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.

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”. While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the (...) effects of knowledge framing and its impact on ethical, medical, economical and legal decisions. (shrink)

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”. While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the (...) effects of knowledge framing and its impact on ethical, medical, economical and legal decisions. (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)

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)

The term “ethics” covers a multitude of virtues and possibly some sins where ethical perspectives differ. Given the diversity of ethical philosophies there is a question about what common ground can, or should, inform health research ethics. At a minimum it must be consistent with the law. Beyond that, ethics embraces a variety of possible approaches. This raises the question—what criteria are applied in determining the appropriate approach and what standards by way of quality control are applied to its decisional (...) application by ethics committees or other authorities exercising responsibility in this difficult area. The particular issue of ethical perspectives on the use of “big data” in medical research also raises complex issues for consideration. (shrink)

Next SectionThere has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting (...) the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. (shrink)

Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated. There are several reasons explaining this difference, and all of them point to the difficulty of conducting well-designed (...) RCTs in surgery. However, we argue that none of these arguments is decisive and that, under certain conditions, surgical RCTs can be morally justified and methodologically sound. Although ethical constraints restrict the number of testable surgical procedures, and surgical trials might not be as dependable as pharmaceutical RCTs, our analysis suggests that, in certain cases, it is possible to obtain high-quality evidence about the safety and efficacy of surgical procedures. Untested surgical treatments may prove to be ineffective and harm patients. Therefore, regulation of surgical procedures seems not only morally acceptable and able to provide reliable scientific evidence, but also desirable and justified from an ethical-political standpoint. (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)