This blog post was written by Heilien (Lienkie) Diedericks, PhD candidate in Global Health & Social Medicine.
From the 5th to the 9th of August 2019, I had the pleasure to attend the 25th Annual Conference for the World Association for Medical Law (WAML) in Japan, Tokyo. It was a vibrant meeting consisting of more than 200 delegates from all over the world. One of the central aims of the 25th meeting was to ‘construct a bridge between medical law, bioethics and legal medicine’. Consequently, while most of the presentations were from a legal perspective, almost each paper attempted to tease out ethical implications arising from within (and without) their chosen legal frameworks. What was striking, however, was the absence of bioethics and medical ethics scholars both in presenting and attending the conference. I was one of the few presenters with a mainly bioethics/ethics background, and I found some of the legal discussions touching only superficially on ethically complex issues. As such, I believe this conference illustrates anew the need for sustained interdisciplinary collaboration between the medical legal profession, bioethics, and the medical humanities.
My own presentation focussed on the ethical implications of regulating pharmaceutical drugs embedded with digital sensors in a rapidly evolving digital health regulatory environment. I concluded that ethical dilemmas occur at a number of junctions in the regulation of Abilify Mycite, the first ‘digital pill’ to be approved by the Food and Drug Administration (FDA). It seems that little ethical deliberation was given about the effects that such a product might have on patients, and if the potential benefits would exceed potential harms. Indeed, the FDA released no guidance on the ethical use of Abilify MyCite. An ethical risk-benefit analysis is blatantly missing when one considers that Abilify MyCite was never approved by the FDA to improve medication-taking adherence – precisely one of the supposed benefits to patients. Furthermore, the way that Abilify MyCite was regulated through the FDA 510(k) process highlights how current regulation and policy lags behind a rapidly evolving digital health sector. Such a lag in regulation could lead to ineffective and potentially harmful approvals. It is therefore crucial that ethicists and regulatory specialists alike take up the challenge to address the rapidly evolving regulatory landscape of digital medicine more broadly.
My presentation was well-received, and I was awarded the 2019 Young Scientist Award for Outstanding Presentation – one of the two awards given annually to a researcher under the age of 35. The paper on which my work is based has also gone through for consideration for the Davies Award, a larger prize which will be decided upon at the 2020 Annual WAML Conference in Toronto.
Attending this conference, with the generous funding of the Institute of Medical Ethics, is one of the many opportunities that has resulted from completing the MSc in Bioethics and Society at King’s. The strength of the work produced at the GHSM is that it is sensitive to the narratives of those affected by biotechnologies and medical issues more broadly, and that it is interdisciplinary. This approach to research chimes well with the conference’s opening address by Prof Rihito Kimura: a moving call to action. A survivor of the Hiroshima bombing during the Second World War, Prof Kimura traced his life-story as it intersected with emerging biotechnologies. He stressed the importance of researchers to pay close attention to the narratives of persons ‘on the ground’, thereby ensuring that our academic theory and research is grounded in an ethical sensitivity which permeates every decision. He ended his opening address with an affecting poem, ‘When We say Hiroshima’ by Sadako Kurihara. I conclude with a short extract:
For the gentle response, “Ah, Hiroshima,”
we would have to abandon our weapons as we were supposed to do so,
We would have to get rid of the foreign military bases in Japan.
Until that day,
Hiroshima will remain a city embittered by cruelty and distrust.
We will remain a pariah scorched by radioactivity.
For the gentle response, “Ah, Hiroshima,”
We must first cleanse our soiled hands.
About the author
Heilien (Lienkie) Diedericks is a PhD candidate in the Department of Global Health & Social Medicine. Her research is part of the Health System Strengthening in Sub-Saharan Africa (ASSET) project. Her PhD is funded generously by the NIHR ASSET grant and the Oppenheimer Memorial Trust (South Africa).
Lienkie completed a MSc in Bioethics and Society at King’s, with her dissertation focusing on the ethical and regulatory implications of pharmaceutical drugs being embedded with ingestible sensors to track adherence.
Lienkie has written for the Guardian about the digital pill. You can read her piece here: