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Bioethics ISSN 0269-9702 (print); 1467-8519 (online) Volume 29 Number 5 2015 pp 342–352

doi:10.1111/bioe.12111

IS THERE A RIGHT TO ACCESS INNOVATIVE SURGERY? DENISE MEYERSON

Keywords innovative surgery, rights

ABSTRACT Demands for access to experimental therapies are frequently framed in the language of rights. This article examines the justifiability of such demands in the specific context of surgical innovations, these being promising but non-validated and potentially risky departures from standard surgical practices. I argue that there is a right to access innovative surgery, drawing analogies with other generally accepted rights in medicine, such as the right not to be forcibly treated, to buy contraceptives, and to choose to have an abortion, including a post-viability abortion where the mother’s life or health is threatened by the pregnancy. I argue that we accept these rights because we believe that people are entitled to try to preserve their lives and health and to make choices of an important and intensely personal kind, and I suggest that a person’s choice of medical treatment should be seen in the same light. However, since few rights are absolute, I also consider the circumstances in which it may be justifiable to limit the right to access innovative surgery. In discussing this question, I apply the human rights standard of proportionality, comparing the importance of the reasons for limiting the right with the severity of the invasion on liberty.

1. INTRODUCTION Traditional modes of medical governance are increasingly under challenge by patients and patient activist groups, many of whom mobilise around the idea of human rights in order to advance their health interests.1 One prominent focus for rights-based demands is access to controversial new drugs, devices and procedures. Patients argue that the barriers to access imposed by regulators and administrative bodies breach their right to decide whether to assume the risks associated with promising but unproven treatments. The 1980s campaign by HIV/AIDS activists in the United States to obtain access to experimental drugs and reform the drug approval

process is an early example of this phenomenon,2 but the struggle over experimental therapies continues. Indeed, it has recently been described as ‘poised to become the issue that defines the interplay of law and medicine.’3 The ‘right to health’ may figure in the arguments of patients, but reliance may also be placed on more traditional rights, such as the right to life and the right to privacy (in the sense of being left alone to make important and intensely personal decisions about one’s life). This article reflects on the legitimacy of these demands in the specific context of innovative surgical procedures. Such procedures have been described as ‘a new or modified surgical procedure that differs from currently accepted local practice, the outcomes of which have not 2

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S. Woods & P. McCormack. Disputing the Ethics of Research: The Challenge from Bioethics and Patient Activism to the Interpretation of the Declaration of Helsinki in Clinical Trials. Bioethics 2013; 27: 243– 250.

N.E. Lombard. Paternalism vs. Autonomy: Steps Toward Resolving the Conflict Over Experimental Drug Access Between the Food and Drug Administration and the Terminally Ill. JHBL 2007; 3: 163–189: 170. 3 L.V. Romano & P.D. Jacobson. Patient Access to Unapproved Therapies. J Health Life Sci Law 2009; 2: 45–72: 49.

Address for correspondence: Professor Denise Meyerson, Macquarie Law School, Macquarie University, North Ryde, NSW 2109, Australia. Email: [email protected] Conflict of interest statement: No conflicts declared © 2014 John Wiley & Sons Ltd

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been described, and which may entail risk to the patient.’4 In order to assess rights-based arguments for access to innovative procedures, I use the human rights method of proportionality analysis, which takes a two-stage approach when people complain that their rights have been violated. The first question is whether a human right has been infringed. I argue that blocking patients from undergoing potentially therapeutic innovative surgery does infringe their rights. However, since few rights are absolute, this does not usually dispose of the issue. Instead, it is necessary to move to the second stage, which involves determining whether there are competing considerations that justify overriding the right, while bearing in mind that rights protect fundamental interests and consequently that infringements of them cannot be justified unless a particularly strong argument can be made for doing so.5 With this in mind, I evaluate the ‘secondstage’ arguments for overriding the right to choose innovative surgery.

2. ‘BRAIN SURGERY’ I will begin by exploring the rights of access of desperately ill patients, using a hypothetical scenario loosely based on some recent events that took place at the University of California, Davis (UCD). Two neurosurgeons at UCD had read reports that suggested that patients with glioblastoma who have post-operative infections live longer than patients who do not get infections.6 With the consent of three terminally ill patients suffering from glioblastoma, the surgeons deliberately introduced bacteria into their brains. Although institutional approval and FDA oversight were necessary in terms of university policies and government regulations, the surgeons circumvented these processes. The first patient developed sepsis and died six weeks after the procedure. The second patient was reported as having a reduction in her brain tumour, giving the surgeons hope that the procedure was efficacious. She died just over a year later. Before she died, the surgeons had treated the third patient, who died of sepsis after 14 days. At about this time, the University ordered the surgeons to stop the treatment. Investiga4

W.L. Biffl et al. Responsible Development and Application of Surgical Innovations: A Position Statement of the Society of University Surgeons. J Am Coll Surg 2008; 206: 1204–1249: 1206. 5 The two-stage approach is embodied in many constitutions and rights-instruments, sometimes in respect of specific rights and sometimes in respect of all the protected rights. For a general discussion of proportionality analysis, see M. Tushnet. Advanced Introduction to Comparative Constitutional Law. Cheltenham: Edward Elgar Publishing; 2014. pp. 71–73. 6 See M. Baker. Can Bacteria Fight Brain Cancer? Nature News 27 July 2012. DOI: 10.1038/nature.2012.11080.

tions subsequently found that the surgeons had violated the faculty code of conduct.7 Since my interest is in determining whether patients have the right to make their own decisions about whether to undergo innovative surgery, not in the ethics of the surgeons’ conduct, I will adapt the facts by supposing that the surgeons were not in breach of the faculty code of conduct. I will suppose that the surgeons had submitted their proposed treatment to an institutional committee charged with oversight of innovative care, and that the committee had refused permission on the grounds that use of the bacteria was too risky and there were insufficient reasons for thinking that it would be effective. If this had happened, could the patients have complained that the committee had unjustifiably violated their rights? In considering this question, I will begin by making a number of assumptions that seem not to have been present in the actual UCD case. First, I will assume that there is sufficient preliminary evidence, for instance, from animal studies, to suggest that survival in patients with glioblastoma may be prolonged by deliberate infection of their wounds, even though the procedure is nonvalidated, may cause increased suffering and may even hasten a patient’s death. The reason I make this assumption is that few people will think that patients are entitled within the health system to access surgery known to be dangerous or ineffective. Such treatment could not be regarded as medically appropriate by any standards. By contrast, demands for access to innovations for which there is at least some preliminary evidence of benefit raise difficult moral questions. Of course, the strength of the evidence base for a particular innovation, and therefore the extent to which it is non-validated, is necessarily a matter of degree. The IDEAL Collaboration, which has developed a framework for evaluations of surgical innovations, has outlined the successive stages in surgical innovation from idea through to development, exploration, assessment and long term study.8 However, even at the idea stage, which refers to the first time a procedure is used in human beings, there must be some evidence, perhaps from pre-human work, to support the innovative approach. For the purposes of my discussion I will assume that at a minimum such evidence is in place. Secondly, it is beyond the scope of this article to consider the extent to which people can legitimately claim a positive right to medical treatment and for this reason I will assume that the cost of the procedure will be met by the patients themselves. I will also assume a healthcare 7

M. Lundstrom. UC Davis Surgeons Resign after Bacteria-in-Brain Dispute. The Sacramento Bee Aug 25, 2013. Available at: http:// www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after .html [Accessed 21 Nov 2013]. 8 P. McCulloch et al. IDEAL Framework for Surgical Innovation 1: The Idea and Development Stages. BMJ 2013; 346: f3012. DOI: 10.1136/bmj.f3012.

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Is There a Right to Access Innovative Surgery? context in which there is no shortage of health workers or health facilities. These assumptions are necessary in order to exclude the complicating factor of limited health resources. However, a complete analysis would have to address budgetary issues. Thirdly, I will assume that stringent efforts have been made to achieve informed consent in light of the vulnerability of dying patients. Arthur Caplan observes that ‘the desire to hope for the best – what is sometimes termed the therapeutic misconception – is often present on the part of those facing death’.9 He also notes that those who develop innovative approaches and hope to become pioneers in their field may have an interest in not presenting information objectively.10 These are significant concerns that speak in favour of special safeguards. Caplan himself mentions measures such as subject advocates, waiting periods, assessments of comprehension, and strict restrictions on conflicts of interest by information providers.11 I will assume that such safeguards are in place: an exacting standard of disclosure has been met, the existence of genuine consent is beyond doubt, and it is clear that the purpose of the procedure is to benefit the patient. Finally, since the issue of interest is a moral issue, not an issue about the legal obligations of oversight committees, I need to exclude any fear of legal sanctions that might otherwise cloud the moral analysis. I will therefore suppose that the institution cannot, for instance, be fined or have funding withdrawn in the event of adverse outcomes.12 I will assume, in other words, that the only obligation of an oversight committee considering whether to allow a patient access to innovative surgery is to ensure that its decisions conform to ethical standards. This scenario, which I will call ‘Brain Surgery’, raises a relatively narrow question. It concerns dying patients who have no other feasible options and who wish to undergo a procedure at their own expense, which may potentially be beneficial in light of preliminary evidence. Furthermore, their surgeon believes the procedure is in their best interests and they have been scrupulously informed about its experimental nature. Can such patients argue that blocking them from undergoing the procedure is a violation of their rights? 9 A. Caplan. Is it Sound Public Policy to Let the Terminally Ill Access Experimental Medical Innovations? Am J Bioeth 2007; 7(6): 1–3: 2. 10 Ibid: 2. 11 Ibid: 2. 12 Proposed United States legislation (the Access, Compassion, Care and Ethics for Seriously Ill Patients Act), which seeks to expand access to investigational drugs, biologic products, and devices for terminally ill patients, requires patients to sign a waiver indemnifying drug companies and physicians against liability for adverse events. For discussion, see S. Shah & P. Zettler. From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy. Yale J Health Policy Law Ethics 2010; 10: 135–196: 176–177.

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Brain Surgery is similar in some ways to the issue that arose in the United States Abigail Alliance litigation.13 This litigation concerned access to unapproved drugs that have successfully completed Phase I testing and for which there is therefore some evidence of safety, in the sense that unacceptable toxicity has not been revealed. However, over 90% of drugs that have passed Phase I testing do not pass Phases II and III,14 which study the effectiveness of the drugs and gather more information about their safety. In terms of FDA regulations, drugs need to pass through these later phases before restrictions on their sale and distribution can be lifted. Before such time, the drugs are available only to patients enrolled in clinical trials or patients given special dispensation under certain narrow exceptions. The Abigail Alliance for Better Access to Developmental Drugs argued that the regulations were unconstitutional, claiming that they infringed the constitutional right of competent, terminally ill, adult patients to access experimental drugs that have passed Phase 1 testing, on the advice of their doctors, in circumstances where no other treatment options exist. As in Brain Surgery, the right for which the Alliance argued was narrow. First, the Alliance was advocating on behalf of terminally ill patients for whom there are no other available treatment options. Secondly, the Alliance’s arguments concerned rights of access to drugs recommended by a doctor and that have been found safe enough to be eligible for further testing. The issue was argued as a matter of US constitutional law and the Alliance was unsuccessful largely because of technical legal issues that are not of interest for present purposes. These included the fear of judicial activism in creating new constitutional rights; the legitimacy of judges’ questioning the scientific conclusions of expert agencies; and the need for the Alliance to pass a difficult legal test, which involved showing that the claimed right was deeply rooted in American history, legal traditions and practices. The case is nevertheless useful because some of the arguments expressed in it are relevant to a consideration of the moral issues presented by Brain Surgery, and I will draw on these arguments in Sections 3 and 4. However, I will also call attention in Section 6 to some morally relevant differences between unapproved drugs and innovative surgery.

3. POSITIVE OR NEGATIVE? A good starting point is a question posed by Richard Epstein: is a right to accept medical treatment the 13

Abigail Alliance for Better Access to Developmental Drugs v Von Eschenbach, 445 F.3d 470 (D.C. Cir. 2006) (‘Abigail I ’); rev’d en banc, 495 F.3d 695 (D.C. Cir. 2007) (‘Abigail II’); cert.denied, 128 S. Ct. 1069 (2008). 14 Caplan, op. cit. note 9, p. 3.

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opposite side of the coin from the right to reject medical treatment?15 It is uncontroversial to say that competent, informed patients have the right to refuse treatment, regardless of how foolish the refusal may seem to be, and even if they will die as a result. Most people’s views on this matter are unswervingly anti-paternalist. But if it is obvious that patients should be able to choose death, why should they not be able to ‘choose life’, by choosing risky surgery that may possibly prolong or even save their lives? If anything, one might assume that the latter would be less troubling than the former, given the traditional governmental interest in the preservation of life. Some of the judges in the Abigail Alliance litigation were sympathetic to this line of reasoning, saying that the ‘logical corollary’ of the right to reject life-sustaining treatment is the freedom to decide ‘whether to assume any known or unknown risks of taking a medication that might prolong [one’s] life’.16 Someone might object that non-validated surgery does not count as a ‘medical treatment’, and hence that even if there is a right to accept medical treatment, such a right would not extend to accepting non-validated surgery. However, as noted previously, this article is not concerned with claims to access surgical innovations that are known to be dangerous or ineffective. It is concerned only with innovations for which there is some, albeit limited, evidence of potential benefit. Such innovations are comparable to unapproved drugs and we regard these as ‘medical treatments’, because we allow them to be trialled and released for compassionate use in certain circumstances, notwithstanding their experimental nature. This is not to say that any right to accept risky medical treatment would be absolute. In accordance with the two-stage approach outlined in Section 1, even if such a right were to exist, it would still be necessary to consider whether there are sufficiently strong competing interests to justify overriding it, and in making this determination the degree of uncertainty about the risks of the treatment would clearly play some role (see Section 6). This does not, however, affect the present point: since the innovative surgical approaches with which this article is concerned are approaches for which there is some evidence base, they are correctly categorised as ‘medical treatments’, by contrast with treatments that have not been tested at all or are entirely unsupported by evidence. A second possible objection to comparing the right to accept treatment with the right to refuse treatment is that the latter is a freedom or negative right – the right to be free from coercive interference – whereas the former is a positive right. Some of the Abigail Alliance judges sought to distinguish the situations on this basis, saying that the 15 R.A. Epstein. The Erosion of Individual Autonomy in Medical Decisionmaking: Of the FDA and IRBs. Georgetown Law J 2008; 96: 559–582: 569. 16 Abigail I, 484.

right sought by the Alliance was an ‘affirmative right’.17 This view has also found favour among some commentators.18 Although these judges and writers do not explain why they regard this as relevant, presumably it is because positive rights are more controversial and potentially more onerous than negative rights, in so far as the latter merely limit the exercise of power against the rightholder, whereas the former give right-holders the ability to compel positive action, possibly against the wishes of and at considerable cost to the duty-bearer. However, while it is true that many demands for medical treatment are positive claims to the provision of a service, there are strong arguments against categorising the right asserted by the Abigail Alliance and the hypothetical right asserted in Brain Surgery as positive claims. These patients are not claiming that they have a positive right to treatment at state expense, or insisting that an unwilling drug manufacturer should be forced to supply them with drugs, or that an unwilling surgeon should be forced to operate on them. Instead, they are complaining that official decisions have interfered with their freedom to choose a form of medical treatment offered by a willing provider and to be paid for out of their own pockets. Consider, by way of analogy, laws that prohibit access to contraceptives, such as those that used to exist in the United States. When litigants complained that these laws violated their rights, they were not asserting a positive right to be provided with contraceptives at the government’s expense. Instead, they were complaining that the government had actively interfered in their freedom to make decisions about personal and private matters. The right on which they relied was negative, and in order to respect their rights the government was merely obliged to refrain from passing anti-contraception laws, so that people could purchase contraceptives from pharmacists willing to supply them. No costly or intrusive affirmative measures were required. Similarly, the patients represented by the Abigail Alliance and the Brain Surgery patients are asking for the removal of official obstacles, so that they may buy drugs from manufacturers willing to supply them (which may or may not be the case),19 or choose to undergo, at their own expense, surgery recommended and willingly provided by their surgeon. No doubt, there is also a large difference between contraceptives, on the one hand, and unapproved drugs and risky surgery on the other, namely, that the former are known to be largely safe and effective, whereas the latter are not. Access to unapproved drugs might also be harmful to third parties – for instance, by having 17

Abigail I, 495. Romano & Jacobson, op. cit. note 3, p. 61. 19 In fact, there are many disincentives that might make manufacturers unwilling to supply them. See J. Menikoff. Beyond Abigail Alliance: The Reality behind the Right to Get Experimental Drugs. Kansas Law Review 2008; 56: 1045–1074: 1060–1066. 18

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Is There a Right to Access Innovative Surgery? detrimental consequences for scientific research. However, these differences merely alert us to the fact that there might be powerful reasons for limiting people’s freedom to access unapproved or non-validated treatments – reasons that do not exist in the case of the freedom to access contraceptives. While I will discuss these reasons later (section 6), they do not affect the categorisation of the right sought in Abigail Alliance and Brain Surgery, somehow turning it from a liberty claim against governmental or institutional coercion into a positive claim. I conclude that if there is a morally relevant difference between refusing treatment and the Abigail Alliance/ Brain Surgery situations, it cannot lie in the negative/ positive distinction. In both cases, a liberty interest is at stake – the interest in making medical decisions without interference by a government agency or institutional decision-maker. Some of the judges in the Abigail Alliance litigation recognised this, saying ‘the Alliance seeks to have the government step aside by changing its policy’.20 The fact that the interest in consenting to undergo Brain Surgery is correctly categorised as a liberty interest, not a positive entitlement, removes one source of resistance to regarding it as a right. However, not all liberty interests deserve the status of rights, with the concomitant special protection which that status attracts. We therefore need to determine whether the interest in being allowed to undergo innovative procedures is so fundamental as to amount to a right. I turn to this next.

4. WHAT RIGHTS ARE AT STAKE? The fact that Brain Surgery is a last resort makes the liberty interest very weighty. Unlike patients who are not terminally ill, the patients in Brain Surgery can argue that withholding approval is an infringement of their negative right to life, which is the right not to be interfered with in trying to preserve one’s life.21 The Abigail Alliance made a similar argument, drawing an analogy between the situation of people whose lives are threatened by an attacker and terminally ill people. The law recognises a right to self-defence, which is the right to use force that would otherwise be illegal in an attempt to overcome immediate and serious danger threatened by an aggressor. The Alliance argued that terminally ill people are in a similarly life-threatening situation and should consequently be able to rely on a right to ‘medical self-defence’ – the right to defend oneself against medical threats through medical treatment, including taking experimental drugs that people who are not dying might legitimately be prevented from taking. 20 21

Abigail I, 484. Abigail II, 714–715.

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The Alliance further argued that US law implicitly accepts the idea of a right to medical self-defence, because it prohibits the state from interfering with access to lifesaving medical procedures in the context of abortion. In particular, US law takes the view that although it is permissible to ban post-viability abortions (because once the foetus is viable, the governmental interest in preserving life is considered to be more important than reproductive choice), an exception needs to be made for women whose lives are threatened by an ongoing pregnancy. Since their lives are endangered, they have a right to a post-viability abortion that is not available to other women whose lives are not at risk.22 Of course, there is also a point of disanalogy between self-defence and taking unapproved drugs: the right to self-defence competes with the state’s interest in prohibiting the private use of violence, whereas any right to ‘medical self-defence’ would compete with a different state interest – the paternalistic interest of preventing people from undergoing medical treatments that are thought to be unduly risky. There is also a difference between post-viability abortions in order to save a mother’s life and taking unapproved drugs, namely, that the health benefits of the former are known to outweigh the health risks, whereas there is uncertainty about the medical appropriateness of the latter. These concerns will be dealt with in Section 6, where I discuss the circumstances in which the right to try to preserve one’s life can legitimately be restricted in the light of competing safety interests. It is also worth mentioning that some of the judges in the Abigail Alliance litigation resisted the analogy between taking experimental drugs and self-defence, stating that self-defence is limited to the use of reasonable force, whereas taking drugs that might be unsafe to defend oneself against disease does not amount to reasonable force.23 However, this would seem to overlook the fact that the reason why self-defence is limited to reasonable force (by which is meant force that is not excessive in the circumstances) is because the aggressor has rights to bodily integrity. By contrast, there is no need for the ‘force’ applied to a disease to be limited to what is reasonable, since the choice to accept experimental medical treatment does not involve the use of force against another person. The legal arguments described above have moral correlates, because it is plausible to think that we have a moral right to defend ourselves against aggressors and that a woman has a moral right to abort a viable foetus when the pregnancy endangers her life. And if these moral rights are accepted, it would appear inconsistent to 22

Abigail II, 709. See also E. Volokh. Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs. Harv Law Rev 2007; 120: 1813–1846: 1815–1816, 1824–1826. 23 Abigail II, 710.

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say that dying patients do not have the moral right to accept medical treatment that represents, in their doctor’s view, their only chance of prolonging their lives. This is a relatively narrow point, which shows that patients who are dying have the right to choose innovative surgery offered by their surgeons. But many patients who are suffering from a medical condition that is less serious might also seek such access on the recommendation of their surgeons. Do they have a negative right to try to protect their health, on analogy with the negative right to try to preserve one’s life – a right that they can assert against institutional decision-makers who seek to prevent them from undergoing the surgery? There are well-known legal cases that recognise a negative right to protect one’s health. One of these cases, described as ‘the human rights success story of recent years’,24 concerned rights of access to antiretrovirals at public hospitals in South Africa. The South African government had restricted the availability of an antiretroviral shown to prevent transmission of HIV from mother to child during childbirth. Access was permitted at only a handful of pilot sites, as a result of which very few mothers received it. The restrictions were not justified by cost considerations, since the manufacturers had offered the drug to the government free of charge for five years. Instead, the government, which was known for its ‘AIDS-denialism’, argued that the safety and efficacy of the drug were in doubt. A challenge to this policy, invoking the right to heath care contained in the South African Constitution, was successful, the Court finding that the government had violated its obligation not to impair the right of access to healthcare services,25 and ordering it to make the drug available when medically indicated in the view of professionals.26 This decision did not affirm a controversial positive entitlement to be provided with health benefits. Instead, as Jessie Hill observes, it protected the negative dimension of the right to health, which she describes as ‘a right to be free from stateimposed harm resulting from administrative and bureaucratic regulations that pose obstacles to obtaining medically appropriate care’.27 Hill also gives another example of a well-known legally recognised negative right to health, referring to the fact that under US law, laws that seek to ban post-viability abortions must contain an exception allowing the procedure to be performed not only in order to save the moth-

er’s life, as mentioned above, but also in order to protect her health. Hill argues that this approach likewise presupposes the idea that there is a legal right to noninterference in efforts to protect one’s health.28 Once again, the legal approach to the right to health, as entailing rights of access to medical drugs or procedures, is morally attractive. It is plausible to think that a woman has a moral right to abort a viable foetus when the pregnancy poses a serious risk to her health and that HIVpositive patients who wish to take antiretrovirals at no cost to the state should be allowed to do so. Consider, also, the ban in several countries on the sale and distribution of mifepristone, a drug used for termination of early pregnancy. Although the drug is on the World Health Organization’s Model List of Essential Medicines,29 its opponents believe that access to it would make it too easy to obtain an abortion. These bans impose increased health risks on women who would have an abortion regardless but are forced to go through a surgical procedure that their doctor regards as more risky than a medical abortion. Anyone who regards these bans as morally illegitimate implicitly accepts a right to protect one’s health by obtaining appropriate medical care without government interference.30 This is, once again, not to deny that there is a difference between the antiretroviral and abortion examples on the one hand, and innovative surgery on the other, namely, that the health benefits of the former are known to outweigh the health risks, whereas there is only limited evidence for the health benefits of innovative surgery, and the procedure might even make a person’s condition worse. However, there is no reason to think that the interest in protecting one’s health via surgery whose health benefits are known is more fundamental than the interest in protecting one’s health via surgery whose benefits are less certain. Of course, a person’s right to protect their health might legitimately be restricted in the light of safety concerns, but we should not confuse this second stage of the inquiry with the first-stage inquiry into whether the right exists at all. As mentioned previously, I have deferred the second-stage issues until Section 6. So far I have argued that patients who wish to undergo innovative surgery for which there is some evidence of benefit may invoke the negative right to life (if they are dying) or the negative right to health (if they are ill but their condition is not life-threatening). I will now

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T. Murphy. Health and Human Rights. Oxford and Portland, Oregon: Hart Publishing; 2013. p. 55. 25 Minister of Health v Treatment Action Campaign (2002) 5 SA 721 (CC), para 46. 26 Ibid: para 135. 27 B.J. Hill. Reproductive Rights as Health Care Rights. Columbia J Gend Law 2009; 18: 501–549: 527–528. See also J.A. Robertson. Controversial Medical Treatment and the Right to Health Care. Hastings Cent Rep 2006; 36: 15–20: 15.

Hill, op. cit. note 27, p. 532; Roe v Wade, 410 U.S. 113, 163–164 (1973). 29 J. Erdman, A. Grenon & L. Harrison-Wilson. Medication Abortion in Canada: A Right-to-Health Perspective. Am J Public Health 2008; 98: 1764–1769: 1767. 30 Compare laws that ban ‘partial-birth’ abortions but fail to make an exception for cases in which the procedure might be medically advisable. For discussion from the perspective of US law, see Hill, op. cit. note 27, pp. 533–534, 543–545.

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Is There a Right to Access Innovative Surgery? consider whether patients whose life or health is under threat may also invoke the right to privacy to support their wish to undergo innovative surgery. There are at least three different dimensions of the right to privacy: the right to physical privacy (spaces from which others may be excluded), informational privacy (control over access to information about oneself), and decisional privacy (a right to be free from interference in making important choices of a particularly intimate and personal kind).31 It is privacy in the decisional sense – the need to respect individual autonomy and self-determination in intensely personal areas of life – with which I am concerned. Plausible candidates for privacy-based liberties are the right to decide whether to engage in same-sex sexual conduct, to refuse medical treatment, to use contraceptive drugs, and to have a pre-viability abortion. These are all important choices of a highly personal nature, which most people believe should be respected. Furthermore, two of them (contraception and abortion) involve claims to access medical treatment. The question is whether a dying or ill person’s choice to undergo innovative surgery is analogously private. Since it is no less important and no less personal, it is difficult to see how this question could be answered in the negative. Of course, as noted in connection with the negative rights to health and life, the liberty to determine intimate matters may come into conflict with and be overridden by sufficiently powerful competing considerations. This does not, however, mean that the liberty does not exist at all. I have argued that the choice to undergo innovative surgery when one is ill or dying is private. But it might be observed that some medical treatments, such as abortion before viability, are private even in the absence of a medical reason to undergo them, and it might be wondered whether the choice to undergo innovative surgery in the absence of a medical reason should also be regarded as private. For instance, should innovative cosmetic surgery or futuristic enhancement surgery be regarded as private, perhaps on the grounds that one has a right to do with one’s body as one pleases? These questions cannot be answered within the scope of this article, which is concerned only with innovative surgery for which there is some evidence of therapeutic benefit. My method throughout has been to argue outwards in an incremental fashion, beginning with generally accepted and relatively uncontroversial ideas, such as the privacy of reproductive choices, and demonstrating that potentially therapeutic innovative surgery engages comparable interests. Whether this argument can be extended even further to the freedom to improve one’s appearance or enhance one’s performance would require investiga31

A.L. Allen. Constitutional Law and Privacy. In: D. Patterson, editor. A Companion to Philosophy of Law and Legal Theory. Malden, MA: Blackwell Publishing; 1996. pp. 139–155: 140.

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tion of the importance of these freedoms in comparison to other freedoms, such as reproductive freedom. These are large issues that cannot be dealt with here. To sum up the conclusions of this section: it is plausible to argue that there is a range of ‘medical freedoms’ to which people are entitled. It is a violation of our negative rights should official decision-makers erect barriers to medical choices that include: (1) forcing medical treatment on competent individuals; (2) forbidding them to buy contraceptives; (3) banning post-viability abortions in circumstances where the mother’s life or health is endangered by the pregnancy; (4) banning or restricting abortions before viability; and (5) banning methods of abortion that may be safer than the methods that the government permits. I have argued that the same concerns that animate these rights (self-preservation, health and privacy) also support the idea of a right to undergo potentially therapeutic innovative surgery recommended by surgeons.

5. RIGHTS AND PROPORTIONALITY ANALYSIS Some may resist the arguments made in the previous section on the basis that they imply that patients should be allowed to make any decisions they want and that the state should entirely retreat from regulating the practice of medicine. Peter Jacobson and Wendy Parmet, for instance, say that if one accepts a fundamental rights analysis, rooted in patient autonomy, ‘why not return to a deregulated world in which patients can obtain access to any drug they believe will be lifesaving or lifeenhancing?’32 However, matters are not as all-or-nothing as Jacobson and Parmet suggest. We do not have to choose between embracing anti-statist, free-market libertarianism and denying that patients have any rights when it comes to choice of treatment. First, the freedom to accept treatment for which I have argued is a freedom that arises within the field of medicine,33 and recognition of such a freedom would not (and should not) preclude the state from prohibiting unscrupulous entrepreneurs from providing dangerous quack treatments to the public. Secondly, Jacobson and Parmet seem to assume that anyone who defends the idea of a right to accept medical treatment must regard the right as absolute. In fact, most rights-theorists do not argue that fundamental rights can never be justifiably overridden. 32

P.D. Jacobson & W.E. Parmet. A New Era of Unapproved Drugs: The Case of Abigail Alliance v Von Eschenbach. JAMA 2007; 297: 205–208: 207. 33 On the difference between campaigns for freedom outside and within orthodox medicine, see L.A. Grossman. The Origins of American Health Libertarianism. Yale J Health Policy Law Ethics 2013; 13: 76–134: 131–134.

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Instead, they argue that rights have substantial priority over competing interests, which means that they cannot be overridden on grounds that would suffice when rights are not at stake. According to rights-theorists, when rights are not at stake, decisions by authorities that invade individuals’ interests are permissible as long as they are not illogical or irrational. For instance, to use an example given by Ronald Dworkin, although motorists may have an interest in driving up a particular street they do not have a right to do so. This means that the government can justify a law prohibiting motorists from driving up the street on the basis of a routine utilitarian calculation that ‘the gain to the many will outweigh the inconvenience to the few’.34 By contrast, according to rights-theorists, rights deserve heightened (though not necessarily absolute) protection, which means that any limitation on rights must be proportionate. This more demanding test requires more intensive scrutiny of the authority’s justification for invading the right. For present purposes, the most important aspect of such heightened scrutiny involves a normative judgement as to whether the benefits of the measure are sufficiently important to justify the degree of invasion on the right. Consider the facts of a recent Australian case, which illustrate the concept of proportionality in the context of access to medical treatment.35 A woman who had been receiving IVF treatment was sentenced to three years imprisonment. She wished to continue the treatment at her own expense, since if she waited to be released from prison, her age would make her ineligible for treatment. The prison authorities refused to grant approval, on the grounds that allowing her access to IVF treatment would undermine the credibility of the corrections system, be inconsistent with community expectations that prisoners forfeit the opportunity to make a ‘lifestyle choice’, and create a precedent.36 The applicant argued that the authorities had infringed her rights, including her right to non-interference with private and family life. Although in the end the case was decided on other grounds, if we were to apply a human rights approach to this matter, the question would be whether the authorities’ objectives were sufficiently important to justify denying a prisoner her last chance to have a child (assuming that her status as an ex-prisoner would have precluded her from adopting). It is hard to imagine that this question might be answered affirmatively. Although the authorities’ objectives were no doubt legitimate, and could have logically formed the basis for a decision if rights were not at stake, violations of rights need to pass the test of proportionality, and in this particular case, the seriousness of the incursion on the applicant’s right to 34 R. Dworkin. Taking Rights Seriously. London: Duckworth; 1977. p. 191. 35 Castles v Secretary to the Department of Justice [2010] VSC 310. 36 Ibid: para 154.

non-interference with private and family life would seem to be disproportionate relative to the public interest arguments made by the authorities. Adopting this approach, I would argue that although, for all the reasons I have provided, the interest in accessing potentially therapeutic innovative surgery recommended by a surgeon is always fundamental enough to count as a right, this does not mean that the right is unqualified or absolute. Instead, it means that any argument for restricting it needs to pass the human rights standard of proportionality. It follows that we need to investigate the reasons oversight committees might provide for vetoing a patient’s choice of treatment, exploring whether they are sufficiently powerful to justify the severity of the intrusion on individual liberty. I turn to this matter next. Once cost has been excluded, the possible reasons are of two kinds: concerns for patient safety and fear of detrimental social consequences.

6. COMPETING INTERESTS One obvious competing interest would be monetary but I have excluded the cost of the treatment as a possible reason for withholding approval, by stipulating that the cost will be borne by the patients themselves. If this were not the case, the resource implications of innovative surgery might in certain circumstances justify restrictions on the right to undergo it. In such cases, it would be a matter of limiting any positive rights to be provided with health benefits by reference to their affordability. However, to keep the discussion within reasonable limits, I have explicitly excluded resource issues from consideration and focused only on the negative aspects of the right to health. In some ways, the negative right to choose innovative surgery would seem to raise fewer competing concerns than some of the other negative rights discussed in Section 4. When someone’s life is threatened by an aggressor, we allow them to kill the aggressor if that is the only way they can defend themselves. When a woman’s health is threatened by pregnancy with a viable foetus, again we allow the use of lethal force. By contrast, undergoing innovative surgery does not involve forcibly attacking anyone, which would seem, if anything, to give it a greater claim to protection than these other choices.37 However, although the right to undergo innovative surgery does not conflict with another person’s right to bodily integrity, it does raise concerns about patient safety. In this respect, the choice to undergo innovative surgery is more troubling than some of the other choices discussed in Section 4. With the exception of refusing 37

Volokh, op. cit. note 22, makes a similar point about access to experimental drugs (p. 1818).

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Is There a Right to Access Innovative Surgery? life-sustaining treatment, the expected benefits of exercising the other rights considered in Section 4 clearly exceed the risks, whereas this is not the case with innovative surgery. Indeed, some innovative procedures have led to severe morbidity and mortality,38 as the UCD case itself attests. This point of difference raises the possibility that safety considerations might be weighty enough to trump patients’ rights to try to preserve their lives, protect their health and make intensely personal choices about their medical treatment. In my view, there is a spectrum of possibilities, depending on how much evidence there is about the risks of the surgery and how ill the patient is. At one end of the spectrum are procedures that are known to be dangerous and to have no chance of success. Even terminally ill patients should not be allowed to undergo such procedures and it is justifiable to prevent them from doing so, since the objective of protecting patients from known and certain harm is sufficiently important to justify the interference with autonomy. As the US Supreme Court observed in a case considering access to Laetrile, even dying patients need to be protected against toxic and ineffectual drugs – ‘the vast range of self-styled panaceas that inventive minds can devise’.39 For similar reasons, it is, in my view, legitimate to impose criminal sanctions on doctors who import drugs that are known to be dangerous and supply them to informed, consenting patients.40 The key characteristic of dangerous quack treatments is that forbidding access to them poses no risk to people’s lives or health, which means that compulsion of this kind is not inconsistent with recognising that people have a right to preserve their lives and protect their health. However, the situation is different when it comes to surgery about which there is scientific uncertainty, and whose potential risks are offset by some, albeit limited, evidence of potential benefit. Notwithstanding legitimate concern about exploiting desperate patients in the interests of advancing knowledge, and about the unknown risks of harm attached to undergoing surgery that has not been proven to be safe and effective, there are also unknown risks attached to foregoing surgery that offers some hope of benefit.41 The harm of missing out on prolonging one’s life is destined never to be disclosed. However, it is no less real than the harm of hastening one’s death should innovative surgery go wrong. I have argued elsewhere that when contemplating innovative surgery that carries unknown risks, surgeons 38

J.S. Barkun et al. Evaluation and Stages of Surgical Innovation. Lancet 2009; 374: 1089–1096: 1091. 39 US v Rutherford, 442 U.S 544, 558 (1979). 40 The constitutionality of such a law in the United States was considered in People v Privitera 591 P.2d 919 (Cal. 1979). 41 Cf Cass Sunstein’s discussion of the risks attached to foregoing new technologies: C. Sunstein. Laws of Fear. Cambridge: Cambridge University Press; 2005. pp. 14–15.

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should take a moderate precautionary approach. On a very strong precautionary approach, a surgeon would consider only the potential risks of an innovative approach and not its potential benefits. A more moderate approach would recommend a slight presumption against innovation, prescribing that surgeons should err on the side of caution in so far as the risks of innovation are concerned, but not to a large extent. This is not because caution is desirable per se but rather because cognitive and other biases may lead surgeons to be more optimistic about the chances of success than is objectively warranted.42 However, even on a moderate precautionary approach, the calculation must be affected by the patient’s situation. For instance, a patient who is dying and has no other options stands to benefit much more from an innovative procedure than they stand to lose, and consequently even a moderately precautionary surgeon might recommend the procedure, and the patient might wish to undergo it. Yet an oversight committee might disagree. In general, institutional committees can be expected to take a strongly precautionary approach, because the risks of action (surgery) are likely to be much more salient to such a body than the risks of inaction (no surgery) – in part, perhaps, because, unlike the risks of approving surgery, the risks of failing to approve surgery will never be known and cannot become a source of complaint. We will never know if someone who dies might have lived had they undergone surgery. By contrast, when innovative surgery goes wrong, the institution may be blamed.43 However, I have argued that rights are always at stake when a patient wishes to undergo potentially therapeutic innovative surgery, which means that an oversight committee needs to justify its decisions to a high standard, and it is difficult to see how an oversight committee’s concerns about safety could be sufficiently powerful to override a dying patient’s choice. In such a case, avoiding the risks of innovation would be bought at too high a price, since the harm to liberty would be quite disproportionate compared with what can be achieved for the patient by denying access. If a patient has little to lose, and there is some chance of great gain, a concern for the potential dangers or the inefficacy of the surgery is not sufficiently compelling to trump the patient’s right to try to preserve their life. As some of the judges in the Abigail Alliance litigation observed, ‘[d]enying a terminally ill patient her only chance to survive . . . presupposes a dangerous brand of paternalism’.44 Likewise, in the Quinlan case, the Court was of the view that the government’s interest in the preservation of life weakens ‘as the 42

D. Meyerson. Innovative Surgery and the Precautionary Principle. J Med Philos 2013; 38(6): 605–624. 43 Cf Epstein, op. cit. note 15, who makes a related point about IRBs (p. 581). 44 Abigail II, 728.

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prognosis dims’.45 This argument becomes even stronger when one considers that patients have the right to refuse life-sustaining treatment, as a result of which the risk of death is certain to materialise. The more difficult question concerns the point at which safety concerns become weighty enough to trump the rights of people who want to undergo innovative surgery but are not terminally ill. It is not possible to give a bright-line answer to this question, since there are many factors bearing on the issue which are not only matters of degree but may also have to be traded off against each other. One of these factors is the extent of the uncertainty about the risks of the surgery, which diminishes as an innovation passes through the various stages of developing an evidence base, as outlined by the IDEAL collaboration. The wider the evidence base becomes, the harder it becomes to justify an interference with patients’ rights to avail themselves of the potential benefits of an innovative approach. Relevant factors also include the seriousness of the illness, how much the patient stands to benefit from the surgery if it is successful, what other options they have, and so on. Depending on the mix of these factors, it will be more or less difficult for an oversight committee to demonstrate that the price paid by a patient in foregoing a potential improvement in health is proportionate in light of what stands to be achieved by denying access. For instance, vetoing a patient’s choice to undergo a very new procedure for a relatively trivial condition will be easier to justify than vetoing a choice to undergo a more established procedure for a very serious condition. However, the key point is that, even in the former case, the patient’s right to protect their health is at stake, which means that the justification for overriding the patient’s wishes needs to meet the standard of proportionality, which is a higher standard than the standard that applies when safety considerations compete with interests that do not have the status of rights. Consider, for instance, laws that force manufacturers to include air bags in cars. Such laws increase the cost of cars and they therefore interfere with the liberty of carbuyers who would prefer to spend less and forego the protection. However, the liberty in question is not fundamental and the laws do not invade anyone’s rights. It will consequently be relatively easy for the government to justify such regulations as long as they are not based on obviously false factual determinations: if it is reasonable to think that air bags reduce injuries, the regulations should survive scrutiny. By contrast, when expert bodies such as oversight committees use safety considerations to prevent patients from making intensely personal decisions about how best to protect their health in consultation with their surgeons, rights are at stake, and such 45

In re Quinlan, 70 N.J. 10, 355 A.2d 647, 664 (1976).

bodies consequently need to make a stronger case. This will involve giving reasoned consideration to all the relevant factors and the provision of convincing arguments, not merely reasonable arguments, if they wish to forbid access. I have discussed the circumstances in which paternalistic considerations might be sufficiently powerful to justify the infringement of patients’ rights. I turn now to consider whether there are any other governmental interests in controlling access to experimental treatment and, in particular, whether societal interests and potential harms to third parties might play such a role. When it comes to unapproved drugs, many authors argue that allowing patients expanded access would have very detrimental consequences for society. For instance, Shira Bender and two co-authors argue that expanded access would compromise the drug development process and jeopardise the advancement of medical knowledge. They provide three reasons. First, unwarranted ‘hype’ about a drug might lead to the drug becoming available without proper studies into its effectiveness. Secondly, there would be no incentive for pharmaceutical companies to fund costly drug trials if they could profit from the sale of drugs before completing trials. Thirdly, if patients were allowed to use Phase I drugs as treatments, they would be excluded from participation in clinical trials and there might not be enough subjects on which to test the drugs, which would in turn delay the ultimate results.46 Elizabeth Weeks Leonard makes a related point, arguing that if patients could buy experimental drugs on the open market, they would be less willing to participate in drug trials, given the risk of being assigned to a placebo or control group.47 Since rigorously conducted clinical trials serve the interests of countless other future patients by generating the most reliable information about the safety and efficacy of drugs, Leonard concludes that ‘the public’s interest in cold science outweigh[s] human compassion for dying patients’.48 Whatever the merits of these arguments, they have less traction when it comes to considering access to surgical innovations, because surgical and pharmaceutical innovations follow different development paths.49 Randomised controlled trials and systematic reviews in surgery are much less common than studies evaluating new drugs.50 This is because of features specific to surgery that make the formal evaluation of surgical interventions 46

S. Bender, L. Flicker & R. Rhodes. Access for the Terminally Ill to Experimental Medical Innovations: A Three-Pronged Threat. Am J Bioeth 2007; 7(10): 3–6. 47 E.W. Leonard. The Public’s Right to Health: When Patient Rights Threaten the Commons. Washington University Law Review 2009; 86: 1335–1396: 1358. 48 Ibid: 1386. 49 McCulloch, op cit. note 8. 50 Barkun, op.cit. note 38, p. 1089.

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Is There a Right to Access Innovative Surgery? more complex. For instance, surgical trial protocols that use placebo controls (sham procedures) or controls with no treatment are often ethically problematic. There are also practical problems, such as the small size of target populations and the fact that double-blind studies are usually not possible. It is also difficult to standardise surgical procedures as a precursor to their evaluation.51 Outcomes in surgery are affected by a range of complex factors, such as the attributes of the surgeon, variations in surgical strategy, the contribution of other members of the team, and preoperative and postoperative management.52 For these and other reasons, innovation in surgery is much more difficult to evaluate and regulate than pharmaceutical innovation. This helps to explain why, for instance, there are no FDA regulations governing the testing of procedures that do not involve new drugs or new devices.53 It also means that patients who demand access to innovative surgery are not controversially seeking to bypass governmental regulations, as was the case in the Abigail Alliance litigation, and that providing patients with access to innovative surgery does not compete with the public’s interest in scientific progress to the same extent as providing access to unapproved drugs. This is not to say that the evaluation of surgical innovations cannot or should not be improved. It is only to say that allowing access to innovative surgery would not threaten the advancement of medical knowledge to the same extent as allowing access to unapproved drugs.

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that an innovative procedure is too risky should automatically trump a patient’s assessment that the risk is worth taking. On the other view, the patient’s wishes should always be respected. My view is that an oversight committee is entitled to veto access to innovative procedures but that it needs to have a powerful justification for doing so – one that passes the human rights test of proportionality. This is because the choice to undergo innovative surgery is an intensely personal choice made in an effort to preserve one’s life or protect one’s health, meriting the special, rights-based protection conferred on comparable medical choices. The arguments for blocking access must consequently be stronger than those that would suffice to prohibit risk-taking in areas of life that are not protected by rights. If a patient is terminally ill, it will be very difficult to demonstrate proportionality. If a patient is not terminally ill, it may be easier to demonstrate proportionality, depending on the circumstances. However, even when a patient is not terminally ill, it will not be enough for a committee to show that its concerns are reasonable. Instead, it will need to show that what stands to be gained by prohibition is sufficiently important to compensate for the interference with the patient’s rights. If a committee cannot satisfy this test, it may convey its belief that a procedure is medically inadvisable, while leaving the ultimate choice up to patients themselves in consultation with their doctors.

Acknowledgements

7. CONCLUSION In this article I have steered a middle path between two views. On the one view, an oversight committee’s belief 51

R.M. Sade. Surgical Innovation: Too Risky to Remain Unregulated? Ann Thorac Surg 2006; 82: 1957–1958: 1957. 52 P.L. Ergina et al. Surgical Innovation and Evaluation 2: Challenges in Evaluating Surgical Innovation. The Lancet 2009; 374: 1097–1104. 53 Barkun, op.cit. note 38, p. 1091.

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I am grateful to Katrina Hutchison, Jane Johnson and especially Wendy Rogers for helpful comments. I would also like to thank two anonymous referees for their constructive suggestions. Swantje Lorrimer-Mohr provided assistance with the footnotes. Research towards this paper was partly supported by an Australian Research Council Linkage Grant (LP110200217 ‘On the cutting edge: Promoting best practice in surgical innovation’). Denise Meyerson is a Professor of Law in the Macquarie Law School at Macquarie University, a member of the INCISIVE Research Team based at Macquarie University, and an Honorary Research Associate in the Department of Private Law at the University of Cape Town.