New brain treatments: proceed with care
24 June 2013
New technologies that can help people with serious disorders affecting the brain are needed, but must be used in ways that put the care and safety of patients first, says a report by the Nuffield Council on Bioethics.
The report looks at ethical issues raised by technologies that ‘intervene’ in the brain (neural stem cell therapies, deep brain stimulation, transcranial brain stimulation and brain-computer interfaces). These technologies offer the potential to help people with severe conditions, such as Parkinson’s disease, Alzheimer’s disease, depression and stroke, for whom other treatment options have not been effective. For example they could help to control involuntary movements, replace damaged brain cells or assist communication.However, there is not yet enough evidence about how effectively these technologies work. There are concerns over possible unintended consequences of their use and that premature speculation about their potential might raise false hopes amongst patients.
The Council says that we need smarter regulation that encourages innovation in this area whilst recognising the complexity of the brain and prioritising the delivery of safe and effective treatments for patients in need. Amongst a number of recommendations, the Council suggests that better methods are needed for collecting doctors’ experiences of using these neurotechnologies, and that counselling should be provided for patients considering treatments that require surgery.
“Increasing numbers of people suffer from brain disorders, such as stroke, Alzheimer's, and Parkinson's, and there is a great need for new and effective treatments. But the brain is so important, and our understanding of it is still limited, so we must proceed with great care,” said Professor Tom Baldwin, Chair of the Nuffield Council’s enquiry. “We need to harness the benefits and minimise the possible harms raised by novel neurotechnologies. And to do that we need regulation that protects people from unnecessary harm and informs them of risks, but does not stifle innovative approaches to treating severe brain disorders”.
The report, Novel neurotechnologies: intervening in the brain sets out an ethical framework and recommendations to guide the practices of those involved in the development, regulation, provision and communication of novel neurotechnologies.
Sharing of evidence
The Council says that more could be done to bring together and make the most of existing evidence from research and from new treatments. It recommends that publicly accessible registers of information about the use of novel neurotechnologies should be established through joint efforts of professional bodies such as the Association of British Neurologists, Society of British Neurological Surgeons and the Royal College of Psychiatrists.
Professor Graeme Laurie, a member of the Nuffield Council on Bioethics and one of the authors of the report, said: “There are gaps in our understanding of exactly how the brain responds to these interventions, and of the extent of research going on in this area. This increases the challenge faced by doctors, researchers and the patients themselves in trying to assess the potential of these treatments. We need better systems to record and make available the evidence that is out there so that patients can be better informed and treatments get to the patients who need them”.
Care of patients and research participants
The Council says that independent counselling should be offered to patients who are deciding whether to opt for the more invasive forms of treatment, so that patients and those close them can explore the implications.
“Given that these treatments offer no guarantees, that there are real risks, and that people using them could be investing a great deal of hope in them, we feel strongly that counselling should be offered to patients who are considering treatment using invasive neurotechnologies, as these are most likely to present a complex mix of benefits and side effects” said Professor Ilina Singh, co-author of the report.
The Council also offers suggestions for measures to mitigate possible harms to people taking part in research trials for neurotechnologies.
“If we think about trials of devices, it is understandable that if a device is taken back from somebody at the end of a trial that has worked really well for them, they might find that incredibly distressing” said Professor Singh. The Council recommends that researchers must make absolutely plain to participants, before they agree to take part in a trial, what will happen when the study finishes, and exactly what support they will be offered.
Where clinical trials of neural stem cell therapies require a control group, one possible approach could involve some people undergoing surgery but not receiving the stem cells. The Council calls for guidance to be developed on when, if ever, it would be ethically appropriate to use ‘sham’ neurosurgery in this way.
The Council notes the huge influence of media communications about new developments in neurotechnologies. In order to minimise harms that can be caused to patients by undue speculation and hype, it says that those involved in communicating the possible uses of these technologies must exercise responsibility by not raising false hopes and unrealistic expectations about these.
Uses outside of health care and health research
Some small studies of stimulating the brain with external devices have claimed to show small improvements in participants’ performance in exercises that test memory or language. It is also possible to buy gaming devices that claim to use brain signals to control game movement, by using a brain-computer interface (BCI) headset.
Professor Singh said “It is unclear how, if at all, these supposed ‘enhancement’ effects seen in very small studies would translate into practical benefits in the real world, and we are concerned about false or misleading claims about what these might offer”. Children and young people might be encouraged to use them for educational purposes, or to want to try out the games. Whilst we need to know more about the effects of these non-medical uses, we also don’t want to encourage unnecessary interventions in the brain.
The Council says that advice must be given to teachers and parents about the limited evidence on the effectiveness of neurodevices for educational benefits. It also recommends observational research of children who already use neurotechnologies for gaming or learning as a way of gaining knowledge about possible effects on the developing brain.
The Council also calls for the European Commission to classify neurodevices as medical devices, even if they are being used for other purposes, so that their possible health impacts are given appropriate attention.
NOTES TO EDITORS
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2. The project
The Nuffield Council on Bioethics established a Working Party in November 2011 to examine the ethical issues raised by novel neurotechnologies that intervene in the brain. The Working Party includes members with expertise in clinical, developmental and applied neurosciences, ethics, law, philosophy, communications and sociology.
To inform its deliberations, the Working Party:
Responses to the consultation will be available alongside the report on the Council’s website www.nuffieldbioethics.org from 17:00 GMT on Monday 24 June 2013.
3. Working Party members
Note: The members of the Working Party were appointed for their personal knowledge and expertise, and do not necessarily represent the views of their organisations.
Longer biographies are available at:
Thomas Baldwin (Chair)
Professor of Philosophy, University of York
Honorary Senior Lecturer in Clinical Neurosciences at the University of Southampton, and Consultant in Clinical Neurophysiology, Poole Hospital
Professor of Developmental Neurobiology, University College London
Professor of Communications Research, Cardiff School of Journalism, Media and Cultural Studies, Cardiff University
Professor of Medical Jurisprudence and Director of Research, School of Law, University of Edinburgh
Professor of Developmental Neurobiology and Head of the Centre for the Cellular Basis of Behaviour, King’s College London
Professor of Sociology and Head of Department of Social Science, Health and Medicine, King’s College London
Emeritus Professor of Neurobiology, Department of Life, Health and Chemical Sciences, Open University and Emeritus Professor, Genetics and Society, Gresham College, London
Professor of Science, Ethics and Society, Department of Social Science, Health and Medicine, King’s College London
Professor of Human Brain Research, Institute of Cognitive Neuroscience, University College London
Professor of Cybernetics, University of Reading
4. About the Nuffield Council on Bioethics
The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. The Council has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics.