Center Assistant Professor Dr. Laura Cabrera and co-authors Hayden M. K. Boyce, MD, Rachel McKenzie, and Robyn Bluhm, PhD, have an article in the August 2018 issue of Neurosurgical Focus. “Conflicts of interest and industry professional relationships in psychiatric neurosurgery: a comparative literature review” stems from the authors’ Science and Society at State (S3) project, “Psychiatric Interventions: Values and Public Attitudes.”
Abstract: Objective: The research required to establish that psychiatric treatments are effective often depends on collaboration between academic clinical researchers and industry. Some of the goals of clinical practice and those of commercial developers of psychiatric therapies overlap, such as developing safe and effective treatments. However, there might also be incompatible goals; physicians aim to provide the best care they can to their patients, whereas the medical industry ultimately aims to develop therapies that are commercially successful. In some cases, however, clinical research may be aiming both at improved patient care and commercial success. It is in these cases that a conflict of interest (COI) arises. The goal of this study was to identify differences and commonalities regarding COIs between 2 kinds of somatic psychiatric interventions: pharmacological and neurosurgical.
The full text is available online via Journal of Neurosurgery (MSU Library or other institutional access may be required to view this article).
I love puzzle rooms and detective novels. When medicine looks like a puzzle room, I become fascinated as a non-MD aspiring detective. When that medical mystery reveals an ethical problem, I really get in gear, as a clinical (neuro) ethicist.
Reading about the “Mystery of sonic weapon attacks at US embassy in Cuba” made me consider how physicians engage in a puzzle, and how piecing the story together leads to a hypothesis, as if in a puzzle room. Patients with strange and mysterious medical symptoms, suspicious circumstances, and the culprit? Uncertain – inexplicable narratives, patterns, and complaints that do not head in a clear prognostic direction. A story that continues to unravel. Doctors are detectives, and medicine can be a journey through a puzzle room to discover clues about the cause of ailments. Within the story, technology is the enemy but perhaps also a friend; providers embrace technology as it seems to promise a definitive answer.
The ethical problem: We do not make patients privy to the fact that medicine is something of a puzzle room, and that medicine’s technological tools carry substantial uncertainty. Instead, medical technology is presented as offering the path to a concrete solution. Uncertainty is rarely addressed by providers, or presented to patients who pay for expensive technologies, and equally who might suffer under their use. The medical world operates in a political and cultural system, which affects how providers want to see symptoms and technology. Patients get carried along with the tide. The embassy story made me think about the role of a clinical ethicist. Who challenges the patient, who challenges the doctor, who challenges the technology? Should clinical ethicists be detectives too?
What is/was going on in the Cuba case? Early news storiesreported that a sonic weapon might have harmed American diplomats. Diplomats claimed hearing loss, speech problems, vision issues and nausea after perceiving high-pitched noises and thumps. Canadian diplomats (and their children!) might have been harmed too. Reports indicated uncertainty about the culprit: “None of this has a reasonable explanation.” Experts submitted that no detrimental sonic weapon with this power had yet been developed. However, plagued by symptoms, diplomats were called back for safety reasons; reasonably, they were not expected to endure permanent threats to their health, lives and livelihood.
Since the diplomats had not experienced blunt trauma, their condition was baffling. Research, as JAMA published, suggested that many of the 21 study participants showed various “objective” signs that could indicate neurologic injury, i.e., symptoms often found in individuals post-concussion. About the culprit, the authors stated: “The unique circumstances of these patients and the consistency of the clinical manifestations raised concern for a novel mechanism of a possible acquired brain injury from a directional exposure of undetermined etiology.” Per the study, MRI findings indicated a shift change in white matter, possibly suggesting a neurological foundation to the problem.
Critics of the study were less sure (see references 3, 5, 6, and 8 below). They questioned the MRI tool and laid out different approaches to the puzzle, in full public view. Critical analysists, including a Cuban author, labeled the symptoms as potentially psychosomatic, the result of a conversion disorder. Suggesting a mass-psychogenic illness, the authors submitted that the hype around Cuba generated a “bias,” creating anxiety and hypersensitivity. They contested the finding’s objectivity as based on self-report or subjective interpretations of the researchers. Hence objective conclusions were elusive. Critics offered that: “Medical diagnosis at any given time depends to some extent on the current state of scientific knowledge, historical and cultural context, and the framework through which a disease is conceptualized.” However, this context was explicitly ignored by another expert who favored a physical approach. In a Neurology Today article by Dan Hurley, Dr. Terry Fife stated: “Just because an MRI is normal doesn’t mean everything else is normal. Many conditions in the past that we thought were subjective turned out to be quite real.”
Intrigue around the sonic attacks made me consider how mechanistic conclusions are rarely called into question. In this case, the critical perspective came from fellow physicians, which is reassuring; the system does not often question mechanistic truths. I wonder what mechanisms exist in the real life clinic? I hear about cases in which the most powerful physician might reference MRI results, and oppose the withdrawal of life support. Contrary to the whole team of other providers, who describe the clinical picture as awful and exacerbating the patient’s suffering, as well the family, who indicate that the patient would not want continued life support, the physician objects to withdrawal, stating that the MRI tool does not confirm the clinical picture; this physician wishes to continue full steam ahead. Without questioning his tool (i.e., the MRI), or the technological questions of his colleagues, the patient is unreasonably made to suffer.
Tools to facilitate any type of “certainty,” like MRIs, are popular reference points used to instill trust in our patients and our families. Just as the detective’s magnifying glass stands for scrutiny and expertise, the stethoscope stands for the physician’s trustworthiness. In foggy medical settings, heart monitors and MRI machines are powerful symbols to generate certainty and clarity. The health care setting presents them as supersonic tools. In cases where the results are questioned, the setting proposes that the patient must be “wrong” and not the technology. As illustrated in the Cuban diplomats’ case, the alternative explanation for their symptoms goes straight to mass psychogenic illness. Instead of having a somatic origin, because we could not view something, the symptoms must be caused by a mental state.
What is the role of a clinical ethicist within this culture? The story made me consider how much we need to walk into the medical puzzle room. Especially where medical tools are obstacles because of their presumed “definitive” clarity. Where physicians ignore questionable methodologies, should ethicists then be the detective? Pull out their magnifying glass, and use their tools of critical questions? Who should ask what is real and what is not? Whose role is it to challenge the patient, the doctor, the technology?
Marleen Eijkholt, JD, PhD,is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine. Dr. Eijkholt is also a Clinical Ethics Consultant at Spectrum Health System.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 31, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.
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Should we be worried about the use of direct brain stimulation to improve memory? Well, it depends. If we think of people with treatment refractory memory conditions, or those situations where drugs are not helping the patient, such an approach might seem like the next sensible step. There is reason, however, to remain skeptical that this strategy should be used to improve the memories of people who function within a normal memory spectrum.
The quest to improve memory is hardly new. Throughout time people have engaged in ways to improve their memories, such as eating particular foods, employing mnemonic strategies, or taking certain drugs, but the quest does not end there. A recent New York Times article discussed findings from a direct brain stimulation study (Ezzyat et al., 2018) on the possibility of using brain stimulation to rescue functional networks and improve memory. In that study, 25 patients undergoing intracranial monitoring as part of clinical treatment for drug-resistant epilepsy were additionally recruited with the aim of assessing temporal cortex electrical stimulation on memory-related function.
The prospect of using brain stimulation to improve memory, initially introduced in the 1950s (Bickford et al., 1958) re-emerged in 2008 when a study using hypothalamic continuous deep brain stimulation (aka open-loop DBS) to treat a patient with morbid obesity revealed an increased recollection capacity in that same patient (Hamani et al., 2008). Subsequent studies have attempted to prove that direct brain stimulation is useful for memory improvement. However, the data on open-loop deep brain stimulation currently remains inconclusive.
The approach by Ezzyat and colleagues, wherein neural activity is monitored and decoded during a memory task, suggests an improvement over open-loop approaches. In this treatment modality stimulation is delivered in response to specific neural activity, detecting those times when the brain is unlikely to encode successfully and rescuing network activity to potentially improve overall performance.
In that study stimulation was triggered to respond exclusively to those patterns of neural activity associated with poor encoding, effectively rescuing episodes of poor memory and showing a 15% improvement in subsequent recall. Indeed, those results might sound promising, but this type of memory intervention raises a number of ethical issues.
In a very direct fashion memory is related to the core of who we are. It allows us to build an interpretation of ourselves and our environments, and in so doing gives us orientation in time as well as in our moral life. As surrealist Luis Bunuel put it, “Life without memory is no life at all … Our memory is our coherence, our reason, our feeling, even our action. Without it, we are nothing …” Equally, memory plays a crucial role in cognition, learning, and performance, and as such it is not a surprise that many people feel particularly drawn to memory improvement strategies. Yet there are salient, concerning issues when directly meddling with the human brain, including those risks associated with deep electrode insertion such as infection, hemorrhage, seizure and hardware complications. One might reasonably question whether a 15% memory improvement is worth such high stakes risks?
Another concern is the potential for undesirable – but as yet undetermined – side effects. Those uncertainties are why it seems unlikely that such an approach will be used in healthy individuals or for mild memory dysfunction cases. Still and yet, closed-loop deep brain stimulation has alternative utility. It can be used to improve understanding about the specific brain target most centrally related to certain memory functions, and then use that information to employ less invasive interventions, such as transcranial magnetic stimulation (TMS).
The sorts of studies engaged by Ezzyat’s team and others overlook the fact that memories are not just physically located within the cranial cavity. We have external technologies such as photographs, videos, and agendas to help us remember, and so one might reasonably ask if we really need invasive brain implants to achieve the same ends? The brain’s plasticity is equally overlooked, erroneously assuming that the same brain targets will bring equivalent outcomes for healthy individuals as well as for those with memory impairments. Moreover, the identified interventions improve memory encoding, but do not help with the many errors to which memory is perplexingly prone, such as misattribution, suggestibility, and bias. For healthy individuals, addressing those common memory errors could potentially be more helpful than improving encoding with brain stimulation.
In addition, certain types of memory enhancement could bring new perspectives on one’s life, and even affect the ability to understand the past and imagine the future. In fact if we truly were to remember everything we encounter in our lives we might well be overburdened with memories, unable to focus on current experiences and afflicted by persistent memories of those things that we deem unimportant.
Open-loop neural implants already bring a different configuration of human agency and moral responsibility. Closed-loop implants with their ability to both stimulate and continuously monitor neural patterns bring further issues for consideration, such as neurosecurity (e.g. brain hacking) and mental privacy. Improved connectivity of this type of implant further enables the potential for malicious interference by criminals. Concerns about mental privacy figure prominently in other neurotechnologies, which, similar to brain implants, have the ability to access neural data correlated with intentions, thoughts, and behaviors. This enhanced proximity encroaches on the core of who we are as individuals, providing access to mental life that in the past was accessible only to oneself.
Finally, the media hype in itself is problematic. The New York Times’ article mentioned that the 15% improvement observed in the Ezzayt study was a noticeable memory boost. This sort of inflated media coverage does a disservice to the good intentions and professional rigor of scientists and engineers, and misleads the reader to be either overly-optimistic or overly-worried about the reported developments.
With these many considerations in mind, it is clear that direct brain stimulation will replace neither pharmaceuticals nor less invasive memory improvement options anytime soon. Those who crave memory improvement through memory intervention technologies might best be mindful of the aforementioned ethical and social considerations.
Laura Cabrera, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Translational Science & Molecular Medicine at Michigan State University.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 10, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.
You must provide your name and email address to leave a comment. Your email address will not be made public.
Center Assistant Professor Dr. Laura Cabrera and co-author Judy Illes (University of British Columbia) have a comment article in the February 2018 issue of The Lancet Neurology. Their article is titled “Balancing ethics and care in disorders of consciousness.”
Summary: Neuromodulatory interventions that rely on the premise that stimulation activates or promotes brain circuit signals are being applied to a wide range of therapeutic targets in neurological and psychiatric disorders. The numbers of patients with whom these interventions are being tested, the range of approaches, and the variety of methods are all on the rise. Paralleling these trends are the increasing numbers of countries doing clinical trials, and the coverage of them in the press.
The full text is available online through The Lancet (MSU Library or other institutional access may be required to view this article).