The use of placebo controls in surgical research, or ‘sham surgery’ as it sometimes described, raises a number of ethical issues. Despite such issues, sham surgery is presently being employed, albeit very rarely, in surgical research. In this paper, the ethical implications of such control groups are discussed in the context of research into various conditions, including Parkinson's Disease and arthritis. Conflicting ethical considerations include: i) patients' best interests in relation to the harms and risks involved; ii) the need for (...) more rigorous methods in surgical research, and iii) the question of patient autonomy. Contextual features which may influence the ethical acceptability of a specific sham-controlled surgical trial are discussed. (shrink)

Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a (...) proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinson's Disease is provided here, followed by an analysis of the key ethical issues which such trials raise. (shrink)

Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...) surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

In recent years, neuroscience has been a particularly prolific discipline stimulating many innovative treatment approaches in medicine. However, when it comes to the brain, new techniques of intervention do not always meet with a positive public response, in spite of promising therapeutic benefits. The reason for this caution clearly is the brain’s special importance as “organ of the mind”. As such it is widely held to be the origin of mankind’s unique position among living beings. Likewise, on the level of (...) the individual human being, the brain is considered the material substrate of those traits that in combination render each person unique. In view of this preeminent significance of the brain, it is understandable that, in general, interventions into the brain are considered a delicate issue and that new techniques of intervention are scrutinised with particular care. However, in doing so it is important not to go to the opposite extreme and shy away from promising new therapeutic approaches for debilitating disorders of the brain. With respect to the new techniques of brain intervention a broad interdisciplinary perspective is required to discern irrational fear from justified concern. Hence, the Europäische Akademie established a project group consisting, on the one hand, of experts from different fields of medicine who have got first-hand experience of applying the techniques at issue and, on the other hand, of philosophers and a legal expert. The task of this team was to review the state of the art with respect to each single technique of intervening in the brain, to indicate future developments, and to address the ethical and legal issues common to all of them. The project’s outcome is the book at hand. (shrink)

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive (...) regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. (shrink)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

In this article, we argue that contemporary biomedicine is shaped by two, seemingly incommensurable, organizational logics, the ‘regime of truth’ and the ‘regime of hope’. We articulate their features by drawing on debates sparked by the recent clinical trial of a new approach to the treatment of Parkinson’s Disease. We also argue that the ‘self’ is configured in the very same process whereby these two organizational logics interlock and become mutually dependent, so that the ‘self’ might be said to be (...) the effect of a ‘parasitic’ relationship between the regimes of ‘truth’ and ‘hope’. We then bring these two arguments to bear on the contrasting views of the relationship between embodiment and political subjectivity articulated by Michel Foucault and Giorgio Agamben, on the one hand, and Paul Rabinow and Nikolas Rose, on the other hand. (shrink)

Sham surgery is a controversial and rarely used component of randomised clinical trials evaluating surgical interventions. The recent use of sham surgery in trials evaluating efficacy of intracerebral fetal tissue grafts in Parkinson’s disease has highlighted the ethical concerns associated with sham surgery controls. Macklin, and Dekkers and Boer argue vigorously against use of sham surgery controls. Macklin presents a broad argument against sham surgery controls while Dekkers and Boer present a narrower argument that sham surgery is unnecessary in the (...) specific setting of fetal tissue engraftment for Parkinson’s disease. I defend sham surgery controls against both these criticisms. Appropriate clinical trial design, sometimes including sham surgery, is needed to ensure that false positive trial results do not occur and endanger public safety. Results of a completed trial of fetal tissue grafting for Parkinson’s disease are used to illustrate the potential benefits of, and problems associated with, sham surgery controls. Sham surgery controls, however, should be employed only when absolutely necessary. I suggest criteria for appropriate use of sham surgery controls. (shrink)