Neurotech Policy James J. Hughes Ph.D. Executive Director, Institute for Ethics and Emerging Technologies Public Policy Studies, Trinity College, Hartford

Neurotech Policy

James J. Hughes Ph.D.Executive Director, Institute for Ethics and Emerging Technologies

Public Policy Studies, Trinity College, Hartford CT

[email protected]

January 10, 2012 Trinity College, Hartford CT

Institute for Ethics and Emerging Technologies

Broad Frame for Neurotech

Internal

External

Hardware Software


External Hardware

Pictures, written language and numbers outsourced the brain

Started with clay and paperToday wearable computersSmart phones Aug cogThe wireless

exo-cortex


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


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

IndustryLobbies

(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

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


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


Neuroprosthetics & NNI

NIH Neural Prosthesis Program Cochlear & retinal

implants Peripheral neural

prosthetics Brain implants

National Nanotechnology Program Ethical, Legal and Other

Societal Issues


Prosthetic Limbs

Indirect neural control

Direct neural control

Haptic feedback


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”


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


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


Deep Brain Stimulation

DepressionObsessive-compulsive disorder

1% of the population has seizure disorders, such asEpilepsy Parkinsons Disease


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.


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


Brain-Computer Interfaces


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


Non-Problems

Supersoldiers Sports enhancement Disappearing disabled cultures Authenticity


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


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


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


“Authenticity”

Avoidance of SSRIs, ADD drugs

Not human, not me

ButSelf image is

malleableProsthetics easily

incorporated


Old Problems

Safety of devices Autonomy and addiction Moving line between

disability/normal/enhanced

Unequal access Ownership & intellectual

property Privacy & cybersecurity


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

(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

Autonomy & Addiction

Remote behavior control of criminals, soldiers, astronauts

Wireheading: mood control

Blurred culpability: developer, software, user



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


Superhuman Abilities

5% to 35% college students use off-label stimulants as study aids


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


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



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


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


Timing of Implants

Accelerating pace of innovationEspecially rapid

advances in biocompatible materials

Cochlear implantsCritical language windowDestruction of cochlear

tissue


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


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


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



For more information

Institute for Ethics and Emerging Technologiesieet.org

Me: [email protected]

These slides:

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

Documents

Neurotech Policy James J. Hughes Ph.D. Executive Director, Institute for Ethics and Emerging Technologies Public Policy Studies, Trinity College, Hartford