neurotech policy james j. hughes ph.d. executive director, institute for ethics and emerging...
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Neurotech Policy
James J. Hughes Ph.D.Executive Director, Institute for Ethics and Emerging Technologies
Public Policy Studies, Trinity College, Hartford CT
January 10, 2012 Trinity College, Hartford CT
Institute for Ethics and Emerging Technologies
Broad Frame for Neurotech
Internal
External
Hardware Software
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External Hardware
Pictures, written language and numbers outsourced the brain
Started with clay and paperToday wearable computersSmart phones Aug cogThe wireless
exo-cortex
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External Software
Communication with other people: verbal, electronic
Collaborative knowledge: Meetings, Markets, Wikipedia, Google
Calendars & To do lists Info visualization Biofeedback Expert systems and
intelligent agents
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Internal Hardware
Nutritional supplements Clinical drugs Stem cells and tissue engineering Deep brain stimulation Gene therapies Brain-computer interfaces Transcranial magnetic stimulation Nanorobotics
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Countervailing Influences
Science Policy
Consumer Lobbies
IndustryLobbies
(Phrma, NIO, etc)
Experts (NAS, etc.)
Medical Associations(AMA, etc)
Thinktanks (Brookings, AEI, Cato,
etc.)
Points of Influence
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NIH/NIMH funding of
basic research
Private investment
Product Development
FDAClinical Trials
Development of Standards
of Care
Public Insurance Coverage
PrivateInsurance Coverage
Post Approval Surveillance
and Research
DEA/criminal control of off-label use and illegal drugs
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Pro-Science Citizen Lobbies
Disease lobbies
JDRF, ACT-UP, Alzheimers
Stem cell research lobby groups
State stem cell funding campaigns
Consumer protection groups
Critiquing politicized science policy
Anti-psychiatry groups
Mental patients rights, Aspie rights, Scientology
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Neuroprosthetics & NNI
NIH Neural Prosthesis Program Cochlear & retinal
implants Peripheral neural
prosthetics Brain implants
National Nanotechnology Program Ethical, Legal and Other
Societal Issues
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Prosthetic Limbs
Indirect neural control
Direct neural control
Haptic feedback
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NBIC Convergence
Nano-Bio-Info-Cogno Program (2003-) Psychopharmacology Genetic engineering Nanotechnology Artificial intelligence Cognitive science
The accelerating convergence of all these for “enhancing human performance”
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Cognos and Brain Modeling
Modeling brain systems and cognitive processes will allow rapid testing of neurotechnology
Blue Brain Project (IBM, Swiss)
Cognos Project Finetuning of evolving
exocerebrum against models of the neocortex
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Tissue Engineering
Stem cells engineered into therapeutic neural tissue
Nanomaterials as scaffolding and mesh around which stem cells can grow tissues and neural bridges
Using electrical stimulation of cells through the mesh to control the growth of the tissue
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Deep Brain Stimulation
DepressionObsessive-compulsive disorder
1% of the population has seizure disorders, such asEpilepsy Parkinsons Disease
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Cochlear and Visual Implants
By 2010, approximately 219,000 people worldwide received cochlear implants.
In US, 42,600 adults and 28,400 children received them.
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Brain Damage & Neuroprosthetics
Post-stroke brain injury is leading cause of disability in U.S.
One in 250 suffer from the effects of head injuries
About 750,000 people with cerebral palsy in the U.S.
About 75,000 quadriplegics in the U.S.
Lou Gehrig's Disease or ALS and muscular dystrophy each effects about 15,000 Americans
“Locked-in state”
Neuro-regenerative Rx
Neuroprosthetics
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Brain-Computer Interfaces
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NanoNeural Robotics
Ray Kurzweil 2030s? Self-replicating Two-way
communication with trillions of neurons
Networked inside and out
Perfect virtual reality, mind back-up, upload
Non-Problems & Old Problems
Some ethical issues are false problems, at least from an Enlightenment POV
Others are old problems, like ensuring safety and access
A few are novel because of the efficacy of neuroprosthetics
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Non-Problems
Supersoldiers Sports enhancement Disappearing disabled cultures Authenticity
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SuperSoldiers
Ethics of military force, or of military applications
Does neurotech change likelihood of exploiting soldiers
as guinea pigs or in the field ability to exercise judgment in
field, reduce collateral damage (drones)
likelihood of engaging in conflicts
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Sports Enhancement
ADD drugs?Sports is a rule-
governed gameIf athletes want to use
neurotechnology to compete they can start their own leagues
Not relevant to society
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Disappearing Disabilities
99% of disabled happy to give up their disabilities
Only children forced to use Last century: dramatic decline in
veteran and civilian amputees 1000 amputees from Iraq/Afghan vets 1000+ surgeons in Civil War, 60,000+
amputees Changes cost-benefit analysis for
social priority-setting (Loeb) Difficulty in commercializing the direct
neural control prosthethics developed by DARPA or others
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“Authenticity”
Avoidance of SSRIs, ADD drugs
Not human, not me
ButSelf image is
malleableProsthetics easily
incorporated
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Old Problems
Safety of devices Autonomy and addiction Moving line between
disability/normal/enhanced
Unequal access Ownership & intellectual
property Privacy & cybersecurity
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Safety
Federal Food, Drug, and Cosmetic Act covers all implants and other devices "intended to affect the structure or any function of the body of man or other animals“
But FDA’s 510k (similar to prior approval)
loophole Center for Devices and Radiological
Health underfunded to handle scope and pace of innovation
Authority inadequate to gather clinical trial information or compel reporting of post-approval adverse events
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Are military IRBs’ reviews adequate to protect soldiers from experimental technologies
(Il)legal Psychoactive Drugs
DEA has 5 categories of scheduled drugs, then over the counter
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Data Censoring by Investigators
The aggregation of experimental outcomes by health systems
Assure completeness of result reporting
Autonomy & Addiction
Remote behavior control of criminals, soldiers, astronauts
Wireheading: mood control
Blurred culpability: developer, software, user
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Home Health Monitoring
Telemedicine Wireless devices, linked
to health system Blood Pressure Monitors Glucometers Peak Flow Meters Pulse Oximeters Weight Scale
Defining Disabled/Enhanced
When Medicare changed its definition for coverable cochlear implants from deafness to severe hearing loss it expanded coverage for millions of seniors
Similar fights over Depression (transient grief) vs. mood enhancement Attention-deficit vs. performance enhancement
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Superhuman Abilities
5% to 35% college students use off-label stimulants as study aids
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Modafinil (Provigil)
Developed and approved as treatment for narcolepsy and “excessive day-time sleepiness”
Schedule 4 controlled substance
Diagnostic Creation of ADD
1930s stimulants prescribed to treat “minimal brain dysfunction”
1960s “minimal brain dysfunction” “learning/behavioral disabilities” and “hyperactivity”
Ritalin synthesized in 1950s, prescribed in 1960s
DSM-II (1968): “Hyperkinetic Reaction of Childhood”
DSM-III (1980): “ADD (Attention-Deficit Disorder) with or without hyperactivity”
DSM-III-R (1987): “ADHD”
ICD-10: “Hyperkinetic disorders”
DSM-IV criteria diagnose 4x more ADHD than the stricter ICD-10 criteria
Unequal Access
In every other industrialized country the debate is what should be in or out of the plan
Here it is up to 1500 private and 60 or so public insurance plans
Critical: Speed of innovation of cheap versions
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Ownership & Property
Human gene patenting Pharmaceutical and neurodevice patent overreach Expansion of Chinese neurotech device production
(e.g. Medtronic) International IP Protection Humanitarian exemption and pricing
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International Harmonization
Harmonization of regulation within the OECD (including Japan) will speed innovation
Global Harmonization Task Force (Devices)
International Conference on Harmonization (Drugs)
Privacy and Cybersecurity
Already issue with mobile technology and RFID
Privacy of biometric information - controversy in 2002 over the VeriChip patient ID and tracking system
Implanted medical records, e-cash, telecom
Battlefield biotelemetry Wireless hacking of prosthetics (Jay
Radcliffe: insulin pump hacking) Self-hacking to control drug
administration Required registration of high-power
prosthetics
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National security secrecy and corporate IP inhibit open source innovation, translation to application
See: 2005 EU Report “Ethical Aspects of ICT Implants in the Human Body”
Newer Problems
Timing of implants and upgradeability
Structural unemployment
Remote behavior control
Mood controlBlurred culpability
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Timing of Implants
Accelerating pace of innovationEspecially rapid
advances in biocompatible materials
Cochlear implantsCritical language windowDestruction of cochlear
tissue
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Structural Unemployment
Prior cases: literate/numerate workers Digital divide smartphones
Competing not only against automation and globalization, but also against brain-machine enhanced workers (vets?)
Cog enhancement drugs AugCog
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Neuropolicy Organizations
International Society for Neuroethics
Dana Foundation
MacArthur Foundation Network on Law and Neuroscience
Center for Neurotechnology Studies, Potomac Institute for Policy Studies in Arlington, Virginia
Neurotechnology Industry Organization
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Neuropolicy Experts
Walter Glannon, Philosophy, University of Calgary
David Eagleman, Neuroscience, Baylor College of Medicine
Jonathan Moreno, Center for American Progress
Martha Farah, Upenn Center for Neuroscience and Society
Hank Greely, Stanford Program in Neuroethics
Judy Illes, Chair in Neuroethics, Univ of British Columbia
Michael Gazzaniga, Cognitive Neuroscience, Dartmouth College
Zach Lynch, Neurotechnology Industry Organization
Diana Zuckerman, Alliance for a Stronger FDA
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For more information
Institute for Ethics and Emerging Technologiesieet.org
These slides:
http://ieet.org/archive/20120110-neurotechpolicy.ppt