StemCell Therapy

December 21, 2014 A Role for Clinical Ethics Consultants in Stem Cell Tourism Recently Dr. Christopher Thomas Scott of Stanford University wrote a great paper titled The Case of Stem Cell Counselors inStem Cell Reportswhich draws parallels from the field of genetic counseling arguing for the need for stem cell counsellors (1). Scott outlines that due to increases in the number of stem cell trials combined with fraudulent therapies being offered around the world, the time is ripe for having counsellors help patients navigate the clinical stem cell research/therapy landscape. These experts can help patients identify and distinguish legitimate trials from unproven interventions, explain the risks, benefits and therapeutic options, and serve as a resource to provide them with educational information. On a related topic, my colleagues and I at AMBI were going to write a paper arguing that clinical ethics consultants should be involved in countering the impact of stem cell tourism and serve as a resource for patients who are contemplating undertaking an unproven stem cell based intervention (SCBI). We thought that clinical ethics consultants are in a unique position to offer advice and counselling to patients seeking unproven SCBIs for a few reasons. The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit ourwebsite. November 23, 2014 Deregulation and Free Markets for Stem Cell Products Paolo Bianco and colleague Douglas Sipp wrote a very provocative and interesting piece recently published in the journalNature(http://www.nature.com/news/regulation-sell-help-not-hope-1.15409)discussing a movement to permit stem cell medicines, among others, to be sold in the market without the requirement to show much safety and efficacy data permitting the market to determine safety and effectiveness of compounds. Here, patients would basically pay to obtain products and also be research subjects. Certain powerful groups are calling for the deregulation of clinical medicine as a business model to bring innovative products to the marketplace. But before I begin explaining what Bianco and Sipp discuss, we need to cover the current system of regulatory oversight of medical products. The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit ourwebsite. September 23, 2014 Stem Cell Tourism and Patient Education What is the role of public education and stem cell tourism? What type of education is available to patients, caregivers and the public? Can public education actually change peoples minds such that they wont undergo an unproven stem cell-based intervention (SCBI)? These are the questions I will discuss here. But first, lets just give a brief description of stem cell tourism and outline some of the proposals discussed to stop this industry. The Stem Cell Tourism Industry and Ways to Curtail the Market Briefly, stem cell tourism is a term used to describe an Internet-based, direct-to-consumer advertised industry where patients receive unproven SCBIs for a range of diseases and injuries. Many clinics offering unproven SCBIs are in countries with lax regulations and enforcement. However, these clinics are also increasingly popping up in highly regulated countries like the U.S., U.K. and Australia. The term stem cell tourism is misleading because patients may not necessarily need to travel a great distance to receive such interventions, and focuses on patient behaviors instead of others involved in this market including regulatory agencies and the providers offering them. Moreover, there are some real risks to stem cell tourism. Beyond patients being financially exploited, there are several reports of tumors, lesions, tremors, other problems, and even deaths of individuals receiving unproven SCBIs. And there seems to be a stem cell treatment for just about every disease and injury, no matter how severe or benign if the patient can pay anywhere from $8,000-$30,000. Clinics advertise for serious conditions such as heart disease, stroke, MS, Parkinsons disease, ALS, and spinal cord injury among many others. You might have also heard of major NFL stars receiving SCBIs for sports injuries, movie stars receiving anti-aging stem cell treatments, and even a U.S. Governor receiving stem cells for chronic back pain. The fact that celebrities and public figures are receiving untested SCBIs is likely to make it seem that they are safe and effective and only bolsters the market. Yet there are very few bonafide stem cell treatments out there. While more clinical trials using stem cells are underway (1), it will become increasingly difficult for patients to discern between a legitimate clinical study and a fraudulent intervention. And because of all the hype, ethical issues, and misconduct scandals having to do with stem cell research, having patients become injured due to an unproven SCBI is not only bad itself of course, but also can seriously stifle the stem cell field. The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit ourwebsite. March 30, 2014 Stem Cell Tourism & Education I have written on this blog about the topic of stem cell tourism and the different strategies that have been proposed to stop the phenomenon. Just to provide a background on the topic from a previous blog: stemcell tourism is used to describe an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinsons disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions. Of the several strategies people have discussed, one of the first has been on the topic of providing education to patients and the public. Here, people argue that providing education on the dangers of stem cell tourism might actually sway patients to not undertake unproven stem cell interventions. As some scholars have mentioned, education might not be as effective because it depends on a rationale actor model where we assume that patients will behave rationally and make choices based on weighing the harms and benefits of seeking unproven treatments. More so, such an argument does not sufficiently consider the hope patients have to ameliorate their disease, reduce pain or other symptoms, and increase their quality of life. While these counterarguments are certain rational and likely to be true, there is yet no solid evidence showing whether education on stem cell tourism is effective at swaying people from traveling for unproven interventions. But even if before we go into whether education might influence a patients decision to travel for unproven stem cell treatments, I think we need to assess the role of patient education in medicine. The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit ourwebsite.

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