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October 2, 2013 | Posted By Zubin Master, PhD

I have previously discussed the topic of stem cell tourism in previous AMBI blogs. To provide a brief introduction from another blog, stem cell tourism is used to 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 Parkinson’s 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.

In my previous blog, I briefly described several ways to stop stem cell tourism including: 1) strengthening regulatory scrutiny and enforcement in many nations and perhaps developing a system of international governance that oversees clinical stem cell research and treatment; 2) 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; 3) stopping smaller clinics from starting up by having scientists evaluate requestors of materials (i.e., stem cell lines, media etc.) and have scientists responsibly share with only those requestors who will use them for legitimate purposes; and 4) to manage the therapeutic hopes and spiritual distress of patients suffering from various diseases. Today, I will discuss in greater a detail a new method Douglas Sipp and I proposed in a paper recently published in The Monitor.

In this paper, we argued for a unique role of having patient advocacy groups stop stem cell tourism by coming together and with one voice, reaffirming the importance for robust research and regulatory scrutiny. We were inspired to write this paper because of (i) false accusations claiming that scientists, bioethicists, regulators and others have direct conflicts of interests making them biased, and (ii) some empirical evidence suggesting that patients seem to distrust their domestic research and regulatory system in their home countries. But first let me demonstrate the accusations and distrust through a few powerful quotes.

Dr. Paul Knoepfler from UC Davis School of Medicine has a popular Lab Stem Cell Blog where he writes about many topics related to stem cell research including the premature translation and commercialization of stem cell science. Beyond writing for his blog, he also writes for others and in one blog titled “Considering a Stem Cell Treatment From a Clinic? Have a Listen” for the Huffington Post, one comment he received by a co-founder of StemCellPioneer explained,

I believe a dialog with patients is long overdue. We need to be included and our needs and concerns should be addressed. Patients are tired of having research scientists and others who may have conflicts of interest "protect" us. The media needs to do a much better job of vetting those that they claim are "experts" or claim to speak for the stem cell industry. Many times, these spokespeople have limited expertise or conflicts of interest that prevent them from being fair and unbiased. Let's get serious and if you say you have no conflict of interest or horse in the race, then please accept my offer to field questions from real patients.

This is one example that scientists and others have conflicts of interest, perhaps based on the idea that scientists desire continuing to proliferate their research and simply don’t care about bringing therapies to the marketplace. As Knoepfler clearly explains in one of his blogs,

Making that kind of accusation, however, is a common tactic of proponents of stem cell deregulation; throw unfounded charges of conflicts of interest against anyone who raises concerns about clinics. Another weapon is to accuse stem cell researchers of being uncaring or disconnected from reality or somehow not as smart or caring as the MDs selling the stem cell treatments. The sad irony is that as the false accusations of conflicts of interest are thrown at stem cell researchers, it is somehow ignored that the MDs involved are raking in millions of dollars of patients’ money.

In addition to accusations of conflicts of interest, there are also several lines of evidence that patients distrust their domestic research and regulatory system. In one paper I wrote, I quoted some work originally done by Christen Rachul, previously a researcher at the University of Alberta’s Health Law Institute who in a blog analysis of patients seeking stem cell treatments discovered quotes of distrust. One blogger wrote,

Of coarse [sic] the mainstream medical research bodies will be skeptical of what the Chinese are doing but the point is that they are doing some­thing and that something is tangible and real now. What they are doing is creating hope and after being there myself, this is a hope based on real life experiences not just fictitious episodes or placebo induced improvements that many researchers would claim. (Master et al., Journal of Law Medicine and Ethics, Spring 2013, p254-268)

In the above paper, we also quoted a transcript from a study by Chen and Gotweiss interviewing patients who travelled to a major stem cell clinic in China to seek treatment:

The Chinese doctors are better than Canadian doctors, Canadian doctors are greedy, they work for the rich, but the Chinese doctors are happy to help, they are more responsible to their patients, and more professional. Our doctors in Canada said Chinese medicine was 30 years ahead of Canada. We think highly of Chinese doctors, we receive very good care and have positive experi­ence here. (H. Chen and H. Gottweis, Bioethics, 2013, p194-207)

The quotes reported here about conflicts of interests of stem cell scientists, physicians and others, and the growing skepticism and distrust of the research and regulatory system in nations like the U.S., Canada, U.K. are quite powerful. They point to the notion that those of us concerned with stem cell tourism are fighting an uphill battle. We are battling the hope patients have for an opportunity to have some cure or relief of pain and symptoms associated with their disease. Probably, we come off preachy while stem cell clinic providers offer hope. Patients may not see stem cell providers as peddling snake-oil, but as people offering a way to help them even if it the treatment was experimental and potentially dangerous.

Based on this rationale, Doug Sipp and I reasoned that perhaps patient advocacy groups can play a role in stopping stem cell tourism by reiterating the message for the need of thorough research and regulatory oversight over stem cell therapies before people get seriously harmed. Patient advocacy groups are trusted brokers of information and have remained immune from the widespread critiques placed upon people like me. Patients within such disease groups share a common medical condition and face similar disease-related challenges. The sharing of personal narratives of patients and family, and ways to handle and manage the mental, emotional and medical aspects of the disease forms a new set of knowledge different than what health professionals and scholars might offer. Thus patient advocacy groups become a trusted voice that could more effectively pass on the message and educate their constituency that research demonstrating treatment safety and efficacy is needed and this is done through a regulatory system governing clinical research. Patient advocacy groups are thus insulated from the accusations of bias, conflicts of interest and distrust thrown upon researchers, physicians and others.

So how would this work? Patient advocacy groups from a range of diseases where stem cell therapy may be an effective modality for treatment should come together, deliberate, and issue a joint statement explaining the need for rigorous research and regulatory oversight. Several patient advocacy groups have already engaged in such practices including ALS Worldwide and Multiple Sclerosis Society UK. But greater coordination is needed to have a more powerful voice if such a message is to be heard.

There would be several challenges to this proposal. While there are many patient disease advocacy groups in countries like the U.S., Canada, Australia and the U.K., such groups are less common outside the English-speaking world and thus such a strategy may have limitations in other non-Western countries. Furthermore, some patient advocacy groups might not buy into the strategy. They may be advocates for a deregulated market despite lacking evidence of safety and efficacy. Lastly, a message of this sort and any educational material on clinical stem cell research and medicine needs to convey how to discern between validated therapies, clinical research and trials, and unvalidated interventions and these demarcations may not be so clear and change as science and medicine progresses. This is crucial point as patients would want to enroll in clinical trials and not mistaken a valid stem cell therapy from those providing untested versions.

Patient advocacy groups are well organized, trusted, and can communicate and educate their constituency and other groups more effectively than other individuals and 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 are likely to be most effective at persuading patients to not seek untested stem cell therapies.

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.

1 comments | Topics: Bioethics and Public Policy, Education, Patient Advocacy, Stem Cell Research, Stem Cell Tourism

Comments

sushma gupta

sushma gupta wrote on 12/21/13 3:04 AM

Good blog. Thanks.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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