Old AJOB Rut re. Prenatal Dex Picks up New Steam as Undisclosed Double Loyalties and Dependencies of Now Editor Skip Nelson are Suggested

Amended 2014-04-18: see bottom of this post!

I'm sure several readers remember a long series of posts across 2011-12, connected to a series of internal troubles in the management of the American Journal of Bioethics. One of the roots of all that mess was a controversy that eventually led to the resignation of Hilde Lindemann from the AJOB editorial board in protests of its managerial operations, followed by other weighty ones later by, e.g. Udo Schuklenk and John Lantos. Eventually, after much external pressure, following a less than elegantly handled stepping over to private business by then editor-in-chief, Glenn McGee (later to become CEO of the now defunct stem cell banking, cosmetics and therapeutic business RNL Europe), the drop-out of the AJOB operation of both him and his wife Summer Johnson McGee, who had initially been appointed to advance to co-editor with the new EiC appointed to succeed McGee.

The last post with any substance out of this mess was this one, and the entire series is found here.

The affair leading to the resignation of Lindemann connected to a critical scrutiny, and eventual letter to the FDA, signed by a large number of bioethicists, regarding some unresearched, non-evidence based, experimental off-label prenatal drug treatment at the Mount Sinai hospital with regard to congenital adrenal hyperplasia. This led to a long series of complicated controversies involving AJOB, later leading up to the developments summarised above, and one of those concerned the possible conflict of interests of several centrally placed AJOB managerial figures. Among those involved was Robert “Skip” Nelson, now editor-in-chief of the AJOB Empirical Bioethics journal, at the time ethicist linked to the FDA (he still is, as a matter of fact), who sent a letter to the Office for Human Research Protections on the Prenatal Dex case, as it came to be known, clearing the accused doctor of having broken any FDA regulations. Now it is reported that, apparently, Nelson at the same time had close and live ties, to AJOB and the people in the management who were deeply involved in one side of the controversy. That is, it is argued in a recent post by Alice Dreger and Ellen K Feder (who belong clearly to the other side, it must be added), one of the prime expert sources had hidden loyalties and dependencies that remained undisclosed and is now holding a gallant EiC title in the AJOB family of journals.

The whole story and argument is told much better than I ever could by Alice Dreger and Ellen K. Feder themselves at the superb Canadian Impact Ethics blog.

Amendment:
Skip Nelson contacted me personally after posting the first version of this report, and made clear that he finds nothing new in what is described by Dreger and Feder, that no payments to him from AJOB have ever been involved in his service as EiC, that he performs this job as part of his FDA assignment, and that what he claimed in his letter to the OHRP regarding Prenatal Dex remains true (Dreger's and Feder's view on that is set out here). Nelson also told me that he has no plan to respond publicly to Dreger and Feder. This post has been amended in the light of that in a few places above.

Lots to do at the American Journal of Bioethics

As readers of this blog know, I have informed about and commented quite a bit on various controversies and debates surrounding the American Journal of Bioethics – when it comes to standard ways of ranking academic journals, the by far most influential of those in the field of bioethics and medical ethics, as well as celebrated for its pioneer editorial design with main "target articles" and rapid responses, plus a parallel publication online at the Bioethics.net, a research, news and comment portal for bioethics. Notwithstanding these qualities, the recent events I have been reporting about have undoubtedly scarred AJOB as an institution and left the current management with a challenging task of restoring lost trust. A short reminder:

1. A high profile resignation from the editorial board by Hilde Lindemann due to doubts about the soundness of the journal's editorial and managerial policies (here, here, here).

2. An impossible conflict of interest situation within the editorial management of AJOB created when former editor in chief Glenn McGee resigned to take up a post as full-time consultant for the private stem cell banking company, CellTex, while his wife (a distinguished bioethicist ijn her own right, but under default legislation, of course, sharing the financial ties of her husband), Summer Johnson McGee took over the AJOB rudder (together with David Magnus). It didn't help the case that Glenn McGee's resignation process and move to CellTex was far from ideally managed (creating lots of completely unnecessary questions) or that the Cell Tex operation itself is highly questioned among bioethics researchers. My reports and comments are here, here, here, here, here, here. The affair resolved itself when Glenn McGee announced his resignation from the CellTex job (thereby severing the vested conflict of interest ties affecting Summer Johnson McGee), but had at that point already effected two heavy resignations from the editorial board by John Lantos (who provided a strongly worded explanation) and Udo Schüklenk, himself editor in chief of the journal Bioethics (the latter however, still listed as a board member at the AJOB website).

This last affair had a bit of a semi-relevant aftermath, when CellTex, the stem cell company to which Glenn McGgee had been signed on to provide ethics consultancy threatened University of Minnesota bioethicist Leigh Turner (as well as his university) with lawsuits, when he wrote a letter to the FDA, urging them to investigate CellTex. Almost simultaneously, Glenn McGee did a very similar thing to Carl Elliott, a bioethics professor at the same university as Turner, for his published criticism of McGee's involvement with CellTex, leading to a retraction by the publisher Slate. See here, and here. None of those events, of course, did any good for the stained reputation of AJOB and one would have wished the journal some peace and quiet to be able to set the ship back on a straight course. However, it does not seem to end there.

Earlier this year, it was revealed that a leading researcher of the Center for Practical Bioethics, Myra Christopher was to be included in a US Senate probe into suspected heavy duty corruption due to the sponsoring from pharmacological companies in the area of pain medication and care. Now, until not very long time ago, both the McGee's were attached to CPB and Christopher herself is a member of the AJOB editorial board. So far pretty circumstantial and not really a link. However, a very recent revelation is that AJOB, when publishing an article with Christopher as co-author, neglected to publish a meaty description of her conflicts of interests due to the pharma sponsorship of CPB, plus missed (possibly due to omissions by Christopher to follow the proscribed COI disclosure procedure) other similar COI's of her co-authors. More details are at William Heisel's Reporting on Health blog; here and here. In any case the link between the troubles at AJOB and the serious allegations against CPB and Christopher is through this development clearly more than circumstantial. AJOB has allowed the possibly corrupt situation at CPB to enter into its midst, and it did so when its editor in chief and one other editor was academically based at CPB, so that the journal was effectively run from there, and even more so its parallel online extension Bioethics.net.

Now, queried by Reporting on Health, David Magnus, one of the new editors in chief of AJOB described how steps are now taken to beef up the COI disclosure procedures of the journal. Together with the resolving of the conflict of interest situation, this bodes well for the journal's future, albeit the uphill that has to be climbed by Magnus and Johnson McGee and their co-workers on the editorial and managerial side of AJOB has not exactly become less steep. Being a fan of AJOB, it makes me happy to detect Magnus' resolve to clear up any remaining irregularities or integrity problems at AJOB, and thus take important steps to restore its reputation.

One of the things that continues to create suspicion and confusion is the relation and connection between AJOB and Bioethics.net. This, I assume what was explained Hilde Lindemann's doubts with regard to the ownership of AJOB, and the latest post at Reporting on Health displays confusion around where information about AJOB is to be had – at the T&F website of the journal or at Bioethics.net. It has, through the first of the controversies mentioned above, been made very clear that AJOB is owned and published by Taylor & Francis, which in turn are not involved in the ownership or operation of Bioethics.net. But, of course, there is a business deal of some sort between T&F and Bioethics.net, lest the latter would not be able to offer its members automatic access to all AJOB material or so vigorously promote AJOB (no doubt contributing to its popularity and impact). When I checked before, when controversy no. 2 above was going on, none of these things were made very clear at the Bioethics.net website. However, the information given has now clearly improved and the ownership of Bioethics.net as well as its business link to AJOB is now described in the Bioethics.net "about" section, thus:

Bioethics.net is owned and operated by Bioethics Internet Group. Bioethics Internet Group (BIG) is wholly owned by Summer Johnson McGee, Ph.D. Funding for bioethics.net is provided by paid banner advertisements appearing on the website and a stipend from Taylor and Francis, Inc.

To me, this explains a lot why it "had" to be Summer Johnson McGee who took over the rudder when Glenn McGee resigned to take up the CellTex job. Although separate financial and organisational entities, only one of which with financial ties to the McGee's, Bioethics.net and AJOB are very much dependent on each other. Or AJOB is at least dependent on Bioethics.net to the extent that the latter does contribute to the success of the journal. Or perhaps the double involvement in Bioethics.net and AJOB helps to fund the no doubt unusually complicated editorial operation of the journal's ambitious design? In any case, it would seem very probable that Bioethics.net stands and falls as a business with the link to AJOB. So far, perhaps not much of a problem for AJOB from an integrity perspective. But it may need to be discussed to what extent it may be a problem that the editor in chief of AJOB has a direct financial interest in what is being published by AJOB (since that will affect the traffic of Bioethics.net and, through that, advertisement revenue of BIG, owned by Johnson McGee).

In any case, another matter for Magnus, Johnson McGee and the editorial board – as well as responsible officers at Taylor & Francis, of course – to ponder as they all continue their efforts to restore AJOB to its former glory.

Mike King on My Take on the Sexism Accusation re. Criticism of New AJOB Management.

Mike King of the Bioethics Centre at the University of Otago, New Zealand, has provided an interesting comment to my latest post on the issue of a severe conflicts of interest within the new management of the American Journal of Biotehics.

Mike points out that, apparently, some of the leaning on AJOB and the McGee's around the net may have been read as a slanderous rant about Summer Johnson McGee not being qualified for the job of editor in chief, but getting it only because of her marriage to Glenn McGee, the resigning editor in chief, or – alternatively – that Johnson McGee, as a woman, would be unable to think for herself in relation to her husband.

I agree wholeheartedly with Mike King that if this was all there was to the criticism against AJOB, this criticism would indeed be nothing more than a dirty piece of sexist garbage. However, arguments of the sort alluded to have certainly not been what I have been set forth as the basis of my criticism (see my former posts, starting with last one linked to above). Neither is it to be found in the critical messages of Howard Brody or John Lantos. And, frankly, I cannot see how anyone could read that into either of our critical contributions on this matter.

So, just to be crystal. crystal clear: my claim is based on the fact that the link of marriage between the old and the new editor in chief preserves the vested conflicts of interest created by the former signing on as full time consultant for a dodgy, private stem cell therapy company. This since marriage by default makes the financial interests of spouse intertwined.

That's all there is to it.

The Conflict of Interest Claim Towards New AJOB Editorial Arrangement is not Sexist

The controversy surrounding the new editorial arrangement for the American Journal of Bioethics after Glenn McGee decided to step down in order to work full time as consultant for stem cell company CellTex (covered in former posts here, here and here) continues, now in the landscape of big science, in this news article in Nature.

In the article, new editor in chief, Summer Johnson McGee defends the decision of publisher Taylor & Francis to appoint her editor in chief against the criticism that this cements rather than resolves the conflict of interest created by Glenn McGee's move to industry:

Responding to questions from Nature, Summer Johnson McGee says that the journal has a conflict-of-interest policy that requires editors to withdraw from reviewing a manuscript if they perceive a conflict. She calls allegations that her appointment results from her relationship with her husband “baseless and sexist”.

Now, the firtst line of defense here has already been addressed by the critics, in particular by John Lantos, who resigned from the AJOB editorial board over this matter. And I happen to agree with John about how much of a wife-of-Ceasar-principle has to be applied in the case of defending the credibility of bioethics journals. Simply put: one of the well-known logics of conflicts of interests is that they tend to make you bad at spotting where the conflict is actualised in particular cases. Thus, the report c-o-i based on subjective perception principle is not by itself good enough. A broader margin of safety against suspicion is required to uphold the credibility of a leading ethics journal.

More interesting is Johnson McGee's second line of defense. The claim of "baselessness" is, of course a complete misnomer and question-begger. It is a fact that she and Glenn McGee are married and that, in virtue of that arrangement, vested interests of Glenn McGee are by default also such interests of Summer Johnson McGee. Therefore, I have argued, the conflict of interest is not resolved but rather sustained by switching from one to the other in the leading editorial management role of AJOB.

Now, this way of arguing is, Johnson McGee seems to hold, sexist. Well, Summer, allow me to retort that it is in fact this very line of defense of yours that is a case of sexism. The argument based on default economic relations between spouse holds regardless of the sex or gender of the people involved in this relationship. That is, my argument would have stuck just as much had the roles between you and Glenn been reversed (you being the one leaving the e-i-c position for industry, and Glenn taking up your managerial torch). What you seem to claim is that you should be let off the hook because you happen to be a woman. That, if anything, is a sexist line of argument.

If this is all there to say in defense of the new AJOB editorial arrangements, I would say that the state of things in the management of this journal appear to be even worse than what they appeared to be before. For I cannot convince myself that even Johnson McGee herself seriously believes in what she tries to sell through Nature. This, I would say is not the voice of conviction, but of desperation.

Press release from Taylor & Francis on the New AJOB Management

Relating to my two posts yesterday on the controversy surrounding this (here and here): Today, via Twitter and Facebook, a press release from the publisher of the American Journal of Bioethics, scientific publishing giant Taylor & Francis, on the journal's new managerial arrangements has been distributed. Anyone can get it from here.

In short, T & F simply announces the new arrangement: Summer Johnson McGee and David Magnus as the new editor in chief team and states that Glenn McGee is "retiring", while advising the transfer to the new arrangements over a 2 months period (which is perfectly in order). Unsurprisingly, there is no comment whatsoever of the criticism that the new arrangement has attracted. There is, however, an attempt at an explanation of why Summer Johnson McGee is to be EiC in spite of her sharing the conflict of interest that explains Glenn McGee's resignation (due to their marriage): David Magnus demanded this arrangement for accepting himself stepping in as EiC. This explanation was commented on by John Lantos in yesterday's post. In short: if this is indeed the reason for the new arrangements it is, in extension, a worrying sign of poor judgement and undue focus on practicalities over integrity of both Magnus and Taylor & Francis.

Now, I can see the reason for wanting Summer Johnson McGee to go on with AJOB: she has been working with the journal (and it's sibling website and blog) in an executive capacity for a long time and probably know all the ropes better than most others. However, such practical reasons weigh lightly when balanced against the credibility, integrity and reputation of AJOB and it's spin-off journals. Not to belittle the competence and experience of either Glenn McGee or Summer Johnson McGee or David Magnus (should his condition for accepting to be EiC be as firm as it sounds), but these are things that can be passed on to other people where no embarrassing conflict of interest ties staining the reputation of AJOB will exist.

So I land once again in the conlusion I announced yesterday: AJOB is a fantastic achievement. But in light of the carreer choice made by Glenn McGee, to remain fantatstic it needs to completely severe all ties (except, of course, the recognition as founder and former management) - direct as well as indirect - to him – which, as things stand, includes also Summer Johnson McGee. As indicated by John Lantos, it is both surprising and rather disturbing that this is not obvious to David Magnus and the representatives of Taylor & Francis.

John Lantos resigns from the AJOB editorial board

As a direct result of the affair with regard to the American Journal of Bioethics that I discussed in my former post, John Lantos, Director of the Children's Mercy Bioethics Center and Professor of Pediatrics at the University of Missouri-Kansas City School of Medicine, as well as Fellow of Clinical Medical Ethics at the University of Chicago, to which he belonged for over 20 years, just announced his resignation from the editorial board of AJOB via a post in the closed Facebook group Bioethics International. I've contacted John and he has given me permission to quote this post here, which I will do without further comment:

After thinking about AJOB since the story broke, here's where I stand:

As a long time supporter and admirer of the American Journal of Bioethics, a former member of the Editorial Board, and a friend of both current and former editors, it pains me to see what has happened. AJOB has been a great journal and I have been, until now, proud to be on its Editorial Board. But recent events make it clear that the journal has lost credibility in ways that tarnish not just the names of people associated with it but also the reputation of the entire field of bioethics.

To me, the key issues are not the ones of procedure that have gotten so much attention. Instead, they are issues of substance. They raise questions about the judgment of the editors and, more importantly, about the goals of the publisher. If, as we’ve been told, Taylor and Francis 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. 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?”

An academic journal in any field, and especially in a field as value-laden as bioethics, must earn the trust of readers and writers alike. Authors need to know that reviews will be fair. Readers need to know that suggested revisions are not politically or financially motivated. The current arrangements offer no such assurance. We want to know what is really going on – and what will go on – and who will be making decisions -- when the journal decides what to publish on issues ranging from research ethics, stem cell controversies, conflicts of interest, relationships between industry and academia, innovative therapy, FDA regulation, patient deaths in clinical trials, research standards in other countries, cozy relationships between biotech companies and state governments, and a host of other issues that have direct financial implications for the new editor-in-chief and the ongoing “founding editor.” AJOB’s current policy for dealing with such conflicts is that editors “…will recuse themselves from any involvement in decisions where they have a financial or other conflicting interest.” In other words, “Shut up and trust us.” I am afraid I have lost trust.

I have, sadly, resigned from the AJOB Editorial Board. As long as the current leadership structure is in place, I will no longer submit papers to AJOB. I have withdrawn a paper that was in press and due out in March. I will discourage my colleagues from submitting papers to AJOB. I will not cite papers published in AJOB. 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.

Confidence Lost: The McGee's, Celltex and the American Journal of Bioethics

The past week or so, a new controversy related to the vastly successful journal The American Journal of Bioethics and its management has been a growing buzz in my field of research speciality. I have reported before about such a controversy (here, here and here), which in that case rather quickly deteriorated into a storm of more and more personal accusations between what at the time looked to me as a bunch of rather overinflated egos, of less and less interest from a bioethics point of view. There was also a very strange former questioning of AJOB's fine impact factor, which I will not even link to here, since it was obviously based on lies about it being based on high degree of internal citations. In fact, AJOB has less degrees of internal citations than most other ethics journals tracked by Thomson Reuter. The journal AJOB is a success, and it is a real success especially in terms of making bioethics publication have a real impact on medicine and medical science – hence the fine citation record, which anyone can use their university's Web of Science subscription to check. 'Nuff said on that.

This latest scandal, however, seems to me to be more of a real deal. This since there are a number of principal matters of publication ethics and bioethics implied, rather than just controversy over singular editorial policy decisions and insubstantiated slander. The matters are:

1. Glenn McGee's handling of his shift from editor in chief of AJOB to President of Ethics and Strategic Initiatives of the private stem cell business CellTex. The verdict has to be: not very nicely done at all. See: Leigh Turner's blog for more.

2. The attempt to resolve the obvious conflict of interest created by that shift by appointing McGee's wife, Summer Johnson McGee as the new EIC and for Glenn McGee to keep some managerial (rather than just ceremonial in terms of founder, full stop) ties to AJOB. See the previous link and this one for more. The vested interests of Glenn McGee in terms of his financial ties to CellTex cannot, in my view, be separated from those of Summer Johnson McGee for the very reason that they are married and thereby under default arrangement share private economic interests and resources.

3. The issue of the ethics of a bioethics scholar to assist a firm that offers non-FDA approved stem cell therapies in a manner that very much resembles the activities of the Burzynski clinic that I have been posting about. Read more about this here.

4. The implied result of having Glenn McGee more or less indirectly in a position of power in relation to an FDA-connected editor of a journal in the AJOB family, where publications may influence whether or not CellTex products will eventually receive FDA clearance. (see previous links).

I personally like AJOB and its special editorial idea very much and I also have the highest regard for its contribution to the positioning of bioethics as a research speciality, but the combination of the above four matters  taken together cannot but leave an ugly stain on its record of credibility. By themselves, they also each stain the credibility of both Glenn McGee and Summer Johnson McGee as bioethics scholars. By implication, this taints also other people involved in the managerial and editorial operation around AJOB. But the root of all this is the ruined credibility of Glenn McGee as bioethics scholar.

Simply put, Glenn: how can I from this day know what master you speak for when you make decisions, assessments, arguments, and so on? As a bioethics colleague: why isn't your first action re. CellTex the obvious one of refusing to be affiliated with it before they either close down their questionable operations or obtain proper approval for their activities?? None of the answers to the latter question that I can imagine inspire confidence, I'm afraid. In light of this, how could you ever imagine that the moves made regarding the management of AJOB would get the journal off the hook in terms of conflicts of interests and reduced credibility. AJOB is your child, I can see that, and I can also see that you care very much for this child of yours to do well in your absense. However, the path entered by the decisions made in recent times is not promoting that end, quite the opposite.