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 use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive—one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific evidence. This (...) is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham. Using one such CAM technique as a case study—electroencephalography (EEG) neurofeedback for attention-deficit/hyperactivity disorder (ADHD)—this paper explores the ethics of providing therapies that may have some beneficial effect, although one that is likely due to placebo effect. First, we provide background on EEG neurofeedback for ADHD and its evidence base, showing how it has proven to be equivalent to—but not better than—sham neurofeedback. Subsequently, we explore whether offering therapies that are claimed to work via specific physical pathways, but may actually work due to the placebo effect, constitute deception. We suggest that this practice may constitute unintentional deception regarding mechanism of action. Ultimately, we argue that providers have increased information provision obligations when offering treatments that diverge from standard of care and we make recommendations for mitigating unintentional deception. (shrink)

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests. The majority of participants stated that consumers purchased tests out of curiosity and sought a general interpretation of test results (...) by a healthcare professional. Most respondents were skeptical of the quality of tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary. (shrink)

Electroencephalography (EEG) neurofeedback is a type of biofeedback that purportedly teaches users how to control their brainwaves. Although neurofeedback is currently offered by thousands of providers worldwide, its provision is contested, as its effectiveness beyond a placebo effect is unproven. While scholars have voiced numerous ethical concerns about neurofeedback—regarding opportunity cost, physical and psychological harms, financial cost, and informed consent—to date these concerns have remained theoretical. This pilot study aimed to provide insights on whether these issues were supported by empirical (...) data from the experiences of neurofeedback users. Semi-structured telephone interviews were conducted with individuals who had used EEG neurofeedback for themselves and/or for a child. The majority of respondents (N = 36) were female (75%), white (92%), and of higher socioeconomic status relative to the U.S. population. Among adult users (n = 33), most (78.8%) resorted to neurofeedback after having tried other therapies, and were satisfied with the treatment (81.8%). The majority paid for neurofeedback out-of-pocket (72.7%) and considered it to be good value for money (84.8%). More than half (57.6%) considered neurofeedback to be a scientifically well-established therapy. However, of those, 78.9% were using neurofeedback for indications not adequately supported by scientific evidence. Concerns regarding opportunity cost, physical and psychological harms, and financial cost are not substantiated by our findings. Our results partially support concerns regarding insufficient understanding of limitations. This study underlines the disconnect between some of the theoretical concerns raised by scholars regarding the use of non-validated therapies and the lived experiences of users. (shrink)