The Legal History and Ethics of Stem Cell Research

An interesting aspect of stem cell research is how politically charged it was from its very beginning. Originally born into a conservative playing field, the bounds on stem cell research were never as open as they are now, having been suppressed by political opinion for several decades. Numerous accounts of voting to support stem cell research were blocked by individual opinions of people with the influence to do so. Today, stem cell research is more open and accepted, due to technological advancements, but I think more importantly, a changing political mood. But this freedom allows for more ambitious trials and research to take place, so it is important to allow the field to progress scientifically, without befalling to scandals or fraud like other breakthrough medical applications have in the past.
My primary source is an overview of the current state of stem cell research written by Roger Barker, Professor of Clinical Neuroscience and Honorary Consultant in Neurology at the University of Cambridge and at Addenbrooke’s Hospital (Roger Barker pg.1). Barker has been in his current position for more than ten years with his main interest being neurodegenerative disorders, one of the main proposed applications for stem cell research. He wrote this article in 2013, so the opinions he brings up are very current and relevant to the current status of stem cell research.
Barker gives a brief introduction reciprocating the optimistic potential of stem cell research often seen today. However, he quickly makes a point that stem cell research is highly subject to unchecked optimism and claims that go beyond the evidence given by clinical trials. He says this because there are many “desperate patients and … families [who] will often seek to try any new therapeutic intervention” (Barker pg.1). Barker notes that stem cell transplants have been effective in the field of hematology, namely, using transplants to replenish bone marrow of patients who were treated for cancerous blood disorders (Barker pg.1). However in the case of neural cells, stem cells need to meet a higher standard to be effective, which Barker says none have fully met yet.
In the end of his discussion, Barker says that the field of stem cell research is consistently moving forward every year, as many well-designed trials are being planned and undertaken. Despite this, no trials have shown a level of effectiveness suitable for “mainline” therapies (Barker pg.3). He also warns that the rush to get from the laboratory to the clinic for advancement of therapies could derail the whole field “by a disastrous result of an ill thought out treatment” (Barker pg.3). If that were to happen, then the therapies currently being developed by sound scientific procedures would be ruined by the confusion caused by “the unproven, commercially driven cells of today” (Barker pg.3).
From this article, it seems that stem cell research is a good area to see the difference between therapeutic optimism and therapeutic nihilism. Therapeutic optimism is the notion that modern therapeutic research has the ability to treat even some of the most complex illnesses. Patients with incurable illnesses tend to look at these “promising” therapies with the hope that they will offer a solution. Contrary to that, therapeutic nihilism is the belief that while no better therapeutic solutions currently exist, the current developing therapies hold little to no promise either. For example, if stem cell research suffered some infamously bad treatment making its way into the spotlight, then the general population may feel that stem cells are not the best way to tackle issues such as neurodegenerative disorders, even though it seems there aren’t any significantly more effective treatments to date.
The article also talk about the issue of medical ethics and the standards that we should impose on clinical trials before a new therapy is deemed acceptable. One of the biggest issues scientific medicine has dealt with is clinical ethics. After the French Revolution, the focus of medicine fundamentally shifted from being patient-centered to research-centered. Such a focus has led to times where the interests of the researcher take precedence over the well-being of the patient. During World War II, the experiments done by Nazi medicine displayed one of the most horrific instances of this, but since then, bioethics has become an increasingly important topic for the global scientific community.
One of the main goals of my paper is to describe the political context of stem cell research throughout its development. Modern stem cell research was born right around the same time as pro-life vs. pro-choice debates arose. Since one of the main sources for stem cell research was embryonic tissue (whether it be donated by patients or created in the lab), the research met heavy resistance from conservative political forces, up until the early 21st century. The issue raised by Robert Barker about commercialized stem cells might not be entirely due to the forces of capitalism, but perhaps due to the fact that publicly funded stem cell research was suppressed for several decades. Secondly, I will discuss the implications of the issue of commercialization. I will look at some events that display how ulterior motives can influence the science of medical research, and how the response is handled by the scientific community and the public.
The history of stem cell research is fairly recent. In the early 1900’s European researchers realized the various types of blood cells originated from the same “stem” cell and the idea of these cells was postulated for some time. But it was not until 1963 when researchers Ernest McCulloch and James Till quantitatively described the self-renewing nature of cells in the bone marrow of mice (History of Stem Cell Research pg.1). This concrete evidence helped kick start the research movement. However, the research would find itself gaining steam in a linear fashion. Recall that in 1973, the famous Roe v Wade court case rules that abortions are fully legal during the first two trimesters of pregnancy. This highly political issue was counteracted by members of Congress, who feared that medical research would exploit the increase of aborted embryos and fetuses for experiments (Embryo and Stem Cell Research pg.1). In response to Roe v Wade, the Department of Health and Human Services (DHHS) placed a temporary moratorium on living embryo research. Congress itself placed a temporary restriction on federally funded clinical research on embryonic tissues, which by nature also extended to the practice of in-vitro fertilization (Embryo and Stem Cell Research pg.1). in 1975, the DHHS lifted the ban on research, but continued to restrict funding. With this political blockade in place, early stem cell research had limited options. Research was not killed however, as the ban was only on embryo research for therapeutic purposes. And so, basic research with living embryos continued, but it was restricted to a manner in which direct and more effective therapies could not be exercised.
Throughout the rest of the 20th century, government institutions continued to stifle embryonic research. In 1987, the National Institute of Health requested using transplants of fetal neural cells for Parkinson’s disease. The DHHS withheld their approval, with the Assistant Secretary of the Health claiming that the research would induce women ambivalent about abortion to have one (Embryo and Stem Cell Research pg.1). In response, the NIH created the Human Fetal Tissue Transplantation Research Panel, which voted 18-3 for approval of using fetal tissue. They argued that the use of the tissue to treat disease was morally distinguishable from the act of abortion. However, the DHHS Secretary decided to ignore this vote and honor the opinion of three conservative panel members who voted against fetal tissue use. The moratorium on embryonic tissue was extended indefinably at this point.
Numerous attempts were made to have the ban lifted, but it took the influence of President Clinton in 1993 to have it done. The NIH Human Embryo Research Panel determined (by an even narrower margin than before) that the creation of embryos specifically for research would not encourage abortions, and therefore was permissible. However, immense public outcry moved Clinton to override the panel’s decision. In 1996, Congress again banned federal funding for embryo research with The Dickey-Wicker Amendment. But because they didn’t specify if that applied to cells already derived from embryos, the NIH legal department ruled that it was okay to fund research with existing stem cells, but not fund the process of deriving stem cells themselves. That ability was still only allocated to the private sector. President Bush issued an executive order in 2001 that prohibited the funding of stem cell research using any cell lines derived after August 9, 2001, citing that there were already more than 60 cell lines available to do research on (Timeline of Major Events in Stem Cell Research Policy pg.1). This statistic was based off the NIH registry, and in reality, only 21 lines were available for research and very few of those were suitable for human use (Legal and Political History of Stem Cell Science pg.1). In 2005, both the House and the Senate passed the Stem Cell Research Enhancement Act, which would allow for stem cells to be derived from embryos that were created for, but not used for, in-vitro fertilization. But yet again, President Bush opposed this by vetoing the bill, and with a 235-193 vote by the House, the vote needed to override the veto was not passed. The exact same thing happened again with a revision of the bill in 2007.
Up to his point in time, embryonic research was stifled again and again by largely conservative opinions about human tissue. This opinion was felt by both political bodies and the public. The ability for the government to regulate medical research was exercised very strongly in the late 20th century and early 21st century. However, with the inauguration of President Obama, embryonic tissue research saw a major shift in support.
Within two of months of inauguration, President Obama issued an executive order in opposition to that of President’s Bushes, declaring that the NIH “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law” (President Obama in Legal and Political History of Stem Cell Science pg.1). This was meant to allow the NIH to develop the guidelines for stem cell research, which they did several months later in July, 2009. A month later, a group of plaintiffs led by somatic (different from embryonic) stem cell scientists James Sherley and Theresha Deisher filed a suit against the NIH, claiming the new federal funding for embryonic research was violating the Dickney-Wicker Amendment. Chief Judge Royce Lamberth of the Washington D.C. District Court initially dismissed the case (Sherley v. Sebelius), claiming the plaintiffs were not affected by the new laws. However, the plaintiffs appealed to the District Court of Colombia and Judge Lambert granted their initial request to stop funding embryonic research, after the case was sent back to him in 2010. But then, the District Court of Appeals blocked Lamberth’s injunction to stop the funding, allowing it to continue while the case remained unsettled. In 2011, Lamberth ruled that the government could continue to fund embryonic stem cell research, even though the restriction was lifted a year ago by the Court of Appeals (Legal and Political History of Stem Cell Science pg.1). Bringing us the near present day, Sherley v. Sebelius was declined to be heard by the Supreme Court in 2013, and Stem Cell Action Coalition spokesperson Bernard Siegel noted that “this [was] a major victory for scientifically and ethically responsible innovative research” (Siegel in Legal and Political History of Stem Cell Science pg.1).
Although now enjoying a more politically liberal embrace, political suppression was not the only key issue of stem cell research. As with many medical treatments that move toward the limelight of mainstream therapy and applications, there is the concern over commercialization and how the presence of an “industry” can change the way a medical innovation is viewed. As Robert Barker said in his article, a trial with largely ill consequences could significantly harm the research field. This has happened before in the medical/pharmaceutical industry. In the 1950’s/1960’s, a German company developed an experimental drug named Thalidomide and quickly realized it was a powerful but non-lethal sedative. After a very rudimentary and non-systematic trial of efficacy, the drug was released to the public. A few years later, people began connecting Thalidomide to a number of symptoms, including birth defects, but its use continued. At this point in time, the Food and Drug Administration was very weak, and in fact, before Thalidomide was approved in the United States, 20,000 people had already been given samples of the drug by physicians (Lecture 9.1). However, in 1961 the news came out that Thalidomide was being withdrawn in Europe, and this had a deep impact on the trust that the public put into modern medicine. This is the kind of scenario that Barker fears, where a hasty implementation of stem cell therapy could have significant backlash, and destroy support for the research. Even more worrisome is the fact that there are many people who are willing to try ‘promising’ therapies to help aid them. This is the core component of therapeutic optimism, wherein people who don’t know anything technical about medicine still assume that whatever it produces is to benefit the patient regardless. However, that notion has been questionable ever since the French Revolution and the shift of medicine from being patient-centered to research-centered.
One of the most noteworthy ethical breaches in stem cell research was committed by Professor Hwang Woo-Suk. Woo-Suk was a researcher at Seoul National University in South Korea. During 2004-2005, he garnered international fame among the community of stem cell research for creating 11 new stem cell lines via somatic cell nuclear transfer. In 2009, Woo-Suk was convicted for illegally using research funding to buy human eggs, although there were no legal restrictions in South Korea for how eggs had to be acquired. However, majority of the women he procured eggs from had not given valid, informed consent. In addition to that, some of his patients were infertile and agreed to donate any excess eggs leftover from their fertility treatment. Woo-Suk and his team assigned quality ratings to these eggs, keeping the higher-quality ones for research and using the lower-quality eggs for the patient’s own treatment. These actions were in clear breach of the Korean Bioethics and Safety Act, and led to Woo-Suk’s work being revoked and discredited. (The Cloning Scandal of Hwang Woo-Suk pg.1). Fortunately for the scientific community, Woo-Suk’s fraud was shrugged off, in part because six months later, a new method was shown to effectively manipulate skin cells into what very closely resembled embryonic cells, which shifted focus away from nuclear-transfer research altogether. Another saving grace of this incident was that Woo-Suk was exposed by a member of his own team, showing the ability of the scientific community to self-regulate. However, this is still an example and reminder of how medical ethics is not a problem of the past.
Today, opinions on stem cell research can be divided into three main groups. There are those that think stem cell research is morally okay, as it focuses mainly on finding therapeutic treatments for people with incurable disorders. There are those that see any rudimentary form of life as still being life, and therefore it must be respected by the standards we place on sentient human beings. However, due to constantly evolving technology and techniques, there are those who might argue that somatic stem cells are permissible to use while embryonic cells are not. Recall that somatic cells are cells that can be taken from adult cell structures and undergo a process of induced pluripotency, meaning that scientists can take these cells and reprogram them to resemble stem cells. However, also remember what Barker said about the current state of stem cell research. That is, there is yet to be a form of stem cells that can be produced and fully function as neural cells. I think that is one of the most interesting topics of stem cell research though, as it aims to solve a problem that we have yet to find a solution.
I believe that the recent support toward stem cell research is a positive turn of events. Science does need to have limits and regulation; otherwise in cases like Woo-Suk and Thalidomide, scientific medicine can lose sight of what is fair and acceptable for the patient in pursuit of other prospects. But even with the case of embryonic cells aside, stem cell technology is consistently advancing, with induced pluripotency making major leaps and bounds. Another good idea for the efficacy of clinical trials that is also mentioned by Barker is that trials should not be performed a population of patients who paid for the treatment. This raises serious ethical issues as to whether or not scientific medicine intends to benefit itself through financial gain, or the public as a whole. Certainly I would like to believe the latter as would many others, and that is why publicly supported studies and trials are important to development of stem cell therapy. Furthermore, to avoid the pitfalls of therapeutic optimism that have happened before, it is important for the scientific community to remain systematic and rigorous so that in the future, any mainstream stem cell therapy can be trusted, reliable, and effective.
Works Cited
Barker, Robert. “Stem Cell Therapies and Neurological Disorders of the Brain: What Is the Truth? | Europe’s Stem Cell Hub | EuroStemCell.” EuroStemCell. N.p., 24 Apr. 2013. Web. 20 Mar. 2014. .
“Brief History of Stem Cell Research.” Science Progress Timeline A Brief History of Stem Cell Research Comments. N.p., 16 Jan. 2009. Web. 20 Mar. 2014. .
“The Cloning Scandal of Hwang Woo-Suk.” Stem Cell Bioethics. N.p., n.d. Web. 20 Mar. 2014. .
“The Commercialization of Stem Cells: Promises and Public Concerns.” Stem Cell Bioethics. N.p., n.d. Web. 20 Mar. 2014. .
Hadenfield, Manal. “Reprogramming: How to Turn Any Cell of the Body into a Pluripotent Stem Cell | Europe’s Stem Cell Hub | EuroStemCell.” EuroStemCell. N.p., 24 Dec. 2012. Web. 20 Mar. 2014. .
“HISTORY OF STEM CELL RESEARCH.” Boston Childrens Hospital. N.p., n.d. Web. 18 Mar. 2014. .
“Legal and Political History of Stem Cell Science.” Stem Cell Bioethics. N.p., n.d. Web. 20 Mar. 2014. .
“Timeline of Major Events in Stem Cell Research Policy.” Timeline of Major Events in Stem Cell Research Policy:. N.p., n.d. Web. 19 Mar. 2014. .
Wertz, D. C. “Embryo and Stem Cell Research in the United States: History and Politics.” Nature.com. Nature Publishing Group, June 2002. Web. 19 Mar. 2014. .

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