Information: Stem Cell Tourism Redux (part 1)

by

The current issue of Kennedy Institute of Ethics Journal contains the first installment in a two part series on the ethics of stem cell tourism, by long time stem cell watcher Cynthia Cohen and Peter Cohen. The Cohens pull together a large body of news reports and internet posts on Russian and Indian private clinics offering stem cell interventions to foreign patients (who travel to these clinics because they cannot receive the nonvalidated interventions in their native countries).

They provide a very critical view of these clinics and the practice of offering nonvalidated stem cell interventions to large numbers of patients outside of clinical trials- a view that readers of this blog will recognize as one that I share: “those who travel to other countries for stem cell treatments enter into a sort of medical Russian roulette.” I would add: they pay large sums to shady characters for the privilege.

The back end of the article takes issue with commentators who have offered a quasi-defense of stem cell tourism, viewing stem cell development as analogous to surgical innovation. These commentators have thus defended the idea of offering stem cells outside the trial context. According to the Cohens, these commentators “do not explain in what respects these interventions resemble surgical procedures and do not furnish reasons why clinical trials are not possible for them.”

There is an intriguing theme in this article that ties in with my recent Science article. Namely, the Cohens are careful to point out that there are many legitimate stem cell scientists in Russia and India that have called on their governments to regulate stem cell clinics because their activities harm the reputation of unaffiliated stem cell researchers in the same country. More on how stem cell scientists have attempted to draw boundaries between their own work and that of these clinics in my next post… (photo credit: Alex McGibbon, (courtesy Banksy), 2006)

BibTeX

@Manual{stream2010-61,
    title = {Information: Stem Cell Tourism Redux (part 1)},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2010,
    month = jun,
    day = 17,
    url = {http://www.translationalethics.com/2010/06/17/information-stem-cell-tourism-redux-part-1/}
}

MLA

Jonathan Kimmelman. "Information: Stem Cell Tourism Redux (part 1)" Web blog post. STREAM research. 17 Jun 2010. Web. 21 Jul 2017. <http://www.translationalethics.com/2010/06/17/information-stem-cell-tourism-redux-part-1/>

APA

Jonathan Kimmelman. (2010, Jun 17). Information: Stem Cell Tourism Redux (part 1) [Web log post]. Retrieved from http://www.translationalethics.com/2010/06/17/information-stem-cell-tourism-redux-part-1/


Expectation is a Vascular Condition: Thoughts on Media Coverage of "Liberation Procedures" for Multiple Sclerosis

by

Disclaimer to all readers: I am not expert in multiple sclerosis. I am not intimately familiar with recent research findings on a novel surgical treatment (“liberation procedure”) for multiple sclerosis that have received wide coverage in the Canadian media.


Now here are my “claimers:” recent media accounts of this novel approach border on the irresponsible, and point to serious problems with the way many media outlets cover translational clinical research. My second “claimer” is that such media coverage has important consequences for patients and the research community.

Finally, a point of clarification: my comments below concern the quality and consequences of media coverage, not the merits of the medical procedure discussed.

Here is the background: on November 20, the Globe and Mail ran a feature by veteran reporters André Picard and Avis Favaro titled “Researcher’s labor of love leads to MS breakthrough.” The story described a novel theory of an Italian researcher, Paolo Zamboni, that MS “is not, as widely believed, an autoimmune condition, but a vascular disease. More radically still, [an] experimental surgery offers hope that MS… can be cured and even largely prevented.” Said Dr. Zamboni, “I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis.” The news story then describes an Italian study that performed the surgical procedure in 65 patients; the patients saw their disease virtually eradicated.

Like practically every other news article of this species, the reporters do two things. First, they truck out a few patients to proclaim the miracle cure (said one: “I don’t remember what it’s like to have MS”). Second, to establish credibility, the reporters throw in the perfunctory killjoy comments of a few scientists: “skeptics warn the evidence is too scant and speculative.”

As observed on the excellent NPR program On the Media, media coverage of medical research and breakthroughsoverflow with optimism and excitement, offering hope for millions.” According to long-time media analyst Gary Schwitzer, “What they don’t overflow with is accuracy, context and journalistic responsibility.” (Schwitzer, by the way, runs an excellent blog on health news coverage).

Here are some concerns I had about the Globe and Mail story:

• the story reports on clinical research findings. The story did not say, however, that the results have not been published and subjected to peer review.

• the story did not say whether the studies were well-designed: was there a control or placebo arm, for example? the story did not mention that placebo responses can be especially high in the setting of surgical interventions. Nor did it mention that placebo responses are often high in the context of remitting diseases like MS.

• the story wrapped logical fallacies within emotive proclamations. For example, what, precisely, could it possibly mean to say “I am confident this could be a revolution…”?

• the story was not linked in any way to any particular event. Usually reports like this follow from major scientific publications, or presentations at medical conferences. This story, however, is “free floating”- which makes it much more difficult to contextualize (why is it being reported now? how well have the findings been vetted? how did the researchers capture the attention of journalists?).

• the story contains statements that are deeply suspicious. One example is that Zamboni claims MS is not an autoimmune condition. Here is the very first line in the abstract of Professor Zamboni’s most recent publication: “Multiple sclerosis is primarily an autoimmune disorder of unknown origin.”

• the story did not address the correlation and causation problem. The story (and Zamboni) claim that vascular malformations cause MS symptoms, because the researcher discovered that many MS patients have “malformed or blocked” veins draining the brain. But an alternative explanation would be that malformations or blockages are themselves caused by MS- that they are symptomatic rather than causal. Any news coverage of correlation should always address the issue of cause.

And the consequences? Do a google search yourself on the procedure (CCVSI) to find out how much chatter there is among expectant patients, who (judging from discussions) are wondering whether they can travel to Italy to receive the “treatment.” And today, the Globe and Mail reports that the MS Society of Canada- portrayed as sourpuss nabobs of negativism in the previous article- will now fund CCVSI “with significant research dollars” in response to “the overwhelming public response to the media stories.”

Surely, more research, more trials, more basic science is needed. If indeed this approach is a promising as reported, it should be subject to rigorous clinical testing. But can anyone seriously argue that media coverage of this low quality should set the research agenda and decide how scarce research resources are allocated? (photo credit: xbloodsin, sepulcrum, 2008)

BibTeX

@Manual{stream2009-77,
    title = {Expectation is a Vascular Condition: Thoughts on Media Coverage of "Liberation Procedures" for Multiple Sclerosis},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2009,
    month = nov,
    day = 24,
    url = {http://www.translationalethics.com/2009/11/24/expectation-is-a-vascular-condition-thoughts-on-media-coverage-of-liberation-procedures-for-multiple-sclerosis/}
}

MLA

Jonathan Kimmelman. "Expectation is a Vascular Condition: Thoughts on Media Coverage of "Liberation Procedures" for Multiple Sclerosis" Web blog post. STREAM research. 24 Nov 2009. Web. 21 Jul 2017. <http://www.translationalethics.com/2009/11/24/expectation-is-a-vascular-condition-thoughts-on-media-coverage-of-liberation-procedures-for-multiple-sclerosis/>

APA

Jonathan Kimmelman. (2009, Nov 24). Expectation is a Vascular Condition: Thoughts on Media Coverage of "Liberation Procedures" for Multiple Sclerosis [Web log post]. Retrieved from http://www.translationalethics.com/2009/11/24/expectation-is-a-vascular-condition-thoughts-on-media-coverage-of-liberation-procedures-for-multiple-sclerosis/


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. 21 Jul 2017. <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/


A Thick Frosting of Science…

by

On September 2, the Washington Post ran a story (“Injections of Hope: Doctors Promote Offshore Stem Cell Shots, but Some Patients Cry Foul”) on an emerging global economy of stem cell medical tourism. It described how patients with conditions ranging from ALS to spinal cord injury travel to offshore clinics to receive unvalidated cell “therapies”–embryonic or otherwise– for $15-50K; less if they bring in new customers.


The article portrays many of the doctors performing these procedures as well outside the mainstream. Many are. But a closer inspection shows many of the scientists and physicians associated with these outfits are having their cake of staying in the mainstream of scientific practice, while getting to eat the fees provided by desperately ill patients.

One example I encountered in my research is Thailand based Vescell, which claims to provide “a revolutionary new treatment for heart disease that actually rebuilds heart tissue using the patient’s own stem cells.” Their web site is a rich trove of moving patient testimonials. These treatments are not approved in the U.S. or Europe, and using them would be considered a flagrant breach of medical ethics outside of clinical trials. Who is on the scientific advisory board of this company? Nobel Laureat Aaron Ciechenover, and University of Toronto-based Ren-Ke Li. Who holds the patent on Vescell’s procedures? The Toronto-headquartered biotechnology company, Theravitae. Surely, policy-makers and fellow researchers can do much more to police these medical confectioners. (photocredit: mityrina 2007)

BibTeX

@Manual{stream2008-138,
    title = {A Thick Frosting of Science…},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = sep,
    day = 4,
    url = {http://www.translationalethics.com/2008/09/04/a-thick-frosting-of-science/}
}

MLA

Jonathan Kimmelman. "A Thick Frosting of Science…" Web blog post. STREAM research. 04 Sep 2008. Web. 21 Jul 2017. <http://www.translationalethics.com/2008/09/04/a-thick-frosting-of-science/>

APA

Jonathan Kimmelman. (2008, Sep 04). A Thick Frosting of Science… [Web log post]. Retrieved from http://www.translationalethics.com/2008/09/04/a-thick-frosting-of-science/


Sell Therapy, European Style

by

Two side-by-side news reports in the August 21 issue of Nature spell more trouble for cell therapy in Europe. The first story follows on previous reports about Austrian urologist Hannes Strasser (see postings on Jul 23 and May 27, 2008). According to an Austrian government report, Strasser “failed to get appropriate approval for the trial from authorities… failed to adequately inform patients… [and used] poor study design.” Strasser’s university has banned him from seeing patients. Somewhat cryptically, the article mentions that “several of the hundreds of patients who have undergone the procedure by Strasser’s team… claim that they have had serious side effects.”  Are these attributable to the intervention?  We shall see.


About 600 kilometers to the Southeast, a Bulgarian deputy minister resigned after the European Union shut down a Sophia-based clinic that provides non-validated bone marrow therapy treatments for victims of spinal-cord trauma, stroke, and neurodegenerative diseases.  The minister reportedly has family members who “own two private companies” that perform the procedures. (photocredit: Eesti, Central Hali Market in Sophia, 2005)

BibTeX

@Manual{stream2008-139,
    title = {Sell Therapy, European Style},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = aug,
    day = 28,
    url = {http://www.translationalethics.com/2008/08/28/sell-therapy-european-style/}
}

MLA

Jonathan Kimmelman. "Sell Therapy, European Style" Web blog post. STREAM research. 28 Aug 2008. Web. 21 Jul 2017. <http://www.translationalethics.com/2008/08/28/sell-therapy-european-style/>

APA

Jonathan Kimmelman. (2008, Aug 28). Sell Therapy, European Style [Web log post]. Retrieved from http://www.translationalethics.com/2008/08/28/sell-therapy-european-style/


Stemming Medical Tourism (part 1)

by

The July 17 issue of Nature reports that a patient participating in a Vienna-based cell transfer study for urinary incontinence won a lawsuit against the University Hospital in Innsbruck for not being “told… the procedure was experimental.”


The case was described in an earlier post in my blog (May 27, 2008: Bladder Trouble at the Frontier).  There are a number of cell transfer strategies that are being applied in clinics, despite absence of reliable data showing efficacy. This should worry conscientious investigators who are trying to shepherd this promising technology platform to clinical application.

Here’s one example: Bankok based company TheraVitae offers cell transfer to advanced heart patients. In future posts, I will explore concerns about an emerging overseas industry in non-validated therapeutics that 1- involve cutting edge therapies, and 2-involve investors, and scientists, whose countries of origin have not yet licensed such therapies for clinical application. (photo credit: Olivander 2006)

BibTeX

@Manual{stream2008-143,
    title = {Stemming Medical Tourism (part 1)},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = jul,
    day = 23,
    url = {http://www.translationalethics.com/2008/07/23/stemming-medical-tourism-part-1/}
}

MLA

Jonathan Kimmelman. "Stemming Medical Tourism (part 1)" Web blog post. STREAM research. 23 Jul 2008. Web. 21 Jul 2017. <http://www.translationalethics.com/2008/07/23/stemming-medical-tourism-part-1/>

APA

Jonathan Kimmelman. (2008, Jul 23). Stemming Medical Tourism (part 1) [Web log post]. Retrieved from http://www.translationalethics.com/2008/07/23/stemming-medical-tourism-part-1/


Search STREAM

Old blog posts


All content © STREAM research

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