Stemming Designs for Inhibitory Government Regulation
Allowing Stem Cell Research to Achieve its Pluripotential
Tom Carmack | Wilson Sonsini Goodrich & Rosati
Posted Monday, December 1, 2003
4 U.C. Davis Bus. L.J. 3 (2003)

Contents and Links:

I. Introduction

II. The Science Behind Stem Cell Research

III. Current Stem Cell Regulation

A. Federal Law

B. State Law

C. Other Countries

IV. The Ethical Debate

A. Destruction of Human Life

B. The Cat is Out of the Bag

C. Adult Stem Cells vs. Embryonic Stem Cells

V. Other Justifications

A. Economic Justifications

B. Scientific Justifications

VI. The Future of U.S. Regulation

VII. Conclusion

I. Introduction [top]

Human embryonic stem cell research has been touted as both the hero and monster of the next age in medical science. While many look to this area of scientific investigation with the hope of finding treatments to incurable diseases and injuries, others fear that it will lead to the devaluation of human life. Feelings run high when considering the extent to which the federal government should fund this controversial research.

The stem cell debate is not a simple case of right and wrong. Advocates on both sides argue that their view will lead to the improvement of humanity and society's values. Although worries over the treatment of human embryos are legitimate, a close examination of the practices associated with stem cell research shows that its use of human embryonic cells does not disrespect human life. The vast medical potential of the research stands to benefit more than 128 million Americans in significant ways.

Embryonic stem cell research already shows promise in treating diseases such as Alzheimer's, Multiple Sclerosis, diabetes, Lou Gehrig's, Huntingtons's, Parkinson's, epilepsy, and cancer. Current research also shows potential for curing debilitating injuries such as paralysis and heart damage. Because of this potential, the United States has a special duty, as one of the world's leading countries in technological innovation, to pioneer this research in a way that will be an example of respect and sensitivity for the rest of the world.

The current federal funding regulations do not promote this goal. Current laws virtually preclude scientists from obtaining the stem cells they need to conduct research. The United States must change these laws to allow scientists to derive stem cell lines from donated embryos and therapeutic cloning. By granting scientists access to embryos that would otherwise have been destroyed in fertility clinics or never come into existence, we ensure that scientists can use these embryos for the greater good in improving other lives.

II. The Science Behind Stem Cell Research [top]

The human body consists of roughly 220 different types of cells. Most cells in the body are very specialized, performing one specific overall function. Stem cells are different from other cells in that they do not have a specialized purpose or role in the human body. Stem cells exist to act as a source for the development or replacement of differentiated cells such as cells in the pancreas, which produce insulin and neurons, which carry electrical impulses.

Embryonic stem cells are usually derived from the undifferentiated cells of a five-day-old embryo that go on to form all the tissue types of the developing fetus. These cells are called pluripotent stem cells because they can differentiate to form a plurality of cell types that make up all of the tissues of the body. Embryonic stem cells cannot produce an entire, functioning human being. This is because removing the blastocyst cells from an embryo separates these cells from the other embryological components necessary to form a human being.

Pluripotent stem cells may also be derived from somatic cell nuclear transfer (cloning). This process consists of transferring the nucleus of a differentiated cell, with its full complement of genetic information, to an egg that has previously had its nucleus removed. The result is the equivalent of a fertilized egg and has the potential to form into a developing fetus. When this cloned embryo reaches the proper stage, cells from the blastocyst can be harvested in the same way they are taken from donated embryos.

Adult stem cells are primer cells that reside in various organs and tissues and can differentiate into the various cell types indigenous to their body part. These resident stem cells are important for purposes of repair and replenishment and come into play when tissue damage occurs. Although some adult stem cells can transdifferentiate, they are generally limited to changing into the types of cells present in their host organ or tissue. Hence, the stem cells are multipotent because they can transform into multiple cell types, but are limited because they are more specialized than embryonic stem cells.

Stem cells have other characteristics besides their unspecialized nature that are important for research. Unlike differentiated cells, stem cells can grow indefinitely in culture. Scientists often grow differentiated cells in culture, but after enough successive transfers from one plate to another, differentiated cells die. This limits their usefulness in research and may not even give researchers the six months necessary to establish a cell line. In contrast, numerous stem cell lines have existed for years, such as those descending from the original human embryonic stem cell cultures taken by researchers at the University of Wisconsin in 1998. Cultured stem cells are considered a stem cell line when they have multiplied for six months or more, without differentiating, and are pluripotent.

Pluripotent stem cell lines are easy to study because they proliferate indefinitely, can be frozen for storage or transport, and can be coaxed to differentiate at any time. The potential uses of embryonic stem cells are virtually boundless. Unfortunately, adult stem cells have proven more difficult to isolate and culture. While embryonic stem cells come from surplus embryos donated by fertility clinics, adult stem cells must be isolated from their nascent tissues. As of yet, scientists do not know where all of these adult stem cells reside in the body, and extracting whole tissues for isolation is not in a donor's best interest. Furthermore, adult stem cells are difficult to culture because they are already more specialized than embryonic stem cells and their reproductive capacity diminishes with time.

Despite their limitations, adult stem cells have some very important advantages over embryonic stem cells. Potential treatments involving adult stem cells do not pose the danger of tissue rejection associated with embryonic stem cell treatments and organ transplantation. Like with organ transplantation, recipients of embryonic stem cell transplants face the possibility of rejection because the body recognizes the tissue as foreign. Such transplant recipients would have to use immunosuppressant drugs, which leave patients more susceptible to infection. In contrast, adult stem cells can be taken from a patient's own body and implanted at the damaged site. Because the cells come from the patient's own body, there is no possibility of rejection. This inherent safety of adult stem cell therapy may be part of the reason adult stem cell therapies already exist and embryonic stem cell therapies do not.

Although adult and embryonic stem cells have some key scientific differences, scientists agree that both possess a huge potential to treat disease and injury. While adult stem cells seem to have a more immediate application in developing practical treatments, the limitless possibilities of pluripotent stem cells evoke visions of a new age of medical science. Continued efforts in stem cell research are vital to unlocking the host of innovative therapies that scientists foresee.

III. Current Stem Cell Regulation [top]

Methods of stem cell regulation vary widely among the world's jurisdictions. While some jurisdictions have banned government funding of embryonic stem cell research, others support it with little restriction. Even within the United States, state laws regulating stem cell research run the gamut between hearty support and full moratoria. The diversity of regulatory schemes relating to stem cell research mirrors the miscellany of public opinion regarding the subject. The relatively new arrival of this area of study on the research scene suggests that many countries have a long way to go before they achieve a stable regulatory framework in this field.

A. Federal Law [top]

Stem cell regulation in the United States reflects a compromise of sorts between proponents and opponents of the research. While opponents object to the destruction of potential human beings that is inherent in the formation of embryonic stem cell lines, proponents tout the research as "mind-blowing." Many opponents of embryonic stem cell research call for a ban on government funding. Proponents believe the research should be lightly regulated so that its full potential can come to bear as soon as possible.

The current "compromise" represents the culmination of conflicting views in the arena of stem cell debate. The history of stem cell regulation in the United States sheds light on the current regulatory deadlock in the area. In 1996, congress reacted to what was then the mere potential engagement in human embryonic stem cell research by enacting what appeared to be a total ban. The ban covered any research leading to the creation of embryos for research purposes or the destruction, discarding, or knowing subjection of embryos to risk of injury or death greater than that allowed for fetuses in utero. This ban, known as the Dickey Amendment, was part of congress' annual spending bills that govern National Institutes of Health (NIH) funding and has been renewed every year since its inception.

By 1998, when the first stem cells were isolated and cultured using private funds, the NIH was still deciding whether it could legally fund stem cell research in light of the Dickey Amendments. Upon request from the NIH, the Department of Health and Human Services (DHHS) opined that congress' ban did not cover pluripotent stem cell research because pluripotent stem cells are not embryos within the meaning of the statute. Because stem cells are derived from only part of an embryo, stem cells are not embryos themselves. Although this seems contrary to the statute, based on the DHHS opinion, the NIH issued Guidelines for Research Using Human Pluripotent Stem Cells, effective August 25, 2000. The main thrust of these guidelines was to assure that funded stem cells were derived from surplus embryos that were created for fertility reasons and donated with informed consent. Because the guidelines primarily gave instruction regarding how to properly derive stem cells for funding, the question whether the NIH guidelines complied with the Dickey Amendment remained open. This question eventually became moot when President Bush mandated a new policy that caused the NIH to withdraw its guidelines on November 2, 2001.

In response to both sides of the continuing stem cell debate, President George W. Bush issued the current stem cell policy during an address to the nation on August 9, 2001. During that address President Bush referred to both "the potential for incredible good" and "respect for life in America and throughout the world" that stem cell research implicates. In light of these issues, he announced the decision that Federal funding for stem cell research would only be available to research involving cell-lines already derived as of the time of his address.

According to the president, more than sixty viable stem cell lines then existed that would be eligible as research subjects under NIH funding. These cell lines would be sufficient for research needs and their use would prevent the further destruction of embryos. Although established stem cell lines relied on the use of surplus embryos from fertility clinics and required the death of the embryos in their formation, they should be put to good use, according to the president. Unlike the NIH guidelines, President Bush's compromise ensures that the Dickey Amendment is satisfied by preventing the further destruction of embryos under federal funding.

To be eligible for federal funding, existing stem cell lines must have been derived: "(1) with informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors." Also by the president's order, the NIH keeps a registry of embryonic stem cell lines that satisfy the eligibility requirements. Currently the NIH asserts that there are seventy-eight eligible stem cell lines. However, only twelve are available for shipping and listed in the NIH registry.

During his speech the president also announced that he would be forming a new President's Council on Bioethics chaired by an expert in biomedical ethics. The president's vision of the council was to explore issues surrounding stem cell research, embryos and other hotbeds of scientific moral debate. So far the council has had several meetings regarding stem cell research but has made no recommendations.

It is important to remember that President Bush's mandate only applies to researchers who receive federal funding. Private researchers are in no way restricted when it comes to stem cell research as long as they do not derive their cell lines from cloning. Though private researchers may use somatic cell nuclear transfer to derive stem cell lines, that avenue may be ending; the US House of Representatives recently passed a bill banning all human cloning, including that used for stem cell derivation. The bill was introduced in the Senate February 5, 2003.

To date, Congress has not responded to the current state of the regulation of federally-funded stem cell research. The president's new mandate is the current guideline the NIH follows when considering grant applicants. The repercussions and value of the current rule will be discussed in part VI below.

B. State Law [top]

Federal policy regarding the funding of stem cell research does not affect the states' ability to pass legislation regarding state funding or the general legality of conducting stem cell research. Several states have pioneered legislation regarding the funding or banning of stem cell research. Like worldviews, states' views vary from one extreme to the other.

California is among the states that have sought to promote stem cell research by passing legislation that goes beyond President Bush's mandate. California Health and Safety Code sections 125115-117 allow researchers to derive stem cells for research purposes. This includes using embryos from fertility clinics, in vitro fertilization for research purposes, and somatic cell nuclear transfer. The California legislature premised its decision on its finding that "open scientific inquiry and publicly funded research will be essential to realizing the promise of stem cell research and to maintain California's worldwide leadership in biomedicine and biotechnology."

This narrow regulation imposes few limitations: Researchers who wish to undertake such projects are to be regulated by institutional review boards; donations must be made with informed consent; although embryological and fetal tissue may be donated, they may not be purchased or sold for "valuable consideration" where valuable consideration means more than transfer costs. While California clearly wishes to promote stem cell research, the prohibition of the sale of tissues relating to stem cell research may reflect lawmakers' awareness of the thorny nature of the ethical issues involved. This awareness is expressed in the legislation.

California's new legislation has already seen results. Researchers say that one of the bill's greatest values is its authorization of somatic cell nuclear transfer. By allowing researchers to use technology that is already in place, they say that the Legislation helps to remove the "chilling effect" of President Bush's mandate. Stem cell research does seem to have picked up in the state-In December of 2002 Stanford University announced the opening of a new privately-funded institute to study embryonic stem cells with the hope of finding cancer remedies. In the wake of California's move, some states are considering bills to open the way for stem cell research within their borders.

Other states do not share California's view concerning the balance between morality and research potential when it comes to stem cells. Many states prohibit any stem cell research that is not beneficial to the embryo or fetus. Minnesota, along with other states, makes conducting therapeutic stem cell research a misdemeanor. Presumably research under Bush's compromise would not be subject to the ban these states impose because it does not require that embryos be harmed. While no state laws that prohibit all embryonic stem cell research, states would be within their rights to legislate in that direction.

C. Other Countries [top]

The current conflict over stem cell funding between the United Kingdom and the European Union illustrates the range of official positions regarding government-funded stem cell research. The United Kingdom is one of the most liberal supporters of stem cell research. It approved government funding of the research in 2000. The Human Fertisation and Embryology Authority, acting under the secretary of state, ensures that researchers follow the provisions of the Human Fetilisation and Embryology Act of 1990. The U.K. policy is much more liberal than the U.S. policy in that it allows scientists to derive their own cell lines. Although the focus in the U.K. is on stem cell lines derived from donated embryos, cell lines derived from therapeutic cloning are also permissible. U.K. stem cell guidelines have led to some of the most extensive stem cell research in the world. In fact, the U.K. is now taking bids from national laboratories to host the world's first stem cell bank. This view represents the far permissive end of the stem cell debate worldwide.

Canada is taking the middle ground in the stem cell debate. The Canadian Institutes of Health Research has issued guidelines for stem cell research eligible for government funding. Much like the now defunct NIH guidelines, the Canadian rule allows researchers to derive new stem cell lines from surplus fertility-clinic embryos but not from cloned embryos.

At the conservative end of the spectrum, the European Parliament recently voted that cloned and donated embryos should be banned as a subject of medical research. The stance of the European Union reflects the feelings of many of its members such as Germany where it is a criminal offense to conduct research that destroys embryos. The parliament must vote again and backing E.U. governments have their say before the ban would become binding. However if the European Parliament passes the ban, the U.K. will be forced to comply with it and change its policies.

Clearly the world is in conflict about how to regulate stem cell research. Some have called for the creation of international guidelines. However, such guidelines may be difficult to draft before countries reach a greater level of consensus.

IV. The Ethical Debate [top]

The legal side of the stem cell debate is rather simple: should the federal government fund stem cell research and if yes, to what extent? Unfortunately, the ethical side of the debate is both complicated and divisive. Intelligent people differ at a fundamental level when considering notions such as cloning, harvesting human embryos, and other stem cell sources. The one thing most people agree on is that the stem cell debate is an important one. Religious conservatives such as President Bush can see the vast potential stem cell research has to offer while staunch supporters of unfettered stem cell research can understand the delicate nature of the subject.

It is essential to the debate that people accept the facts: 1) embryonic stem cell research has vast potential and is different from adult stem cell research, and 2) moral interests that would dictate a ban on stem cell research are valid and strong. This conundrum is regrettable, but there is no need to fudge facts to make a compelling argument on either side. Though the fact that both sides of the debate can be premised on the desire to respect and improve human life compounds the dilemma, society must find a workable solution to the problem.

A. Destruction of Human Life [top]

Discussions concerning embryonic stem cell research and respect for human life turn on two types of potential: 1) the potential of embryos to become functioning human beings with all of the inherent human rights that are their due, and 2) the potential they have to cure a myriad of diseases suffered by millions of people. Both points are important to the question of respect for human life. Both appear to be based on true principles. Yet if we cannot tip the balance to one side or the other, both the rights of future humans and the benefits of stem cell research will be injured.

All people start as fertilized eggs that developed into embryos and continued onto the fetal stage and eventually birth. It is unquestionable that, absent defects, a human embryo can develop into a functioning human being under the right conditions. But the question is whether an embryo constitutes human life.

Life exists when fertilization occurs. The resulting fertilized egg is a cell that is capable of metabolism and reproduction. Whether or not that life is human life is open to endless debate. The fact that embryos give rise to human beings leads to the natural idea that they may constitute human life. The United States Supreme Court has decided that the rights of fetuses are subordinate to the rights of their mothers until the point of viability. However, characterizing an embryo does not involve the same concerns with the personal autonomy of the mother that arise in the context of abortion. The court in Roe v. Wade relied heavily on the idea that a woman should have control over her own body until the baby becomes a functioning human being. Absent that important concern, an embryo should be afforded every possible protection. Like viable fetuses, embryos represent a silent class that cannot represent itself or consent to any treatment imposed upon it.

Many feel concerned that if we use embryos either from in vitro fertilization or other sources, society will lose respect and value for human life. Open the door a little and society may find itself on a slippery slope that leads to human cloning with all of its ugly repercussions, including organ farming. President Bush expressed understanding of this point of view during his address to the nation when he declared, "even the most noble ends do not justify any means." He went on to say that he worries about "a culture that devalues life."

Most proponents of stem cell research would agree that even if embryos do not constitute human life, they have a kind of "specialness" that sets them apart from the pedestrian cell lines that research has employed for years. So perhaps the question should not be whether embryos are human beings but more generally whether they are too inviolable to use for research. Does the specialness of these seeds of human life preclude using them for the good of those who have already reached biological maturity?

While many people would object to the use of embryos for therapeutic research in the abstract, many of those same people would welcome a cure for heart disease, cancer, or paralysis. Millions of human beings need treatments that do not exist-treatments that stem cell research may provide. Is the medical need of today's millions enough to justify the use of embryos that would never go on to form a viable human being anyway?

Embryos are destroyed all the time. "[I]f they're going to be destroyed anyway, shouldn't they be used for a greater good, for research that has the potential to save and improve other lives?" Is it wrong to create an embryo in a fertility clinic and then dispose of it later? These embryos are created in vitro, not in the natural way most of us were conceived. They are created to give reproductive hope to those couples who have trouble producing children. Those embryos that are not needed in this process can still lend hope. Being able to donate surplus embryos for important medical research could be a source of solace and pride for discouraged parents.

Some opponents argue more strongly against somatic cell nuclear transfer than against the use of surplus embryos because the process involves cloning. However, benefits of this practice are great. Creating specialized embryos for research can eliminate worries over tissue rejection and genetic anomalies. Additionally, because these embryos would be created for research purposes, their use could be seen as less objectionable than using surplus embryos because they would never have had the potential to become human beings, as they were not created for that purpose. Simple regulation can abate worries over human cloning by assuring that cloned embryos are used for the proper reasons and with proper respect.

Despite current hype over the controversies surrounding human cloning, ethical distinctions drawn between the use of surplus embryos from in vitro fertilization and the use of embryos created by somatic cell nuclear transfer, or cloning, are overblown. Some opponents of stem cell research and somatic cell nuclear transfer cite the fact that embryos created in fertilization clinics have the possibility of implantation and, subsequently, human life. Therefore, in vitro fertilization serves ethical ends as it gives hope to parents who cannot conceive on their own. However, the fact remains that with in vitro fertilization, somatic cell nuclear transfer, or natural conception, the fate of an embryo rests with its creators. In this way surplus embryos from fertilization clinics and cloned embryos created in a lab are the same; their destiny lies in the hands of others. This is the nature of an embryo no matter its origin.

When an embryo is created through in vitro fertilization or somatic cell nuclear transfer, there is no potential for the embryo to become a human being unless its creators so decide. Such embryos would not exist without scientific intervention. In the processes of in vitro fertilization or natural conception, deciding to allow an embryo to develop does not guarantee its survival. Nevertheless, by allowing in vitro fertilization society has already decided that parents and scientists can ethically decide the fate of the embryos they create. This suggests that it is not the practice of creating embryos but the purpose of their creation that is so troubling. However, whether an embryo is created for reproductive or therapeutic reasons, the outcome is the same-potential benefit to individual human beings or death to unused embryos. We should not rest the decision of whether or not stem cell research should be federally funded on the purpose of embryo creation.

There is no question that destruction of embryos actually destined to develop into mature human beings is unethical. No one is promoting that scenario. Because society already has the power to decide whether an embryo survives or not, scientists should be able to use that power in a way that leads to the benefit of human beings already in existence-beings that have already realized their biological potential. The possibility of curing the sick and injured among us should outweigh our concerns about creating embryos that would have never come into being on their own. By creating such embryos we do not devalue human life but rather give meaning to those seeds of human life that would never have served a purpose otherwise. Those "seeds" that would have remained unused and died with their originators can become something for the human race that is bigger than any one human person. This vision and goal are the essence of what it means to conduct embryonic stem cell research with respect for human life and dignity.

Such grand ethical worries aside, stem cell research lacks the public policy concerns that arise in other societal debates. Other medical practices involve a balance between harm to society and benefit to it. For example, the debate over abortion can be set in terms not based in morality: By reducing the costs of abortion, the government protects a woman's autonomy but promotes sexual irresponsibility and overrides the rights of the developing fetus. Arguably, society has determined that the benefits of abortion outweigh its costs. This is a cost-benefit analysis on a societal level. However, stem cell research does not present the negative policy aspects that abortion does. Also, its potential benefits extend beyond the individual benefits experienced by abortion recipients to the treatment and cure of diseases and injuries that afflict the whole human family. Even those who consider themselves "pro-life" need not disagree with the promotion of stem cell research. While abortion is the termination of a fetus that has already begun to develop in the normal way, using embryos for stem cell research involves putting embryos to a medically beneficial use that would never have had the chance to become a person.

An examination of the groups that support the federal funding of stem cell research is telling. Such advocates include the Juvenile Diabetes Foundation International, the American Heart Association, and the Michael J. Fox Foundation for Parkinson's Research among many others. These groups represent the people who stand to benefit most from embryonic stem cell research. It is easy for opponents to stand behind moral objections when they do not have to face the prospect of debilitating illness.

B. The Cat is Out of the Bag [top]

Stem cell research is a reality. Scientists have used human embryonic stem cells in research since before the first stem cell lines came to being in 1998. The research continues in the public sector of the U.S. within limits set by federal funding and unfettered in the private sector. Countries around the world conduct stem cell research and will continue to do so. Any attempts to place heavy restrictions on stem cell research are futile because it will occur anyway.

Opponents may argue that stem cell research is morally wrong and therefore cannot be condoned, no matter who is doing it. Like crime, we cannot decide to tolerate it simply because it becomes widespread. Other countries may do what they will, but there is no need for the United States to follow their lead. Such thinking is shortsighted even from within an ethical perspective.

The United States is an influential nation, one that could set an example for the world in how to conduct embryonic stem cell research with respect for human life. If we choose to remove ourselves from the running, other countries will fill that void and some research may be conducted in settings that lack the type of ethical oversight the U.S. could provide. Most scientists in the United States do not object to scientific and ethical oversight; they are simply concerned about stifling such an important area of research before determining its merits.

C. Adult Stem Cells vs. Embryonic Stem Cells [top]

Research into adult stem cells is very promising and has already had results in the United States. Adult stem cells have been used to treat cancer, autoimmune diseases, lupus, arthritis, anemias, stroke, cartilage and bone diseases, blindness, blood and liver diseases, heart damage, and others. Although adult stem cells are less plastic (flexible) than embryonic stem cells, scientists have found them to be more capable of transdifferentiation than previously thought and hence more capable of pluripotentiality. Also, contrary to early beliefs, researchers have discovered adult stem cells in most tissue types. The implication of these findings it that the potential benefits of adult stem cell research may be more similar to the benefits of embryonic stem cell research than initially thought.

Perhaps the greatest two selling points of this research are that it does not pose the possibility of tissue rejection and it does not raise the ethical concerns associated with embryonic stem cell research because the source of adult stem cells is the patient's own body. Few have ethical concerns about this promising research. In fact, many think it is so promising that it should be the only form of stem cell research allowed.

Those who say that adult stem cell research is all we need tend to gloss over its downside while attacking embryonic stem cell research on both ethical and practical grounds. They also overlook one very important thing: if adult stem cell research is so promising, embryonic stem cell research is necessarily more promising because embryonic stem cells are not only the precursors of all the specialized cells of the body but adult stem cells as well. In any case, why close off an entire avenue of research when a related field is so fertile?

Ethical concerns aside, criticisms of embryonic stem cell research are unfounded because its problems may be attributed to inhibitory regulation. Opponents cite the fact that embryonic stem cell treatments would require the undesirable use of immunosuppressant drugs. The use of stem cells derived from donated embryos does require them, but we have the technology in somatic cell nuclear transfer to generate embryonic stem cells tailored to the patient's body. However, research has not gone forward on this front because it is forbidden while using federal grants.

Similarly, references to the fact that no embryonic stem cell treatments have reached the clinical trial stage while many adult stem cell treatments have, hide the real issue. Is the lack of results due to an absence of medical potential or to the fact that scientists cannot undertake the research? It is clear that there would be much more research into the medical applications of embryonic stem cells if not for the Bush initiative. As it is, the current U.S. policy has American researchers on the run; it is possible that researchers will relocate to countries whose governments lend broader support to stem cell research in search of positions that do not exist here.

It is naive to discount something without first giving it a chance. The terrific success that adult stem cell research has seen at such an early stage is the very impetus that should cause us to fund embryonic stem cell research to its fullest extent. Together, the two types of stem cell research could be an awesome force in the medical world.

V. Other Justifications [top]

The stem cell debate is an ethical one and rightly so. These issues cut to the heart of American values and ideals. Nevertheless, there are other justifications for funding embryonic stem cell research beyond those encompassed by our current regulatory scheme. These rationales, while not as weighty as their moral counterparts, are important in making regulatory decisions in this arena.

A. Economic Justifications [top]

Jim Clark, the founder of Silicon Graphics, Netscape, Healtheon (now WebMD), and myCFO, provides a simple but compelling reason that the federal government should more broadly fund embryonic stem cell research: if American scientists cannot do the research now, the United States will be out of the running. America's technology companies such as Cisco, Sun Microsystems, and Netscape depended on federal research grants to pioneer the technology that has fueled the American economy in recent years. Given the medical potential of embryonic stem cell research, Mr. Clark's prediction that it will trigger the next age in American technological entrepreneurship does not seem extravagant.

If U.S. scientists are left on the sidelines of stem cell research, a new pharmaceutical industry may grow up outside the United States. While the U.S. is a leader in the pharmaceutical industry now, we may lose our edge as the governments of countries such as the United Kingdom, Australia, China, India, Israel, Singapore and Sweden continue to promote the advancement of stem cell research and its pharmaceutical applications. These are countries that have a pharmaceutical infrastructure already in place. They hold their collective breath as they hope for continued restriction of U.S. stem cell research.

Our economy has benefited greatly from American innovations originating in Silicon Valley. The U.S. cannot afford to cast aside its typical pioneer role in the biotechnology breakthroughs that are around the corner. There is no doubt that the ailing and injured of our country will use the treatments stem cell research will produce. Hopefully, those treatments will be produced here at home, creating more jobs and lower prices.

B. Scientific Justifications [top]

Stem cells show promise in other areas that are indirectly related to medical therapies. Basic stem cell research may help humanity discover the secrets of its development and genetic manipulation. Studying stem cells may help humanity to understand how to prevent or correct developmental disorders because stem cell lines are capable of the same sorts of differentiation as developing embryos. Furthermore, by examining the genetic changes that occur when stem cells are coaxed to differentiate, scientists may be able to understand genetics on a more fundamental level relevant to a broad spectrum of genetic research.

Stem cell research may also alleviate serious non-monetary research costs. To carry out pharmaceutical testing, researchers currently need human or animal subjects. Obvious ethical and societal issues arise when experimental drugs are tested on humans or lab animals. Because stem cell lines consist of human cells that can differentiate into virtually any tissue type, they are ideal test subjects for pharmaceuticals. The reliability of test results using stem cell lines would be virtually indisputable, because they would be equivalent to those derived from human subjects. Even more importantly, such testing would not cause suffering or loss of life.

Scientific advancement is a progression where one discovery is based on those that have come before. History tells us that no one knows beforehand from what corner the needed breakthrough will come. As an enlightened society, we must allow science to move forward. The great potential of stem cell research demands that we support it. Such support would not ignore the ethical concerns raised by the research, but those concerns are better addressed through regulation of the field's uses, not its development. Our history in areas such as the use of nuclear technology in medicine shows us that post-discovery regulation can be effective at managing risks while allowing potential benefits to be explored. If the same regulators who were afraid of nuclear technology had not allowed its use in medical therapies such as radiation treatments and radioisotope tracing, millions of today's cancer survivors would not be with us. The United States must approach the funding and support of stem cell research with the same eye toward the future.

VI. The Future of U.S. Regulation [top]

President Bush's compromise was a masterful one. The deal allowed stem cell research to continue receiving funding while ensuring that moral objections to the destruction of embryos were addressed. No other regulatory framework could achieve similar results at the time. Despite the mandate's appeal in the abstract, it has proved stifling and unworkable.

While seventy-eight eligible embryonic stem cell lines seems like a plentiful reservoir for scientific research, it is not. If stem cell research is to reach its full potential, scientists must be allowed to create their own cell lines to address their particular research needs. Modern biological research is extremely complex and requires specialized resources. To exacerbate the problem further, of the seventy-eight eligible cell lines, only twelve are currently available. This is because the other sixty-six lines are still in early developmental stages and are not ready for distribution. No one knows when they will be available. This supply bottleneck forces researchers to pay up to fifty to one hundred times the normal fee for acquiring these approved lines. However, more than the cost of obtaining these lines, it is the ability to obtain them at all and worries over their quality that most preoccupy researchers. Of the twelve available lines, all were cultured in with mouse "feeder cells" that may have resulted in contamination consisting of viruses and mouse proteins. Such contamination may render any therapeutic application arising from the approved lines unfit for introduction into human patients. Furthermore, by the time researchers obtain approved lines, they are years old leading some to question their present research value. Therefore, tackling the time and cost necessary to obtain approved lines may be a waste. Such obstacles lead researchers to pursue other courses of study.

Scientists throughout the country agree that stem cell research is suffering because of the current regulatory scheme. Despite the possibility of conducting research in the private sector, many scientists have been avoiding the research because of federal funding restrictions. Federal funding is of vital importance because the federal government funds between eighty and ninety percent of biotech research in any given year. Hence, if the industry as a whole is taken as an example, failing to provide broader federal funding for stem cell research is equivalent to restricting it.

Given the percentage of biotech research conducted under federal funding, it is apparent that relying solely, or even predominantly, on market funds is not possible for stem cell researchers given the costly nature of the research. Even if it were possible, institutional difficulties arise when federally-funded research and research that does not qualify for federal funding occur in the same laboratories. It is often difficult to separate research based on funding rather than facilities. For example, if a researcher wanted to conduct stem cell research and federally-funded genetic research at the same time, the researcher would have to maintain separate laboratories, using separate equipment to ensure that the stem cell research did not endanger the funding eligibility of the genetic research. Such measures are prohibitive of one or the other because avoiding entanglement is so costly. The choice between funded research and non-funded research is not a difficult one. The result is a chilling effect on non-federally-funded stem cell research. The only solution to this chilling effect is simple: the federal government must provide funding for embryonic stem cell research arising from newly-derived stem cell lines.

The needed regulation is very straightforward. Rules on this front display the simplicity exhibited by the recent California legislation. Guidelines merely need to indicate what sort of research is allowed and provide some basic restrictions. The California law has the virtue of giving researchers flexibility while leaving room for oversight. While California researchers are subject to institutional review boards, the NIH would assume this role as it has in the past on the federal level.

The NIH guidelines for assuring embryos used in research were not sold, and that they were donated with informed consent, could be reinstated with only one change. Researchers should be allowed to use somatic cell nuclear transfer in order to create more specialized stem cell lines. A new section to the NIH guidelines could be added to include oversight of stem cell lines created using this method.

Assuring that embryos are not sold for "valuable consideration" as required by the California law preserves the dignity merited by the seeds of human life and avoids their propertization, both of which are valid societal concerns. This arrangement closely parallels the federal system preventing the sale of human organs. Organ transplantation has become a regular practice in this country and laws prohibiting the sale of organs prevent them from becoming mere commodities. Unlike with organs, the abundant supply of surplus embryos further reduces the temptation to treat them as property. Additionally, ensuring that cloned embryos are used only for stem cell research addresses the worries associated with therapeutic cloning.

The English stem cell regulatory system shows that scientists can conduct stem cell regulation using both cloned and donated embryos in a way that shows respect for human life and value. Stem cell researchers are not immune to moral and ethical considerations. On the contrary, they are interested in basic research and the exciting possibilities stem cell research has to offer the human family.

VII. Conclusion [top]

While embryonic stem cell research poses serious moral questions, the federal government should fully support it. The halfway support given by current law is inconsistent with the private sector's freedom in this field. The stifling effect of President Bush's mandate will only cause stem cell research to suffer in the United States while surging forward abroad.

Embryonic stem cell research has unmatched medical potential. Moreover, it can be conducted with ethical oversight that would ensure that embryos, which would otherwise go to waste, serve a higher purpose. Allowing scientists to derive new stem cell lines would provide consistency to a system that already allows use of stem cells derived from human embryos.

1 The terms "stem cells" or "stem cell research" will refer to embryonic stem cells unless otherwise indicated.

2 Press Release, The White House, Remarks by the President on Stem Cell Research (Aug. 9, 2001), available at

3 Carly Goldstein, Dipping Into Uncle Sam's Pockets: Federal Funding Of Stem Cell Research: Is It Legal?, 11 B.U. Pub. Int. L.J. 229, 251 (2002).

4 Web Package, University of Wisconsin Madison, The Science of Stem Cells (2001), at

5 NIH, Stem Cells: A Primer (updated Sept., 2002), at

6 Id.

7 NIH, Stem Cells: A Primer (updated May, 2000), at

8 Teruhiko Wakayama et al, Differentiation of Embryonic Stem Cell Lines Generated from Adult Somatic Cells by Nuclear Transfer, 292 Science 740 (2001), available at link.

9 See NIH, supra note 4.

10 Id.

11 See University of Wisconsin, supra note 3.

12 See NIH, supra note 4.

13 Web Package, University of Wisconsin Madison, Why Not Derive Stem Cells from Adults? (2001), at link. Cf. Do no Harm: The Coalition of Americans for Research Ethics, A Review Of The National Institute Of Health's "Guidelines For Research Using Human Pluripotent Stem Cells", 17 Issues L. & Med. 293, 298-9 (2002).

14 Id.

15 See e.g., Nicholas Wade, New York Times, Doctors Use Bone Marrow Stem Cells to Repair a Heart (Mar. 7, 2003).

16 See NIH, supra note 4.

17 See Fact Sheet, The White House, Embryonic Stem Cell Research (August 9, 2001), at

18 See Goldstein, supra note 2 at 229-30.

19 Omnibus Consolidated and Emergency Supplemental Appropriations Act, Pub L. No. 105-277, 511(a), 112 Stat. 2681 (1999); Dickey Amendment of 1996, Pub. L. No. 106-113, § 113 Stat. 1501 (1999).

20 Meredith Wadman, Congress may block stem cell research, 397 Nature 639, 639 (1999), available at link; See Goldstein, supra note 2 at pp. 248-9.

21 Statement Before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Harold Varmus, M.D. Director, National Institutes of Health (Jan. 26, 1999), available at

22 Id. DHHS' letter was dated Jan. 15, 1999.

23 NIH, National Institute of Health Guidelines for Research Using Human Pluripotent Stem Cells, available at

24 Id. at § II.A.2.

25 Federal Register Announcement, Department of Health and Human Services, National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (Nov. 14, 2001), available at.

26 See Press Release, supra note 1.

27 Id.

28 Id.

29 Fact Sheet, The White House, Embryonic Stem Cell Research (August 9, 2001), available at link. According to the NIH this document supercedes their previous guidelines governing pluripotent stem cell research. Federal Register Announcement, Department of Health and Human Services, National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (Nov. 14, 2001), available at; NIH, Notice of Criteria for Federal Funding of Research on Existing Human Embryonic Stem Cells and Establishment of NIH Human Embryonic Stem Cell Registry (Nov. 7, 2001), available at

30 Id.

31 NIH, Information on Eligibility Criteria for Federal Funding of Research on Human Embryonic Stem Cells (last viewed Apr. 14, 2003), available at

32 NIH, Human Embryonic Stem Cell Registry (last updated Nov. 18, 2002), available at

33 See Press Release, supra note 1.

34 See Fact Sheet, supra note 16.

35 See The President's Council on Bioethics, Stem Cells (last viewed Nov. 18, 2003) at

36 Erin P. George, The Stem Cell Debate: The Legal, Political And Ethical Issues Surrounding Federal Funding Of Scientific Research On Human Embryos, 12 Alb. L.J. Sci. & Tech. 747, 799, n. 148 (2002).

37 Human Cloning Prohibition Act of 2003, H.R. 534, 108th Cong. (2003).

38 Human Cloning Ban and Stem Cell Research Protection Act of 2003, S. 303, 108th Cong. (2003).

39 Cal. Health & Safety Code §§ 125115-117 (West 2003).

40 S.B. 253, c. 789 § 1(f) (Cal. 2002).

41 Health & Safety Code, supra note 38 at § 125115(b).

42 Health & Safety Code, supra note 38 at § 125116.

43 Health & Safety Code, supra note 38 at § 125117.

44 S.B. 253, supra note 39 at § 1(g).

45 Constance Holden, California Flashes a Green Light, 297 Science 2185 (2002) available at link.

46 Id.

47 Constance Holden, Stanford Gets Gift for New Institute, 298 Science 2307 (2002), available at link.

48 Richard Pérez-Peña, Broad Movement is Backing Embryo Stem Cell Research, N.Y. Times, Mar. 16, 2003, available at link.

49 Alo H. Konsen, Are We Killing The Weak To Heal The Sick?: Federally Funded Embryonic Stem Cell Research, 12 Health Matrix 507, 528(2002).

50 Minn. Stat. Ann. § 145.422 (West 2003).

51 Constance Holden, Wayne Kondro, Canada Gives OK for New Cell Lines, 295 Science 1816 (2002) available at link.

52 Allison C. Ayer, Stem Cell Research: The Laws Of Nations And A Proposal For International Guidelines, 17 Conn. J. Int'l L. 393, 406-7, n. 151 (2002).

53 Human Fetilisation and Embryology Act (1990) (Eng.); See Ayer, supra note 50 at pp. 406-7.

54 Id.

55 See Holden, supra note 50.

56 Id.

57 Id.

58 Id.

59 Andrew Osborne, MEPs vote against stem cell research, Guardian Unlimited (Apr. 11, 2003) available at link.

60 Konsen, supra note 48 at 527, n. 87.

61 Id.

62 Ayer, supra note 51 at pp. 414-19.

63 Roe v. Wade, 410 U.S. 113 (1973).

64 Press Release, supra note 1.

65 See Goldstein, supra note 2 at 256. Even the most staunch supporters of federal funding for stem cell research retain concern for ethical questions that do not arise in research involving "typical" cell lines.

66 Robert P. Lanza et al, Ethical Reasons for Stem Cell Research, 292 Science 1299 (2001), available at link.

67 See George, supra note 35 at 797.

68 James J. McCartney, Embryonic Stem Cell Research and Respect for Human Life: Philosophical and Legal Reflections, 65 Alb. L. Rev. 597, 612 (2002).

69 Press Release, supra note 1.

70 See McCartney, supra note 67 at 612-15.

71 George, supra note 35 at 792-3.

72 See Lanza, supra note 65.

73 Do No Harm: The Coalition of Americans for Research Ethics, A Review Of The National Institute Of Health's "Guidelines For Research Using Human Pluripotent Stem Cells", 17 Issues L. & Med. 293, 301-2 (2002).

74 Id. at 294-98.

75 Wade, supra note 14; Id. at 299-300.

76 C.f McCartney, supra note 67 at 608-12.

77 Do No Harm, supra note 72 at 293.

78 Id. at 304.

79 See Donald Kennedy, Stem Cells: Still here, Still Waiting, 300 Science 365 (2003), available at link; Rick Weiss, Stem Cell Strides Test Bush Policy, Washington Post, Apr. 22, 2003 at A01, available at, link.

80 See Diane Gershon, Stem cell Research, 422 Nature 928-9 (2003), available at link.

81 Jim Clark, Squandering Our Technological Future, N.Y. Times, Aug. 31, 2001, at A19, available at link.

82 Gershon, supra note 79.

83 See NIH, supra note 4.

84 Id.

85 Cell Registry, supra note 31.

86 Elias Zerhouni, Stem Cell Programs, 300 Science 911, 911 (2003), available at link.

87 Sheryl Gay Stolberg, Stem Cell Research is Slowed by Restrictions, Scientist Say, N.Y. Times, Sept. 26, 2002, at A27, available at link.

88 See Kennedy, Weiss, supra note 78.

89 Id.

90 See Holden, supra note 44; Weiss, supra note78.

91 Stolberg, supra note 86.

92 See Holden, supra note 44.

93 Kenneth Sutherlin Dueker, Biobusiness on Campus: Commercialization of University-Developed Biomedical Technologies, 52 Food & Drug L.J. 453, 457-9 (1997); Federation of American Societies for Experimental Biology, Federal Funding for Biomedical and Related Life Sciences Research FY 1998 Recommendations, 16 (1998) at link

94 See Clark, supra note 80.

95 See Health & Safety Code, supra note 38 at § 125117.

96 42 USC § 274e (West 2003).