|Gov. Rick Perry|
Former and possible future Presidential candidate, Texas Governor Rick Perry is a big supporter of adult stem cells. They form part of his plan to boost the state economy by investing in "cutting-edge technology." He and his allies have been "laying the foundation for the commercialization of the controversial procedure in Texas" for months, according to the Texas Tribune.
Perry is also a patient, with a recurring back injury. In July 2011, he was treated with an infusion of his own stem cells, which had been removed and cultured at a lab run by RNL Bio (more on them here and here). When this news broke, it provoked a scathing column by Professor, and prominent public bioethicist, Art Caplan, who called it "an irresponsible choice that endangered himself and anyone who might follow his lead." Caplan concluded that Perry:
equates creationism with evolution ... and is using and promoting "treatments" that are at present more closely tied to quackery then medicine.
Perry's doctor, Stanley Jones, had never performed the procedure before — it was not then and is still not FDA-approved — but had traveled to Japan for stem-cell treatment himself in 2010. That too was an RNL Bio treatment, but it was performed in Japan because it is illegal in South Korea, where the company is based.
Here's where this multi-national controversy begins to get tangled together with a dispute currently roiling the field of bioethics. Two of RNL Bio's patients died, and the International Cellular Medicine Society commissioned an expert to investigate. That was Glenn McGee. The findings, reported in late 2010, were that one death was probably unrelated to the stem-cell treatment, the other likely triggered by it; but that informed consent was given in both cases, so the company was essentially off the hook.
McGee was then at the Center for Practical Bioethics, and Editor-in-Chief of the American Journal of Bioethics (AJOB), one of the highest-profile publications in the field. He has now moved to Celltex Therapeutics, a Texas company specializing in stem cells and partnered with RNL Bio. Celltex was founded by Dr Jones and David Eller, a Perry backer, former business partner of Jeb Bush and longtime Republican donor.
McGee's move to Houston has certainly raised eyebrows, especially since it seems that some dissembling has been involved. Leigh Turner has documented here the "scrubbing" of the Internet to, for example, remove the first announcement of McGee's then-pending resignation from AJOB, and replace it with one that seems to show him having left the position before starting work at Celltex, which finally announced his arrival last Friday. Carl Elliott put together "A reporter's guide to the American Journal of Bioethics scandal" (which includes some links to Biopolitical Times). Alice Dreger has also weighed in, asking pointedly, "Who's Policing the Ethicists?"
Indeed, one member of the Editorial Board, John Lantos, has now resigned. As the former President of the American Society for Bioethics and Humanities, his decision carries some weight. Lantos is withdrawing a previously submitted paper, will discourage others from publishing in AJOB, and will not even cite papers published there. His resignation letter ends:
In my opinion, the editors have failed to establish the degree of transparency that should be minimally acceptable for any journal and certainly for one charged to host a forum in which ethical evaluations are right at the center.
Other authoritative commentators, such as Christian Munthe and Howard Brody, are particularly concerned about McGee's loss of credibility, and problems arising directly or indirectly out of the Celltex connection. The potential conflicts of interest are exacerbated by the fact that someone who works for the FDA, who in turn are likely to rule on Celltex products, was appointed in 2010 by McGee to edit AJOB Primary Research, a companion title. Kaustuv Basu at Inside Higher Ed mentioned previous issues (Hilde Lindemann quit the board last year, with complaints about a lack of transparency) while also giving space to those such as Laurence McCullough and Paul Root Wolpe who seem to consider the matter a storm in a teacup.
Perry's push for commercial stem cells in Texas is having an effect. Last Friday, the Texas Medical Board gave preliminary approval to a set of rules on adult stem cells in Texas that are less stringent than those originally proposed. The final paragraph of the article in Monday's Texas Tribune is devoted to a quote from Glenn McGee, identified as "president of strategic initiatives for Houston-based Celltex Therapeutics":
"Texas decided, unlike anyone else in the country or anyone in the world, to take a position on how to think about stem cells and the practice of medicine," McGee said. "I think Texas will become the source for articles about adult stem cell use in peer reviewed articles."
Presumably the last word in the quote should be "journals." McGee's comment is extremely odd for a Celltex employee; it suggests that he still thinks as an editor. He may have joined a growing industry, albeit one operating in some regulatory interstices at best, and he may even have the intention to help regularize it. But there does seem to be a growing sense that he is damaging the field of bioethics.
Bioethics is likely not Governor Perry's strong suit. As he promotes a technology that is widely viewed as sketchy and premature, and locally is run by his cronies, we should keep a careful eye on Texas.
Update (Feb. 21): These controversies have now attracted the attention of both Nature and Slate. David Cyranoski's piece in Nature includes comment from bioethicist Insoo Hyun, now at Case Western, who helped write the informed consent procedure that Hwang Woo-Suk ignored when gathering human eggs for research, and warns about the difficulties involved in balancing the demands of industry and of ethics. Carl Elliott's Slate article includes a useful summary, with more on RNL Bio, stem cell tourism, and the exemplary work of Doug Sipp in monitoring stem cell scams.
Previously on Biopolitical Times:
Posted in Bioethics, Biotech & Pharma, Pete Shanks's Blog Posts, Stem Cell Research, The States
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