By Zubin Master, PhD
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 people’s minds such that they won’t undergo an unproven stem cell-based intervention (SCBI)? These are the questions I will discuss here. But first, let’s just give a brief description of stem cell tourism and outline some of the proposals discussed to stop this industry.
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, Parkinson’s 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.
Several strategies to curtail this market have been proposed. Many have turned to increasing regulations, which have been met with limited success. But using legal mechanisms alone to regulate this international market may only partially address the problem because clinics have been known to move to a more permissive environment and rebrand themselves continuing business without a hiccup. I have previously discussed how scientists on the ground can share lines and reagents responsibly such that providers will be unable to obtain the necessary materials to start-up a dubious clinic (2). One bioethicist has begun a letter writing campaign to the U.S. Food and Drug Administration alerting the regulatory agency to questionable practices happening in our backyard (3). And several others have discussed how professional regulation by medical licensing bodies can take punitive measures towards physicians who engage in stem cell tourism practices (4). Last but not least, another major approach to quell the stem cell tourism market is to educate patients, caregivers and the public about stem cell research, the clinical translation process, and the dangers of unproven SCBIs. Several major organizations have invested seriously in public education on unproven SCBIs including the International Society for Stem Cell Research’s (ISSCR’s) A Closer Look website (5), Stem Cell Australia’s The Australian Stem Cell Handbook (6), and the U.K. MS Society’s Stem Cell Therapies in MS handbook (7) among others. Along with collaborator Professor Timothy Caulfield at the University of Alberta, we have invested in designing and disseminating a patient handbook as well (8). Yet despite these notable efforts, overall there seems to be relatively little publically available comprehensive information on stem cell therapies and tourism.
Public Education and Stem Cell Tourism
We recently completed a study published in Cell Stem Cell evaluating 50 scientific organizations and 125 patient advocacy groups to assess the nature and quality of online information available on stem cell therapies and tourism (9). To provide a comparison, we looked at educational content on the science of stem cells, ethical and policy issues, and information about stem cell treatments and tourism. While 51% of scientific organizations and 21% of patient advocacy groups had information on stem cell science, both sets of organizations had equally low levels of information on unproven SCBIs ranging from 12% to 16%. These results show that while a few groups have made serious efforts to educate patients and the public, overall, there is little information out there (9).
Several have argued that education may not alter patient demand for unproven SCBIs because this approach depends on a rational actor model that assumes individuals will behave rationally and do what is optimal, based on the factual information presented (10). It is likely that patients become less risk averse and are willing to take their chances. The term “What have I got to lose?” is a common response by patients (11). Yet this view fails to adequately consider the value of public education on unproven SCBIs. First, education alone can never be thought to sufficiently achieve major public health goals in the absence of other interventions, and second, education should aim to provide more than simple functional literacy (e.g., knowledge on stem cell research and unproven SCBIs). It should aim to promote communicative/interactive literacy to improve an individual’s capacity to act independently on knowledge, increase self-confidence, and permit greater autonomy and personal empowerment (12, 13). For example, we know that some patients who have undergone unproven SCBIs have regretted their decisions (14) and so, may be public education might help some reconsider options. Education may also be helpful to counter some misinformation e.g., provider claims that SCBI are risk free if they are from their own body. And it may also help those seeking registered stem cell clinical trials recognize dodgy clinics advertising unproven interventions as “experimental treatments.” We must recognize that the question of whether educational campaigns on stem cell therapies and unproven SCBIs are effective remains empirically unassessed.
Many earlier health literacy campaigns on anti-smoking or college binge drinking have relied simplistically on the transmission of information and were of limited success because they did not necessarily promote healthy behaviors. However, more recently, strategies to improve public health messages have increased in theoretical sophistication and we know that message framing can help shape individual perceptions and motivate healthy behaviors (15). So perhaps education campaigns on stem cell therapies and unproven SCBIs can begin to incorporate message framing and other methods to more effectively promote healthy behaviors. More research is needed to better understand the effectiveness of current patient education on SCBIs and to improve our understanding of patient perceptions of risk and benefits of receiving unproven SCBIs so that we may better design more effective educational material.
Guest Post was written by Dr. Zubin Master, Assistant Professor at the Alden March Bioethics Institute, Albany Medical College and Research Associate at the University of Alberta’s Health Law Institute.