Neurotech Policy
James J. Hughes Ph.D.
Executive Director,
Institute for Ethics and Emerging Technologies
Public Policy Studies, Trinity College, Hartford CT
James.Hughes@trincoll.edu
January 10, 2012
Trinity College, Hartford CT
Broad Frame for Neurotech
Hardware
Internal
External
Institute for Ethics and Emerging Technologies
Software
External Hardware
Pictures, written language and
numbers outsourced the brain
 Started with clay and paper
 Today wearable computers
 Smart phones
 Aug cog
 The 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
Consumer
Lobbies
Medical
Associations
(AMA, etc)
Thinktanks
(Brookings,
AEI, Cato,
etc.)
Science
Policy
Industry
Lobbies
(Phrma, NIO,
etc)
Experts
(NAS,
etc.)
Copyright Institute for Ethics and Emerging Technologies 2005
Points of Influence
NIH/NIMH
funding of
basic
research
FDA
Clinical
Trials
Development
of Standards
of Care
DEA/criminal
control of offlabel use and
illegal drugs
Public
Insurance
Coverage
Private
investment
Product
Development
Private
Insurance
Coverage
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Post Approval
Surveillance
and Research
Pro-Science Citizen Lobbies

Disease lobbies

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Stem cell research lobby groups

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State stem cell funding
campaigns
Consumer protection groups

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JDRF, ACT-UP, Alzheimers
Critiquing politicized science
policy
Anti-psychiatry groups

Mental patients rights, Aspie
rights, Scientology
Copyright Institute for Ethics and Emerging Technologies 2005
Neuroprosthetics & NNI

NIH Neural Prosthesis
Program

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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-)

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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
Depression
 Obsessive-compulsive
disorder

1% of the population has
seizure disorders, such as
 Epilepsy
 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

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Ray Kurzweil
2030s?
Self-replicating
Two-way
communication
with trillions of
neurons
Networked inside
and out
Perfect virtual reality, mind back-up, upload
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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

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
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 rulegoverned game
 If athletes want to use
neurotechnology to
compete they can start
their own leagues
 Not relevant to society

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Disappearing Disabilities

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99% of disabled happy to give up
their disabilities
Only children forced to use
Last century: dramatic decline in
veteran and civilian amputees

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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
But
 Self image is
malleable
 Prosthetics easily
incorporated

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Old Problems

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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

Are military IRBs’ reviews
adequate to protect
soldiers from experimental
technologies
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(Il)legal Psychoactive Drugs

DEA has 5
categories of
scheduled
drugs, then
over the
counter
Data Censoring by Investigators
The aggregation of
experimental
outcomes by
health systems
 Assure
completeness of
result reporting

Copyright Institute for Ethics and Emerging Technologies 2005
Autonomy & Addiction

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Remote behavior
control of
criminals,
soldiers,
astronauts
Wireheading:
mood control
Blurred
culpability:
developer,
software, user
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Home Health Monitoring

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Telemedicine
Wireless devices, linked
to health system
Blood Pressure Monitors
Glucometers
Peak Flow Meters
Pulse Oximeters
Weight Scale
Copyright Institute for Ethics and Emerging Technologies 2005
Defining Disabled/Enhanced

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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

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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

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
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

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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)
Copyright Institute for Ethics and Emerging Technologies 2005
Privacy and Cybersecurity
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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
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”
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Newer Problems
Timing of implants
and upgradeability
 Structural
unemployment
 Remote behavior
control
 Mood control
 Blurred culpability

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Timing of Implants

Accelerating pace of
innovation


Especially rapid
advances in
biocompatible materials
Cochlear implants
Critical language window
 Destruction of cochlear
tissue

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Structural Unemployment

Prior cases:

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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
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Walter Glannon, Philosophy, University of Calgary
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David Eagleman, Neuroscience, Baylor College of Medicine
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Jonathan Moreno, Center for American Progress
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Martha Farah, Upenn Center for Neuroscience and Society
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Hank Greely, Stanford Program in Neuroethics
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Judy Illes, Chair in Neuroethics, Univ of British Columbia
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Michael Gazzaniga, Cognitive Neuroscience, Dartmouth College
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Zach Lynch, Neurotechnology Industry Organization
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Diana Zuckerman, Alliance for a Stronger FDA
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For more information

Institute for Ethics
and Emerging
Technologies
ieet.org

Me: director@ieet.org

These slides:
http://ieet.org/archive/20120110-neurotechpolicy.ppt
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