Dr Frankenstein Legal And Moral Status Of Body Parts

The Dilemma of Dr. The Dilemma of Dr. Frankenstein: The Legal and Frankenstein: The Legal and Moral Status of Body PartsMoral Status of Body Parts

Prof. Linda MacDonald Prof. Linda MacDonald Glenn, BioethicistGlenn, Bioethicist

Canadian Association of Canadian Association of PathologistsPathologists

Montreal, Quebec, CanadaMontreal, Quebec, CanadaJuly 6, 2004July 6, 2004

Linda MacDonald Glenn, JD, LLMLinda MacDonald Glenn, JD, LLM• Former Senior Fellow, Institute for Ethics, American Medical Former Senior Fellow, Institute for Ethics, American Medical

Association.*Association.*

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

• Writer and Lecturer. Recent publications: Writer and Lecturer. Recent publications: Ethical Issues in Ethical Issues in Transgenics and Genetic EngineeringTransgenics and Genetic Engineering at at www.actionbioscience.orgwww.actionbioscience.org and Neuroethics, Criminal and Neuroethics, Criminal Responsibility and the Law, Summer 2004 ASBH Exchange, Responsibility and the Law, Summer 2004 ASBH Exchange, and and Biotechnology at the Margins of Personhood: An Biotechnology at the Margins of Personhood: An Evolving Legal ParadigmEvolving Legal Paradigm, available at , available at www.jetpress.orgwww.jetpress.org

• Assistant professor, trial lawyer and advocateAssistant professor, trial lawyer and advocate. . • Director, Board of the Converging Technologies Bar Director, Board of the Converging Technologies Bar

Association Association

Purpose of PresentationPurpose of Presentation

Ethical and Legal implications and Ethical and Legal implications and developments in the Management of developments in the Management of Tissue and Body PartsTissue and Body Parts

Part 1 – Tissue Samples and ResearchPart 1 – Tissue Samples and Research

John Moore Case John Moore Case CommodificationCommodificationCharitable TrustsCharitable Trusts

Patenting of DNA sequences and Patenting of DNA sequences and genetically-altered materialgenetically-altered material

• USPTO prohibition USPTO prohibition of humanzee of humanzee

• Canadian’s Canadian’s prohibition on prohibition on patenting “higher life patenting “higher life forms”forms”

Part 2 – From Property to Quasi-Part 2 – From Property to Quasi-Property?Property?

• Dead Bodies – court Dead Bodies – court rulings that dead rulings that dead bodies are more than bodies are more than mere property – they mere property – they are “quasi-property”.are “quasi-property”.

• Ted Williams saga Ted Williams saga (Bioethics meets (Bioethics meets Jerry Springer)Jerry Springer)

Part 2 – From Property to Quasi-Part 2 – From Property to Quasi-Property?Property?

Frozen embryos – Frozen embryos – from Tennessee to from Tennessee to MassachusettsMassachusetts

Canadian Bill C-6Canadian Bill C-6

Canadian Bill C- 6Canadian Bill C- 6Passed March 9, 2004 - Short titlePassed March 9, 2004 - Short title

1. This Act may be cited as the Assisted Human Reproduction Act. 1. This Act may be cited as the Assisted Human Reproduction Act.

Prohibited procedures:Prohibited procedures:

5. (1) No person shall knowingly5. (1) No person shall knowingly

o (a) create a human clone by using any technique, or transplant a human (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 clone into a human being or into any non-human life form or artificial device;device;

o (b) create an in vitro embryo for any purpose other than creating a (b) create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted human being or improving or providing instruction in assisted reproduction procedures;reproduction procedures;

o (c) for the purpose of creating a human being, create an embryo from a (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 cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into a human being;embryo so created into a human being;

o (d) maintain an embryo outside the body of a female person after the (d) maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspendedexcluding any time during which its development has been suspended

Canadian Bill C- 6Canadian Bill C- 6

o (e) (e) for the purpose of creating a human being, perform any procedure or for the purpose of creating a human being, perform any procedure or provide, prescribe or administer any thing that would ensure or increase 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 the probability that an embryo will be of a particular sex, or that would identify the sex of an identify the sex of an in vitroin vitro embryo, except to prevent, diagnose or treat a embryo, except to prevent, diagnose or treat a sex-linked disorder or disease;sex-linked disorder or disease;

o (f) (f) alter the genome of a cell of a human being or alter the genome of a cell of a human being or in vitroin vitro embryo such embryo such that the alteration is capable of being transmitted to descendants;that the alteration is capable of being transmitted to descendants;

o (g) (g) transplant a sperm, ovum, embryo or foetus of a non-human life form transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being;into a human being;

o (h) (h) for the purpose of creating a human being, make use of any human for the purpose of creating a human being, make use of any human reproductive material or an reproductive material or an in vitroin vitro embryo that is or was transplanted embryo that is or was transplanted into a non-human life form;into a non-human life form;

o (i) (i) create a chimera, or transplant a chimera into either a human being create a chimera, or transplant a chimera into either a human being or a non-human life form; oror a non-human life form; or

o (j) (j) ) create a hybrid for the purpose of reproduction, or transplant a ) create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form.hybrid into either a human being or a non-human life form.

Part 3 – Organ TraffickingPart 3 – Organ Trafficking

• Body Parts for SaleBody Parts for Sale

• Theft and Mutilation Theft and Mutilation

• Need for high end Need for high end diagnostics of parts diagnostics of parts (Rabies incident)(Rabies incident)

Sources of Body PartsSources of Body Parts

Tissue Engineering—An alternative to Tissue Engineering—An alternative to Organ TransplantationOrgan Transplantation

Why Tissue Engineering?Why Tissue Engineering?

Organ Number of people on waitlist as of 5 pm 11/ 10/ 03

Number of transplantsperformed in 2002

Kidney 56317 14776

Pancreas 1464 349

Kidney/ Pancreas 2415 905

Liver 17224 5329

I ntestine 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

Goal of Tissue EngineeringGoal of Tissue Engineering

• To replicate to the greatest extent possible the in To replicate to the greatest extent possible the in vivo function of the tissue/organ being replacedvivo function of the tissue/organ being replaced

• Achieved through hybrid approach, utilizing Achieved through hybrid approach, utilizing both natural and synthetic materialsboth natural and synthetic materials

““Holy Grail” of Tissue EngineeringHoly Grail” of Tissue Engineering

In vitro culture

Expand cellsVascularize tissue

Implant

CellsPatient cellsStem cellsAnimal cells Seed

on scaffold

Tissue Engineering Requires Tissue Engineering Requires Multidisciplinary CooperationMultidisciplinary Cooperation

Characteristics of the LiverCharacteristics of the Liver• 1.5 kg in average adult1.5 kg in average adult

• Blood throughput 1450 ml/minBlood throughput 1450 ml/min• Highly vascularizedHighly vascularized• High oxygen demandHigh oxygen demand

• 5 cell types present5 cell types present

• Many varied functions performedMany varied functions performed• Maintenance of homeostasisMaintenance of homeostasis• Glucose uptake/releaseGlucose uptake/release• Ammonia clearance through urea productionAmmonia clearance through urea production• Lipid processingLipid processing• Plasma protein synthesisPlasma protein synthesis• Bile formationBile formation• Xenobiotic metabolismXenobiotic metabolism

Leading Bioartificial Liver (BAL) Leading Bioartificial Liver (BAL) DevicesDevices

Circe Biomedical HepatAssist™• Phase III trials• 50 g porcine HCs, microcarrier-attached, extracapillary

• Charcoal filtration• Plasma circulation

VitaGen ELAD™(Acquired byVital 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

Primary Cells vs. Cell LinesPrimary Cells vs. Cell Lines

Cell Type Advantages Disadvantages

Primary: Directfrom animaltissue

Potentially retainall differentiatedfunction

Difficult tomaintain viability &differentiatedfunction

May not proliferate

Cell line:Immortalized ortumor-derived

Relatively easyto maintain

Proliferatereadily, for many“generations”

Do not necessarilyretain function ofnormal cells

Safety concerns

Primary cells are used for most tissue engineering applications.

Further Classification of Cell TypesFurther Classification of Cell Types

Cell type Product example Advantages Disadvantages

Autologous(Patientsource)

GenzymeCarticel

No immunerejection

Difficulty/inability togrow up cells

Impractical for certaintissues (e.g. heart)

Allogeneic(Otherhumansource)

OrganogenesisApligraf

ATS Dermagraft

Humansource

Scarce for some tissues Immune incompatibility Transfer of adventitious

agents

Xenogeneic(Otheranimalsource)

Bioartificial liver &pancreas devices

Readilyavailable

Immune incompatibility Function not necessarily

identical Transfer of adventitious

agents

The Promise of Stem CellsThe Promise of Stem Cells

Human embryonicstem cell colony

Type Advantages Disadvantages

Neonatal/Fetal

“Immortal”

Potential to differentiate into anything

Immune incompatibility

Expensive to keep up

How to make them differentiate?

Ethical concerns

Adult Autologous source

Fewer ethical concerns

Able to differentiate into limited number of tissues

Stem Cells: The Answer?Stem Cells: The Answer?

Part 4. Future TrendsPart 4. Future Trends

NBIC – the synergistic combination of 4 major NBIC – the synergistic combination of 4 major areas of science and technologyareas of science and technology

• Nanoscience and Nanoscience and NanotechnologyNanotechnology

• Biotechnology/ Biotechnology/ BiomedicineBiomedicine

• Information Information TechnologyTechnology

• Cognitive ScienceCognitive Science

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.

BRAIN FINGERPRINTING

Summary….Summary….

1.1. Currently the laws are national and generated on Currently the laws are national and generated on a case-by-case basis.a case-by-case basis.

2.2. There is a Need for Internationally-agreed upon There is a Need for Internationally-agreed upon Standards of ConductStandards of Conduct

3.3. Perhaps, develop an International Forum Perhaps, develop an International Forum

4.4. Examine the Issue of Commercialization versus Examine the Issue of Commercialization versus the Common Good, create Charitable Trusts.the Common Good, create Charitable Trusts.

Thank you for your attention!Thank you for your attention!

• A Special Thank You to Sonia E. Miller, A Special Thank You to Sonia E. Miller, Attorney-at-law, President of the Converging Attorney-at-law, President of the Converging Technologies Bar Association (Technologies Bar Association (www.ctba.uswww.ctba.us) ) and and

• C. Chris Hook, MD, Director of Biotech Ethics C. Chris Hook, MD, Director of Biotech Ethics at the Mayo Clinicat the Mayo Clinic

• Dr. J.S. Boyce, Professor, Computer Science, Dr. J.S. Boyce, Professor, Computer Science, Montgomery College, MD.Montgomery College, MD.

• For further info, references contact me at For further info, references contact me at lindaglenn@biomedlaw.comlindaglenn@biomedlaw.com

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