pressures on clinicians and caregivers, creating bias when discussing treatment options, as even the best-intentioned clinicians may overestimate the value of SCT in order to meet obligations.
Human Integrity
The commercialization of SCT and its products leads to additional human integrity concerns. Human integrity refers to the protection of human rights and dignity, especially those of vulnerable populations who might participate in a clinical trial. Anyone familiar with Henrietta Lacks understands the debate surrounding use of human cells and informed consent. Unlike in Japan and most of the European Union (EU), U.S. patent laws do not contain a morality clause and are based exclusively in whether the item meets the uniqueness and usefulness criteria.
Property and intellectual rights laws regarding the disposition of human tissues in the United States are vague and based mostly on court precedents. U.S. courts commonly deny the assignment of tissue property rights to either donors or those possessing the tissues based on a cell’s failure to meet the criteria to be defined as property. However, both EU property law and U.S. intellectual property law recognize that procedures performed on tissues may confer “value” that, in and of itself, meets the property definition. Thus, modification of adult cells into iASC confers a value that can be regulated by property law.
Conversely, laws commonly limit a person’s right to sell their own organs or tissues in order to prevent human exploitation. This fact recognizes the need to prevent abuse of vulnerable populations and is significant to the discussion. The U.S. and the EU recognize an individual’s right to informed consent regarding the disposition of removed tissues, including cells taken for modification into iASC. The question remains as to whether a vulnerable population, who may see the trial as their “last hope,” can make a truly informed decision about the disposition and future use of their cells. It may also be unrealistic to think people are able to negotiate their rights when in such a position.
Perhaps more importantly, this vulnerability also brings into question a patient’s ability to assess quality of life concerns resulting from clinical trials. Regardless of outcome, participants in SCT consistently report lower scores on quality of life evaluations during participation. This is not unexpected and for trials involving non-life-threatening illness may be moot. However, when dealing with life-threatening illness and so called last chance therapies, the ability of patients to make quality of life and end of life care determinations may be compromised.
Coming to terms with a terminal illness is a slow and emotionally challenging process, and caregiver emphasis is placed on balancing treatment against valuing what is left of one’s time while health allows. Treatments such as chemotherapy and SCT reduce the quality of this remaining time in favor of cures or extended life spans, although an extending life span may be of little value if that time is lived with a significantly reduced quality of life. Because it is not uncommon that palliative care must be suspended during trials, patients may be risking undue suffering to participate. These are standing questions in any terminal illness investigation but possibly more pertinent to SCT due to the aforementioned overoptimistic perspective for hope.
Conclusion
Stem cell therapies, including those with induced pluripotent stem cells (iPSC/iASC), show great promise both in the lab and clinically. While the research is still in its infancy, clinical trials involving stem cells are poised to skyrocket in the next generation of medicine and may represent a paradigm shift in therapeutic treatments. Such dramatic change always raises ethical questions in addition to the traditional concerns surrounding all clinical testing. Many of these concerns center around difficulties in assessing the potential for stem cell therapy’s efficacy. Determining risk versus benefit of a clinical trial is necessary if patients are to offer a truly informed consent to participation. Some ethicists argue that previous unwarranted excitement over stem cell research has “poisoned the well,” leaving both clinicians and participants unable to realistically evaluate the potential of SCT. Difficulty in obtaining participants as a result of past fraud may also bias caregivers unduly toward recommending experimental investigations. With the involvement of such vulnerable patient populations, the inability to realistically judge these factors may put them at undue risk without the real possibility of benefit.
The further commercialization of stem cell technologies compounds these concerns. Stem cells and their therapeutic use are at the forefront of biotechnological development, and both production procedures and the cells themselves are patentable. This is beneficial for driving innovation; however, because much of the research is backed by for-profit industries, it may create potential for misdirected accessibility and violations of human integrity. These can include financial hardship for participants, confusion about patient rights, and a misunderstanding over the final disposition of cells and personal genetic material.
Finally, when a clinical trial involves individuals with life-threatening or terminal illness, these worries become profound. People with terminal disease are especially vulnerable to treatments that offer even a glimmer of hope. This understandable human tendency demands that stronger scrutiny be applied when determining harm versus benefit in such studies. Ethicists continue to worry that the unique history of stem cell therapy (such as the Bezwoda fraud) skews this unreasonably against participants.
Michael Rightmire
Biocom Software
See Also: Adult Stem Cells: Overview; Clinical Trials, Ethics of; Clinical Trials Outside the United States; United States.
Further Readings
Cauvin, Henri E. “Cancer Researcher in South Africa Who Falsified Data Is Fired.” New York Times (March 11, 2000). http://www.nytimes..com/2000/03/11/us/cancer-researcher-in-south-africa-who-falsified-data-is-fired.html (Accessed June 2014).
Droste, S., A. Herrmann-Frank, F. Scheibler, and T. Krones. “Ethical Issues in Autologous Stem Cell Transplantation (ASCT) in Advanced Breast Cancer: A Systematic Literature Review.” BMC Medical Ethics, v.12/6 2011.
Edwards, Lisa C. “Tissue Tug-of-War: A Comparison of International and U.S. Perspectives on the Regulation of Human Tissue Banks.” Vanderbilt Journal of Transnational Law, v.41/2 (2008).
Knoepfler, Paul S. “Deconstructing Stem Cell Tumorigenicity: A Roadmap to Safe Regenerative Medicine.” Stem Cells, v.27/5 (May 2009).
U.S. National Library of Medicine. “Autologous Stem Cell Transplantation for Breast Cancer” (October 2009). http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0034016 (Accessed June 2014).
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Clinical Trials, U.S.: AIDS-Related Conditions
AIDS is the acronym for acquired immune deficiency syndrome and represents the most advanced stage of HIV (human immunodeficiency virus) infection affecting about 34 million people worldwide. AIDS is a sexually transmitted disease that can also be acquired through blood contact or saliva.
In the United States, the Centers for Disease Control and Prevention (CDC) estimates that 1,144,500 people age 13 and older are living today with HIV infection. The past decade has witnessed an increase of this number,
