Issue 17(1): Pharmaceutical ethics

Issue 17(1): Pharmaceutical ethics

Journal of Bioethical Inquiry, Volume 17, Issue 1, March 2020

Symposium: Pharmaceutical Ethics

Guest Editors: Narcyz Ghinea, Wendy Lipworth, and Ian Kerridge

Image: Thomas Picard / FreeImages

Editorial

Michael Ashby & Bronwen Morrell

Free Access Cui Bono?

Intro
On reviewing the content of this issue of Journal of Bioethical Inquiry, the question “cui bono?” springs to mind again—lifted from the title of a Harveian Oration delivered in 1977 at the Royal College of Physicians in London, by the late Sir Douglas Black, a distinguished RCP president at the time. From Cicero, it means “who benefits?” Or more literally “to whom the good?” This pithy Latin expression sums up the core question in most of the articles in this edition that consider gains and incentives, perverse or otherwise, be it in a symposium on the ethics of the pharmaceutical industry (Ghinea, Lipworth, and Kerridge 2020), a reflection on commercial interests in medical implant device risks (Richards 2020), or even the consent issue in the Chinese CPISR study (Shaw 2020), and of course, in a discussion of so-called altruistic organ donation (Łuków 2020). At its most fundamental level, can there be any achievement without gain for the stakeholders other than patients or subjects, and what is the true motivation for healthcare and scientific research? Are the motives ever pure? Given the fact that such pursuits are always encased in an ethical context that demands noble and self-denying high principle, what is the role of individual gain or corporate profit? How can these be transparent or regulated? These questions tap into a broader question about the nature of capitalism in the health and biological sciences, as not-for-profit is only a small part of the field.

Editorial

Paul Komesaroff & Ian Kerridge

A Continent Aflame: Ethical Lessons From the Australian Bushfire Disaster

Intro
The havoc wreaked by the disastrous Australian bushfires has caused great pain but has also generated some critical lessons. The damage has been unimaginable: over the course of three months more than seventeen million hectares of forest have been burnt (Gunia and Law 2020; Chapman 2020; Noble 2020), two dozen lives have been lost (Fife-Yeomans 2020), more than two thousand homes have been destroyed (SkyNews 2020), and around a billion animals have been killed (Reality Check Team 2020; Snape 2020; Elsworthy 2020; The University of Sydney 2020). Unknown numbers of rare indigenous species of plants and animals have been rendered extinct (Bevege 2020). Vast areas of Eastern Australia, including the entire Alpine area, have been evacuated (Wahlquist et al. 2020). In addition to the suffering, loss of life, and property damage, the entire country has experienced massive disruption to infrastructure and the economy and unprecedented levels of air pollution (Australian Associated Press 2019; Pengilley 2020; ABC News 2020a).

Guest Editorial

David Shaw

The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing

Abstract
This editorial provides an ethical analysis of the consent materials and other documents relating to the recent creation and birth of twin girls who had their genes edited using CRISPR-cas9 in a controversial Chinese research study. It also examines the “draft ethical principles” published by the leader of the research study. The results of the analysis further intensify serious ethical concerns about the conduct of this study.

Recent Developments

Bernadette Richards

Balancing Interests in Healthcare: What Happens When Commercial Interests Outweigh Patient Welfare and a Brief Overview of the Swinging Pendulum of Informed Consent in Singapore

Intro
When Commercial Interests Outweigh Patient Welfare: Gill v Ethicon Sàrl & Ors a Cautionary Tale
Background to the Decision
Innovation is one of the constants of healthcare: there is an ongoing process of improvement, adaptation, and change with a goal of improving patient care and health outcomes. This is a simple statement that in an ideal world is true, however the reality is that patient welfare is not the only driver of medical innovation. Development cannot proceed without financial backing, and it is unsurprising that there are significant commercial interests involved in medical innovation. This is a practical reality that is neither inappropriate nor unexpected, but care must be taken to ensure that the commercial imperative does not override patient benefit. Unfortunately, this is not always the case and the recent representative action of Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 (Gill v Ethicon) provides a cautionary tale of the widespread harm that can occur when patient welfare is placed below commercial imperatives.

Critical Response

Paul Macneill

A Response to “Fragile Objects”

Abstract
This is a critical response to “Fragile objects: A visual essay,” by Chapman et al. published in the Journal of Bioethical Inquiry (2019, 16(2): 185-189). Whilst “Fragile objects” is evocative of the author(s)’ experience in sitting with a man (“Patrick”), who had been diagnosed with Alzheimer’s, I express concern that there are unwarranted and unsubstantiated conclusions drawn about Patrick’s phenomenological experience of dementia/Alzheimer’s.

Symposium: Pharmaceutical Ethics – Lead Essay

Narcyz Ghinea, Wendy Lipworth & Ian Kerridge

Money, Equity and Access to Medicines

Intro
The prescription of medicines is the most ubiquitous medical intervention. In Australia, a country of 25 million people, almost 300 million publicly funded prescriptions (not including those provided to in-patients in hospitals) are filled per annum (Australian Institute of Health and Welfare 2018), while in the United States over 4 billion prescriptions are filled per annum (Mikulic 2018), and almost half of US citizens report having taken a prescription drug in a given month (Martin et al. 2019). By 2023 it is estimated that over USD1.5 trillion will be spent on medicines per annum (IQVIA Institute 2019), which is roughly equivalent to the annual gross national product of Australia or Mexico. An increasing proportion of this spending is directed towards expensive “specialty drugs” which are predicted to account for up to 50% of pharmaceutical spending in developed countries by 2023 (IQVIA Institute 2019). For example, in the United States it is reported that in 2014, 1% of prescriptions accounted for 32% of medicine spending (American’s Health Insurance Plans 2015). For the same year, the Australia Department of Health reported that cancer drugs accounted for 17% of spending, but only represented 1% of all scripts (Community Affairs Reference Committee 2015). In 2010, for the first time, more “specialty drugs” were approved by the US Food and Drug Administration than “traditional drugs” (America’s Health Insurance Plans 2015). These trends paint a troublesome picture for health systems already struggling to provide fair and equitable access to health care.

Symposium: Pharmaceutical Ethics

Spencer Phillips Hey

Why High Drug Pricing Is A Problem for Research Ethics

Abstract
The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. Indeed, the future price of a drug is routinely ignored and treated as unknowable during the ethical evaluation of the clinical trials that support its development. In this paper, I will argue that ignoring the future price of a drug during the research process is in tension with all three of the major principles of research ethics: it fails to show respect for the research participants, undermines the quality of risk/benefit judgements made by ethical review committees, and makes it impossible to judge future patient access and assess justice.

Symposium: Pharmaceutical Ethics – Original Research

Marcello Ienca & Effy Vayena

“Hunting Down My Son’s Killer”: New Roles of Patients in Treatment Discovery and Ethical Uncertainty

Abstract
The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions—or those of their loved ones—in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement of patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research (PLR) has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks.

Symposium: Pharmaceutical Ethics – Original Research

Sharon Batt, Judy Butler, Olivia Shannon & Adriane Fugh-Berman

Pharmaceutical Ethics and Grassroots Activism in the United States: A Social History Perspective

Abstract
Women’s health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry funds; thousands of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups’ agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy.

Symposium: Pharmaceutical Ethics – Commentary

Ray Moynihan

The Voice of the People, Funded Now by Your Friendly Pharmaceutical Company

Abstract
Pharmaceutical industry funding has transformed much grassroots community activism on health into corporate-sponsored advocacy. This critical commentary outlines recent evidence about industry funding of patient advocacy groups, offers a commentary on the history of grassroots activism appearing in this issue of the journal, and calls for greater scrutiny of the impacts and ethics of such sponsorship.

Symposium: Pharmaceutical Ethics – Original Research

Renaud F. Boulanger, Ana Komparic, Angus Dawson, Ross E. G. Upshur & Diego S. Silva

Developing and Implementing new TB Technologies: Key Informants’ Perspectives on the Ethical Challenges

Abstract

Objective To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics.
Methods Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis.
Results Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation.
Conclusions This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities.

Symposium: Pharmaceutical Ethics – Original Research

Jessica Pace, Tracey-Lea Laba, Marie-Paul Nisingizwe & Wendy Lipworth

Formulating an Ethics of Pharmaceutical Disinvestment

Abstract
There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations—both procedural and substantive—that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

Symposium: Pharmaceutical Ethics – Original Research

Narcyz Ghinea, Wendy Lipworth & Ian Kerridge

Does Consumer Engagement in Health Technology Assessment Enhance or Undermine Equity?

Abstract
Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner.

Original Research

Paweł Łuków

Open Access Pure Altruistic Gift and the Ethics of Transplant Medicine

Abstract
The article argues that altruistic giving based on anonymity, which is expected to promote social solidarity and block trade in human body parts, is conceptually defective and practically unproductive. It needs to be replaced by a more adequate notion which responds to the human practices of giving and receiving. The argument starts with identification of the main characteristics of the anonymous altruistic donation: social separation of the organ donor (or donor family) from the recipient, their mutual replaceability, non-obligatoriness of donation, and non-obligatoriness of reciprocation on the recipient’s part. Since these characteristics are also central to typical market relations, anonymous altruistic donation not only cannot promote solidarity but may encourage proposals for (regulated) markets of transplantable organs. Thus, transplant ethics needs to be reframed. It needs to be rooted in, rather than promote, the practices of giving and receiving known to human societies. As the basis for such reframing, the idea of sharing in another’s misfortune is proposed. It relies on the human practices of giving and receiving and, with appropriate regulatory safeguards, can provide a better conceptual basis for blocking commercial exchanges of human body parts.

Original Research

Courtney Hempton & Neera Bhatia

Deciding For When You Can’t Decide: The Medical Treatment Planning and Decisions Act 2016 (Vic)

Abstract
The Australian state of Victoria introduced new legislation regulating medical treatment and associated decision-making in March 2018. In this article we provide an overview of the new Medical Treatment Planning and Decisions Act 2016 (Vic) and compare it to the former (now repealed) Medical Treatment Act 1988 (Vic). Most substantially, the new Act provides for persons with relevant decision-making capacity to make decisions in advance regarding their potential future medical care, to take effect in the event they themselves do not have decision-making capacity. Prima facie, the new Act enshrines autonomy as the pre-eminent value underlying the state’s approach to medical treatment decision-making and associated surrogate decision-making. However, we contend that the intention of the Act may not accord with implementation of the Act to date if members of the community are not aware of the Act’s provisions or are not engaged in advance care planning. There is a need for further research, robust community advocacy, and wider engagement for the intention of the Act—the promotion of “precedent autonomy” in respect to surrogate medical treatment decision-making—to be fully realized.

Original Research

Carolyn Mason

New Zealand Policy on Frozen Embryo Disputes

Abstract
Disputes between separated couples over whether frozen embryos can be used in an attempt to create a child create a moral dilemma for public policy. When a couple create embryos intending to parent any resulting children, New Zealand’s current policy requires the consent of both people at every stage of the ART process. New Zealand’s Advisory Committee on Assisted Reproductive Technology has proposed a policy change that would give ex-partners involved in an embryo dispute twelve months to come to an agreement before the embryos are destroyed. New Zealand’s current policy and the proposed policy both favour the person who wishes to avoid procreation. Two alternative policy approaches that do not favour procreative avoidance are considered. Using pre-fertilisation contracts to determine the decision reached in embryo disputes allows the couple’s wishes at the time the embryos are created to determine what happens to the embryos if they separate. However, pre-fertilisation contracts are agreements about healthcare and personal relationships, and changing circumstances can make enforcing such agreements unjust. Finally, it is argued that New Zealand’s Family Court system should be used to reach decisions that balance the interests of those involved in the dispute.

Original Research

Michael W. Nestor & Richard L. Wilson

Beyond Mendelian Genetics: Anticipatory Biomedical Ethics and Policy Implications for the Use of CRISPR Together with Gene Drive in Humans

Abstract
Clustered regularly interspaced short palindromic repeats (CRISPR) genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. Technologies for correcting multiple mutations in an in vivo system are already in development. On the surface, the advent and use of gene editing technologies is a powerful tool to reduce human suffering by eradicating complex disease that has a genetic etiology. Gene drives are CRISPR mediated alterations to genes that allow them to be passed on to subsequent populations at rates that approach one hundred per cent transmission. Therefore, from an anticipatory biomedical ethics perspective, it is possible to conceive gene drive being used with CRISPR to permanently ameliorate aberrant genes from wild-type populations containing mutations. However, there are also a number of possible side effects that could develop as the result of combining gene editing and gene drive technologies in an effort to eradicate complex diseases. In this paper, we critically analyse the hypothesis that the combination of CRISPR and gene drive will have a deleterious effect on human populations from an ethical perspective by developing an anticipatory ethical analysis of the implications for the use of CRISPR together with gene drive in humans.

Original Research

Richard B. Gibson

Open Access Elective Impairment Minus Elective Disability: The Social Model of Disability and Body Integrity Identity Disorder

Abstract
Individuals with body integrity identity disorder (BIID) seek to address a non-delusional incongruity between their body image and their physical embodiment, sometimes via the surgical amputation of healthy body parts. Opponents to the provision of therapeutic healthy-limb amputation in cases of BIID make appeals to the envisioned harms that such an intervention would cause, harms such as the creation of a lifelong physical disability where none existed before. However, this concept of harm is often based on a normative biomedical model of health and disability, a model which conflates amputation with impairment, and impairment with a disability. This article challenges the prima facie harms assumed to be inherent in limb amputation and argues in favour of a potential treatment option for those with BIID. To do this, it employs the social model of disability as a means to separate the concept of impairment and disability and thereby separate the acute and chronic harms of the practice of therapeutic healthy-limb amputation. It will then argue that provided sufficient measures are put in place to ensure that those with atypical bodily constructions are not disadvantaged, the chronic harms of elective amputation would cease to be.