New York has become the first, and thus far the only, state to designate the use of taxpayer money to compensate women for selling their eggs to embryonic stem cell research. According to the new policy, taxpayer-funded researchers will be allowed to pay women up to $10,000 for selling their ova for embryonic stem cell experimentation. Critics of this bold move fear that the new policy will lead to the exploitation of women, especially those of low income.
The new policy was announced by the Empire State Stem Cell Board, which is responsible for deciding how to spend $600 million in state tax dollars. According to David Hohn, vice chairman of the Board’s two committees that endorsed the new policy, "We want to enhance the potential of stem cell research. If we are going to encourage stem cell research as a solution for a variety of diseases, we should remove barriers to the greatest extent possible. We decided to break new territory."
One of the goals of the new policy is to produce custom-tailored cells and tissue through the process known as somatic cell nuclear transfer (SCNT), the same procedure that is used both in reproductive cloning and in so-called therapeutic cloning. An extraordinarily large number of ova, however, are necessary for the procedure, which has never actually successfully produced a human stem cell line, and attempts to solicit the uncompensated donation of eggs have largely failed. According to Dr. Douglas Melton, codirector of the Harvard Stem Cell Institute, "The lack of compensation has meant it’s been nearly impossible to get enough eggs." Paying women to sell their eggs is therefore presumed to correct the problem, although many people find this to be flawed reasoning.
The new policy is contrary to that of every other state in the country and, most notably, it is defiantly in violation of the scientific guidelines on embryonic stem cell research as issued by the National Academy of Sciences. Furthermore, the initial draft of the stem cell research guidelines issued by the National Institutes of Health has specifically forbidden SCNT, per the specific recommendation of President Obama, whether for purposes of reproductive cloning or therapeutic cloning. When the final version of the NIH guidelines is issued next month, thereby establishing official national research policy within the U.S., this new state policy of New York will most certainly be in violation of national research laws unless NIH specifically legalizes SCNT for therapeutic cloning, which thus far NIH has indicated it is unlikely to do. Paying women for the sale of their eggs, regardless of the intended purpose, is also likely to be specifically forbidden in the NIH guidelines.
Not surprisingly, however, the move is welcomed by those proponents of embryonic stem cell research who are aggressively focused on embryonic stem cell research, and only embryonic stem cell research, at the expense of all else. According to Susan Solomon, for example, cofounder of the private, nonprofit organization known as the New York Stem Cell Foundation, "This is a really great, appropriate policy. This could help us to pursue some critical experiments that we hope will lead to treatments for devastating diseases."
Many others, however, question the wisdom of such a policy, including many who are strong advocates of embryonic stem cell research. According to Dr. Jonathan Moreno, professor of bioethics at the University of Pennsylvania, "In a field that’s already the object of a great deal of controversy, the question is, are we at the point where we really need to go that route in order to do the science? I’m not convinced."
There are many risks, medical and otherwise, which are known to be associated with the buying and selling of human ova. As described today in The Washington Post, "Donors must undergo weeks of hormone injections to stimulate their ovaries to produce eggs, and then a painful procedure to extract the eggs. The procedure can in rare cases cause a dangerous overstimulation of the ovaries, and there are concerns about the possible long-term risks of hormonal stimulation."
In addition to the medical risks of egg donation, there is also the risk of commercial exploitation, especially among those women in the lower income demographics. According to Father Thomas Berg, director of the Westchester Institute for Ethics and the Human Person, who is also a Catholic priest and a member of the Empire State Stem Cell Board’s ethics committee, "With the economy the way it is, you don’t need to be a rocket scientist to know that when a woman is looking at receiving up to $10,000 to sign up for a research project, that’s an undue inducement. I think it manipulates women. I think it creates a trafficking in human body parts."
Many people agree. According to Laurie Zoloth, a bioethicist at Northwestern University, "Whenever society starts to pay for relationships that are traditionally done with altruism and generosity within families, it raises the issue of whether there is anything that is not for sale."
Proponents of "therapeutic cloning" claim that the technique potentially offers a new mode of treatment in the repair and regeneration of tissue and organs. Especially in the field of organ transplantation, where immune rejection is common, therapeutic cloning is often seen as a way of eliminating this problem of immune rejection. A number of highly respected scientists insist that this view is incorrect, however, and that immune rejection still exists in therapeutic cloning, along with a myriad of other complexities and problems.
In therapeutic cloning, stem cells are created from a donor for the main purpose of providing tissue, such as for organ repair, in the event that the donor might need such treatment at a future date. The way in which this is done is through somatic cell nuclear transfer (SCNT), the same procedure by which scientists created Dolly the sheep – the world’s first cloned mammal who was "born" in 1996 and had to be euthanised in 2003 at the age of 6 because of a progressive form of lung cancer.
In SCNT, the nucleus (which contains the DNA) from a somatic (mature, differentiated, non-stem cell) cell from an adult donor is transferred into an enucleated egg (an egg from which the nucleus has been removed), thereby yielding a new type of cell which is then given an external stimulation to begin mitotic division, in the same way that a single celled embryo would begin to develop. In actuality, the resulting cluster of dividing cells constitutes a cloned embryo. When the egg has divided into approximately 100 cells (known as a blastocyst, the stage in embryogenesis that precedes the embryo and is preceded by the zygote), the inner cell mass is then removed and cultured into an embryonic stem cell line, which is expanded to produce the desired, healthy, "therapeutic" cells – such as nerve cells, muscle cells, organ tissue, etc.. These new cells are then transplanted back into the patient, who is presumed to be the same person as the donor of the original somatic cell, in order to avoid immune rejection. A single cell, cultured in a dish by itself, will divide to form a population of identical cells such that the resulting cloned embryo and its cells, in this particular case, are therefore genetically identical to the donor. A problem remains with the mitochondria, however, which originate with the egg, not the donor nucleus, so consequently the mitochondria in the resulting cells are not genetically matched to the donor, and this fact can still cause immune rejection. Nevertheless, since therapeutic cloning requires the deliberate creation and disaggregation (destruction, in other words) of a human embryo, even President Obama has referred to the process as unethical, and NIH has thus far vowed not to allow federal funding for such a procedure.
Ethical controversies aside, however, David A. Prentice, Ph.D., Senior Fellow for Life Sciences at the Family Research Council in Washington, D.C. and formerly a professor of medical and molecular genetics at the Indiana University School of Medicine, adds that cloning is unsafe purely for scientific reasons, and he points out that even apparently healthy clones have abnormalities in gene expression. "A review of all the world’s cloned animals suggests that every one of them is genetically and physically defective," he says. He also cites Ian Wilmut, the creator of Dolly the sheep, who points out that, "There is abundant evidence that cloning can and does go wrong and there is no justification for believing that this will not happen in humans." (Quoted in "Gene defects emerge in all animal clones", Sunday Times of London, 4/28/02).
Indeed, the success rate of SCNT is extremely low, as 277 nuclear transfers were required to enucleated the eggs from which Dolly the sheep was created. It has been pointed out that even when animals are successfully cloned, every one of them, without exception, suffers from numerous genetic abnormalities. Even Dolly the sheep was "born" with incomplete epigenetic reprogramming – the heritable erasure and remarking of genes that determines either normal or abnormal development. Currently, the highest efficiency rate of SCNT cloning in any species is 7% (with pigs), and in most species the success rate is below 1%. However, even when successful, from 10,000 genes that were analyzed in cloned mice, approximately 400 of these genes were found to express genetic abnormalities. Dr. Prentice offers some further alarming statistics on the success rates, or the lack thereof, of cloned animals:
Dolly the sheep, the first cloned animal: 1 live birth out of 277 cloned embryos. Success rate = 0.4%.
Cloned mice: 5 live births out of 613. Success rate = 0.8%.
Cloned pigs: 5 live births out of 72 cloned embryos implanted. Success rate = 7%.
Cloned goats: 3 live births out of 85 cloned embryos implanted. Success rate = 3.5%.
Cloned cattle: 30 live births out of 496 cloned embryos implanted. Success rate = 6%.
Cloned cat: 1 live birth out of 188 cloned embryos. Success rate = 0.5%.
Cloned gaur: 1 live birth out of 692 cloned embryos. Success rate = 0.1%.
Cloned rabbits: 6 live births out of 1852 cloned embryos. Success rate = 0.3%.
Somatic cell nuclear transfer is such a can of worms, scientifically as well as ethically, that the procedure has never actually produced a human stem cell line, despite claims in 2005 by Hwang Woo-suk of South Korea that he had done so. His claims were later proven to be fraudulent, and the resulting scandal had a lasting impact upon South Korea’s national stem cell research policy. (Please see the related news article on this website, entitled, "South Korea Conditionally Lifts Embryonic Stem Cell Research Ban", dated April 29, 2009).
Merely attempting the procedure, however, whether for purposes of reproductive or therapeutic cloning, is enough to place women at a number of risks, and the statistics alone render the procedure impractical. For example, in order to treat all of the 17 million people in the U.S. who suffer from diabetes, Dr. Prentice has made some sobering calculations. Allowing for 10 eggs harvested per donor, and allowing for a generous 20% cloning efficiency to achieve the blastocyst stage, as well as a generous 10% efficiency rate at initiating the embryonic stem cell culture, a minimum of 850 million eggs would be required, which translates into 85 million women of childbearing age who would be required as donors. This would be more than one-third the population of the United States, who would be needed as egg donors for the treatment of a group of people roughly one-sixteenth as large in population size.
While high dose hormone therapy and surgery have been developed to obtain eggs in large numbers, such techniques nevertheless pose significant health risks by jeopardizing the donor’s immediate health and future reproductive success. Additionally, it has already been seen in other countries that the possibility for commercial exploitation puts economically disadvantaged women in particular jeopardy. Overall, as Dr. Prentice concludes, therapeutic cloning may be judged as unsuccessful. Transplantation remains one of its many problems, and Dr. Prentice cites W.M. Rideout as having stated, "Our results raise the provocative possibility that even genetically matched cells derived by therapeutic cloning may still face barriers to effective transplantation for some disorders." (W.M. Rideout et al., "Correction of a genetic defect by nuclear transplantation and combined cell and gene therapy," an online publication in Cell, 3/8/2002).
It has been proposed by a number of researchers that cloning is not able to provide the claimed medical treatments, and Drs. James Thomson ("the father of embryonic stem cell science") and Alan Trounson, among others, add that there is a very low chance of success in the clinical use of therapeutic cloning. (Dr. James Thomson, "Multilineage differentiation from human embryonic stem cell lines", Stem Cells, 2001; Dr. Alan Trounson, "The derivation and potential use of human embryonic stem cells", Reproduction, Fertility and Development, 2001). Additionally, Dr. Irving Weissman of Stanford University and Dr. John Gearhart have both stated before the President’s Council on Bioethics (when it existed, although this week President Obama abolished the Council) that transplant rejection will still occur, even though the cells from the cloned embryos are considered "genetically identical" to the donor. (Dr. Irving Weissman, 2/13/2002, before the President’s Council on Bioethics; Dr. John Gearhart, 4/25/2002, before the President’s Council on Bioethics). Even Dr. Thomas Okarma, President and CEO of the Geron Corporation, the leading embryonic stem cell company, has pointed out that cloning is not commercially viable, stating that, "The odds favoring success are vanishingly small, and the costs are daunting. It would take thousands of [human] eggs on an assembly line to produce a custom therapy for a single person. The process is a nonstarter, commercially." (Quoted by Denise Gellene in, "Clone Profit? Unlikely", Los Angeles Times, 5/10/2002). Corroborating such views, Drs. Odorico, Kaufman and Thomas have written, "The poor availability of human oocytes, the low efficiency of the nuclear transfer procedure, and the long population doubling time of human embryonic stem cells make it difficult to envision this becoming a routine clinical procedure." (Odorico JS, Kaufman DS, Thomson JA, "Multilineage differentiation from human embryonic stem cell lines," Stem Cells, 2001).
Dr. Prentice adds, however, that it is unlikely that large numbers of mature human oocytes would actually be available for the production of embryonic stem cells, particularly if hundreds are required to produce each embryonic stem cell line. "The technical capability for nuclear transfer would also need to be widely available, and this is unlikely," he says. As Dr. Alan Trounson adds, "In addition, epigenetic remnants of the somatic cell used as the nuclear donor can cause major functional problems in development, which must remain a concern for embryonic stem cells derived by nuclear transfer. Although it is possible to customize embryonic stem cells by therapeutic cloning or cytoplasmic transfer, it would appear unlikely that these strategies will be used extensively for producing embryonic stem cells compatible for transplantation." (Alan O. Trounson, "The derivation and potential use of human embryonic stem cells," Reproduction, Fertility and Development, 2001). As Dr. Irving Weissman, director of the Institute of Stem Cell Biology and Regenerative Medicine at Stanford University, stated in his testimony before the President’s Council on Bioethics (when it existed, prior to President Obama abolishing the Council), "I should say that when you put the nucleus in from a somatic cell, the mitochondria still come from the host. And in mouse studies it is clear that those genetic differences can lead to a mild but certainly effective transplant rejection, and so immunosuppression, mild though it is, will be required for that." (Dr. Irving Weissman, 2/13/02, before the President’s Council on Bioethics). Similarly, Dr. Alan Trounson, the Australian embryonic stem cell scientist and president of the California Institute for Regenerative Medicine, stated as early as 2002 that cloning had become "unnecessary and obsolete". He says that stem cell research continues to advance so rapidly, every day, that therapeutic cloning has been surpassed by other, safer and more effective procedures. "My view," he stated in 2002, "is that there are at least three or four other alternatives that are more attractive already." Emphasizing the point that therapeutic cloning faces too many "logistical problems," and that other techniques show "greater promise" and offer "better options," Dr. Trounson adds, "I can’t see why, then, you would argue for therapeutic cloning in the long term, because it is so difficult to get eggs and you’ve got this issue of [destroying] embryos as well." ("Stem cell cloning not needed, says scientist", The Age [Melbourne], 7/29/2002; "Stem cell research outpaces cloning", The Australian, 7/29/2002; "Therapeutic cloning no longer necessary: expert", AAP Newsfeed, 7/29/2002).
Additionally, therapeutic cloning – which has never successfully produced a human stem cell line but instead is still in the hypothetical stage – has been rendered irrelevant and unnecessary in light of mounting clinical success over the past few years involving "immune privileged" adult stem cells such as mesenchymal stem cells (MSCs) which have been shown to be "universal donor" cells, meaning that anyone can receive these cells without the risk of immune rejection. MSCs have been shown to differentiate into a wide variety of tissue types and are abundantly available and easily obtainable from noncontroversial sources such as adult bone marrow and umbilical cord blood. Precisely for reasons such as these, MSCs are already therapeutically available in clinics throughout the world, and in the United States a number of adult stem cell companies have products developed from MSCs which are advancing through FDA-approved clinical trials. MSCs are merely one example of a large number of different types of adult stem cells which have already demonstrated clinical success in the treatment of a wide range of diseases and injuries, and which have already advanced far beyond the hypothetical laboratory stage, unlike embryonic stem cells and cloning. Many scientists whose research had been focused on SCNT in the past – including Dr. Ian Wilmut himself, the creator of Dolly the sheep – have since moved away from SCNT and have turned their attention to other, more viable, sources of stem cells, which include not only iPS (induced pluripotent stem) cells but also adult stem cells. To claim that no alternative exists to embryonic stem cells and cloning is to be entirely ignorant of some of the greatest and most dramatic breakthroughs in the history of medical science.
It would seem as though the authors of the newly announced New York state policy have not done their homework. Nevertheless, those individuals who are personally responsible for establishing the new policy remain defiantly confident that they have made the right move, despite unanimous advice to the contrary, from all the leading embryonic and adult stem cell experts throughout the world.
Even staunch embryonic stem cell advocates are calling the new policy an "unnerving precedent".
