Commercial opportunities and ethical pitfalls in personalized medicine: A myriad of reasons to revisit the myriad genetics saga

Current Pharmacogenomics and Personalized Medicine

Volumn 11, Issue 2, 2013, Pages 98-109

  So, Derek ^a   Joly, Yann ^a  

^a MCGILL UNIVERSITY   (Canada)

Author keywords

BRCA genes; Breast and ovarian cancer; Commercialization; Direct to consumer advertising; Gene patents; Genetic diagnostic tests; Myriad genetics; Trade secrets

Indexed keywords

BRCA1 PROTEIN; BRCA2 PROTEIN;

ADVERTIZING; ARTICLE; BIOTECHNOLOGY; CONSUMER; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; ECONOMIC EVALUATION; ETHICAL DECISION MAKING; GENE MUTATION; GENETIC PREDISPOSITION; HUMAN; INTELLECTUAL FREEDOM; MARKETING; PATENT; PERSONALIZED MEDICINE;

EID: 84888088935     PISSN: 18756921     EISSN: 18756913     Source Type: Journal    
DOI: 10.2174/1875692111311020003     Document Type: Article

References (78)

1. Barnes DR, Antoniou AC. Unravelling modifiers of breast and ovarian cancer risk for BRCA1 and BRCA2 mutation carriers: update on genetic modifiers. J Intern Med 2012; 271(4): 331-43.
2. Gold ER, Carbone J. Myriad Genetics: In the eye of the policy storm. Genet Med 2012; 12: S39-70.
3. Reynolds T. NCI-Myriad Agreement Offers Testing at Reduced Cost. JNCI J Natl Cancer Inst 2000; 92(8): 596.
4. Kesselheim AS, Mello MM. Gene Patenting-Is the Pendulum Swinging Back? N Engl J Med 2010; 362: 1855-8.
5. GenomeWeb. Myriad's Q2 Revenues Increase 21 Percent; New $200M Stock Buyback Program Launched. 2013; Available from:http://www.genomeweb.com/clinical-genomics/myriads-q2-revenues-increase-21-percent-new-200m-stock-buyback-program-launched [Accessed February 20, 2013].
6. GenomeWeb. Myriad Expects BRACAnalysis to Remain Best Seller in 'Post-Patent' Era. 2013; Available from: http://www.genomeweb.com/clinical-genomics/myriad-expects-bracanalysis-remain-best-seller-post-patent-era [Accessed February 20, 2013].
7. Carlson B. Gene Patents on the Line. Biotechnol Healthc 2009; 8(4): 8-10.
8. Cook-Deagan R, Heaney C. Patents in Genomics and Human Genetics. Annu Rev Genomics Hum Genet 2010; 11: 383-425.
9. United States Code - Title 35: Patents.
10. World Trade Organization. Trade-Related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization. 1994; Available from: http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm [Accessed February 20, 2013].
11. Caulfield T, Bubela T. & Murdoch C J. Myriad and the mass media: the covering of a gene patent controversy. Genet Med 2007; 9: 850-5.
12. Caulfield T. Policy conflicts: gene patents and health care in Canada. Community Genet 2005; 8, 223-227.
13. U.S. Patent No. 5,693,473. Issued Dec 2, 1997.
14. U.S. Patent No. 5,837,492. Issued Nov 17, 1998.
15. U.S. Patent No. 5,747,282. Issued May 5, 1998.
16. U.S. Patent 6,124,104. Issued Sept 26, 2000.
17. Carbone J, Gold ER, Sampat B, et al. DNA patents and diagnostics: not a pretty picture. Nat Biotech 2010; 28(8): 784-91.
18. van den Belt H. Direct-to-Consumer Genetic Testing: How the Promise of a Personalised Approach is Being Squandered. In: Genomics, Obesity and the Struggle over Responsibilities. Korthals M, Ed. Dordrecht: Springer, 2011; pp. 113-30.
19. Cook-Deegan R, Conley JM, Evans JP et al. The next controversy in genetic testing: clinical data as trade secrets? Eur J Hum Genet 2012; Available from: http://www.nature.com/ejhg/journal/vaop/ncurrent/full/ejhg2012217a.html [Accessed February 20, 2013].
20. Cook-Deegan R, Chandrasekharan S, Angrist M. The dangers of diagnostic monopolies. Nature 2009; 458: 405-6.
21. Canada Patent No. 2,196,790. IssuedOct 10, 2000.
22. Canada Patent No. 2,239,733. Issued Apr 3, 2001.
23. Caulfield T. Human Gene Patents: Proof of Problems. Chi.-Kent L Rev 2009; 84 (1): 133-46.
24. Myriad Pro. Financial Assistance Programs: MFAP. Available from: https://www.myriadpro.com/mfap [Accessed February 20, 2013].
25. Gold ER, Caulfield T, Ray P. Gene patents and the standard of care. Can Med Assoc J 2002; 167(3): 256-7.
26. Cook-Deegan R, Derienzo C, Carbone J, et al. Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Comparing breast and ovarian cancers with colon cancers. Genet Med 2010; 12: S15-38.
27. Resnik DB. The morality of human gene patents. Kennedy Inst Ethics J 1997; 7(1): 43-61.
28. Kontos EZ, Viswanath K. Cancer-related direct-to-consumer advertising: a critical review. Nat Rev Cancer 2011; 11: 142-50.
29. Matloff E, Caplan A. Direct to Confusion: Lessons Learned from Marketing BRCA Testing. Am J Bioeth 2008; 8(6): 5-8.
30. Carlson B. DTC Advertising: Where Do Genetic Tests Fit? Biotechnol Healthc 2009; 6(1): 6-7.
31. Mouchawar J, Hensley-Alford S, Laurion S, et al. Impact of direct-to-consumer advertising for hereditary breast cancer testing on genetic services at a managed care organization: A naturally-occurring experiment. Genet Med 2005; 7(3): 191-7.
32. Murray ML, Cerrato F, Bennett RL, et al. Follow-up of carriers of BRCA1 and BRCA2 variants of unknown significance: Variant reclassification and surgical decisions. Genet Med 2011; 13: 998-1005.
33. Calò V, Bruno L, La Paglia L et al. The Clinical Significance of Unknown Sequence Variants in BRCA Genes. Cancers 2010; 2(3): 1644-60.
34. Spearman AD, Sweet K, Zhou X-P, et al. Clinically Applicable Models to Characterize BRCA1 and BRCA2 Variants of Uncertain Significance. J Clin Oncol 2008; 26(33): 5393-400.
35. Lowery JT, Byers T, Axell L, et al. The impact of direct-to-consumer marketing of cancer genetic testing on women according to their genetic risk. Genet Med 2008; 10: 888-94.
36. Burrill & Company. Biotech 2009: Life Sciences: Navigating the Sea Change. Available from: http://www.burrillandco.com/Biotech2009old.html [Accessed February 20, 2013].
37. Association of University Technology Managers. Licensing Surveys - AUTM. Available from: http://www.autm.net/AM/Template.cfm?Section=Licensing_Surveys_AUTM&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=6&ContentID=2409 [Accessed February 20, 2013].
38. GenomeWeb. JP Morgan Healthcare Conference, Day One: Myriad Genetics; Bruker; Genomic Health; Qiagen; Waters. 2013; Available from: http://www.genomeweb.com/jp-morgan-healthcare-conference-day-one-myriad-genetics-bruker-genomic-health-qi [Accessed February 20, 2013].
39. Myrexis. Myrexis, Inc. Announces Board Approval of Plan of Complete Liquidation and Dissolution. 2012; Available from: http://investors.myrexis.com/releasedetail.cfm?ReleaseID=720278 [Accessed February 20, 2013].
40. Pollack A. Despite Gene Patent Victory, Myriad Genetics Faces Challenges. The New York Times 2011 (Aug 24); Available from: http://www.nytimes.com/2011/08/25/business/despite-gene-patent-victory-myriad-genetics-faces-challenges.html?_r=1&[Accessed February 20, 2013].
41. Myriad. Current Products. Available from: http://www.myriad.com/products/ [Accessed February 20, 2013].
42. Baker M, Policy paper: Myriad turns cancer genetic data into trade secrets. Nature News Blog Oct 2012; Available from: http://blogs.nature.com/news/2012/10/policy-paper-myriad-turns-cancer-genetic-data-into-trade-secrets.html [Accessed February 20, 2013].
43. m. Myriad Genetics Opens Molecular Diagnostic Testing Lab in Munich, Germany. 2012; Available from: http://www.bio-m.org/en/news/myriad-genetics-opens-molecular-diagnostic-testing-lab-in-munich-germany.html [Accessed February 20, 2013].
44. Cancer Voices Australia v. Myriad Genetics Inc. [2013] FCA 65.
45. Karow J. Complete Genomics Expects Moderate Price Decline, Growing Capacity in 2012. 2012; Available at: http://www. genomeweb.com/print/1042131 [Accessed February 20, 2013].
46. Holman CM. Debunking the Myth that Whole-Genome Sequencing Infringes Thousands of Gene Patents, Nat Biotechnol 2012; 30(3): 240-4.
47. Radice P, De Summa S, Caleca L, et al. Unclassified variants in BRCA genes: guidelines for interpretation. Ann Oncol 2011; 22(suppl 1): i18-23.
48. Akbari MR, Zhang S, Fan I, et al. Clinical impact of unclassified variants of the BRCA1 and BRCA2 genes. J Med Genet 2011; 48: 783-6.
49. Vallée MP, Francy TC, Judkins MK, et al. Classification of missense substitutions in the BRCA genes: A database dedicated to Ex-UVs. Hum Mutat 2012; 33: 22-8.
50. Capanu M, Concannon P, Haile RW, et al. The WECARE Study Collaborative Group, Begg CB. Assessment of rare BRCA1 and BRCA2 variants of unknown significance using hierarchical modeling. Genet Epidemiol 2011; 35: 389-97.
51. European Society of Human Genetics. Privately owned genetic databases may hinder diagnosis and bar the way to the arrival of personalised medicine: ESHG reacts to today's report in the European Journal of Human Genetics. 2012; Available from: https://www.eshg.org/13.0.html [Accessed February 20, 2013].
52. McElligott S, Field RI, Bristol-Demeter M, et al. How Genetic Variant Libraries Effectively Extend Gene Testing Patents: Implications for Intellectual Property and Good Clinical Care. J Clin Oncol 2012; 30(24): 2943-5.
53. EUR-Lex. Directive 96/9/EC of the European Parliament and of the Council of 11 march 1996 on the legal protection of databases. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996L0009:EN:NOT. [Accessed February 20, 2013].
54. Caulfield T., Cook-Deegan RM, Kieff FS, et al. Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies. Nat Biotechnol 2006; 24(9): 1091-4.
55. Ahn C. Pharmacogenomics in Drug Discovery and Development. Genomics Informatics 2007; 5(2): 41-5.
56. Bates S. Progress towards personalized medicine. Drug Discov Today; 15(3-4): 115-20.
57. (TM). Genome Medicine 2013; 5(8). Available from: http://genomemedicine.com/content/pdf/ gm412.pdf. [Accessed March 29, 2013].
58. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987; 235 (4785): 177-82.
59. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the Her-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244 (4905): 707-12.
60. Pollack A. Studies Back Length of Herceptin Cancer Treatment. The New York Times 2012 (Oct 1); Available from: http://www.nytimes.com/2012/10/02/business/current-length-of-herceptin-treatment-is-supported-by-studies.html [Accessed March 29, 2013].
61. Ferrusi IL, Marshall DA, Kulin NA, et al. Looking back at 10 years of trastuzumab therapy: what is the role of HER2 testing? A systematic review of health economic analyses. Per Med 2009; 6(2): 193-215.
62. Kondro W, Sibbald B. Patient demand and politics push Herceptin forward. CMAJ 2005; 173(4): 347-8.
63. Woelderink A, Ibarreta D, Hopkins MM, et al. The current clinical practice of pharmacogenetic testing in Europe: TPMT and HER2 as case studies. Pharmacogenomics J 2006; 6: 3-7.
64. Marcial G. Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf. Forbes 2012 (Mar 15); Available from: http://www.forbes.com/sites/genemarcial/2012/03/15/roche-accelerates-defense-strategy-to-protect-breast-cancer-drug-herceptins-turf/ [Accessed March 29, 2013].
65. Dako. Agilent Technologies Completes Acquisition of Dako. 2012; Available from: http://www.dako.com/ca/index/aboutdako/newsevents/ news/news_agilent_technologies_completes_acquisition_of_dako.h tm [Accessed March 29, 2013].
66. Dako. FDA Approves Dako's HercepTest™ and HER2 FISH pharmDx™ Kit as Companion Diagnostics for Genentech's New Cancer Drug Perjeta™. 2011; Available from: http://www.dako.com/ca/index/aboutdako/newsevents/news/fda_approves_dako_s_herceptest_and_her2_fish_pharmdx_kit_as_ompanion_diagnostics_for_genentech_s_new_cancer_drug_perjeta.htm [Accessed March 29, 2013].
67. Agilent Technologies. FDA Approves Two Dako Assays as Companion Diagnostics for Genentech's New Breast Cancer Medicine Kadcyla. 2013; Available from: http://www.agilent.com/about/newsroom/presrel/2013/05mar-dk13004.html [Accessed March 29, 2013].
68. Druker BJ. STI571 (Gleevec™) as a paradigm for cancer therapy. Trends Mol Med 2002; 8(4): S14-8.
69. Druker BJ. Translation of the Philadelphia chromosome into therapy for CML. Blood 2008; 112(13): 4808-17.
70. von Schaper E. Novartis Cannibalizes Gleevec to Boost New Cancer Drug. Bllomberg. 2012; Available from: http://www.bloomberg.com/news/2012-10-25/novartis-cannibalizes-gleevec-to-boost-new-cancer-drug.html [Accessed March 29, 2013].
71. Limb J. Glivec debate poses vital issues. Consumer Project on Technology. 2002; Available from: http://www.cptech.org/ip/health/gleevec/vitalissues05182002.html [Accessed March 29, 2013].
72. Lyon E, Gastier Foster J, Palomaki GE, et al. Laboratory testing of CYP2D6 alleles in relation to tamoxifen therapy. Genet Med. 2012; 14(12): 990-1000.
73. Li YY, Jones SJ. Drug repositioning for personalized medicine. Genome Med. 2012; 4(3): 27.
74. NASDAQ. Myriad Genetics, Inc. Revenue & Earnings Per Share (EPS). 25 February 2013; Available from: http://www.nasdaq.com/symbol/mygn/revenue-eps#.USuZZx2Hsi4 [Accessed February 20, 2013].
75. NASDAQ. Myriad Genetics Inc. Historical Stock Prices. 2013; Available from: http://www.nasdaq.com/symbol/mygn/historical#.USu1cFrF19k [Accessed February 20, 2013].
76. NASDAQ. NASDAQ Biotechnology Index. 22 February 2012; Available from: http://www.nasdaq.com/dynamic/nasdaqbiotech_activity.stm [Accessed February 20, 2013].
77. GenomeWeb. Myriad to Replace BRACAnalysis, Other Hereditary Cancer Tests with MyRisk Panel. 9 May 2013; Available from: http://www.genomeweb.com/sequencing/myriad-replace-bracanalysis-other-hereditary-cancer-tests-myrisk-panel [Accessed May 9, 2013].
78. Myriad. Myriad Genetics Reports Third Quarter Fiscal Year 2013 Results. 7 May 2013; Available from: http://investor.myriad.com/releasedetail.cfm?ReleaseID=762769 [Accessed May 9, 2013].