Not Just a Pretty Face: Legal and Ethical Issues

in Regenerative Nanomedicine

1

Human Enhancement and Nanotechnology, Western Michigan University, March 28-29, 2009

Linda MacDonald Glenn, Albany Medical CenterJeanann S. Boyce, Montgomery College

Linda MacDonald Glenn 2

Linda MacDonald Glenn, JD, LLM

• Assistant Professor, Albany Medical Center, Alden March Bioethics Institute

• JD, LL.M. in Biomedical Ethics from McGill University, Montreal, Canada

• Senior Fellow Institute for Ethics and Emerging Technologies

• Women’s Bioethics Project Scholar

• In a former life, trial lawyer and advocate.

Co-Presenter

• Dr. Jeanann Boyce– Professor of Computer Science at Montgomery

College and Adjunct Professor of Information Science at Johns Hopkins and Bowie State University.

– Member of Robotics International, Society of Manufacturing Engineers.

– Teaches AI programming and Information Systems, ED Chair District of Columbia Engineering & Architectural Societies

– Developed and implemented first Ethics in the Information Age courses at University of Maryland University College and Montgomery College

NIH Definition

NIH Definition of

•  Tissue engineering / regenerative medicine is an emerging multidisciplinary field involving biology, medicine, and engineering that is likely to revolutionize the ways we improve the health and quality of life for millions of people worldwide by restoring, maintaining, or enhancing tissue and organ function.

• Tissue engineering can have diagnostic applications where the tissue is made in vitro and used for testing drug metabolism and uptake, toxicity, and pathogenicity.

Ability to Exploit Living Cells in Variety of Ways

1. Biomaterials: including novel biomaterials that are designed to direct the organization, growth, and differentiation of cells in the process of forming functional tissue by providing both physical and chemical cues.

2. Cells: including enabling methodologies for the proliferation and differentiation of cells, acquiring the appropriate source of cells such as autologous cells, allogeneic cells, xenogeneic cells, stem cells, genetically engineered cells, and immunological manipulation.

3. Biomolecules: including angiogenic factors, growth factors, differentiation factors and bone morphogenic proteins

Ways con’t…4. Engineering Design Aspects: including 2-d cell expansion,

3-d tissue growth, bioreactors, vascularization, cell and tissue storage and shipping (biological packaging).

5. Biomechanical Aspects of Design: including properties of native tissues, identification of minimum properties required of engineered tissues, mechanical signals regulating engineered tissues, and efficacy and safety of engineered tissues

6. Informatics to support tissue engineering: gene and protein sequencing, gene expression analysis, protein expression and interaction analysis, quantitative cellular image analysis, quantitative tissue analysis, in silicon tissue and cell modeling, digital tissue manufacturing, automated quality assurance systems, data mining tools, and clinical informatics interfaces.

Stem Cells Research

Includes research that involves stem cells, whether from embryonic, fetal, or adult sources, human and non-human. It should include research in which stem cells are isolated, derived or cultured for purposes such as developing cell or tissue therapies, studying cellular differentiation, research to understand the factors necessary to direct cell specialization to specific pathways, and other developmental studies.

 

Tissue Engineering Is Not..

• It should not include transgenic studies, gene knock-out studies nor the generation of Chimeric animals.

Tissue Engineering

• 4 Brothers—Jay, Chuck, Marty, and Frank Vacanti

• Cartilage molded around a biodegradable polymer,impregnated with patient’s own cells• Scaffold, surgical coral

Pittsburgh Tissue Engineering Initiative:University of Pittsburgh School of Medicine and UPMC Health

System • McGowan Institute on Regenerative Medicine• Biomedicals• Medical devices and Artificial Organs• Cellular Therapeutics -Tissue engineering with

nanomagnets Nanowerk Mar.29, 2009 Hemodynamics

they perform the cell patterning using external magnetic forces with which they control the organization of cells on a substrate and create a 3D multicellular assembly to guide cell adhesion.

Tissue Engineering (cont’d)

Nanofluidic Chips

• $100 Genome analyzer is the goal• Currently can read entire human genome

in less than 8 hrs.• BioNanomatrix Corporation• Untangles up to 1,ooo,ooo DNA base

molecules• Mild electrical charge drives the DNA

through the chip• Potential medical diagnostic tool to tailor

treatment to a patient’s genetic profile.

Nanopiezotronics

• Nanowires which can power medical devices and serve as tiny sensors

• Zinc oxide bends through local vibrations creating an electrical current

• Can be used in implants, such as the knee to monitor stress as a sensor

• Neural implants such as hearing aids without batteries

14

Laser Suturing

• Uses commonly used liquid, Rose Bengal• With the light, but not the heat of the

laser• Forces the collagen in cells to knit

together • Replaces needle and thread• Useful for nerve, eye, and blood vessel

surgeries• Still in clinical trials

15

Cellular Fusion

• Microfluidic chips paired with stem cells to create hybrids of fused membranes

• Can be used to reprogram cells• Potentially creating embryonic stem

cells from adult ones

16

Using Electron Beam Melting to Create Patient Specific Craniofacial Titanium

Implants

• Custom prostheses from CT data

• Design strategy for cranioplasty and mandibular reconstruction

• Porous implants • Custom Titanium

implants with controlled mechanical properties

17

BioMEMS for Surgery

• Micro Electro Mechanical Systems• Can combine sensors with surgical

tools• Sensor catheters• Perform heart surgery on a beating

heart with small incision

18

19

The Law of Accelerating Returns

• The price-performance, capacity & bandwidth of information technologies progresses exponentially through multiple paradigm shifts– Specific to information technology

• not to arbitrary exponential trends (like population)• Still need to test viability of the next paradigm

– A scientific theory• 25 years of research• Part of a broader theory of evolution• Inventing: science and engineering

– Moore’s law just one example of many– Yes there are limits

• But they’re not very limiting– Based on the physics of computation and

communication– and on working paradigms (such as nanotubes)

20

Reverse Engineering the Brain:the ultimate source of the templates of intelligence

21

The (converging) Sources of the Templates of Intelligence

• AI research• Reverse Engineering the Brain• Research into performance of the

brain (human thought)– Language: an ideal laboratory for

studying human ability for hierarchical, symbolic, recursive thinking

• All of these expand the AI tool kit

22

23

2015: The Incredible Shrinking Computer

• Images written directly to our retinas• Ubiquitous high bandwidth connection to

the Internet at all times• Electronics so tiny it’s embedded in the

environment, our clothing, our eyeglasses• Full immersion visual-auditory virtual

reality• Augmented real reality• Interaction with virtual personalities as a

primary interface• Effective language technologies

24

• Advances in nanoelectronics coupled with our growing understanding of human brain function has enabled neuroscientists to conceive of brain implantable computational systems to:

• - repair damaged portions of the brain

• - enhance neural capabilities beyond our natural capabilities

25

Examples are: - sense the onset of seizures and suppress them via implanted deep brain stimulators.- interface the brain with neuroprosthesis or disabled limbs. - augment brain memory function by replacing damaged hippocampal structures.

SAPNS repair for the animal brain

Ellis-Behnke R. G. et.al. PNAS 2006;103:5054-5059

©2006 by National Academy of Sciences

27

28

2029: An intimate merger• $1,000 of computation = 1,000 times the human

brain• Reverse engineering of the human brain completed• Computers pass the Turing test• Nonbiological intelligence combines

– the subtlety and pattern recognition strength of human intelligence, with

– the speed, memory, and knowledge sharing of machine intelligence

• Nonbiological intelligence will continue to grow exponentially whereas biological intelligence is effectively fixed

29

Nanobots provide…• Neural implants that are:

– Noninvasive, surgery-free– Distributed to millions or billions of points in the brain

• Full-immersion virtual reality incorporating all of the senses– You can be someone else– “Experience Beamers”

• Expansion of human intelligence– Multiply our 100 trillion connections many fold– Intimate connection to diverse forms of nonbiological intelligence

30

Average Life Expectancy (Years)

Cro Magnon 18

Ancient Egypt 25

1400 Europe 30

1800 Europe & U.S.

37

1900 U.S. 48

2002 U.S. 78

31

Promise versus Peril

• GNR enables our creativity– and our destructiveness

• Ethical guidelines do work to protect against inadvertent problems– 30 year success of Asilomar Guidelines

32

Promise versus Peril cont.

• So what about advertent problems (asymmetric warfare)?– Designer pathogens, self-replicating nanotech,

unfriendly AI (Yudkowsky)….– So maybe we should relinquish these

dangerous technologies?– 3 problems with that:

• Would require a totalitarian system• Would deprive the world of profound benefits• Wouldn’t work

– Would drive dangerous technologies underground

– Would deprive responsible scientists of the tools needed for defense

33

• Okay, let’s say that overcoming disease is a good thing, but perhaps we should stop before transcending normal human abilities….– So just what is normal?– Going beyond “normal” is not a new story.

• Most of the audience wouldn’t be here if life expectancy hadn’t increased (the rest of you would be senior citizens)

– We are the species that goes beyond our limitations• We need not define human by our limitations

– “Death gives meaning to life…and to time”• But we get true meaning from knowledge: art, music,

science, technology

34

• Scientists: “We are not unique”– Universe doesn’t revolve around the

Earth– We are not descended from the Gods

• But from apes….worms….bacteria…dust

• But we are unique after all– We are the only species that creates

knowledge….art, music, science, technology…• Which is expanding exponentially

35

So is the take-off hard or soft?

• Exponential growth is soft…– Gradual…– Incremental…– Smooth…– Mathematically identical at each point…

• But ultimately, profoundly transformative

Property-Personhood Continuum(Proposed Legal Paradigm)

Property Property

(Inanimate Objects)(Inanimate Objects)

Full Full PersonhoodPersonhood

(Attendant (Attendant rights & rights &

responsibilities)responsibilities)

Quasi-propertyQuasi-property

(Chimeric Humanoids)(Chimeric Humanoids)Fetuses EmbryosFetuses Embryos

Ex UteroEx Utero

Cyborgs Cyborgs AndroidsAndroids

A/IA/I

Negative LibertiesNegative Liberties

Biotechnology at the Margins of Personhood: An Evolving Legal Paradigm, J. of Evolution and TechnologyBiotechnology at the Margins of Personhood: An Evolving Legal Paradigm, J. of Evolution and Technology

Cognitively impaired Cognitively impaired

Recommendations and Conclusions

• The establishment of a common lexicon between policy makers, implementation agents, and multidisciplinary users for terms such as ‘proportional autonomy.’

• Creation of recommendations similar to the Asilomar Guidelines.

• More rigorous informed consent because of potential irreversibility.

Recommendations and Conclusions

As different forms of sentient beings and cyborgs are created in the technical environments, if we don’t start thinking policy NOW, the courts will be the ones to determine where these creations fall on the continuum of personhood.

(And hard cases make bad law)

The future?

“We need not fear the Us versus Them scenario as computers get smarter, because we will be them. We will continually incorporate more and more computer technology into ourselves and our lives, until we become one with it..” – Ray Kurzweil

(It’s already happening! How many of us carry our PDAs or wireless devices his small wireless computer to our meetings (and everywhere else). When someone has a question no one can answer, in just a few seconds, we conjure up the answer with Google)

Transcendent Man

Asilomar Conference on Recombinant DNA

40

http: unithertechnologyconference.com

Thank you for your attention!• For further info, contact us:

• jsboyce@att.net; lglenn3000@gmail.com