Sunday, February 12, 2012

A reporter's guide to the American Journal of Bioethics scandal

So you've read the Twitter feeds and the blogs, but you are still not sure exactly what is going on with the story. All you know is that it has something to do with dubious stem cell treatments, a bioethics journal editor, the FDA, Rick Perry, a puppy-cloning stem cell outfit in Korea, and a couple of unexpected deaths. You want to investigate further, but you need a guide. That's what I hope to give you here.

THE CHARACTERS

RNL Bio: a South Korea-based based company at the center of the “stem cell tourism” controversy. RNL Bio prepares stem cells and distributes them to clinics all over the world, which then market stem cell therapy to patients for cosmetic purposes and anti-aging therapy, as well as serious illnesses such as Parkinson's disease and kidney failure. These stem cell therapies are illegal in South Korea, so RNL Bio has set up operations in other countries, including the U.S., China and Japan. The FDA has not approved these treatments and many reputable researchers believe they are risky and ineffective. In November 2010, the Korean media reported that two patients had died after receiving RNL Bio stem cell injections.

Background:





CellTex Therapeutics: a brand-new Texas stem cell clinic with a $30 million licensing agreement from RNL Bio. CellTex was founded by Stanley Jones, the Texas surgeon who made headlines for injecting Rick Perry with stem cells for back pain last year, and David G. Eller, the former chairman of the board of Texas A&M University. (Apparently, the company was initially called BioLife Stem Cell Corporation, and the name was later changed.) CellTex has also hired Glenn McGee, the editor of the American Journal of Bioethics, as President of Ethics and Strategic Initiatives. On Friday, the Texas Medical Board cleared the way for companies such as CellTex to start offering stem cell infusions.

Background:




International Cellular Medicine Society: a non-profit association of approximately 1100 physicians and patients involved in stem cell treatments. Based in Salem, Oregon, ICMS was co-founded by Christopher Centeno, the chief medical officer of a stem cell company called Regenerative Sciences. 

Background:



Glenn McGee: a bioethicist and current President of Ethics and Strategic Initiatives at CellTex. McGee is the founder of Bioethics.net and The American Journal of Bioethics (also known as AJOB), as well as its family of journals, which include AJOB Neuroethics and AJOB Primary Research. McGee has a controversial history. After being denied tenure at the University of Pennsylvania, he was offered an endowed chair at Albany Medical Center and a position as director of the Alden March Bioethics Institute. In 2008, McGee was dismissed from the Institute amid a cloud of allegations that included 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, Summer Johnson McGee), exaggerating his credentials, and misleading prospective employees about job prospects at the Institute. Soon after departing the Institute, McGee launched a for-profit bioethics business called BENE. In 2009, when he moved to a new endowed chair at the Center for Practical Bioethics in Kansas City, he brought his various bioethics enterprises with him. At some point in late 2011 – the exact timing is disputed – he took a new position with CellTex Therapeutics, the stem cell clinic in Houston.

Background:





THE NARRATIVE

In November 2010, the Korean press reported that two patients had died after receiving stem cells for anti-aging therapies from RNL Bio. One died of a pulmonary embolism in Japan. The other failed to wake after being given an anesthetic in China. The ICMS investigated the deaths; Glenn McGee, who was then on the ICMS Board of Directors, conducted a bioethics inquiry as part of that investigation. His brief report found little if any fault with RNL Bio; he recommended better informed consent procedures and more ethics training. (Later, in August 2011, ICMS expelled RNL Bio from its membership, after it failed to comply with even the minimal remediation requested by ICMS.)

In February 2010, McGee launched AJOB Primary Research and appointed Robert (“Skip”) Nelson as editor of the journal. Nelson is a pediatrician and bioethicist, but more importantly, he works for the FDA. The FDA is responsible for regulating stem cells; the decision by the Texas Medical Board to allow therapies such as those that CellTex offers can be viewed as a challenge to the FDA’s authority to regulate stem cells.

In mid-December, McGee began representing CellTex in press accounts of its opening in Sugar Land, Texas, near Houston. At that point, he was identified as “President of Strategic Initiatives” for the company. But he was also still working as the editor-in-chief of the American Journal of Bioethics. Last week, as questions were raised, he quickly turned over the job of editor to his wife, Summer McGee, who is now named as co-editor of AJOB, along with David Magnus of Stanford University. However, statements by McGee have suggested that he plans to remain associated in some fashion with the journal.

Background:






THE ETHICAL QUESTIONS:

Was the McGee “bio-ethical investigation” of RNL Bio a legitimate investigation, or was it a whitewash? If it was a legitimate investigation, why is the only publicly accessible account of it so brief, obscure and limited in scope?

Was it proper for a bioethics journal editor (McGee) to take a job with the financial partner (CellTex) of the company (RNL Bio) he had recently cleared of ethical wrongdoing?

Is it a conflict of interest for McGee to edit a bioethics journal while working for a stem cell company? And if so, is the conflict managed by transferring the job to his wife?

Is it ethically proper for Nelson, the FDA employee who edits AJOB Primary Research, to be professionally associated with McGee, given McGee's current employment by a company marketing a controversial treatment unapproved by the FDA?

Further reading:

For more background, you might want to look at the Twitter feed of Leigh Turner, a Biopolitical Times post by Pete Shanks, this blog entry by Alice Dreger, and a post by Doug Sipp at Stem Cell Treatment Monitor titled ICMS “investigates” RNL.

-- Carl Elliott

3 comments:

  1. Hi Carl- Excellent review of the background and current state of this morass. I doubt I am the only reader who views your list of ethics questions as more or less rhetorical...

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  2. I hope this is picked up by the media as they have been incredibly slack of late in properly researching the players behind these shams. Its also about time that the 'enablers' were brought to account!!

    Tamra Lysaght

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  3. Thanks for this review. I was trying to explain this business to someone and kept getting tangled up, but this is very clear and concise.

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