For nearly three months, the editor-in-chief of a major bioethics journal worked for a company apparently engaged in activities that were clearly unethical and possibly illegal.  From at least December 15, 2011 to February 10, 2012, Glenn McGee served as Editor-in-Chief of The American Journal of Bioethics while also working as a senior executive at Celltex Therapeutics.  According to Nature, Celltex arranges costly, unapproved stem cell procedures for patients with multiple sclerosis, Parkinson’s disease, and other serious illnesses.  On February 9, after being criticized for editing AJOB while employed at Celltex, McGee announced that he would “retire” from AJOB March 1, 2012.  One day later, members of AJOB’s Editorial Board were informed of McGee’s resignation.  Board members were also told that McGee’s replacements were Summer Johnson McGee, his wife, and David Magnus.  Over the past month, David Magnus and Summer Johnson McGee have responded to criticism of AJOB with denials and face-saving strategies that fail to address fundamental questions about the relationship of both Glenn McGee and AJOB to Celltex.

David Magnus claims that Glenn McGee left AJOB to work for “a stem cell company.”  This benign description of Celltex fails to acknowledge that Celltex sells clinically unproven, non-FDA approved adult stem cells to vulnerable patients.  Evidence has been available for months on a blog entitled Debbie’s Journey, where Debbie Bertrand provides a detailed account of the stem cell infusions she received from Celltex.  Included on her blog is a photo of a Celltex RNL Bio dinner engagement at which Ms. Bertrand presented a patient’s perspective on receiving stem cells for multiple sclerosis.  According to the program, Glenn McGee provided both the greeting and closing remarks at this event.  He therefore would have had an opportunity to hear Debbie Bertrand describe her experience as one of Celltex’s patients.  Ms. Bertrand reportedly paid Celltex $30,000 for stem cell processing, banking, and the infusions she received.

Ms. Bertrand is not alone.  Dr. Jamshid Lotfi (the physician who administered stem cells to Ms. Bertrand) told Nature that he had provided stem cells processed by Celltex to over twenty patients with multiple sclerosis and Parkinson’s disease.  Celltex reportedly pays Lotfi $500 every time he administers stem cells.  Although there is no way to know whether the FDA will investigate Celltex or what the outcome of such an investigation might be, it is worth mentioning that other individuals involved in arranging, selling, and administering non-FDA approved stem cells have been charged and arrested.

Perhaps the strangest aspect of McGee’s involvement with Celltex is his expertise in “ethical issues in tissue and gene banks, and ethical issues in stem cell research.”  According to his biography on bioethics.net, McGee “pioneered Penn’s stem cell policy,” “co-authored the text that became bills or stem cell legislation in four states,” served as an FDA panel member, and delivered the “Tisherman Dean’s Lecture on Stem Cell Ethics at the University of Pittsburgh.” Yet at Celltex, he worked for a company that sold stem cell injections and infusions outside the framework of FDA regulations.  I do not think it an exaggeration to state that in accepting employment at Celltex, Glenn McGee betrayed his chosen field of bioethics, not to mention his colleagues and readers of AJOB.

What have we been told by AJOB so far?  According to David Magnus, McGee was “working to transition out of his role at AJOB as soon as he accepted his new position.”  Magnus claims that “this can be attested to by a number of leaders within the field of bioethics.”  Whatever some of McGee’s colleagues might say about his “transition” efforts, the reality is that Glenn McGee worked at Celltex and served as Editor-in-Chief of AJOB until he was publicly criticized for this egregious conflict-of-interest.  When caught, his LinkedIn account, Google+ account, and the Editor’s page on bioethics.net were all scrubbed of information revealing the conflict of interest and Celltex issued a press release that attempted to backdate his resignation from AJOB to November 2011.

The journal’s “solution” to the conflict of interest was to hire McGee’s wife, Summer Johnson McGee, as the next Co-Editor-in-Chief of AJOB.  Magnus assumes full responsibility for this decision, and claims to be shocked at assertions that the appointment of Glenn McGee’s wife is perceived as a form of nepotism.  Both Magnus and Summer Johnson McGee herself have said that criticisms of her appointment constitute sexism.

I see three reasons why Summer Johnson McGee should not have been selected as Glenn McGee’s replacement.  First, the journal could have conducted an actual search and used fair and transparent decision-making to select the best candidate.  When the spouse of the previous editor is appointed without a search, without considering other possible candidates, and without using criteria that are known to other parties with an interest in the outcome of the decision, there are credible grounds to worry that someone is being hired due to “connections” and family ties rather than on the basis of their professional accomplishments.

Second, an appointment to the Editor-in-Chief position of an academic journal should be connected to a scholar’s publication record, prior editing experience, and other relevant accomplishments.  Summer Johnson McGee would have been a stronger candidate if many of her publications were not two-page editorials published in AJOB during her husband’s tenure as Editor-in-Chief. Of course, what I think about Summer Johnson McGee’s publication record is not important.  What is significant is that David Magnus simply insisted that she serve as Co-Editor with him, and apparently no one else was in a position to propose that other candidates deserved consideration.

Third, Summer Johnson McGee is married to a man who at the time of her appointment was the bioethicist for a company profiting from the sale of clinically unproven, non-FDA-approved stem cells to vulnerable patients.  This relationship does not make her a bad person or someone who deserves to be censured by her colleagues, but it does mean that she is the last person who should have been selected as his replacement.  Being married to a bioethicist employed by a company profiting from selling clinically unproven stem cells to vulnerable patients with chronic illnesses is not a conflict-of-interest to be managed through recusal, policies, and committees.  It is a moral and legal disaster scene.  Editors of The American Journal of Bioethics should be nowhere in the vicinity of such activity.

While David Magnus claims full responsibility for this decision, members of the Editorial Board have now had a month to respond to this choice.  With only two individuals known to have resigned from AJOB’s Editorial Board, it appears that other board members have no objection to the way the editors are handling the situation.  The last four months reveal that AJOB suffers from a fundamental failure of governance and responsible leadership.  Members of AJOB’s editorial staff and Editorial Board could have insisted that McGee resign from his position as Editor-in-Chief before he accepted the position at Celltex.  When McGee resigned after being caught in a conflict-of-interest they could have fully disentangled the journal from Celltex and Glenn McGee by hiring someone other than his wife to co-edit the journal.  The journal could have been steered away from the rocks even after McGee began working for Celltex if board members had publicly disclosed that they were unaware of his move and would resign if McGee remained as editor.  Instead, just two board members left the board while the new editors attempt to maintain that the former editor simply “retired” in order to move to the private sector.

To date, AJOB’s announcements about “changes” at the journal have failed to address basic questions concerning why Glenn McGee remained as Editor-in-Chief while also working at a company engaged in clearly unethical activity, why we are all supposed to accept vague, dubious claims suggesting that this never really happened, and why Summer Johnson McGee was selected as the next Co-Editor-in-Chief of AJOB while her husband was employed at Celltex.  Even if members of AJOB’s Editorial Board circle the wagons now, the credibility of the journal has been destroyed.  The destruction of AJOB’s academic standing was completed when Glenn McGee went to work for a company profiting from sale of clinically unproven, non-FDA-approved stem cells to vulnerable, chronically ill patients, and his friends and colleagues failed to address the situation.  Instead, they chose to respond with bluster, denials, and face-saving accusations directed at anyone unwilling to remain silent and accept their conduct.

Leigh Turner

March 9, 2012

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From at least December 15, 2011 to February 9, 2012, Glenn McGee served as Editor-in-Chief of The American Journal of Bioethics (AJOB) while also working as an executive at Celltex Therapeutics Corporation (CellTex).  On February 9, 2012, several individuals began tweeting about McGee’s conflict-of-interest and demanding that he resign from AJOB.  The next day, members of AJOB’s Editorial Board were informed that McGee was stepping down as journal editor.

Following Glenn McGee’s exit from AJOB, the appointment of Summer Johnson McGee as one of the next two Co-Editors-in-Chief of the journal provoked a controversy among bioethicists.  Largely (though not entirely) neglected in the dispute concerning Glenn McGee’s conflict-of-interest and his subsequent replacement by his wife is any sustained effort to examine Celltex, the company Glenn McGee joined while still editor of AJOB.  For example, David Magnus, the other journal co-editor, blithely describes Celltex as a “stem cell company”, as though it is much like any other life sciences firm, while failing to acknowledge what it is about this company that makes Glenn McGee’s decision to take a position there so disturbing.  Conflicts-of-interest are sometimes examined in abstract terms, paying little attention to how particular features of companies can make them more or less problematic employers for bioethicists.  Here, I turn away from the abstract and toward the particular, examining what can be learned about Celltex.

In brief, Celltex takes adult stem cells obtained from human adipose tissue (what most of us call “fat”) and then processes and banks these cells.  The stem cells are later injected and infused into individuals who are ill, injured, or interested in using stem cells for cosmetic purposes.  Celltex’s corporate partner is RNL Bio, a South Korean company known for cloning dogs, preparing stem cells that are administered to customers in China, Japan, and Mexico, and selling expensive cosmetics such as “Dr. Jucre’s Million Stem Cell Magic Concentrate.”  Together, the two companies operate The Celltex RNL Bio Stem Cell Processing Facility in Sugar Land, Texas.  The ribbon-cutting ceremony for the facility occurred December 15, 2011.  CellTex’s senior management team includes Chairman and Chief Executive Officer David G. Eller, Vice President and Chief Medical Officer Dr. Stanley Jones, President, Ethics Research Division, Dr. Glenn McGee, and Vice President, Donna Lee.

Celltex brings to the partnership approximately thirty investors from the oil-and-gas industry.  In turn, RNL Bio provides Celltex with technical expertise in processing and banking stem cells.  According to the Technology Licensing and Purchase Agreement between Celltex (called BioLife Stem Cell Corporation at the time the agreement was signed) and RNL Bio, Celltex licenses from RNL Bio “patent rights to certain adult stem cell Technology.”  In particular, Celltex licenses from RNL Bio, “the right to develop, market, manufacture, make, use, sell, license and sub-license certain stem cell technologies which are applied to humans and animals.”  Celltex paid RNL Bio $30 million to license RNL Bio’s stem cell technology.  Depending upon how much money Celltex earns from banking stem cells and providing stem cells to customers, it could in total pay RNL Bio an additional $270 million in licensing fees.

The list of stem cell-related interventions RNL Bio licenses to Celltex includes: “Fat derived autologous stem cell extraction and culture; Fat derived autologous stem cell banking, Fat derived autologous stem cell treatment, Fat derived allogenic stem cell treatment (HLA typing), Placenta derived autologous stem cell extraction and culture, placenta derived autologous stem cell banking, placenta derived autologous stem cell treatment, Placenta derived allogenic stem cell treatment (HLA typing),” and stem cells for cosmetic purposes.  In short, while Celltex specializes in banking and providing adult stem cells, its business plan includes extracting, banking, and administering other sources of stem cells.  Celltex’s licensing agreement states that RNL Bio “will, as quickly as possible, assist Licensee in beginning the treatment of patients.”  Planned operating capacity at the start of business operations is described as “at least 250 patients per month.”

Celltex’s website is password-protected.  It is therefore difficult to know exactly how Celltex promotes itself to customers.  However, Celltex’s fee schedule provides insight into Celltex’s marketing strategy.  For $1750 the company provides “a batch culture and transport of a minimum of 50 million autologous mesenchymal stem cells.” For $50,000 the company provides the lifetime banking option of “blood analysis, fat tissue collect and transport, stem cell extraction, culturing, preparation, lifetime cryopreservation, and unlimited transport of cultured cells for a minimum of 2 billion autologous mesenchymal stem cells.”

Stem cell research has considerable promise and in future it is possible that medical interventions based upon different types of stem cells will be used to treat numerous illnesses and injuries.  Acknowledging that stem cell research might eventually lead to safe and effective medical therapies, there are many reasons to be concerned about Celltex’s business activities.  By far the most pressing legal, ethical, and medical issue is that stem cells prepared by Celltex apparently are being infused and injected into Celltex customers even though Celltex has no clinically proven, FDA-approved adult stem cell interventions to market.  Such activity appears to contravene FDA regulations governing administration of adult human stem cells.

In July 2011, Dr. Stanley Jones, Celltex’s Vice President and Chief Medical Officer, administered to Texas Governor Rick Perry adult stem cells taken from Perry’s own fat tissue.  The stem cells Jones injected into Perry were reportedly prepared at the Celltex RNL stem cell facility.  Governor Perry is CellTex’s most famous recipient of stem cells but he is not the only person to receive stem cells processed and banked by Celltex.  To the contrary, it appears that Celltex, without first conducting clinical trials or obtaining FDA approval, is both banking stem cells and providing individuals with stem cells that are then injected or infused into them.  Precisely how stem cells reach Celltex’s clients is unclear.  It seems that stem cells are prepared at the Celltex stem cell bank and then transported to nearby clinics.  There, physicians and other health care providers administer the stem cells to clients.  In a blog post, one Celltex client mentions that her cells are being processed prior to her next infusion.  This same customer mentions “meeting people who are also having treatments—some I had talked with by phone because their relatives or friends wanted them to know about the option of stem cells.”  She also describes observing additional Celltex customers getting ready to have stem cells administered.  “I had my 5th infusion today and am now the recipient of a total of 1 billion new stem cells.  While I was having my treatment, we were able to visit with three other people who were there to meet with the doctor and make preparations to begin the process.”  This patient’s blog contains photos of the clinic where she received infusions, Celltex employees, and the health care providers involved in administering stem cells to her.

The legal, ethical, and scientifically legitimate way to bring adult stem cells into the realm of mainstream medical practice is to first conduct clinical trials approved by the Food and Drug Administration (FDA) and assess safety and efficacy.  Adult stem cells need to be tested in the context of properly designed clinical trials because it is important to determine whether adult stem cells have any effect beyond the placebo effect.  No matter how many individuals are enthusiastic about the promise of adult stem cells—and Celltex’s partner, RNL Bio, has a history of using patient testimonials as a marketing device—rigorous clinical trials are required to confirm that adult stem cells used for a particular purpose work better than placebos and do not cause harm.

Celltex’s apparent decision to provide adult stem cells to clients is disturbing because at least two patients who received adult stem cells from RNL Bio died after having stem cells administered to them.  One RNL Bio customer died in Japan and a second client died in China after receiving stem cells prepared by RNL Bio.  There are reports of other individuals stating that they were harmed by the adult stem cells they received.  For example, former customers claiming they had been injured by the stem cells they received disrupted a RNL Bio news conference in South Korea.  Whether the stem cells provided to these individuals caused death or injury is unknown and needs to be investigated.  The South Korean Food and Drug Administration reportedly initiated an investigation of the two deaths but there is no publicly accessible English-language report of its findings.  Another organization, The International Cellular Medicine Society, also investigated these two deaths but the statements it produced fail to provide comprehensive analysis of ethical and clinical issues related to the deaths.  Given these prior deaths and the inadequate manner in which they were investigated, there is reason to question whether clients of Celltex and RNL Bio are receiving safe and effective interventions.

RNL Bio reportedly has administered stem cells to 10,000 clients.  However, studies published by RNL Bio researchers are based upon small sample sizes rather than hundreds or thousands of research participants.  For example, in one study, adult stem cells were administered to ten individuals suffering from various medical problems.  The study sample included research subjects with autoimmune hearing loss, multiple sclerosis, polymyotitis, atopic dermatitis, and rheumatoid arthritis.  The study did not use randomized controlled trial methodology or blinding in an attempt to reduce study bias.  It also does not seem to have gone through IRB review.  In a second study stem cells were administered to eight individuals with spinal cord injury.  These publications appear to be representative of articles published by RNL Bio researchers. The studies are uncontrolled case studies.  They do not randomize research participants to a novel intervention versus the existing standard of care.  There is no attempt to control for researcher bias.  Sample sizes are too small to reach meaningful conclusions.  These studies provide no reassurance that RNL Bio has products ready for FDA approval and commercial sale.  If these publications reflect the quality of scientific research undergirding Celltex’s stem cell technology, there is reason to suspect that Celltex is far from having adult stem cell interventions ready for commercialization and routine clinical use.

Celltex depends upon RNL Bio for scientific expertise and experience conducting adult stem cell research.  And yet, despite reportedly putting adult stem cells into thousands of customers, RNL Bio does not have stem cell-based interventions approved by either the US FDA or the South Korean FDA.  To date, it appears that RNL Bio has initiated clinical trials that either failed to generate significant findings or were halted by the South Korean Food and Drug Administration.  Reports of morbidity and mortality in individuals receiving stem cells provided by RNL Bio combined with limited evidence concerning safety and efficacy of RNL Bio’s “stem cell technology” generate serious concerns about Celltex’s apparent willingness to market and sell infusions and injections of adult stem cells.  Also cause for concern is a report stating that Celltex representatives emphasize the safety of adult stem cells.  It is possible that clients of Celltex are receiving inadequate information about risks associated with having clinically unproven stem cells administered to them.

Safety and efficacy of Celltex’s adult stem cell injections and infusions are unknown.  Adult stem cells marketed by Celltex might play a role in treating illnesses and injuries, cause harm, or have no discernable effect upon health and illness.  It is conceivable that individuals with multiple sclerosis and other serious health problems are paying for stem cells that provide no clinical benefits or expose them to unnecessary risks.  Celltex has a legal, ethical, scientific, and clinical duty to establish safety and efficacy of its products, demonstrate that it is providing clinically proven medical interventions, and obtain FDA approval before selling stem cells to customers.  With a bioethicist in a senior executive position, Celltex’s management team must be aware of the company’s moral responsibilities to the recipients of the stem cells it provides and its legal obligation to obtain FDA approval prior to initiating clinical trials and selling stem cells to clients.

When, whether, and how the FDA will respond to Celltex’s business operation is uncertain.  An investigation by the FDA appears warranted because available evidence suggests that Celltex’s clients are receiving clinically unproven, non-FDA-approved adult stem cells that fall within the regulatory authority of the FDA.  If the FDA begins asking questions about Celltex’s business operation the company might respond by claiming that the FDA has no legal authority over the adult stem cells that it processes, banks, and administers to clients.  The FDA’s current legal action against Regenerative Sciences Incorporated, another company that markets adult stem cells and administered stem cells to clients without first seeking and obtaining approval from the FDA, suggests that the FDA would respond to such a claim by asserting its authority to regulate administration of adult stem cells into humans.  The process could begin (as happened with Regenerative Sciences) with the FDA sending Celltex a warning letter stating that the company must comply with FDA regulations.  If it appeared that customers of Celltex continued obtaining accessing to stem cells the FDA might then go to court and seek an injunction.  However, if the FDA concludes that customers of Celltex are at risk of harm, it is conceivable that the FDA could act in a more forceful manner.  With the bioethicist Glenn McGee employed at Celltex as a senior corporate executive, if the FDA chooses to initiate legal action against Celltex’s management team the field of bioethics might witness the next phase of an unusual career arc that began in the halls of academe, proceeded to the corporate boardroom, and could reach the courtroom.  And with Glenn McGee’s spouse, Summer Johnson McGee, his replacement as Editor-in-Chief of The American Journal of Bioethics, one bioethics journal will have front-row seats should FDA officials initiate legal proceedings against Celltex.  I think it reasonable to predict that if such an event occurs, at least some members of AJOB’s Editorial Board will wish that the journal to which their names are attached had not been allowed to drift quite so close to the action.

Leigh Turner

February 28, 2012

 

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David Cyranoski examines the Glenn McGee, American Journal of Bioethics, CellTex disaster in the latest issue of Nature. The title of his article is, “Editor’s move sparks backlash: Bioethicists are forced to consider their purpose as leading practitioner joins controversial stem-cell company.”  Everyone following this debacle needs to read Cyranoski’s article.  Here are some excerpts:

John Lantos on Taylor and Francis’ (publisher of AJOB) apparent willingness to retain Glenn McGee as Editor-in-Chief of AJOB after McGee accepted an appointment at CellTex:  “Imagine if the Editor of the New England Journal of Medicine 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?’”

David Cyranoski and Insoo Hyun on what McGee’s move to CellTex means for bioethicists: “Bioethicists are questioning whether it can ever be acceptable to work for companies, which, they argue, may be using the appointment to present a veneer of ethical probity.  The episode brings to a head concerns that have emerged among bioethicists over the past decade, says Insoo Hyun, a stem-cell bioethicist at Case Western Reserve University in Cleveland, Ohio. ‘It’s a perfect storm,” he says. 

David Cyranoski on AJOB, conflict-of-interest, and resignations from AJOB‘s Editorial Board: “During McGee’s tenure as editor-in chief of the AJOB, four editors are known to have resigned from the editorial board because of differences in opinion over how the journal handles conflict of interest.  Two left this month, including Lantos, who wrote on his blog that he will no longer work with the journal because of McGee’s simultaneous employment at the AJOB and CellTex, and frustration over the lack of a clear conflict-of-interest policy at the AJOB.”

Jan Helge Solbakk, University of Oslo, suggests that McGee’s move to CellTex reveals how bioethics has moved from social and ethical critique to corporate lackey: “Mainstream bioethics is no longer speaking truth to power,” Solbakk says.  ”Instead it has become the handmaiden of the medico-industrial complex, and of bioscience and technology.”

David Cyranoski on CellTex, RNL Bio, and McGee’s role in “investigating” RNL Bio before becoming an executive at CellTex: “Working for a respected company may be acceptable to some bioethicists, but McGee’s new employer comes with a great deal of baggage. CellTex, which was founded last year and as yet has no website, licenses stem-cell technology from Seoul-based RNL Bio.  The South Korean company has made a business out of taking fat cells from people, processing them in a way that they say increases the number of mesenchymal stem cells, and then reinjecting them in an effort to treat conditions such as spinal cord injury.  McGee already had a connection with RNL Bio.  In 2010, two patients died following injections of RNL’s cells.  McGee, working for stem-cell lobby group the International Cellular Medicine Society, based in Salem, Oregon, helped to conduct an investigation into the company.  This concluded that only one of the two cases was likely to be related to the injections, and because the patient understood the risk the company was not culpable. Jin Han Hong, the then president of RNL’s US subsidiary, admitted in 2010 that there was no clinical-trial evidence proving that these treatments are effective.”  

Insoo Hyun on bioethicists working for stem cell companies: “I know first hand how difficult it is to separate conflict of interest–to maintain the role of bioethicist.  I know you need to not be too chummy with enterprises trying to speed ahead in stem cells.”

Source: David Cyranoski. 2012. Editor’s move sparks backlash: Bioethicists are forced to consider their purpose as leading practitioner joins controversial stem-cell company.” Nature. February 21.

 

Introduction

Bioethicists disagree about whether it is ethically proper for them to accept money from the pharmaceutical and biotechnology industries, but until recently, there has never been a time when bioethics scholars felt compelled to consider the possibility that a bioethicist might operate a bioethics journal—or, in this case, “family” of journals—from the corporate boardroom.  Last week, it became apparent that Glenn McGee, Editor-in-Chief of The American Journal of Bioethics (AJOB), was working as President, Ethics Research Division for Celltex Therapeutics Corporation, a stem cell clinic and banking facility in Texas.  Though McGee has worked for Celltex since at least mid-December and perhaps earlier, reports of McGee’s conflict of interest did not start circulating among bioethicists until the last few days.

There are many elements to this story and events continue to unfold; here I limit myself to providing a brief chronological account, supported by documentation, of how McGee’s conflict of interest was detected, how he attempted to dodge accusations of a conflict of interest by handing the title of Editor-in-Chief to his wife, Summer Johnson McGee, and David Magnus, and how there has subsequently been an attempt to backdate McGee’s resignation date as Editor-in-Chief of AJOB and scrub various websites in a manner that makes it appear as though he was no longer serving as Editor-in-Chief of AJOB by the time he began working at Celltex.  I find this last act particularly noteworthy.

Such conduct generates questions that must be confronted by Glenn McGee, members of AJOB’s Editorial Board, participants in the larger “community” of bioethicists, and anyone else concerned with conflicts-of-interest, the integrity of academic journals, and organizational arrangements that allow and even enable unethical conduct without, it appears, anyone in a position of responsibility taking steps that might have prevented behavior that we all should acknowledge as damaging to the integrity of bioethics.

Glenn McGee Joins Celltex Therapeutics

Whatever the exact date at which McGee joined Celltex, it is clear that by mid-December 2011 he was serving as Editor-in-Chief of AJOB while also employed as President of Celltex’s Ethics Research Division.  On December 15, 2011, Houston Business Journal published an article about Celltex; McGee is quoted and identified as Celltex President of Strategic Initiatives.  That same day, McGee delivered the Greeting and Closing Remarks at a Celltex-RNL Bio dinner reception held at The Houstonian Hotel’s Jupiter Room.  The agenda (proceed to link and scroll down to 12th photo) lists McGee’s title as Celltex’s President of Ethics and Policy. The next day, December 16, McGee conducted an interview with Kuhf Houston Public Radio.  The station identified him as Celltex’s President of Strategic Initiatives.  Through the remainder of December, all of January, and through the first week of February 2012 McGee continued to serve as the Editor-in-Chief of AJOB while working as a President at Celltex.  The situation changed February 9-10, 2012.

At this point in the narrative I must introduce Doug Sipp, an American who lives in Japan and is well-known for his scholarship on “stem cell tourism”.  Some of you might recognize his name from his appearance on the 60 Minutes episode examining stem cell tourism and stem cell scams.  To the best of my knowledge Sipp is the first researcher to identify McGee’s conflict-of-interest and express skepticism about McGee’s attempt to edit AJOB from Celltex.  In a blog entry, Stem cell graft, Texas-style, Sipp noted this conflict-of-interest and also drew attention to what appeared to be a second conflict-of-interest involving McGee.  McGee’s employer, Celltex, paid $30 million upfront to license RNL Bio’s stem cell technology and in time might pay an additional $270 million.  Prior to accepting employment at Celltex McGee investigated the deaths of two individuals who had received stem cells provided by RNL Bio.  Sipp’s blog expressed concern about McGee’s prior work investigating RNL Bio and his subsequent move to a senior executive position at a company with tight financial links to RNL Bio.  Sipp’s post got my attention.  I began visiting various websites McGee uses to promote himself and it became apparent that McGee was indeed continuing to edit AJOB from Celltex.  McGee’s LinkIn page, the Editor’s page on the AJOB section of bioethics.net, and his Google+ page all identified him as President of Celltex and Editor-in-Chief of AJOB.

On February 9, 2012, I began tweeting about McGee’s conflict of interest.  Later on the 9th, after a flurry of tweets calling for McGee to resign as Editor-in-Chief of AJOB and asking members of the Editorial Board to resign if he remained as Editor, an editor at Reuters tweeted a link to McGee’s LinkedIn account.  There, a post announced McGee’s pending “retirement” from serving as Editor-in-Chief of AJOB.  The LinkedIn post stated: “I am writing to let you know that as of March 1st, 2012 I will step down from my role as Editor-in-Chief of The American Journal of Bioethics.” Later in the announcement McGee intimated that his time as Editor-in-Chief of AJOB might extend beyond the beginning of March.  He wrote, “I will continue in my role through the production of AJOB’s June issue and continue to provide advice and counsel as asked going forward.”  The announcement was dated 1/30/2012.  You can find a copy of that announcement here.

By 11:00 PM February 9, this announcement—an announcement that acknowledged McGee was presently serving as Editor-in-Chief of AJOB, that he would not vacate the position until March 1, 2012, and that he was turning the editorial job over to his wife and a colleague—had disappeared from McGee’s LinkedIn account.

Just as the February 9 announcement disappeared from the Internet, other web pages underwent a scrubbing.  They emerged in a form that deleted evidence of McGee’s conflicted role in serving simultaneously as AJOB Editor and Celltex President.

For example, take the AJOB section of bioethics.net.  On February 9, 2012, “The Editors” section on the AJOB component of bioethics.net listed Glenn McGee as Editor-in-Chief.  By February 12, 2012, Glenn McGee was no longer identified as Editor-in-Chief.  Instead, David Magnus and Summer Johnson McGee were listed as Co-Editors-in-Chief.

McGee’s LinkedIn account also underwent some scrubbing.  On February 9, 2012, McGee’s LinkedIn account listed his current appointments as President, Ethics Research Divison at Celltex Therapeutics Corporation and Editor-in-Chief at The American Journal of Bioethics.  By February 12, 2012, the LinkedIn account had been changed to read “President, Ethics Research Division at Celltex Therapeutics Corporation.” Editor-in-Chief of AJOB was no longer listed as a “current” activity.  Instead, “Founding Editor-in-Chief at The American Journal of Bioethics” was listed under the category “Past”.

McGee’s Google+ account was also changed to eliminate statements revealing that he was serving as Editor of AJOB while also working as a President at Celltex.  On February 10 he was listed as Editor in Chief of AJOB (See cached webpage with title still present) By February 12 he was listed as President at Celltex.

Interestingly, there is at least one website that has not been scrubbed.  As of February 12, 2012, McGee remains listed as Editor-in-Chief on the AJOB home page of the journal publisher, Taylor & Francis.  Someone should tell AJOB’s publisher that McGee is not in Kansas any more.

On February 10, 2012, one day after the February 9, 2012 announcement of McGee’s March 1, 2012 departure as AJOB Editor was posted and then deleted, Celltex issued a press release announcing McGee’s appointment as Celltex’s President of Ethics and Strategic Initiatives.  The press release states, “Dr. McGee, who resigned his position as the John B. Francis Chair at the Center for Practical Bioethics and his role as editor-in-chief of The American Journal of Bioethics in November 2011, was the founder of the publication.  Under his leadership, The American Journal of Bioethics became the leading journal in its field.  He is now serving in an advisory capacity with the journal until March 1, 2011 (sic).”  This press release is now posted at sites all over the Internet.  For example, you can find it here,  here, and here.  As someone who read McGee’s February 9 announcement of his March “retirement” as well as his self-identification as Editor-in-Chief of AJOB up to and including February 9, 2012, it seems to me that the practical effect of announcing “news” of McGee’s appointment to Celltex is to backdate his resignation as Editor-in-Chief of AJOB to November 2011.  With this Internet sleight-of-hand McGee’s conflict-of-interest is being made to disappear.

Beyond the Internet Scrubbing

Three issues merit close analysis by members of the AJOB Editorial Board, participants in the larger bioethics community, and everyone interested in academic integrity and the credibility of the field of bioethics.

To begin, it appears that the first—and let us all hope the last—attempt to edit a bioethics journal from within the walls of the senior executives’ suite has not ended well.  But just when and how did it start?  And did members of the Board of Editors, distinguished scholars all, sanction McGee’s decision to edit AJOB from CellTex?  I would like to know how this spectacle started, whether members of the Board of Editors of AJOB were aware of this conflict-of-interest and endorsed it, and, if they were unaware of the conflict, why they did not know and yet are listed as members of the Editorial Board.

Second, there are approximately seven billion people on our planet.  I find it striking that there are some members of the bioethics community who apparently believe that a reasonable way—indeed the best of all possible ways—for McGee to handle such an egregious conflict-of-interest is to attempt to deflect criticisms by handing AJOB to his wife.  If AJOB has a future, and at this point perhaps it is best if it doesn’t, what is needed is a complete break from current leadership and full movement of the journal out of the McGee family.

Third, McGee could have avoided being accused of a conflict-of-interest by resigning as Editor-in-Chief of AJOB before accepting a position at Celltex.  Had he taken this step we all could put aside discussion of AJOB and consider why a bioethicist is now a senior executive at a company that plans to sell non-FDA-approved stem cells.  McGee did not choose this option.  He could have picked a more difficult path, maintained the conflict-of-interest in the face of criticism, and waited to see whether contributors, reviewers, and members of the Board of Editors dropped away from AJOB.  (Judging by the last few days, I think it plausible that McGee could have himself started injecting stem cells into Celltex customers and manuscripts would have continued arriving at AJOB, reviewers would have continued submitting their reviews, and members of the Editorial Board would have continued doing whatever it is that they do.)  Available evidence indicates that McGee did not pursue these first two choices.  Instead, what we have is some shady third strategy that involves scrubbing the Internet of evidence revealing the conflict-of-interest and having Celltex blast across the web a press release that backdates his departure to November 2011.

Scrubbing the Internet is a relatively straightforward undertaking and if it succeeds time shifts and a new, improved conflict-of-interest free chronology replaces what appears to have been a hurried leap from a seat that suddenly became quite hot.  As it happens, documenting Internet scrubbing is also a fairly straightforward matter.  I must acknowledge, though, what an odd experience it is to sit and watch the Internet being scrubbed in real-time.

And So Here We Are

Serving as Editor-in-Chief of AJOB while employed as a senior corporate executive at Celltex is an undeniable conflict-of-interest.  The extent of damage caused by this behavior is not yet known.  Bioethics is already regarded as a greasy, low-grade area of scholarship by many of our academic colleagues.  Will the field’s reputation continue to drop as a result of this embarrassment?  Handing the position of Editor to a spouse seems to me an insult to the idea that conflicts-of-interest must be addressed and resolved in a serious, credible manner.  Facing the threat of lawsuits, Joe Paterno transferred to his wife full ownership of their home.  I’m sure most of us scoff when we hear of such behaviour.  We see the act for what it is.  And yet when McGee is called out for handing the position of Editor-in-Chief to his wife some bioethicists go to extraordinary lengths to defend this choice.  How can we berate others for behavior we tolerate among ourselves?  And finally, what future is there for a bioethicist whose primary response when caught in a conflict-of-interest is to scramble across the Internet in a mad rush to scrub from existence all signs of the conflict?

 

Leigh Turner

February 14, 2012

Note correction: Two readers wrote and noted that the word “whether” appeared twice in first sentence. Duplicate word removed February 15, 2012.

 

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