Dodgy Stem-Cell Firm CellTex tries to Bully Critical Bioethicist into Silence

Just a short note on this, because it is important. Otherwise, I'm on sick-leave and will post sparsely for a while.

Texas based adult stem cell company CellTex tries to bully bioethics professor Leigh Turner into retracting a letter that he sent to FDA, urging the authority to look into if not the operations of CellTex violate federal US regulation on the licensing of pharmaceuticals and equivalent products (such as stem cells for clinical use). The letter is now streamed online for easy inspection.

CellTex was recently in focus in Nature due to alleged unethical use of unlicensed stem-cell treatments, and its recruitment and  almost as quick loss of prominent bioethics professor Glenn McGee as its own in-house consultant, a process in turn provoking waves due to McGee's ties to the management of a leading ethics journal (see my last post of the latter affair here).

Further comments on CellTex's move on Turner can be found here and here. A general comment on the bully tactics of dodgy stem cell firms in the US can be found here. For my own part, I must confess myself amazed at how perfectly CellTex conforms to the analogy to the quackery Burzynzki Clinic that I made in my first posting. This - trying to intimidate bloggers and critics by threatening lawsuits - is exactly what the people behind the Burzynski scam uses as last resort when criticism becomes too hot to handle (see here and here and here). But in the CellTex case, there is a further twist. For what Turner has done is simply his job as bioethics scholar and citizen: He has contacted the appropriate state authority in light of worries over the legality of a commercial operation coming out of him analysing the practice of CellTex as a bioethicist. He has not declared the operation of CellTex illegal, he has simply asked FDA to look closely into the matter and mentioned a few reason for initiating such a probe. So no way that this will ever reach a court of law, and almost as unlikely that charges will actually be filed against Turner. This is pure bullying and harassment tactics meant to awake fear and create silence.

But, hey, CellTex, you know what?! This backfires badly and does nothing else than expose your own fear! The response to Turner's criticism is clear evidence that leading people inside CellTex are seriously scared of what an FDA probe would demonstrate. The more the reason for FDA to make a move, don't you think?

Fun, Fun , FUN for All of Us Philosophy Geeks: Fauxphilnews

Philosophy humour is, I think, about the most geeky and esoteric there is in the world of academic comedy. But for all of us who are on the inside, it is a sheer pleasure when someone pulls it off well. For, as you would expect, philosophers are no less ready to unleash their entire battery of critical scrutiny in cases where the subject is used for other purposes than, well..., the subject, than they are in those seminar rooms where the subject is in fact the subject and not something else - like having fun. Anyway, this new site, Fauxphilnews, does it better than most, I would say. And judging by the very happy and frequent sharing of every post on Twitter and Facebook by my colleagues – as well as prestigious mention by The Splintered Mind, I'm not alone in my appreciation.

David Magnus Defends the New Managerial Solution for AJOB as Udo Schuklenk Resigns from the Editorial Board

At last, there is word directly from the bench of the accused in the recent controversy regarding the new managerial solution for the American Journal of Bioethics after the Glenn McGee resigned as editor in chief to join a rather dodgy private stem cell company [since Slate retracted the article linked to here, apparently following threats of lawsuits from McGee, this link is now broken. Thanks to Nature, the background on the murky business of CellTex is still around, however] as full-time adviser/lobbyist/expert. My former posts on this matter are here: 1, 2, 3, 4 and 5. Today, I learned that another heavy resignation from the board of editors following these events has occurred: Udo Schuklenk has announced that he steps down from this position, preferring to keep his exact reasons confidential with reference to being being part of the editorial management of a competing journal, Bioethics.

David Magnus, one of the two newly appointed editors in chief – the other being Summer Johnson McGee, whose appointment I have criticised – addresses the rather rich variety of critical reactions to the new AJOB order, as well as its background, in a post at AJOB's adjunct blog. Given the amount of criticism that I have been mounting, I think it is only fair to cross post what David writes in its entirety (my comments can be found below, after the post):

David Magnus Corrects the Record Regarding AJOB

Over the past couple of weeks, a great deal of drama has played out regarding changes at the American Journal of Bioethics. While we appreciate all of the support we have received from our Editorial Board and much of the leadership in the field, a number of misleading or false claims have been made about which I feel obligated to respond.

1. It has been claimed that the Editorial offices of AJOB were relocated to Celltex. This is false. It is a matter of public record that the offices of the journal have been and continue to be based at 3030 Post Oak Blvd. #805 in Houston, Texas. These are not the offices of Celltex and Celltex housed no AJOB editorial office or AJOB activity on their premises.
2. It has been claimed that Glenn McGee took the job at Celltex and planned to continue to serve as both EIC of AJOB while working at Celltex until bloggers and twitter revelations forced a hasty change in plans.  In fact, when Glenn first decided that he was likely to move to the private sector, he decided it would be best to resign from AJOB. Transition plans began then—and this can be attested to by a number of leaders within the field of bioethics, since a number of them were aware of the transition plans.
3. Most of the attacks fail to acknowledge that Glenn had already been working to transition out of his role at AJOB as soon as he accepted his new position. During the transition he had no role in the oversight or acceptance of manuscripts for the journal. Failure to acknowledge that he was in the process of transitioning out of AJOB and that conflict of interest provisions had been put in place is a misleading rendition of events.
4. Charges of nepotism have been raised against the appointment of Summer Johnson McGee as the co-EIC of AJOB. This charge is false. It was my idea (not Glenn’s) for Summer to be proposed as co-EIC. It was up to Taylor and Francis (not Glenn and not me) to make the final decision to sign her to a long-term contract as co-EIC.  This is one of the more offensive charges, since it fails to acknowledge the reality that Summer is a scholar in her own right and that she is in fact the backbone of the journal. Anyone familiar with the workings of the journal knows that Summer has taken on more and more responsibility for the journal over the past several years—unfortunately while getting little recognition for her contributions.
5. There has also been a charge that Summer is too conflicted to serve as co-EIC or that her COI cannot be managed or mitigated. This issue has already been addressed, but to reiterate: conflicts of interest are ubiquitous among journal editors. What is unusual in this case is that one of the sources of spousal COI is actually known. In contrast, most of us know very little about what, if any, COI issues exist regarding spouses or other family members of most bioethics journals (for the record, my wife is a public librarian). As we have already stated, Summer will have to recuse herself from any possible COI, including those that may arise out of the fact that her husband works for a stem cell company.  I do not believe that this will be hard and knowing the range of manuscripts that we typically review, it will be a minority of submissions. I will personally review all manuscript submissions (as will Summer) and no editor will be involved in manuscripts for which they have a COI. Since we have two co-EIC’s and two new Associate Editors, we believe that it should be relatively easy to divide any labor. To improve our management of COI issues and to update our now 10 year old COI policy, we are shortly going to be looking for volunteers among the three Editorial Boards to create a standing COI committee and charge them with helping to create guidelines and processes for better managing COI’s. We have actually been successfully managing conflicts of interest among ourselves for a long time (for example, an article was recently accepted that was written by one of my faculty) and there is no reason to believe that recusing Summer from reviewing the manuscripts where a COI exists can not be accomplished.

Going forward, Summer and I have a lot of exciting plans for AJOB. We plan on creating several committees (not just a COI committee) to explore ways of improving and expanding the journal and bioethics publishing generally. We also look forward to instating a business meeting for our Editorial Board at ASBH each year, a working meeting where we will update our board members on the state of AJOB, solicit their opinions, and hear reports from the committees we have created. These are but two ideas among many that we plan to institute. We have two new Associate Editors who have agreed to join us (we will send an announcement about this shortly). And we are excited about the opportunity to lead AJOB—the most cited journal in the field.

 David Magnus, PhD

Now, of these sorts of criticism, I have wielded only one, the fifth and last one, although I did point out in my initial post that the handling of the publication of the transition, its procedural steps and its background has been far from as open, professional and clear-cut as one would have expected from the leading journal of a flourishing field of research. Apart from not appreciating the impact on trust of the many serious mistakes that has been made in this process (by the former and/or the new management, by Taylor & Francis, and so on), David, I think, addresses several of the points of criticism fairly well. However, I do think that his take on the fifth still leaves much to ask for. What he says in so many words is this:

1. Yes, through Summer Johnson McGee's marriage to Glenn McGee, AJOB does have a clear-cut conflict of (vested) interest built into its editorial management, but that may very well be the case with other journals too!  

This hardly needs comment, does it? Imagine a prosecutor arguing thus: I have clear evidence to prosecute person P for the crime C, but since there are possible other individuals that might have been possible to prosecute for other crimes, had I only had the evidence, prosecuting P for C is out of the question. Case closed.

2. AJOB will be beefing up its organisation for handling the actualisation of the COI of Summer Johnson McGee (and other COI's that may appear) in particular cases, so that it does not wholly depend on the subjective judgement of the person attached to the COI, or other people of the editorial management, alone, but another three people recruited from the editorial boards of all AJOB journals.

This seems like a necessary minimal step given 1, but is it sufficient? Well, in the end this comes down to trust, doesn't it? My position here is rather like the one voiced by John Lantos: In the face of a journal that prefers to house and attempt to "manage" a serious COI in the midst of its highest management when it is quite possible to avoid it in the first place, I do not feel a tingling buzz of increased confidence and trust, rather the other way around. I, as I suspect most of my colleagues do, ask myself the obvious question: why does David Magnus make this far from necessary choice that seriously threatens the credibility of the journal? Why, for instance, does he not start with a clean editorial slate and manage the practicalities of the transition by engaging both McGee and Johnson McGee in temporary advisory capacities to this effect – naturally, rewarded to the extent that their high qualifications and competence require? The point here is not that there may be answers to these questions and that the string of follow-up questions and subsequent answers may go on for a long time. The point is that, from the point of view of the best interest of the journal, there are obvious strategies to avoid having these questions being actualised in the first place. Not choosing these from  the start undermines trust, and trust is what David Magnus above asks of all of us who care for the integrity of AJOB and the field of bioethics research. It doesn't add up, simple as that.