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After grappling with the issue--scientifically, ethically, and morally--I believe that both embryonic and adult stem cell research should be federally funded within a carefully regulated, fully transparent framework that ensures the highest level of respect for the moral significance of the human embryo. Because the unique interaction between this promising but uncharted new science with the ethical and moral considerations of life is continually evolving and presenting new

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   As a legislator, I have been consistent in my work to ensure that human life is treated with the utmost respect and dignity. I am pro-life. My voting record in the Senate has consistently reflected my pro-life philosophy. In my 6-plus years in the Senate, I have voted time and time again to preserve human life. For instance, I am proud to have been a leader in the fight to ban the partial-birth abortion procedure. As a physician, my sole purpose has been to preserve and improve the quality of life.

   Throughout my career on the forefront of heart and lung transplantation, I have had to face the ethics of life and death with my patients and their families. As a surgeon, I have frequently removed a heart from one individual whose brain has died and placed that heart into another patient who would otherwise die. But this requires determining when brain death has occurred a process that was very controversial when it was first developed just 33 years ago.

   A similar dilemma now confronts us in the field of embryonic stem cell research, and I have turned to my own experience as a transplant surgeon for wisdom. The question is much like that faced in the early days of organ transplantation--do we remove organs and tissue for transplantation and research from an individual who is brain dead, but whose other organs continue to live and function normally? Do we allow research using stem cells derived from blastocysts that could, if implanted, become a fetus, but which the parents clearly have determined to discard? I believe this is the proper course, but only under the strictest of regulations to ensure a clear separation between the decision of whether to discard excess embryos or donate them for adoption and the option to donate such embryos for research.

   Scientifically, I consider human embryonic stem cell research to be a promising and important line of inquiry. I am fully aware and supportive of the advances being made each day using adult stem cells. However, it seems clear that research using the more versatile embryonic stem cells does have greater potential than research using adult stem cells and may, under carefully considered and appropriate conditions, be conducted ethically. The scientifically prudent course for us as policymakers seems to provide for the pursuit of both embryonic and adult stem cell--research allowing researchers in each field to build on the progress of the other.

   Let me make this clear, however. To say that the research may ethically be conducted is not to say that the guidelines promulgated by the National Institutes of Health (NIH) are sufficient, as some of my colleagues have asserted. To the contrary, they are severely lacking in appropriate safeguards. Nor do any of the present versions of legislation pending in Congress to authorize ES research include sufficient protections.

   Therefore, federal funding for stem cell research should be contingent on the implementation of a comprehensive, strict new set of safeguards and public accountability governing this new, evolving research--to ensure the progress of this science in a manner respectful of the moral significance of human embryos and the potential of stem cell research to improve health.

   I transplant hearts and lungs. I spent 20 years in both medical training and engaged in surgery. I am board certified in two surgical specialties. I have spent countless hours research and publishing this research in peer-reviewed medical journals. I was active in clinical transplantation. In each case, families of the donor individual has completed a comprehensive informed consent process giving consent to organ donation. I would weekly get calls in the middle of the night summoning me to the operating room, where I would come face-to-face with individuals near death and their grieving families. Through these experiences, I have seen firsthand the impact that medical progress and technological have had in reshaping legal and ethical criteria, and, in turn, I have seen how ethics has shaped the practice of medicine.

   Historically, death was not particularly difficult to determine or define. Generally, all vital systems of the body--respiratory, neurological, and circulatory--would fail at the same time and none of these functions could be prolonged without the maintenance of the others. With major technological advances in life support, particularly the development of ventilators, it is possible to keep some bodily systems functioning long after others have ceased.

   Over time, most state laws adopted a neurological standard for determining when death occurs. Thus, it has become common, accepted practice that requires that both the cerebral cortex and the brain stem irreversibly cease to function--this is the so-called ``whole brain death'' standard. There is now broad public support for organ donation upon this basis. But the interplay of science, ethics, and policy did not come easily.

   As we came to no longer face the inevitable simultaneity of systemic failures, it became necessary to define with greater precision which physiological systems are indicators of life and which are not. In 1968, a Harvard Medical School special committee report first urged that brain death be used rather than the older definition of irreversible circulatory-respiratory failure. This was later embraced by a Presidential Commission in 1981 as a recommendation for state legislatures and courts.

   In this context of life and death decision-making, physicians remove organs from individuals for the purpose of organ donation based upon the informed consent of families after determination of ``brain death,'' at which time the individual is considered to be dead. However, this decision-making process is carefully protected to ensure that the decision to withdraw life support or declare brain death is made entirely independent of any consideration of obtaining the individual's organs for donation. Even though the body and other organs and tissues are technically alive with the assistance of ventilators and other medical devices, the brain has ceased to function. When I removed a heart--or a heart and lungs--other organs were living and still functioning. Their organs would be used to save the lives of others. If the family consents following a comprehensive and broadly accepted consent process, we permit surgeons to remove living organs from the body of the individual.

   The decision to donate the organs of brain dead individuals is, as it should be, a decision separate from all other medical decision-making. It is made by informed consent of family to carry out the intent of the individual. It meets both ethical and practical requirements. First, it ensures that families are not faced with this difficult decision at a time when they are already struggling with saying good-bye to a loved one. It ensures that the treating physician is not the individual approaching the family for consent. On a very practical, public policy level, it strengthens the organ donation procedure by reassuring the public that decisions of best medical treatment are clearly divorced from the considerations of organ donation.

   The example of organ and tissue donation holds one framework to review in fashioning an approach that both respects the human embryo and promotes this new, evolving research. I believe that the human embryo is inherently valuable and has moral significance regardless of whether it will be implanted in a woman's uterus or is left-over in the colder, artificial setting of an infertility clinic. Because an embryo holds a high measure regardless of status, that embryo should be afforded a high level of respect.

   Because embryonic stem cells appear capable of indefinite self-renewal and differentiating into all adult cell types, this research has tremendous potential to provide new, important cell-based therapies.

   Research using adult stem cells also holds tremendous promise for treating disease, and recent studies have altered long-held conceptions about the abilities and usefulness of adult stem cells. However, there appear to be characteristics--in particular, that they appear to have more limited life spans, are presently more difficult to isolate in useful quantities, and may not be able to form all cell types--that may limit

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   Nonetheless, it appears clear that research using adult stem cells does not hold the same potential for medical advances as does the use of the more versatile embryonic stem cells. But, as in all research endeavors, what we are considering is the potential for advancements. Scientifically, we will see the best advances in both adult and embryonic research by allowing the two to proceed along parallel tracks, fostering valuable collaboration and interplay between researchers on each side.

   Some of my colleagues have advocated that the guidelines promulgated by the National Institutes of Health provide a sufficient framework to ensure that embryonic stem cell research can be conducted ethically. I strongly disagree. On the contrary, I find the NIH guidelines lacking in appropriate safeguards.

   Therefore, Federal funding for stem cell research should be contingent on the implementation of a strict new set of safeguards and public accountability governing this new, evolving research. The following 10 points are essential components of a comprehensive framework that allows stem cell research to progress in a manner respectful of the moral significance of human embryos and the potential of stem cell research to improve health.

   One, require a rigorous informed consent process: To ensure that blastocysts used for stem cell research are only those that would otherwise be discarded, require a comprehensive informed consent process establishing a clear separation between potential donors' primary decision to donate blastocysts for adoption or to discard blastocysts and their subsequent option to donate blastocysts for research purposes. Such a process, modeled in part on well-established and broadly accepted organ and tissue donation practices, will ensure that donors are fully informed of all of their options.

   As with organ and tissue donation, we must first ensure that health care providers make no mention of the option to donate excess embryos until completion of infertility treatment and the decision has been made independently by both members of a couple to discard embryos remaining in frozen storage at the clinic. Once that decision has been made, the destiny of the embryos is certain. When couples make this decision and authorize a clinic to discard the embryos, it is clear that the embryos will be dead within a short time frame. Only after both members of a couple have made a firm decision to discard these additional embryos should health care providers or researchers be allowed to approach them about the opportunity to donate these embryos for use in research.

   Moreover, the NIH regulations should strengthen the informed consent process by requiring stronger informed consent. And regulations should ensure greater oversight and accountability in the derivation process by requiring site visits of labs where cell lines are derived and prospective approval of line derivations.

   Two, ban embryo creation for research: The creation of human embryos solely for research purposes should be strictly prohibited.

   Last week, researchers announced the creation of three ES cell lines derived from embryos created for the express purpose of research. Limiting federal funding to research using embryos left over after being created for reproductive purposes will not prevent the creation of embryos only for research purposes by unethical researchers. Such an action has been nearly universally decried from all quarters. Therefore, we should include a comprehensive ban on the creation of embryos through IVF for the sole intent of performing research.

   Three, continue funding ban on derivation: Strengthen and codify the current ban on federal funding for the derivation of embryonic stem cells.

   While we find it important to scientific research and ethically acceptable that limited and strictly regulated ES research proceed, this does not mean that federal funds should be used in the derivation of ES cells. Rather, a continued ban on federal funding for the derivation of ES cells is a right and proper indication and acknowledgment that the American people are conflicted on the ethical and moral propriety of this issue and do not feel that the proper use of federal funds is in the derivation process.

   Four, ban human cloning: Prohibit all human cloning to prevent the creation and exploitation of life for research purposes.

   Ban all uses of human cloning. Most are agreed in their opposition to reproductive cloning. It is important, however, to also ban non-reproductive or research cloning both for the practical, implementation reason of making it more likely that such a ban on reproductive cloning will be successful as well as for the broader moral reasons shared by the majority of the American people that human embryos should not be created for the purpose of research and exploitation.

   Five, increase adult stem cell research funding: Increase federal funding for research on adult stem cells to ensure the pursuit of all promising areas of stem cell research.

   Although not presently as scientifically promising as ES research, AS research has seen many advancements in recent years and holds important potential for treating disease and injury. Many scientists have noted that not enough science has been completed to determine which of the two lines of inquiry will produce therapeutic applications and that it is therefore scientifically premature to limit research to one type of research only. Accordingly, in funding ES research, it is important to see that this is done in a manner complementing ongoing AS research so that both

   lines of inquiry are pursued aggressively and that neither is pursued to the scientific detriment of the other.

   Six, provide funding for embryonic stem cell research only from blastocysts that would otherwise be discarded: Allow Federal funding for research using only those embryonic stem cells derived from blastocysts that are left over after in vitro fertilization (IVF) and would otherwise be discarded.

   Specifically, the regulations should allow the use only of embryos that were created but unused for infertility treatment. These may only be donated from IVF clinics following completion of infertility treatment. Regulations should also include safeguards to prevent unethical creation of embryos in excess of clinical need.

   Seven, limit number of stem cell lines: Restrict federally funded research using embryonic stem cells derived from blastocysts to a limited number of cell lines. In addition, authorize Federal funding for stem cell research for five years to assure ongoing Congressional oversight.

   Limiting the number of cell lines would allow Federal funding to jumpstart the research into the basic properties of ES cells for more in-depth discovery of the capabilities, shortfalls, and properties of these cells, while respecting the ethical sensitivity of the research to the American people. Moreover, numerous researchers have expressed concern that, because existing embryonic stem cell lines would not be in accord with the present guidelines and regulations laid down by NIH, additional cell lines will have to be created. By limiting the creation of cell lines, the research will go forward, but under strong restrictions.

   Eight, establish a strong public research oversight system: Establish appropriate public oversight mechanisms, including a national research registry, to ensure the transparent, in-depth monitoring of federally funded and federally regulated stem cell research and to promote ethical, high quality research standards.

   A national research registry would serve as a holding and distribution facility that would provide another level of Federal oversight and control in the process. The registry would also be able to serve an important role of tracking the progress of this research as well as providing a strong oversight mechanism to track the research and its attention to public regulations.

   Nine, require ongoing, independent scientific and ethical review: Establish an ongoing scientific review of stem cell research by the Institute of Medicine (IOM) and create an independent

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   Stem cell research is so significant both ethically and scientifically, that continued Congressional oversight is important. All of this research should be the subject of ongoing scientific and ethical review.

   Ten, harmonize restrictions on fetal tissue research: Because stem cell research would be subject to new, stringent Federal requirements, ensure that informed consent and oversight regulations applicable to federally funded fetal tissue research are consistent with these new rules.

   These principles provide for an appropriate amount of research using human embryonic stem cells but ensure that such research is not conducted to the detriment of research utilizing adult stem cells. They balance the desire to move this research forward on a greater scale with the imperative to maintain the highest level of oversight to prevent abuses and the importance of continuing Federal oversight as this research advances.

   These 10 principles help answer the question I posed earlier: ``Is there a line that should not be crossed even for scientific or other gain?'' The clear response is ``Yes.'' It is clear to me that the creation of human embryos for research purposes should not be undertaken, regardless of the potential for scientific gain. It is clear to me that the use of human cloning should be strictly prohibited to prevent the commoditization and exploitation of human life. It is clear that the present restriction on the use of Federal funds for the derivation should be maintained and strengthened to reflect the concerns of the American people.

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