Ethical Concerns in the Emergence of Stem Cell Therapies

Benjamin Schanker

AbstractStem cells hold great promise in the future of medicine. Tissue engineering, organ repair or replacement and neurological growth are only a few of the many proposed benefits of stem cell therapy. While safe and efficacious stem cell therapies are currently limited in number, research efforts are continually growing and significant improvements can be expected in upcoming years. There are a growing number of international providers claiming to offer stem cell therapies for a variety of ailments. Stem cells have arisen in policy debates and a lack of universal agreement on their use, safety and morality suggests these debates will become more widespread and impassioned. Issues that have arisen with the evolution of stem cells include patient safety, the exploitation of desperate patients, and distribution of resources. Developing science and growing hype warrant ethical scrutiny to ensure the nonmaleficence of patients and a balance between patient safety and scientific progress. A conservative approach combining domestic control with international regulation is recommended to simultaneously monitor and foster the promising, but perilous world of stem cells..

INTRODUCTION
Stem cells have the potential to repair, replace, or create tissue. They therefore hold promise in treating conditions like Parkinson’s disease, heart disease, Alzheimer’s disease, spinal cord injury, diabetes, arthritis, stroke, blindness, blood diseases, baldness, teeth loss and many others. Furthermore, stem cells have the potential to replenish immune cells during chemotherapy and help fight infectious disease. Some have even speculated that complete organs may one day be created and transplanted using stem cells. However, stem cell hype has been highly criticized; many argue that exaggerated benefits and unrealistic hopes are all that exist.

Preclinical trials testing stem-cell based therapies have indicated positive results (Deshpande, et al 2006; Laflamme, et al 2007). A few clinical trials have begun for cardiovascular disease (Arnesen, et al 2007; Boyle, et al 2006) and Batten disease (Taupin, 2006) and many more are expected. Bone marrow transplant procedures using adult stem cells have been used for the past forty years, but evidence of safe and effective therapies using stem cells derived from other sources is limited. However, the ability to obtain stem cells from umbilical cords, menstrual blood, placentas and adults offers a less ethically controversial alternative to obtaining embryonic stem cells from aborted fetuses. Some researchers are even studying the use of stem cells derived from animals. There may eventually come a day when organs or limbs can be manufactured, neuronal growth stimulated, or bone growth and height increased using stem cells. These further advances will certainly raise questions around issues of what it means to be a human being and what impact artificial body parts or enhancement will have on human dignity.

The physical challenges that arise in use of stem cells include rejection by the immune system and tumor formation (Gallagher and Forrest 2007). Furthermore, infection remains a noteworthy cause of mortality in the stem cell transplant population (Wilck and Baden 2008). In spite of scarce evidence of safety and efficacy, various stem cell therapies have been offered to patients (Dobkin, et al 2006) and are often very expensive (Enserink 2006). There are over 20 international providers claiming to offer stem cell based therapies for numerous conditions. Marketing is often done over the internet and the list of conditions they claim to treat with stem cells is extensive. Their wide catalog of purported services helps fuel medical tourism, which is expected to rise in the next few decades.


PROTECTION OF PATIENTS
Patients with terminal or irreversible illnesses are extremely vulnerable to exploitation. An enormous amount of money can be made with stem cell science; international providers currently advertise costs between about $5,500 to over $40,000 with claims that treatments may need to be repeated several times. The vast majority of these treatments have not been internationally accepted as efficacious. As stem cell science progresses, the market for stem cell providers is sure to grow substantially.

Amidst quickly advancing medical technology and research, and growing stem cell hype, patients lacking sufficient medical knowledge are easily attracted to interventions claiming to cure disease. Terminal patients may be more likely to undergo alternative or experimental therapies due to the nature of their condition.  According to Dr. Jonathan Waxman, Professor of Oncology at the Imperial College of London, it is estimated that up to 80% of all patients with cancer use alternative treatments as supplements to traditional methods. Similarly, the lack of available effective treatments for conditions like Alzheimer’s or spinal cord injury may induce feelings of desperation, or a “better-than-nothing” mentality. Experimental treatments may offer hope when conventional medicine may leave patients feeling helpless.

While the efforts of providers to offer a cure for ill patients may be laudable, a financial exploitation of desperate patients is morally decadent. Stem cell hype and/or lack of sufficient understanding of current stem cell science may persuade patients to undergo unverified interventions with unrealistic expectations. A therapeutic misconception often exists among patients and researchers in which the experimental treatment is excessively perceived as likely to benefit the patient, while potential negative consequences are underestimated.

On the contrary, when a terminal patient has a fleeting chance or hope of survival, isn’t an audacious and uncertain experimental treatment justified? Few would argue against avoiding medical interventions that cause more harm than good, but the benefits and detriments of different stem cell treatments are not always clear-cut. Some argue that if there is any chance of benefit, experimental stem cell therapies are justified, and that despite a terminal illness, patients remain autonomous to decide. Although rational patients certainly have the right to make personal choices, it should ultimately be the responsibility of government to prevent fraud and exploitation of desperate patients.

Beike Biotech, a Chinese stem cell therapy provider, inadvertently highlights a danger of quickly advancing science. “Beike takes the most advanced biotechnological research in the world, specifically stem cell therapy, and applies it clinically at a rapid pace” (Beike Biotech 2008). The hasty application of uncertain treatments may subject patients to excessive risk, and be harmful. In the creation of new drugs or treatment procedures, there is typically equipoise between benefit and harm to patients, in which case clinical trials are completed specifically to establish the safety and efficacy of treatments. Without sufficient evidence of these, stem cell therapies should not be provided to the public.

REGULATION
The regulation of stem cell use in both research and clinical settings varies between states and internationally. At the United States federal level, new stem cell based interventions are regulated by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. Proposed treatments are treated similarly to drugs, with comparable procedures of FDA review and approval (Federal Register 2004). While in many developed nations regulation is similar, many countries lack significant regulatory bodies. Several of the current international stem cell intervention providers are located in countries like China, India, Taiwan, or Mexico, where medical regulations are less stringent.

A more radical perspective advocates progression of clinical trials in humans and rapid implementation of therapies to hospitals and patients in need. Conservatives, on the other hand, assert that long-term risks are unknown and progress must be completed slowly and cautiously. The conservative perspective has greater substance in this debate. Prior to implementation of stem cell therapies, international peer-reviewed literature indicating safety and efficacy should be present. Furthermore, standardized assessments of treated patients over time-elapsed intervals should be completed to ensure knowledge of long-term side effects.

Several prominent researchers believe it is delusional to think that stem cell cures for serious degenerative disorders are right around the corner (Tilghman 2004; Winston 2005). While new, successful stem cell therapies may be unlikely this decade, they will certainly emerge in clinical settings over time, and questionable therapies are already being offered by international providers. Preemptive steps need to be taken to ensure adequate regulation and oversight. Increased awareness of the issues and legislative action are necessary to protect patients. International discussion and discourse by global institutions like the World Health Organization are essential. Regulation, though, may significantly hinder scientific progress, much like current limits in the U.S. on stem cell lines within federally-funded research. Negative inhibitory regulations should be removed, and political debate should be promoted for effective policy evolution.

SCARE RESOURCES and JUSTICE
Considering the potentially high costs, stem cell therapies are likely to contribute to continually growing health care expenditures. Some worry that the development of stem cell therapies will exacerbate health care inequities. Furthermore, some health policy experts are concerned that the massive funds being spent on stem cell research are not the best use of scare resources (Yuasa 2005). On one hand, the successful use of stem cell therapies has the potential to reduce future costs of treating extended illnesses like Parkinson’s or diabetes. On the other hand, developing safe and efficacious technology is expensive, and in the end may not be cost-effective. But stem cells offer such an immense promise for the future of medicine that disregarding their potential and prohibiting further research would be an injustice to humanity and its future generations. 

Another concern is that an increase in use of embryonic stem cells may create a market for embryos that will raise potent ethical issues that parallel issues in the market for organs. If researchers or clinics are in need of embryos, the exploitation of economically vulnerable women is one of many concerns, after of course the initial debate of whether using embryos for research is justified at all. Marketing for eggs on college campuses has increased significantly in the past few decades (Norsigian 2005), and financial compensation for donation of eggs is extremely controversial (Steinbrook 2006).
Furthermore, if stem cell science allows neuronal or muscle cells to be manufactured and administered to a patient, issues in enhancement and human dignity will surely arise. Stem cells may become equivalent to performance enhancing drugs in athletics or academic areas. Proponents of enhancement posit that individuals have the autonomy to decide and that enhancement increases the quality of life. Opponents argue that the use of stem cells for enhancement will create social stigmas and degrade individuality. Regardless of the normative answers, ethical debate is necessary to politically uncover how society and humanity should proceed in all issues pertaining to medicine and science.

CONCLUSION
There are imperative issues that must be dealt with as stem cell science advances. While potential is inspiring, negative repercussions may also be imminent. The integrity of individuals and society rests in the hands of stem cell debate. In the coming years, vulnerable patients are likely to be exploited and excessive risks likely to be taken. A conservative approach is necessary to minimize the use of potentially dangerous therapies and their resulting detriments. Though it is easy to marvel at the promise of stem cells or become enraptured in their hype, volatile clinical applications require careful regulation. While research restrictions should generally be limited, patient well-being should remain the primary focus. A skeptical approach to advancing stem cell science is likely to minimize life-threatening mistakes. Throughout history mankind has witnessed deplorable scientific endeavors; unnecessary tragedy can and should be avoided by taking preventative measures. Ethical discussion and greater legislative regulation are necessary to ensure proper social and scientific progress.   

 


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