Obesity in Childhood and Adolescence on Morbidity and Premature Mortality in Adulthood: Systematic Review, 35 INT'L J. OBESITY 891 (2011).
30. See Should Healthy People Have Their Genomes Sequenced at This Time?, WALL ST. J. (Feb. 13, 2013, 5:03 PM), http://online.wsj.com/article/ SB10000872396390443884104577645783975993656.html;
31. Should Healthy People Have Their Genomes Sequenced at This Time?, supra note 43.
32. See generally COMM. ON A FRAMEWORK FOR DEVELOPING A NEW TAXONOMY OF DISEASE, NAT'L RES. COUNCIL OF THE NAT'L ACADS., TOWARD PRECISION MEDICINE: BUILDING A KNOWLEDGE NETWORK FOR BIOMEDICAL RESEARCH AND A NEW TAXONOMY OF DISEASE (2011).
33. Monya Baker, Big Biology: The 'Omes Puzzle, 494 NATURE 416, 418-19 (2013).
34. See Recommendations, U. S. PREVENTATIVE SERVS. TASK FORCE (Dec. 2010), http://www.uspreventiveservicestaskforce.org/recommendations.htm.
35. Adriana Bermudez, Can We Do the Same in the Developing World?, 99 GYNECOLOGIC ONCOLOGY S192, S192-93 (2005).
36. Charles M Kilo & Eric B. Larson, Exploring the Harmful Effects of Health Care, 302 J. AM. MED. ASS'N 89, 89 (2009).
37. William G. Woods et al., A Population-Based Study of the Usefulness of Screening for Neuroblastoma, 348 LANCET 1682, 1682 (1996);
38. S. Barrette et al., Treatment Complications in Children Diagnosed with Neuroblastoma During a Screening Program, 24 J. CLINICAL ONCOLOGY 1542 (2006).
39. See, e.g., Virgina A. Moyer, Screening for Prostate Cancer: U. S. Preventive Services Task Force Recommendation Statement, 120 ANNALS INTERNAL MED. 120 (2012).
40. See generally Abraham B. Bergman & Stanley J. Stamm, The Morbidity of Cardiac Nondisease in Schoolchildren, 276 NEW ENG. J. MED. 1008 (1967).
41. See generally F. L Mastaglia & M. Needham, Update on Toxic Myopathies, 12 CURRENT NEUROLOGY & NEUROSCIENCE REP. 54 (2012);
42. Willaim S. David et al., Case Records of the Massachusetts General Hospital: Case 7-2012-A yg-Year-Old Man with Pain and Weakness in the Legs, 366 NEW ENG. J. MED. 944 (2012).
43. See Nicholas J. Roberts et al., The Predictive Capacity of Personal Genome Sequencing, SCI. TRANSLATIONAL MED., May 2012, at 58-59;
44. Steven A. Narod, BRCA Mutations in the Management of Breast Cancer: The State of the Art, 7 NATURE REV. CLINICAL ONCOLOGY 702, 702-03 (2010).
45. John M. Eisenberg, Ten Lessons for Evidence-Based Technology Assessment, 282 J. AM. MED. ASS'N 1865, 1868 (1999).
46. Delos M. Cosgrove et al., Ten Strategies to Lower Costs, Improve Quality, and Engage Patients: the View from Leading Health System CEOs, 32 HEALTH AFF. 321, 321 (2013).
47. See Cruzan v. Dir., Mo. Dep't of Health, 497 U. S. 261, 278-79 (1990) ("The principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions.").
48. See Washington v. Glucksberg, 521 U. S. 702, 720 (1997) ("We have also assumed, and strongly suggested, that the Due Process Clause protects the traditional right to refuse unwanted lifesaving medical treatment.").
49. Canterbury v. Spence, 464 F.2d 772, 780 (D. C. Cir. 1972).
50. See generally RUTH R. FADEN & TOM L. BEAUCHAMP, A HISTORY AND THEORY OF INFORMED CONSENT (1986);
51. LAW IN PUB. HEALTH PRAC. 274 (Richard A. Goodman et al. eds., 2d ed. 2007).
52. Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191, 110 Stat. 1936
53. (codified as amended in scattered sections of 42 U. S. C.).
54. David Veroff et al., Enhanced Support for Shared Decision Making Reduced Costs of Care for Patients with Preference-Sensitive Conditions, 32 HEALTH AFF. 285, 291 (2013).
55. Leroy Hood & Stephen H. Friend, Predictive, Personalized, Preventive, Participatory (P4) Cancer Medicine, 8 NATURE REV. CLINICAL ONCOLOGY 184, 186 (2011).
56. Virginia Hughes, It's Time to Stop Obsessing About the Dangers of Genetic Information, SLATE (Jan. 7, 2013, 3:51 PM), http://www.slate.com/articles/ health-and-srience/medical-examiner/2013/01/ethics-of-genetic-information-whole- genome-sequencing-is-here-and-we-need.html;
57. Misha Angrist, You Never Call, You Never Write: Why Return of 'Omic' Results to Research Participants Is Both a Good Idea and a Moral Imperative, 8 PERSONALIZED MED. 651 (2011).
58. See generally Troy Brennan et al., Medical Professionalism in the New Millennium: A Physician Charter, 136 Ann. Internal Med. 243 (2012).
59. See generally Ellen Wright Clayton & Amy L. McGuire, The Legal Risks of Returning Results of Genomics Research, 14 GENETICS IN MED. 473 (2012).
60. See generally Summer Sawyer Allen, & Sandhya Pruthi, The Mammography Controversy: When Should You Screen?, 60 J. FAM. PRAC. 524 (2011).
61. See generally Peter B. Bach et al., Benefits and Harms of CT Screening for Lung Cancer: A Systematic Review, 307 J. AM. MED. ASS'N 2418 (2012).
62. Debbie Saslow et al., American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography, 57 CA: CANCER J. FOR CLINICIANS 75, 83 (2007).
63. See Kimberly S. H. Yarnall et al., Family Physicians as Team Leaders: "Time" to Share the Care, PREVENTING CHRONIC DISEASE: PUB. HEALTH RES., PRAC, & POL'Y, Apr. 2009, at A59.