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Posts by James Giordano, PhD

Guiding the Tide of Neurotechnology: Coordinating the Currents of Sea-Change

BY JAMES GIORDANO, PhD

 

Recently, the Food and Drug Administration (FDA) solicited input to guide ways that the agency regards and handles “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes”, in accordance with good practices regulation (21 CFR 10.115). The FDA will use this draft guidance to “…assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes”, and “… aid industry and FDA staff in considering the benefits and risks of medical devices that target … the cause or progression of neurological disorders or conditions” (such as movement disorders, like Parkinson’s disease and dystonia; as well as other pathologies, like Alzheimer’s dementia, Tourette’s syndrome, chronic pain, and psychiatric conditions such as depression).

The goal of the FDA regulation process is to establish that drugs and devices provided for medical care are safe and technically sound and the general constructs of Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) are aligned with such aims. But like any policies that tend to entail broad concepts, the real-world utility, viability and value of these programs are contingent upon: (1) the relative appropriateness to the context(s) in which any device is employed; and (2) if and how use-in practice reflects and is supported by the scope of regulatory oversight and control.

In recent years, IDE and HDE application, review and approval has become easier and more efficient; this is a notable improvement – and a step in the right direction. However, it may be that aspects of the overall structure and certain specifics of the IDE and HDE are not well suited to meet the contingencies (and exigencies) of actual clinical use of certain neurotechnologies, like deep brain stimulation (DBS).   For example, the current regulatory framework necessitates filing and securing an IDE as a first step in investigator-initiated research (IIR) and/or other off-label use of DBS in those cases where other approaches have been shown to be ineffective or untenable, and for which DBS may prove to be viable as “humanitarian care”. In such instances, it may be that the proverbial cart precedes the horse, and the HDE might be more practical and valuable given both the nature of the disorder and treatment, and the value of the HDE in establishing a basis for further (and/or expanded) application, as supportable by an IDE.

Moreover, while both IDE and HDE establish parameters for using DBS in practice, neither regulatory mechanism creates or enforces a basis for provision of economic support necessary for right and good use-in-practice. As our recent work has demonstrated, non-payment of insurance costs for pre-certified DBS interventions has been, and remains a problem of considerable concern. Absent the resources to provide: 1) DBS as a demonstrably-important or necessary treatment option for those patients with conditions that are non-responsive to, or not candidate for other therapeutic options , and 2) continuity of clinical services as required, the sustainability of this neurotechnology may become questionable (Rossi, Okun, and Giordano, 2014). This is contrary and counter-productive to recent federal incentives to maximize benefits of translating extant and new neurotechnologies into clinically-relevant and affordable care, and to implementing precision medicine . This was the focus of much discussion at the fourth National Deep Brain Stimulation ThinkTank held last month in Gainesville, FL.

In the main, actions taken by the FDA to streamline the IDE and HDE process should be applauded. Yet, while certain aspects of the IDE and HDE mechanisms may be in order and valuable for regulating use of DBS, others may require re-examination, revision, or replacement, so as to remain apace with the rising tide of developments in the field, and needs and necessities of patients and clinicians in practice. In this vein, we recommend further study of IDE and HDE mechanisms to determine what works, what doesn’t, and what can – and should – be done to both improve these practices. It is our hope that doing this will fortify regulatory, policy and legal processes to ensure that they are aligned with, directive toward, and supportive of concomitant changes in standard of care guidelines and federal insurance structure.

Important to this endeavor would be both the development of a governmental-commercial enterprise to guide industrial efforts in neurotechnology (e.g.- a National Neurotechnology Initiative; NNTI), as well as the establishment and enactment of federal laws (e.g.- a neurological information non-discrimination act; NINA) to govern potential use(s) of information obtained through DBS and related neurotechnologies that are elements of novel big data initiatives. This might be something of a sea-change, and effecting such change will demand that the constituent currents flow in the same direction. If programs such as the BRAIN initiative and agendas of precision medicine and big data are to function as a “translational estate”, and work in ways that enable technically apt and ethically sound patient care, then what is needed is coordination of the institutions, organizations, resources and activities involved. Without doubt, this will entail considerable effort, which might make waves in the status quo; but we believe that it represents a worthwhile endeavor to achieve genuine and durable progress in the development and – right and good – use of neurotechnology in clinical practice.

 

ABOUT THE AUTHOR

James Giordano, PhD Adjunct Professor Director, Neuroethics Studies    James Giordano, PhD

James Giordano, PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.


 

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The Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.; Moisset, et al.; Avery, et al.; Fagerlund, et al.) and forms of deep brain stimulation) (Russo, et al.; Gosset, et al.; Boccard, et al.), and highly specific analgesic ligands and novel pharmaceutical delivery preparations (Tseng, et al.; Healy, et al.; Molet, et al.), may each and all have value in augmenting – or in certain circumstances, perhaps replacing – other methods of pain control.

But any such view to improved approaches to pediatric pain care must also acknowledge a host of neuroethical issues. Thus, while the use of assessment neurotechnologies may be seen as relatively low risk, we must still consider potential burdens and harms of over- or mis-reliance upon perceived objectivity, misdiagnosis, and bias and stigma (of predisposition to pain, and in the subsequent provision of care and social regard). And while interventional neurotechnologies offer great potential to effectively mitigate certain types of pain, we must acknowledge the intersection of unknowns arising from a tentative understanding of the brain, nascent neurotechnology, and the possible longitudinal effects of altering brain structure and function during development.

On one hand the need to address pediatric pain prompts calls for rapid translation of pain research to clinical assessment and care to lessen the burden of the suffering child. On the other, consideration, if not caution must be taken to avoid burdens and harms that may occur as a result of heightened expediency from bench-to-bedside. Tension between these motives could impede the scope and progress of neurotechnologically-based approaches to assessment and treatment of pediatric pain. How then to proceed?

Working in collaboration with Dr. Stefan Friedrichsdorf and his team at the Children’s Hospital and Clinics of Minneapolis, our group has called for a balance, in which we advocate prudent evaluation and use of tools and techniques of brain science that are currently and soon to be available confronting the problem of pediatric pain. Building upon prior work of Liana Buniak, current research scholars Dr. Faisal Akram and Christelle Khadra are addressing the neuroethical issues generated by neurotechnological approaches to assessment and care of pediatric pain.

We posit that priority must be given to:

  • Funding the development and articulation of prospective, longitudinal research in pediatric pain management focusing on the benefits of various types of assessment and intervention, and long-term bio-psychosocial consequences incurred by implementing – or not implementing – particular approaches.
  • Sustained discourse and deliberation focusing on the neuroethical issues associated with pain care in children;
  • Ongoing examination – and possible revision – of guidelines, policies and laws to insure the probity of pediatric pain research and clinical care.

Our group is fond of the adage “measure twice and cut once”, and we unapologetically re-assert this summons here. But it’s important to note that we do not advocate this as an “either/or” proposition, but instead as a “both/and” obligation to meet the neuroethical opportunities and challenges afforded by advancing brain science in the clinical care of those most vulnerable, and to sustain the right and good use of neuroscience and its technologies in society across generations.

James Giordano PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

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The Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.; Moisset, et al.; Avery, et al.; Fagerlund, et al.) and forms of deep brain stimulation) (Russo, et al.; Gosset, et al.; Boccard, et al.), and highly specific analgesic ligands and novel pharmaceutical delivery preparations (Tseng, et al.; Healy, et al.; Molet, et al.), may each and all have value in augmenting – or in certain circumstances, perhaps replacing – other methods of pain control.

But any such view to improved approaches to pediatric pain care must also acknowledge a host of neuroethical issues. Thus, while the use of assessment neurotechnologies may be seen as relatively low risk, we must still consider potential burdens and harms of over- or mis-reliance upon perceived objectivity, misdiagnosis, and bias and stigma (of predisposition to pain, and in the subsequent provision of care and social regard). And while interventional neurotechnologies offer great potential to effectively mitigate certain types of pain, we must acknowledge the intersection of unknowns arising from a tentative understanding of the brain, nascent neurotechnology, and the possible longitudinal effects of altering brain structure and function during development.

On one hand the need to address pediatric pain prompts calls for rapid translation of pain research to clinical assessment and care to lessen the burden of the suffering child. On the other, consideration, if not caution must be taken to avoid burdens and harms that may occur as a result of heightened expediency from bench-to-bedside. Tension between these motives could impede the scope and progress of neurotechnologically-based approaches to assessment and treatment of pediatric pain. How then to proceed?

Working in collaboration with Dr. Stefan Friedrichsdorf and his team at the Children’s Hospital and Clinics of Minneapolis, our group has called for a balance, in which we advocate prudent evaluation and use of tools and techniques of brain science that are currently and soon to be available confronting the problem of pediatric pain. Building upon prior work of Liana Buniak, current research scholars Dr. Faisal Akram and Christelle Khadra are addressing the neuroethical issues generated by neurotechnological approaches to assessment and care of pediatric pain.

We posit that priority must be given to:

  • Funding the development and articulation of prospective, longitudinal research in pediatric pain management focusing on the benefits of various types of assessment and intervention, and long-term bio-psychosocial consequences incurred by implementing – or not implementing – particular approaches.
  • Sustained discourse and deliberation focusing on the neuroethical issues associated with pain care in children;
  • Ongoing examination – and possible revision – of guidelines, policies and laws to insure the probity of pediatric pain research and clinical care.

 

Our group is fond of the adage “measure twice and cut once”, and we unapologetically re-assert this summons here. But it’s important to note that we do not advocate this as an “either/or” proposition, but instead as a “both/and” obligation to meet the neuroethical opportunities and challenges afforded by advancing brain science in the clinical care of those most vulnerable, and to sustain the right and good use of neuroscience and its technologies in society across generations.

 

James Giordano PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

 

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Neuroethics – Surfing the Waves of Neuroscience’s Hard Problem

BY JAMES GIORDANO, PhD

Recently, William Carroll of Blackfriars Hall at the University of Oxford reflected upon a Sunday NY Times article by Karl Ove Knausgaard about neurosurgery. Knausgaard marveled at both the subtlety of the technique (in the cases discussed, in the adept hands of noted neurosurgeon/author Dr. Henry Marsh), and at the idea that all of our thoughts, emotions, actions, if not our “self” might be nested within the folds and crevices of the brain. Carroll too appreciates the capabilities and insights of neuroscience, but ponders Knausgaard’s reductionist view, and in so doing offers the possibility for some middle ground between materialism and dualism. Caroll’s essay prompts us to confront what philosopher/cognitive scientist David Chalmers has called the ‘hard problem’ of neuroscience, namely, how the great stuff of consciousness occurs in the grey stuff of the brain. My colleagues Drs. Peter Moskovitz of George Washington University, and John Shook of the University of Buffalo and I have also been examining the “hard problem”, as well as the problem of falling into “is/ought” kinds of thinking when it comes to what the brain sciences can provide to conceptions of the self, sentience, morality and our social interactions.

Neuroscience, as a science (which possesses the tools, techniques and intent to only study the natural world) is based upon a philosophical ground of metaphysical naturalism, and as such, engages methodological naturalism. Tenets of naturalism include materialism and reductionism, but the brain sciences take some license here. Granted, neuroscience is unraveling more and more of the structure-function relationships of the brain. But the hard problem persists; and given the absence of tools or techniques to solve it at present, the most rational explanation of how the grey stuff is involved with the great stuff of consciousness and cognition relies upon token physicalism and/or inter-theoretical reduction as an explanatory model. Simply put, this posits that the contents of our subjective consciousness (i.e. – thoughts, feelings, emotions, etc.) represent tokens of some set of processes of the embodied brain (as it exists in an organism that is embedded in environments).

Any current postulate on how consciousness occurs (and what it really is) at best remains speculative. Here we could give a nod to theories of complexity and emergentism, but not too deeply, as we run risk of using one hypothetical simply to explain another (rather than actually doing justice to the explanans-explanandum relationship). As Carroll notes, from an Aristotelian-Thomistic perspective, brain science has afforded a pretty good view of material, and (especially when taken with other sciences) formal causality, but efficient causality – and final causality (if the latter is meaningful) – remain unexplained. So, let’s admit that there is much to nature that we still do not understand (else the mission of science would be moot), and that the core tenet of neuroscience, as science, is to remain self-critical and self-revising.

Is consciousness a mystery as Colin McGinn and his colleagues (“the mysterianists”) have asserted, or (as I tend to believe) a puzzle to be solved? Well, even McGinn has wavered a bit, moving from claims that we have reached a point of cognitive closure, to instead contending that our current state of understanding is best described as “approaching a cognitive cusp.” We may not solve the puzzle all at once, and I hold that like any really good puzzle, what is puzzling and important is both how the pieces or elements of the construct fit together and what they depict. But there’s arguably more to it: as we approach the puzzle it’s important to ask what it means, that is, what we will do with it, at varying stages and levels of solution. To paraphrase philosopher Hannah Arendt, what’s of real value is not just the work, but instead, is the intent of the task, and how we employ the outcomes of our labors at each step of the way.

Neuroscience can depict how brains work (albeit not completely). Putting neuroscience to work to describe what brain networks are involved in various cognitive, emotional and behavioral processes, including those involved in what individuals and communities hold to be “moral”, is noteworthy, and meaningful. But neuroscience can’t – and shouldn’t be used to – tell us how we ought to think, feel and behave, what morality is, or how to live the “good life”. Yet, the temptation to posit a purely biological basis for what is “normal”, “right”, and/or “good” looms large. Positing a “neuroscience of ethics” is fine on a descriptive level, but we must be critical of – and prepared for – attempts at using this to be prescriptive. And I perceive this as happening on a variety of levels, from the scientific to the socio-political.

Perhaps then, the really hard problem is knowing what to do with the information and capabilities we possess, what to do about the information and capabilities we lack, and knowing if we will be wise enough to know the difference, or recognize our own tendencies toward oversimplification and hubris. So, with a view to neuroscience – and neuroethics – I think that passively sitting upon a cognitive cusp is a precarious position that can foster hazardous perspectives upon the puzzles – and applications – of neuroscience. Brain science will, and arguably should, move forward, and such advancements will certainly exert effect in medical, legal and cultural domains. In light of this, I assert that we must actively “surf” a cognitive crest. This is where and why the discipline and practices of neuroethics as the “ethics of neuroscience” should come to the fore. How we surf, staying balanced and off the rocks, affords opportunity to gain insights to the task, provides a differing view of where we may be going (and from where we’ve come), and makes us better at staying afloat amongst waves of scientific discovery in an often changing, and sometimes stormy social sea.

 

James Giordano, PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

 

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Keeping up with PCCB’s James Giordano, PhD

Photo of James Giordano, PhD from http://www.ccnelsi.com/
Photo of James Giordano, PhD from http://www.ccnelsi.com/

 

If you’re interested in current issues and topics in neuroethics, be sure to keep up with PCCB’s Professor James Giordano, PhD. 

One of his most recent posts on BioMed Central’s blog discusses the increasing influence of neuroscience on the “world stage,” and both the promises and problems associated with this rapidly growing field.  Professor Giordano advocates for the simultaneous progression of neuroethics and neuroscience, suggesting that “there should be no new neuroscience without neuroethics.”

Connect with us and stay tuned for more from Professor Giordano and PCCB!

Neuroethics: Responsibilities at the Intersection of Brain Science and Society

BY JAMES GIORDANO, PHD

 

The term “neuroethics”, although first coined to describe ethical issues of neurology and the brain sciences, has obtained broader meaning and use. Cognitive scientist and philosopher Adina Roskies has claimed that the field addresses both the “neuroscience of ethics “and the “ethics of neuroscience”. Let’s delve into the first, and leave the second for later…and for a bit of balance. I think that the “neuroscience of ethics” is a somewhat inaccurate description. I offer that what’s really being studied are the structures and functions of the brain that are involved in the ways that moral thoughts (including emotions) are developed and processed, and how these are engaged in various actions in different environmental circumstances and situations. Our group refers to this as “neuro-ecology”: not to add yet another “neuro-neologism” to the fray, but to more accurately describe both the ways that these neural processes function – and what the field is dedicated to studying.

What is becoming clear is that moral cognition and decision-making doesn’t seem to be much different from any other forms of judgments and actions – at least on a neurological level. Moral decisions and behaviors involve memories, relating to others, reinforcements, anticipation of and response to rewards and punishments, and emotions of pleasure, discomfort, and pain. There isn’t a “moral center”, some “nucleus moralis” in the brain.

Current evidence reveals that a number of brain structures can be involved in what are construed to be moral decisions. Every decision and action – whether considered to be moral or otherwise – involves a perception of the circumstances and actors involved, some orientation to a prior event that was similar or referential to the present situation, recall of actions – of self and others – and their consequences, and recollection of the emotions that the actions and outcomes evoked.

It’s also likely that we develop these functions as a result of interactions and experiences throughout our lifetimes. We possess sensitivity and capability to respond to cues, and learn from our environment and from others (barring of course, certain disorders, such as psychopathy, that render these processes dysfunctional). We have innate skills that establish a proto-moral groundwork, and enable us to acquire a sense of “good”, “bad” “right”, and “wrong” from an increasing circle of others (e.g.- family, friends, strangers and the not-so-friendly) and interactions with the communities in which we live, and formal and informal institutions, mores and norms we encounter.

The functional patterns of brain activity involved in moral-type thoughts – and resulting decisions and behaviors – appear to differ based on a number of factors, including age (i.e.- adolescents seem to be more self-centered, as if this were a great surprise), sex (i.e.- females appear to be somewhat more perceptive and responsive to others’ emotions… perhaps no great shock there either), group influence, first or third person perspectives , and outcomes (yes, it does seem that everyone appears to have “a price” that might make them change their mind about moral matters!) .

Although we tend to use “preferred” or learned cognitive patterns and beliefs in our intuitions, rationalizations and judgments, it appears that each of us actually employs a range of cognitive reasoning functions and abilities when faced with a problem or decision that we hold to be “moral” in its value and effect. In short, moral cognition involves reasoning and justification processes that are more of an admixture of ethical precepts. We are all ethical polymaths, at least to some extent.

Can “the neuroscience of ethics” tell us what is “good”, and how to live our lives? No, not really; but neuroscience can provide insights to how various circumstances, actions and effects influence the brain, and what and how brain functions are involved in various thoughts, emotions and behaviors. What’s more neuroscience affords tools to access and affect the brain, and the ways we think, emote and act.

And therein lies the interaction with – and need for- the “ethics of neuroscience”. Regardless of how we put neuroscience to work, it’s vital to address the ways that various techniques and tools are used in brain research, and how the results and products of brain science are used in larger contexts of medicine, individual and public life, and in social and political spheres.

There is great power in the capabilities of neuroscience. With power comes profound responsibility, and this responsibility is borne by the field of neuroethics. Thus, it will be increasingly important to develop, cultivate and sustain the field through supported programs of neuroethics education and training, at a variety of levels. Elsewhere, I’ve called for “no new neuroscience without neuroethics”, and un-apologetically do so again here. Indeed, what we do with neuroethics will be critical to what we do both in brain science, and with the knowledge and abilities it conveys – both now and in the future.

Dr. James Giordano is Chief of the Neuroethics Studies Program in the Pellegrino Center for Clinical Bioethics, Co-director of the O’Neill Institute-Pellegrino Center Program for Brain Science and Global Health Law and Policy, and Professor in the Department of Neurology at Georgetown University Medical Center.   To learn more about his work, go to: www.neurobioethics.org.

 

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