Literature DB >> 27256135

Contrasting Medical and Legal Standards of Evidence: A Precision Medicine Case Study.

Gary E Marchant1, Kathryn Scheckel1, Doug Campos-Outcalt1.   

Abstract

As the health care system transitions to a precision medicine approach that tailors clinical care to the genetic profile of the individual patient, there is a potential tension between the clinical uptake of new technologies by providers and the legal system's expectation of the standard of care in applying such technologies. We examine this tension by comparing the type of evidence that physicians and courts are likely to rely on in determining a duty to recommend pharmacogenetic testing of patients prescribed the oral anti-coagulant drug warfarin. There is a large body of inconsistent evidence and factors for and against such testing, but physicians and courts are likely to weigh this evidence differently. The potential implications for medical malpractice risk are evaluated and discussed.
© 2016 American Society of Law, Medicine & Ethics.

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Year:  2016        PMID: 27256135      PMCID: PMC5137582          DOI: 10.1177/1073110516644210

Source DB:  PubMed          Journal:  J Law Med Ethics        ISSN: 1073-1105            Impact factor:   1.718


  50 in total

1.  Genetic warfarin dosing: tables versus algorithms.

Authors:  Brian S Finkelman; Brian F Gage; Julie A Johnson; Colleen M Brensinger; Stephen E Kimmel
Journal:  J Am Coll Cardiol       Date:  2011-02-01       Impact factor: 24.094

2.  Genetic risk factors for major bleeding in patients treated with warfarin in a community setting.

Authors:  J A Roth; D Boudreau; M M Fujii; F M Farin; A E Rettie; K E Thummel; D L Veenstra
Journal:  Clin Pharmacol Ther       Date:  2014-02-06       Impact factor: 6.875

3.  Warfarin, genes, and the (health care) environment.

Authors:  Dhruv S Kazi; Mark A Hlatky
Journal:  JAMA Intern Med       Date:  2014-08       Impact factor: 21.873

4.  A pharmacogenetic versus a clinical algorithm for warfarin dosing.

Authors:  Stephen E Kimmel; Benjamin French; Scott E Kasner; Julie A Johnson; Jeffrey L Anderson; Brian F Gage; Yves D Rosenberg; Charles S Eby; Rosemary A Madigan; Robert B McBane; Sherif Z Abdel-Rahman; Scott M Stevens; Steven Yale; Emile R Mohler; Margaret C Fang; Vinay Shah; Richard B Horenstein; Nita A Limdi; James A S Muldowney; Jaspal Gujral; Patrice Delafontaine; Robert J Desnick; Thomas L Ortel; Henny H Billett; Robert C Pendleton; Nancy L Geller; Jonathan L Halperin; Samuel Z Goldhaber; Michael D Caldwell; Robert M Califf; Jonas H Ellenberg
Journal:  N Engl J Med       Date:  2013-11-19       Impact factor: 91.245

5.  Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal.

Authors:  Dar Dowlatshahi; Kenneth S Butcher; Negar Asdaghi; Susan Nahirniak; Manya L Bernbaum; Antonio Giulivi; Jason K Wasserman; Man-Chiu Poon; Shelagh B Coutts
Journal:  Stroke       Date:  2012-05-03       Impact factor: 7.914

6.  Laboratory and clinical outcomes of pharmacogenetic vs. clinical protocols for warfarin initiation in orthopedic patients.

Authors:  P A Lenzini; G R Grice; P E Milligan; M B Dowd; S Subherwal; E Deych; C S Eby; C R King; R M Porche-Sorbet; C V Murphy; R Marchand; E A Millican; R L Barrack; J C Clohisy; K Kronquist; S K Gatchel; B F Gage
Journal:  J Thromb Haemost       Date:  2008-07-24       Impact factor: 5.824

7.  Meta-analysis of randomized controlled trials reveals an improved clinical outcome of using genotype plus clinical algorithm for warfarin dosing.

Authors:  Zhenqi Liao; Shaoguang Feng; Peng Ling; Guoqing Zhang
Journal:  J Thromb Thrombolysis       Date:  2015-02       Impact factor: 2.300

8.  The largest prospective warfarin-treated cohort supports genetic forecasting.

Authors:  Mia Wadelius; Leslie Y Chen; Jonatan D Lindh; Niclas Eriksson; Mohammed J R Ghori; Suzannah Bumpstead; Lennart Holm; Ralph McGinnis; Anders Rane; Panos Deloukas
Journal:  Blood       Date:  2008-06-23       Impact factor: 22.113

9.  The rules remain the same for genomic medicine: the case against "reverse genetic exceptionalism".

Authors:  James P Evans; Wylie Burke; Muin Khoury
Journal:  Genet Med       Date:  2010-06       Impact factor: 8.822

Review 10.  Oral anticoagulation: a critique of recent advances and controversies.

Authors:  Munir Pirmohamed; Farhad Kamali; Ann K Daly; Mia Wadelius
Journal:  Trends Pharmacol Sci       Date:  2015-02-17       Impact factor: 14.819

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  3 in total

1.  Physicians' duty to recontact and update genetic advice.

Authors:  Yvonne A Stevens; Grant D Senner; Gary E Marchant
Journal:  Per Med       Date:  2017-06-08       Impact factor: 2.512

2.  From Genetics to Genomics: Facing the Liability Implications in Clinical Care.

Authors:  Gary Marchant; Mark Barnes; James P Evans; Bonnie LeRoy; Susan M Wolf
Journal:  J Law Med Ethics       Date:  2020-03       Impact factor: 1.718

3.  Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

Authors:  Susan M Wolf; Laura M Amendola; Jonathan S Berg; Wendy K Chung; Ellen Wright Clayton; Robert C Green; Julie Harris-Wai; Gail E Henderson; Gail P Jarvik; Barbara A Koenig; Lisa Soleymani Lehmann; Amy L McGuire; Pearl O'Rourke; Carol Somkin; Benjamin S Wilfond; Wylie Burke
Journal:  Genet Med       Date:  2017-08-31       Impact factor: 8.822

  3 in total

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