August 30, 2013 | Posted By Zubin Master, PhD

Stem cell tourism is a pejorative term used to describe clinics that offer untested stem cell interventions as bonafide therapies to patients with injuries and diseases. This includes Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. We used to think about stem cell tourism as potential patients traveling to clinics from countries like the US, UK, Canada and Australia to countries with lax regulations, but this simply is not the case anymore. There are several clinics within the US that offer stem cell interventions to treat back aches or sports injuries. This direct-to-consumer market has more recently attracted celebrity types including several high profile athletes, Hollywood stars, and even a US State Governor.

Clinics generally tend to overemphasize benefits, and use rhetoric terms like “alternative medicine” or “experimental treatment” to explain that it is another form of treatment not offered by conventional medicine. But at the end of the day, there is an almost complete lack of scientific evidence supporting the claims made by clinics in regards to the efficacy of these stem cell interventions. The evidence provided to patients is based only on testimonials by other patients; no other measures are used to determine treatment efficacy. The overemphasis of benefits when patients tell others of how great they feel and how it has helped them and given hope only fuels their frustration and distrust in their domestic healthcare, research and regulatory system. The stem cell clinics play on the hype and power of stem cells and they stand to make money as therapies range from $5,000 to $30,000 and in many cases clinics require patients to have repeated treatments.

Several methods have been proposed by academics and others concerned about stem cell tourism to stop the industry from further flourishing. The first includes developing regulations intra-nationally or developing some form of international guidance. The International Society for Stem Cell Research (ISSCR) has done exactly that. ISSCR has developed a patient handbook, several web-based guidance documents, a book on the clinical translation of stem cell research, and even created a program where they would investigate clinics that patients have sought out and might wish to visit. This latter was met with threats of legal action by tourism clinics which forced ISSCR to shut down the website. Despite the leadership that ISSCR has shown for the responsible conduct of stem cell research and clinical practice, many of these clinics continue to proliferate.

A second mechanism proposed was to educate patients, physicians, and the general public about the threats of stem cell tourism, how to spot stem cell clinics, and perhaps even about the clinical translation of stem cell research. In a study I have led, there seems to be very little web-based information about stem cell tourism and clinical translation and thus it is unclear how effective education would be. As patients have a lack of trust towards their domestic country’s research and regulatory system, it is doubtful whether education will sway patients to trust their research and regulatory system. Certainly the social science literature on the public understanding of science has shown that education does not necessarily foster trust, instead that trust in particular scientific institutions (i.e., medicine, private sector research, publically funded research) play a larger role in influencing public trust. Public trust is also dynamic, not a static phenomenon and how “public” is defined or who are the public or social groups also vary in their trust towards science and medicine.

A third method I proposed with my colleague Dr. David Resnik is to stop new stem cell tourism clinics from starting up by scientists sharing reagents (e.g., stem cell lines, growth solutions, genes) responsibly. Scientists share reagents with other scientists located in different institutions through material transfer agreements (MTAs). We felt that scientists could stipulate in their MTAs the purposes that e.g., a stem cell line can be used for. If as an example a stem cell line is not of clinical grade because it hasn’t been properly tested for pathogens or animal byproducts, this may be something stipulated by the scientists who share their reagents. In addition, scientists can look up the CVs of requestors, their websites and other information to ensure that they are likely to use the cells for legitimate research purposes and not for stem cell tourism.

A fourth method proposed by Insoo Hyun is to manage the therapeutic hopes or spiritual distress patients may have about their disease. Certainly there is data suggesting that patients who seek stem cell tourism feel it is their only option left, are willing to assume the risks, and feel that they are knowledgeable about the disease and the stem cell intervention they are seeking. How to manage the frustration and distress such patients feel may be a way to help them cope and mange better and could help them accept the fact that stem cell tourism clinics may not be able to help them. Hyun proposed that physicians can direct patients to hospital based resources i.e., pastoral care or medical social workers. Certainly patient disease groups are an excellent way that patients sharing a common disease can come together and share information, coping strategies and other aspects that can make their life better and reduce stress however possible.

A final method I proposed with Doug Sipp in a paper that will soon be published in The Monitor is for patient advocacy groups to come together to educate and advocate with one voice the need for robust research and reaffirm the importance for regulatory scrutiny. We argued that patient advocacy groups have remained immune from the widespread critiques such clinics have proposed on regulators, physicians and scientists indicating that such groups have alternative motives and interests that prevent the development or release of therapies to the public. This has further fueled the distrust of patients explained earlier. In addition, patient advocacy groups are well organized, trusted, and can communicate and educate their constituency and other groups more effectively than other organizations. A coalition of patient groups for major diseases where stem cell research may help could coordinate and issue a joint response about the issues of stem cell tourism, the need for rigorous science and regulations, and be more effective at persuading patients, physicians and regulatory authorities.

It is likely however that all five of these ideas may be necessary to undertake in order to effectively quell stem cell tourism. Yet developing these strategies takes a fair bit of leadership, coordination and political will and it is uncertain whether this will be possible. As more stem cell clinical trials employing stem cells are being done, it might be increasingly difficult for patients to discern legitimate clinical research from the selling of snake oil. The awareness of stem cell tourism is not very high and certainly isn’t a huge priority for most nations. But efforts need to start somewhere and all of us in academia and medicine need to make an effort to raise awareness and stop the stem cell tourism industry from continuing in some capacity.

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 our website.

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