Published on October 15, 2007
“Biomedical Technology: Legal Issues, EthicalDilemmas, Moral Concerns & Social Controversy”Larry SternCollin College: “Biomedical Technology: Legal Issues, Ethical Dilemmas, Moral Concerns & Social Controversy” Larry Stern Collin College Slide2: The Biotechnological Presence Slide3: Indicators of the “Biotechnological Presence” ~200,000 patents filed @ year Several hundred-thousand peer-reviewed articles in scientific journals @ year Hundreds of biotech companies listed on the Stock Market Slide5: Indicators of the “Biotechnological Presence” Using the search engine “google” = “hits” “Biotechnology” 118,000,000 “Gene Therapy” 7,700,000 “Stem Cell Research” 12,500,000 “Human Cloning” 1,780,000 “Therapeutic Cloning” 385,000 “Cloning” 26,000,000 “Designer Baby” 510,000 “Bioethics” 10,600,000 Slide21: Potential Benefits Slide23: Potential Health Benefits Biotechnological developments have the potential to conquer cancer grow new blood vessels in the heart block the growth of blood vessels in tumors create new organs from stem cells reset the primeval genetic coding that causes cells to age. Slide24: Potential Health Benefits On the horizon are artificial chromosomes containing genes which could be introduced into a developing human embryo and protect against HIV spinal cord injuries diabetes prostate and breast cancer Parkinson’s disease Alzheimer’s disease Slide25: Potential Health Benefits Soon, scientists should be able to identify genetic errors almost as quickly as a supermarket scanner prices a load of groceries. By 2100, a doctor’s visit will include a scan of our DNA, taken from a swab of our cheek or skin cells. Based on the results, the doctor will prepare a health risk profile and recommend a diet of genetically engineered foods that deliver preventive medicines as well as lifestyle changes to reduce the risk of disease and disability. Slide26: “Gene of the Month Club” “aggression” “rape” “novelty-seeking” “risk-taking” “infidelity” “alcoholism” “depression” “homosexuality” “learning disabilities” “schizophrenia” Slide27: OGOD “One gene, one defect” Slide33: “The Apple Doesn’t Fall Far From the Tree” Slide34: Dean Hamer National Institutes of Health Slide39: Sex & Spatial Thinking Slide42: “Is being bad in one’s blood?” Oprah Winfrey August 24, 1992 Slide45: Multiplicity Slide48: 1992 Slide49: 1997 Slide50: 1997 Slide51: Sociological Issues & Problematics Slide52: Sociological Issues and Problematics All actions have multiple consequences, some of which are intended, most of which are not. “The road to hell is paved with good intentions.” Conflict is built-in to the fabric of society. On the micro level: People who occupy different social positions and who - as a result - experience the world differently, tend to have distinctly different yet legitimate world views (including interests, values, attitudes). Sociologists are concerned with the distribution of conflicting opinions, the social factors that account for these differences, how they are negotiated and resolved, and the social factors affecting the resolution of the debates. Slide53: Family Economy Science Education Religion Politics The Social System Institutional Autonomy & Interdependence MORALS VALUES Slide54: Social Institutions Academic freedom; Growth of knowledge; Technological development Profitability; Competitiveness Morals & values; “Playing God” Security and well-being Reproductive Autonomy Legal Issues; Fairness; Distributive Justice; Balancing competing views Critical thinking; Awareness Slide55: Gene Therapy Cloning Stem-cell Research Genetic Enhancements Medical Applications Biomedical Procedures Slide56: The A.R.T. of Making Babies Assisted Reproductive Technology Slide57: Artificial Insemination by Donor (AID) First recorded case in 1884 By 1924: 123 AIDs/47 pregnancies By 1925: 185 AIDs/65 pregnancies By 1957 ~100,000 in the U.S. By 1960, 5,000 to 7,000 annually. Between 1986 & 1987, ~172,000 in the U.S. with half using donor sperm Slide58: Legal Questions Was Artificial Insemination by Donor (AID) performed without a husband’s specific consent adultery? In the 1956 case Doornbos v. Doornbos an Illinois judge declared that AID was adultery even in the presence of spousal approval. Most other jurisdictions in the U.S. saw it differently and held that since no bodily union between the woman and the sperm donor occurred, AID fell outside the customary definition of adultery. Moreover, it could not, the courts argued, be held as grounds for divorce—although it could in France. Slide59: Legal Questions What is the legal status of the children conceived through AID? Were they or were they not legitimate? In the mid-1960s, Georgia and then Oklahoma passed laws declaring any offspring of AID to be legitimate if the procedure was undertaken with the husband’s consent; however, state legislatures in several other states, including Indiana, Virginia, and Wisconsin, voted down similar provisions. New York – like many other states – consigned AID babies to the same marginal legal status as those born out of wedlock or put up for adoption, and would assign parental rights to the social father only if he went through formal adoption proceedings – a costly process that was often circumvented through subterfuge. Slide60: Could a sterile husband petition to deny paternity and thus be absolved of any financial responsibility? Legal Questions Could a sperm donor be sued for damages if the resultant child was in any way defective? Should a sperm donor be allowed “visitation rights? (CM v. CC, 1977, in Cumberland County, New Jersey) Slide61: Louise Joy Brown, the first “test-tube baby,” born July 25, 1978. Slide65: Legal and Ethical Issues Antiabortion statutes did not apply, since lawmakers had provided criminal penalties only for destroying or attempting to destroy implanted fetuses. The death of a blastocyst in a petrie dish could not legally be equated with an induced miscarriage. Social critics anticipated a test-tube baby race that would rival the space race, in which countries competed to improve their wealth, influence and power by adopting policies of selective breeding. Members of Parliament insisted that it receive no government support and, as a result, Britain’s Medical Research Council flatly rejected grant applications for research of this type. Slide66: Legal and Ethical Issues Ethicists argued that there was no way – at this point in time – of finding out in advance whether or not the viable progeny of the procedures of in vitro fertilization, culture, and transfer of human embryos into a womb would emerge healthy and intact, without physical or mental impairments or genetic abnormalities. And the potential child, of course, could not possibly give informed consent. Slide67: Gene Therapy Slide72: Genetic Enhancements Slide73: Designer Babies Slide74: The “Frankenstein Effect” Prometheans coming together to breed a new human species with a higher intellect and love of one's people. A communion of intellect and beauty for thesimple reason that it can be done. This creation is what gives us purpose and meaning. No other justification is required for this program to advance our Promethean species.: Prometheans coming together to breed a new human species with a higher intellect and love of one's people. A communion of intellect and beauty for the simple reason that it can be done. This creation is what gives us purpose and meaning. No other justification is required for this program to advance our Promethean species. Slide79: Watson worries that society will be too scared to use genetics to make people as perfect as they can be. Watson argues that the information gained from unraveling the genome will allow society to eradicate and prevent not only diseases but also any other traits that might be deemed undesirable. James D. Watson, Nobel laureate co-discoverer of the structure of DNA Slide80: Watson believes that women and their right to make reproductive choices could create the ideal future, where prenatal genetic screening keeps the sick or handicapped from ever being born and disease from being a serial killer. James D. Watson, Nobel laureate co-discoverer of the structure of DNA Slide81: Watson is also a proponent of so-called human-germline engineering, in which doctors could add or delete elements from egg and sperm cells that will be passed down to future generations. James D. Watson, Nobel laureate co-discoverer of the structure of DNA Slide82: Adding genes that will turn slow learners into whiz kids, he said, or those to prevent smokers from ever developing lung cancer, or genes making people HIV-resistant, might be part of the future. James D. Watson, Nobel laureate co-discoverer of the structure of DNA Slide83: September 13, 1999 Slide84: Suppose scientific discoveries make it possible for parents to select genetic traits such as intelligence, height or artistic talent when planning to have a child. Which comes closer to your view - parents should be allowed to select the traits they wish their child to have (or) parents should not be allowed to select the traits for their child and the child should be born with whatever traits it would naturally have? Slide85: Suppose scientific discoveries make it possible for parents to select genetic traits such as intelligence, height or artistic talent when planning to have a child. If you were having a child, and this was possible, would you - select the traits you wanted your child to have (or) let the child be born with whatever traits he or she would naturally have? Slide86: A UK woman is reported to be pregnant following an attempt to conceive a “savior sibling” to treat her seriously ill two-year old son. In September 2004, the Human Fertilisation and Embryology Authority granted Joe and Julie Fletcher permission to have a tissue-matched baby to help treat Joshua, who has an incurable blood disorder. The decision followed the HFEA's recent policy change in this area, allowing couples to use preimplantation genetic diagnosis (PGD) for testing IVF embryos solely to check their suitability as a potential cord blood donor for an existing sick child. Joshua Fletcher has Diamond Blackfan anaemia, a rare blood condition that could be cured with a blood stem cell transplant from a tissue-matched donor. “Savior Sibling” September 2004 Slide87: Having failed to find a matched living donor, his parents applied to use PGD to conceive an IVF baby who would be able to provide Joshua with compatible umbilical cord blood cells. If transplanted to Joshua, these cells could stimulate his body to produce its own healthy red blood cells. According to the couple's doctor, Mohammed Taranissi, the transplant operation has an 85 per cent chance of success. He stressed that although Julie Fletcher had tested positive for the pregnancy, it was still 'very early days'. “Savior Sibling” September 2004 Slide88: Surfing for Sperm on the Internet Slide89: Robert Graham 1906-1997 The Repository for Germinal Choice (Nobel Sperm Bank) Our special purpose is to give babies the best possible start in life. This is how we do it: We search the nation for men in excellent health who in addition have accomplished something outstanding, or men who, though young, demonstrate great potential. Always these men have high intelligence. This, like good health, can be handed on to offspring. Slide90: seed Exploring the "Nobel Prize sperm bank.” The Myths of the Nobel Sperm Bank The truth about who gave sperm, how they gave it, and who used it. By David Plotz Posted Friday, Feb. 23, 2001, at 12:00 AM PT seed Exploring the "Nobel Prize sperm bank.” The "Genius Babies," and How They Grew Help Slate tell the story of the Nobel Prize sperm bank. By David Plotz Posted Thursday, Feb. 8, 2001, at 12:00 AM PT Slide91: Advertisement in Princeton University student newspaper, March 1, 1999 Slide96: Cloning Animal - Human Reproductive - Therapeutic Slide97: Cloning - Xeroxing the Soul? Slide100: Clonaid is a company founded by a religious group called Raelians, a religious cult who believe the first humans were cloned by space aliens 25,000 years ago. Under the guidance of their spiritual leader, Claude Vorihon, they have taken on human cloning as a sacred mission. Claude Vorihon former French journalist, spiritual leader of the Raelians Slide101: We do not have any ethical concerns . . . Individuals should have the right to use their genes the way they want, and to reproduce the way they want. We, at Clonaid, will make sure that it is safe and reliable before using it as we did with the cloning procedure.” Clonaid Dr. Brigitte Boisselier Slide102: Regardless of whether or not you think it should be legal, please tell me whether you believe that in general it is morally acceptable or morally wrong to clone animals. Moral Acceptability of Cloning Animals Slide103: Moral Acceptability of Cloning Humans Regardless of whether or not you think it should be legal, please tell me whether you believe that in general it is morally acceptable or morally wrong to clone humans. Slide104: Cloning: Circumstances - May 6 - 9, 2002 Do you favor or oppose . . . Slide105: Reproductive Cloning Slide107: Margin of Error +/- 3% Slide108: l---------------White---------------l----Black---L More than seven-in-ten in every religious group oppose experimentation into human cloning. Moreover, the opposition largely arises from moral objections, not concerns over the safety of cloning. While white evangelical Protestants are more likely than others to cite moral concerns, majorities in every group base their opposition to cloning on the belief that it is morally wrong. Even seculars, who oppose research on the cloning of human beings by 56%-33%, are more influenced by moral beliefs than by safety concerns. Religious Beliefs and Opposition to Cloning Slide109: Tell me if you agree or disagree with reproductive cloning Slide110: Tell me if you agree or disagree with reproductive cloning January 2003 Slide111: Therapeutic Cloning Slide113: Tell me if you agree or disagree with therapeutic cloning January 2003 Slide114: At their annual meeting, the American Medical Association endorsed therapeutic cloning, if performed under careful supervision. The new AMA policy permits doctors to opt out of performing the procedures if they personally consider it to be unethical. This decision puts the nation's largest organization of doctors in conflict with the Bush administration. AMA endorses therapeutic cloning June 17, 2003 Slide115: Stem Cell Research Slide116: For each of the following, please tell me if it is --very important, somewhat important, not too important, or not at all important -- to you personally. (Gallup poll, July 10-11, 2001). Slide117: On August 9, 2001 President Bush announces that the federal government would fund research only on stem cells that come from existing stem cell lines, and that no government money would go to assist research on stem cells from newly destroyed embryos, from embryos created specifically for research purposes, or from cloned embryos. Slide118: Gallup Poll, August 5 - 7, 2005 Do you think the federal government should - or should not - fund research that would use newly created stem cells from human embryos? These results are based on telephone interviews with a randomly selected national sample of 1,004 adults, aged 18 and older, conducted Aug, 5-7, 2005. For results based on this sample, one can say with 95% confidence that the maximum error attributable to sampling and other random effects is ｱ3 percentage points. Slide119: Gallup Poll, August 5 - 7, 2005 Do you think the federal government should - or should not - fund research that would use newly created stem cells from human embryos? These results are based on telephone interviews with a randomly selected national sample of 1,004 adults, aged 18 and older, conducted Aug, 5-7, 2005. For results based on this sample, one can say with 95% confidence that the maximum error attributable to sampling and other random effects is ｱ3 percentage points. Slide120: Gallup Poll, August 5 - 7, 2005 Do you think the federal government should - or should not - fund research that would use newly created stem cells from human embryos? These results are based on telephone interviews with a randomly selected national sample of 1,004 adults, aged 18 and older, conducted Aug, 5-7, 2005. For results based on this sample, one can say with 95% confidence that the maximum error attributable to sampling and other random effects is ｱ3 percentage points. Slide121: Gallup Poll, May 20 - 22, 2005 Which would you prefer the government to do - place no Restrictions on government spending on stem cell research, ease the current restrictions to allow more stem cell research, keep the current restrictions in place, or not fund stem cell research at all? Slide122: Gallup Poll, May 20 - 22, 2005 American Opinion on Stem Cell Restrictions: Demographics Slide130: Scientists in South Korea have extracted and grown stem cells from cloned, early human embryos, a breakthrough in “therapeutic cloning” research. Using a modified version of the technique used to clone Dolly the sheep, the team, based at the Seoul National University, created 30 cloned human embryos. The researchers extracted stem cells from 20 of these, from which they managed to grow one human embryo stem (hES) cell line. They have also shown that these cells can grow into different embryo tissues in the laboratory, and into adult tissues when transplanted into mice. Their work, which will be published in the journal Science, has been hailed as 'a landmark paper' by other scientists, and could pave the way for research into new treatments for many diseases. Cloned human embryo stem cell breakthrough February 12, 2004 Slide131: Federal Law Slide132: Overall, do you approve or disapprove of Bush’s decision on stem cell research? (Gallup Poll, August 9, 2001) Slide133: Which is more important? (based on those who have heard at least a little about this issue) - March 2002 Conducting research toward medical cures 47% Not destroying human embryos 39 Don’t know 14 By a narrower margin (47%-39%), those who have been paying attention say conducting stem cell research is more important than not destroying the potential life of embryos involved in such research. Slide134: Morality of Stem Cell Research Using Human Embryos May 6-9, 2002 Slide141: Two new studies suggest that at least 25 per cent of the embryonic stem (ES) cell lines available for use by federally-funded US researchers have 'little potential even as research tools'. This is because they are too difficult to keep alive and were initially grown using mouse “feeder” cells, which would cause them to be rejected by patients' immune systems and diminishing their potential as a medical treatment. President Bush has restricted the use of federal funds to ES cell research conducted on cell lines created before 9 August 2001. Over 200 Members of the House, including some pro-life Republicans and Democrats, have signed a letter to President Bush asking him to repeal his policy on federal funding for embryo stem cell research. Bush's approved stem cell lines show little potential November 1, 2004 Slide142: Stem Cell Research Enhancement Act 26 May 2005 The US House of Representatives has approved a bill that would overturn President Bush's current policy on human embryonic stem (ES) cell research. Members of the House voted 238-194 in favor of the Stem Cell Research Enhancement Act of 2005. Fifty Republican members voted in favor of the new legislation, along with a large majority of Democrat representatives. Slide143: Stem Cell Research Enhancement Act 26 May 2005 The new legislation would allow an extension of federal funding for research using ES cells derived from embryos left over from fertility treatments and donated by patients. It would not allow funds for ES cell research on embryos that are created expressly for research purposes. Patients cannot be paid for embryo donation and that they must have full knowledge of how the donated embryos would be used. Slide145: US Senate stem cell vote postponed until 2006 21 October 2005 Senate Majority Leader Bill Frist has proposed postponing until 2006 a vote on a bill that would expand federal funding for human embryonic stem (ES) cell research. Although the bill has already passed through the US House of Representatives, it stalled in the Senate this summer. Slide146: US Senate stem cell vote postponed until 2006 21 October 2005 President Bush has vowed to veto any bill that would extend this policy, should it be passed by the Senate. Slide147: Senate Majority Leader Bill Frist has proposed postponing until 2006 a vote on a bill that would expand federal funding for human embryonic stem (ES) cell research. Although the bill has already passed through the US House of Representatives, it stalled in the Senate this summer. Current policy, set by President George Bush on 9 August 2001, only allows state funds to be used for research on ES cell-lines that were created before that date. The President has vowed to veto any bill that would extend this policy, should it be passed by the Senate. US Senate stem cell vote postponed until 2006 21 October 2005 Slide148: State Laws Reproductive Cloning & Therapeutic Cloning Slide149: By 59% to 41% of votes, Californians said "yes" to Proposition 71, the California Stem Cell Research and Cures Initiative November 2, 2004 Proposition 71 authorizes the state to sell $3 billion in bonds and then dispense nearly $300 million a year for 10 years to researchers for human embryonic stem-cell experiments, including cloning projects intended solely for research purposes. It bans the funding of cloning to create babies. A new research entity, the Institute for Regenerative Medicine, will be created to distribute the funds and establish research guidelines. The proposition also calls for the state constitution to be amended to guarantee biologists' right to do embryonic stem-cell research, and protect the institute from interference or supervision by the legislature. Slide150: Fourteen states currently have laws pertaining to human cloning. Louisiana also enacted legislation that prohibited reproductive cloning, but the law expired in July 2003. As of November 16, 2005 . . . 130 separate pieces of legislation have been introduced or prefiled in 29 states Slide155: The legislature of Washington state has rejected a bill that would have banned human reproductive cloning but would have allowed the cloning of embryos for ES cell research purposes, sometimes known as therapeutic cloning. The state's Senate voted 26-23 against the proposals. Washington - April 2005 The House of Representatives had passed a bill that would have provided from 2007, $23 million per year for ES cell research, under new state guidelines. But the Senate version was filibustered. Maryland - April 2005 Slide156: The Massachusetts legislature passed a law - after overruling a veto by state Governor Mitt Romney - that allows embryos to be cloned for medical research purposes, but prohibits human reproductive cloning. The law also establishes a stem cell advisory committee to oversee ES cell research in the state and establish safeguards, although it does not provide state funds for researchers. The House of Representatives had passed the bill by 119 votes to 38 in May, it passed through the state Senate by 34 votes to two. Massachusetts - May 2005 Slide157: The governor of the US state of Wisconsin announced that he would allocate $750 million to ES cell research and other scientific research. Governor Jim Doyle said that $375 million of the money, sourced from both state and private funds, would be used to establish and build an ES cell research institute - the Wisconsin Institute for Discovery - at the University of Wisconsin-Madison, between 2005 and 2015. Governor of Wisconsin Announces Plan to Spend $750M on Embryonic Stem Cell Research November 17, 2004 Slide160: The state Senate of Ohio has approved legislation that would limit the use of state funds for 'therapeutic' cloning and human embryonic stem (ES) cell research. It would also prevent people in the state benefiting from therapies developed in other states or countries that had been developed using cloning techniques or ES cells. The bill passed through the Senate last week by 21 votes to 11. The bill will now pass to the Ohio House of Representatives, where a similar but even more restrictive bill - banning even the use of private funds - has stalled due to lack of support. Ohio - November, 2005 Slide161: Florida may be the next US state to fund embryonic stem (ES) cell research, under a proposed constitutional amendment put forward by the group Floridians for Stem Cell Research and Cures (FSCRC). The proposal would allocate $200 million over ten years to the Research and states that the only embryos that can be used for ES cell research are those that are left over from fertility treatments and donated by women who specify that they may not be implanted in their wombs or any other woman's. Florida might be next to fund ES cell research 23 September 2005 Slide162: American women underwent about 100,000 fertility treatments in 2000, the latest year for which statistics are available, resulting in the birth of about 35,000 babies. The most common procedure, in vitro fertilization, usually generates more embryos than are immediately needed, and extras are typically frozen for possible use later. Frozen Embryos Of the approximately 60 million women of reproductive age in 1995 in the United States, about 1.2 million, or 2%, had had an infertility-related medical appointment within the previous year, and an additional 13% had received fertility services in their lives. Slide163: How do couples dispose of or dispense remaining frozen embryos that they no longer will use for their own conception purposes? Four options: Couples can opt to leave them in storage, donate them to an infertile couple, donate them to research, or allow them to thaw and be destroyed. Frozen Embryos Slide164: RAND researchers Gail L. Zellman and C. Christine Fair, together with the Society of Assisted Reproductive Technology (SART) Working Group led by David Hoffman, MD, sent a survey to all 430 assisted reproductive technology facilities in the United States, 340 of which responded. Estimates for nonresponding clinics were developed using a statistical formula based on a clinic's size and other characteristics. The results show that as of April 11, 2002, a total of 396,526 embryos have been placed in storage in the United States. Frozen Embryos http://www.rand.org/publications/RB/RB9038/ Slide165: The vast majority of stored embryos (88.2 percent) are being held for family building Frozen Embryos 2.8 percent of the total (11,000) designated for research. Of the remaining embryos, 2.3 percent are awaiting donation to another patient, 2.2 percent are designated to be discarded, 4.5 percent are held in storage for other reasons, including lost contact with a patient, patient death, abandonment, and divorce. Slide168: in vitro fertilization To proponents, in vitro fertilization was seen a means of alleviating both infertility and fetal abnormalities. From their perspective, IVF would not only be a boon to the thousands of women with tubal blockage, which rendered them incapable of conceiving normally, but also usher in an age in which medicine might address disease at the level of the genes, prenatally. Fertilization in the lab would enable the researchers to examine a microscopic human being – one in its very earliest stages of development – and as a result gain new knowledge about genetic disorders. Embryos fertilized in the lab could be discarded if flawed. And here, of course, lies the major controversy. Slide169: March 26, 2004 Slide170: April 2, 2004 Slide171: US Court rules that embryos are not persons: October 31, 2005 The Arizona Court of Appeals has ruled that a couple cannot sue for “wrongful death” over embryos lost or destroyed by a fertility clinic. William and Belinda Jeter sued the Mayo Clinic for wrongful death after it lost or destroyed the five “pre-embryos” they had created in vitro and cryopreserved, when they were meant to be transferred to another doctor. Jeter et ux. v. Mayo Clinic Arizona The court defined the fertilised eggs as 'pre-embryos', holding that they had not even reached the point where they could be defined as embryos. Then it said that Arizona State law does not define a days-old human pre-embryo kept outside the womb as a human person, further adding that to succeed in a wrongful death action in relation to a fetus, it must be viable and able to survive outside of the womb. Slide172: Legal Issues Davis v. Davis, (Tenn, 1992) Kass v. Kass (NY, 1998) Woodward ex rel. Estate of Woodward v. Commissioner of Social Security (Mass. 2002) Slide173: No Contract Balancing Test Favoring the Right to Avoid Procreation Davis v. Davis, (Tenn, 1992) Slide174: Davis v. Davis, (Tenn, 1992) Mary Sue and Junior Lewis Davis attempted in vitro procedures six times - at a cost of $35,000 - without success. Next, they decided upon cryopreservation, which permitted extraction of several ova at once, which then could be inseminated together in the lab and allowed to develop as fertilized zygotes and either implanted into Mary Sue or cryopreserved for future implantation Nine fertilized eggs, or zygotes, were allowed to develop in Petri dishes until they matured to the four- to eight-cell stage. Slide175: Davis v. Davis, (Tenn, 1992) Two were implanted - the procedure was unsuccessful - and the remaining seven were frozen in nitrogen and stored at minus 196 degrees centigrade. Before another procedure could be attempted, Junior filed for divorce, citing “irreconcilable differences.” The Davises had not signed any agreement between themselves or with the clinic, nor had they ever discussed what to do in the event of death, divorce, or other circumstances. Mary Sue wished to either use or donate the remaining embryos to a childless couple. Junior did not desire to have another child. Slide176: Davis v. Davis, (Tenn, 1992) The woman has a right to procreate The father has a right not to procreate The embryo has a right to life Judge Young ruled that “life begins at conception” and that the “best interests” of the “children” was “implantation to assure their opportunity for live birth.” The Tennessee Supreme Court overruled and awarded custody to the father - who had them destroyed almost immediately. Slide177: Kass v. Kass (NY, 1998) A Contract Favoring the Right to Avoid Procreation Enforced Slide178: Kass v. Kass (NY, 1998) In issue is the Disposition of five frozen, stored pre-embryos, or “pre-zygotes,” created five years ago, during the parties’ marriage, to assist them in having a child. Now divorced, appellant (Maureen Kass) wants the pre-zygotes implanted, claiming this is her only chance for genetic motherhood. Respondent (Steven Kass) objects to the burdens of unwanted fatherhood, claiming that the parties agreed at the time they embarked on the effort that in the present circumstances the pre-zygotes would be donated to the IVF program for approved research purposes. Slide179: Kass v. Kass (NY, 1998) Supreme Court granted appellant custody of the pre-zygotes and directed her to exercise her right to implant them within a medically reasonable time. The court reasoned that a female participant in the IVF procedure has exclusive decisional authority over the fertilized eggs created through that process, just as a pregnant woman has exclusive decisional authority over a nonviable fetus, and that appellant had not waived her right either in the May 12, 1993 consents or in the June 7, 1993 "uncontested divorce" agreement. Slide180: Kass v. Kass (NY, 1998) While a divided Appellate Division reversed that decision, all five Justices unanimously agreed on two fundamental propositions. First, they concluded that a woman's right to privacy and bodily integrity are not implicated before implantation occurs. Second, the court unanimously recognized that when parties to an IVF procedure have themselves determined the Disposition of any unused fertilized eggs, their agreement should control. Slide181: A.Z. v. B.Z. (Mass. 2000) A Contract Favoring the Right to Procreate Found Unenforceable Slide182: A.Z. v. B.Z. (Mass. 2000) The facts of this case are similar to those in Kass and involved a dispute in a divorce action over the disposition of frozen embryos after a contract was entered into. An IVF procedure resulted in extra embryos that the couple decided to have cryogenically frozen for use in future implantations. The wife, without the husband's knowledge, later had half the frozen embryos thawed and unsuccessfully implanted. Subsequently, the *289 couple divorced, and the husband Sought a permanent injunction to prohibit his former wife from using the remaining embryos Slide183: A.Z. v. B.Z. (Mass. 2000) The couple, as required by the physician, signed a consent form relating to the cryopreservation of the embryos. The consent form addressed the disposition of the embryos under a variety of circumstances, including separation of the parties. The first form stated that in the case of separation, the wife was to have control of the embryos for use in implantation. The husband signed a completed form for the first procedure and thereafter signed blank forms. The blank signed forms were completed with substantially similar language as the first consent form and signed by the wife. Slide184: A.Z. v. B.Z. (Mass. 2000) The court found the consent form legally insufficient to be an enforceable contract. In invalidating the apparent agreement, the court found that the contracts did not represent the intent of the husband and were really intended as a form to assist the reproductive clinic. The court also found that because the form lacked a temporal element, it was not dispositive four years later and under a fundamental change in the parties' relationship - divorce. As a matter of law, the court held that the agreement could not be binding in divorce because it did not provide for custody, support, and maintenance in the event a child was born from the embryos. Slide185: A.Z. v. B.Z. (Mass. 2000) The court found that, at a fundamental level, it is against public policy to force parenthood. Like the Tennessee Supreme Court and the New York Court of Appeals, the Massachusetts Supreme Judicial Court found that the right to avoid procreation was truly the governing principle in deciding the disposition of embryos. Slide186: In re Marriage of Witten (Iowa, 2003) All Contracts Between Couples Subject to the Mutual Consent of Both Parties Slide187: In re Marriage of Witten (Iowa, 2003) Prior to IVF treatment, the couple executed an "Embryo Storage Agreement" providing that the embryos would "be used for transfer, release or disposition only with the signed approval of both Client Depositors.” Several embryos were created, but implantation in Tamera was unsuccessful. At the time of their divorce proceedings,seventeen embryos remained cryogenically frozen. Slide188: In re Marriage of Witten (Iowa, 2003) During the divorce proceedings, Tamera sought control over the seventeen embryos to be implanted in a surrogate mother. Tamera stated that she wanted to be genetically linked with her child. "She adamantly opposed the destruction of the embryos" or use by another couple. Arthur opposed destruction of the embryos, but he also opposed granting control to Tamera and requested that disposition of the embryos be subject to the mutual consent of him and Tamera. Slide189: In re Marriage of Witten (Iowa, 2003) The Supreme Court of Iowa held that “agreements entered into at the time in vitro fertilization is commenced are enforceable and binding on the parties ‘subject to the right of either party to change his or her mind about disposition up to the point of use or destruction of any stored embryo.’” The court adopted a standard requiring mutual consent and explained that embryos will be stored until an agreement between the couple is reached. In so doing, the Court inherently recognized the right to avoid procreation. Each party is essentially given the right to avoid procreation by simply refusing to consent to any disposition other than destruction. Slide190: Posthumous Reproduction Slide191: In January, 1993, about three and one-half years after they were married, Lauren Woodward and Warren Woodward were informed that the husband had leukemia. At the time, the couple was childless. Woodward ex rel. Estate of Woodward v. Commissioner of Social Security (Mass. 2002) Advised that the husband's leukemia treatment might leave him sterile, the Woodwards arranged for a quantity of the husband's semen to be medically withdrawn and preserved, in a process commonly known as "sperm banking." The husband then underwent a bone marrow transplant. The treatment was not successful. The husband died in October, 1993. Slide192: In October, 1995, the wife gave birth to twin girls. The children were conceived through artificial insemination using the husband's preserved semen. In January, 1996, the wife applied for two forms of Social Security survivor benefits:"child's" benefits and "mother's" benefits. Woodward ex rel. Estate of Woodward v. Commissioner of Social Security (Mass. 2002) The Social Security Administration (SSA) rejected the wife's claims on the ground that she had not established that the twins were the husband's "children" within the meaning of the Act. Slide193: The Court concludes that limited circumstances may exist, consistent with the mandates of our Legislature, in which posthumously conceived children may enjoy the inheritance rights of "issue" under our intestacy law. These limited circumstances exist where, as a threshold matter, the surviving parent or the child's other legal representative demonstrates a genetic relationship between the child and the decedent. The survivor or representative must then establish both that the decedent affirmatively consented to posthumous conception and to the support of any resulting child. Even where such circumstances exist, time limitations may preclude commencing a claim for succession rights on behalf of a posthumously conceived child. Woodward ex rel. Estate of Woodward v. Commissioner of Social Security (Mass. 2002) Slide194: February 2005 Slide195: Chicago - February 2005 Illinois judge Jeffrey Lawrence refused to dismiss a wrongful death suit brought by Alison Miller and Todd Parrish against a fertility clinic in Chicago. The plaintiffs allege that the defendant, the Center for Human Reproduction in Chicago, discarded their nine embryos and thereby ended the embryos’ lives. According to Judge Lawrence a fetus qualifies as a deceased person for purposes of the Wrongful Death Act and that "a pre-embryo is a 'human being' ... whether or not it is implanted in its mother's womb." Slide196: Chicago - February 2005 To support his ruling Judge Lawrence cited another Illinois law that specifically finds that an "unborn child is a human being from the time of conception and is, therefore, a legal person.” Slide197: US Court rules that embryos are not persons: The Arizona Court of Appeals has ruled that a couple cannot sue for “wrongful death” over embryos lost or destroyed by a fertility clinic. William and Belinda Jeter sued the Mayo Clinic for wrongful death after it lost or destroyed the five “pre-embryos” they had created in vitro and cryopreserved, when they were meant to be transferred to another doctor. Jeter et ux. v. Mayo Clinic Arizona October 31, 2005 Slide198: Jeter et ux. v. Mayo Clinic Arizona The court defined the fertilized eggs as “pre-embryos,” holding that they had not even reached the point where they could be defined as embryos. The court stated that Arizona State law does not define a days-old human pre-embryo kept outside the womb as a human person, further adding that to succeed in a wrongful death action in relation to a fetus, it must be viable and able to survive outside of the womb. Slide199: Think about embryos that have been created in a laboratory by fertilizing a woman’s egg outside the womb and have not been implanted in a woman’s womb. Which comes closer to your view about this type of embryo -- the embryo is a human life that should be given the same protection as all other human lives, or, the embryo has the potential for life, but is not the same as a life, because it cannot develop on its own. (Gallup Poll, August 10-12, 2001) Life to be treated with same protection as other human lives Potential for life, but cannot develop on its own 36% No opinion 60% 4% When does life begin? Slide200: Potential Life Life Human Life Personhood Slide201: Potential Life? Slide202: Potential Life, or Life? Slide203: Life, or Human Life? Slide204: Potential Life Life Human Life Personhood Slide205: A few hours after conception when the ovum splits into two cells. Some regard human personhood as being defined by the act of cell splitting. About 12 days from conception when pregnancy begins. i.e. when the fertilized ovum has developed to the blastocyst stage and has attached itself to the lining of the uterus. About two weeks from conception when a yellow streak develops in the embryo. This will later become the neural tube which will be protected by the backbone. Once this develops, it is impossible for the embryo to split into a pair of identical twins. The concept of personhood implies a single entity; twins would be two persons. Before this stage of development, the embryo may still split and become two persons. 3 weeks from conception when the embryo is about 2 mm long and has started to develop visible external body parts. When does “Personhood” begin? Slide206: 4 weeks from conception when its heart starts to beat. 6 weeks from conception, when brain waves can be first sensed. 2 months, when the fetus has lost its neck structures which resemble gill slits, and its face resembles that of a primate. 3 months, when the fetus begins to “look like” a baby. 4 months, when the fetus' face has developed to the point where one can tell one fetus from another. About 24 weeks, when the fetus becomes viable, (i.e. able to live outside the womb). When does “Personhood” begin? Slide207: When does “Personhood” begin? 6 months or later, when its brain has developed to a particular degree. The cerebral cortex is in place and “large-scale linking up of neurons” begins around the 24th to 27th week of pregnancy – the sixth month. Scientists have “measured brain-wave patterns like those during dreaming at 8 months gestation.” Some believe that the fetus becomes a human person only after it has been delivered and is breathing on its own. There is some Biblical justification for this belief. Genesis 2:7 states that God made Adam's body from the dust of the ground. But it was only after God “breathed into it the breath of life” that “man became a living person.” Slide210: Nancy Reagan has been lobbying for a change in President Bush's policy on research into human embryo stem cells. The 81-year-old wife of former president Ronald Reagan has been “obliquely but persistently campaigning” for federal funding of therapeutic cloning and embryo stem cell research. Slide211: Bush Prods Senate to Adopt Ban on All Cloning April 10, 2002 WASHINGTON (CNN) -- President Bush on Wednesday pressed the Senate to forbid the cloning of human embryos either for research or reproductive purposes, saying any reason for human cloning would be unethical. “Anything other than a total ban on human cloning would be unethical,” he said in a speech at the White House. “Research cloning would contradict the most fundamental principle of medical ethics -- that no human life should be exploited or extinguished for the benefit of another.” Bush endorsed legislation sponsored by Sens. Sam Brownback, R-Kansas, and Mary Landrieu, D-Louisiana, that would make it a federal crime punishable by up to 10 years in prison to create a cloned human embryo. The bill has 29 Senate co-sponsors but Landrieu, is the only Democrat to sign onto the measure. Identical legislation passed the House last year by a vote of 265-162, but the Senate is far more divided than the House on the cloning issue. Slide212: UN Sidesteps International Cloning Ban November 20, 2004 The Legal Committee of the General Assembly of the United Nations (UN) last week abandoned proposals to adopt an international convention on human cloning. A proposal led by the US and Costa Rica, which called for an international treaty banning all forms of human cloning, including for medical research, was abandoned in favor of a more general non-binding UN declaration against reproductive cloning. All 191 United Nations members had agreed on the need for a treaty to prohibit reproductive cloning. But a vote has been stalled for three years by sharp differences over whether to broaden the ban, as the United States advocated, to prohibit cloning to create stem cells for research, part of a field known as therapeutic cloning.