Cited By
View all- Flore JFlore J(2023)Ingestible Sensors: Embodied Care with/for DataThe Artefacts of Digital Mental Health10.1007/978-981-99-4322-7_4(75-95)Online publication date: 14-Sep-2023
Digital Pills and Promises: Ethical Regulation of Digital Medication
Pages 63 - 67
Abstract
In November 2017, the United States Food and Drug Administration (FDA) approved the world's first "digital pill', Abilify MyCite (aripiprazole, an anti-psychotic drug). The manufacture and marketing of digital medication has been accompanied by vigorous promoting of its benefits, most notably its positive effect on medication adherence. However, contrary to academic and media publications linking Abilify MyCite either directly or indirectly to the so-called "adherence crisis", there is little published evidence to suggest that the technology improves adherence. In fact, the product is not meant to, nor is it approved for, improving patient adherence. The vigorous marketing of Abilify MyCite as an adherence intervention raises a crucial question: How does a product with significant implications for patient privacy and autonomy come to be marketed around a use for which it was not regulated? This question is addressed by examining which key stakeholders shape digital health product regulation, with a particular focus on recent inroads that big tech companies have made in digital health and the pharmaceutical industry.
References
[1]
Brown University. (2017). "From the FDA: FDA approves Abilify pill with sensor that tracks compliance'. The Brown University Child & Adolescent Psychopharmacology Update. p8.
[2]
Abilify MyCite. (2019). "An Overview of the ABILIFY MYCITE® System'. [Online]. Available at: https://www.abilifymycite.com/about. [Accessed on 13-09--2019].
[3]
Pascal Lehoux, Fiona, A. Miller and Geneviève Daudelin. (2017). "Converting clinical risks into economic value: The role of expectations and institutions in health technology development'. Technological Forecasting & Social Change.17: 206--216.
[4]
Frans Berkhout. (2006). "Normative expectations in systems innovation". Technology Analysis & Strategic Management. 18(3--4): 299--311.
[5]
Harro van Lente. (2012). "Navigating foresight in a sea of expectations: lessons from the sociology of expectations'. Technology Analysis & Strategic Management. 24(8): 769--782.
[6]
Mads Borup, Nik Brown, Kornelia Konrad and Harro van Lente. (2006). "The sociology of expectations in science and technology'. Technology Analysis & Strategic Management. 18 (3/4): 285--298.
[7]
James T Reason and Alan Petersen and Ivan Krisjansen (2015). "Assembling 'the bioeconomy': Exploiting the power of the promissory life sciences'. Journal of Sociology. 51(1): 28 --46.
[8]
Steve Sturdy. (2017). "Personalised Medicine and the Economy of Biotechnological Promise'. The New Bioethics. 23(1): 30--37.
[9]
Nik Brown and Mike Michael. (2003). "A Sociology of Expectations: Retrospecting Prospects and Prospecting Retrospects'. Technology Analysis & Strategic Management. 15 (1): 3--18.
[10]
Jasper Deutin and Arie Rip. (2000). "The Narrative Shaping of a Product Creation Process' in Contested Futures (eds. Nick Brown and Brian Rappert). Oxon: Ashgate Publishing. pp65 -- 86.
[11]
Donald W Light and Joel R Lexchin. (2012). "Pharmaceutical research and development: what do we get for all that money?' BMJ.345: e4348.
[12]
Barbara Prainsack. (2017). Personalized Medicine: Empowered Patients in the 21st Century? New York: NYU Press.
[13]
Jeffery Shuren, Bakul Patel and Scott Gottlieb. (2018). 'FDA Regulation of Mobile Medical Apps'. JAMA. 320(4): 337--338.
[14]
Neil Pollock and Robin Williams. (2010). "The business of expectations: How promissory organizations shape technology and innovation'. Social Studies of Science. 40(4): 525--548.
[15]
Sastry Chilukuri, Rena Rosenberg, and Steve Van Kuiken. (2014). "A digital prescription for pharma companies". McKinsey & Company. [Online]. Available at: https://www.mckinsey.com/industries/pharmaceuticals-and- medical-products/our-insights/a-digitalprescription-for-pharma-companies. [Accessed on 04-05--2018].
[16]
STAT. (2018). "A data-driven era: Why digital tools are critical to life science players'. [Online]. Interview with Dr Jörg Schikert, partner at the Munich office for Hogan Lovells. Available at: https://www.statnews.com/sponsor/2018/01/09/digital-health-tools/. [Accessed on 13-07--2018].
[17]
Sarah Neville. (2017). "Digital pill offers chance of new life to old drugs'. Financial Times. [Online]. Available at: https://www.ft.com/content/150b9338-c939--11e7-aa33-c63fdc9b8c6c. [Accessed on 31-08--2018].
[18]
Interviewee 7, personal communication, 25 July 2018.
[19]
Crunchbase. (2019). "Proteus Digital Health'. [Online] Available at: https://www.crunchbase.com/organization/proteus-biomedical#section-funding-rounds/ .[Accessed on 12-06--2018].
[20]
Rebecca Robbins. (2018). "At $1,650 per month, the first digital pill will soon roll out to certain Medicaid patients with mental illness' STAT. [Online]. Available at: https://www.statnews.com/2018/08/30/abilify-digital-medicaid-mental-illness/?utm_source=STAT+Newsletters&utm_campaign=0b5b6a87aa-MR_COPY_12. [Accessed 19-09--2019].
[21]
Sy Mukherjee. (2017). "The Digital Pill Era Is Here-And It Could Help Solve a $300 Billion Health Care Problem'. Fortune Magazine. [Online]. Available at: http://fortune.com/2017/11/14/fda-digital-pill-proteusotsuka/. [Accessed on 17-07=2018].
[22]
Otsuka. (2019). "Otsuka And Proteus® Announce the First U.S. FDA Approval of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)'. [Online]. Available at: https://www.otsuka-us.com/discover/articles-1075. [Accessed on: 03-07--2018].
[23]
Interviewee 6, personal communication, 27 July 2018.
[24]
FDA. (2017). "FDA approves pill with sensor that digitally tracks if patients have ingested their medication'. [Online]. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication. [Accessed on 01/09/2018].
[25]
FDA. (2017). "Digital Health Innovation Action Plan'. [Online]. Available at: https://www.fda.gov/media/106331/download [Accessed on 01/09/2018].
[26]
Katja Neubauer. (2018). "eHealth at EU level: Perspectives from the European Commission'. Slides of presentation held at the joint meeting of the European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations. [Online]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2018/06/WC500251102.pdf . [Accessed on 01-09--2018].
[27]
Juliet Bauer. (2018). "Working together for a digital future'. NHS England online blog. [Online]. Available at: https://www.england.nhs.uk/blog/working-together-for-a-digital-future/. [Accessed on 02-09--2018].
[28]
Cosgrove, Lisa et al. (2019). "Digital aripiprazole or digital evergreening? A systematic review of the evidence and its dissemination in the scientific literature and in the media'. BMJ: Evidence synthesis, mental health. http://dx.doi.org/10.1136/bmjebm-2019--111204.
[29]
Otsuka. (2019).
[30]
Interviewee 2, personal communication, 3 August 2018.
[31]
Interviewee 3, personal communication, 4 August 2018.
[32]
Jeffery Shuren, Bakul Patel and Scott Gottlieb. (2018); STAT. (2018).
[33]
Michael J. Malinowski. (2016). Handbook on Biotechnology Law, Business and Policy. St Paul (USA): West Academic Publishing.
[34]
Wendy Z.N. Teo. (2017). "FDA and the Practice of Medicine: Looking at Off-label Drugs'. Seton Hall Legislative Journal. 41(2): 305--327.
[35]
Interviewee 6, personal communication, 25 July 2018.
[36]
Interviewee 7, personal communication, 25 July 2018.
[37]
FDA. (2012). "Evaluation of automatic class III designation (De Novo) for Proteus Personal Monitor including Ingestion Event Marker'. [Online]. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/K113070.pdf. [Accessed on 20-07--2018].
[38]
FDA. (2014). "Proteus 510(k) 2014'. [Online]. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133263.pdf. [Accessed on 20-07--2018].
[39]
FDA. (2015). "Proteus Digital Health System'. [Online]. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150494.pdf. [Accessed on 20-07--2018].
[40]
Michael J. Malinowski. (2016).
[41]
Interviewee 7, personal communication, 25 July 2018.
[42]
Tia P. Powell. (2017). "The 'smart pill' for schizophrenia and bipolar disorder raises tricky ethical questions'. STAT.[Online]. Available at: https://www.statnews.com/2017/12/05/smart-pill-abilifyethics/?utm_campaign=trendmd-internal. [Accessed on 31-08--2018].
[43]
Tia P. Powell. (2017).
[44]
Adam Hedgecoe and Paul Martin. (2003). 'The Drugs Don't Work: Expectations and the Shaping of Pharmacogenetics'. Social Studies of Science. 33(3): 327--364.
Recommendations
Ethics of Electronic Health Record Systems
This article describes how healthcare and IT are combatting the ethical implications of electronic health records EHRs in order to make them adopted by over 90% of small practices. There is a lack of trust in EHRs and uneasiness about what they will ...
Ethical, legal and social issues for personal health records and applications
Robert Wood Johnson Foundation's Project HealthDesign included funding of an ethical, legal and social issues (ELSI) team, to serve in an advisory capacity to the nine design projects. In that capacity, the authors had the opportunity to analyze the ...
Comments
Please enable JavaScript to view thecomments powered by Disqus.Information & Contributors
Information
Published In
November 2019
147 pages
ISBN:9781450372084
DOI:10.1145/3357729
- Program Chairs:
- Patty Kostkova,
- Caroline Wood,
- Arnold Bosman,
- Floriana Grasso,
- Michael Edelstein
Copyright © 2019 ACM.
Permission to make digital or hard copies of all or part of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for profit or commercial advantage and that copies bear this notice and the full citation on the first page. Copyrights for components of this work owned by others than ACM must be honored. Abstracting with credit is permitted. To copy otherwise, or republish, to post on servers or to redistribute to lists, requires prior specific permission and/or a fee. Request permissions from [email protected]
Sponsors
- SIGKDD: ACM Special Interest Group on Knowledge Discovery in Data
- University College London: University College London
Publisher
Association for Computing Machinery
New York, NY, United States
Publication History
Published: 20 November 2019
Check for updates
Author Tags
Qualifiers
- Short-paper
Conference
DPH2019
Sponsor:
- SIGKDD
- University College London
DPH2019: 9th International Digital Public Health Conference (2019)
November 20 - 23, 2019
Marseille, France
Contributors
Other Metrics
Bibliometrics & Citations
Bibliometrics
Article Metrics
- View Citations1Total Citations
- 168Total Downloads
- Downloads (Last 12 months)18
- Downloads (Last 6 weeks)1
Reflects downloads up to 21 Sep 2024
Other Metrics
Citations
Cited By
View all- Flore JFlore J(2023)Ingestible Sensors: Embodied Care with/for DataThe Artefacts of Digital Mental Health10.1007/978-981-99-4322-7_4(75-95)Online publication date: 14-Sep-2023
View Options
Get Access
Login options
Check if you have access through your login credentials or your institution to get full access on this article.
Sign in