Wednesday, September 23, 2009

Quack You! Medical Tourism and Stem Cells

In the September 2009 issue of Nature Biotechnology, Jane Qiu reports on a thriving trade in nonvalidated stem cell interventions for incurable illnesses ("Trading on Hope"). The article provides numerous examples of overseas clinics that cater primarily to North American and European clientele in offering pricey, unproven stem cell transplants for incurable conditions like spinal cord injury, Parkinson's disease, and autism. Many of these clinics make extravagant claims in their promotion materials.

Encouragingly, policy makers are beginning to take notice. China, for example, has issued new regulations on clinical application of novel interventions; it requires licensing for clinics that provide unproven stem cells. India has issued guidelines on stem cell research and therapy. As noted previously in this blog, the scientific society ISSCR issued guidelines urging clinicians to offer nonvalidated stem cell interventions to patients only in the context of clinical trials designed to test safety and efficacy. Problem is (according to the article), guidelines are sporadically enforced, if that.

I think there is much more that governments and professional societies can and should do to stem this unethical conduct. Though most of these clinics are located outside of North American and Europe, some overseas clinics have reputable, North American / European scientists and clinicians on their advisory board or have partnerships with biotechnology companies that are based in North America / Europe. Examples include Stemedica (which includes several Stanford and UCSD faculty on its advisory board), and Theravitae (which has involved close collaboration with University of Pittsburgh clinicians), and Vescell (which includes Nobelist Aaron Ciechanover on its scientific advisory board). All of these companies offer stem cell interventions to large numbers of patients outside trials, and make claims that their interventions are effective when, in fact, they remain unproven.

1- Research ethics policies should condemn scientist-clinicians who travel or collaborate abroad in delivering nonvalidated, potentially risky interventions overseas outside the context of a clinical trial. Policies should state clearly the imperative of subjecting nonvalidated interventions to systematic study.
2- Institutions should not allow these clinics to trade on their reputations, and should sanction faculty members who are involved in such activities.
3- professional societies in medical fields (e.g. cardiology) and research areas (stem cells, gene transfer) should steward the standing and credibility of their research field by developing policies and standards that discourage inappropriate activities-- through social pressure-- by providing a benchmark against which the conduct of scientists and clinicians can be judged.

(photo credit: Insert Photographer Here, 2006)


Anonymous said...

You better check your facts. Theravitae does not have any collaboration with University of Pittsburgh. Contact the University and see for yourself. Year ago, they had a brief collaboration with Dr. Patel while he was at Pitt but Dr. Patel teminated that relationship long ago.

Anonymous said...

"...years ago..." not "year ago" - sorry

Anonymous said...

You should also verify that the TV scientific board still actually exists. The last time they reported meeting was in 2005. Are you sure these scientists are still active board members? Has it occured to you that their web site might not be accurate? Do us all a public service and contact each board member to see if he is still a member and find out the last time it convened. Also, you can leave Dr. Belkin out since he is a shareholder in TV. Dr. Suphachai is also benefits financially from treating TV patients.

Jonathan Kimmelman said...

Thank you, Anonymous, for your comments:
1- I described Therivitae's collaboration with Pitt/ Dr. Patel using past tense, so I'm not clear where the dispute is here. I do not know whether Dr. Patel terminated the relationship with them, or whether Pitt forced him to terminate it following Pitt's regrettable entanglement in the Woo-Suk Hwang affair
2-Yes- web sites do get outdated. I have not contacted members of the board-- I'm just reporting what I've been able to learn from public sources. If a scientist has a falling out with a organization / company that has fallen into disrepute, I leave it to them to insist that their name be removed from promotional web materials.
3- If you have any further information about any of the above, please feel welcome to post here.

Doug Sipp said...

I enjoyed the post. I believe that Dr Patel has since moved to the University of Utah, where he continues to do research on cell therapy for heart conditions. His name has cropped up on other Asian stem cell clinic websites in Japan and Singapore, but I have not been able to verify whether these claims of association are accurate (he has not answered emails about this). I believe that Dr Ciechanover is no longer involved with Theravitae or its sister company VesCell, and my impression is that he dissociated himself after learning of the nature of the venture (this would need verification). The industry of offshore stem cell treatments appears to continue to grow, and the International Society for Stem cell Research has convened a task force to develop public resources to counter some of the bad information that is out there.

Jonathan Kimmelman said...

Well, there you have it, from no less an authority on Asia and stem cell research than Doug Sipp.

Thanks, Doug, for providing this really helpful update. More troubling, still, institutions continue to market themselves using scientists who have disaffiliated.

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