The problematic side of precision medicine (original) (raw)
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Book: Precision Medicine eds. Hans-Peter Deigner and Matthias Kohl eBook ISBN: 9780128054338 Paperback ISBN: 9780128053645
This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. We will characterize clinical innovation as “new and insufficiently validated practice” because it resembles medical practice in terms of the aim to directly benefit individual patients. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features. We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research.
BMC Medical Ethics
Background Precision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review. Methods We used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided 665 different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine. Results Many patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceiv...
Tensions in ethics and policy created by National Precision Medicine Programs
Precision medicine promises to use genomics and other data-intensive approaches to improve diagnosis and develop new treatments for major diseases, but also raises a range of ethical and governance challenges. Implementation of precision medicine in " real world " healthcare systems blurs the boundary between research and care. This has implications for the meaning and validity of consent, and increased potential for discrimination, among other challenges. Increased sharing of personal information raises concerns about privacy, commercialization, and public trust. This paper considers national precision medicine schemes from the USA, the UK, and Japan, comparing how these challenges manifest in each national context and examining the range of approaches deployed to mitigate the potential undesirable social consequences. There is rarely a " one size " fits all solution to these complex problems, but the most viable approaches are those which take account of cultural preferences and attitudes, available resources, and the wider political landscape in which national healthcare systems are embedded.
Lagging Behind? Are Regulations Keeping Pace With The Precision Medicine Revolution
Today's Esquire, 2022
The ultimate path that precision medicines will take is unclear, although it is already apparent that diseases that hitherto were classed as ‘untreatable’ can potentially be treated (and, in a few cases, are being treated). These conditions are genetic diseases and certain cancers. While scientific thinking has advanced and technologies have followed suit, the ethical issues that stem from these innovations are lagging. These ethical issues relate to privacy, data security, and law. To tailor treatments for patients requires the capture and analysis of vast amount of patient-centric data. However, doubts are being expressed as to how well-equipped global health systems are to handle such data and over the level of maturity that exists in terms of ethical and legal regulation. Sandle, T. (2022) Lagging Behind? Are Regulations Keeping Pace With The Precision Medicine Revolution?, Today’s Esquire, 14th November 2022 at: https://www.todaysesquire.com/2022/11/14/lagging-behind-are-regulations-keeping-pace-with-the-precision-medicine-revolution/
The Hastings Center report, 2017
The United States' ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients' empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term "genomic citizenship"; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the de...
Clinical judgement in precision medicine
Journal of Evaluation in Clinical Practice, 2018
Precision medicine, which aims to individualize care based upon the unique combination of genetic, environmental, and lifestyle features in particular patients, will require an evolution in clinical decision making. Practitioners of precision medicine will need to utilize an expanded body of medical knowledge derived from a wide variety of sources. Clinical judgement in the case-based reasoning necessary for individualizing care will involve understanding and utilizing methodological approaches not commonly invoked in medicine, including mechanistic and qualitative research results. Instead of searching for an answer in the published literature, precision medicine demands clinical judgement that finds the reasons for clinical decisions within, not without, the patient. KEYWORDS epistemology, philosophy of medicine, practical reasoning 1 | INTRODUCTION Precision (aka personalized) medicine (PM) commits to improving the understanding of the specifics regarding a person's genetics, lifestyle, and environment that can be used to individualize care. 1 Announced with much fanfare, including an initiative by President Barack Obama,
Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants' attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research. Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to broaden the focus of discussion beyond individual choice and individuals' moral interests. The uptake of those concepts in precision medicine is to be welcomed. However, as data and medical information from research participants in precision medicine cohorts will be collected on an individual basis, translating a participatory approach in this emerging area may prove cumbersome. Therefore, drawing on Joseph Raz's perfectionism, we propose a principle of respect for autonomous agents that, we reckon, can address many of the concerns driving recent scholarship on partnership and public participation, while avoiding some of the limitations these concept have in the context of precision medicine. Our approach offers a normative clarification to how becoming partners in precision is compatible with retaining autonomy. Realigning the value of autonomy with ideals of direct engagement, we show, can provide adequate normative orientation to precision medicine; it can do justice to the idea of moral pluralism by stressing the value of moral self-determination: and, finally, it can reconcile the notion of autonomy with other more communitarian values such as participation and solidarity.
Problems, challenges and promises: perspectives on precision medicine
Briefings in bioinformatics, 2015
The 'precision medicine (systems medicine)' concept promises to achieve a shift to future healthcare systems with a more proactive and predictive approach to medicine, where the emphasis is on disease prevention rather than the treatment of symptoms. The individualization of treatment for each patient will be at the centre of this approach, with all of a patient's medical data being computationally integrated and accessible. Precision medicine is being rapidly embraced by biomedical researchers, pioneering clinicians and scientific funding programmes in both the European Union (EU) and USA. Precision medicine is a key component of both Horizon 2020 (the EU Framework Programme for Research and Innovation) and the White House's Precision Medicine Initiative. Precision medicine promises to revolutionize patient care and treatment decisions. However, the participants in precision medicine are faced with a considerable central challenge. Greater volumes of data from a wid...
Precision medicine: drowning in a regulatory soup?
Journal of Law and the Biosciences, 2016
and Director of the Centre for Law and Genetics. The broad theme of her research is the regulation of biotechnology and human genomics and genetics. She is particularly interested in the commercialization of genetic knowledge and patenting of
Ethics in Personalized Medicine
2020
Even though scientists introduce the field of personalized medicine as a revolutionary salvation for many of the problems society has, the inherent implications this realm exhibits might sometimes slip into controversial polemics. Because of its immense potential, people worldwide are struggling to entirely understand the basis as well as the consequences of advancement in precision medicine and whether it indeed provides more contentment than harm. From all the writings on the topics of ethics in medical practices, genocides, fortunate or unfortunate experiments, jurisprudence of clinical trials as well as the epistemology of medicine (so from mere philosophical concepts to pragmatic medical practices) dating from the Ancient Greek times up to the present days, one can understand that generally in medicine, processes cannot only be applied on the grounds of utilitarian insights, but the meaning of being a human must be comprehended on a deeper level.