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Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete

U.S. News and World Report, March 4, 2009

Citing a number of examples which demonstrate the "markedly diminished need for expanding these cell lines for either patient therapy or basic research", Bernardine Healy, M.D., explains in clear and logical terms why embryonic stem cells are obsolete.

According to Dr. Healy's article in U.S. News and World Report, "Even for strong backers of embryonic stem cell research, the decision is no longer as self-evident as it was, because there is markedly diminished need for expanding these cell lines for either patient therapy or basic research. In fact, during the first six weeks of Obama's term, several events reinforced the notion that embryonic stem cells, once thought to hold the cure for Alzheimer's, Parkinson's, and diabetes, are obsolete. The most sobering: a report from Israel published in PLoS Medicine in late February that shows embryonic stem cells injected into patients can cause disabling if not deadly tumors."

As Dr. Healy further explains, "The report describes a young boy with a fatal neuromuscular disease called ataxia telangiectasia, who was treated with embryonic stem cells. Within four years, he developed headaches and was found to have multiple tumors in his brain and spinal cord that genetically matched the female embryos used in his therapy." (Please see the related news article on this website, entitled, "Fetal Stem Cell Therapy Could Prove Fatal", dated February 17, 2009).

Such findings should make everyone rethink, among other things, Geron's upcoming clinical trials with human embryonic stem cells, and Dr. Healy even suggests that the U.S. FDA (Food and Drug Administration) should reconsider the wisdom of having granted such authorization in the first place. According to Dr. Healy, "His experience [the Israeli boy who developed the tumors] is neither an anomaly nor a surprise, but one feared by many scientists. These still-mysterious cell creations have been removed from the highly ordered environment of a fast-growing embryo, after all. Though they are tamed in a petri dish to be disciplined, mature cells, research in animals has shown repeatedly that sometimes the injected cells run wildly out of control - dashing hopes of tiny, human embryos benignly spinning off stem cells to save grown-ups, without risk or concern. That dream was still alive only a few weeks before this report. Within days of Obama's inauguration, the Food and Drug Administration approved its first-ever embryonic stem cell study in humans: the biotech company Geron's plan to inject highly purified human embryonic cells into eight to 10 patients with acute spinal cord injuries. (The cells are from a stem cell line approved by Bush because it predated his ban). The FDA should now be compelled to take another look: Are eight to 10 patients enough, or one year of monitoring sufficient, to assess safety? And doctors who participate in the trial will have to ask what every doctor must ask before performing research on a human subject: Were I this patient, would I participate? Would I encourage my loved ones to do so?"

In acknowledging the extraordinary successes that have already been accomplished with adult stem cells, Dr. Healy adds, "Even as the future of embryonic stem cells has dimmed, adult stem cell research has scored major wins evident just in the past few months. These advances involve human stem cells that are not derived from human embryos. In fact, adult stem cells, which occur in small quantities in organs throughout the body for natural growth and repair, have become stars despite great skepticism early on. ... Such stem cells can be removed almost as easily as drawing a unit of blood, and they have been used successfully for years in bone marrow transplants. To date, most of the stem cell triumphs that the public hears about involve the infusion of adult stem cells. We've just recently seen separate research reports of patients with spinal cord injury and multiple sclerosis benefiting from adult stem cell therapy."

Even iPS (induced pluripotent stem) cells, which are also not without their own dangers, are more promising than embryonic stem cells, and on this topic Dr. Healy cites not only the inherent medical risks of iPS cells but also the advice of the first scientist who ever isolated an embryonic stem cell, the famous Dr. James Thomson. As Dr. Healy describes, "While these cells [iPS cells] might become a choice for patient therapy in time, scientists are playing this down for now. Why? These embryonic-like cells also come with the risk of cancer. James Thomson, the stem cell pioneer from the University of Wisconsin who was the first to grow human embryonic stem cells in 1998, is an independent codiscoverer of iPS cells along with Japanese scientists. Already these reprogrammed cells have eclipsed the value of those harvested from embryos, he has said, because of significantly lower cost, ease of production, and genetic identity with the patient. They also bring unique application to medical and pharmaceutical research, because cells cultivated from patients with certain diseases readily become laboratory models for developing and testing therapy."

Finally, Dr. Healy points out another important distinction which is often overlooked, namely, the distinction between the simple act of overturning President Bush's restriction on the use of federal funding for human embryonic stem cell research, which President Obama has promised to do, and the far more difficult task of repealing the Dickey-Wicker Amendment, which became law under the Clinton Administration and which forbids both the creation and the destruction of embryos for scientific research. In regard to this matter, Dr. Healy has this to say: "The importance of stem cells for medical research has never been greater, and the scientific and public clamor for unimpeded research is fully understandable. But it's important that Obama and everyone supporting a lifting of the ban be clear with the public on what is involved in this decision; it's more complex than advertised. The more ethically charged decision - less understood by the public and one Congress has avoided - involves the ban on creating human embryos in the laboratory solely for research purposes. In fact, President Clinton is the one who balked at allowing scientists to use government money for embryo creation and research on stem cells harvested from such embryos; Bush only affirmed the Clinton ban. The scientific community has been able to attract nonfederal money for such work, and it is going on all the time in stem cell institutes. Scientists want relief from the inconvenience and expense of keeping that work and the money that supports it separate from federal dollars. Reversing the Executive Orders of 2 prior presidents on embryo creation, which even the Congress has been unwilling to tackle, is a far bigger issue than lifting the ban on the use of IVF embryos slated for destruction. Obama stands for transparency, and it's important for him to make sure the public understands his decision, including that all stem cells are not the same or created equally."

Dr. Bernardine Healy, a cardiologist who has spent more than 25 years practicing medicine, is currently a senior writer and health editor for U.S. News and World Report, and the author of the magazine's "On Health" column. A graduate of Harvard Medical School, she was one of only ten women out of a class of 120 Harvard Medical School students at that time. She is a former Professor of Medicine at Johns Hopkins University School of Medicine where she was also Director of the Coronary Care Unit and Assistant Dean for Post-Doctoral Programs and Faculty Development. She has served in the capacity of Presidential Advisor under several administrations, beginning in 1984 when President Reagan appointed her as Deputy Director of the White House Office of Science and Technology Policy. In 1991, President George H.W. Bush appointed her as the first woman Director of the National Institues of Health, and in the George W. Bush administration she was appointed in 2001 to the President's Council of Advisors on Science and Technology where she served as an advisor on bio-terrorism. Additionally, she was President of the American Heart Association from 1998 to 1999, and President and CEO of the American Red Cross from 1999 to 2001, during which time she led the response of the American Red Cross to the terrorist attacks of September 11th, 2001, which included the creation of a $200 million family grant program for the families of victims and the initiation of a stratetic blood reserve from extra blood collections, among other programs. From 1995 to 1999 she was Professor of Medicine and Dean of the College of Medicine and Public Health at Ohio State University. She has written 2 books and coauthored more than 220 peer-reviewed manuscripts on cardiovascular research and health science policy. Despite her numerous administrative, executive and Presidential appointments, from which she became known for her outspoken and innovative policy-making decisions, she has continued to treat patients throughout much of her career. She has also served as a medical correspondent for CBS news.



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