Literature DB >> 20393310

Myriad Genetics: In the eye of the policy storm.

E Richard Gold1, Julia Carbone.   

Abstract

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.

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Year:  2010        PMID: 20393310      PMCID: PMC3037261          DOI: 10.1097/GIM.0b013e3181d72661

Source DB:  PubMed          Journal:  Genet Med        ISSN: 1098-3600            Impact factor:   8.822


  69 in total

1.  Underwhelmed: hyperbole, regulatory policy, and the genetic revolution.

Authors:  T Caulfield
Journal:  McGill Law J       Date:  2000-05

2.  European-wide opposition against the breast cancer gene patents.

Authors:  Gert Matthijs; Dicky Halley
Journal:  Eur J Hum Genet       Date:  2002-12       Impact factor: 4.246

3.  Effects of patents and licenses on the provision of clinical genetic testing services.

Authors:  Mildred K Cho; Samantha Illangasekare; Meredith A Weaver; Debra G B Leonard; Jon F Merz
Journal:  J Mol Diagn       Date:  2003-02       Impact factor: 5.568

4.  Evidence and anecdotes: an analysis of human gene patenting controversies.

Authors:  Timothy Caulfield; Robert M Cook-Deegan; F Scott Kieff; John P Walsh
Journal:  Nat Biotechnol       Date:  2006-09       Impact factor: 54.908

5.  Statement of the American Society of Clinical Oncology: genetic testing for cancer susceptibility, Adopted on February 20, 1996.

Authors: 
Journal:  J Clin Oncol       Date:  1996-05       Impact factor: 44.544

6.  How human geneticists in US view commercialization of the Human Genome Project.

Authors:  I Rabino
Journal:  Nat Genet       Date:  2001-09       Impact factor: 38.330

7.  Contending visions in the evolution of genetic medicine: the case of cancer genetic services in Ontario, Canada.

Authors:  Fiona Alice Miller; Mita Giacomini; Catherine Ahern
Journal:  Soc Sci Med       Date:  2008-04-23       Impact factor: 4.634

8.  Spectrum of mutations in BRCA1, BRCA2, CHEK2, and TP53 in families at high risk of breast cancer.

Authors:  Tom Walsh; Silvia Casadei; Kathryn Hale Coats; Elizabeth Swisher; Sunday M Stray; Jake Higgins; Kevin C Roach; Jessica Mandell; Ming K Lee; Sona Ciernikova; Lenka Foretova; Pavel Soucek; Mary-Claire King
Journal:  JAMA       Date:  2006-03-22       Impact factor: 56.272

9.  Patient responses to the disclosure of BRCA mutation tests in hereditary breast-ovarian cancer families.

Authors:  Henry T Lynch; Carrie Snyder; Jane F Lynch; Peggy Karatoprakli; Abdon Trowonou; Kelly Metcalfe; Steven A Narod; Gordon Gong
Journal:  Cancer Genet Cytogenet       Date:  2006-03

10.  When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results.

Authors:  Fiona A Miller; Mita Giacomini; Catherine Ahern; Jason S Robert; Sonya de Laat
Journal:  BMC Med Ethics       Date:  2008-02-22       Impact factor: 2.652

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  28 in total

1.  The Bermuda Triangle: The Pragmatics, Policies, and Principles for Data Sharing in the History of the Human Genome Project.

Authors:  Kathryn Maxson Jones; Rachel A Ankeny; Robert Cook-Deegan
Journal:  J Hist Biol       Date:  2018-12       Impact factor: 1.326

Review 2.  Baseball bats and chocolate chip cookies: the judicial treatment of DNA in the myriad genetics litigation.

Authors:  Ian Binnie; Vanessa Park-Thompson
Journal:  Cold Spring Harb Perspect Med       Date:  2014-12-18       Impact factor: 6.915

Review 3.  Patentability of genes: a European Union perspective.

Authors:  Paul Cole
Journal:  Cold Spring Harb Perspect Med       Date:  2014-10-16       Impact factor: 6.915

4.  Economic Evaluation Alongside a Clinical Trial of Telephone Versus In-Person Genetic Counseling for BRCA1/2 Mutations in Geographically Underserved Areas.

Authors:  Yaojen Chang; Aimee M Near; Karin M Butler; Amanda Hoeffken; Sandra L Edwards; Antoinette M Stroup; Wendy Kohlmann; Amanda Gammon; Saundra S Buys; Marc D Schwartz; Beth N Peshkin; Anita Y Kinney; Jeanne S Mandelblatt; Yaojen Chang; Aimee M Near; Karin M Butler; Amanda Hoeffken; Sandra L Edwards; Antoinette M Stroup; Wendy Kohlmann; Amanda Gammon; Saundra S Buys; Marc D Schwartz; Beth N Peshkin; Anita Y Kinney; Jeanne S Mandelblatt
Journal:  J Oncol Pract       Date:  2016-01       Impact factor: 3.840

Review 5.  Patents in genomics and human genetics.

Authors:  Robert Cook-Deegan; Christopher Heaney
Journal:  Annu Rev Genomics Hum Genet       Date:  2010       Impact factor: 8.929

6.  Framing Ethical Concerns and Attitudes towards Human Gene Patents in the Chinese Press.

Authors:  Li Du; Sijie Lin; Kalina Kamenova
Journal:  Asian Bioeth Rev       Date:  2020-08-01

7.  Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Authors:  Li Jiang
Journal:  Sci Eng Ethics       Date:  2018-03-12       Impact factor: 3.525

Review 8.  Gene patents: a broken incentives system.

Authors:  Yun-Han Huang
Journal:  J Relig Health       Date:  2013-12

9.  Genetics. Moving beyond "isolated" gene patents.

Authors:  Arti K Rai; Robert Cook-Deegan
Journal:  Science       Date:  2013-06-27       Impact factor: 47.728

10.  Gene patents and personalized cancer care: impact of the Myriad case on clinical oncology.

Authors:  Kenneth Offit; Angela Bradbury; Courtney Storm; Jon F Merz; Kevin E Noonan; Rebecca Spence
Journal:  J Clin Oncol       Date:  2013-06-13       Impact factor: 44.544

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