Prosthetic Ethics - Institute for Ethics and Emerging Technologies

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Nov 25, 2013 (3 years and 6 months ago)

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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

James.Hughes@trincoll.edu

January 10, 2012

Trinity College, Hartford CT

Institute for Ethics and Emerging Technologies

Broad Frame for Neurotech

Internal

External

Hardware

Software

Institute for Ethics and Emerging Technologies

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

Institute for Ethics and Emerging Technologies

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

Copyright Institute for Ethics and Emerging Technologies 2005

Countervailing Influences

Science
Policy

Consumer
Lobbies

Industry

Lobbies
(Phrma, NIO,
etc)

Experts
(NAS,
etc.)

Medical
Associations

(AMA, etc)

Thinktanks

(Brookings,
AEI, Cato,
etc.)

Points of Influence


Institute for Ethics and Emerging Technologies 2012

NIH/NIMH
funding of
basic
research

Private
investment

Product
Development

FDA

Clinical
Trials

Development
of Standards
of Care

Public
Insurance
Coverage

Private

Insurance
Coverage

Post Approval
Surveillance
and Research

DEA/criminal
control of off
-
label use and
illegal drugs

Copyright Institute for Ethics and Emerging Technologies 2005

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

Institute for Ethics and Emerging Technologies 2012

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


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


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

Institute for Ethics and Emerging Technologies 2012

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 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


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

But


Self image is
malleable


Prosthetics 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

Copyright Institute for Ethics and Emerging Technologies 2005

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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Copyright Institute for Ethics and Emerging Technologies 2005

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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Copyright Institute for Ethics and Emerging Technologies 2005

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 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

Institute for Ethics and Emerging Technologies 2012

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

Institute for Ethics and Emerging Technologies 2012

Institute for Ethics and Emerging Technologies 2012

For more information


Institute for Ethics

and Emerging
Technologies

ieet.org



Me:

director@ieet.org



These slides:

http://ieet.org/archive/20120110
-
neurotechpolicy.ppt