Despite the relative lack of information on the future implications of stem-cell therapies, research has sped ahead (Daley, et al. 793). As an example of the rapid pace of research, the International Society for Stem Cell Research, arguably the biggest international professional organization involved in stem cell research, has been obliged to update its guidelines three times in ten years (Daley, et al. 787). The purpose of this paper is to present some of the controversies evoked by stem cell research and therapies.
One of the reasons given for the rapid uptake of stem cell therapies is the appeal of novelty (Charo 901). Charo suggested that emerging technologies that have yet to be sanctioned by the medical establishment in the U.S. are subject to medical tourism. Private clinics circumvent Food and Drug Administration regulations by recruiting patients from within the U.S., but administering therapy outside the country (Charo 902). Further, Charo recommended that policies be put in place now be prevent gene-editing from becoming another example of medical tourism (901). Charo’s basic argument is that the public needs to be protected from itself and rigorous clinical trials need to be conducted in order to bring novel therapies from the laboratory into clinical use (902).
The other side of the argument is that once a new technology indicates promise, it is difficult to prevent its further exploration. The U.S. attempted to forestall stem cell research on its own soil on political and moral grounds and the result is that the rest of the world, notably Europe, has surged ahead. Stem cell research and therapy may be a moral issue for some, but the larger problem is the wisdom of having medical research legislated by government. Surely the question of who has the right to decide what are acceptable medical research topics and interventions should be firmly in the hands of those who are in the best position to judge the potential value of new technologies — the medical community.
Stem cell interventions have also caused controversy in the area of economics. Today, the biggest global cause of mortality and morbidity is heart disease. Heart disease annually costs the American health care system more than $200 billion (Lambers and Kume 751). Despite recent advances in therapy for cardiac failure, the prevalence, hospitalization, and mortality continues to escalate (Boyle 330). The primary cause of heart disease is massive dysfunction or loss of cardiomyocytes (Lambers and Kume 751). There is sufficient preclinical evidence that stem cell therapy is now a safe and efficient means of managing heart failure among humans (Orlic, et al. 705). Therefore, it makes good economic sense for the Unites States Department of Health and Human Services to advocate for larger and better stem cell clinical trials, at least in the field of chronic diseases.
If stem cell therapy represents a dramatic advance in the treatment of human injury and disease, why is in not wholeheartedly accepted by the medical community? In their review of the scientific and ethical complexities of stem cell research, Gruen and Grabel (2163) echo some of the concerns mentioned by Charo (901). Gruen and Grabel (2163) state that scientists face major roadblocks in their ability to advance stem cell research. The authors suggested that there needs to be a greater management of public expectations regarding stem cell therapies (Gruen and Grabel 2164). One of the issues mentioned by Gruen and Grabel (2164) is the difficulty inherent in obtaining a genuine patient informed consent in light of heightened patient expectations caused by the media. Gruen and Grabel (2164) suggested the interesting idea of revising key elements of the informed consent form in pace with the research. The continuous revising of informed consent forms may not prove to be a feasible notion, but the point about public education remains. Stem cell research is a highly complex and fluid field and the task of mass public education can be daunting. However, few of us understand the mechanisms behind the electric light bulb but we have learned to use it safely. A public education campaign does not need to focus on the biochemistry of stem cell therapies in order to convey what the therapy can or cannot do.
Another thorny issue that Gruen and Grabel bring to light is scientific integrity in the face of press clamouring for medical breakthroughs. The authors recommend that scientists need to think more carefully about research ethics when it comes to publicizing their claims, particularly when based on uncorroborated results (Gruen and Grabel 2165). This statement reflects solid research practice that has been enshrined for years in the scientific method — study results need to be replicable.
Gruen and Grabel’s suggestion (2165) that the individual scientist be more personally cognizant of ethical concerns surrounding stem cell research brings additional questions to light. The National Institutes of Health (NIH) are the biggest funders of medical research and their standard requirements for scientific rigour are high. Institutionalizing ethical standards by making stem cell funding contingent on restrictions regarding claims could be an option. However, other factors must be considered when taking this route, and they are the political pressure on the NIH to direct funding into certain areas.
This paper has addressed a few of the controversial issues involved in stem cell therapy and clearly they are considerable. The problematic issues surrounding stem cell research seemed to have moved from the more faith-oriented concerns about the recovery of stem cells from aborted fetuses and the cloning of human embryo tissue into the arena of ensuring scientific rigour and patient rights. This shift does not resolve any of the moral issues, but it does place them within the context of science rather than religion, which allows stem cell research to advance, albeit cautiously.
Works Cited
Boyle, Andrew J. “Stem cell therapy for cardiac repair: Ready for the next step. Circulation 114 (2006): 339-352. DOI: 10.1161/circulationaha.105.590653
Charo, R. Alta.” On the Road (to a Cure?) — Stem-Cell Tourism and Lessons for Gene Editing.” New England Journal of Medicine 374.10 (2016): 901-903. Print.
Daley, George Q., et al. “Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.” Stem Cell Reports 6 (2016): 787-797. Print.
Gruen, Lori and Grabel, Laura. “Concise Review: Scientific and Ethical Roadblocks to HumanEmbryonic Stem Cell Therapy.” Stem Cells 24 (2006): 2162–2169. doi: 10.1634/stemcells.2006-0105
Lambers, Erin and Kume, Tsutomu. “Navigating the labyrinth of cardiac regeneration.” Developmental Dynamics 245.7 (2016): 751-761. DOI: 10.1002/dvdy.24397
Orlic, Donald, et al. “Bone marrow cells regenerate infarcted myocardium.” Nature. 410 (2001): 701–705. Print
