Tuesday, 12 March 2013

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.


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......