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      Ethics, Evidence and Economics in the Pursuit of “Personalized Medicine”

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          Abstract

          Despite enthusiastic advocacy for what personalized medicine might be able to deliver and major investments into the development of this, there remain disappointingly few examples of personalized medicine in routine clinical practice today, particularly in high areas of unmet need such as cancer. We believe that this is because personalized medicine challenges the moral, economic and epistemological foundations of medicine. In this article, we briefly describe the scientific premises underpinning personalized medicine, contrast these with traditional paradigms of drug development, and then consider the ethical, economic and epistemological implications of this approach to medicine.

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          Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells.

          B Druker, S TAMURA, E Buchdunger … (1996)
          The bcr-abl oncogene, present in 95% of patients with chronic myelogenous leukemia (CML), has been implicated as the cause of this disease. A compound, designed to inhibit the Abl protein tyrosine kinase, was evaluated for its effects on cells containing the Bcr-Abl fusion protein. Cellular proliferation and tumor formation by Bcr-Abl-expressing cells were specifically inhibited by this compound. In colony-forming assays of peripheral blood or bone marrow from patients with CML, there was a 92-98% decrease in the number of bcr-abl colonies formed but no inhibition of normal colony formation. This compound may be useful in the treatment of bcr-abl-positive leukemias.
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            Media influence on Herceptin subsidization in Australia: application of the rule of rescue?

            Glenn Salkeld, Simon Holding, Ross MacKenzie … (2008)
            In August 2006, the Australian government announced that Herceptin (Trastuzumab) would be added to the national Pharmaceutical Benefits Scheme (PBS) of government-subsidized drugs, for treatment with adjuvant chemotherapy of HER2 breast cancer. Following initial reticence, the health minister responded to a campaign by patients and patient advocacy groups by announcing PBS subsidization which lowered the cost of a weekly dose from A$1000 to A$30. The cost to the government would be A$470 million over three years for treatment of an estimated 2100 women annually. We analysed the news frames used in all direct and attributed statements (n=239) in television news coverage of the discourse preceding the Herceptin decision by the Australian government. Five Sydney free-to-air channels between October 2005 and August 2006. News frames or themes. Of five news frames identified, one ('desperate, sick women in double jeopardy because of callous government/incompetent bureaucracy') accounted for 54% of all reported statements. Government financial parsimony was framed as responsible for the women's plight, with drug industry pricing never mentioned. Claimed benefits of Herceptin often conflated cancer non-recurrence and survival and favoured quantification rhetoric which emphasized percentage increases in improvement rather than the more modest increases in absolute survival. News frames invoking key tenets of the 'rule of rescue' dominated television discourse on Herceptin. Clinicians, patients, their families and patient advocacy groups invoking the rule of rescue can increase the likelihood of achieving their objective of gaining access to expensive healthcare such as pharmaceuticals. Rational, criteria-based public health policy will find it hard to resist the rule of rescue imperative.
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              Assessing Personalized Medicines in Australia

              Tracy Merlin, Claude Farah, Camille Schubert … (2013)
              Background. Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of “personalized medicine” has accelerated. Models for insurance subsidy of biomarker/test/drug packages (“codependent technologies” or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision. Methods. We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process. Results. The framework consists of 5 components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent. Conclusions. The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Pers Med
                Journal ID (iso-abbrev): J Pers Med
                Journal ID (publisher-id): jpm
                Title: Journal of Personalized Medicine
                Publisher: MDPI
                ISSN (Electronic): 2075-4426
                Publication date (Electronic): 27 March 2014
                Publication date Collection: June 2014
                Volume: 4
                Issue: 2
                Pages: 137-146
                Affiliations
                [1 ]Centre for Values Ethics and Law in Medicine, University of Sydney Medical Foundation Building (K25), University of Sydney, Sydney, NSW 2006, Australia
                [2 ]Australian Institute of Health Innovation, University of New South Wales, Sydney, NSW 2052, Australia; E-Mail: wendylipworth@ 123456gmail.com
                [3 ]Centre for Values, Ethics and Law in Medicine, University of Sydney Medical Foundation Building (K25), University of Sydney, Sydney, NSW 2006, Australia; E-Mail: ian.kerridge@ 123456sydney.edu.au
                Author notes
                [* ]Author to whom correspondence should be addressed; E-Mail: jlewis@ 123456med.usyd.edu.au ; Tel.: +44-778-545-1099.
                Article
                Publisher ID: jpm-04-00137
                DOI: 10.3390/jpm4020137
                PMC ID: 4263969
                SO-VID: fc383f03-0767-4977-b0e7-5b5b9b11d849
                Copyright © © 2014 by the authors; licensee MDPI, Basel, Switzerland.
                License:

                This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license ( http://creativecommons.org/licenses/by/3.0/).

                History
                Date received : 02 December 2013
                Date revision received : 17 February 2014
                Date accepted : 21 February 2014
                Categories
                Subject: Commentary

                Keywords: individualized medicine,pharmacology,ethics,economics,medicine,knowledge
                Data availability:
                Keywords: individualized medicine, pharmacology, ethics, economics, medicine, knowledge

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