The embryonic stem cell company Geron, and the multinational conglomerate General Electric, have announced the signing of a global licensing agreement in which Geron will provide human embryonic stem cells (hESCs) to GE’s Healthcare division for the toxicity testing of drugs. The hESCs will not be used for the development of cell-based therapies.

According to a statement that GE made in 2005, "GE will not be associated with the primary harvest of human embyro-derived cells or tissues. We acknowledge the considerable debate and take very seriously the ethical and societal issues associated with research using stem cells derived from embryonic or fetal tissue. We conduct our research in an ethically and scientifically responsible manner."

Therefore, according to Geron, the hESCs that are to be provided to GE were derived from human embryonic stem cell lines that were approved under policies established by the Bush administration in 2001. Contrary to popular misconception, hESC research was not forbidden under the Bush administration but in fact was conducted in laboratories and corporations across the entire United States during the entire Bush presidency. As long as the research met specific guidelines, it even received federal funding, and if it did not meet those guidelines then the research was usually conducted anyway, but with private funding instead of federal funding.

Under the new agreement between GE and Geron, Geron will provide the hESCs to GE who will develop and commercialize lab equipment that facilitates the use of the hESCs in drug development and toxicity screening. The lab equipment will then be marketed to pharmaceutical companies and research labs. According to Konstantin Fiedler, general manager of cell technologies at GE’s Healthcare division, the market for toxicity testing is expected to be in the hundreds of millions of dollars by 2020, from which Geron will begin receiving royalties by 2010.

Scientists from both companies will collaborate in the venture, with GE Healthcare providing all R&D funding. According to David Earp, senior vice president for business development and chief patents counsel at Geron, "We had an asset that we were not able to exploit fully." According to Konstantin Fiedler, general manager of cell technologies at GE Healthcare, "This agreement marks a further step in GE Healthcare’s cell technology strategy aimed at addressing the potential of stem cell applications in the drug discovery and therapy markets."

In 2008, GE earned over $17 billion in revenue, of which approximately $1.5 billion was through its life-sciences related business, which GE began expanding in 2003 with a number of acquisitions and parnerships that included the $9.5 billion acquisition of Amersham PLC, a biotech firm based in the UK which had developed specialized technology in nucleic acid blotting, radiochemical labeling and detection. Other acquisitions and partnerships in the biotech sector have included an agreement between GE and the StemSource technology division of Cytori Therapeutics, a stem cell banking company whose products GE will commercialize in ten European countries. (Please see the related news article on this website, entitled, "Cytori and General Electric Agree Upon Collaboration", dated May 8, 2009). In the past, most of the revenue generated from GE’s Healthcare division has come from diagnostic and imaging equipment, sales of which are declining in response to the efforts by public and private insurers to reduce costs. GE is now in the process of plans to reposition its business strategies.

In January of this year, Geron received FDA clearance to commence the first hESC clinical trials ever to be performed, which were to begin in the summer. Results of the trials will not be obtained for years, however. (Please see the related news article on this website, entitled, "FDA Approves First Human Embryonic Stem Cell Trial", dated January 23, 2009).

Contrary to popular misconception, actual cell-based therapies are still years away for hESCs, and even decades away by some accounts – which is precisely why this new licensing agreement between Geron and GE involves the use of hESCs not for the development of cell-based therapies, per se, but for the use of the hESCs in the development and toxicity testing of drugs. Even Dr. James Thomson, "the father of embryonic stem cell science", who was the first person ever to isolate a hESC in the laboratory, has emphasized this point on a number of occasions. His own company, Cellular Dynamics International (CDI), which he cofounded in 2004, also specializes not in the development of clinical therapies from hESCs, but instead in the use of hESCs for drug development and toxicity testing. (Please see the related news article on this website, entitled, "Cellular Dynamics and Mount Sinai Sign Licensing Agreement", dated May 29, 2009).

Financial details of the agreement between Geron and GE were not disclosed.

Geron’s shares rose 15% after the announcement, to $7.67, while GE’s stock fell to $11.72.

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".

Several months before their mandate was scheduled to expire, members of the President’s Council on Bioethics were abruptly asked by the White House to cancel a planned meeting, and they were informed that their services are no longer needed. Although the Council’s charter would have automatically expired in September of this year, the Council officially no longer exists as of June 11, 2009.

According to White House press officer Reid Cherlin, President Obama disbanded the Council because he saw it as "a philosophically leaning advisory group". At some undesignated time in the future, Obama intends to appoint a new commission on bioethics that will "offer practical policy options", according to Mr. Cherlin. Currently, however, the Obama administration now finds itself in the rare historic position of being without any advisory bioethics council at all.

Although it was known, and expected, that President Obama would have to create his own, new commission on bioethics when the charter of the current President’s Council on Bioethics would expire in September of this year, it was unexpected that Obama would actually abolish the Council prematurely. The fact that he has done so a full three months before the designated completion of the Council’s charter is in some ways a surprise to many, though in other ways not a surprise at all.

The U.S. President’s Council on Bioethics was formed by President George W. Bush in November of 2001, and its members have not hesitated to criticize what they view as Obama’s mistakes in stem cell policy thus far. In March of this year, for example, over half the members of the Council issued a formal letter of objection to Obama in which they sharply criticized the heavy bias of his new stem cell policy, which many scientists and doctors besides those who were members of the Council find to be without valid scientific basis. Needless to say, such criticism has not enamored the Council to President Obama nor to his supporters of embryonic stem cell research, all of whom have responded in return with their own personal criticisms of the Council and its members. One such critic, Dr. Alta Charo of the University of Wisconsin at Madison, is herself known to be heavily biased in favor of embryonic stem cell research, in which she is heavily invested with her own personal work, at the exclusion of anything having to do with adult stem cells. Nevertheless, she is often quoted as an "authority" on the topics of stem cells and bioethics, and is expected to be among those appointed by President Obama to his new commission on bioethics, whenever exactly that might be.

There are many bioethicists, however, such as Dr. Ruth Faden of Johns Hopkins University, who point out that "all presidential commissions are structured in the context of a particular administration." With this fact in mind, and given his record thus far, Obama’s new commission is expected to be heavily unbalanced in favor of embryonic stem cell research, with little or no recognition of the successes that have already been achieved with adult stem cell therapies. Nor is Obama’s new commission, whenever exactly it might be formed, expected to acknowledge the fact that adult stem cell therapies, which already exist, could be made available in the U.S. to patients now, today, were it not for the FDA’s insistence that endogenous, autologous adult stem cells must be categorized as "drugs" and therefore regulated according to the same outdated and lethargic FDA laws to which pharmaceutical medications are subject. Scientists and doctors who are actually attempting to help patients by treating real diseases and injuries with adult stem cell therapies understand that this FDA stance is a major legal obstacle that continues to prevent adult stem cell therapies from being made available to patients within the United States, and it is this FDA law which is driving adult stem cell clinics out of the U.S. to any and every other country in the world. Such a topic is never even addressed, however, by President Obama nor his cabinet nor by embryonic stem cell researchers in the U.S. who are concerned primarily with being guaranteed their own share of NIH funding – despite the fact that even the "father of embryonic stem cell science", Dr. James Thomson, has said that embryonic stem cells will probably not be scientifically viable as clinical therapies for at least another decade, at the earliest, due to the many medical problems that are inherent in embryonic stem cells, not the least of which is the fact that embryonic stem cells are required, by definition of pluripotency, to cause teratomas (tumors). To blame the lack of availability of stem cell therapies in the U.S. on a previous administration is to ignore entirely the new and very serious problems which currently exist under the current administration. And meanwhile, as the seriously flawed FDA ruling on endogenous, autologous adult stem cells continues to drive adult stem cell therapies overseas – while precious taxpayer dollars are funnelled almost exclusively into embryonic stem cell research even though such research is not expected to produce even one clinical therapy before another decade has elapsed – exactly how many patients who are in desperate need of a clinical stem cell therapy today, not in ten years from now, will die?

As early as January of this year, Dr. Robert P. George, a professor of jurisprudence and director of the James Madison Program in American Ideals and Institutions at Princeton University, wrote the following in an article entitled, "A Diverse Bioethics Council?", which was printed in the Public Discourse, a publication of Princeton University’s Witherspoon Institute:

"In 2002, when George W. Bush announced the names of his appointees to the President’s Council on Bioethics, there were liberal bioethicists who complained that the President had ‘stacked’ the council with ‘religious conservatives’ who shared his views on questions of embryonic stem cell research and ‘therapeutic cloning’. More than a few media outlets reported this claim as if it were a fact. It was, however, a spectacular falsehood. Nearly half of the eighteen members of the council fundamentally disagreed with the President on key issues. Several had supported Vice President Gore over Bush in the election. The Bush council, chaired by Dr. Leon Kass, was the most intellectually and ideologically diverse bioethics advisory body ever constituted – far more diverse than its predecessor, the National Bioethics Advisory Commission under President Bill Clinton. … Although President Bush got no credit for it, he had created a council that represented the range of viewpoints held by reasonable and responsible Americans on the most urgent and divisive bioethics questions facing the country. This enabled his council to produce reports that improved the quality of public debate by equipping citizens and policy makers with solid factual information vetted by experts representing different points of view on key ethical questions, and informing them of the best arguments available on competing sides of hot-button issues. It is likely that President Obama will soon constitute a bioethics advisory council of his own. When he does, will he favor the country with a council as diverse as his predecessor’s? Will as many as a third of its members have been McCain supporters? Will nearly half hold strong pro-life views that contradict the President’s own beliefs about the moral status of the human embryo and related questions? Will Obama be as open to differing perspectives and ideas as Bush was? If not, what will the bioethicists and others who originally complained about Bush allegedly ‘stacking’ his council with like-minded people say? What will we hear from writers and commentators in the media who reported that Bush had stacked the Council with religious conservatives?"

Time will tell.

Among those whom President Obama considers to be too "philosophical" is Edmund D. Pellegrino, M.D., the most recent Chairman of the President’s Council on Bioethics as well as Professor Emeritus of Medicine and Medical Ethics at Georgetown University and a former director of the Kennedy Institute of Ethics at Georgetown University, who has coauthored 24 books and more than 550 published articles while simultaneously continuing to see and treat his own patients over the years. In addition to the numerous other committees on which he serves, in 2004 Dr. Pellegrino was also appointed to the International Bioethics Committee at the United Nations. Perhaps the United Nations is also too philosophical and should also be abolished.

On the website of The President’s Council on Bioethics, www.bioethics.gov, the dates of the Council’s existence are displayed, November 28, 2001 – June 11, 2009, followed by the notice, "This site is now being archived."

(Please see the related news article on this website, entitled, "Members of The President’s Council on Bioethics Object to Obama’s Stem Cell Policy", dated March 26, 2009).

The U.S. company Neostem, which operates a number of adult stem cell collection centers, has signed an exclusive 10-year-long contract with Enhance Biomedical Holdings Limited (EBHL), the China-based subsidiary of Enhance Holding Corporation. The new agreement allows both companies to collaborate in the development of a network of adult stem cell collection and treatment centers in Taiwan and throughout a number of provinces in China.

According to the terms of the agreement, NeoStem will train EBHL staff in the proper implementation of the proprietary adult stem cell technology developed by NeoStem, for which EBHL has been granted the exclusive rights to utilize throughout Asia. In return, NeoStem will receive from EBHL a six-figure technical assistance fee, in addition to royalties on gross revenues and other associated fees over the 10-year period. The 10-year contract is renewable upon its completion.

As stated on their website, "NeoStem is the first company to provide adult stem cell collection and banking services to the general adult population. NeoStem’s medically proven process is a minimally invasive, painless and safe way to collect your own adult stem cells."

Since the U.S. FDA (Food and Drug Administration) has outlawed the use of autologous adult stem cell therapies in the U.S., an increasing number of U.S. adult stem cell companies are forced to take their business overseas. Only in the U.S. are each person’s own adult stem cells considered to be a "drug", according to the U.S. FDA, and as such, each person’s own adult stem cells are therefore subject to the same outdated and lethargic laws that regulate the pharmaceutical giants and other industrial manufacturers of medication. Consequently, people can obtain adult stem cell therapies just about anywhere at all in the world, except in the United States, which is especially ironic since most of the adult stem cell therapies that exist throughout the world were pioneered either in the United States or by U.S. researchers who have been forced to conduct their research outside of the United States. But now, U.S. citizens will be pleased to know that soon they will be able to add an entire new network of adult stem cell treatment centers throughout China to the growing list of foreign countries where adult stem cell therapies may be legally obtained.

In a new study which examines the cellular mechanisms that cause gray hair, scientists learn more about the mammalian aging process.

Cellular stress has long been known to accelerate aging, and more specifically it is the damage incurred by DNA which causes all the characteristics that are associated with advanced age. Now, scientists are one step closer to elucidating precisely what these various cellular and molecular mechanisms might be.

Led by Dr. Emi Nishimura, researchers at the Tokyo Medical and Dental University have examined the association between environmentally imposed chemical damage and graying hair. Graying hair is associated with aging not only in humans but also in other mammals, and is often the focus of cellular studies. In Dr. Nishimura’s experiment, laboratory mice were subjected to a variety of cellular assaults which included chemical injections and whole-body x-rays. The mice then began growing gray hair, which revealed permanent damage to the stem cells of their hair follicles upon analysis.

The cellular DNA of every living species is constantly under attack by damaging agents that include chemical pollutants, ultraviolet light and ionizing radiation, among others. A single mammalian cell can experience as many as 100,000 stressful "events" per day, any one of which would be enough to damage the cell’s DNA. This relentless assault throughout life by innumerable natural as well as manmade environmental stressors inevitably results in permanent damage to the DNA. The cummulative effects of this "DNA weathering" will eventually, beyond a certain point, become externally visible. When a certain amount of DNA damage is inflicted upon the stem cells of hair, graying is the resulting external sign.

Hair follicles contain stem cells which mature into melanocytes, which are the cells that produce melanin, which is the pigment that gives hair its color. These stem cells are especially vulnerable to cellular stress, however, which is why very few people make it to an advanced age without succumbing to gray hair. For the first couple decades of life, the stem cells in hair follicles are plentiful enough that there is simultaneously an abundance of those stem cells which differentiate into pigment cells, and those that merely reproduce into identical "daughter" stem cells. Consequently, pigment is continually being added to new, growing hair. But as the decades of life continue to accumulate, so do the cellular assaults, and an increasing percentage of the stem cells in the hair follicles will continue to mature until finally there are no more pigment cells left. Hair without pigment is gray.

In the past, the exact mechanisms by which the number of pigment cells in hair decreased were not fully elucidated, although DNA damage has been understood to play a key role. As Dr. Nishimura explains, the accelerated maturation of hair follicle stem cells may be the body’s "more sophisticated way" of purging the damaged stem cells, rather than just forcing the cells to die through more ordinary apoptotic (cellular death) mechanisms.

The topic of aging is a complex one, and it has implications for a number of medical and scientific fields, including not only stem cell therapies but cancer. How and why we age has always been a topic of general human interest. The exact mechanisms by which particular cells age, die, and either are or are not replaced by new cells, is of increasing scientific interest as well. Dr. Leonard Hayflick, the renowned cell biologist and founder of "molecular gerontology", played a key role in our understanding of these cellular mechanisms. By his discovery of the built-in limitations of cellular longevity, he established the fact that there exists a limit to the number of times that normal (noncancerous) cells can divide. This limit is known as the "Hayflick limit". While employed in cell biology and mycoplasmology at Wistar in the 1950s, Dr. Hayflick noticed that each cultured human and animal stem cell has a predetermined number of times that it can replicate in order to create another stem cell. Prior to his discovery of this, it had been commonly and erroneously believed for at least sixty years, since the turn of the previous century, that cells would continue to divide indefinitely. Dr. Hayflick discovered that cells stop growing after about 50 divisions, or population doublings. As he described, "They continued to eat, excrete waste, and perform all the metabolic housekeeping necessary to stay alive. They just didn’t replicate anymore. Eventually, debris attached to them, and they ultimately suffered ‘degeneration’." (From Stephen S. Hall, "Merchants of Immortality", 2003). It is now commonly understood that normal cells in culture have a finite limit to the number of times they can divide – unlike cancer cells, which are the only "immortal" cells, and can continue to divide indefinitely. But the discovery was initially a startling one. Together with Paul Moorhead, Dr. Hayflick published his revolutionary findings, which contradicted the current dogma of that era, first in Experimental Cell Research in 1961, and again in an updated version in Experimental Research, in 1965. Entitled, "The limited in vitro time of human diploid cell strains," this seminal paper introduced the new idea that the number of times a human cell is capable of dividing is innately limited. The paper had previously been rejected by the Journal of Experimental Medicine, and Dr. Hayflick still possesses the now famous rejection letter, in which the journal’s editor wrote, "The largest fact to have come out from tissue culture in the last fifty years is that cells inherently capable of multiplying will do so indefinitely if supplied with the right milieu in vitro." (Ibid.) Time will tell exactly how many other dogmatic pillars shall be overturned by future discoveries. Meanwhile, Dr. Hayflick’s discovery not only shattered conventional "wisdom", but it also focused attention on the cell as the fundamental location of aging. Dr. Hayflick was able to demonstrate for the first time that both mortal and immortal mammalian cells exist. Much of modern cancer and stem cell research today is based upon this distinction.

The cellular senescence (from the Latin, "senex", meaning "old man" or "old age"), or cellular death, discovered by Dr. Hayflick is now known to involve the successive shortening of chromosomal telomeres with each cell cycle as cells repeatedly divide. This feature of replicative cell senescence has become an established principle in biogerontology, the field of aging, although the exact mechanisms behind this process are still not yet fully understood. In addition to the successive shortening of telomeres, other factors in the process of DNA replication during cell division also contribute to "aging", such as cumulative DNA damage and mutation, as well as cross linkage. Despite the "Hayflick limit", however, it has also been shown that cells may be immortalized, thereby "crashing right through the Hayflick limit and continuing for dozens more cell doublings", by the extension of telomeres with telomerase. ("Hayflick Unlimited: Extension of Life Span by Introduction of Telomerase into Normal Human Cells." Science, 1997). In 1998, although it was somewhat disappointing as a commercial venture, the Geron Corporation developed techniques for extending telomeres, thereby demonstrating the ability of lengthened telomeres to prevent cellular senescence. Clearly, more work in this field will no doubt impact clinical applications of cancer and stem cell therapies.

Meanwhile, at least regarding the subject of gray hair, a number of interesting commercial and entrepreneurial opportunities continue to present themselves. Since it is virtually impossible to avoid DNA and stem cell damage throughout life, a global market exists for a procedure that would immortalize melanocytes, perhaps by extending the telomeres of these cells with telomerase. As Dr. Linzhau Cheng of the Johns Hopkins Institute of Cell Engineering has hypothesized, "We may soon have anti-graying creams for aging populations."