Information: Stem Cell Tourism Redux (part 1)

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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 Sep 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/


California Dreamin: CIRM Announces New Stem Cell Awards

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California’s Institute for Regenerative Medicine just announced a series of large funding awards to fund translational research initiatives involving (mostly) stem cells. The projects funded are telling with respect to what was funded, and what they will attempt to achieve.


First, notwithstanding a press release containing the words “bringing stem cell therapies to the clinic,” several projects are really dressed up gene transfer studies. Thus, one team will use gene transfer in hematopoietic stem cells for sickle cell anemia; another two will use gene transfer to stem cells for treating brain malignancies; another RNAi for HIV. All this is only further evidence that the field of stem cells is devouring gene transfer. Other projects are aimed more at getting “stem cells out of the clinic” by using small molecules or monoclonal antibodies to destroy stem cells causing malignancies.

Second is the sweeping ambition. As it stands today, only one clinical trial involving embryonic stem cell-derived tissues has been initiated. The projects funded under these awards are “explicitly expected to result in a filing with the FDA to begin a clinical trial.” Given that these projects are funded for four years, CIRM seems to be banking on the prospect of at least a few of these initiating phase 1 trials within five years. Four of these proposals involve goals of implanting embryo-derived tissues, and two of these involve non-lethal conditions–macular degeneration and type I diabetes (technically, other awarded projects involve nonlethal, though extremely morbid conditions). Another involves implantation of embryo-derived tissues for Amyotrophic Lateral Sclerosis. It will be interesting to see how many of these meet their translational objectives, and how investigators will navigate the ethical, regulatory, and social complexity of initiating clinical testing. (photo credit: Michael Ransburg, 2008)

BibTeX

@Manual{stream2009-80,
    title = {California Dreamin: CIRM Announces New Stem Cell Awards},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2009,
    month = nov,
    day = 5,
    url = {http://www.translationalethics.com/2009/11/05/california-dreamin-cirm-announces-new-stem-cell-awards/}
}

MLA

Jonathan Kimmelman. "California Dreamin: CIRM Announces New Stem Cell Awards" Web blog post. STREAM research. 05 Nov 2009. Web. 21 Sep 2017. <http://www.translationalethics.com/2009/11/05/california-dreamin-cirm-announces-new-stem-cell-awards/>

APA

Jonathan Kimmelman. (2009, Nov 05). California Dreamin: CIRM Announces New Stem Cell Awards [Web log post]. Retrieved from http://www.translationalethics.com/2009/11/05/california-dreamin-cirm-announces-new-stem-cell-awards/


Prime Time for Embryonic Stem Cells?

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According to a recent report in the Washington Post, researchers at Geron have received approval from FDA to initiate the first ever human trial involving stem cells derived from human embryos.  A story in the most recent issue of Nature provides more background.


Briefly, the study will involve transplanting tissues derived from human embryonic stem cells into patients who have recently suffered severe spinal cord injury. The principle behind the study is that the embryo-derived oligodendrocytes might repair myelin and restore the ability for nerves to transmit impulses.  According to the Nature report, Geron, submitted 22,000 pages of material to FDA, including data from 24 studies involving over 2000 animals.

So is the decision to initiate studies at this juncture prudent?  That’s impossible to know without seeing the supporting data. What I can comment on, however, is the recurrence of a rhetoric that glosses trial initiation– rather than trial outcome– as a medical achievement in itself.  Whereas the former is a regulatory event, the latter is a clinical event. In my book about gene transfer, I argue that this sets up a cycle of expectation that is difficult to sustain given the scientific and clinical uncertainties. We saw this in the early days of gene transfer. Some examples of this “trial initiation”=”medical achievement”:

• “This… marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.” (Thomas Okarma, Geron chief executive)
• “Today’s news… is a milestone in the new era of hope…” (Amy Comstock Rick, Coalition for the Advancement of Medical Research)
• “This is what we’ve all been waiting for” (Robert Lanza, Advanced Cell Technology)
• “The announcement boosted the price of shares in [Geron]… up 56% from the day before the announcement” (Meridith Wadman, Nature, Jan 27, 2009)

I wish Geron, and the patients enrolled in this study, all the best.  But if embryonic stem cell work is anything like practically every other major medical advancement, be prepared for a very long, tough slog with lots of setbacks.  In one of the stories, Sean Tipton from the Coalition for the Advancement of Medical Research, commented  “This is a trial of one particular application, not a trial of all embryonic stem cells.” That sounds just about right. (photo credit: no typographic man, UlamSpiral (negative), 2006)

BibTeX

@Manual{stream2009-111,
    title = {Prime Time for Embryonic Stem Cells?},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2009,
    month = jan,
    day = 30,
    url = {http://www.translationalethics.com/2009/01/30/prime-time-for-embryonic-stem-cells/}
}

MLA

Jonathan Kimmelman. "Prime Time for Embryonic Stem Cells?" Web blog post. STREAM research. 30 Jan 2009. Web. 21 Sep 2017. <http://www.translationalethics.com/2009/01/30/prime-time-for-embryonic-stem-cells/>

APA

Jonathan Kimmelman. (2009, Jan 30). Prime Time for Embryonic Stem Cells? [Web log post]. Retrieved from http://www.translationalethics.com/2009/01/30/prime-time-for-embryonic-stem-cells/


Stems and Blossoms (part 2): Really Informed Consent

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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. 21 Sep 2017. <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/


Stems and Blossoms (part 1): Justice

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Shortly before I left for holiday, the International Society for Stem Cell Research (ISSCR) issued a policy paper, “Guidelines for the Clinical Translation of Stem Cells,” outlining ethical and scientific considerations for researchers designing translational trials involving stem cells (whether stem cell derived, adult, or embryonic).


In my opinion, the document wins the award for most forward thinking and comprehensive statement on the ethics of a translational enterprise. It shows that the stem cell research leadership has closely studied mistakes made by translational researchers in other highly innovative fields.  But the guidelines do more than look backwards; they proactively contemplate fairness and justice considerations as well.  Here are a few justice-related excerpts:

On responsiveness: “The ISSCR strongly discourages conduct of trials in a foreign country solely to benefit patients in the home country of the sponsoring agency. The test therapy, if approved, should realistically be expected to become available to the population participating in the clinical trial through existing health systems or those developed on a permanent basis in connection with the trial.”

On reasonable availability: “As far as possible, groups or individuals who participate in clinical stem cell research should be in a position to benefit from the results of this research.”

On diversity: “Stem cell collections with genetically diverse sources of cell lines should be established”

On access and licensing: “Commercial companies, subject to their financial capability, should offer affordable therapeutic interventions to persons living in resource-poor countries who would otherwise be wholly excluded from benefiting from that stem cell-based therapy. Academic and other institutions that are licensing stem cell therapeutics and diagnostic inventions should incorporate this requirement in their intellectual property license”

On review: “Regulatory and oversight agencies (local, national, and international) must explicitly include the consideration of social justice principles into their evaluations.”

On trial participation: “… the sponsor and principal investigator have an ethical responsibility to make good faith, reasonable efforts whenever possible to secure sufficient funding so that no person who meets eligibility criteria is prevented from being considered for enrollment because of his or her inability to cover the costs of the experimental treatment.”

In upcoming posts, I will comment on other aspects of the ISSCR guidelines. (photo credit: Helen K, Stems, 2008)

BibTeX

@Manual{stream2008-115,
    title = {Stems and Blossoms (part 1): Justice},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = dec,
    day = 28,
    url = {http://www.translationalethics.com/2008/12/28/stems-and-blossoms-part-1-justice/}
}

MLA

Jonathan Kimmelman. "Stems and Blossoms (part 1): Justice" Web blog post. STREAM research. 28 Dec 2008. Web. 21 Sep 2017. <http://www.translationalethics.com/2008/12/28/stems-and-blossoms-part-1-justice/>

APA

Jonathan Kimmelman. (2008, Dec 28). Stems and Blossoms (part 1): Justice [Web log post]. Retrieved from http://www.translationalethics.com/2008/12/28/stems-and-blossoms-part-1-justice/


From Bench to Ringside: The Presidential Debate

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Last night, Obama and McCain confronted each other in the final Presidential debate. A flagging economy and two wars have left little room in the two campaigns for discussion of science, policy, and human research. Yet last night’s debate touched on two themes: embryonic stem cell (hES) research, and biomedical research funding.


Obama accused McCain of opposing embryonic stem cell research. From what I can tell, McCain actually supported the use of embryonic tissue for research and opposed Bush’s ban and vetoes. But the logic of McCain’s attacks on Obama, of late, are that personal associations tell us something about who a person is and where they stand. And McCain pals around with embryo research opponents like his running mate.

Contrast the two candidates’ statements on hES research from Sciencedebate 2008– a group that invited McCain and Obama to declare positions on various science policy issues. McCain stated “While I support federal funding for embryonic stem cell research, I believe clear lines should be drawn….”  The remainder of his response qualifies his support.  On his own website, McCain stops short of declaring support–or opposition– for hES research, and talks more about what he would oppose than what he would support.  Obama’s support is more full-throated at Sciencedebate 2008: “As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines… embryonic stem cells remain the ‘gold standard,’ and studies of all types of stem cells should continue in parallel for the foreseeable future.”

Elsewhere at Sciencedebate 2008, Obama’s campaign singled out gene transfer in a statement on genetics: “As a result [of safety issues involving ‘gene therapy’], the NIH established the Recombinant DNA Advisory Committee…. Until we are equipped to ascertain the safety of such methods, I will continue to support the activities and recommendations of the Recombinant DNA Advisory Committee.” [Note: Harold Varmus chairs a science advisory committee for the Obama campaign. Varmus reorganized RAC when he was the director of the NIH under the Clinton administration]

What about research– specifically translational research?  Just as they do for Joe the plumber, both candidates support NIH research. According to a report in Science (“Scientists Strive for a Seat at the Table of Each Campaign,” Jeffrey Mervis, 26 Sept), Obama pledged to double the NIH budget in five years. Elsewhere, his campaign said 10 years. Maybe the latter figure is inflation adjusted? Obama’s statement on Science and Innovation singles out “rapid translation of medical research.”

I am not aware of any clear statements on translational research from McCain, though he favors greater funding for NIH, and based on his debate and website, he seems to have a soft spot for autism research. As on other issues, McCain is less willing to commit to a timetable on NIH budget doubling. (photo credit: Thomas Hawk, Wordle of McCain and Obama convention speeches, 2008)

BibTeX

@Manual{stream2008-129,
    title = {From Bench to Ringside: The Presidential Debate},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = oct,
    day = 16,
    url = {http://www.translationalethics.com/2008/10/16/from-bench-to-ringside-the-presidential-debate/}
}

MLA

Jonathan Kimmelman. "From Bench to Ringside: The Presidential Debate" Web blog post. STREAM research. 16 Oct 2008. Web. 21 Sep 2017. <http://www.translationalethics.com/2008/10/16/from-bench-to-ringside-the-presidential-debate/>

APA

Jonathan Kimmelman. (2008, Oct 16). From Bench to Ringside: The Presidential Debate [Web log post]. Retrieved from http://www.translationalethics.com/2008/10/16/from-bench-to-ringside-the-presidential-debate/


A Thick Frosting of Science…

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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 Sep 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/


Is Embryonic Stem Cell Research Fully Developed?

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As reported by Monya Baker in the April 10 issue of Nature (and Alicia Mundy in Wall Street Journal, April 11), FDA is convening a public hearing on the safety of therapies derived from embryonic stem cells as I write this blog entry. (Note: for info on the meeting, visit http://www.fda.gov/OHRMS/  DOCKETS/98fr/E7-24629.htm)


As yet, (reputable) researchers have not yet administered embryo-derived tissues to human beings. For several years, however, Geron has talked about a trial involving volunteers with spinal chord injury. The Nature report says that Geron intends to submit their IND this summer.

I (and others) have previously warned about too hasty a move into human clinical trials.  There are several concerns: 1- will embryo-derived tissues develop into cancers? 2- how will we assay this risk preclinically?  3-how will human volunteers be monitored? 4-embryo derived tissues are heterogeneous. What kinds of purity standards should be expected?  Each of these questions is incredibly complex, dividing into numerous sub-questions.

Let’s hope that researchers avoid some of the mistakes made in the field of gene transfer– and that the FDA plays a more proactive role in establishing appropriate guidelines. One troubling difference between this field and gene transfer is that initial studies of the latter took place in public settings.  Expect that embryonic stem cell tissue transplantation studies will largely take place beyond the gaze of the public. (photo credit: uiruriamu 2007)

BibTeX

@Manual{stream2008-161,
    title = {Is Embryonic Stem Cell Research Fully Developed?},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2008,
    month = apr,
    day = 11,
    url = {http://www.translationalethics.com/2008/04/11/is-embryonic-stem-cell-research-fully-developed/}
}

MLA

Jonathan Kimmelman. "Is Embryonic Stem Cell Research Fully Developed?" Web blog post. STREAM research. 11 Apr 2008. Web. 21 Sep 2017. <http://www.translationalethics.com/2008/04/11/is-embryonic-stem-cell-research-fully-developed/>

APA

Jonathan Kimmelman. (2008, Apr 11). Is Embryonic Stem Cell Research Fully Developed? [Web log post]. Retrieved from http://www.translationalethics.com/2008/04/11/is-embryonic-stem-cell-research-fully-developed/


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