Neurotherapies for diagnostics and treatment—such as electroencephalography (EEG) neurofeedback, single-photon emission computerized tomography (SPECT) imaging for neuropsychiatric evaluation, and off-label/experimental uses of brain stimulation—are continuously being offered to the public outside mainstream healthcare settings. Because these neurotherapies share many key features of complementary and alternative medicine (CAM) techniques—and meet the definition of CAM as set out in Kaptchuk and Eisenberg—here we refer to them as “alternative neurotherapies.” By explicitly linking these alternative neurotherapy practices under a common conceptual framework, this paper (...) draws attention to, and critically considers, the cross-cutting ethical and legal issues related to the provision of these services. The first section of this paper provides an updated empirical overview of uses of SPECT neuropsychiatric evaluations, EEG neurofeedback, and experimental/off-label forms of brain stimulation. Next, drawing on CAM bioethics scholarship, we highlight the pertinent ethical issues in the alternative neurotherapy context, including the truthful representation of evidence base, marketing to vulnerable populations, potential harms, provider competency, and conflicts of interest. Finally, we consider the principal legal issues at stake for the provision of alternative neurotherapies in the U.S., namely those related to licensing and scope-of-practice considerations. We conclude with recommendations for future research in this domain. (shrink)

The human right to health, insofar as it is widely recognized, is typically thought to include the right to fair access to adequate healthcare, but the operating conception of healthcare in this context has been under-defined. This lack of conceptual clarity has often led in practice to largely Western cultural assumptions about what validly constitutes “healthcare” and “medicine.” Ethnocentric and parochial assumptions ought to be avoided, lest they give justification to the accusation that universal human rights are mere tools for (...) Western imperial agendas. At the same time, a right to healthcare that is not also explicitly the right to effective healthcare rapidly loses meaning. This paper strives to provide an account of medicine with the flexibility to accommodate cultural difference in forms of practice, while also aiding in the articulation of a minimum for medical systems to meet the standards set out in a human right. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

The use of complementary and alternative medicine is increasing in the Western world. However, there is no clear evidence of effect of alternative therapies. Moreover, there is no consensus between practitioners and researchers as to the right way of assessing the efficacy of alternative therapies. To investigate practitioners’ perspective on evidence and ways of assessing efficacy twelve in-depth interviews were conducted in Denmark with acupuncturists, including physicians practising acupuncture, acupuncturists with a health-related background, and acupuncturists without a health-related background. Two (...) themes predominated the study, first, the interviewees’ general reflections on how it is possible to establish knowledge about an effect of acupuncture; and second the interviewees’ reflections on the use of randomized controlled trials in acupuncture, including obstacles and alternatives to conducting randomized controlled trials. Further, two conceptions of what constitutes evidence were identified: a biomedical conception and an experience-based conception. Most interviewees were sceptical about the use of randomized controlled trials in acupuncture. Two reasons, especially, were given for this scepticism. First, practical and instrumental reasons concerning the specific elements of the randomized controlled trial or relating to limited resources; and second, value-based reasons are concerning the nature of acupuncture. However, the interviewees were really opposed only to a certain kind of randomized controlled trial, the so-called explanatory trial. They would actually welcome a pragmatic trial. The study gives valuable insight into an under explored field and provide a platform for further investigation, and a better informed discussion of the subject. (shrink)

The more popular complementary and alternative medicine (CAM) has become, the more often it is demanded that the integration of CAM should be limited to those approaches that are scientifically proven to be effective. This paper argues that this demand is ethically and philosophically questionable. The clinical legitimacy being gained by CAM and its increasing informal integration should instead caution against upholding the biomedical framework and evidence-based medicine as conditions of acceptance. Patients’ positive experiences with CAM deserve a truly scientific (...) exploration of non-biomedical conceptualizations of health and illness. It is also problematic to request scientific evidence when there is proven resistance against CAM in research institutions, under-funding and a lack of suitable research methodologies. This is even more so, when much conventional medicine is not practiced with the same level of evidence as demanded from CAM. (shrink)