Ethics and DBS
Research institutions and commercial firms pursuing new deep brain stimulation therapies for neuropsychiatric disorders have faced a number of hurdles, including clinical trial design, regulatory approval, device development, and obtaining funding. At least one more set of challenges awaits them, and that is ethical concerns raised by clinicians, advocacy groups, and the general public.
In a recent article in the Journal of Alzheimer’s Disease, three psychiatry professors from the University of Pennsylvania raised ethical concerns regarding the use of DBS to treat AD. The authors, Andrew Siegel, an assistant professor of clinical psychiatry in the Perelman School of Medicine at Penn, and his colleagues Marna Barrett, and Mahendra Bhati, now at Stanford University, raised questions regarding decision making and post-study treatment access.
The professors asked if the patient will still have the capacity for informed consent as the trial progresses. They also want assurance that patients know what therapeutic benefit they are receiving. And they want trial sponsors to address the issue of whether or not the device will remain after the trial ends, and if so, who will pay for it? “As the number of people affected by Alzheimer’s continues to grow, along with its substantial costs to individuals, their families, and society, novel therapies are urgently needed. DBS is one such treatment modality that has shown promising early results,” Siegel said. “However, this enthusiasm should be tempered by prudent ethical considerations to help better protect the patients.” The authors suggest an IRB-mandated decision-making capacity assessment tool, or an “auxiliary consenter” not affiliated with the study.
The first two issues are reasonable but would seem to apply to a trial of any treatment modality targeting psychiatric disorders, not just to DBS. Individuals with cognitive deficits will always present a challenge to clinicians seeking informed consent, whether for a clinical trial or an approved therapeutic regimen. And clinical trial participants are always at risk of having overly optimistic expectations of therapeutic benefit, particularly if they end up in the control arm of a study. So it’s not clear why DBS trials pose additional ethical risks.
The third issue they raise does have merit. The authors believe denying a patient access to the only intervention known to alleviate their suffering is tantamount to violating the sacrosanct principle of “do no harm.” This brings to mind the patients in Northstar Neuroscience’s depression study who had to be explanted—despite their satisfaction with the device—because Northstar closed its doors after the failed stroke trial. Trial sponsors should indeed do everything in their power to insure that participants who were helped by the device get to keep it.
James Cavuoto
Editor and Publisher