The Bush administration's policy on embryonic 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 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.

Cord blood stem cell research was both furthered and hampered by legislation in 2003 (Cord Blood Stem Cell Act 2003). The act created a donor list that would be available for practitioners to quickly seek type and cross specific cord blood cells to use as a replacement for more risky bone marrow transplant procedures, nationalizing a donor bank system that already exists but according to congress is in need of regulation.

Though the legislation may seem moralistic the proponents seem to be winning the war on the need for research, despite the moralistic standards of even some of the presenters of the legislation, as the posabilites of stem cell research are clearly speaking for themselves and the productivity of the research that has already been conducted in just a few short years is astounding and in need of protection, as can be seen in the Human Cloning Ban and Stem Cell Research Protection Act of 2003. Yet, also seen in the act is a the furtherance of the restrictions on human cloning, establishing penalties and more specific scientific standards of practice for researchers.

A d) PENALTIES-

1) CRIMINAL PENALTIES- Whoever intentionally violates paragraph (1), (2), or (3) of subsection (b) shall be fined under this title and imprisoned not more than 10 years.

2) CIVIL PENALTIES- Whoever intentionally violates paragraph (1), (2), or (3) of subsection (b) shall be subject to a civil penalty of $1,000,000 or three times the gross pecuniary gain resulting from the violation, whichever is greater.

3) FORFEITURE- Any property, real or personal, derived from or used to commit a violation or attempted violation of the provisions of subsection (b), or any property traceable to such property, shall be subject to forfeiture to the United States in accordance with the procedures set forth in chapter 46 of title 18, United States Code.(Human Cloning Ban and Stem Cell Research Protection Act of 2003 available online)

The establishment of such penalties for interstate transport and human cloning practices sets precedence, creating a legalistically enforceable set of penalties for a previously unlegislated issue. The work gives law enforcement, on all levels the right to intervene in insinuating circumstances and also makes the violation of such acts a federal violation, penalized by the federal law enforcement system.

In general the wording and standards in the legislation has matured to include very specific acts of biological determination.

The legislation in the Human Cloning Ban and Stem Cell Research Protection Act of 2003 is far more representative of a more scientifically savvy legislature and government in general and includes defined terminology that restricts the ability of scientists to perform human cloning and separates those doing legitimate research, or that which is allowed in all previous legislation from those who may be conducting illegal cloning.

PROHIBITION ON CONDUCTING NUCLEAR TRANSPLANTATION ON FERTILIZED EGGS- A somatic cell nucleus shall not be transplanted into a human oocyte that has undergone or will undergo fertilization.

A d) FOURTEEN-DAY RULE- An unfertilized blastocyst shall not be maintained after more than 14 days from its first cell division, not counting any time during which it is stored at temperatures less than zero degrees centigrade.

A e) VOLUNTARY DONATION OF OOCYTES-

1) INFORMED CONSENT- In accordance with subsection (b), an oocyte may not be used in nuclear transplantation research unless such oocyte shall have been donated voluntarily by and with the informed consent of the woman donating the oocyte.

2) PROHIBITION ON PURCHASE OR SALE- No human oocyte or unfertilized blastocyst may be acquired, received, or otherwise transferred for valuable consideration if the transfer affects interstate commerce.

A f) SEPARATION OF IN VITRO FERTILIZATION LABORATORIES FROM LOCATIONS AT WHICH NUCLEAR TRANSPLANTATION IS CONDUCTED- Nuclear transplantation may not be conducted in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures.

A g) CIVIL PENALTIES- Whoever intentionally violates any provision of subsections (b) through (f) shall be subject to a civil penalty in an amount that is appropriate for the violation involved, but not more than $250,000.'.

Conclusion

The savvier the legislature becomes the more complicated and invasive the legislation becomes for the scientist. As one avenue opens up another door closes. Though all sides must be heard and all issues must be addressed with regard to the use of human cells for disease research the issues regarded as important by the federal government seem to be expanding as exponentially as the research itself. Challenging the industry to continually assert and reassert the need to follow the rule of the law in the face of so much potential. The demonstration of the initial restrictions on federal funding of stem cell research only in certain circumstances has evolved into the development of illegalizing research, even privately funded on issues outside the moral legislation of the federal government. Many scientists are concerned that if this trend continues the restrictions will negate the creative possibilities of stem cell biology research.