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Posts by James Giordano, PhD

Good for You? Good for Me! Flattening the Curve through the Combinations of Altruism

By Will McCreadie and James Giordano PhD

The Arabian Babbler bird is unusually generous; babblers sing and dance together, give gifts to each other, groom one another, and even compete fiercely for the privilege of helping their peers.  They feed each other’s young and vie to guard the territory while the others in their group forage.  As a species, they exemplify traits of altruism – acts of benefiting others – along a spectrum of egoism (i.e.- eliciting some relative benefit to self). Within this spectrum is competitive altruism, wherein agents act in ways that appear “selfless”, but which enable their own gain by affording some advantage within and among others. As well, there is reciprocal altruism, which entails giving in order to obtain something in return. These are not mutually exclusive; altruistic behaviors often send strong social signals that can boost the giver’s reputation.  This can lead to upward mobility within a group, and augment self-worth and well-being, as sustained by their position and supportive actions of the group, in the future.

As we have noted, every altruistic act has an egoistic component. It’s how brains work: we sense and perceive the world (and our place and status within it) through the subjective lens of self-embodiment. On some level, whether subtly or overtly, we weigh our choices and decisions for action upon the consequences that will be incurred (for ourselves) in and along temporal scale (i.e.- “Being good to others affords some good for me now and/or good for me later”, etc.). It seems that competitive giving can result in more prosocial behavior than anonymous altruism alone. Competitive altruism plays an significant role in human generosity, and allows for a deeper understanding of how people are responding to COVID-19. In turn, this may allow better incentivization(s) for altruism. Such incentives characteristically appeal to the key factors of social signaling: visibility, credibility, and social resonance.

Visibility

For generosity to be a social signal, it must be noticeable – or at least recognizable. This helps to explain why very few donations are anonymous.  A 2019 study of GoFundMe data revealed that only 21% of donations were made anonymously, and the median anonymous donation was less than the median attributed donation.  This is consistent with prior work that has shown that people tend to be far more generous when their giving is public. Clearly, visibility of some form and level plays a critical role in most peoples’ giving.

Credibility

The ethologist Amotz Zahavi was among the first to propose that an altruistic act can be a social signal, and this precept was a foundational element of what he called the handicap principle.  In this framework, making a sacrifice signals evolutionary fitness because it is a costly (and therefore hard to fake) sign that the giver is “well-off” enough to be generous. Thus, more significant acts of altruism send stronger – and better – social signals.

Social Resonance

Social norms also contribute to the valuation of particular signal. In the short- or long-term, the signal must convey something of benefit, both to the group and the giver about what is given, as well as what will be perceived as the relative value of the identity, role, and/or place of the giver within the social ecology, in order to make the signal of the altruistic act(s) worthwhile.

Altruism and COVID-19

There are two reasons to care about the spectrum of altruism as we fight the pandemic.  First, it explains acts of giving that might seem otherwise irrational. Most charitable behaviors appear to make little “egoistic” sense, because the cost of the action(s) is, by definition, to the giver, and not explicitly recouped. In other words, the proverbial “juice” does not seem to be “worth the squeeze”. But it depends on what juice, how much, and who’s savoring it.  Both reciprocal and competitive altruism expand constructs and contexts of costs and benefits to include status.  While there’s an initial cost to giving, the benefactor can increase their social status if the signal is visible, credible, and resonant.

Second, competitive giving can result in better outcomes for society as a whole. If one person donates an hour of their time to fighting the virus, someone else may contribute an hour and a half, escalating the social standard for acceptable contribution.  If these signals are visible and valuable, someone else – who perhaps wouldn’t otherwise make a contribution – may step in, feeling some socially related self-referential impetus to be at least as good as their peers. Scaling this dynamic across millions of people can radically augment our response to the virus.

Mask Wearing: Competitive Altruism Creating a New Norm

Masks are one of the most economically attractive coronavirus responses, because they offer considerable benefit for minimal cost. It’s been projected that if 95% of people wear a mask in public gatherings of any sort, 67,000 American lives could be saved by December 1st.

However, mask wearing is still far from universal. It’s been shown that men are particularly resistant to wearing face coverings, and are more likely to feel that masks are “uncool” and “signs of weakness”.

Competitive altruism could play a role in mitigating or reversing this trend. Masks are already visible and reliable signals (it’s hard to fake wearing one), but it will be important, and may be necessary to establish mask-wearing status competitiveness in order to prompt new social norms.

As we’ve noted before, it’s time for masks to be considered aspirational and ‘cool’.  Normalizing masks as an extension of personal identity and benevolent intent increases their social resonance. This sends signals that make it more “competitively desirable” for people to wear masks in public amidst the ongoing COVID crisis; establishing mask-wearers as “crusaders against COVID” and contributory to social welfare. In this way, they take on a heroically giving aspect to their social identity. And, if masks are considered fashionable, people can seek status by choosing expressive materials and creative designs. The more perceived effort someone puts into their mask habits (even if that perception is one of “I ordinarily would never wear a mask, but for the good of others, I will”), the more robustly reliable the signal, and the greater the potential for positive competition and its beneficial social effect(s).

If people can compete to protect each other (i.e.- competitive cooperative altruism), the greater the common good. Indeed, we can gain considerable insight from the past: Aristotle was right – doing good for others is rewarding for oneself. As we fight the pandemic, we should stop babbling about wearing or not wearing a mask, and embrace masks – and our actions for others – as a form of positive self-expression, with attributes for both ourselves and society.

 

Accept the Responsibilities of Participating in Public Health

By James Giordano PhD, Professor, Departments of Neurology and Biochemistry and Senior Scholar-in-Residence, Pellegrino Center for Clinical Bioethics

The SARS-CoV-2 virus is not taking the summer off.  Recent studies by Stephanhie Pfänder and colleagues at Ruhr University Bochum (GER) have shown that the virus remains viable for almost 18 hours at temperatures of 86 degrees Fahrenheit.

While many constraints on business openings and social gatherings have relaxed, COVID hasn’t cratered, and current efforts to regain socio-economic stability, while still being topics of contention in government, are in fact precariously balanced upon peoples’ participation in doing what it takes to sustain public health.

Public health is about us, but cannot happen without us; because we are that public. It is our health, individually and collectively, that is the goal, and as such we must be – and remain – committed to the process. Continue to maintain physical distancing when out in the community, and acknowledge and accept that being in public spaces requires your active role in public health.

So, when out and about, cover your nose and mouth:

ACCEPT THE TASK .  .  . WEAR A MASK.

Photo: St. Ignatius Masked at Loyola U Medical Center Maywood Illiniois. Photo courtesy Daniel Dillinger MD

Wearing Masks and Asserting Meaning: Insights from the Neurocognitive Science of Cool

By Will McCreadie and  James Giordano, PhD

Beginning this week, the nation as a whole will attempt relaxation of social restriction, re-engagement of public activities, and re-opening of certain businesses and venues. Four months ago, people wearing masks stood out. Now it’s those who don’t that often catch a sideways glance. Yet, despite the ongoing risk of infection amidst calls and efforts for relaxing social restrictions, some people are rebelling against wearing protective gear. Just this past weekend, when one maskless family was asked on the street about their lack of PPE, they responded, almost in unison “masks aren’t cool”. At the same time, A-list celebrities like Jennifer Lopez and Alex Rodriguez have been “corona-shamed” and labeled arrogant for not wearing masks. Why the discrepancy?

Research in neurocognitive science suggests that sentiments of “cool” are actually a complex combination of feelings of fear and aspiration. It combines the desire to be differentiated with the need to feel accepted. Studies indicate that deciding something is cool draws on two functional systems of the brain: the default mode network (DMN), and the salience network (SN). The DMN is linked to introspection and the determination of value – the rewards associated with being “cool”, while the SN plays a role in fear (often seeking to balance fears of both the behavior in question, and of being ostracized).

Such patterns of thought, emotion, and behavior are the focus of somewhat new disciplines of neuroeconomics and neuromarketing. The use of masks provides a perfect natural experiment to gauge how “cool” works, because they haven’t been common in our society since the 1918 flu pandemic, and have been now thrust into the social-spotlight.

When deciding if something is “cool,” our brains calculate the relative benefits and costs of that choice. We rarely need to ponder this judgement; we just “feel it”. The human brain takes less than 300 milliseconds to form an opinion, assessing events and consequences in our past, with the current situation, and making predictions about the near-term and future consequences of our decisions and actions. This is the phenomenon of automatic valuation.

Deciding whether something is cool, and worth the “investment” in terms of benefit, burden, and risk, comes down to figuring out what maximizes its – and your – utility. Our brains go through a rapid series of inquiry: Will this choice help me or hurt me? In the near term, or in the future? Is it the best of my available options? People aren’t perfectly rational, so we tend to base decisions and actions upon our beliefs and experience of what’s most useful.

In the case of masks, the obvious tradeoff is freedom versus safety; but considering “cool” in the equation demonstrates that other forces are also at work. What we find “cool” and feel good about depends on the image of ourselves we want to convey. We are strongly social creatures, who are sensitive to the ways we’re regarded. Whether or not you wear a mask conveys a signal (even if you don’t realize it). Social signaling plays a significant role in what we wear, and do.

This partly explains the divide in public stances on PPE. In neuroeconomic terms, masks are an identity good. People who wear masks (or dress up their Twitter profiles with mask pics) may hope to signal their virtue and intelligence, by highlighting the relative sacrifice of their comfort, both for the good of others (and for their own good – both to prevent infection, and to be perceived as socially responsible). People making unusual homemade masks may seek to highlight their resourcefulness and creativity. Those without masks are signaling something else: confidence, rebelliousness, bravery, or foolishness and selfishness — depending on your perspective.

There is also a status system in mask culture. Any recollection of middle school will surely bring to mind the in-group/out-group dynamic that plays a substantive part in determining what we find cool: with people on the “outside” aspiring to copy and outdo people on the “inside” to gain acceptance. Primate studies show this hierarchical behavior to be a side-effect of evolution. Status, and belonging to an in-group were valuable for our ancestors because the chances of survival were higher for a group member than an outcast. This primal need to conform may be a one of the factors in seeking to be “cool”. At the same time, no one wants to feel like a faceless member of the herd. To be cool, we strive for acceptance without homogeneity, and differentiation without alienation from the group.

Almost overnight COVID-19 has created a new in-group: people wearing masks. Like any major trend, there are subgroups within the mask-wearing set. The professional grade mask signals that you either are a “front-line” worker, that you have enough money to afford a scarce item, or that you’ve got good connections. People in different age groups also try to gain status by signaling different things. Teens, for example, may want branded masks (searches for designer masks increased 100-fold from mid-February to mid-April). Part of the reason why a teen covets a Supreme face mask ($450 online if you can get it), while their parents would never wear one, is that their peer groups value different things. Teens tend to want to be edgy and unique.

A significant element of cool in the age of COVID-19 is competitive – and reciprocal – altruism, which is another form of social signaling. Whether it’s the CEO of Flexport sending 3 million masks to Amsterdam, or the CEO of Twitter giving away almost a billion dollars and tracking it in a Google spreadsheet, people and companies are vying to be the most creative and effective responders to the virus. If selflessness wasn’t a valuable social signal, people would make these donations anonymously. Our research has shown that every altruistic act has an egoistic component. It’s “cool to be kind”, and as a result such acts of altruism make the actor feel good.

For many people, masks are an entirely new form of self-expression whose usefulness goes beyond their protective benefit. Simply put, as we strive to re-start our socio-economic engines for the benefit of both individuals and the population at large, masks are a currency of capability and cool. So, whether it’s making a statement of individualism, asserting acts of altruism, or evidencing a stance of responsibility, masks are a medium to represent ourselves in a commitment to each other.

Will McCreadie studies computer science and economics at Georgetown University, where he is a Baker Scholar and a Carroll Fellow.  His research in neuroeconomics examines the neurological underpinnings of decision-making.  Will’s current work explores the biological causes and economic implications of the human desire to be accepted.  He is on Twitter @McCreadieWill

James Giordano PhD is Professor in the Departments of Neurology and Biochemistry, Chief of the Neuroethics Studies Program, and Senior Scholar-in-Residence of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.

Navigating the COVID Crisis: A Call to Virtue, and Hope for Prudence

 

By James Giordano, PhD, MPhil

“Lead; follow; or get out of the way.”

Lee Iacocca

 

The COVID-19 crisis has impacted each and all in ways that range from inconvenience to inconsolable loss. Such times bring into stark relief the need – and ethical obligation – for an open society’s political establishment to exercise its purpose, process, and leadership to protect the polis it serves. This mandates comprehensive appraisal of all available information and establishment of facts – defined as “something known or proved to be true” – with recognition that facts can and often do change as a consequence of more detailed investigation and evolution of circumstance. Facts provide the basis for developing knowledge. This knowledge is important to effectively inform decision-making, develop planning, prepare necessary responses, and maintain public awareness, guidance, and trust.

A number of years ago, I was involved in a NATO modelling exercise that was intended to assess relative capabilities and weaknesses in United States’ biosecurity readiness and response. I had the interesting distinction of directing the “bad guy team” – to simulate development and implementation of a “biological agent” that would pose a potentially expansive threat to public health, safety, and stability. Interestingly, the exercise illustrated that the disruptive and ultimately destructive factor was not the biological agent itself, but rather the spread of misinformation, which heightened peoples’ uncertainties, preyed upon their relative lack of understanding of science, and manipulated the public need for sound, stable leadership.  In other words, it wasn’t the bug, but the bamboozling that fractured public trust, disrupted the capability of government, and created further opportunities for destructive effects in biomedical, socio-economic, and cultural domains and dimensions.

As the simulation played out, the “good guys” could not initially stem the tide of disruption that misinformation, miscommunication, and mistrust created.  To rebound and regain national stability required a concentrated, dedicated effort of establishing credible resources, providing accurate, appropriately communicated information, and fostering and sustaining cooperation and collaboration. Crucial to this enterprise was sound leadership, which served as a sail, rudder, and keel to “take the wind of change” – regardless of direction, intensity, and harshness – and harness it to steadily steer ahead a recuperative path. Such leadership requires trust, teamwork, and respect for and reliance upon those who are best qualified to navigate often treacherous courses, so as to “lead from the front of the boat.”

Sound leadership entails ethical stewardship of power. Ethical leadership responsibly assumes both the benefit and burden of command – in often self-effacing ways – so as to maximize the good of those being led, especially in times of uncertainty, insecurity, and need. The country – and world – is faced with a pandemic.  Professional forums and media of all sorts are rife with bellicose language about “fighting the war” on this “adversary,” the SARS-Cov-2 virus.

Such talk may be familiar to prior generations’ recall of mobilization of national resources during World War II, efforts of the space race, and in more recent memory, the aftermath of 9/11.  For a more biomedical example, we look back to the influenza pandemic of 1918, compare the morbidity and mortality it sustained to losses during the first world war, and frame the impact of the current COVID-crisis in terms of casualties of recent wars in the Middle East and Viet Nam. Perhaps such rhetoric is useful, as it drums up public spirit, poses a “grand challenge,” and harnesses “big science” to engage a common cause.

But if we use such language, and exemplify the triumphs of previous bellicose efforts, then we must also examine when, how, and why similar endeavors failed. History is rich with international and domestic instances of leaders who did not respect the wisdom and heed the counsel of expert field commanders, intelligence services, scientists and engineers. In so doing, those leaders fell prey to intellectual shortsightedness, egotism and/or narcissism, and as a result, acted impulsively and foolishly at least, and in ways gravely erroneous – and with dismal consequences – at worst. Let both the successes and failures of the past serve as lessons to be learned.

To be sure, the COVID crisis is humbling in many ways. It has brought to light our vulnerabilities and threatens much that we value. This is not the time for hubris, a lack of veracity, vindictiveness, or sarcasm. The public is anxious if not frightened. The present is wrought with burden and the future is uncertain. As a scientist, I call for confidence in, and reporting of facts – as they are known, and as they change. As an ethicist, I know all too well the importance of facts to decision-making and reasoned action, and I implore the need for responsible cooperation, collaboration, and communication. And as a citizen, I hope for an end to petty partisanry, and the sound shepherding of truth, intention, and commitment to assume a more prudent path through – and recovery from – this pandemic.

James Giordano PhD, MPhil, is Senior Scholar-in-Residence of the Pellegrino Center for Clinical Bioethics, and Professor in the Departments of Neurology and Biochemistry at Georgetown University Medical Center, Washington, DC.  For more of Dr. Giordano’s work on COVID-19, please visit our web site.

Stem Cells for Central Neurotrauma

BY SAM WU, BS, KEVIN T. FITZGERALD, SJ, PhD, and JAMES GIORDANO, PhD

Central neurotrauma: epidemiological and social impacts

Central neurotrauma – or insult to the central nervous system that results in disturbance or loss of neural circuitry, axonal pathways, or neural cells – such as, spinal cord injury (SCI) traumatic brain injury (TBI), and stroke can incur significant impact on patients’ quality of life (Struzyna, et al., 2017; Wu, FitzGerald, and Giordano, 2018). The National Spinal Cord Injury Statistical Center estimates that in 2017, 285,000 persons in the U.S. were living with spinal cord injury (SCI) (National Spinal Cord Injury Database, 2017). In addition, TBI affects approximately 1.5-2 million persons annually in the U.S., with 75,000 to 100,000 of these cases being severe (Johnson, Stewart, and Smith, 2013; Bose, Hou, and Thompson, 2015), while stroke causes 1 out of every 20 deaths in the US annually (Yang, et al., 2017).

The impact of central neurotrauma can be both short- and long-term, with neurological damage and accompanying symptoms lasting for months, years, or even for the remainder of a person’s life. In part, this is because the adult nervous system has only limited ability to regenerate neurons and repair itself following major injury (Struzyna, et al., 2017; Wu, FitzGerald, and Giordano, 2018). Signs and symptoms vary with the type and severity of neurotrauma, and can include sensory, motor and autonomic impairment (Johnson, Stewart, and Smith, 2013; Bose, Hou, and Thompson, 2015; Tsintou, Dalamagkas, and Seifalian, 2015). While pharmacological and surgical interventions can provide some value in managing certain symptoms, these approaches are often of only limited benefit, and do not repair structural damage or lead to replacement of lost tissue (Kabu, et al., 2016; Diaz-Arrastia, et al., 2014; Bansal, et al., 2014; Cramer, 2015).

 

The potential of regenerative therapies

In light of this situation, there are considerable clinical and socioeconomic incentives to develop more effective regenerative treatments for central neurotrauma.  Among these are cell-based approaches, intended for use either singularly or in combination with pharmacological and/or structural treatments (Fouad, et al., 2005; Oraee-Yazdani, et al., 2016; Bento, et al., 2017). Therapies currently being explored for neuro-regenerative and reparative properties involve the use of pluripotent cells derived from embryonic stem cells, fetal stem cells, mesenchymal stem cells, adult neural stem cells (NSCs), induced pluripotent stem cells (iPSCs), Schwann cells, or olfactory ensheathing cells (Wu, FitzGerald, Giordano, 2018).

Preclinical trials of some of these cell-based therapies have had promising outcomes, and are facilitating the possible use of certain types of stem cell interventions for central neurotrauma in human clinical applications. For example, transplanted NSCs have provided neuroprotection, neurotrophic support, immunomodulation, and cell replacement – all of which enable neuroregeneration in the injured CNS (Martino and Pluchino, 2006; Jin, et al., 2011; Pluchino, et al., 2005; Bonner, et al., 2011). Furthermore, mesenchymal stem cells, which are relatively easy to obtain from multiple allogeneic and autologous sources, have been widely used in SCI clinical trials (Wu, FitzGerald, Giordano, 2018). In contrast, translation of other stem cell-based therapies, such as those involving embryonic stem cells or fetal stem cells, have been hindered by technical and ethical challenges related to procurement, transplantation (Nakamura and Okano, 2013; Hockemeyer and Jaenisch, 2016), and safety (Sadowski, et al, 2010; Webowetski-Ogilvie, et al., 2009).

Reprogramming strategies open the door for new possibilities

Improved techniques for cellular reprogramming have enabled the use of other autologous cell sources to be induced to become pluri- or multi-potent stem cells. These reprogrammed cells can alleviate concerns about incompatibility and rejection when transplanted. Combinations of specific transcription factors can be used to generate iPSCs or NSCs from autologous somatic cells (such as fibroblasts, melanocytes, adipocytes, mesenchymal stem cells, cord blood, and others) (Yamanaka, Ralston, and Stephenson, 2006; Kim, et al., 2009; Sun, et al., 2009). Additionally, reprogramming techniques can be used to convert somatic cells directly into neural precursor cells (NPCs) or NSCs, without having to go through intermediate pluripotent stages that may increase the risk of mutagenesis and tumorigenicity (Kelaini, Cochrane and Margariti, 2014; Lujan, et al., 2012; Shahbazi, et al., 2016; Wu, FitzGerald, Giordano, 2018).

Persistent concerns

While research suggests the potential of these innovative stem cell-based therapies for neuro-regeneration and repair, ongoing technical, ethical, legal, and social issues remain and must be addressed. These issues include the validity of patient informed consent given for a particular procedure (in part due to the relative lack of information about the long-term characteristics of reprogrammed cells), the provision and distribution of stem cell resources (inclusive of possible venues for medical tourism), and the importance – if not necessity – of continuing studies of, and clinical care for, those patients receiving reprogrammed neural stem cells (Giordano, 2011; Giordano, 2017; Giordano, 2015; Wu, FitzGerald, and Giordano, 2018).

With reflection upon the past, engagement in the present, and a keen and prudent eye toward the future, it is likely that the most viable regenerative approach to treating central neurotrauma will involve a combination of customizable interventions, inclusive of the use of current and newly developed stem cell technologies. A priority toward realizing these treatments will be the time- and cost-efficient development of high-quality cells that can be translated into safe, affordable and accessible clinical therapies. To achieve this goal will require the increased and ongoing cooperation and collaboration of science, medicine, economics, and policy to ensure that the most valuable therapies are pursued and provided to patients in need.

See On the Viability and Potential Value of Stem Cells for Repair and Treatment of Central Neurotrauma: Overview and Speculations for a more comprehensive review of current and emerging stem cell technologies for central neurotrauma.

 

ABOUT THE AUTHORS


 

Sam Wu, BS is Program Manager and Research Assistant at the Pellegrino Center for Clinical Bioethics.  Sam is completing a MS in Clinical and Translational Research at Georgetown University. 

 

 

Kevin T. FitzGerald, SJ, PhD is the John A. Creighton University Chair and Professor in the Creighton University School of Medicine, Department of Medical Education.  He joins Creighton from Georgetown University, where he was the Dr. David Lauler Chair of Catholic Health Care Ethics in the Pellegrino Center for Clinical Bioethics.  

 

giordano-2017

James Giordano, PhD, MPhil is Chief of the Neuroethics Studies Program and Scholar-in-Residence at the Pellegrino Center for Clinical Bioethics, Professor in the Departments of Neurology and Biochemistry at Georgetown University Medical Center.  He is also Distinguished Visiting Professor of Brain Science, Health Promotions and Ethics at the Coburg University of Applied Sciences, Health Promotions and Ethics at the Coburg University of Applied Sciences, Coburg, Germany.  He currently serves as an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council on Human Research Protections.

 

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“Philosophy and ethics in the frontiers of brain science”

“With large scale international programs entering new phases, upcoming meetings and a growing debate, new discoveries in brain science always keep fostering ethical and social questions. Philosophy matters, in this field more than in any other, because it reminds us that science sometimes is not only obtaining new facts, but also engaging new ways of thinking about them.”

New Post from Dr. James Giordano on BioMed Central Blog.

The Dangers and Challenges of Weaponizable Neuroscience: A Call for Renewed Engagement

Photo Source: This Image was released by the United States Navy with the ID 021015-N-6996M-109 (http://bit.ly/2oQFUdh)

 

BY DR. DIANE DIEULIIS and DR. JAMES GIORDANO

The chemical weapon attack in Syria that has killed at least 70 people employed the nerve gas sarin. And, it is believed that it was the nerve agent VX that was used to assassinate Kim Jong-nam in a public airport. These uses of nerve agents violate the international Chemical Weapons Convention (CWC). While the Syrian government signed the CWC in 2013, it was never ratified, and of course, signatory agreement does not guarantee compliance. Nor do such treaties among nation states necessarily provide any security against the development and use of biological and chemical weapons by non-state actors. These events are disturbing and, we believe, portend a larger, and ever growing issue of how such neurological agents could be used, altered and/or developed anew as weapons.

International advances in brain science over the past decade are enabling ever greater capabilities to control neurological processes of thought, emotion and behavior. So, while the CWC and Biological Toxin and Weapons Convention (BTWC) prohibit development of drugs, microbes and toxins that can be made into weapons, these prohibitions are not absolute – many of these substances can be – and are – used in basic neuroscience research, or in research programs that seek to develop defenses against biochemical weapons. What’s more, new tools and methods with which to edit genes, such as CRISPR/Cas9, can make it easier to modify bacteria, viruses or certain toxins to be weaponized. Until recently, these approaches were regarded as not yet ready for human applications; but the use of CRISPR-modified cells in humans by scientists in China has established both a new timetable and a new level of risk for such possibilities. Gene editing kits are commercially available and not excessively expensive. Thus, real concerns arise about the ability of both state and non-state actors to bio-engineer agents, including those that act on the nervous system. In light of this, last year, then Director of National Intelligence James Clapper identified the very real potential to use gene editing to create lethal or highly disruptive biological agents; a warning that was seconded by the President’s Council of Advisors on Science and Technology (PCAST).

In its military response to the events in Syria, the United States government has strongly communicated that continued use of these agents ‘…crosses a line’.   Indeed it has. The time to “wait and see” if neuroweapons will be developed and used has passed. The specter of available agents has been realized, and with it, should be recognition that the tools that make science easier to execute, and more accessible, should also prompt revision of the ways such methods and products are regarded and regulated. Indeed, recognizing the risk and growing threat of neuroweapons is important; but we believe insufficient. There is profound ethical obligation to acknowledge that science and technology can be used to harm as well as heal. As we further make strides to explore and affect the brain, it is critical to pay close attention to the directions that each and every step may lead. Thus, it will be essential to pursue and obtain a deeper and fuller understanding of the ways brain science can be harnessed to create weapons, and to establish more comprehensive, ethical guidelines and oversight policies.

A working group of the European Union’s Human Brain Project (HBP) is focusing efforts on a thorough review of what constitutes ‘dual use’ applications of brain science, both within the HBP programs, and more broadly; recommending more stringent policies for regulation of neuroscientific research that can be employed in such ways. This is laudable and noteworthy, even if only as a first step. But perhaps the more imposing issues remain: such research will still likely be conducted by individuals and groups that do need heed proposed guidelines or policies; and while it may be possible to regulate research (at least to some extent), the use of neuroweapons by state and non- state actors is far more difficult to address and control. Let these challenges serve as opportunities for action. We suggest that the scientific executive committees of both the BTWC and CWC could be utilized as forums for acknowledging and assessing the potential risks and threats posed by current and near-term capabilities in brain science, and that the international community of brain scientists and ethicists further proactive discourse and engagement toward informing and developing policies and regulations to govern dual-use neuroscientific research and its applications. We believe that such action would represent a necessary response to a real and growing danger.

Diane DiEuliis

James Giordano

 


ABOUT THE AUTHORS

dieuliis-diane

Dr. Diane DiEuliis is Professor at National Defense University, in the Center for the Study of Weapons of Mass Destruction. Her research areas focus on emerging biological technologies, biodefense, and preparedness for biothreats. Dr. DiEuliis also studies issues related to dual use research, disaster recovery research, and behavioral, cognitive, and social science as it relates to important aspects of deterrence and preparedness.

giordano-2017Dr. James Giordano is Professor in the Departments of Neurology and Biochemistry, Chief of the Neuroethics Studies Program in the Pellegrino Center for Clinical Bioethics, and Co-director of the O’Neill-Pellegrino Program for Brain Sciences and Global Health Law and Policy at the Georgetown University Medical Center. He serves as a Task Leader and Researcher of the EU Human Brain Project’s Working Group on Dual-Use, and is an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council for Human Research Protections.

 

The views expressed in this blog do not necessarily represent those of the EU Human Brain Project, the US Department of Health and Human Services, or the United States Department of Defense.


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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.

 

Connect with PCCB for more updates on our research and events:

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