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The Dilemma of Dr.
Frankenstein: The Legal and
Moral Status of Body Parts
Prof. Linda MacDonald
Glenn, Bioethicist
Canadia...
Linda MacDonald Glenn, JD, LLM
• Former Senior Fellow, Institute for Ethics, American
Medical Association.*

• LL.M. in Bi...
Purpose of Presentation
Ethical and Legal implications and
developments in the Management of
Tissue and Body Parts

Linda ...
Part 1 – Tissue Samples and Research

John Moore Case
Commodification
Charitable Trusts

Linda MacDonald Glenn - copyri...
Patenting of DNA sequences and
genetically-altered material
• USPTO prohibition
of humanzee

• Canadian’s

prohibition on
...
Part 2 – From Property to QuasiProperty?
• Dead Bodies – court

rulings that dead
bodies are more than
mere property – the...
Part 2 – From Property to QuasiProperty?
 Frozen embryos –

from Tennessee to
Massachusetts

 Canadian Bill C-6

Linda M...
Canadian Bill C- 6
1. This Act may be cited as the Assisted Human Reproduction Act.
Prohibited procedures:
5. (1) No perso...
Canadian Bill C- 6
o (e) for the purpose of creating a human being, perform any procedure or
provide, prescribe or adminis...
Part 3 – Organ Trafficking
• Body Parts for Sale
• Theft and Mutilation
• Need for high end
diagnostics of parts
(Rabies i...
Sources of Body Parts

Linda MacDonald Glenn - copyright 2004
Tissue Engineering—An alternative to
Organ Transplantation

Linda MacDonald Glenn - copyright 2004
Why Tissue Engineering?
Organ

Number of people on wait
list as of 5 pm 11/10/03

Number of transplants
performed in 2002
...
Goal of Tissue Engineering
• To replicate to the greatest extent possible the in
vivo function of the tissue/organ being r...
“Holy Grail” of Tissue Engineering
Cells
Patient cells
Stem cells
Animal cells

Seed on
scaffold
In vitro
culture
Expand c...
Tissue Engineering Requires
Multidisciplinary Cooperation

Mike Sefton, http://www.utoronto.ca/IBBME/research/tissue.htm
L...
Characteristics of the Liver
• 1.5 kg in average adult
• Blood throughput 1450 ml/min
• Highly vascularized
• High oxygen ...
Leading Bioartificial Liver (BAL)
Devices
VitaGen ELAD™
(Acquired by
Vital Therapies, Inc.
10/03)
• Phase II trials
• Tumo...
Primary Cells vs. Cell Lines
Cell Type
Primary: Direct
from animal
tissue

Advantages

Disadvantages

• Potentially

retai...
Further Classification of Cell Types
Cell type

Product example

Advantages

Disadvantages

Autologous
(Patient
source)

•...
The Promise of Stem Cells

Human embryonic
stem cell colony

Linda MacDonald Glenn - copyright 2004
Stem Cells: The Answer?
Type

Advantages

Neonatal/ • “Immortal”
Fetal
• Potential to
differentiate into
anything

Adult

...
Part 4. Future Trends

Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
NBIC – the synergistic combination of 4 major
areas of science and technology

• Nanoscience and
Nanotechnology

• Biotech...
Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
BRAIN FINGERPRINTING

Dr. Farwell tests Terry Harrington, who is in
prison for murder. The test proved that the record
in ...
Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
Linda MacDonald Glenn - copyright 2004
Summary….
1. Currently the laws are national and generated on
a case-by-case basis.

2. There is a Need for Internationall...
Linda MacDonald Glenn - copyright 2004
Thank you for your attention!
• A Special Thank You to Sonia E. Miller,

Attorney-at-law, President of the Converging
Tech...
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Dr frankenstein legal and moral status of body parts 1

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Dr frankenstein legal and moral status of body parts 1

  1. 1. The Dilemma of Dr. Frankenstein: The Legal and Moral Status of Body Parts Prof. Linda MacDonald Glenn, Bioethicist Canadian Association of Pathologists Montreal, Quebec, Canada
  2. 2. Linda MacDonald Glenn, JD, LLM • Former Senior Fellow, Institute for Ethics, American Medical Association.* • LL.M. in Biomedical Ethics from McGill University, Montreal, Canada • Writer and Lecturer. Recent publications: Ethical Issues in Transgenics and Genetic Engineering at www.actionbioscience.org and Neuroethics, Criminal Responsibility and the Law, Summer 2004 ASBH Exchange, and Biotechnology at the Margins of Personhood: An Evolving Legal Paradigm, available at www.jetpress.org • Assistant professor, trial lawyer and advocate. • Director, Board of the Converging Technologies Bar Association Linda MacDonald Glenn - copyright 2004
  3. 3. Purpose of Presentation Ethical and Legal implications and developments in the Management of Tissue and Body Parts Linda MacDonald Glenn - copyright 2004
  4. 4. Part 1 – Tissue Samples and Research John Moore Case Commodification Charitable Trusts Linda MacDonald Glenn - copyright 2004
  5. 5. Patenting of DNA sequences and genetically-altered material • USPTO prohibition of humanzee • Canadian’s prohibition on patenting “higher life forms” Linda MacDonald Glenn - copyright 2004
  6. 6. Part 2 – From Property to QuasiProperty? • Dead Bodies – court rulings that dead bodies are more than mere property – they are “quasi-property”. • Ted Williams saga (Bioethics meets Jerry Springer) Linda MacDonald Glenn - copyright 2004
  7. 7. Part 2 – From Property to QuasiProperty?  Frozen embryos – from Tennessee to Massachusetts  Canadian Bill C-6 Linda MacDonald Glenn - copyright 2004
  8. 8. Canadian Bill C- 6 1. This Act may be cited as the Assisted Human Reproduction Act. Prohibited procedures: 5. (1) No person shall knowingly o (a) create a human clone by using any technique, or transplant a human clone into a human being or into any non-human life form or artificial device; o (b) create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures; o (c) for the purpose of creating a human being, create an embryo from a cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into a human being; o (d) maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspended Linda MacDonald Glenn - copyright 2004
  9. 9. Canadian Bill C- 6 o (e) for the purpose of creating a human being, perform any procedure or provide, prescribe or administer any thing that would ensure or increase the probability that an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo, except to prevent, diagnose or treat a sex-linked disorder or disease; o (f) alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants; o (g) transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being; o (h) for the purpose of creating a human being, make use of any human reproductive material or an in vitro embryo that is or was transplanted into a non-human life form; o (i) create a chimera, or transplant a chimera into either a human being or a non-human life form; or o (j) ) create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form. Linda MacDonald Glenn - copyright 2004
  10. 10. Part 3 – Organ Trafficking • Body Parts for Sale • Theft and Mutilation • Need for high end diagnostics of parts (Rabies incident) Linda MacDonald Glenn - copyright 2004
  11. 11. Sources of Body Parts Linda MacDonald Glenn - copyright 2004
  12. 12. Tissue Engineering—An alternative to Organ Transplantation Linda MacDonald Glenn - copyright 2004
  13. 13. Why Tissue Engineering? Organ Number of people on wait list as of 5 pm 11/10/03 Number of transplants performed in 2002 Kidney 56317 14776 Pancreas 1464 349 Kidney/Pancreas 2415 905 Liver 17224 5329 Intestine 165 107 Heart 3547 2155 Lung 3891 1042 Heart/Lung 184 33 • One person added to wait list every 14 min • One patient dies every 85 min waiting for transplant United Network for Organ Sharing/ Organ Procurement and Transplantation Network Linda MacDonald Glenn - copyright 2004
  14. 14. Goal of Tissue Engineering • To replicate to the greatest extent possible the in vivo function of the tissue/organ being replaced • Achieved through hybrid approach, utilizing both natural and synthetic materials = Linda MacDonald Glenn - copyright 2004
  15. 15. “Holy Grail” of Tissue Engineering Cells Patient cells Stem cells Animal cells Seed on scaffold In vitro culture Expand cells Vascularize tissue Linda MacDonald Glenn - copyright 2004 Implant
  16. 16. Tissue Engineering Requires Multidisciplinary Cooperation Mike Sefton, http://www.utoronto.ca/IBBME/research/tissue.htm Linda MacDonald Glenn - copyright 2004
  17. 17. Characteristics of the Liver • 1.5 kg in average adult • Blood throughput 1450 ml/min • Highly vascularized • High oxygen demand • 5 cell types present • Many varied functions performed • Maintenance of homeostasis • Glucose uptake/release • Ammonia clearance through urea production • Lipid processing • Plasma protein synthesis • Bile formation • Xenobiotic metabolism Linda MacDonald Glenn - copyright 2004
  18. 18. Leading Bioartificial Liver (BAL) Devices VitaGen ELAD™ (Acquired by Vital Therapies, Inc. 10/03) • Phase II trials • Tumor-derived human HC line, fiber attached, extracapillary • Plasma circulation Algenix LIVERx • Phase I trials • 80 g porcine HCs, collagen-entrapped, fiber lumen • Whole blood perfusion Circe Biomedical HepatAssist™ • Phase III trials • 50 g porcine HCs, microcarrier-attached, extracapillary • Charcoal filtration • Plasma circulation Linda MacDonald Glenn - copyright 2004
  19. 19. Primary Cells vs. Cell Lines Cell Type Primary: Direct from animal tissue Advantages Disadvantages • Potentially retain • Difficult to all differentiated maintain viability & function differentiated function • May not proliferate Cell line: • Relatively easy • Do not necessarily Immortalized or to maintain retain function of tumor-derived normal cells • Proliferate readily, for many • Safety concerns “generations” Primary cells are used for most tissue engineering applications. Linda MacDonald Glenn - copyright 2004
  20. 20. Further Classification of Cell Types Cell type Product example Advantages Disadvantages Autologous (Patient source) • Genzyme Allogeneic (Other human source) • Organogenesis • Human source Apligraf® • Dermagraft® ATS • Scarce for some tissues • Immune incompatibility • Transfer of adventitious agents Xenogeneic (Other animal source) • Readily Bioartificial liver & • • Immune incompatibility • Function not necessarily identical • Transfer of adventitious agents Carticel® pancreas devices • immune • No Difficulty/inability to rejection grow up cells • Impractical for certain tissues (e.g. heart) available Linda MacDonald Glenn - copyright 2004
  21. 21. The Promise of Stem Cells Human embryonic stem cell colony Linda MacDonald Glenn - copyright 2004
  22. 22. Stem Cells: The Answer? Type Advantages Neonatal/ • “Immortal” Fetal • Potential to differentiate into anything Adult • Autologous source • Fewer ethical concerns Disadvantages • Immune incompatibility • Expensive to keep up • How to make them differentiate? • Ethical concerns • Able to differentiate into limited number of tissues Linda MacDonald Glenn - copyright 2004
  23. 23. Part 4. Future Trends Linda MacDonald Glenn - copyright 2004
  24. 24. Linda MacDonald Glenn - copyright 2004
  25. 25. Linda MacDonald Glenn - copyright 2004
  26. 26. NBIC – the synergistic combination of 4 major areas of science and technology • Nanoscience and Nanotechnology • Biotechnology/ Biomedicine • Information Technology • Cognitive Science Linda MacDonald Glenn - copyright 2004
  27. 27. Linda MacDonald Glenn - copyright 2004
  28. 28. Linda MacDonald Glenn - copyright 2004
  29. 29. Linda MacDonald Glenn - copyright 2004
  30. 30. BRAIN FINGERPRINTING Dr. Farwell tests Terry Harrington, who is in prison for murder. The test proved that the record in Harrington’s brain did not match the crime and did match his alibi. Harrington is appealing for a new trial. Brain Fingerprinting was found admissible in court in the case Dr. Farwell tests suspected serial killer JB Grinder. The test proved the record in Grinder’s brain matched the murder of July Helton. Grinder then pled guilty and was sentenced to life in prison. Linda MacDonald Glenn - copyright 2004
  31. 31. Linda MacDonald Glenn - copyright 2004
  32. 32. Linda MacDonald Glenn - copyright 2004
  33. 33. Linda MacDonald Glenn - copyright 2004
  34. 34. Summary…. 1. Currently the laws are national and generated on a case-by-case basis. 2. There is a Need for Internationally-agreed upon Standards of Conduct 3. Perhaps, develop an International Forum 4. Examine the Issue of Commercialization versus the Common Good, create Charitable Trusts. Linda MacDonald Glenn - copyright 2004
  35. 35. Linda MacDonald Glenn - copyright 2004
  36. 36. Thank you for your attention! • A Special Thank You to Sonia E. Miller, Attorney-at-law, President of the Converging Technologies Bar Association (www.ctba.us) and • C. Chris Hook, MD, Director of Biotech Ethics at the Mayo Clinic • Dr. J.S. Boyce, Professor, Computer Science, Montgomery College, MD. • For further info, references contact me at lindaglenn@biomedlaw.com Linda MacDonald Glenn - copyright 2004

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