Posts

Showing posts with the label FDA

Consumer Neurotechnology: New Products, More Regulatory Complexity

Image
By Anna Wexler Anna Wexler is a PhD candidate in the HASTS (History, Anthropology, Science, Technology and Society) at MIT and a 2015-2016 visiting scholar at the Center for Neuroscience and Society at the University of Pennsylvania. Her dissertation focuses on the ethical, legal and social implications of emerging neuroscience technology, with a particular focus on the home use of noninvasive brain stimulation. Just when it seemed like the consumer neurotechnology market couldn’t get any stranger—after all, who would’ve expected that a sleek white triangle could be placed on the forehead for “calm” or “energy” vibes—two new products recently hit the market that further complicate the challenges of regulating this emerging market. Halo Sport is a brain stimulator marketed for athletic enhancement that utilizes technology similar to transcranial direct current stimulation (tDCS), while Nervana , which began taking pre-orders in March, is the first noninvasive vagus nerve stimulation ...

Brain devices: Navigating collaborations between industry, government, and researchers

Image
by Paul J. Ford, PhD Dr. Ford is Director of the NeuroEthics Program at the Cleveland Clinic. He is an active clinical ethicist, and teaches ethics to medical students, residents, and fellows. His publications have appeared in Science, The Hastings Center Report, Neurology, Neuromodulation, and Journal of Medical Ethics. He is also a board member for AJOB Neuroscience . This spring (June 3-4, 2015) the National Institutes of Health (NIH) as part of the BRAIN Initiative convened an eclectic group of individuals in hopes of encouraging more investigator initiated studies of currently approved neuromodulation and neuro recording devices for new indications (agenda, session videos, and program goals available here ). The participants, both on the program and in the audience, specifically included industry, researchers, universities, and governmental agencies. I was delighted to participate in the workshop and was impressed by the number of sincerely interested parties across the spect...

Predicting Alzheimer's Disease: Potential Ethical, Legal, and Social Consequences

Image
By Henry T. Greely, J.D. Henry T. (Hank) Greely is the Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics at Stanford University. He directs the Stanford Center for Law and the Biosciences and the new Stanford Program in Neuroscience and Society   SPINS).  He is also a member of the  AJOB Neuroscience  Editorial Board. Would you want to know the date and time of your death? Life-Line , the first published fiction by Robert A. Heinlein, one of the giants of 20 th century science fiction, explored that question. The story’s protagonist, Hugo Pinero, had invented a machine that could tell precisely when individuals would die, but, as Pinero found to his distress, he could not intervene to change their fates. Would you want to know whether you would be diagnosed with Alzheimer disease (AD)? This question is rapidly leaving the realm of science fiction; indeed, it already has for some unlucky people. Our ability to pred...

The Army's on Ecstasy: Marching toward an ethical drug policy

Image
Post-traumatic stress disorder (PTSD) among American soldiers returning from Iraq and Afghanistan has reached epidemic proportions, affecting between 75,000 to 225,000 veterans. In fact, suicide is now the leading cause of death in the army , with more soldiers dying by suicide than in combat. Frustratingly, existing treatments for PTSD are limited and ineffective for between 25-50% of patients. Last year a clinical trial using MDMA (i.e. Ecstasy) in conjunction with psychotherapy was shown to ameliorate PTSD symptoms far more effectively than any other known treatment. Despite these promising results, it could be ten years or more before MDMA is approved for use in treating PTSD, and even then clinicians will face additional hurdles until our nation’s drug policy is seriously overhauled. Given the public health imperative for effective PTSD treatment, it’s high time to rethink our stance toward illegal drugs and create an ethical drug policy that paves the way for expedient psychede...