Category Archives: Neurotechnology

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

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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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