"Neurohype" is one ethical concern with BRAIN initiative
Time is right for bioethicists to tackle issues
Many ethical considerations will be examined with The Brain Research through Advancing Innovative Neurotechnologies initiative, including privacy, moral responsibility for one's actions, stigmatization and discrimination, and ensuring protection of vulnerable populations. Some other key ethical issues are:
- insufficient evidence of safety of efficacy of treatments;
- excessive "hype" that can result in unrealistic expectations;
- whether neurotechnologies will be translated into clinical care in a reasonable timeframe.
There is no shortage of ethical considerations involving the Brain Research through Advancing Innovative Neurotechnologies (BRAIN), a $100 million initiative launched by President Obama that aims to uncover new ways to treat, prevent, and cure brain disorders. "There are already many serious ethical considerations with respect to neurotechnologies. The BRAIN initiative might mitigate some of those concerns, while reporting of it could exacerbate some others," says Henry T. Greely, JD, director of the Stanford Center for Law and the Biosciences and chair of the steering committee at Stanford Center for Biomedical Ethics, Stanford, CA.
"This is a concerted effort to advance our understanding of neuroscience," says Thomas Cochrane, MD, MBA, senior ethics consultant at Brigham and Women’s Center for Bioethics and assistant professor of neurology at Harvard Medical School in Boston. "Specifically, a coalition of scientists would like to characterize human neuroanatomy down to the level of connections between individual neurons and groups of neurons."
Better understanding of normal brain function is expected to lead to better understanding of disease states, then to new treatment strategies for those diseases, and possibly the opportunity for enhancement of normal function.
"Like any major scientific advance, big advances in neuroscience have the potential for great good and also for harm," says Cochrane. "The good news about these questions is that we’ve got a little time — not a lot, but some — to think carefully about them, before the really big disruptive changes come."
In the conversation about the BRAIN initiative, bioethicists must find a middle ground between excessive hype and excessive skepticism, says Erik Parens, PhD, senior research scholar at The Hastings Center in Garrison, NY.
"The brain is one very important organ in a very complex body, which interacts with still more complex local and global environments," says Parens. "Making headway in understanding one part of that vast system will be fascinating. But it won’t be a panacea any more than mapping the human genome was."
Safety and efficacy
The Presidential Commission for the Study of Bioethical Issues will examine broad ethical concerns for human and animal participants in neuroscience research, as well as the societal implications of discoveries that could arise from the BRAIN Initiative, according to communications director Hillary Wicai Viers. These include questions relating to privacy, personal agency, moral responsibility for one’s actions, stigmatization and discrimination, and the appropriate use of neuroscience in the criminal justice system.
"As important research is done that has the potential to shape what we know about conditions like Alzheimer’s and Parkinson’s — and other diseases that afflict tens of millions — careful reflection on the ethics of neuroscience will help establish appropriate interventions on the human brain, she says.
It is necessary to ensure protection of vulnerable populations, such as individuals with cognitive impairments, and educate a wider range of researchers, ranging from linguists to economists, who might not be familiar with human participants research protections.
Greely says the biggest concern right now is "neurohype" — lots of excitement coupled with insufficient evidence as to what neurotechnologies can realistically do. "There is lots of activity going on without a lot of good evidence that it works," he says. "People aren’t paying enough attention to what exactly has been shown to work, and what could plausibly work within a realistic timeframe."
It’s not yet known whether cranial stimulators work for anything other than FDA-approved purposes, or what their safety is like for anything else, for instance. "And optogenetics is a wonderful research tool for doing neuroscience in mice, but a lot of the reporting seems to gloss over the difficulties of going from mice to human," says Greely. "Safety and efficacy is not just a regulatory issue. It’s an ethical issue."
Timing of treatments
It is unclear whether neurotechnologies developed and articulated under the BRAIN initiative will be translated into clinical care within a reasonable window of time. "We must be equally concerned about the ampliative claims and underestimated potential adverse effects that prompt over-expedience in moving novel technologies to the clinical forefront," says James Giordano, PhD, chief of the Neuroethics Studies Program at Edmund D. Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center in Washington, DC. Concerns include unanticipated mid- to long-term effects, and the relative benefits, burdens, and harms incurred by either omission or commission. He recommends bioethicists take these steps:
- Realistically assess the capabilities of neurotechnologies.
- Develop approaches to either prevent problems, or resolvethem early.
- Consider what areas and types of neurotechnology are being subsidized, fortified, and advanced.
- Assess how these developments will affect local, regional, national, and global societies, economics, and politics.
Greely says that in some cases, expectations for neuroscience in medicine have been somewhat disappointing. It was hoped, for example, that in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, there would be more physical indicators of mental illnesses. "I think people hoped you could do an MRI [magnetic resonance imaging] and see OCD [obsessive-compulsive disorder] or see autism, and we can’t," he says. "The brain is a really complicated physical organ, and we haven’t been able to see those yet."
In the clinical setting, bioethicists can help doctors to confront unrealistic expectations. "People hoping for miracles are likely to be disappointed," says Greely. "They may be seeing beautiful brain images in magazines, but it is not yet at a stage where it helps very much with medical treatment."
Cochrane expects the controversy will come to an end when treatments are developed for the diseases in question, or when it’s determined what prognostic value these tests have, and for which patients. Meanwhile, he says, "it’s the medical ethicist’s job to keep the excitement over these new technologies in perspective."
- Thomas Cochrane, MD, MBA, Senior Ethics Consultant, Brigham and Women’s Center for Bioethics, Assistant Professor of Neurology, Harvard Medical School, Boston. E-mail: [email protected].
- James Giordano, PhD, Chief, Neuroethics Studies Program, Edmund D. Pellegrino Center for Clinical Bioethics, Georgetown University Medical Center, Washington, DC. Phone: (202) 687-1160. E-mail: [email protected].
- Henry T. Greely, JD, Director, Stanford (CA) Center for Law and the Biosciences. Phone: (650) 723-2517. E-mail: [email protected].
- Erik Parens, PhD, Senior Research Scholar, The Hastings Center, Garrison, NY. Phone: (845) 424-4040 ext. 224. E-mail: [email protected].
