63 Neuroethics
Mr. L is a 65-year-old man who has entered early retirement after a long and successful career as a business executive. Having had little time to keep up with current political events, let alone scientific events for which he always had particular curiosity while making his fortune, he has begun to devour a number of major newspapers each day and listen to medical talk shows. He even recently bought a subscription to a high-quality science news publication geared for the educated lay public, and goes on the Internet daily to read news alerts he has signed up for about major scientific advances. His interest in having a brain scan is piqued by Internet and print media advertisements for a computed tomographic scan of the whole body, which includes a free head scan, and by announcements from a nearby university known to be doing cutting-edge Alzheimer’ research recruiting for subjects in his age group. He is puzzled by some claims made that preventive brain scans find serious conditions before the manifestations of symptoms. He asks his physician if he should purchase the scan service and if the research opportunity he is offered could serve the same purpose.
What is neuroethics?
Neuroethics is a new field at the intersection of bioethics and neuroscience that focuses on the ethics of neuroscience research and the ethical issues that emerge in the translation of neuroscience research to the clinical and public domain (Marcus, 2002; Illes and Racine, 2007). Although there are lively discussions on the nature of this new field (Doucet, 2005; Illes and Racine, 2005; Vries, 2005), the single most important factor supporting it is the opportunity for an increased focus and integration of the ethics of medical specialties (neurology, psychiatry, and neurosurgery) and of the ethics of related research to improve patient care. Research on medical neurostimulation techniques (e.g., deep brain stimulation) is a good example to illustrate why there is an important need for integrated interdisciplinary ethical approaches. Neurology and psychiatry separated more than a century ago, and surgical procedures for psychiatric illness (psychosurgery) such as leucotomies and lobotomies have left a history of abuse and unethical behaviors (Gostin, 1980). However, recent techniques for deep brain stimulation that are now widely applied to neurological disorders such as epilepsy and Parkinson disease are being introduced in psychiatry (Abbott, 2005; Chittenden, 2005; Mashour et al., 2005; Mayberg et al., 2005). Discussion has even been initiated on the potential for these techniques to enhance mood and cognitive function in normal individuals (Wolpe, 2002; Farah et al., 2004). Given the scope of the issues and the nature of the challenges found in this example of technology transfer (e.g., informed consent), we can no longer approach the ethics of different medical specialties in an isolated manner. Neuroethics is, therefore, an effort to bring together neuroscientists, physicians, ethicists, and other scholars to address the ethical challenges brought about by the diseases of the mind and brain.
Other important issues discussed in neuroethics span the breadth of scholarship in bioethics and include topics in neuroscience research, healthcare, and policy. The alteration of cognition and mood in normal individuals (“cognitive enhancement”) with neuropharmaceuticals is one major area in which physicians will play an increasingly important role. For example, lifestyle uses of the stimulant methylphenidate to augment memory and concentration (Babcock and Byrne, 2000; Kroutil et al., 2006) and the sleep medication modafinil to enhance alertness (Vastag, 2004) are emerging with unknown social and public health consequences. Another important area of neuroethics concerns the ethical use of neuroimaging technology outside the medical setting. There are social and economic pressures for rapid availability of applications such as lie detection. They raise fundamental issues of privacy and autonomy (Editorial, 2006), especially given sometimes overstated promises and threats disseminated through the media (Racine et al., 2005a). These are a few examples of the major issues that have led to the emergence of neuroethics. In addition to these, others are shown in Table 63.1. Physicians and allied healthcare providers must tackle them with an eye to serving as gatekeepers between biomedical science and society. In this chapter, we focus on direct-to-consumer advertising (DTCA) of neuroimaging services and specifically discuss the role of physicians in this currently evolving environment. We have chosen this topic given its overall relevance to and immediacy for physicians.
Why is neuroethics important?
Physicians have long acted as the gatekeepers to medical technology and healthcare. Polls indicate that trust in physicians is high (British Medical Association, 2005; Gallup Poll, 2005) and physicians, with their knowledge, expertise, and the patient’s best interests in mind, are best placed to help and inform their patients in health-related decisions (Pellegrino and Thomasma, 1988). Accordingly, and conforming to fiduciary obligations to the patient (American Medical Association, 2001), physicians must promote patient autonomy while avoiding risks (non-maleficence) and maximizing the possible beneficial outcomes (beneficence) of healthcare products and information (Beauchamp and Childress, 2001). However, the physician’s role of gatekeeper is currently put to the test by patient information seeking and by aggressive commercial campaigns that market not only traditional health products (e.g., pharmaceuticals) but also health services (e.g., neuroimaging) and alternative medicines (e.g., “natural” products to treat neurological and psychiatric diseases) (Racine et al., 2007). The commitment of physicians to evidence-based practice and the patient’s welfare is, therefore, complicated in the context of a rapid explosion of attractive health claims for DTCA products and services. In this chapter, we suggest that proactive mitigation of risks and informed approaches to ethical challenges are the best route to high-quality patient information and sound patient–provider relationships.
Ethics
The DTCA of healthcare products refers to a spectrum of marketing practices based on a combination of information and promotion strategies and directed at consumers through different media (e.g., newspapers, the Internet; Illes et al., 2003a, 2004a; Caulfield, 2004; Hollon, 2004). The situation specifically discussed here is the DTCA of self-referred imaging services. Self-referral to healthcare products and services in the USA has risen steadily since the mid 1980s when the US Food and Drug Administration (FDA) moratorium on DTCA of pharmaceuticals was lifted. Since the late 1990s, self-referral to whole-body computed tomography (CT) and magnetic resonance imaging (MRI) for early screening of cancer, cardiovascular disease, and other disorders has followed this trend.
There has been some discussion in the medical and scientific community concerning whether CT and MRI scans are advertised in the media for unwarranted uses (O’Malley and Taylor, 2004). Studies of DTCA of neuroimaging services have found that risks were not consistently reported in advertisements and that a strong emphasis was put on patient success stories (Illes et al., 2004a; Racine et al., 2007). Consequently, the most widely discussed ethical topic related to DTCA concerns the quality of healthcare and scientific information offered to patients and the public through advertisements. Are these advertisements empowering patient autonomy and improving health information or hindering them by conflating information with promotion (Wolfe, 2002; Hasman and Soren, 2006)? Aware of the current challenges, the American Medical Association (1999) has asked physicians to “take an active role in ensuring that proper advertising guidelines are enforced and that the care patients receive is not compromised as a result of direct-to-consumer advertising.” The proper ethical role of physicians interacting directly or indirectly with private sector facilities offering such products is another area of debate (Cho, 2002).
The case outlined at the start of this chapter also features an opportunity for a layperson to participate in neuroimaging research. There is now a growing interest in the science and challenges related to the healthcare and public uses of neuroimaging. Examples of ethical issues include confidentiality of brain scans that can reveal patient identity (Olson, 2005), hasty social uses of neuroimaging as a lie-detection device (Wolpe et al., 2005), and ethical use of predictive neuroimaging (akin to genetic testing) (Rosen et al., 2002). One of the most compelling and concrete research ethics issues is the unexpected discovery of abnormal findings in the context of research (i.e., incidental findings; Illes et al., 2004b, c, 2006).
Law
The legal and regulatory context of DTCA is complex. Only in the USA and New Zealand is it legal to advertise directly prescription drugs to consumers. Other healthcare products such as medical devices and dietary supplements are not as strictly regulated and monitored for safety and marketing (New York State Task Force on Life and the Law, 2005).
Regarding neuroimaging research, we know that physicians acting as investigators must respect all applicable research guidelines, such as the Helsinki Declaration. How the current guidelines would apply to advising volunteers to participate in a research study (in which the physician is not involved) is less clear, but physicians should not recommend participation in a study not approved by an institutional oversight committee. We are unaware of neuroimaging researchers being held liable for the disclosure or non-disclosure of abnormal neuroimaging findings. However, some legal precedents point to the possible existence of fiduciary obligations of researchers conducting non-clinical research to disclose clinically relevant information (Grimes v. Kennedy Krieger Institute, Inc., 2001).
Policy
In matters of DTCA of healthcare products in the USA, there is evidence of a policy gap in the regulation of healthcare products, neuropharmaceuticals being more tightly regulated and monitored by the FDA than neuroimaging services and natural neuroproducts (Racine et al., 2007). Health authorities and many professional societies have specifically warned against self-referred whole-body imaging since it is currently not indicated for any medical condition (Health Canada, 2004).
No formal and specific policies currently exist for handling the ethics of neuroimaging research, but all relevant general ethics regulations and guidelines remain applicable. An important step in that direction is the results of a workshop sponsored by several institutes of the US National Institutes of Health and Stanford University. Certain fundamental principles to incidental findings achieved broad consensus (Illes et al., 2006). Among these principles was that researchers must respect the subject’s right to privacy – the right to know and not to know – and, therefore, anticipate the possibility of detecting brain anomalies in their research. The methods for dealing with this possibility must be clearly articulated in institutional review protocols and consent forms (Illes et al., 2006).
Empirical studies
Direct-to-consumer advertising and public understanding of neuroscience
There is evidence of growing commercialization of imaging services. In the USA, there is a widespread distribution of centers offering self-referred whole-body imaging, with a concentration on the east and west coasts (Figure 63.1). Despite calls for clinical trials, better regulation of these services and even closure of several privately held and academically based centers, the resilience of the industry suggests that in the USA innovative medical technology is rapidly equated with better care because of the support for market-based approaches to a range of services emphasizing consumer choice and responsibility (Fuchs, 1968; Illes et al., 2003a). In Canada, the number of CT and MRI imaging scanners in free-standing facilities has steadily increased from 1998 to 2004 (Figure 63.2).
Figure 63.1. Geographic distribution of whole-body screening centers in the USA (updated from Illes et al., 2003a).
Figure 63.2. . Number of magnetic resonance imaging (•) and computed tomographic (
) scanners in free-standing imaging facilities in Canada. (Data from the Canadian Institute for Health Information, 2004.)Marketing of imaging services, like marketing of prescription pharmaceuticals, is accomplished through print and broadcast media and generally capitalizes on a range of consumer emotions and potential motivations, from fear about disease to promises of health (Shiv et al., 1997; Terzian, 1999; Duke et al., 2001; Wolfe, 2002; Arthur and Wuester, 2003). Several studies have reported that, when commercial interests are at stake, print advertisements, printed information for providers and consumers, and self-accessible web-based materials all fail to provide truly balanced information in terms of completeness and quality for frontier health products and services (Cho et al., 1997; Gollust et al., 2002, 2003; Risk and Petersen, 2002). For imaging services, consumers may not be made aware, for example, of the possibility or rate of false-positive findings and the procedures needed to follow up ambiguous test results, or of the absence of clinical trials validating the benefit of screening asymptomatic individuals. References to the potential risk of radiation associated with CT scans are alsonotably missing. In contrast, advertisements for MRI services by the same companies make explicit reference to the non-invasive character of this non-radiation modality. These strategies may have an adverse impact on patient views about well-substantiated primary care disease-screening practices. In one series of studies relevant to imaging services, DTCA for genetic screening in print media and on the Internet was heavily criticized for the inadequate presentation of the complexity and probabilistic nature of the information being advertised, the exaggerated promises, and the lack of scientific evidence for the clinical value of the product (Gollust et al., 2002, 2003).
Further evidence suggests that psychiatric and neurological patients are targets of current DTCA practices. Findings from the literature show that the multibillion marketing investments are geared toward the newer pharmaceuticals for chronic conditions with huge market potentials such as psychiatric and neurological illnesses (Gahart et al., 2003; Hollon, 2004; Styra, 2004). In a study on “DTCA visits” (i.e., visits where the patient initiated discussion about a prescription drug advertised on broadcast media), anxiety, depression, and pain were found to be prevalent target conditions (Weissman et al., 2004). Moreover, its has been shown that the Internet per se is more often used by patients with self-reported stigmatized conditions (e.g., anxiety, herpes, or urinary incontinence) than by patients with non-stigmatized conditions (e.g., cancer, heart problems) to get health information, communicate with healthcare professionals, and utilize healthcare based on Internet information (Berger et al., 2005).
Data on public and patient understanding of neuroscience also suggest that information available through print media is an inadequate source of healthcare information and that it creates high or false expectations about benefits and risks. For example, a recent study that examined press coverage (1995–2004) of frontier neurotechnology (e.g., electroencephalography, positron emission tomography, neurostimulation techniques, neurogenetic testing) for ethical content and reporting practices found that coverage in major newspapers in the USA and UK (more than 1000 articles) was overwhelmingly optimistic except for neurogenetic testing, where almost half of articles featured the “pros and cons” of neurogenetic testing technology. Most technologies went unexplained when they were mentioned in articles (Racine et al., 2005b). Various other studies of medical technologies such as prescription pharmaceuticals (Cassels et al., 2003), neuroimaging (Racine et al., 2005a), and genetics research and technologies (Conrad, 2001; Bubela and Caulfield, 2004; Kua et al., 2004; Racine et al., 2006) have consistently shown that the benefits are hyped and that the risks are underdiscussed.
Risks of neuroimaging research and incidental findings
Like all research, neuroimaging carries risks, such as the potential for breach of confidentiality and physical risks. One of the challenges of neuroimaging research ethics is the occurrence of incidental findings of clinical consequence in non-clinical neuroimaging research. With tens, if not hundreds of thousands of volunteers and patients in Canada, the USA, and Europe participating in research, this is no surprise (Illes et al., 2003b). Although population statistics vary from study to study, even a 1–2% rate of findings yields a high number of people who may then face difficult life decisions about follow-up, and accompanying psychological and financial costs, as indicated in some self-reported cases (Anon., 2005; Hilgenberg, 2005). Current data suggest that approximately 15% of the asymptomatic population of research subjects have unusual variations in their brain structure and in 2–8% of these the findings are clinically significant (Katzman, 1999; Kim et al., 2002; Illes et al., 2004c). These data reflect higher rates than some population studies (Central Brain Tumor Registry of the United States, 2004; Weber and Knopf, 2006) but seem to vary consistently with age, gender, and even with the geography of the data taken. Procedures for handling these findings in the research environment vary substantially, and range from strict protocols to ad hoc procedures (Illes et al., 2004b). Subjects have reported that they expect that if an abnormality is present it will be discovered and disclosed to them (Kirschen et al., 2006). Accordingly, benefits could be expected from simple participation in research, creating potential therapeutic misconceptions (Appelbaum et al., 1987).
How should I approach neuroethics in practice?
We can expect that growing numbers of patients will bring to the clinic information found through the Internet and other media regarding prescription drugs, natural products, genetics tests, and whole-body and brain scans (Gollust et al., 2002; Illes et al., 2003a, 2004a; Check, 2005; Racine et al., 2007). For patients suffering from neurological and psychiatric disorders, the increasing targets of such technology in the open marketplace, vulnerability and compromised decisional capacity are critical factors. Physicians must be aware of the type of claims backing the products patients can learn about and purchase. Physicians should approach patient information on frontier technologies such as neuroimaging with the patient’s needs in mind. In cases of conflicting interests, the patient’s interest must come first and, if the physician cannot achieve this, the patient’s care should be conferred to a colleague. Knowledge of the current trends and literature is vital for guiding patients who seek counseling on these matters. Akin to encouraging physician consultation for prescription drugs, consumers interested in self-referred imaging services would benefit considerably from involvement of personal physicians in procedure selection and follow-up.
The case
This case presents some of the topics discussed in the neuroethics literature today and that clinicians may face as frontier neurotechnology is translated into healthcare products and services. The two parts of the case introduce many issues in patient information and physician counseling. Our immediate analysis and discussion focuses, first, on public understanding of neuroscience in a context of DTCA for healthcare products and services such as neuroimaging, and, second, on informing patients about research participation in neuroimaging research. More broadly, we hope that this case will also spark discussion on technology transfer and patient information in areas other than neuroscience, such as prenatal genetic testing for a broad range of disabling conditions (Check, 2005).
Self-referred imaging and direct-to-consumer advertising
The physician should inform the patient that self-referred whole-body imaging is not medically indicated for any condition, and the overall value of such screening is still open to debate. Further, the patient should be informed that imaging findings may lead to follow-up testing with a certain degree of morbidity and risks to future insurability. The patient could have tacit expectations about neurotechnology that should be discussed in the light of current scientific and medical evidence. Given that some misconceptions of neuroimaging may be acquired from the media, and that practices of DTCA are still emergent, advance consultation should be encouraged. Patients’ questions provide an ideal opportunity for clarifying the pitfalls of unregulated healthcare services and products.
Neuroimaging research
The physician should inform patients that imaging modalities have varying risks even for non-invasive procedures with low-risk profiles. For example, discovery of abnormal findings and other consequences are possible. Participation in any research project should be based on consent and patients may expect to be fully informed about their rights as research subjects. It is essential that physicians dispel therapeutic misconceptions and assist patients, as needed, in differentiating between expectations that are reasonable and appropriate for medical care versus those for medical research.
Advising and counseling patients on healthcare and research uses of frontier neurotechnology
The following advice can be used when counseling patients.
- Inform patients that current sources of scientific and healthcare information transmitted in the media do not provide a substitute for physician counsel and advice.
- Inform patients that medical use of whole-body screening is not currently supported by scientific evidence.
- Inform patients that participation in research may result in unexpected findings that may need follow-up.
- Be prepared to address therapeutic misconceptions and the value of alternative medicine.
- As suggested by the American Medical Association, communicate to the FDA or other relevant authorities wrongful and misleading health messages found in media advertising.
- Promote both patient autonomy and trust in the patient–physician relationship.