Update: The University of Minnesota Psychiatry Research Ethics Scandal

This is to update a little bit on the situation with regard to the disgraceful twists and ugly and very possible bona fide cover-up activities and general lack of transparency of the University of Minnesota management to avoid a real investigation of the tragic, Astra Zeneca sponsored psychiatry drug trials that caused several suicides and that raise a number of serious queries about irregularities and abuse, such as possibly falsified consent forms. I have reported about this increasingly shameful affair here, here and here.

A petition to the governor of Minnesota to launch an independent investigation of the University of Minnesota psychiatry department has assembled almost 3 000 names – many of which are prominent medical researchers or practitioners and bioethicists from all over the world, who are baffled by the University's attitude and actions – and on Facebook, a Community Alliance for Ethics in Minnesota Psychiatry page has been launched.

Today, Carl Elliott, medical ethicist at the very same university who relentlessly has been pressing for release of vital documents and investigations, summarises where the whole thing currently stands in this blog post at Huffington Post. Carl's final judgement of his own university is not uplifting, and you can read or follow links to descriptions of the latest disgraceful dance-steps of the management to avoid exposure of what for every such move just keeps looking dirtier and dirtier:

In the 23 years I have been teaching and writing about the ethics of medical research, I have never come across a case of abuse this outrageous. Nor have I ever encountered university officials so aggressive in stonewalling legitimate investigation and intimidating critics.

I will, of course, continue to report on the future developments with regard to this business. In the meantime, if you haven't already done so, you may inspect and consider signing the petition to the Minnesota governor for an independent investigation of University of Minnesota Psychiatry.

Threats, Libel, Calls for FDA & Government Action – and a Petition to the Governor: Research Ethics Morass at the University of Minnesota Psychiatry Continues

The sad and disgraceful story about the appalling unwillingness of the University of Minnesota to in any way investigate closer what several pieces of evidence suggest may very well be a major research ethics scandal in its psychiatry department continues. The scandal involves drug trials connected to several major Pharma companies, such as Astra-Zeneca, but for once it is not them who appear to be doing the bad deed – it is the university itself.

Former reports on this by myself are here, and here. The reporting of University of Minnesota bioethicist Carl Elliott is assembled here – an overview of the basic background story about apparently mishandled psychiatric drug trials linked to at least one death by suicide is here. In the Scientific American, blogger and clinical trial specialist Dr. Judy Stone is also reporting and commenting on the case, here.

So, what's new?

Well, first of all, not only does the University of Minnesota clearly bend its own rules inside out to avoid what would otherwise be the obvious line of action: investigate, clarify and report with full disclosure and transparency. It has, it now appears, sunk so low as to use its own General Counsel – one Mark Rotenberg, who just happens to be identical to the lawyer who has been attempting to whitewash this story and motivate the avoidance of investigations – to in so many words try to threat Elliott with possibly disciplinary actions for pressing on for an inquiry. Yes, that's right, a university threatens one of its academic employees – a bioethics professor at that – for simply insisting on that the truth be sought out and revealed. In short: for doing his job well.

In fact, not only that – the University of Minnesota President, Eric Kaler has chosen this well-timed moment to hint that research ethics regulation at the University, not least with regard to academia-industry collaboration in psychiatry may be "excessively burdensome" and expressing a "low tolerance of risk" and that "we’re afraid a misdeed of two decades ago will reappear again" – the latter obviously referring to past very serious misconduct cases (described in the post linked to above) in, where do you think? – yes indeed, the department of psychiatry. Nice.

Second, the University has finally tried to respond to the claim of Elliott that several patient consent and other forms seem to exist in duplicate but not differing – for instance, not all are signed! – versions, apparently originating from different times. This is covered in Elliott's former postings linked to above, as well as Dr. Stone's astute analysis in the Scientific American. The formerly mentioned General Counsel, Mark Rotenberg, responds on behalf of the university in an article in the Star Tribune to this is, again in so many words: Hey, you probably faked those yourself – or the families of the victims did!! That is, he doesn't mention any particular party and uses the word "authenticity", but in context the content is clear. Being a European, even though I am a Scandinavian and thus possibly with some kinship to the mysterious Minnesota ways of academia, I may be misinformed of some legal peculiarities: but isn't it at least a little bit legally troublesome to accuse other people of illegal actions (forgery of official legal documentation is a criminal act in Minnesota and the USA, isn't it?) without any shred of evidence?

Elliott's own response is the obvious and only sensible one (besides suing the guy for libel, that is): if you say so, help me to find out! Substantiate your claim! Open the files! Disclose the evidence! That is, run the investigation that should have been run ages ago, but that you and those you serve have denied and forestalled!

Third, Elliott has now officially written to both the Office of Civil Rights of the U.S. Department of Health and Human Services and to the Office of Compliance of the FDA to call for investigations of related parts of this troubling story. The letters you can see and download below.

   Letter to HHS Civil Rights About Possible HIPAA Violations by   MarkingsonCase

 

   Request  that FDA Office of Scientific Investigation to investigate "evaluation to consent" forms... by   MarkingsonCase

And Elliott is not the only one acting. A close friend and the mother of Dan Markingson, the young man whose death by suicide is clearly linked to one of the deeply suspicious psychiatry research trials involved in this potential scandal, is petitioning the Minnesota Governor to investigate the University of Minnesota for its refusal to act and investigate. You can read the statement and, if you want to, sign it yourself here.

There will be more, I'm sure......

Continuing stinks out of University of Minnesota Psychiatry: If it looks like it, smells like it and sounds like it, at least it deserves an inquiry...

This is just to point interested readers to what looks more and more as a multi-layered bona fide research ethics scandal at the psychaitry department of the University of Minnesota, involving at least one death and possible falsified patient documents in order to fake proof of consent. My US colleague Carl Elliott has been covering this mess for a long time, patiently trying to have the university's own research intergrity administration take hold of the case, and work it as they should. However, instead of doing what a university in this situation is supposed to do – namely acting in a prudent and transparent way to undo any unsubstantiated suspicions – it continuously acts to sweep whatever crap it is they feel they need to hide under a dirty, old mat of hollow and increasingly unsound or even obviously invalid bureaucracy blabber.

Is it as simple and disgraceful as one commentator at Carl's blog suggest, that:

...the University of Minnesota will never look into these issues because they are scared too death of what they might find, or actually might have already found. /..../ The University at this point has no option but to stay the course of denial, for to give in and admit fault would open the flood gates...

??

Read more here.

Updates on this case will follow as they appear by way of Carl.

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.