Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special features of both surgery and innovation.
- Ethics of innovative surgery
- informed consent
- conflicts of interest
- research ethics
- surgical ethics
- applied and professional ethics
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- Ethics of innovative surgery
- informed consent
- conflicts of interest
- research ethics
- surgical ethics
- applied and professional ethics
Innovation in surgery has contributed to progress in medicine and to enhanced longevity and quality of life. It has led to new devices and procedures, such as heart valves and organ transplants, yet in spite of its considerable potential for good, innovative surgery generates significant ethical challenges. Roughly speaking, these can be grouped around concerns about patient harm, informed consent, distribution of healthcare resources and conflicts of interest. In this paper we argue that some of these issues may be resolved through better evidence gathering and more comprehensive regulation, but that others will be more resistant to resolution owing to special features of both surgery and innovation. We begin by briefly canvassing various definitions of surgical innovation before expanding on the ethical issues surgical innovation creates. Finally, we consider to what extent regulation and evidence can deal with these ethical concerns.
What is innovative surgery?
One major difficulty in exploring the ethics of innovative surgery lies in the lack of a clear definition of innovation, which lies somewhere on a spectrum between the necessary variations of usual practice and surgical research. Heart valves and organ transplants are examples of innovation in surgery, as they are devices and procedures that were (at least for a period of time) regarded as innovative. However, there is little consensus in the literature as to how to define surgical innovation. For instance, is innovation a process or an event? If it is a process, how can we identify the start and end points, and how long does an innovation remain so? Laparoscopic cholecystectomy (‘keyhole’ surgery to remove the gall bladder through a series of small incisions rather than a single large incision) is now a standard procedure rather than an innovation, but single-port laparoscopic cholecystectomy (using only one incision rather than two to four) is currently an innovation. If innovation is an event, how many times can the event occur and still be regarded as innovative? A second set of questions arise in relation to whether an innovation is absolute or relative to a particular surgeon, institution or healthcare jurisdiction. An operation that is standard in one hospital may, for example, be new to surgeons and healthcare teams at another hospital. Owing to the ‘learning curve’ phenomenon to be described below, this is an ethically relevant dimension of innovation.
Despite the difficulties in attempting to define innovation, the exercise is important, since for both ethical and regulatory purposes it is central to ensuring all parties (surgeons, patients, regulators, bioethicists, etc) are referring to the same phenomenon. However, this task is not our main focus. For our purposes we will define surgical innovation as involving some form of deviation from standard surgical practice and/or as relative to the surgeon.
Ethical issues generated by surgical innovation
Categorising the ethical issues generated by innovative surgery is an important philosophical exercise. It is possible to carve up the issues in a number of ways, such as by how they are generated (eg, from epistemological shortcomings, regulatory failings, etc) or according to whom or what they bear on (eg, individual patients, surgeons, hospitals, healthcare or public health generally). In this paper, however, in order to capture the central concerns most economically and in terms that readily appeal to established ethical debates, concerns will be grouped into four categories: harm to patients, informed consent, distribution of healthcare resources and conflicts of interest,i each of which will be briefly discussed in turn.
Surgical innovations have the potential to cause increased mortality and morbidity in comparison with standard treatments, thereby generating the most obvious source of patient harm. The relevance and potency of this concern is borne out by historical cases where innovative surgery has harmed patients. Examples include routine episiotomy during childbirth; treating angina by tying off one of the arteries in the chest wall, and stomach ulcer disease by freezing the lining of the stomach; early efforts to artificially sustain circulation with implant devices; uptake of laparoscopic (or ‘keyhole’) surgery; and various procedures to treat a range of cancers.1 In these cases, performance of the innovative procedures could potentially be justified by appeals to beneficence as the procedures were intended to benefit the patients involved. This justification does not work, however, with some developments in transplant surgery, where healthy donors acting to benefit others are exposed to potentially harmful new procedures. For instance, the introduction of donation of part of the liver from one patient for transplantation into another (known as right hemiliver transplantation LDRHT) was associated with increased donor morbidity and mortality.2
Apart from direct physical harms to patients, there are additional harms associated with innovative surgical treatments if these are safe but not effective.ii Ineffective treatments may seem less problematic than those which increase mortality and morbidity but the matter is not so straightforward as surgery itself is invasive and not benign—there are associated risks arising from infection, anaesthesia, length of hospital stay and so forth. Exposing patients to such harms is difficult to justify if an intervention is no better or might be worse than standard treatments. Committing to surgical intervention may also mean other treatment options are foreclosed, so that there are opportunity costs associated with pursuing the surgical route.
In addition, there can be burdens for patients and their families generated by innovative surgery which go beyond physical harms and include financial imposts or psychological hardship.1 Healey and Samanta suggest that in the context of pioneering treatments, harms should be construed broadly to include ‘loss of trust or damage to the reputation of the medical profession’.3
Finally, even if innovative procedures are in themselves safe and efficacious, patients are exposed to harms if the procedure is new for a particular surgeon. This is the ‘learning curve’ phenomenon, which refers to the increased risks to patients incurred while an individual surgeon or surgical team obtains competency in procedures that are new to them.
The second group of ethical concerns involves patient autonomy, which risks being compromised owing to the difficulties of achieving valid informed consent for innovative surgery. Barriers to valid consent can arise in a number of ways. First, patients may not be told that they will be (or in fact have been) exposed to a new technique or procedure. While this may be reasonable if the innovation occurred in response to an emergency, such withholding of information is difficult to justify when innovations are planned. It may be argued that in some cases, such information is of a technical nature (eg, whether a surgeon is using an innovative anatomical approach) and thus beyond the usual bounds of informed consent. However, the information is surely germane to the patient if the innovation, no matter its nature, is associated with increased risks. Next, even if patients are consulted about a proposed innovation, informed consent may be difficult to achieve, since evidence about the risks and benefits of innovative procedures is often lacking, especially in the early stages of innovation, which makes it difficult to meet the requirement for patients to be fully informed. This situation is analogous to that of informed consent to research, where the risks are similarly unknown. Nevertheless, with consent to research, there are agreed standards about the level of information that participants should receive and this is subject to external scrutiny by a research ethics review process; with innovative surgery there are no agreed standards and there may be no oversight.
A further problem for informed consent to innovative surgery relates to a general tendency to equate newness with increased benefit or quality. This is not limited to patients; claiming novelty is a standard advertising tactic used to sell all manner of goods. However, patients exposed to innovative surgery are generally seeking treatment,iii which may increase their vulnerability to this kind of tendency.iv It is well known that patients entering research often harbour misconceptions about the intent and likely benefits of the research. Therefore it is reasonable to assume that a similar mechanism may occur with patients receiving innovative surgery. In the case of innovative surgery, patients might tend to assume the best—namely, that they are being offered a treatment option that is better than others, rather than one with unknown or poorly understood outcomes. Trust in the authority of surgeons is a factor that could exacerbate this misconception.v
Fair distribution of healthcare resources requires limiting expenditure to interventions with proven safety and efficacy, rather than wasting money on ineffective and/or dangerous procedures.vi Innovative surgery poses a challenge to this general principle for a number of reasons. As discussed above, the safety and efficacy of new procedures may not be well established.4 Innovations may, and indeed have, become standard practice before the collection and publication of data to substantiate their effectiveness. For instance, the use of tying off chest wall arteries to treat angina was widespread until its effects were shown to be no better than placebo,5 while prefrontal lobotomy, cutting nerves in the lower back as a treatment for blocked arteries in the legs, removal of an upper rib to treat pain and numbness around the shoulder, jejunoileal exclusion (a type of bypass surgery) for obesity, and extended radical mastectomy for breast cancer are all now obsolete innovations, withdrawn from practice as evidence emerged about increased harms or lack of effectiveness.6 At the time of their introduction, however, these procedures diverted resources from other effective treatments for the same conditions, or from the general healthcare spending pool. Surgical innovations are almost always more expensive than existing treatments, hence their introduction has a significant opportunity cost, especially where this diverts resources from cheaper and possibly safer and more effective options. The rapid uptake of new procedures and devices is reinforced by the optimism bias that is common among surgeons and institutions.1 This refers to a tendency to overestimate the positive effects of an innovation, which thereby contributes both to difficulties in evaluating the effectiveness of innovation and to widespread uptake of procedures with poorly understood outcomes.
Our final set of ethical challenges concern conflicts of interest, which may affect individual surgeons, and/or institutions. Surgeons are charged with acting in the best interest of their patients, and patients rely on their surgeons to give well-grounded opinions about what is likely to be the most effective way of treating a disease or condition, but there are a number of reasons why surgeons may be exposed to conflicts of interest with respect to innovative treatments, with the attendant danger that clinical decision-making is compromised.
Perhaps the most obvious source of conflicts of interest is economicvii and associated with the desire to attract new referrals and the development of new devices. For instance, conflicts can arise if a surgeon has invested in a new technique or procedure,viii or if a device manufacturer finances and delivers training for surgeons. In this latter case the surgeon gains experience in one kind of technique or procedure over possible competitors thereby preferring it, but a deeper ‘brand loyalty’ may also be established because the surgeon feels in some sense obligated to that particular manufacturer, and is in turn rewarded for using their products. Apart from conflicts of interest arising from economic gain, conflicts may also be created by the significant prestige attached to pioneers in all fields, including surgery. To be an innovator is to have a reputation for flair and creativity,ix and in surgery to be a pioneer means extending the reach of the medicine and potentially reducing the suffering of present and future generations. Career benefits and elevated social status follow from being a surgical innovator; these may not be perceived as conflicts of interest analogous to economic gains as they occur within the profession and thus may be seen as a legitimate part of the surgical role.x Despite the congruence between being a surgeon and being an innovator, there remains the potential for the desire to innovate itself to create conflicts of interest, with their attendant dangers.
Conflicts of interest can directly and intentionally prejudice decision-making, although they can also have more insidious impacts. A surgeon might not be consciously swayed by their financial interest in a device manufacturer, yet find that they prefer that device over other options for no well-grounded reason. This preference might inadvertently constrain and reduce the options they pursue in the future. As noted above there may also be an optimism bias at play where a surgeon genuinely believes that an innovation has succeeded or is better than other strategies, in spite of there being no empirical evidence to support this. This may be especially problematic as surgeon decision-making is highly valued and rarely questioned.xi
Institutions such as universities and hospitals, just as surgeons, can fall prey to conflicts of interest with respect to innovative surgery. Conflicts may arise because institutions may depend on funding from device manufacturers and seek to cultivate a reputation for being at ‘the cutting edge’. Both surgeons and institutions therefore are susceptible to conflicts which may lead to the pursuit of innovation despite risk to patients and in the absence of adequate evidence to support its use.
Addressing the ethical issues
If the ethical issues identified above are to be resolved, then it seems plausible to suggest that their causes need also to be uncovered and investigated. There are two factors that commonly contribute to one or more of the ethical challenges that we have identified. These are inadequate data about the safety and efficacy of innovations and lack of regulatory oversight. If, for instance, better data existed on innovations before their formal adoption and obtaining these data was mandated through regulation, then risk to patient safety and knowledge about the efficacy of treatments would be less problematic. Patient decision-making and consent could also be better informed. Similarly, a more just distribution of healthcare resources could be secured if better evidence existed on which to base funding decisions. Even conflicts of interest might be illuminated and potentially mitigated if clinical decisions were grounded in actual data since, in a sense, such conflicts are only able to gain purchase owing to uncertainty about safety and efficacy.
One potential model for regulating the introduction of surgical innovations is the regulation of pharmaceutical products. In many countries evidence about safety and/or efficacy is required before licensing the introduction of new pharmaceutical agents.xii This process works with variable success; nonetheless, despite the practical problems there is at least an in-principle commitment to secure an evidence base before regulatory approval. Such an approach to surgical innovations would go some way towards dealing with the ethical challenges, and indeed already operates with the introduction of devices. However, some of these issues will be resistant to resolution via better evidence gathering and regulation owing to special features of both innovation and surgery.
Evaluation of surgical procedures presents specific challenges compared with evaluation of pharmaceutical agents. Surgery is complex, involving components which cannot easily be isolated from one another and thereby independently assessed. Surgery is performed by a team which, in addition to possibly involving multiple surgeons, includes anaesthetists, nurses, etc. The skill, experience and choices of all these individuals impact on surgical outcomes. Surgery does not involve an isolated set of mechanical actions, but instead depends on broader features of the healthcare environment such as the nature of pre- and postoperative care, access to relevant facilities and so on. Ergina et al7 cite the case of coronary artery bypass graft surgery to illustrate the complexity of surgery and the attendant difficulties such surgery presents for evaluation. The operation consists of several procedures and there are different strategies which can be adopted to tackle each of these stages, all of which can potentially affect the outcomes.
Another challenge for evaluation hinges on the fact that surgical outcomes depend on the performance of surgeons. And surgeons must learn how to perform a particular procedure, with earlier attempts less likely to be as safe and efficacious as later ones. There is no straightforward formula to capture this learning curve and so no clear indication when a surgeon will deliver their optimal performance.
Randomised controlled trials, frequently regarded as the ‘gold standard’ for pharmaceutical evaluations, are more challenging to run in surgery, though not in principle impossible. The timing of any randomised controlled trial is problematic because new surgical procedures do not appear fully formed—they emerge and develop over time. If evaluation is undertaken too early a potentially promising intervention might be stopped, but if evaluation is delayed, the intervention might already be widely employed. In the latter case, equipoise necessary for performing a trial might be lost and the recruitment of trial participants compromised. Randomisation, blinding and provision of adequate study controls are all issues which require special attention in surgery.7
Owing to the nature of surgery there is also a question about who funds data collection. While it is plausible to expect pharmaceutical manufacturers and device manufactures to contribute to trial and evaluation costs, the situation is not nearly so clear cut for modified or entirely new surgical interventions or for technical procedural changes that do not involve new equipment.
The nature of innovation itself presents a challenge to improved data collection on surgical procedures. There is an irreducible element of uncertainty about the new so that some patient safety and efficacy concerns will be rare or long term and, consequently, will only be revealed over time and with more widespread adoption of a procedure and the related exposure of larger cohorts of patients. There will always be a first in human, and always first in human with what turns out to be problematic feature x. Recently, models have been proposed for addressing the evidence gap,7–9 but as has been argued, these models do not deal with all of the ethical challenges.10
Just as enhanced evidence gathering appears to offer a solution to some of the ethical issues generated by surgical innovation, so too does regulation, but again, owing to features of both surgery and innovation, regulation has its own shortcomings. To be effective, regulation needs to capture all relevant change but not be so burdensome that it risks stifling innovation and progress. Knowing a priori the relevant features of innovation that will require oversight is, however, not easy to anticipate and links to the more general problem of defining innovation. There is a problem about what constitutes mere variation which requires no special attention, and what is innovation.xiii For instance, will differences in technique be important in at least some cases? With the move from open to laparoscopic living kidney donation, two techniques have emerged which may result in relevantly different outcomes—hand-assisted removal and removal achieved solely through the use of laparoscopic instruments. Even when two techniques are independently safe and efficacious, combining them may generate unexpected problems; for example, a significant innovation in gastrointestinal surgery involved combining two procedures with well-established outcomes—namely, open gall bladder removal (cholecystectomy) and laparoscopic (‘keyhole’) surgery, yet the new procedure resulted in a significant increase in injuries to the bile ducts.2
The very nature of surgery itself presents an issue for regulation. Historically, the practice has been relatively unregulated; surgeons have wide discretionary latitude within the privacy of the operating theatre. There may also be a resistance to regulation among surgeons and a culture of independence that makes regulation particularly challenging.
Surgical innovation poses a number of ethical challenges relating to patient safety, informed consent, just use of healthcare resources and conflicts of interest. None of these challenges are unique to surgery, but there are specific features about surgery that complicate the identification and resolution of these challenges. A necessary first step to resolving these issues is to develop a robust and comprehensive taxonomy of surgical innovation that captures the ethically relevant dimensions. Once this is achieved, work can proceed in identifying when and where lack of evidence is a problem, and how this can be remedied. In tandem, we need to develop imaginative and nuanced ways of overseeing and regulating surgical innovation; ways that protect the necessary variations in routine practice that are part of every surgeon's skill set, but that capture both the successes and failures of innovative practices that extend current surgical boundaries. Such steps are necessary to protect patients while supporting surgical innovations, from which we all stand to benefit.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
↵i In addition to representing a standalone ethical issue, conflicts of interest may also contribute to patient harm.
↵ii Ahmed quotes DJ Roy that ‘many innovations show no advantage over existing treatments when… subjected to properly controlled study.’ Ahmed AS. The last twist of the knife: encouraging the regulation of innovative surgical procedures. Columbia Law Review 2005;105:1529–62, 1538.
↵iii An exception would be the case of LDRHT noted above.
↵iv Patients may even pressure surgeons to offer innovative treatments, because they falsely equate novelty with superiority. See Mastroianni AC. Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy. Health Matrix: Journal of Law Medicine 2006;16:351–442.
↵v As Mastroianni notes decisions occur ‘within a culture of deference to surgeon decision-making and a culture that highly values those who innovate.’ Mastroianni AC. Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy. Health Matrix: Journal of Law Medicine 2006;16:351–442, 362.
↵vi The focus here is on a closed healthcare system such as exists in Australia. If a globally just distribution of healthcare resources were sought it would have to deal with issues such as the 90–10 divide identified whereby only 10% of healthcare funding goes to problems which have an impact on 90% of the world's population.
↵vii Frader and Caniano cite economic self-interest in addition to fashion, psychology and the influence of opinion leaders, as non-clinical reasons which influence what should be evidence-based decisions. Frader JE, Caniano DA. Research and innovation in surgery. In: McCullough LB, Jones JW, Brody BA, eds. Surgical ethics. New York: Oxford University Press, 1998:217–41.
↵viii As James W Jones notes ‘Surgeon-inventors may find themselves becoming businesspersons rather than independent scientists, and, as such their interests are unavoidably conflicted, particularly if their laboratory provides the introductory data for marketing.’ The situation is even more troubling if the company is a small one relying on one product or technology. Jones JW. Ethics of rapid surgical technological advancement. Ann Thorac Surg 2000;69:676–7, 676.
↵ix This may be particularly valued in a profession with strong craft links and traditions. Mastroianni also discusses how innovation and risk taking have been valued. Mastroianni AC. Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy. Health Matrix: Journal of Law Medicine 2006;16:351–442.
↵x Sade gives an interesting account of the various factors which motivate a surgeon to be an innovator. Morreim H, Mack MJ, Sade RM. Surgical innovation: too risky to remain unregulated? Ann Thorac Surg2006;82:1957–65, while Mastrionni discusses how professional bodies reward innovation. Ibid.
↵xi As noted earlier Mastrioianni discusses a ‘culture of deference to surgeon decision-making’. Ibid. 362.
↵xii For instance Australia has the Therapeutic Goods Administration, the UK has the National Institute for Health and Clinical Excellence and the USA the Food and Drug Administration.
↵xiii In some of the literature (particularly articles written by surgeons) there is a tendency to run-together surgical variations and innovations. The rationale behind this move appears to be to suggest that external oversight and regulation are not required for surgeons engaged in innovative surgery, because such innovation is effectively simply a form of variation that they routinely and successfully undertake all the time.
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