Myriad Genetics: In the eye of the policy storm.
From the late 1980s, a storm surrounding the wisdom, ethics, and economics of human gene patents has been brewing. The various winds of concern in this storm touched on the impact of gene patents on basic and clinical research, on health care delivery, and on the ability of public health care systems to provide equal access when faced with costly patented genetic diagnostic tests. Myriad Genetics, Inc., along with its subsidiary, Myriad Genetic Laboratories, Inc., a small Utah-based biotechnology company, found itself unwittingly in the eye of this storm after a series of decisions it made regarding the commercialization of a hereditary breast cancer diagnostic test. This case study examine the background to Myriad's decisions, the context in which these decisions were made and the policy, research and business response to them.
Gold
E Richard
ER
McGill Faculty of Law, McGill University, 3644 Peel Street, Montreal, Quebec, Canada. richard.gold2@mcgill.ca
Carbone
Julia
J
D001709:Biotechnology; D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics*; D003132:Commerce / Q000191:economics / Q000941:ethics; D005260:Female; D005796:Genes; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D005820:Genetic Testing / Q000941:ethics*; D005823:Genetics; D006291:Health Policy; D006297:Health Services Accessibility / Q000191:economics / Q000941:ethics*; D006801:Humans; D007753:Laboratories; D010330:Patents as Topic / Q000941:ethics*; D011933:Reagent Kits, Diagnostic; D014589:Utah
D011933:Reagent Kits, Diagnostic
Cancer Genet Cytogenet. 2006 Mar;165(2):91-7
16527602
JAMA. 2006 Mar 22;295(12):1379-88
16551709
Soc Sci Med. 2008 Jul;67(1):152-60
18436360
Nat Genet. 2001 Sep;29(1):15-6
11528382
McGill Law J. 2000 May;45(2):437-60
12688281
J Mol Diagn. 2003 Feb;5(1):3-8
12552073
Eur J Hum Genet. 2002 Dec;10(12):783-5
12461683
Nat Biotechnol. 2006 Sep;24(9):1091-4
16964215
J Clin Oncol. 1996 May;14(5):1730-6; discussion 1737-40
8622094
BMC Med Ethics. 2008 Feb 22;9:4
18294373
New Genet Soc. 2003 Dec;22(3):271-96
15115034
Community Genet. 2005;8(4):228-34
16244477
Genet Med. 2005 May-Jun;7(5):311-6
15915082
JAMA. 2002 Oct 9;288(14):1762-7
12365961
Health Law J. 2002;10:123-46
14748275
J Natl Cancer Inst. 2003 Jan 1;95(1):8-9
12509391
Science. 2004 Mar 19;303(5665):1757-8
15031474
Science. 1997 Dec 12;278(5345):1874
9417630
Cancer Res. 1999 Jan 15;59(2):455-61
9927062
Am J Manag Care. 2005 Oct;11(10):601-8
16232001
J Clin Oncol. 2002 Nov 15;20(22):4485-92
12431973
N Engl J Med. 2006 Aug 10;355(6):543-5
16899772
Gynecol Oncol. 2003 Jan;88(1 Pt 2):S8-10; discussion S11-3
12586076
Lancet. 1991 Jul 13;338(8759):82-3
1676470
J Child Fam Nurs. 1999 Sep-Oct;2(5):388-90
10795196
Clin Invest Med. 2001 Jun;24(3):147-57
11437066
Soc Stud Sci. 2005 Feb;35(1):5-40
15991444
Nature. 2000 Oct 26;407(6807):934
11069152
Clin Genet. 2004 Oct;66(4):311-7
15355433
J Natl Cancer Inst. 2000 Apr 19;92(8):596
10772669
J Med Genet. 2002 Nov;39(11):817-21
12414821
Kennedy Inst Ethics J. 2006 Jun;16(2):105-28
17036443
Science. 1998 May 1;280(5364):698-701
9563938
MedGenMed. 2005 Jun 29;7(2):60
16369438
Nature. 2002 Feb 7;415(6872):577-9
11832913
Nature. 1995 Dec 21-28;378(6559):789-92
8524414
West J Med. 2001 Sep;175(3):168-73
11527843
MMWR Morb Mortal Wkly Rep. 2004 Jul 16;53(27):603-6
15254451
Int J Cancer. 2006 May 1;118(9):2281-4
16331614
South Calif Interdiscip Law J. 1996 Winter;5(1):25-40
16211765
Public Aff Q. 2004 Oct;18(4):299-344
15812959
Rev Am Hist. 2002 Mar;30(1):114-23
11949674
Am J Hum Genet. 1993 Apr;52(4):678-701
8460634
Nat Biotechnol. 2000 Aug;18(8):820
10932143
Soc Sci Med. 2000 Sep;51(6):821-9
10972427
Health Law J. 1999;7:69-90
11066370
Nat Genet. 1996 Mar;12(3):333-7
8589730
Lancet Oncol. 2005 May;6(5):301-10
15863378
Am J Hum Genet. 1991 Feb;48(2):232-42
1990835
EMBO Rep. 2002 Dec;3(12):1120-2
12475923
Kennedy Inst Ethics J. 2006 Mar;16(1):1-37
16770885
Am J Med Genet. 1999 Mar 19;83(3):157-63
10096590
Eubios J Asian Int Bioeth. 2003 Mar;13(2):57-9
17117541
Health Aff (Millwood). 2006 Jul-Aug;25(4):911-22
16835169
Aust New Zealand Health Policy. 2006 Nov 08;3:13
17092338
Nat Biotechnol. 2006 Jan;24(1):31-9
16404390
Am J Hum Genet. 1992 Mar;50(3):476-82
1539589
Community Genet. 2005;8(4):235-42
16244478
Eur J Hum Genet. 2002 Oct;10(10):599-606
12357330
Science. 1994 Oct 7;266(5182):66-71
7545954
Prev Med. 2002 Jun;34(6):590-5
12052018
Genet Med. 2007 Dec;9(12):850-5
18091435
Science. 1994 Sep 30;265(5181):2088-90
8091231
Cancer Epidemiol Biomarkers Prev. 2002 Jan;11(1):79-87
11815404
Nature. 2003 May 8;423(6936):105
12736643
Science. 1990 Dec 21;250(4988):1684-9
2270482
J Clin Oncol. 2003 Jun 15;21(12):2397-406
12692171
Nat Rev Genet. 2002 Oct;3(10):803-8
12360238
Eur J Cancer Care (Engl). 1998 Sep;7(3):174-80
9793009