In the original film, Basil Rathbone plays a normal, if highly strung, scientist who, step by step, is made &quot;mad.&quot; Upon inheriting the Frankenstein estate, he and his family move there, with no intention of carrying out his father's &quot;unholy&quot; work. Yet the authorities and the villagers of Frankenstein suspect he will carry out researches like those of his father. When Wolf discovers that the monster still survives in a coma, tended by Ygor, he revives the monster, under controlled conditions, hoping to vindicate his father. Needless to say, he gets carried away when he does so, and things go awry. Soon he is alienating nearly everybody, and only when he destroys his father's reanimated creation is he restored to the good graces of the community. There is one overriding theme: that man is taking too much upon himself when he decides to play God, for which he does not have the ability.
My intent is to inform, help identify the issues, raise questions and advocate for a cautious, thoughtful approach.
One of the best known cases in the area of ownership of tissue samples is the Moore Case: A former patient, John Moore, had hairy-cell leukemia; his spleen had been removed at a medical center affiliated w/UCLA, as part of the cancer treatment. Unbeknownst to him, his cells had a unique quality that researchers at UCLA used to develop at patented cell line (called the Mo Cell Line) estimated value of $3 billion. When John Moore sued, the Supreme Ct of California held he did not have a sufficient property interest to be entitled to a portion of the profits. (Analogies) The problem lies the potential extension of such acceptance to include human beings. Of course, most people w/o doubt disagree w/trading humans as commodities (slave trading), but let’s exam the context – we may be talking about complete human beings. However, when you shift to part of human beings, opinions start to shift . As a result, organs are being bought and sold and cells and gene sequences are being patented at an incredible rate. The donation of body parts, tissues, and organs can have deep moral significance. Should human tissue and medical data be barred from commercial exchange? Are financial incentives appropriate? What about fairness to donors, access to research and incentives for innovation? Since tissue, blood, and med-data are already being collected and sold, we need to consider property right and benefits to the community - the greater good.
One proposed solution for ethical dilemmas that these problems pose is the formation of a charitable trust as a model for genomic biobanks. In the US, amassing millions of samples in private tissue banks; many of these companies act as brokers of tissue and health data for a wide range of researchers. The role of academic medical centers as suppliers for these private “biobanks” has received little attention. Informed consent – the knowledge that one’s biopsy sample might be used for research, needs to be a process of communication, not just a form to be filled out. – Biobanks often ask for open-ended permission, but the permission forms are often misleading – no market value, will be thrown away, or “hospital-based research protocols” suggesting altruistic donation or that the activity is a scientific and educational endeavor occurring in the context of medical care. The model of the charitable trust is an elegant and flexible legal model – when a person agrees to donate tissue, the recipient has a responsibility to serve as a trustee, or steward, of the tissue to ensure protection of the contribution. (e.g. – International Red Cross). Academic medical centers are well qualified in taking leadership role in initiating and governing tissue trust. (Biotech & pharma companies could be partners w/tissue banks, negotiating IP arrangments w/commercial researchers.
A person who contravenes any of sections 5 to 9 is guilty of an offence and ( a ) is liable, on conviction on indictment, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding ten years, or to both; or ( b ) is liable, on summary conviction, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding four years, or to both.
A two-year, $24 million program from the U.S. Defense Advanced Research Projects Agency, launched last fall, is rapidly expanding the boundaries of brain-machine interface research. The six projects funded by DARPA ’s program — including Berger ’s at the University of Southern California — aim to develop technologies that will not only restore but will also augment human capabilities. This coordinated, well- funded “big science”approach to understanding how minds and machines can interact, he says, could have “transformational consequences for defense and society.” The effort will yield a new generation of electrodes, computer chips, and software that might eventually equip soldiers, for example, to control super fast artificial limbs, pilot remote vehicles, and guide mobile robots in hazardous environments, using only the power of their thoughts. Even more remarkable, such devices could enhance decision-making, upgrade memory and cognitive skills, and even allow one person ’s brain to communicate wirelessly with another ’s.
Although such applications are as speculative as they are spectacular, scientists no longer view them as pure fantasy. Their new optimism is fueled in part by a host of recent advances in neuroscience, interface hardware, and signal processing. And the influx of money certainly doesn’t hurt. “DARPA is putting much larger resources into the area than has ever been seen before,” says William Heetderks, director of the Neural Prosthesis Program at the National Institutes of Health. And because researchers in this field of innovative ideas, he adds, the new funding “will have a tremendous effect.”
Nano - the art of manipulating materials on an atomic or molecular scale, is the enabling mechanism or delivery system by which the bio, info, and cogno will converge Bio – including genetic engineering, gene therapy, transgenics (crossing species) and related topics Info – Informatics, advanced computing and communications Cognitive Science – the study of our brains and nervous, ranging from mapping to manipulation. ( Sonia : Neurotechnology is the set of tools that influence the central nervous system, in particular the brain, to achieve a desired effect. It encompasses nanotechnology, genetic engineering, physical augmentation, cellular implantation, electronic stimulation, psychopharmaceuticals, and non-pharmacologic neurotechnologies ) The NSF and the Dept of Commerce of commerce have made grant monies available to leading experts from government, the academic research community and the private sector to explore the nature and size of the potential opportunities in NBIC convergence.
The key to being able to restore or augment human capabilities, he says, will be gaining access to the brain signals in an unobtrusive way —ideally, without wires, electrodes, or surgeries. And though this vision is still years away, our minds may already be on the road to a new way of thinking.
If we are just “meat-bots” programmed by our genetics and biological chemistry, what does that say about our views of personal responsibility?
Remember to take a thoughtful cautious approach to these issues, as art and literature are full of examples of science going awry and egos falling into hubric disasters.
Dr Frankenstein Legal And Moral Status Of Body Parts
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 July 6, 2004
Linda MacDonald Glenn, JD, LLM <ul><li>Former Senior Fellow, Institute for Ethics, American Medical Association.* </li></ul><ul><li>LL.M. in Biomedical Ethics from McGill University, Montreal, Canada </li></ul><ul><li>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 </li></ul><ul><li>Assistant professor, trial lawyer and advocate . </li></ul><ul><li>Director, Board of the Converging Technologies Bar Association </li></ul>
Purpose of Presentation <ul><li>Ethical and Legal implications and developments in the Management of Tissue and Body Parts </li></ul>
Part 1 – Tissue Samples and Research <ul><ul><li>John Moore Case </li></ul></ul><ul><ul><li>Commodification </li></ul></ul><ul><ul><li>Charitable Trusts </li></ul></ul>
Patenting of DNA sequences and genetically-altered material <ul><li>USPTO prohibition of humanzee </li></ul><ul><li>Canadian’s prohibition on patenting “higher life forms” </li></ul>
Part 2 – From Property to Quasi-Property? <ul><li>Dead Bodies – court rulings that dead bodies are more than mere property – they are “quasi-property”. </li></ul><ul><li>Ted Williams saga (Bioethics meets Jerry Springer) </li></ul>
Part 2 – From Property to Quasi-Property? <ul><li>Frozen embryos – from Tennessee to Massachusetts </li></ul><ul><li>Canadian Bill C-6 </li></ul>
Canadian Bill C- 6 <ul><li>Passed March 9, 2004 - Short title 1. This Act may be cited as the Assisted Human Reproduction Act. </li></ul><ul><li>Prohibited procedures: </li></ul><ul><li>5. (1) No person shall knowingly </li></ul><ul><li>(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; </li></ul><ul><li>(b) create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures; </li></ul><ul><li>(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; </li></ul><ul><li>(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 </li></ul>
Canadian Bill C- 6 <ul><li>(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; </li></ul><ul><li>(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; </li></ul><ul><li>(g) transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being; </li></ul><ul><li>(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; </li></ul><ul><li>(i) create a chimera, or transplant a chimera into either a human being or a non-human life form; or </li></ul><ul><li>(j) ) create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form. </li></ul>
Part 3 – Organ Trafficking <ul><li>Body Parts for Sale </li></ul><ul><li>Theft and Mutilation </li></ul><ul><li>Need for high end diagnostics of parts (Rabies incident) </li></ul>
Tissue Engineering—An alternative to Organ Transplantation
Why Tissue Engineering? <ul><li>One person added to wait list every 14 min </li></ul><ul><li>One patient dies every 85 min waiting for transplant </li></ul>United Network for Organ Sharing/ Organ Procurement and Transplantation Network
Goal of Tissue Engineering <ul><li>To replicate to the greatest extent possible the in vivo function of the tissue/organ being replaced </li></ul><ul><li>Achieved through hybrid approach, utilizing both natural and synthetic materials </li></ul>=
“Holy Grail” of Tissue Engineering In vitro culture Expand cells Vascularize tissue Implant Cells Patient cells Stem cells Animal cells Seed on scaffold
Mike Sefton, http://www.utoronto.ca/IBBME/research/tissue.htm Tissue Engineering Requires Multidisciplinary Cooperation
Characteristics of the Liver <ul><li>1.5 kg in average adult </li></ul><ul><li>Blood throughput 1450 ml/min </li></ul><ul><ul><li>Highly vascularized </li></ul></ul><ul><ul><li>High oxygen demand </li></ul></ul><ul><li>5 cell types present </li></ul><ul><li>Many varied functions performed </li></ul><ul><ul><li>Maintenance of homeostasis </li></ul></ul><ul><ul><li>Glucose uptake/release </li></ul></ul><ul><ul><li>Ammonia clearance through urea production </li></ul></ul><ul><ul><li>Lipid processing </li></ul></ul><ul><ul><li>Plasma protein synthesis </li></ul></ul><ul><ul><li>Bile formation </li></ul></ul><ul><ul><li>Xenobiotic metabolism </li></ul></ul>
Leading Bioartificial Liver (BAL) Devices <ul><li>Circe Biomedical </li></ul><ul><li>HepatAssist™ </li></ul><ul><li>Phase III trials </li></ul><ul><li>50 g porcine HCs, microcarrier-attached, extracapillary </li></ul><ul><li>Charcoal filtration </li></ul><ul><li>Plasma circulation </li></ul><ul><li>VitaGen ELAD™ </li></ul><ul><li>(Acquired by </li></ul><ul><li>Vital Therapies, Inc. </li></ul><ul><li>10/03) </li></ul><ul><li>Phase II trials </li></ul><ul><li>Tumor-derived human HC line, fiber attached, extracapillary </li></ul><ul><li>Plasma circulation </li></ul><ul><li>Algenix LIVERx </li></ul><ul><li>Phase I trials </li></ul><ul><li>80 g porcine HCs, collagen-entrapped, fiber lumen </li></ul><ul><li>Whole blood perfusion </li></ul>
Primary Cells vs. Cell Lines Primary cells are used for most tissue engineering applications.
NBIC – the synergistic combination of 4 major areas of science and technology <ul><li>Nanoscience and Nanotechnology </li></ul><ul><li>Biotechnology/ Biomedicine </li></ul><ul><li>Information Technology </li></ul><ul><li>Cognitive Science </li></ul>
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…. <ul><li> </li></ul><ul><li>Currently the laws are national and generated on a case-by-case basis. </li></ul><ul><li>There is a Need for Internationally-agreed upon Standards of Conduct </li></ul><ul><li>Perhaps, develop an International Forum </li></ul><ul><li>Examine the Issue of Commercialization versus the Common Good, create Charitable Trusts. </li></ul>
Thank you for your attention! <ul><li>A Special Thank You to Sonia E. Miller, Attorney-at-law, President of the Converging Technologies Bar Association ( www.ctba.us ) and </li></ul><ul><li>C. Chris Hook, MD, Director of Biotech Ethics at the Mayo Clinic </li></ul><ul><li>Dr. J.S. Boyce, Professor, Computer Science, Montgomery College, MD. </li></ul><ul><li>For further info, references contact me at [email_address] </li></ul>