Medical Examiner

The Celltex Affair

An ethics scandal strikes the world of bioethics.

Ra Jeong-Chan, CEO of RNL Bio.
Ra Jeong-Chan, CEO of RNL Bio, speaks at a press conference on dogs cloned through fat stem cells in Seoul

Photograph by Jung Yeon-Je/AFP/Getty Images.

The stem-cell tourism industry is not exactly renowned for ethical probity, much less scientific rigor. Given its reputation for peddling untested remedies to desperate patients, not to mention its starring role in several sting operations on 60 Minutes, a few eyebrows went up when one of the nation’s leading journals of medical ethics relocated to the offices of a commercial stem cell clinic in Sugar Land, Texas. In December, the editor of the American Journal of Bioethics, a man called Glenn McGee, took up a new job with Celltex Therapeutics as its president for ethics and strategic initiatives. He now works for a new business venture that is partnered with a shady South Korean company known for its commercial puppy-cloning ventures, and co-founded by the surgeon who made headlines last year by treating Rick Perry’s back pain with unapproved adult stem cells. Some bioethicists are defending the move, suggesting that any potential conflicts of interest can be managed, but they have failed to appreciate the extent of McGee’s questionable history with stem cell tourism—in particular, his dubious “bio-ethics investigation” of two deaths linked to the South Korean firm that’s involved with Celltex.

In October 2010, the Korean press began reporting on a pair of patients who died after receiving stem cell infusions from a controversial Seoul-based company called RNL Bio. Since such treatments are banned in South Korea, RNL has aggressively marketed its products in other countries. Some clinics that license RNL products overseas market them for expensive “cosmeceutical” purposes. Others have targeted patients with serious illnesses such as Parkinson’s and multiple sclerosis. In Japan, a patient getting RNL treatments died of a pulmonary embolism; another RNL patient in China died after being given an anesthetic. The company quickly denied responsibility for the deaths at a raucous press conference, and the Korean authorities launched an investigation.

The possibility that RNL treatments were killing patients also prompted a private-sector inquiry. In December 2010, an industry association called the International Cellular Medicine Society (ICMS) dispatched two of its board members to investigate the alleged stem-cell deaths: Michael Freeman, an epidemiologist and the board’s president, and bioethicist Glenn McGee. This should have set off alarm bells from the start. The ICMS is made up largely of providers of stem cell treatments; in fact, the head of the South Korean company, Ra Jeong Chan, was himself a member of one of the society’s advisory boards. The choice of McGee to lead an ethics investigation was equally inauspicious. McGee had been denied tenure at the University of Pennsylvania in 2004, and then fired from his next job at the Albany Medical College for allegedly forging the signatures of three co-authors on a paper submission, engaging in an extramarital affair with a junior colleague (who is now his wife), exaggerating his credentials, and misleading prospective employees about their job prospects. By the time the ICMS decided to send him to Korea, he was working at The Center for Practical Bioethics, a nonprofit institution in Kansas City.

Most of the time, experimental and potentially risky treatments are offered to patients only through research studies that have already been subjected to a thorough ethical review. In fact, one of the most troubling aspects of stem-cell tourism is the fact that so many of the companies involved have refused to subject their treatments to scientific scrutiny in rigorous clinical trials. In any case, the decision to conduct a bioethical inquiry post-hoc was unusual in the field.

When Freeman and McGee finished up the investigation in December 2010, their findings were portrayed as an exoneration of RNL, even though they’d stated that one of the deaths was likely to have been “caused or triggered” by the stem cell procedure. “South Korean company cleared in deaths following stem cell therapy,” reported CNN. At a press conference in Seoul, McGee explained—not inaccurately—that the fact of the patients’ having died after receiving treatment didn’t mean the treatment caused their deaths. Less than a year later, McGee had left Kansas City to take his new job with Celltex, the financial partner of RNL Bio.

The story might have gone unnoticed but for the detective work of Douglas Sipp, a researcher at the RIKEN Center for Developmental Biology in Kobe, Japan, who runs the watchdog blog Stem Cell Treatment Monitor. Soon after the bioethics investigation report was issued, Sipp pointed to its alarming superficiality, noting in particular the troubling contribution made by McGee. The exact nature of his contribution to the full report is unclear, but the brief ethical review he completed as a follow-up is so opaque and evasive as to be almost unreadable. He studiously avoids any reference to the actual concerns that most bioethicists have about stem cell treatments: their potential dangers, the absence of evidence that they improve health, the unwillingness of their providers to go through proper regulatory channels, and­—as a result of all that—­the high risk of their being used to exploit vulnerable patients. Instead, McGee makes a number of soft recommendations surrounding informed consent and better ethics training. “The foremost principle of biomedical ethics is putting the patient’s interests first, but I cannot how see how that has been served here,” Sipp says. “The whole thing seems tawdry.”

To its credit, the International Cellular Medicine Society eventually expelled RNL Bio from its membership in August 2011, after the company failed to comply with even some minimal suggestions for improvement. But as Sipp pointed out on his blog, the expulsion does not seem to have hurt RNL profits. In February 2012, for example, the Texas Medical Board cleared the way for RNL to sell its products via Celltex, against the wishes of the U.S. Food and Drug Administration.

Last week, my colleague at the University of Minnesota Leigh Turner began blogging and tweeting about the conflicts of interest raised by housing the American Journal of Bioethics at Celltex. In response, a number of confusing and conflicting statements were issued by Celltex, McGee, and the editorial staff of the journal. McGee announced that he was resigning as editor, and that his wife would share his vacated spot on the masthead with a scholar at Stanford. On Thursday, Feb. 16, John Lantos, a pediatrician and former president of the American Society for Bioethics and Humanities, announced that he had resigned from the editorial board and was boycotting the journal. “If, as we’ve been told, [the publisher of the journal] really asked Glenn McGee to stay on as editor once he’d taken a job at Celltex, and if they really believed that the resulting conflicts-of-interest were manageable, one must wonder about both their judgment and their mission,” Lantos wrote. “Imagine that the editor of the New England Journal took a job as Vice President at Merck, and the Mass Medical Society asked him to stay on as editor, opining that the conflicts of interest would be manageable. One might rightly wonder, ’What are these people smoking?’

Of course, that question would be even more acute if the editor in question had helped cover up the risks of Vioxx, the dangerous pain drug that Merck was forced to withdraw from the market in 2004. The most troubling question about this entire affair turns on the relationship between McGee, Celltex, and RNL. Did McGee help whitewash two deaths from stem cell treatments and parlay that whitewash into a corporate position?