Ethical issues in direct-to-consumer healthcare: A scoping review.

An increasing number of health products and services are being offered on a direct-to-consumer (DTC) basis. To date, however, scholarship on DTC healthcare products and services has largely proceeded in a domain-specific fashion, with discussions of relevant ethical challenges occurring within specific medical specialties. The present study therefore aimed to provide a scoping review of ethical issues raised in the academic literature across types of DTC healthcare products and services. A systematic search for relevant publications between 2011-2021 was conducted on PubMed and Google Scholar using iteratively developed search terms. The final sample included 86 publications that discussed ethical issues related to DTC healthcare products and services. All publications were coded for ethical issues mentioned, primary DTC product or service discussed, type of study, year of publication, and geographical context. We found that the types of DTC healthcare products and services mentioned in our sample spanned six categories: neurotechnology (34%), testing (20%), in-person services (17%), digital health tools (14%), telemedicine (13%), and physical interventions (2%). Ethical arguments in favor of DTC healthcare included improved access (e.g., financial, geographical; 31%), increased autonomy (29%), and enhanced convenience (16%). Commonly raised ethical concerns included insufficient regulation (72%), questionable efficacy and quality (70%), safety and physical harms (66%), misleading advertising claims (56%), and privacy (34%). Other frequently occurring ethical concerns pertained to financial costs, targeting vulnerable groups, informed consent, and potential burdens on healthcare providers, the healthcare system, and society. Our findings offer insights into the cross-cutting ethical issues associated with DTC healthcare and underscore the need for increased interdisciplinary communication to address the challenges they raise.

Policies of US Companies Offering Direct-to-Consumer Laboratory Tests.

This qualitative study assesses the practices and policies of companies offering direct-to-consumer laboratory testing in the US.

Opportunity Cost or Opportunity Lost: An Empirical Assessment of Ethical Concerns and Attitudes of EEG Neurofeedback Users.

Background: 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. Methods: Semi-structured telephone interviews were conducted with individuals who had used EEG neurofeedback for themselves and/or for a child. Results: 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 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. Conclusion: 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.

Neurofeedback as placebo: a case of unintentional deception?

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.

Ethical and Legal Considerations of Alternative Neurotherapies.

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.

'It's much more grey than black and white': clinical geneticists' views on the oversight of consumer genomics in Europe.

Aim: Direct-to-consumer (DTC) genetic tests (GT) have created controversy regarding their risks and benefits. In view of recent regulatory developments, this article aims to explore the attitudes of European clinical geneticists toward the oversight of DTC GT. Materials & methods: Fifteen semi-structured interviews were performed with clinical geneticists based in ten European countries. The transcripts were thematically analysized in an iterative process. Results & conclusion: Respondents strongly supported quality standards for DTC GT equal to those applied within the healthcare setting. Despite participants unanimously considering the involvement of healthcare professionals to be important, mandatory medical supervision was controversial. In this regard, promoting education and truth-in-advertising was considered as being key in maintaining a balance between protecting consumers and promoting their autonomy.

The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues.

Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits-such as expanding access to testing and reducing the risk of exposure for consumers and medical personnel-it also raises significant ethical and regulatory concerns. This article reviews these challenges and shows how they parallel and also diverge from prior concerns raised in the DTC health testing arena. The first part of this paper provides an overview of the landscape of diagnostic and serological tests for COVID-19, anticipating how provision models are likely to evolve in the future. The second part discusses five primary issues for DTC COVID-19 tests: test accuracy; potential misinterpretation of results; misleading claims and other misinformation; privacy concerns; and fair allocation of scarce resources. We conclude with recommendations for regulators and companies that aim to ensure ethically marketed DTC COVID-19 tests.

Third party interpretation of raw genetic data: an ethical exploration.

In the wake of recent regulations targeting direct-to-consumer genetic testing (DTC-GT), an increasing number of websites have emerged that offer consumers alternative means to derive health information from their DTC-GT raw data. While the ethical concerns associated with DTC-GT have been extensively discussed in the literature, the implications of third party interpretation (TPI) websites have remained largely unexplored. Here we sought to describe these services and elucidate their ethical implications in the context of the current DTC-GT debate. We reviewed five popular TPI websites that use SNP-based genomic data to report health-related information: Promethease, Interpretome, LiveWello, Codegen.eu, and Enlis Personal. We found that many of the ethical concerns previously described in DTC-GT also applied to TPI websites, including inadequate informed consent, questionable clinical validity and utility, and lack of medical supervision. However, some concerns about data usage and privacy reported in DTC-GT were less prominent in the five TPI websites we studied: none of them sold or shared user data, and 3/5 sites did not retain data in the long term. In addition, while exaggerated claims and inaccurate advertising have been frequently problematic in DTC-GT, advertising was minimal in the TPI sites we assessed, and 4/5 made no claims of health benefits. Overall, TPI adds a new dimension to the ethical debate surrounding DTC-GT, and awareness of these services will become increasingly important as personal genomics continues to expand. This study constitutes the first detailed ethical analysis of these services, and presents a starting point for further research and ethical reflection.

Regulating the advertising of genetic tests in Europe: a balancing act.

Direct-to-consumer (DTC) genetic tests (GT) have provoked criticism over their potential adverse impact on public health. The European Parliament called for a ban on DTC advertising of GT during the debate for the adoption of a European Regulation on in vitro diagnostic medical devices. This proposal, however, was not ultimately retained in the final text. Instead, the regulation includes an article prohibiting misleading claims for this kind of advertising. These two different approaches raise questions about the optimal degree of regulation. Herein, we provide an overview of the ways GT have been advertised and related ethical issues. Subsequently, the laws regulating the advertising of GT at the European Union and national level are examined. Finally, recent regulatory developments are discussed.

Current ethical and legal issues in health-related direct-to-consumer genetic testing.

A variety of health-related genetic testing is currently advertized directly to consumers. This article provides a timely overview of direct-to-consumer genetic testing (DTC GT) and salient ethical issues, as well as an analysis of the impact of the recently adopted regulation on in vitro diagnostic medical devices on DTC GT. DTC GT companies currently employ new testing approaches, report on a wide spectrum of conditions and target new groups of consumers. Such activities raise ethical issues including the questionable analytic and clinical validity of tests, the adequacy of informed consent, potentially misleading advertizing, testing in children, research uses and commercialization of genomic data. The recently adopted regulation on in vitro diagnostic medical devices may limit the offers of predisposition DTC GT in the EU market.

Attitudes of cystic fibrosis patients and their parents towards direct-to-consumer genetic testing for carrier status.

BACKGROUND: An increasing number of direct-to-consumer (DTC) genetic testing companies have started offering tests for carrier status of autosomal recessive disorders. MATERIALS & METHODS: A written questionnaire was administered to 47 patients and 65 parents of children with Cystic Fibrosis (CF), a common severe autosomal recessive disorder, to assess their views about the offer of DTC carrier tests. All participants were recruited from a CF patient registry in Belgium. RESULTS & CONCLUSION: We found that very few patients and parents were aware of the offer of DTC genetic testing for carrier status, and were generally skeptical. A strong preference for the healthcare system over commercial companies as the provider of the test was observed. However, many participants believe people should have a right to access DTC genetic tests provided by commercial companies.