Quack You! Medical Tourism and Stem Cells

by

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)

BibTeX

@Manual{stream2009-84,
    title = {Quack You! Medical Tourism and Stem Cells},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2009,
    month = sep,
    day = 23,
    url = {http://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/}
}

MLA

Jonathan Kimmelman. "Quack You! Medical Tourism and Stem Cells" Web blog post. STREAM research. 23 Sep 2009. Web. 19 Nov 2019. <http://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/>

APA

Jonathan Kimmelman. (2009, Sep 23). Quack You! Medical Tourism and Stem Cells [Web log post]. Retrieved from http://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/


Stems and Blossoms (part 2): Really Informed Consent

by

There is a strain within the clinical and bioethics community that takes a minimal view of informed consent: investigators are supposed to provide requisite information to volunteers; if research subjects fail to comprehend this information, pity for them. This view brings to mind a memorable exchange between Inspector Clouseau and a hotel clerk (Clouseau: “does your dog bite?” Clerk: “No.”  Clouseau then extends a hand; the dog lunges at him.  “I thought you said your dog doesn’t bite.” Clerk: “Zat is not my dog.”)


The ISSCR guidelines take a bold stand on informed consent. “Investigators involved in clinical research must carefully assess whether participants understand the essential aspects of the study.”  The guidelines go on to state “ideally, the subject’s comprehension of information should be assessed through a written test or an oral quiz during the time of obtaining consent.” Once again, ISSCR shows vision here in going well beyond the legalistic conception of informed consent described above.

The ISSCR guidelines also urge researchers to:
• explain possible irreversibility of some toxicities
• describe the sources of stem cells
• inform patients that researchers “do not know whether they will work as hoped”

These laudable recommendations aside, I might have hoped for more guarded language about the therapeutic value of early phase studies. For one, the guidelines use mostly “therapeutic” language, for example, using the aspirational term “cell therapy” instead of the neutral term “cell transfer.” Second, the third item above logically means that the probability of benefit is less than 100%; experience tells us, however, that when interventions are highly novel, major therapeutic benefits for early phase trials are very improbable. (photo credit: Helen K, Stems, 2008)

BibTeX

@Manual{stream2008-114,
    title = {Stems and Blossoms (part 2): Really Informed Consent},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = dec,
    day = 30,
    url = {http://www.translationalethics.com/2008/12/30/stems-and-blossoms-part-2-really-informed-consent/}
}

MLA

Jonathan Kimmelman. "Stems and Blossoms (part 2): Really Informed Consent" Web blog post. STREAM research. 30 Dec 2008. Web. 19 Nov 2019. <http://www.translationalethics.com/2008/12/30/stems-and-blossoms-part-2-really-informed-consent/>

APA

Jonathan Kimmelman. (2008, Dec 30). Stems and Blossoms (part 2): Really Informed Consent [Web log post]. Retrieved from http://www.translationalethics.com/2008/12/30/stems-and-blossoms-part-2-really-informed-consent/


Search STREAM

Old blog posts


All content © STREAM research

admin@translationalethics.com
Twitter: @stream_research
3647 rue Peel
Montreal QC H3A 1X1