Congressional action and policies towards stem cell research

¶ … foundationally promising research discoveries of the twentieth century is Stem Cell Biology. Only announced as a possible scientific breakthrough in late 1998, significant research has begun on stem cells, yet even the announcement of the potential benefits by the National Academy of Science that comes with the then recent isolation of human stem cells did little to curb potential controversy and conflict.

Shannon 9)

Within the recent elections the issue of stem cell research has come to the forefront of consideration by voters, experts, opponent groups and proponent groups. The most substantial challenge to the recent federal rulings against stem cell research, by the Bush administration, is the passing of proposition 71 in California, which will create, and fund a 3 billion dollar stem cell research institute in the state of California.

Advocates of stem cell research are overjoyed at the collective snubbing of what some consider the dogmatic and conservative approach that the Bush administration and the current congress have taken to outlaw the use of new stem cell lines, therefore severely limiting the ability of scientists to conduct research in a productive manner. With the passing of this bill proponents expect to see other states follow suit to create a network of "legitimate" scientific resources, all in opposition of the federal stance on stem cell research, thought by many to be a pure and simple attempt to legislate morality. (Elias, November 3, 2004, "California's $3 billion stem cell proposition passes")

The issue of embryonic stem cell research has become so hotly contested and politically important that President George W. Bush discussed it in his first prime-time presidential address on August 17, 2001. The presidential address and President Bush's later decision to modify existing policy on embryonic research evoked debate among key players on both sides of the issue.

Stevens) more developed understanding of the official statement of the president with regards to stem cell research, in his 2001, can be found at the National Institutes for Health Website.

On August 9th, 2001, President George W. Bush announced that federal funds may be awarded for research using human embryonic stem cells if the following criteria are met:

The derivation process (which begins with the destruction of the embryo) was initiated prior to 9:00 P.M. EDT on August 9, 2001.

The stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed.

Informed consent must have been obtained for the donation of the embryo and that donation must not have involved financial inducements. (NIH Website "NIH Role in Federal Policy")

As the federal governments leading biomedical research organization, they are then charged with the implementation and support of Bush policy. In their quest to support such policy they become a sort of watch dog group cataloging the 71 identified stem cell groups which meet the guidelines of the president and funding groups that study only within these federally mandated guidelines. Due to the fact that federal funding has been historically the most utilized resource by most research institutions the guidelines immediately changed the face of embryonic stem cell research, though not illegalizing research on stem cell lines outside the criteria essentially drying up the resources they needed to function.

Many conservatives who advocate a total funding ban, such as the Catholic Church and anti-abortion groups, have accused President Bush of breaking his campaign promise to prohibit federal funding of research involving the destruction of living embryos. (14) Taking another view, some scientists, citizens, and lawmakers supported Democratic efforts to reverse President Bush's decision and make embryonic stem cells more available for research. Scientists fear that limitations on federal funding will keep them from realizing the huge potential of stem cell research.

Stevens)

The resulting response from the scientific community and now individual states has been to privatize outside research and in the case of California allocate funding from within state budgets rather than federal budgets.

This work will address the issues of stem cell research, first be briefly describing the research itself and the expert opinions of its potential as a way to develop cures or diseases that have previously confounded many medical scientists. It will then go on to thoroughly discuss the stem cell research issue as a political/ethical/moral issue tracing the evolution of the issue through the various legislative processes and through the various bioethics groups who both support and oppose the research. The work will show the overall evolution of stem cell research as an issue facing the American people and the medical world specifically as one that may severely challenge the culture of the United States as it continues to define its recognized major role in the development of disease treatment and cure.

Stem Cell Research Explored

The greater understanding of the mutability of stem cells has led many scientists to believe that there will soon be a practical way to treat and respond to diseases that most, in the past believed to be human pariahs unable to be combated with curative therapy. Stem cell biology has led to a the potential for a promising future in the ability to treat and "cure" diseases that have long plagued the human population. The promise can be compared only to such discoveries as that of the involvement of germs in infection through the link with post treatment death and the disease fighting properties of antibiotics. With such a discovery on the horizon of human capabilities it is imperative that the reader has at least a basic understanding of the stem cell and its potential.

Recent reports on the isolation and successful culturing of the first human embryonic stem cell lines have generated great excitement and brought biomedical research to the edge of a new frontier...To understand the importance of this discovery as well as the related scientific, medical, and ethical issues, it is absolutely essential to first clarify the terms and definitions.

Borror, O'Rourke and Skirboll 54) short list of terms with their respective long descriptions will help to alleviate the potential for confusion of this very intricate issue. The political and ethical issues of stem cell research are often seen to be wallowing in the semantic quagmire of medical and scientific understandings, in much the same way as the criminal justice system, comprised of peer juries and expert witnesses first dealt with DNA findings.

Totipotent. Stem Cells, which are cells that have the ability to divide for indefinite periods in culture and to give rise to specialized cells such as blood or skin or brain tissue, are best described in the context of normal human development. Human development begins when a sperm fertilizes an egg and creates a single cell that has the potential to form an entire organism. This fertilized egg is totipotent, meaning that its potential is total -- it can produce any kind of tissue found in the mature organism.

In the first hours after fertilization, this cell divides into two identical totipotent cells. This means that either one of these cells, if placed into a woman's uterus, has the potential to develop into a fetus. Approximately four days after fertilization and after several cycles of cell division, these totipotent cells begin to specialize, forming a hollow sphere of cells, called a blastocyst.

Borror, O'Rourke and Skirboll 54)

Even the novice is aware of the ability of medical science to create this phenomenon outside the human body using donated human materials. Such work has been done for decades as a fertility treatment for couples somehow unable to provide this for themselves naturally. At this stage most such cell bodies are implanted into the womb of a waiting patient to grow to maturity and be delivered in the same manner as any other child. Yet, the ability of science to duplicate this natural occurrence without the intention of implantation or the knowledge of the greater scientific body as a means for experimentation is one of the perceived dangers associated with human research.

Pluripotent Stem Cells. The blastocyst has an outer layer of cells; inside the hollow sphere is a cluster of cells called the inner cell mass. The outer layer of cells will divide to form the placenta and other supporting tissues needed for fetal development in the uterus. The inner cell mass cells will eventually form virtually all of the tissues of the human body...These inner cell mass cells are pluripotent -- they can give rise to many types of cells but not all types of cells necessary for fetal development. Because their potential is not total, they are not totipotent and they are not embryos. In fact, if an inner cell mass cell were placed into a woman's uterus, it would not develop into a fetus.

(Borror, O'Rourke and Skirboll 54)

Within the above definitions even the most novice reader would begin to see an ethical issue that creates potential controversy. In most stem cell research totipotent cells are not needed as the desire is not to create an entire living organism, which would be likened to cloning in some cases, but to create specialized cells that develop into tissue and organs for specific uses, everything from skin for graphs to full beating hearts for transplant.

For some the issue then arises when the pluripotent cells are removed from the blastocyst, as this very act negates the ability for the cell group to develop into a human being. "Note that the process of changing from totipotent to pluripotent to multipotent cells is not reversible -- that is, pluripotent stem cells do not produce totipotent stem cells, and multipotent stem cells do not produce pluripotent stem cells."

Borror, O'Rourke and Skirboll 54) Additionally, the proponents of stem cell work cite the pluripotent as incapable of producing a human being therefore not a destruction of life, hence leading to the Bush decision to ban the creation of new lines of stem cells, as it would require the destruction of further human totipotent cells.

Multipotent. The pluripotent stem cells undergo further specialization into multipotent stem cells, which are committed to giving rise to cells that have a particular function. Examples of this include blood stem cells that give rise to red blood cells, white blood cells, and platelets; and skin stem cells that give rise to the various types of skin cells...While stem cells are extraordinarily important in early human development, multipotent stem cells are also found in children and adults. For example, consider one of the best understood stem cells, the blood stem cell. Blood stem cells reside in the bone marrow of every child and adult, and in fact, they can be found in very small numbers circulating in the blood stream. Blood stem cells perform the critical role of continually replenishing our supply of blood cells -- red blood cells, white blood cells, and platelets -- throughout life. A person cannot survive without blood stem cells.

It is for this reason and others that many pro-life advocates prefer to see funding for stem cell research to move toward the use of stem cells present in the adult human rather than that of an undeveloped embryo. Many legislators, briefed in the intricacies of the basic stem cell concepts and abiding by a moralistic foundation similar to George W. Bush have opted to limit the use of the more readily available and historical sources for stem cells. The conservative then prefer to seek out legislative results that limit the use of embryonic stem cells and in their thinking force the scientific community to redirect their investigations toward the scientifically less promising and more challenging, in many ways adult stem cell research. One promising development in the issue of stem cell research is the limitation of recipient rejection in umbilical cord source blood for bone marrow transplantation, though limited offers promising solutions if the ownership of such sources can be more readily defined.

Bourque and Sugarman 65) Proponents of stem cell research on the other hand demonstrate considerable concern about the limitation of resources as the adult stem cell is already specialized and only a few specialized groups are identified and accessible.

Stem Cell Biology a Political Issue

One would believe that with the discovery of such a potentially promising line of treatment the developed and developing world would embrace the new science and begin to test and even implement its use. To some degree this has been the case, yet despite the promise of stem cell biology and the long list of potential disease cures the bioethics of stem cell biology have left much of the research and mostly its potential growth in a quagmire of political and religious debate. It seems that at the same rate that new possibilities are perceived by the scientist and clinicians in research theory and practice the number of groups and individuals raising questions about the ethics and morality of the line of research and creating statements and standards that are designed to hopefully sway the decisions of government on the issue of stem cell research.

Nelson 49) number of authoritative groups, hoping to guide both publicly and privately funded research on human embryonic stem cells, issued reports on the ethical problems involved. These bodies include the Ethics Advisory Board constituted by Geron Corporation; the American Association for the Advancement of Science (AAAS) in concert with the Institute for Civil Society [1] the Center for Bioethics and Human Dignity [2] and, most recently, the National Bioethics Advisory Commission, which was established by executive order of the president in 1995 to provide recommendations concerning governmental policies or activities as they involve ethical issues emerging from biological research and its clinical applications. [3]

Of these four bodies, only the Center for Bioethics and Human Dignity, a Christian educational foundation, has been implacable in its opposition to all research involving the destruction of embryos, no matter how it is funded. The other committees have given a more or less cautious green light to stemcell research.

Nelson 49)

The President's Council on Bioethics, is a brain trust that guides the president in his understanding of policy implementation on issues of bioethical import. The most recent changes in council strongly lean in favor of Bush's individual morality on the issue of stem cell research and the like. "...the Bush administration dropped renowned cell biologist -- and proponent of embryonic stem-cell research -- Elizabeth Blackburn from the President's Council on Bioethics, in favor of Diana Schaub, a political scientist who believes cloning to be 'evil.'" ("To Those Who've Been") Though not a practice new to this president many scientists and researchers are clearly concerned about the stacking of the cards in favor of further limitations on research using embryonic stem cells, and many other bioethical and often controversial issues.

The American Medical Association has been historically in favor of stem cell biology research "Our AMA: (1) encourages strong public support of federal funding for research involving human pluripotent stem cells (PSC)"

Eiseman 89) As a representative of thousands of practicing physicians and research physicians the words of such an organization are paramount to the development of projects and programs that further the development of stem cell technology. The organization has a generally moderate conception of that which it deems ethical in research and development and adopts the standards associated with another influential organization, The National Bioethics Advisory Commission.

An article in the August 2, 1999, American Medical News reviewed NBAC's recommendations on human stem cell research (Gianelli, 1999). The article gave details of NBAC's final deliberations on stem cell research, relating that NBAC adopted an _intermediate_ position that an embryo merits respect as human life, but not at the level generally accorded to persons. The article highlighted several of NBAC's key recommendations, including that research involving stem cells from embryos left over from infertility treatments and research involving germ cells from aborted fetuses should be federally funded; research using embryos created solely for research purposes, through either in vitro fertilization or cloning techniques, should not be federally funded; a national review panel and public registry should be established; and proper informed consent procedures must be followed for embryo and tissue donors.

Eiseman 89)

The political pull of a very large lobbying group, the AMA is felt yet the resulting moderate response to the use of discarded embryos has not been entirely reflected in the conservative legislation detailed later in this work.

Another group of interest that has demonstrated considerable pull on the conservative side is the Coalition of Americans for Research Ethics. "The Coalition of Americans for Research Ethics, reported that scientific evidence does indicate that adult stem cells are a viable alternative."

Hentoff 19) The moralistic organization strongly asserts the ideals of the alternative federal legislation associated with many conservative legislators and many of Bush's supporters and advisors. Though funding is the demonstrative beginning for the creation of government control over the issue of the bioethics of stem cell research the resulting controversy seems to have incited legislative action to further define the legality not only of funding support but of that which is legal or illegal. The beginning step was the assertion that cloning of human cells is illegal. Some ardent proponents of stem cell biology would conclude this to be the beginning of the end of a promising line of scientific medical research while more moderate thinkers applaud the action of the federal government as a realistic step toward regulating the bioethics of this new and promising research base before it goes completely astray of the purpose of curing and treating human disease.

Stem Cell Legislation

Recent stem cell legislation lends in the favor of the conservative, as has been said before. This is likely a result of the more conservative elements in congress having the strongest moral/ethical feelings about the need to curtail the acts of scientists before what they consider amoral acts occur. This standard can be clearly seen in the language of the Human Cloning Prohibition Act of 2001

6)(A) it will be nearly impossible to ban attempts at reproductive cloning' once cloned human embryos are available in the laboratory because-- i) cloning would take place within the privacy of a doctor-patient relationship;

ii) the transfer of embryos to begin a pregnancy is a simple procedure; and iii) any government effort to prevent the transfer of an existing embryo, or to prevent birth once transfer has occurred would raise substantial moral, legal, and practical issues; and B) so, in order to be effective, a ban on human cloning must stop the cloning process at the beginning... (Human Cloning Prohibition Act of 2001, available online)

The need for strict restrictions on human cloning is relatively universally accepted, even the international community has taken strides to challenge the scientific trend toward human cloning, considering those rouge scientists still researching such cell biology in humans to be outside the bioethics community. Though the language of the legislation has a strong moralistic tone, especially in the description of the reasons why human cloning should not be tolerated.

3) efforts to create human beings by cloning mark a new and decisive step toward turning human reproduction into a manufacturing process in which children are made in laboratories to preordained specifications and, potentially, in multiple copies; (Human Cloning Prohibition Act of 2001, available online)

Additionally the moralistic tone of the work can be seen in the demonstrative description of the potential use of human cloned embryos as a resource for stem cell research.

4) creating cloned live-born human children (sometimes called reproductive cloning') begins by creating cloned human embryos, a process which some also propose as a way to create embryos for research or as sources of cells and tissues for possible treatment of other humans; (5) the prospect of creating new human life solely to be exploited and destroyed in this way has been condemned on moral grounds by many, as displaying a profound disrespect for life, and recent scientific advances indicate that there are fruitful and morally unproblematic alternatives to this approach; (Human Cloning Prohibition Act of 2001, available online)

Other legislation creates similar definitive restrictions on the use of human embryo cells and stem cell biology. The tone continues to be moralistic but arguably it has become more and more conservative as the influential members of the differing committees of experts on the subject continue to play out potentially amoral possibilities for the use of embryo cells. In the Responsible Stem Cell Research Act of 2001 allows for the creation of a National Stem Cell Donor Bank, and funding limitations for this service and the NIH funding qualifications. It defines those stem cell lines that qualify as:

qualifying human stem cells' means human stem cells obtained from human placentas, umbilical cord blood, organs or tissues of a living or deceased human being who has been born, or organs or tissues of unborn human offspring who died of natural causes (such as spontaneous abortion). (Responsible Stem Cell Research Act of 2001 available online)

The Stem Cell Research Act of 2001 further qualifies the responsibilities of the NIH and those scientists conducting embryo research to donors who have given consent and only from surplus cells previously intended for implantation but now not needed. Stepping away from the Stem Cell Research Act of 2000 only in that it seems to remove the restriction of nominal profits for researchers or developers. Additionally it makes clear that any scientist who knowingly violates or disrupts interstate commerce in the obtaining of stem cell lines can be sanctioned. An additional piece of legislation of interest is the House Continuing Resolution expressing support for federal funding of pluripotent stem cell research which demonstrates the attempt by congress to demonstrate a need to refocus funding and research on pluripotent stem cell research, earlier defined as the stem cell research associated with gleaning stem cells from non-embryonic sources rather than embryonic resources, restricting the recreation of the original pluripotent derived research which was based around the separation of the pluripotent cells from the foundational blastocyst, which could potential create a human embryo.