“What You Need to Know about Stem Cells” Presenter’s Notes Accompanying the PowerPoint Presentation

“What You Need to Know about Stem Cells” Presenter’s Notes Accompanying the PowerPoint Presentation Prepared by the Stem Cell Action Network (SCAN) www.stemcellaction.org The notes in this document amplify information in the SCAN PowerPoint presentation on stem cell research You can use these notes to help you give this presentation to an audience Additional materials that you may find helpful in preparing your presentation are available online at: http://www.stemcellaction.org/presentation.htm The presentation and these notes are designed to serve the needs of a presenter who is not a scientist and who does not know much about stem cell research Please don’t be intimidated by the complexity of this subject! Technical expertise is not needed to give this presentation These notes are posted on the SCAN website at www.stemcellaction.org/presentation.htm Encourage those in your audience who have Internet access to read these notes if they wish to learn more about the points made in your presentation Also helpful in “boning up” on the basics of SCR (stem cell research) are the following online resources: Regarding the science of stem cell research: Princeton University Department of Molecular Biology http://www.molbio.princeton.edu/courses/mb427/2001/projects/09 Stem Cell Network (a Canadian organization) http://www.stemcellnetwork.ca/engage National Institutes of Health (NIH) Stem Cell Information http://stemcells.nih.gov/index.asp Regarding he ethics of stem cell research: http://www.physweekly.com/archive/99/10_04_99/pc.html Stem cell research is a many-faceted enterprise In preparing your presentation, don’t feel that you have to cover every single point made on the slides And don’t be daunted by the amount of material that we’ve included in these notes We realize that this is much more information here than would ever be fitted into a talk on this subject Tailor what you say to the needs and attention span of your audience Choose whatever you believe will be relevant and helpful to that audience If questions are thrown at you that you cannot answer, then relay them to us at SCAN (Idelle@stemcellaction.org), and we will try to reply in a timely way Here are addition guidelines 1 There are several ways of giving this presentation to an audience If you not have access to PowerPoint presentation technology, then you may take a “lowtech” approach, using only printed materials Especially for an audience of ten or twenty or so, that will work fine Whatever form your presentation takes, it’s a good idea to accompany your talk with a printed document that you hand out to members of your audience You can make copies of the Word-document version of the presentation at your local photocopy shop and distribute them to your audience (This document includes the two slides on California You may delete them if you're addressing a non-California audience.) You can also ask the photocopy shop to make 11X17 inch color representations of the three explanatory diagrams in the presentation: "Embyronic Stem Cells” “Stem Cells from In Vitro Fertilization (IVF)” “Human Therapeutic Cloning (SCNT)” For a diagram that combines diagrams and above, see: "IVF and SCNT Stem Cell Sources" By clicking on these images (try using a right-click, if your mouse has one), you can download them to your computer You can then email them to your local photocopy shop, to be printed out in 11X17-inch color Kinkos will this for less than $2/slide If your audience is a small one, you can display the printed images to them while you discuss the scientific aspects of the research In June, we will hold the "First International Stem Cell Action Conference" at the University of California in Berkeley Please invite your audience members to attend this historic event You can download, copy, and distribute the Conference Flier to your audience You can go to your local photocopy shop and ask them to make 11X17 inch color representations of the three explanatory diagrams in the presentation, entitled    “Embyronic Stem Cells” “Stem Cells from In Vitro Fertilization” “Human Therapeutic Cloning (SCNT)” For a diagram that combines the last two diagrams above, see: "IVF and SCNT Stem Cell Sources" Files containing these images are posted at http://www.stemcellaction.org/presentation.htm By right-clicking on these images you can download them to your computer You can then email them to your local photocopy shop, and they can print them out in 11X17 color Kinkos will this for less than $2/slide It is a good idea to accompany your talk with a printed hand-out that you distribute to members of your audience We have prepared such a hand-out and it is available at: http://www.stemcellaction.org/presentation.htm You presentation is an overview, and in most cases shouldn’t last longer than 30 to 45 minutes You don’t want to lose the interest and attention of your audience The most important parts of your presentation are likely to be the science, ethics, and advocacy of the research You may wish to focus on these three areas, giving less attention to the details of the political regulation and support for the research Be sure to hand out to your audience the flier about the conference, and invite audience members to attend Encourage members to learn more about the conference by visiting the website www.fisca.info, and/or telephoning Raymond Barglow, whose phone number is at the bottom of the flier (The conference flier is included as Appendix of this document, and is also available on line at http://www.stemcellaction.org/presentation.htm.) Ask audience members to provide you with their email addresses, if they are willing to be added to the SCAN emailing list or if they have an interest in the conference Encourage discussion during or following your presentation Be open to questions that audience members ask about any aspect of the research – scientific, ethical, or political If people have qualms about the prospects or ethics of the research, they should feel free to express them Please remain tolerant and friendly toward people who question the research for one reason or another Slide: What are stem cells? Stem cells are the raw material from which all of the body’s mature, differentiated cells are made Stem cells give rise to brain cells, nerve cells, heart cells, pancreatic cells, etc The cells that make up a human body are of different types and specialize in doing specific kinds of work, just as in society, different people have different jobs All cells, however, either are stem cells or come from stem cells Cells of the heart, the brain, bones, the pancreas – whatever kind of cell you care to mention – all have their origins in the versatile stem cell Once a stem cell has specialized, however, it cannot develop into yet another type of cell Stem cells don’t get to change careers cell differentiation is an irreversible process Stem cells are found in embryos during their first few days of development, in fetal tissue, and more rarely in organs such as the heart, bones, brain, etc Slide: What’s so special about stem cells?  They are self-renewing they can replicate themselves over and over for a very long time  They have the potential to replace cell tissue damaged by severe illnesses  Understanding how stem cells develop into healthy and diseased cells will assist the search for cures Stem cells are a raw material that has the capacity to renew itself Stem cells can divide over and over, for a very long time, generating an unlimited number of identical undifferentiated cells exactly like themselves A stem cell “line” is composed of a culture of self-replicating stem cells Stem cells generate all of the cell types that a human body needs Stem cells’ two key properties – their self-renewing capacity and their capacity to become mature, specialized cells make them well suited to restoring tissue that has deteriorated Like a very versatile building material, stem cells can be molded into just the right form to repair a human body Let’s look at this restorative process in a little greater detail, to better understand how stem cell research can lead to cures Some children are born with organs that not work right A child with juvenile diabetes, for example, has a pancreas that does not generate enough insulin – a hormone needed by the body in order to digest sugars Adults too sometimes have cells or entire organs that have become damaged so that they no longer function well In the brain of a person who has Parkinson’s or Alzheimer’s disease, for example, neurons no longer work in the normal way In a spinal cord injury, crushed or damaged cells cause paralysis In a heart attack, heart muscle is destroyed and replaced by useless scar tissue In each of these cases, the result is illness, disability, and suffering Doctors and scientists have long been looking for a way to replace damaged or worn-out tissue in the human body with new healthy tissue, thereby giving patients a new lease of life The most promising path to cures is the regeneration of differentiated tissue from stem cells, and especially from embryonic stem cells which are the most plastic and versatile cells in the human body Research using these cells may yield the cures needed by the nearly 100 million Americans afflicted by conditions ranging from Parkinson’s, Alzheimer’s diseases, heart disease, and spinal cord injury to juvenile diabetes, multiple sclerosis, ALS, and many other medical conditions It is, however, NOT only in the domain of regenerative medicine that stem cells will prove medically useful Here are two additional valuable applications of the research: Scientists will observe and learn how stem cells give rise either to normal differentiated cells or to diseased ones Discovering in this way how diseases begin and develop will help us find more effective treatments and cures 2 Stem cell research can also assist in the testing of drugs for safety and effectiveness Before trying a new drug out on human subjects, we can see how it affects the development of stem cells into healthy or diseased tissue Slide: Two kinds of stem cells  Embryonic (also called “pluripotent”) stem cells are capable of developing into all the cell types of the body  Adult stem cells are less versatile and more difficult to identify, isolate, and purify Scientists work with both embryonic and adult stem cells These two kinds of stem cell have quite different properties, and research using both is essential – the research will advance most effectively if it “walks on two legs,” so to speak We don’t yet know which kind of stem cell – embryonic or adult will prove to be most useful for medical purposes Studies done on both stem cell types are likely to play an essential role in finding new treatments and cures Most scientists believe, however, that embryonic stem cells are the more promising because they are “pluripotent,” meaning that they have the potential to differentiate into tissue of any organ (brain, liver, heart, pancreas, etc.) of the human body Adult stem cells, on the other hand, are, at best, "multipotent," meaning that they generate just a few tissue types Adult stem cells exist in small amounts throughout the body They are relatively rare, however, and less plastic (capable of transforming into diverse cell types) than are embryonic stem cells Adult stem cells taken from the skin only become skin, cartilage cells only become cartilage, etc An additional problem with adult stem cells is that they don’t replicate well in a lab – so it’s difficult to obtain enough of them to work with Embryonic cells hold more promise than adult ones for two additional purposes that we’ve already mentioned: 1) understanding the origins and development of disease processes, and 2) testing new drugs It should be noted, however, that to date, only adult stem cells have been used successfully in medical therapies – most notably in treatments for non-Hodgkin’s lymphoma and Leukemia Embryonic stem cells have been used successfully for treatment purposes in animal studies, but have not yet been shown to be effective for human beings Moreover, using adult stem cells in medical treatment may have one significant advantage over embryonic stem cells – the adult cells may be less likely than embryonic ones to stimulate the growth of tumors This is a potential problem that regenerative medicine may need to address and solve Research using embryonic stem cells hasn’t been around as long as research using the adult variety But the pluripotency of these cells – their capacity to generate all of the body’s cell types may make them especially useful in understanding and healing illnesses of tissue deterioration or loss Slide: Embryonic Stem cells Researchers extract them from a 5-7 days old blastocyst They can divide to form more of their own kind, thereby creating a stem cell line This research aims to induce these cells to regenerate tissue that the body needs  Embryonic stem cells are found in a days-old embryo called a blastocyst A blastocyst is a ball of between 128 and 256 cells that exists from about day to day following conception  The ES cells in a blastocyst are part of the inner cell mass (ICM) These cells are removed from the blastocyst and cultured – in a petri dish for example -where they can be kept alive and encouraged to reproduce, thereby creating a stem cell line This procedure destroys the blastocyst  ES cells are pluripotent - they have the ability to become any type of cell in the body (except for cells in the placenta or umbilical cord, which are generated out of the cells surrounding the ICM  The medical potential of stem cells has convinced many people to support stem cell research, including research that works with embryonic stem cells One of the most famous advocates of ES cell research is Michael J Fox He has Parkinson’s Disease, and is the founder of the Michael J Fox Foundation, an organization that supports Parkinson’s Disease research Of the $17 million donated so far, over $4 million has gone to ES cell research  Another famous advocate of ES cell research is Christopher Reeve, the star of the Superman movie series When he was thrown from a horse, he severed his spine, losing the use of his arms and legs He regularly speaks on the importance of ES cell research as a possible cure for his and other conditions  Embryonic stem cell research is a very young science, and may have a long way to go before it yields medical benefits It is noteworthy, though, that the curative potential of stem cells has already been demonstrated in animal studies Here are three examples: Parkinson’s Disease A team led by Lorenz Studer, M.D at the Memorial Sloan-Kettering Cancer Center, working with scientists from Cornell University and the University of Connecticut, used cloned cells to generate dopamine nerve cells in mice – these are the cells that Parkinson's patients lack The cloning technique insured that these cells would be immunologically acceptable to these mice The mice had a disease very similar to Parkinson's, which the experimental therapy alleviated Possibly this kind of therapy can be made to work with human beings as well Juvenile Diabetes "Diabetes," the journal of the American Diabetes Association (July 25, 2003), reports that researchers at the Univ of Wisconsin observed mouse embryonic stem cells differentiate into a variety of specialized cells, including insulin-producing cells Therapeutic cloning to generate such cells may solve problems facing promising therapies like the Edmonton protocol The Edmonton protocol is a procedure developed in Canada for transplanting healthy, insulin-producing islet cells into people with Type diabetes Most Edmonton protocol treatments are quite successful – experimental data indicate that the transplanted cells continue to generate insulin for years Two factors, however, limit the usefulness of this protocol: 1) Pancreatic islet cells are rare, and 2) the treatment induces a rejection response by the body’s immune system The second of these problems all but rules out the use of this treatment for children with juvenile diabetes Therapeutic cloning – as we will see in a moment could solve both of these problems Spinal cord injury A number of studies done on animals with spinal cord injuries have shown that stem cell transplants are capable of treating these injuries For example, a research team at the University of California at Irvine has demonstrated that when cells derived from human embryonic stem cells were transplanted into rats that had received a spinal cord injury, improvements in the animals’ ambulatory activity could be observed approximately one month later Slide: Two Sources of Embryonic Stem Cells Excess fertilized eggs from IVF (in vitro fertilization) clinics Therapeutic cloning (somatic cell nuclear transfer) There are currently two main sources of blastocysts – and of pluripotent stem cells derived from them that researchers can use to advance the search for cures: Scientists can use stem cells from left-over embryos that would otherwise be discarded from fertility clinics From these cells, healthy new tissue can possibly be formed to replace the tissue that an illness or injury has damaged or destroyed Scientists can use therapeutic cloning to generate stem cells for research to find cures The technical term for therapeutic cloning is “somatic cell nuclear transfer” (SCNT) Slide: Stem Cells from In Vitro Fertilization (IVF)  Excess embryos from IVF clinics In vitro fertilization is a method of assisted reproduction “In vitro” means outside of the human body For couples who cannot have children in the usual way, in vitro fertilization unites an egg and a sperm in a laboratory setting This results in the formation of one or several embryos (or “blastocysts,” more precisely), one of which can be implanted in a woman’s uterus, where it develops into a baby This procedure often leaves behind one or several excess embryos that are not implanted These embryos – which number in the hundreds of thousands in American fertilization clinics are frozen for future use or discarded They can also be used to contribute to the search for cures, since they are a potential source of embryonic stem cells  Embryos created for research It would be possible to use in vitro fertilization – with donated eggs and sperm to deliberately create blastocysts for research Stem cells extracted from these blastocysts would be used in experiments to advance scientific knowledge and the search for cures The blastocysts would be destroyed in the process of extracting their ES cells In England, the use of embryos discarded by IVF clinics for stem-cell research is allowed, as is the deliberate cloning of human embryos for this purpose  The diagram shows types of differentiated cells that pluripotent stem cells could generate: pancreatic, blood, heart, brain, and liver cells Of course this is not an exhaustive list Every kind of tissue in the human body could possibly be regenerated from stem cells Slide: Somatic Cell Nuclear Transfer (Therapeutic Cloning) Stem cells obtained using this method originate not from a frozen embryo in an IVF clinic but from someone who has already been born The great advantage of stem cells generated in this way is that they could be implanted into the individual from whom they have been derived without generating an immune response The human body recognizes and attacks foreign cells, including stem cells A “foreign” cell is one that has different DNA (that is, different genetic material) than one’s own – as is the case with the cells in an organ transplant, or a stem cell transplant when the stem cells come from someone other than the patient The immune response is a serious obstacle to stem cell therapy – an obstacle that therapeutic cloning eliminates SCNT, which begins with DNA taken from a patient’s cell, would produce stem cells that are genetically identical to that patient cell Therefore these stem cells, also containing the patient’s own DNA, could be used to treat the patient without encountering resistance from his or her immune system Just for this reason, SCNT-generated tissue solves problems that make donor tissue transplants difficult Therapeutic cloning begins by taking a somatic (body) cell from an individual The nucleus of that somatic cell is fused with a donated egg that has had its nucleus removed The resulting cell, with its new nucleus, is genetically identical to the individual because it contains the DNA from one of that individual’s somatic cells The new cell behaves like a fertilized egg and develops into a blastocyst ES cells are extracted from the blastocyst and grown in culture This research cloning process, beginning with a person’s mature, differentiated cells and yielding stem cells genetically compatible with that person, was carried through successfully by Korean scientist earlier this year The leader of the research team, Woo Suk Hwang says, "Our approach opens the door for the use of these specially developed cells in transplantation medicine.” Notice that therapeutic cloning does not involve fertilization it does not involve the union of an egg and a sperm There is no “conception” and no creation of an “embryo” in the usual sense given to these words For this reason, even some people who believe that a human person exists from the “moment of fertilization” approve of therapeutic cloning research, since it does not require fertilization at all Most importantly, therapeutic cloning is not reproductive cloning This point deserves emphasis, since many people aren’t away of crucial differences between these two kinds of cloning The blastocyst with which therapeutic cloning research works exists only in the laboratory It will never be implanted in a woman’s uterus to produce a baby Therapeutic cloning (SCNT) produces no cloned individual (as does reproductive cloning) but only cell tissue that can be used to heal an individual Therapeutic cloning research is strongly approved by scientists This research is endorsed by the American Medical Association, the National Academy of Sciences, the Association of American Universities, and many other medical, scientific, and educational associations Almost all scientists who work in the domain of basic biomedical research view therapeutic cloning (SCNT) research as crucial The National Academy of Sciences has concluded that therapeutic cloning "offers great promise for treating diseases closing these avenues of research may have real costs for millions of people who now have these diseases." Using embryonic cells derived from a person who has a genetically-based, we can examine the development and differentiation of those cells, and learn how the disease gets underway In their statement of support for therapeutic cloning research, forty Nobel Laureates say that it is needed not only to develop cell-replacement therapies, but also to increase our understanding of how inherited genetic predispositions lead to a wide variety of diseases A deeper understanding of how diseases arise will help us to cure them Slide 12 The Ethical Debate In favor of ESCR: Embryonic stem cell research (ESCR) fulfills the ethical obligation to alleviate human suffering Religious and secular ethical traditions recognize compassion as an essential ethical value We are called upon to help one another in times of need and suffering In the Christian tradition, this is expressed as “Love thy neighbor.” The good Samaritan in Jesus’ parable is applauded because he offers healing to the suffering stranger In Judaism, Islam, Buddhism, Hinduism and other religions, doing what we can to remedy human suffering is an ethical ideal Since excess IVF embryos will be discarded anyway, isn’t it better that they be used in valuable research? Using an embryo in biomedical research to find cures is clearly ethically preferable to throwing it away It is worth noting as well that embryos didn’t first become “excessive” because of in-vitro fertilization In the course of nature itself, when an egg is fertilized by a sperm inside a woman’s body, about half of the time this egg does not implant in the uterus That is, about one out of every two fertilized eggs is normally destroyed, without any outside human intervention whatever Is each of these fertilized eggs a person with an absolute right to life? What we confront here is the question: When does personhood really begin – a question that we will return to in a moment, and that these notes explore in detail in “Appendix Following Conception, When Does Personhood Begin?” SCNT (Therapeutic Cloning) produces cells in a petri dish, not a pregnancy This is a point that we’ve already discussed Moreover, the distinction between therapeutic and reproductive cloning can be made in legal terms For example, the proresearch Hatch-Feinstein-Kennedy bill pending in the US Senate specifies that cloning will serve only research purposes, and makes it illegal to implant a cloned egg into a woman’s uterus Against ESCR: In SCNT, stem cells are taken from a days-old, human blastocyst, which is then destroyed This amounts to “murder.” Given that we inhabit a world in which people treat one another inhumanely, and in which scientific research and technologies are routinely used for destructive purposes – building bombs for example – we to need to take care that science serves only ethical purposes, and respects human life But can a blastocyst really be counted as a person with a right to life? Does a blastocyst have an inherent moral status that we should respect? There are many individuals who believe that using human embryos – even if they are of microscopic size and only a few days old – for any purpose other than achieving a pregnancy is unethical This belief is grounded in the idea that the embryo is a fullfledged person, with human interests and rights, from the earliest time of conception There is a risk of commercial exploitation of the human participants in ESCR There exists the possibility that women could be mistreated and exploited in order to obtain eggs from them that will be used in this research This is an entirely legitimate concern But advocates of the research argue that our aim should be to regulate, not to criminalize, the procedures whereby scientists obtain egg cells for research purposes Moreover, there are clearly some cases where the concern for improper incentives or risk of egg donation would not be relevant when a mother wishes to donate an egg to help her child, for example, or to create stem cells that could be used to save her own life If a person can agree to participate, for example, in a dangerous malaria vaccine study to help prevent or cure this disease, why should she be prevented from donating eggs for similar (but much safer) lifesaving research? Legislative bodies with the participation of scientists, medical practitioners, patients' groups, and other interested parties – may need to improve already existing statutes regarding egg donation for any purpose: in vitro fertilization, surrogate motherhood, or therapeutic cloning This is the democratic way to address the relevant social and ethical concerns It is also important to note that by researching therapeutic cloning, scientists hope to understand the biological properties of a cloned egg cell that induce it to generate stem cells Once scientists learn how this cell “re-programming” occurs, they may no longer need to use egg cells at all For further discussion of questions about the donation eggs for research, see below: “Appendix Protecting Donors of Eggs for Medical Research” Slippery slope argument: ESCR will lead to reproductive cloning A “slippery slope argument” is an argument of the following form: A certain action should not be taken because it is a stepping stone to another and another, until something terrible happens Theoretically, therapeutic cloning could pave the way to reproductive cloning, because it develops the technology and the knowledge that might make reproductive cloning possible Again, the concern here is justified In the past scientific technologies that were originally intended to serve benevolent purposes were in fact placed in the service of inhumane purposes In fact, just about any technology can be used in harmful ways But advocates of therapeutic cloning research submit that this possibility calls for regulation, not for prohibition Daniel Perry, president of the Coalition for the Advancement of Medical Research, has pointed out that it is misuse of the research – implantation of a cloned embryo into a women’s uterus that should be made illegal, not the research itself: “There is a clear, bright line that divides reproductive cloning from somatic cell nuclear transfer and that's implantation Without it, no new human life can be created.” On the other hand, legislation may not in fact dissuade every single scientist in the world from attempting a reproductive cloning So there remains a problem here But should the entire domain of therapeutic cloning research be halted out of fear of this possible abuse? Slide 13 Key Ethical Issues The blastocyst used in stem cell research is microscopically small and has no nervous system Does it count as a “person” who has a right to life? This is such a central and controversial question that it merits detailed attention Please see below: “Appendix Following Conception, When Does Personhood Begin?” What various religions say about when personhood begins? Does science have a view on this? There is no consensus among religions about when personhood comes into existence According to the Islamic Koran, a person begins to exist 40 days following conception 40 days is widely accepted within the Orthodox Jewish tradition too as the date before which an embryo is not yet a person Christian faiths vary a great deal in their view on this subject And even within a single faith, opinion varies considerably For example, within the Roman Catholic tradition, Saints Augustine and Thomas Aquinas, two of the most influential Catholic theologians, did not believe that a person yet exists in the early stages of pregnancy (Augustine compares the early fetus to vegetation!) Prior to the 17th century, this view was predominant among Roman Catholic thinkers Opinion polls indicate that most members in each of the major denominations in America – Protestant, Catholic, and Jewish – support stem cell research, including therapeutic cloning In the case of Roman Catholicism, for example, officials of the Church speak out and campaign against the research Yet, according to an ABC News poll done in the United States, Catholics support the research by a margin of 54 percent to 35 percent Bio-ethicist Laurie Zoloth of Northwestern University in Chicago submits that in the case of therapeutic cloning, "No one religion, no one moral authority can claim to be the final arbiter of this work." Scientific findings alone cannot resolve difficult ethical issues But science is relevant to our ethical deliberations, because it provides relevant factual information Science indicates, for example, that the creation of a person is a gradual process – even fertilization occurs not in an instant but over a period of about 24 hours There is no trace of a nervous system – which is required in order to have experience or awareness of any kind in an embryo before it is about two weeks old Factual information of this kind is relevant to our judgment about when a person with a right to life first comes into existence In a society where citizens hold diverse religious views, how can we democratically make humane public policy? In our society, there is an official “separation of church and state.” But in practice, this separation is often not observed Certain religious interests – represented vigorously especially by the religious right in this country – pressure politicians into opposing stem cell research As well, they misinform the public about the science, ethics, and politics of the research This has resulted, for example, in widespread confusion about the different aims of therapeutic cloning and reproductive cloning It’s up to those of us who support life-saving biomedical research to counter all the misinformation that is out there Our main tool for doing so: education of politicians and the public about the safety and humanitarian value of stem cell research Slide 14 Funding and Regulation of Stem Cell Research Slide 15 Federal Legislation Executive branch of the Federal government On August 9, 2001, President Bush issued a long-awaited decision on stem cell research He authorized funding of stem cell research using existing stem cell lines that had been derived from human embryos before August Such research is eligible for Federal funding if the following criteria are met: there must have been informed consent of the donors; they must not have received any payment for their donation; the embryos must have been created not for research but for reproductive purposes, and in excess of clinical need During fiscal year (FY) 2002, the National Institutes of Health (NIH) funded the first grants to conduct human embryonic stem cell research The National Institutes of Health spent more than $387 million on stem cell research in 2002, but the vast majority of that was spent on adult stem cells About $10.7 million was used to fund human embryonic stem cell research, according to the federal agency Of the original 78 lines authorized by President Bush, fewer than 15 are actually functional for research because of contamination and other problems Some lines are beginning to develop genetic abnormalities Thus President Bush’s restriction has had the effect of stifling publicly funded embryonic stem cell research US Congress In March 2004, a bi-partisan effort in House of Representatives got underway to ask President Bush to lift the restriction on federal funding for stem cell research Many Republican and Democratic Representatives have endorsed this effort House of Representatives Bill H.R 534—Human Cloning Prohibition Act of 2003 On February 27, 2003, the House voted 241 to 155 in favor of this legislation, introduced by Representative Dave Weldon (R-FL) H.R 534 would prohibit both reproductive and therapeutic cloning, and includes a criminal penalty of up to 10 years for violation of the provisions of the bill This bill cannot become the lawof the land, however, unless similar legislation is also passed by the Senate Senate Bill S 245—Human Cloning Prohibition Act of 2003 On January 29, 2003, Senator Sam Brownback (R-KS) introduced this bill It would prohibit both therapeutic and reproductive cloning, and is similar to H.R 234 The bill was referred to the Senate Committee on Health, Education, Labor and Pensions, and to date has not come up for a vote on the Senate floor Senate Bill S 303—Human Cloning Ban and Stem Cell Research Protection Act of 2003 On February 5, 2003, Senator Arlen Specter (R-PA) introduced this bill, and it is sponsored as well by Senators Hatch, Feinstein, Kennedy, Harkin, and Miller It would prohibit reproductive cloning but would specifically permit therapeutic cloning, as long as certain safeguards are met It appears that neither the pro-research nor the anti-research legislation proposed above has enough support to be enacted into law Hence, the issue is currently deadlocked in Congress Should either side believe that they could win the requisite votes for passage, that side is likely to press for a vote on the bill it favors Responses to the unsupportive environment in Washington Private industry Given the barriers to stem cell research erected by federal and state government, the private sector has been stepping in to fill the vacuum In some cases, private companies are collaborating with universities and other nonprofit institutions to conduct research studies For example, early this year (2004) the University of Minnesota announced its plans to use private funding to begin research on donated human embryos and to create a new source of stem cells that can serve therapeutic purposes PARAGRAPH REMOVED March, 2004 - Douglas Melton of Harvard University has created 17 embryonic stem cell lines that he plans to make available at no cost to interested researchers The new stem cell lines were created using funds from the **** Juvenile Diabetes Foundation, Howard Hughes Medical Institute, and Harvard April, 2004 - An anonymous donor has given the University of Texas Health Science Center at Houston its largest gift ever, $25 million, to boost its stem cell research program Harvard University will soon launch a multimillion-dollar center to grow and study human embryonic stem cells, in what could be the largest American effort yet to circumvent the Bush administration's tight restrictions on the controversial research Though not housed in a central building, the initiative will be large, even by Harvard standards, with a fund-raising goal of about $100 million, according to the scientists involved Slide 16 State Legislation These states have voted to outlaw reproductive cloning: Arkansas, California, Iowa, New Jersey, Mississippi, Missouri, North Dakota, Rhode Island, South Dakota, Virginia These states prohibit therapeutic cloning: Arkansas, Iowa, Mississippi, North Dakota, South Dakota These states permit therapeutic cloning: California, New Jersey, Missouri, and Rhode Island Pending state legislation Ten states, including Illinois, are considering bills this session that would explicitly permit scientific studies involving stem cells and therapeutic cloning The other nine states are Connecticut, Maryland, Massachusetts, Minnesota-where the public university wants to become a center for stem-cell science New York, Pennsylvania, Rhode Island, Tennessee and Washington Two states that are pro- SCR: California and New Jersey: October, 2003 In California, Governor Gray Davis, in a direct challenge to the Bush Administration, signed a bill into law to promote research on embryonic stem cells, aiming to make the state a safe haven for this cutting-edge biomedical science The measure explicitly supports work on human stem cells, including those extracted from cloned embryos The bill requires clinics that in-vitro fertilization procedures to inform women they have the option to donate discarded embryos to research It requires written consent for donating embryos for research and bans the sale of embryos It is unclear where the new Governor, Arnold Schwarzenegger stands on stem cell research January, 2004 A New Jersey bill passed that permits research involving “human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation.” However, this same bill makes cloning for the purposes of creating a baby a crime punishable by up to 20 years in jail The bill requires that infertility patients be informed that they can donate unused embryos for research purposes Slide 17 International Legislation Embryonic stem cell research is highly controversial not only in the United States but worldwide In the past two years, many nations have begun to tolerate, if not to support, the research In the fall of 2004, the United Nations will consider enacting a global ban on both therapeutic and reproductive cloning Embryonic stem cell research is supported in Sweden, England, Japan, Canada, Israel, Singapore, and Denmark The United Kingdom is developing a stem cell bank that would make a variety of characterized and newly derived stem cell cultures available to researchers The Human Fertilisation and Embryology Authority would oversee the selection of cell lines to be established and included in the bank The Medical Research Council would run the bank In countries where the Catholic Church is influential, most notable in Latin America, embryonic stem cell research is typically outlawed It is noteworthy, though, that the three largest countries in Latin America Mexico, Brazil, and Argentina – have not supported the UN proposal to ban the research Switzerland The Swiss Parliament is considering the possibility of allowing research on stem cells derived from stored embryos remaining at the end of assisted reproduction procedures if they were frozen at seven or fewer days of development The research could only be for non-commercial, therapeutic purposes The proposal bans the creation of embryos specifically for research purposes In addition, work may eventually be allowed on a limited number of stem cell cultures imported from other countries Germany Legislation had banned the use of embryos in Germany for all purposes except reproduction But the import law passed last year takes exception to this legislation and states that approval for import of embryonic stem cells may be given for research that has "high-ranking" goals and for which there are no alternatives to using embryonic stem cells The law also states that only embryonic stem cells that date before January 1, 2002, can be imported into Germany Other requirements include that stem cells come from surplus embryos produced by in-vitro fertilization, and that couples providing the embryos not be paid Canada Canada has passed a bill that bans human cloning but permits research using stem cells derived from embryos The bill still requires "royal assent" from the governor general before it becomes law, but that is considered a formality Regulations in other European Union Countries Opinions on the legitimacy of embryonic stem cell research among EU countries are divided, according to their different ethical, philosophical and religious traditions The members states have taken very different positions on the regulation of the research As of July 2003, some of their positions were: Italy, Luxembourg, Portugal No specific legislation regarding embryonic research Belgium, United Kingdom Allow for the creation of human embryos for stem cell research Austria, Spain, France, Ireland Prohibit the procurement of embryonic stem cells from human embryos Belgium, Denmark, Finland, Greece, Netherlands, Sweden, United Kingdom Allow for the procurement of stem cells from excess embryos Austria, Denmark, Germany, Spain, Finland, France, Greece, Ireland, Netherlands, Portugal Prohibit the creation of human embryos for research Slide 18 United Nations Discussion on a proposal before the United Nations to institute a worldwide ban on all forms of human cloning has been suspended until October 2004 The United States, together with several other countries, initiated the proposal, which would have included a ban on research cloning as well as reproductive cloning But a number of other countries, including Great Britain, objected to the ban on research cloning and wanted to suspend all debate on cloning until 2005 Following intense diplomatic and parliamentary maneuvering, the parties finally agreed to take up the matter in 2004 More about the activity at the United Nations concerning human cloning, and a record of the vote to suspend discussion, may be found at http://www.un.org/law/cloning Appendix I Following Conception, When Does Personhood Begin? In the course of development from conception through birth, when does personhood begin? What is it to be a person? An individual cell – existing for example in heart tissue or muscle tissue —is not in and of itself a person That cell is human, in the sense that it belongs to someone who is of the human species And that cell is alive So, one can say that an individual cell in the body is “human life.” In fact, each time that a cell in the body divides, new human life is created But should we count that new life as a new person, having the same right to life that we attribute to persons? The right to life is very closely associated with being a person We have ethical duties not to each of the cells that make up a person, considered individually and separately, but to the person as a whole The individual cells in our bodies are not persons, morally requiring from us care and protection It follows from this that the relevant question, when we are reflecting on our ethical duties to the unborn, is not: “When does human life begin?” The question, rather, is: “When does human personhood begin? Being a person amounts to more than just being human life Being a person requires, many people believe, possessing a soul or self, or at least a capacity to have thoughts, feelings, and other experiences To be sure, a blastocyst may be regarded as a potential person But “potential” and “actual” are not the same thing An acorn is not an oak tree, although it has the potential to become an oak tree However, notoriously, there is no consensus among human beings regarding when, in the course of human development, a human person first exists Some people say that a person is present when an egg has all of the DNA it needs to begin dividing Some people – those who favor abortion rights say that a full-blown person does not come into existence until birth Hence abortion is not taking the life of a person and is ethically permitted Still others hold an intermediary position: in the earliest stages of formation – the one-celled zygote and the blastocyst – a person does not yet exist Only later is personhood constituted – with implantation in a uterus, formation of a primitive streak (which is the first sign of a nervous system), and/or development into a fetus Those who hold an intermediate view will be inclined to regard abortion as ethically wrong, but embryonic stem cell research as ethically permissible This is the position held by Senator Orrin Hatch of Utah There is a discrepancy between our moral intuitions and our scientific knowledge In morality, we often look for yes or now answers: some actions are permitted; others are is forbidden But science finds continuity and gradation throughout nature Religion too, at its best, acknowledges that development and change are typically gradual processes Many religious faiths (including Roman Catholicism in the tradition of Thomas Aquinas, the most famous Catholic theologian) take a “developmental” view of personhood The developmental view believes that the early embryo only gradually develops into a full human being, and thus is not entitled to the same moral protections that we give to persons The right to embryonic stem cell research is not the only issue that depends on when personhood begins Another such issue is abortion rights People sometimes ask whether there is any relationship between these two issues – stem cell research and abortion rights – so it is worthwhile to clarify the differences In fact, the ethical issues that arise in stem cell research are distinct from those involved in the abortion controversy Support of embryonic stem cell research does not imply any position at all regarding abortion rights Senator Orrin Hatch, for example, is a strong supporter of embryonic stem cell research, but he opposes abortion rights In his book, “Square Peg,” Senator Hatch writes in favor of what he calls a “developmental view of life,” which holds that “an early embryo, before the formation of the primitive streak that will eventually become the spinal cord and brain, does not enjoy the same legal protections as a person This is based in part on the assessment by some scientists that for the first fourteen days, a fertilized egg is little more than a jumble of cells… The blastocysts used for embryonic stem cell research, whether they are developed through the somatic cell nuclear transfer process or are unused embryos from an in vitro fertilization clinic, are not the same as a person or a fetus… If an embryo were the legal equivalent of a person, the use of a variety of contraceptive devices, such as those that impede fertilized eggs from attaching onto the uterine wall, could potentially be considered a criminal act For in vitro clinics, the routine act of discarding "spare" frozen embryos could become an act of murder and would, at a minimum, be inseparable from an abortion.” Hatch’s thinking on this matter reflects, as he says, his discussions with patients and much soul-searching on his part Certainly, the dialogue about when personhood begins is ongoing in the United States and elsewhere in the world Appendix Protecting Donors of Eggs for Medical Research Women of course, like men, will benefit from the cures that biomedical research develops The concern has been raised, however, that women might be exploited by scientific inquiry that uses their eggs in research to help find cures This is a legitimate concern, but it should lead us to regulate, not to ban, the procedures whereby scientists obtain egg cells for research purposes Alta Charo, Professor of Law and Bioethics at the University of Wisconsin Law and Medical Schools, says: “While I respect and applaud this concern for the dignity and well being of women, I believe the concern is unwarranted and, perversely, would harm the millions of women worldwide who act as the primary caregivers for husbands, parents and children sickened by the very illnesses this research might someday cure Cloning does require obtaining eggs from women This is not, however, harmful to them The drugs administered to make egg retrieval possible have been used for infertility patients for decades without any evidence of either short-term or longterm harm, except for some discomfort during the month they are administered Furthermore, the development of transplantable tissue from stem cells derived from cloned embryos is subject to extensive regulation in countries such as the United States and the United Kingdom In the U.S., for example, such research is regulated by the Food and Drug Administration, which requires independent prereview and ongoing oversight of the work, including the effort to obtain human eggs Thus, an independent body reviews all the data concerning the safety of the drugs to be administered, the form of advertising and incentive used to recruit volunteers, and the information given to volunteers to ensure thoughtful informed consent… In addition, many countries around the world already ban the sale of human tissue, whether eggs, sperm, or organs, thus completely eliminating concerns about monetary incentives and exploitation In sum, concerns about the physical and emotional wellbeing of women can be and already are being addressed through research regulation, and not need to be addressed through prohibitions on the research itself.” It is important to recognize as well that eggs from women may be needed only in the early stages of this research By conducting therapeutic cloning research, scientists hope to better understand the biological properties of a cloned egg cell that induce it to generate stem cells Once they learn how this cell “re-programming” occurs, they may no longer need to use human egg cells at all There is also accumulating evidence that stem cells themselves could become the source of eggs for research (The New Scientist (May 1, 2003) To be sure, it is appropriate that there be public oversight of biomedical research standards With respect to egg donation for any purpose whether it be in vitro fertilization, surrogate motherhood, or therapeutic cloning research policy making agencies in the United Nations, with the participation of scientists, medical practitioners, patients' groups, and other interested parties, need to encourage the improvement of already existing legislation This is the cooperative way to address the relevant social and ethical concerns Regulation should, however, be context sensitive For instance, there are clearly some cases where the concern for improper incentives or risk of egg donation would not be relevant when a mother wishes to provide an egg to help cure her child, for example, or to create stem cells that could be used to save her own life Research too can be a valid aim of egg donations If it is legitimate for a person to agree to participate in a dangerous malaria vaccine study to help prevent this disease, why should she be prevented from donating eggs for similar (but much safer) lifesaving research? Women's interests are in fact entirely consistent with the humanitarian aims of stem cell research In fact, women have an especially strong interest in the success of this research In many families, they are the one who provide the painstaking daily care for sick children, husbands, and parents The largest women's organization in the United States, the National Organization for Women (NOW), supports “research in the areas of therapeutic cloning, the use of embryonic stem cells for such research, and the use of federal funds for therapeutic cloning research." ... invite your audience members to attend this historic event You can download, copy, and distribute the Conference Flier to your audience You can go to your local photocopy shop and ask them to make... has one), you can download them to your computer You can then email them to your local photocopy shop, to be printed out in 11X17-inch color Kinkos will this for less than $2/slide If your audience... non-California audience.) You can also ask the photocopy shop to make 11X17 inch color representations of the three explanatory diagrams in the presentation: "Embyronic Stem Cells” ? ?Stem Cells from In