Authors

  1. Warren, Hermine DNP, APRN, CANS, CNM

Abstract

Many health care issues generate minimal passion, promoting benign commentary and support from the various stakeholders involved. Stem cell research does not fall into this category, and on the contrary, embryonic stem cell (ESC) research has continued to foster controversy and emotion. Since 1998, which marked the first successful laboratory isolation of ESCs, this research continues to ignite moral, ethical, and legal debate over its efficacy. The focus of this policy analysis is to introduce the issues, examine and address the various perspectives that surround ESC research, and present policy options and/or solutions that may be used to successfully create a policy consensus regarding this much debated topic.

 

Article Content

PART I: DEFINITION OF THE ISSUE

Introduction

So, what are embryonic stem cells (ESCs) and how do they differ from other human-derived stem cell sources such as adipose tissue or the umbilical cord? Embryonic stem cells can "...theoretically differentiate into virtually any type of human cell, from blood cells to skin cells" (American Association for the Advancement of Science, 2011, p. 1), whereas other human-derived stem cells do not have this capability. In addition, "ESCs are isolated from the inner cell layer of the embryo, called the blastocyst" (American Academy of Neurology, 2004, [P] 16), whereas human and cord stem cells (CSCs) are not. The controversy and heated debates circling ESCs are not in their potential to cure a multitude of diseases, but in their origin (Lo & Parham, 2009). Experts in the field have theorized that ESCs have the potential to significantly improve and potentially eliminate some of society's most deadly diseases such as "cancer, heart disease, Alzheimer's disease, Parkinson's disease, multiple sclerosis and diabetes" (Rader, 2010, pp. 4-5). However, the question that creates the most debate on this subject matter boils down to, "Is embryonic stem cell research a significant scientific breakthrough or is it murder"? This analysis continues to discuss this debatable question.

 

Effect of the Policy Arena

Embryonic stem cell research has had quite an impact on the policy arena. Although Gallup Polls in 2007 indicated, "Six in 10 Americans favored easing restrictions on Stem Cell Research" (p. 1), data revealed considerable opposition toward policies on stem cell research. In addition, Ho, Brossard, and Scheufele (2008) further found that media and public value predispositions have played a critical part in shaping attitudes toward stem cell research that have presented periodic barriers that have affected positive equilibrium in the policy arena. Throughout the decade, there have been attempts at policy to support ESC research, but most have been unsuccessful (White, 2011).

 

Current Politics of the Issue

The politics of ESC have been navigating rough waters for more than a decade. In 2005, both the Senate and the House passed a bill (H.R. 810, the Stem Cell Research Enhancement Act) that would support federal funding from the National Institutes of Health (NIH) for this type of research. President Bush "exercised his first presidential veto on July 19, 2006, when he refused to allow this bill to become law" (White, 2011, p. 1). In 2007, the "Stem Cell Research Enhancement Act" passed in the Senate and the House, but President Bush exercised his veto power again (White, 2011). Federal funding was halted for ESCs, leaving it to private enterprise until 2009 when President Obama lifted Bush's 8-year ban on federal funding of ESC research by executive order (White, 2011). Yet, 5 months later, Chief Judge Royce C. Lamberth blocked Obama's policy, politically throwing the scientific community into a tailspin. Ultimately, 9 months afterward in a 2:1 ruling, the ban for ESC federal funding lifted (Harris, 2011). Ideology, moral conviction, and misunderstanding continue to influence the political pace of ESC research.

 

Level of Policy-Making Progress

According to White (2011), there are two levels of agenda setting, systematic and formal. Embryonic stem cell research is beyond the systematic talking phase of agenda setting but is proceeding very slowly on the formal level (Video Program: Laureate Education, Inc., 2011) Although there is legislation from President Obama to proceed with federal funding for ESC research, it appears that we are decades away from clinical trials (Fumento, 2009). As stated by Walter Zelman, "...I think our system was set up to make change difficult and make it slow and make it incremental, and it still works that way" ([P] 5, Video Program: Laureate Education, Inc., 2011).

 

PART 2: APPLICATION OF A POLICY FRAMEWORK

One invaluable tool for creating a clear systematic approach to successful agenda setting or policy implementation is the utilization of a policy framework. The perfect framework to provide a solid infrastructure for analyzing ESC research is Kingdon's multiple stream theory (Coffman, 2007). Because there is so much controversy surrounding ESC research, there needs to be a framework that not only sufficiently structures the data but also lends support to the theoretical underpinnings that surround the topic. In Kingdon's multiple streams framework, the political stream represents the mood, ideology, or attitudes of both policy makers and the public (Craig, Felix, Walker, & Philips, 2010). In addition, the information that flows within this stream enables analysis of the social, ethical, and moral perspectives concerning ESC research while acknowledging the vast numbers of stakeholders. Kingdon's theory suggests that "there is a three stream process that runs independently of each other (problems, proposals, and politics), but when two of the streams fall in sync, a 'window of opportunity' opens up for successful agenda setting" (Coffman, 2007, pp. 1-2).

 

The theoretical underpinnings of ESC research continue to engage the American public, stakeholders, and policy makers. Over the years, a mounting support has put pressure on many stakeholders who oppose progression of this research. Furthermore, when there is celebrity involvement, such as Michael J. Fox, there is increased media attention, creating additional leverage for a window of opportunity (Ho et al., 2008).

 

Rader (2010) discusses that "...stakeholders of interest include numerous organizations from the science and medical community, pharmaceutical companies, political lobbyists, and the public" (p. 40). Although as Zelman posited, "The more stakeholders you have involved with any issue, the harder it is to find consensus" ([P] 4, Video Program: Laureate Education, Inc., 2011). The political stream also identifies that a change in political office can affect policy and influence agenda setting (Coffman, 2007). The change in executive office from President Bush to President Obama was significant in creating a window of opportunity to support advancement for ESC research.

 

To date, the most significant opposition for ESC research is the moral/ethical questions that it poses and its effect on stakeholders and policy makers. The big moral/ethical question that affects the political stream is when does human life begin? "The opposition defines human life as a process that begins immediately after fertilization and the thought of destroying an embryo to justify saving a life becomes an intolerable appeal (White, 2011). The ethical considerations of ESC research are entrenched in the belief that it is amoral to destroy an embryo and take a life. Thus, for many stakeholders, discussion and controversy focus on ESC research and the ethical quandary of "individual rights versus the common good" (Furcht & Hoffman, 2011). Furthermore, Robertson (2010) confers that ethical controversy may plug the federal funding spigot.

 

The policy stream reflects the potential alternatives or solutions that surround ESC research. Historically, for more than a decade, Democratic policy makers have been advocates of legislation that promoted ESC research whereas a majority of their Republican counterparts have supported opposing viewpoints (White, 2011, p. 1). As Coffman (2007) states regarding Kingdon's political stream, "Proposals are likely to be more successful if they are technically feasible, compatible with decision maker values, reasonable in cost, and appealing to the public" (p. 2).

 

Embryonic stem cell research is technically feasible, but for many of the stakeholders and policy makers, as stated, the moral and ethical theoretical underpinnings have produced opposition, thus creating an obstacle for a policy window. Although legislation, throughout the last 10 years, had passed in the House and the Senate, federal funding and successful policy implementation have evaded ESC research (White, 2011). Yet, as previously mentioned, many stakeholders have been supportive and continue to be supportive of ESC research. For example, in 2007, the American Nurses Association (ANA) Committee on Legislation (2007) came out with a position statement supporting "...the ethical use of stem cells for research and therapeutic purposes that impact health" (p. 1). In addition, in 2009, when President Obama reversed Bush's ban on federal funding of ESC research, the scientific community believed than an important governmental step was taken. In evaluating public support, the Gallup Poll (2009) indicated that a significant number of Americans (52%) support ESC research (p. 1). As Kingdon implies, policy needs to have certain supporting factors to create that push toward a "policy window" and the literature supports that ESC research is once again starting to gain momentum (Robertson, 2010).

 

Finally, the problem stream embodied in Kingdon's theory represents the many issues that may require governmental intervention (Craig et al., 2010). Embryonic stem cell research has encountered numerous barriers while seeking answers to its legal, financial/economic, and regulatory problems. When obstacles decrease the ability for successful agenda setting, the opportunity for combining with other streams to create a "policy window" significantly diminishes. As Coffman (2007) states, "Policy windows are not just chance opportunities..." (p. 2).

 

For some, the legality of ESC research starts with right to life and the constitutional rights of an embryo; whereas for others it is about defining the level of involvement the Supreme Court should have on ESC research and nothing more (Robertson, 2010). The main battles that stakeholders have been trying to address are the economics of ESC research, the federal/state funding, and the appropriate regulations that ensure high-quality research without breaching ethical, moral, or legal standards (Robertson, 2010). For a "policy window" to open, these areas need to be addressed and supported by stakeholders. Although movement in this arena has been slow, there have always been champions of ESC research. For example, even though President Bush had strict reigns on federal spending for ESC research, in 2004, California passed Proposition 71 that committed $3 billion for ESC research (Robertson, 2010). According to Coffman (2007), investing in research alone to define a problem has less chance of success than investing in problem definition and advocating for proposals that may attach to the initial problem. Can ESC research diminish or cure some of the chronic degenerative diseases that have robbed quality of life from millions of people? This question currently remains unanswered.

 

PART 3: POLICY OPTIONS/SOLUTIONS

What Are the Policy Options/Solutions for Addressing the Issues?

 

1. Government funding should maintain the current policy and only support research for existing ESCs-No change.

 

2. Government funding should not support research to create new ESCs but should fund research to study alternative methods of obtaining stem cells-Partial change.

 

3. Government funding should support research to create and study new ESCs-Maximum change.

 

Pros and Cons for Each Suggestion

Each option has its share of pros and cons. The first suggestion, as indicated, shows no change from current research and policy protocols. A theoretical underpinning of using existing ESC lines is "...that there is no 'life' to save, as the embryo is not actively being destroyed" (Hug, 2005, p. 1003). This option is a plus, as it has the potential to promote less controversy from the prolife contingency, although the cons associated with this method seem to outnumber the pluses. Robertson (2010) states that there are only a few lines (stem cells that are cultured in vitro) that are readily available, with minimal genetic diversity. Thus, culturing these lines may increase potential infection and contamination. In addition, another con for the successful progression of ESC research would be the need for more stem cells to be cultured in vitro (Robertson, 2010). Option 1 requires significant funding with potential cost benefits (decreasing morbidity, chronicity of disease, and mortality). Although past research shows the presence of feasibility, existing methods are still too early in the research phase to demonstrate utility and efficiency.

 

Policy Option 2 addresses a partial change where the government would not support ESC research but would financially support alternative methods for obtaining stem cells. The theoretical underpinnings of this option underscore protection of the blastocyst and no tampering of life. For example, federal funding would support research such as adult stem cells (ASCs), CSCs, and somatic cell nuclear transfer (SCNT). Plusses of these methods include providing alternatives for study that do not ethically engage those strong lobbying bodies opposed to embryo destruction, opening the research field to explore other types of stem cell utilization and advancing research for ASCs, CSCs, and SCNT to see their ultimate capacity for "...generating replacement cells and tissues" (NIH, 2009, p. 1). However, the negatives of supporting and funding these types of research methods seem to outweigh the positives. As stated by Hug (2005), ASCs are more difficult to isolate than ESCs, demonstrated by their incapacity for regenerating replacement cells and tissues in any cell other than their cell of origin, increasing potential negative immune responses and rejection. Cord cells have limited versatility, and SCNT, although conceptually new, poses ethical questions as its technology can be considered similar to "human cloning" (McLaren, 2001, p. 131). Cost benefits for ASCs, CSCs, and SCNT are unanswered, as are the effectiveness and efficiencies of these options because research for these processes is still in the infancy stage. There are feasibility and potential utility for these options, although whether they will be promoted and federally funded for continued investigation remains to be seen.

 

Policy Option 3 supports full government funding for the study of ESC research and creating new ESC lines. This option would be considered a maximum change from existing policy. The theoretical underpinnings would support a scientific method of research that has the potential of combating morbidity, mortality, and the hopelessness of chronic disease (Rader, 2010). The positives of this research and how it will change disease progression and treatment plans are endless. For example, as discussed by the American Academy of Neurology (2004), "Changing federal funding policy is critical to permit the full capacity of the biomedical research workforce ... to discover and develop the full potential of ESCs under appropriate scientific and ethical guidance" (p. 1680). Yet, the negatives are unknown, and many believe that insufficient research has been given to the attention of ASCs and CSCs and that morally ESC research should be left unexplored (White, 2011, p. 1). In addition, it is hard to evaluate the effectiveness and efficiency of ESC research as a purposeful methodology because it is still decades away from human studies (Fumento, 2009). Costs will be significant and that is why federal funding is necessary to supplement funding from the private sector (Robertson, 2010). Finally, ESC feasibility is always going to be questioned because of the moral and ethical issues that will always remain.

 

All three options provide the opportunity for leadership, health advocacy, and interpersonal collaboration. As health care providers, we are tasked to be health care leaders and advocates (American Association of Colleges of Nursing [AACN], 2006). Embryonic stem cell research has many stakeholders, both for and against its progression. Registered nurses should, as health care leaders, demonstrate their abilities to influence policy by being actively involved in the legislative process, networking with stakeholders and specialty organizations that can move policy forward, and by educating others including policy makers at the local, regional, and national levels (AACN, 2006).

 

PART 4: BUILDING CONSENSUS

Policy Option 3 seems to have the foremost potential to provide needed advancement for curing many disease entities. Consensus is critical for building the foundation to successfully solve and implement a policy change. Networking with nursing organizations on a local level would begin to build a basis for consensus that establishes a solid platform for the advancement ESC research. There are many organizations, on many levels, that support ESC advancement. Relationships, if properly cultivated, will continue to strengthen consensus. For example, the ANA (2007) supports ESC research. The ANA could be an influential organization to initiate intradisciplinary networking, provide access to the national level, and furnish political guidance. In addition, input from the consumer, a major stakeholder in ESC research, would significantly strengthen consensus while underpinning the need for advancement of this important health care issue as it relates to society at large (Hudson, Scott, & Faden, 2005). Finally, the AACN (2006) stated that advanced practice registered nurses such as doctors of nursing practice should be able to develop, evaluate, and provide leadership for health care policy that would shape health care financing, regulation, and delivery and this should include ESC research.

 

CONCLUSION

This analysis has addressed defining the policy issue, applying a policy framework that explored the issues using a number of contexts, defined theoretical underpinnings of the policy, demarcated stakeholders, options, and/or solutions, and identified how to potentially build a consensus for successful policy implementation. Embryonic stem cell research is a fascinating scientific approach that has the potential of improving and curing medical diseases that have eluded the medical community for decades including spinal cord injuries, multiple sclerosis, diabetes, Parkinson's disease, cancer, Alzheimer's disease, heart disease, hundreds of rare immune system and genetic disorders, and many more" (White, 2011, p. 1). According to Robertson (2010), "Science does not happen in a vacuum but is embedded in the soil of the societies in which it occurs" (p. 201). Are we, as nurses, ready to undertake this challenge and influence policy, as well as science, or is the successful implementation of this policy forever to be morally and ethically blockaded?

 

REFERENCES

 

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