Abstract
Demands for improved access to innovative therapies have prompted a discourse that claims patients have rights to access treatments that may be of benefit, even if evidence that demonstrates safety and efficacy is lacking. This rights-based discourse is grounded in accounts of autonomy and assertions claiming that the state ought to not interfere with the free choices of patients and clinical decision-making. In this essay, we scrutinise these arguments to defend the ethical and legal permissibility of interference in contexts where the uncertainty of benefit and potential for harm creates vulnerabilities that undermine patient capacity for self-determination. In support of this argument, we draw on two theoretical approaches to explore the limits of autonomy in innovative contexts and analyse the legal bases of the rights-based discourse. We then apply this analysis to the case example of stem cell transplantation as an innovative treatment for multiple sclerosis.
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Notes
This definition provided in the Belmont Report to distinguish innovation from clinical research is imprecise but will suffice for the purpose of this essay. For further discussion on the issues around defining innovation, see Agich (2001), Hutchison et al. (2015), Rogers et al. (2014), and Taylor (2010)
See for example Sidaway v Board of Examiners of the Bethlehem Royal Hospital and Ors where Lord Diplock explained that the public would be ‘badly served’ by laws that limited innovation. See also Hunter v Hanley (1955) SC 200.
MS is an autoimmune disease of the central nervous system that worldwide affects an estimated 2.5 million people, mostly women, and usually onsets between 20 and 40 years old (Hersh and Fox 2014).
The Division of Immunotherapy and Autoimmune Diseases at the Feinberg School of Medicine, Northwestern University (2010), which is also running a clinical trial for MS patients, offers the procedure to private patients who are ineligible for the trial. The therapy is also available to private patients at the National Pirogov Medical Surgical Centre (2015) in Russia and the Singapore Raffles Medical Group (2017).
Dr. Colin Andrews, a former neurologist at Canberra Hospital in the Australian Capital Territory (ACT), was interviewed stating that the procedure should be more available to MS patients and was critical of the hospital for discontinuing the procedure following an application to the ACT Human Ethics Research Committee, which was not approved resulting in one patient being unable to continue treatment. A letter from the ACT Chief Minister written in response to the patient is available at https://law.anu.edu.au/sites/all/files/users/u9705219/scan0001.pdf. Accessed January 23, 2017.
Indeed, the patient referred to above in footnote 10 did eventually access the treatment at another hospital on compassionate grounds.
In the medical context, this extends to late-term abortions when the pregnant woman’s life is in danger. If we are permitted to take measures that would harm others in order to prolong our own life, we are also permitted to take measures, and that would not harm anyone in order to prolong our own life. More precisely, the entitlement is to non-interference in the purchase of such measures. See and Grossman (2013), Meyerson (2013), Robertson (2006) for such arguments.
See website http://www.abigail-alliance.org/. Accessed on January 20, 2017.
Phase I trials are focussed on the initial introduction of drugs to human subjects, and as described in the judgement, the primary purpose of this phase is to determine whether the drug is safe enough to continue human testing (Abigail Alliance, 698).
While this specific constitutional argument is applicable only in the USA, their rights-based approach is broadly applicable across all jurisdictions; particularly relevant to our current discussion is the assertion of an autonomous right to choose treatment.
For a full list, refer to ‘Right to Try legislation tracker’; see website http://www.raps.org/Regulatory-Focus/News/Databases/2015/06/24/21133/Right-to-Try-Legislation-Tracker/. Accessed on January 20, 2017.
Described on its website as ‘the place where freedom wins’, the Institute focusses on individual as opposed to state rights. It is described as ‘a leading national movement to use state constitutions and powers reserved to the states to restore and expand our freedoms’. Available at their website: http://goldwaterinstitute.org/en/. Accessed on January 20, 2017.
To access the full text of the model legislation, see this website: https://goldwater-media.s3.amazonaws.com/cms_page_media/2015/1/28/RIGHT%20TO%20TRY%20MODEL%20LEGISLATION%20%282%29_1.pdf. Accessed on January 20, 2017.
A cautionary tale regarding the experimental drug brincidofovir was shared by Bateman-House (2015) when she explained what happened after a patient was administered this drug in an attempt to treat Ebola. Unfortunately, the patient died and there was significant backlash against the company with a significant drop in the stock price. The company withstood the financial threat, but Bateman-House (2015) raised the question of what would have happened if the negative impact had caused the company to fail. A promising drug would have ceased its development and the potential for broader benefit lost.
For example, the activism with HIV patients in the 1980/1990s that influenced the FDA to introduce the ‘compassionate use’ programme and the accelerated approval scheme at the FDA (Epstein 2000).
See Inquest into the death of Sheila Drysdale, 2013/383970, 15/07/2016 [40] and [80].
Ibid
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Acknowledgments
This research was supported with funding from the Humanities and Social Science Fund of the Office of the Deputy President (Research and Training), National University of Singapore (WBS: R-171-000-055-646), and was presented at The Personhood: Autonomy and Vulnerability Research Symposium with support from the Australian Catholic University Research Fund (Grant 2016000412) and funding from the University of Adelaide.
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Lysaght, T., Richards, B. & Muralidharan, A. Exploring the boundaries of autonomy and the ‘right’ to access innovative stem cell therapies. ABR 9, 45–60 (2017). https://doi.org/10.1007/s41649-017-0001-4
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DOI: https://doi.org/10.1007/s41649-017-0001-4