Tuesday, September 1, 2015

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

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 spectrum of roles. Within these conversations it was apparent that there existed many shared values and goals as well as complex challenges for protecting particular interests. It beautifully highlighted the complexities of interactions among varied stakeholders.

Among the group there was a broad interest in performing due diligence in discharging their various duties to their constituents. At its heart, the meeting was a good faith effort to realize a desire to see innovations develop to the point of helping clinical populations, i.e. real people who suffer. This aspect of the BRAIN initiative recognizes the current significant logistical barriers to exploring new uses of existing devices within a research context. Too often the current system in the United States with respect to devices encourages off-label use with retrospective review data, rather than small prospective trials. There are numerous disincentives within the system, some of which are bureaucratic and legalistic in nature (see Kelly et al. discussion.) In developing new ways for investigators to create partnerships with industry, the June meeting announced opportunities that would allow easier access to letters for “right of reference” (a specific type of permission needed from intellectual property owners to allow use of previously submitted safety and engineering data. Kelly et al. discusses this further) as well as standardized intellectual property agreements as part of a streamline for some types of NIH funded research. In addition, the dialogue between industry, researchers, universities, regulators, and funders creates an opportunity to standardize approaches to some of the most difficult ethics challenges in brain implant research, such as long-term access to implant upgrades.

Much of the June meeting itself was dedicated to understanding the mechanisms for collaboration, addressing the challenges of negotiating intellectual property, as well as the need for further aggregation of data across research studies. However, the organizers also dedicated a session specifically to ethics, in which I participated as a panelist. The session included a brief presentation by Joseph Fins, MD followed by panel comments by Christine Grady, MSN, PhD, Scott Kim, MD, PhD, Helen Mayberg, MD, and me. A diverse set of practical ethical issues were addressed relating to both research ethics in general and specific ethical issues in neuromodulation. Scott Kim particularly highlighted the opportunity for neuroethics research that could be undertaken in parallel to the other science conducted during further neurological device studies. This model of integrating ethical investigation in tandem with the initial clinical research provides an opportunity to fully appreciate the research participants’ perspective.

A second session of particular interest to the neuroethics community was a presentation by a Public-Private enterprise, Medical Device Innovation Consortium (MDIC) developed in collaboration with the FDA. This organization “aims to advance regulatory science in the medical device industry.” In particular it has various industry, non-profit, and governmental members. This past spring, they released a report on a framework for use in demonstrating to the FDA whether a risk benefit balance is appropriate from a patient perspective (draft release May 2015). The FDA released a companion draft guideline regarding how patient preferences could be used in the approval process. These draft guidance documents provide an opportunity to include neuroethics research into clinical trials of neurological devices. Scott Kim’s comment regarding the need for rigorous methods to be applied in undertaking the type of ethics research nicely resonates with the intention of the MDIC document to provide guidance of methods.

The initiatives and conversations that occurred during this June 2015 meeting is well worth paying attention to for their long reaching implications on how neurological device research is approached and the ethics opportunities that are available.

Want to cite this post?

Ford, P.J (2015). Brain devices: Navigating collaborations between industry, government, and researchers. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2015/09/brain-devices-navigating-collaborations.html

Tuesday, August 25, 2015

Self/less and transplanting (ID)entities

by Karen Rommelfanger

I recently sat on a panel discussion for an early screening of the movie Self/less. I'm quoted (mostly correctly) with my name (mostly) spelled correctly here.

In Self/less, an aging business tycoon with a terminal illess (played by Ben Kingsley) pays to "shed" his skin for a new, younger, fitter body (played by Ryan Reynolds). See trailer above.

The film, despite the futuristic theme, revisits mundane themes of the Faustian tradeoff or a deal with a devil, ultimately conveying the message that the costs, even for the rich, are too high when trying to cheat death. The title of the movie implies that for the greater good the selfless thing to do is to just die as nature intended.

While the film would surely be categorized as science fiction, there are entrepreneurs quite dedicated to making such a possibility a reality.

Tuesday, August 18, 2015

Why I teach with an English professor

by Krish Sathian, MD, PhD

Dr. Sathian is Professor of Neurology, Rehabilitation Medicine, and Psychology at Emory University, and directs the Neurorehabilitation Program in the Department of Neurology. The recipient of Emory’s 2001 Albert Levy senior faculty award for excellence in scientific research, he is Executive Director of the Atlanta VAMC Rehabilitation R&D Center for Visual and Neurocognitive Rehabilitation and immediate Past President of the American Society of Neurorehabilitation.

Editor's note: The following post is the second of a pair of essays about interdisciplinary teaching we will feature on the blog. Please see its companion piece from last week, Dr. Laura Otis's "Why I teach with a neurologist." It is often said that academic fields are becoming increasingly siloed as specializations become more and more detailed and jargon-filled with each new peer-reviewed paper. The classes co-taught by Professors Otis and Sathian were unique interdisciplinary spaces where students across traditional disciplinary divides were able to wrestle with topics shared by the humanities and sciences: perception, imagination, and art. Is this kind of interdisciplinary inquiry a necessary counterbalance to the siloing of the disciplines? Or could it even be seen as part of the ethical practice of science? Might having more of such classes improve the science literacy of those in the humanities, and keep scientists in touch with the depth of expertise that other fields can contribute (as I have argued in an earlier post)? Should we begin to find ways to institutionalize more of this type of work into the higher education system, or provide more movement between the disciplines? Or is interdisciplinarity merely a fad? Readers: what do you think? 

I consider myself very fortunate to work both as a clinical neurologist in academia, and as a neuroscientist investigating fundamental questions about the brain that may in time have an impact on how we treat people with neurological disorders. My own research over many years has concentrated on studies of perception, but I recently began to study how the brain handles metaphor.

Tuesday, August 11, 2015

Why I teach with a neurologist

by Laura Otis, PhD

Dr. Otis is a Professor of English at Emory University. Although she ultimately obtained a PhD in Comparative Literature and now teaches English literature, she holds a BS in Molecular Biophysics and Biochemistry and an MA in Neuroscience, and she worked in research labs for years. She was awarded a MacArthur fellowship for creativity in 2000 and is currently working as a visiting scholar at the Max Planck Institute for Human Development in Berlin.

Editor's note: The following post is the first of a pair of short essays about interdisciplinary teaching that will be featured on the blog. Stay tuned next week for Dr. Krish Sathian's "Why I teach with an English professor." It is often said that academic fields are becoming increasingly segregated as specializations develop more jargon and become more detailed with each new peer-reviewed paper. However, the classes co-taught by Professors Otis and Sathian are unique interdisciplinary spaces where students across traditional disciplinary divides are able to wrestle with topics shared by the humanities and sciences: perception, imagination, and art. Is this kind of interdisciplinary inquiry a necessary counterbalance to the segregation of the disciplines? Or even part of the ethical practice of science? Might having more classes like this improve the scientific literacy of those in the humanities, and keep scientists in touch with the depth of expertise that other fields can contribute (as I have argued in an earlier post)? Should we begin to find ways to institutionalize more of this type of work into the higher education system, or provide more movement between the disciplines? Or is interdisciplinarity merely a fad and a buzzword? Readers: what do you think? 

In teaching, there are few things worse than realizing you’ve told your students something wrong. The jolt may come a year, five years down the line, but you can’t issue a retraction. They’ve dispersed to medical schools, where they’re now propagating your error. It’s been thirty years since I studied Neuroscience at UCSF, and a few things have changed since then. The human genome has been sequenced. Scientists analyze data on computers. I try to keep abreast of what’s happening, but this is hard while teaching Victorian literature. In this climate of near-worship for Neuroscience, I worry that I could say anything about the brain, and people would believe me. With a neurologist in the room, this can’t happen.

Tuesday, August 4, 2015

Meeting ethological needs: Conflicting data on orca longevity in captivity

by Frans de Waal

Editor's note: Frans de Waal, PhD, is the Charles Howard Candler Professor of Primate Behavior at Emory University and the Director of the Living Links Center at the Yerkes National Primate Research Center. He is also a member of the United States National Academy of Sciences and the Royal Netherlands Academy of Sciences and a member of the AJOB Neuroscience editorial board. His research focuses on primate social behavior, including conflict resolution, cooperation, inequality aversion, and food-sharing.

de Waal, a leading primatologist, makes an argument here for thinking seriously about the captivity of certain animals such as orcas. Of course, the orca also has a sophisticated mammalian brain. Is the defining criterion of our responsibility to other animals their ecological needs, as de Waal suggests, or is it their cognitive function? What do you think?

There is so much to-do about orcas (killer whales) in captivity, with a drumbeat of voices against humans keeping this species, that it was about time we got some data on longevity. Not that longevity is the only measure to consider with regards to the ethics of keeping these fascinating animals, but since there is the claim out there that orcas in human care live short, stressful lives, there is a need to know the truth.

Source: flickr.com

Tuesday, July 28, 2015

Liberating brains from bodies by capturing them with brainets?

by Karen Rommelfanger

Miguel Nicolelis is dedicated to liberating the human brain from the physical constraints of a body.

Recently, brain-machine interface engineer extraordinaire Miguel Nicolelis connected nonhuman animal brains in a modern-day mind meld called the brainet. For those who don't already know him, Nicolelis is an innovator, dedicated to pushing the limits of what is possible with neurotechnology, and a media darling to boot.

One focus of Nicolelis' work has been developing neural prostheses whose function is mediated through wired or wirelessly transmitted electrical activity from arrays of electrodes implanted on the surfaces of nonhuman animal brains. One well-known experiment from the Nicolelis lab involved monkeys that learned to feed themselves a marshmallow  or even operate a robot on a treadmill via direct connection electrodes implanted in their brains and a prosthetic arm. For extra flash, Nicolelis had a 12-lb monkey (based out of a Duke laboratory) operate a 200-lb robot on a treadmill in Tokyo by transmitting its brain activity through an Internet connection. In this same 2013 interview he waxes philosophical, “Our sense of self does not end at end of the cells of our bodies, but it ends at the last layer of the electrons of the tool that we’re commanding with our brains.”

His work has intended applications for humans. One recent media stunt involved a "Mind-controlled robotic exoskeleton"  donned by an individual who was paralyzed from the trunk down. 29-year-old Juliano Pinto kicked off the first ball at the World Cup in 2014 through an electrode studded cap on his head that transmitted recorded electrical activity from his brain to a robotic suit. Hailing from

Tuesday, July 21, 2015

Bring back the asylum: A critical analysis of the call for a "return to 'modern' institutionalization methods"

By Cassandra Evans

Cassandra Evans is a Ph.D. student in Disability Studies at Stony Brook University. She studies mental disabilities and ethics surrounding treatment, services, and access for individuals with mental disabilities. She is currently examining the history of institutions in Suffolk County, Long Island (New York) and what shape the “way forward” from institutionalization will take in the new millennium.

This post is a shorter version of a talk Cassandra gave at the Society for Disability Studies’ national conference in Atlanta, Georgia, June 11, 2015.

In early June, 2015, I visited Pilgrim Psychiatric Center in Brentwood, New York, (Suffolk County, Long Island). As I drove onto the Pilgrim campus, I felt as if I could be entering any of the other scores of institutions around the country—the pictures I’ve seen all look so similar and convey the same eeriness: high rise brick buildings with plain numbers on them, grass growing up all around, broken and barred windows, some areas with trash heaps on the grounds and graffiti on the walls. The names were different, but during their official operations, the treatments and results were similar—many individuals stayed longer than they ever wanted, many died and few were “cured.”

This photo shows a brick high-rise institutional building with a 
gravel road leading away from its parking lot, green grass and 
fresh tire tracks nearby.  Toward the front of the building several 
cars are parked outside the front of the building at the bottom 
floor of this 10- or 12-story, double-winged ward.  “Building 82” 
at Pilgrim Psychiatric Center in Brentwood, New York, is still 
home to many individuals with psychiatric disabilities.  Though 
three out of four institutions in Suffolk County, Long Island were 
closed and their residents deinstitutionalized, others with more 
severe  disabilities or who were more geriatric ended up here.

Photo by Cassandra Evans
While there, I saw pictures and news clippings in the museum that demonstrated how, in the era when institutions were being built and filled—toward the late 1800s and early 1900s until about the 1950s, consensus was that these facilities and the treatments inside of them were “state-of-the-art.” Text describing the 1938 LIFE Eisenstaedt photo essay noted that the pictures are “showing the dark world of the insane and what scientists are doing to lead them back to the light of reason” (Long Island Psychiatric Museum, 2015). While that rhetoric was common then, I wonder if it is similar ableist thinking, this need to normalize that still prevails today, driving new calls to “bring back the asylum.”

It was a recent ethical argument on this topic in the Journal of American Medical Association (JAMA) that prompted me to visit the Long Island Psychiatric Museum. This article, “Improving long-term psychiatric care: bring back the asylum,” by Sisti, Segal and Emanuel (2015) made major waves in both academic and lay literature. In it, the authors argue that because of “transinstitutionalization”—the failure of deinstitutionalization to guarantee appropriate placements for former residents of these homes—the “way forward” for severe psychiatric patients is a return back to the asylum (Sisti et al, 2015).

Tuesday, July 14, 2015

The power of a name: Controversies and changes in defining mental illness

by Carlie Hoffman

The purposes of naming are to help categorize the world in which we live and to aid in grouping similar things together. However, who decides which name is the correct one? Is a child who often cannot pay attention to his classwork “absent-minded,” or experiencing attention deficit hyperactivity disorder? Is a person whose moods often swing from one extreme to the other simply “moody,” or living with bipolar disorder? Naming a lived experience a “mental illness” has the ability to change the social realities of those who receive the diagnosis, altering not only self-perception, but also influencing the perceptions and triggering the biases of others— often in a detrimental manner. So, who has the power to determine how such a label is assigned, and what happens if someone is given the wrong one?

The power affiliated with naming has caused the diagnosis of mental disorders to be fraught with controversy. Mental illnesses are defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM), which has been deemed the “bible” of mental health. According to Dr. Thomas Insel, the director of the National Institutes for Mental Health (NIMH), the goals of the DSM are to create a common language for describing mental illness, and to ensure that mental health care providers use the same terms in the same ways. Thus, when patients visit a psychiatrist in search of a name that will define the symptoms they are experiencing, this name is assigned with the aid of the DSM.

One controversy affecting the diagnosis of mental disorders is the growing concern with medicalization of the “normal” human experience. Medicalization is the process of defining select human experiences or conditions, typically ones that were once considered normal, as medical conditions that warrant professional medical attention. Some level critiques against medicalization, particularly the medicalization of experiences associated with cognitive and emotional function, suggesting it can lead to over-diagnosis of mental disorders as individuals cope with stressors in a typical fashion [5, 11, 13]. A series of controversial changes made to the newest edition of the DSM, DSM-5, have provided a foothold for those concerned with medicalization. The addition of premenstrual dysphoric disorder and the elimination of the bereavement exclusion from the criteria for major depressive disorder have increased the apprehension that typical premenstrual mood and behavioral changes, and the normal grieving process could be classified as mental disorders [7, 13, 14].

Tuesday, July 7, 2015

Charles Bonnet syndrome, musical ears, and normal hallucinations

by Jonah Queen

In a previous post on this blog, I wrote about the Mad Pride movement, which advocates for the rights of, and the end of stigma against, those diagnosed with psychiatric disorders. I discussed how the lack of a clear distinction between “normal” and “abnormal” psychology even leads some activists to think of these conditions as extreme emotional or sensory experiences rather than illnesses. Mad pride advocates see a trend of increasing medicalization within psychiatry, arguing that feelings and behaviors are too readily classified as pathological. But this concern with over-medicalization is not unique to the Mad Pride movement. It is expressed by a wide range of individuals, including those within the mental health establishment. But there is one area where the field of mental health seems to be moving in the opposite direction: hallucinations. DSM-5, which has been criticized for overly broad definitions of psychiatric disorders, is restricting the diagnostic criteria for schizophrenia, making it so that hearing voices (with no additional symptoms) is no longer sufficient for a diagnosis.

The cover of the report in which Charles Bonnet first described the condition which would be named after him (from demneuropsy.com.br)

This change is due to current research that shows hallucinations are not always a sign of psychosis and are also surprisingly common (according to some sources, ten percent of the population occasionally hears voices). Doctors, researchers, and patient advocacy groups are working to spread this knowledge and to overcome the belief among the general population that experiencing hallucinations makes someone “crazy.”

A hallucination is defined as a perceptual experience that does not come from an external source. They can be caused by a variety of disorders (whether psychiatric, neurological, or somatic) and can occur in healthy individuals in response to psychotropic drugs (like hallucinogens such as LSD and psilocybin) or stress (including sleep deprivation). But there are many other common phenomena that can also be described as hallucinations, though they might not be thought of as such due to their mundane and unobtrusive nature. These include experiences that many of us have had, such as hearing your name being called, hearing a phone ringing, or feeling your cellphone vibrating in your pocket, even though none of those things are actually occurring. Sometimes these experiences can be caused by our brains misinterpreting real sounds. Hearing a “phantom” phone ring can happen in response to faint background noise in a frequency similar to that of the ring, since it is a sound many of us are (even unconsciously) always listening for. 

Tuesday, June 30, 2015

New neuro models for the interdisciplinary pursuit of understanding addiction

by Katie Givens Kime

The following post is part of a special series emerging from Contemporary Issues in Neuroethics, a graduate-level course out of Emory University’s Center for Ethics. Katie Givens Kime is a doctoral student in Religion, with foci in practical theology, psychoanalysis, and neuroethics, and her research investigates the religious and spiritual aspects of addiction recovery methods.  

A few years ago, a highly respected and accomplished philosopher at Duke University, Owen Flanagan, surprised everyone when he stood up to speak at Society for Philosophy and Psychology.  A garden-variety academic presentation it was not.  In “What Is It Like to Be An Addict?” Flanagan revealed to 150 of his esteemed colleagues that he had been addicted to various narcotics and to alcohol for many, many years.  Not so long ago, every gruesome morning looked like this:

I would come to around 6:15 a.m., swearing that yesterday was the very last time...I’d pace, drink a cup of coffee, and try to hold to my terrified resolve.  But by 6:56—every time, failsafe, I’d be in my car, arriving at the BP station...at 7 a.m. sharp I’d gather my four or five 16-ounce bottles of Heineken, hold their cold wet balm to my breast, put them down on the counter only long enough to be scanned....I guzzled one beer in the car.  Car cranking, BP, a beer can’s gaseous earnestness—like Pavlov’s dogs, when these co-occur, Owen is off, juiced...the second beer was usually finished by the time I pulled back up to the house, the house on whose concrete porch I now spent most conscious, awake, time drinking, wanting to die.  But afraid to die.  When you’re dead you can’t use.  The desire to live was not winning the battle over death.  The overwhelming need – the pathological, unstoppable – need to use, was. (Flanagan, 2011, p. 77) 

Research on addiction is no small niche of medical science.  It’s an enormous enterprise.  This seems appropriate, since addiction (including all types of substance abuse) is among the top public health crises in the industrialized West. The human suffering and the public (and private) expense wrought by addiction is immense. (See data here, here, and here.)

To that end, two accomplished researchers recently guest lectured here in Atlanta, representing a few dynamic edges of such research.  Dr. Mark Gold lectured for Emory University’s Psychiatry Grand Rounds on "Evolution of Addiction Neurobiology and Treatment Over the Past 40 Years,” and Dr. Chandra Sripada lectured for the Neurophilosophy Forum at Georgia State University on "Addiction, Fallibility, and Responsibility.”