Cross Post: More psychiatric research misconduct at the U? A Fox 9 television report on Dan Markingson and another abused research subject at U of Minnesota Psychiatry

Cross-posting this from the Fear and Loathing in Bioethics blog. It connects to several of my earlier posts, the last of which is here, on the appalling research ethical scandal connecting to University of Minnesota Psychiatry. And once you thought you heard it all, more comes to light through this Fox 9 documentary:

KMSP-TV

When having watched it, you might want to sign this petition to the Minnesota governor for an independent investigation of the University of Minnesota pertaining these matters.

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.

Slides to Two Recent Talks Connecting the Themes of Ethics, Crime and Psychiatry are Now Online

Just to inform that the slides to my two talks at the 33rd International Congress of Law and Mental Health, held in Amsterdam earlier this summer, are now available online for viewing, download and sharing via my Academia.edu site. Both talks represent work in progress, where I am in the beginning of combining thinking on different topics that I have been touching on in isolation before, but which are nevertheless related through their connection to certain aspects of criminal law policy connecting to medical views of human nature.

They are:

1. The Return of Lombroso? Ethical and Philosophical Aspects of  (Visions of) Forensic Screening

Abstract
Italian nineteenth century criminologist Cesare Lombroso is notorious for his seminal ideas about criminality and anti-social behaviour resulting from physiological anomalies that should be detected by society and used for forensic preventive purposes. After an extended period of disrepute following World War II, similar ideas have been resurrected in psychiatry, genetics, neurology and criminology in the past decade or two. In particular, there is a growing focus on early detection and application of preventive measures. This development actualizes a complex web of ethics and policy issues having to do with the well-known fact that screening and prevention in the health area are far from ethically clear-cut activities and actualize vivid prospects of doing extensive harm to individuals as well as society. Also, taken to its extreme, it actualizes the idea of using prenatal or preimplantation testing to preselect against children with a predisposition for criminal or antisocial behaviour. In the forensic case, such screening-prevention strategies will connect further to a complicated issue about the proper use of risk-assessment models for societal decision-making for precautionary purposes. Based on former work in all of these areas, this presentation will outline and analyze the basic issue of the defensibility of activities of this sort, with the perspective of forestalling unintentional harm to individuals and society.

And.....

2. Hate Crime, Mental Disorder and Criminal Responsibility

Abstract
Hate crimes are ordinary crimes committed in connection with a negatively prejudiced, biased, disparaging, or antagonistic attitude towards the victim in terms of a perceived membership of a social group. Some hate crimes are elaborate political acts of terror or elaborate persecution, some are so-called “hate speech”, but the overwhelming majority are instances of mundane criminality, involving everything from murder to theft and harassment. Hate crime policies rest on the idea that the bias or “hate”feature make such crimes worse, and that offenders for this reason should be held more firmly responsible. At the same time, the attitude of making a crime into a hate crime involves more or less distorted ideas about reality, together with a willingness to transgress social norms on that basis. In some cases, these views amount to major delusions, resistant to rational scrutiny. In other cases, we may move closer to a point where the belief-desire cluster can be seen as ordinary negligence. Thus, many hate crimes have features that may be argued acting to diminish responsibility according to standard ideas in the philosophy of punishment. The presentation maps underlying value conflicts, tensions, and incoherence in legal practice connected to this complexity of criminal law.

Enjoy for what it's worth!

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......

New details on the University of Minnesota psychiatry morass: suspicion of vital documents falsified and hidden from court

More on what I posted on a few days ago with regard to a thickening enigma around the ethics of the so-called CAFÉ study – involving Astra-Zeneca and associated with at least one death – at the psychiatry department of the University of Minnesota, here.

To read the new developments, looki here! In short, as new evidence occurs the suspicions about a bona fide coverup, featuring falsified consent documents and other vital pieces of evidence hidden from court investigations – are strengthened.

I repeat myself when under stress: At the very least, the University of Minnesota should have a slight urge to look into to this, not least since it appears to be imperative according to its own regulative statutes.

More will follow, 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.

Why Anders Behring Breivik is Probably both Criminally Insane and Legally Accountable

Today, the Norwegian forensic psychiatric experts assigned the task to assess whether or not Anders Behring Breivik (the perpetrator of the Oslo bombings and the mass murders on Utøya) is legally accountable under Norwegian law – Torgeir Husby and Synne Sørheim – delivered their report. Their conclusion is that Behring Breivik was suffering from a serious psychiatric illness (paranoid psychosis) when committing his crimes (here, here, here, here, here, here, here, here, here, here). News-reports unanimously declare that this makes it very likely that Behring Breivik will be ruled legally unaccountable for his crimes. Perhaps they are right, but is he unaccountable? Really?

I suggest that, in this case, we see an example of how severe psychotic illness need not, as a matter of fact, imply moral or legal unaccountability.

According to the psychiatrists who have made the evaluations, ABB describes severe delusions of paranoia, megalomania and grandeur (ABB experienced himself as an appointed defender of the Norwegian people against the horrible threat of muslims, a forthcoming king, et cetera). They also describe him as both suicidal and very dangerous to the the public and, reportedly there are speculations of ABB possibly having been sexually molested as a small child.

Now, of these points, the last two ones have no implication whatsoever for either the medical question (is ABB clinically mentally ill?) or the legal question of accountability. The presence of a risk of suicide may be an indicator of mental illness, but not necessarily at the time of the crimes, albeit possibly motivating psychiatric care no matter how the ensuing legal process falls out. However, the delusions of ABB (which I for now assume that the psychiatrist have ascertained not having been fabricated by ABB) without doubt describe a case of severe psychosis. In fact these descriptions alone are sufficient for declaring ABB seriously mentally ill at the time of the crimes.

Now, when the concept of moral and legal unaccountability are discussed, severe psychosis is one of the paradigmatic cases held out. Someone suffering from severe psychosis is the iconic representation of being stark raving mad and, for sure, no one in such a state can be accountable for their actions. Right? Well....., as you might guess, I will question this inference.

The classic idea of moral and legal accountability connects intimately to the legal notion of culpa – the idea of a wrongful action being someone's 'fault'. The idea is that if you are unaccountable this cannot be the case for you even if the action was wrong (against the law) and was physically caused by movements of your body. This, for instance, is how we view offenses committed by small children, sleepwalkers, and so on. Now, the classic doctrine of legal accountability states two main conditions: (1) understanding of the nature of the act, (2) ability to control the performance of the act. If you lack enough of any of these, you are legally unaccountable and cannot be guilty of a crime.

Around the world, there is some variation as to how (1) and (2) are interpreted (if you want to dive into issues and problems implied by this and other peculiarities around the meeting of psychiatry and the law, have a look here and here). In particular, it varies how tightly connected the concept is to clinical psychiatric terminology and methods. In the end, however, accountability is a legal or moral, not a psychiatric notion, so there is no conceptual or logical necessity involved in taking the step from a clinical diagnosis to a legal verdict. In any case, the typical case of severe psychosis will normally be viewed as activating at least clause (1) and sometimes also clause (2). This, however, seems to depend on the fact that common psychotic delusions are not like ABB's.

The psychotic delusions of ABB described by the psychiatric experts according to the reports have a common theme. They are all about ABB imagining there to be a sound and valid moral justification for what he did. He is convinced that Norway is threatened by an invasion of dangerous muslims, and that the Norwegian establishment forms a fifth column to this threat against an imagined "real" Norway, where "real" Norwegians truly want him to take the actions that he eventually did take. Now, the first part of this delusion is actually not very different from the one apparently held by rather a lot of European voters these days. Thoughts in this direction have been commonplace in the rhetoric of the new European racist political movement, which I analysed in a series of blog posts a while back. The second part seems to be no worse than the average world view of your typical conspiracy theorist (most of whom walk about as free persons). It is the third part, it seems to me, that makes ABB seriously mentally disturbed; the fact that his mind facilitates a world-view which provides a justification (of sorts) for him – ABB – to take bold and normally unlawful and deeply immoral action. The perceived threat and the lack of trust in authorities to prevent the threat may as such just as well lead to apathy or emigration. But combined with the third idea of having a special mission from the "real" Norwegian people to commit destruction and mass murder we have a severe mental illness. Obviously, then, diagnosing a mental illness has a substantial moral element. It is the presence of a delusion that allows ABB to break the most important of laws and moral prohibitions there are with an intact conscience that makes him clearly mentally ill – besides being egocentric, delusional, weird and racist.

However, while this is good reason to declare ABB as severely mentally ill, it is not a case for claiming him not to fall under any of the two conditions of accountability mentioned above. ABB clearly understood that he was killing people against their will and that this is a crime. He also understood that under normal circumstances even he would judge these act to be seriously morally wrong (thus the need for a delusional reason for why they where permissible in this case), so he obviously was fully capable of understanding what it means for an action to be wrong in both the legal and moral sense. Moreover, the whole story of his deeds is a witness of someone in full control of his actions. ABB did clearly not do as he did because he could not help himself, he did it because he really wanted to. He choose to do it and he was as able as anybody else doing something wrong to choose something else instead. The psychosis, moreover, did not expose ABB to any immediately threatening hallucinations that might have been a reason to declare his actions as sprung out of panic.

Here is my reading: ABB was indeed severely clinically psychotic when committing his crimes. But this psychosis had nothing to do with his understanding of the nature of the act or his ability to control it. Or, to the extent that a perceived moral justification is to be included in a person's understanding of an act, he was no less able to understand the nature of his act than anybody else committing a serious crime in the belief of being morally justified. Such as the criminal effectively embracing ethical egoism in caring nothing for his victims and all for himself, such as the Israeli hit squads that went after Nazi war criminals and the ones responsible for the Munich attacks, such as the band of bankrobbing and murdering neo-nazis that have just been apprehended in Germany, such as the very islamist terrorists that were on ABB's mind. And so on.

All of these might, using the clinical tools of psychiatry be declared to suffer from severe psychotic delusions in the same way that ABB does. But all of them are nevertheless fully accountable for what they did. And so is Anders Behring Breivik.

Abortion, Mental Health Problems and the Politicisation of Science

Just the other day, several UK newspapers (here, here) reported about a new, ambitious study on the relationship between abortion and mental health problems. Undertaken by Priscilla Coleman, professor at the Bowling Green State University, and published in the well-renowned journal, British Journal of Psychiatry, the study is a so-called meta-analysis where data and results from many different studies in this area are brought together and analysed as a whole. The result is that evidence speaks in favor of a significant statistical correlation between abortion and elevated risks of mental health problems after abortion. Not surprisingly, this news have been ceased on by political campaigners who want to push for more restrictive abortion legislation. Coleman herself is markedly more modest, concluding only that...

Consistent with the tenets of evidence-based medicine, this information should inform the delivery of abortion services.

In the news reporting, this statement has generally been read as a call for telling abortion seeking women about the risks. Now, if you believe in individual liberty, women's right to decide over their own body or is generally oriented towards pro-choice positions on abortion, this may not appear to be very shocking. After all, abortion is a serious medical or (when undertaken in later stages of pregnancy) surgical procedure that is often undertaken in the context of a personal crisis. If there indeed is a link between undergoing this procedure and suffering mental health problems, this should be explained to women contemplating abortion, shouldn't it? However, there are several question marks surrounding Coleman's result and what conclusions can be inferred from it, both scientifically and with regard to policy.

First, neither the news reporting, nor the abstract to the actual article reveals if and to what extent Coleman's analysis has controlled for relevant so-called confounders – i.e. other factors contributing to the onset of mental health problems. In particular, it is unclear to what extent the analysis has factored in the presence of mental health problems or risk factors for such problems before abortion and, indeed, pregnancy. When I had reason, several years back, to look at research in this area undertaken in Sweden, a repeated phenomenon was that there indeed were correlations between abortion and mental health problems, but that the occurrence of this problems almost always could be linked to the presence of such problems (or risk factors for them) before abortion or even the actual pregnancy. Now, Coleman's results indeed indicate that women who undergo abortion have elevated risks compared to a substantial control group. However, in lack of controlling for the presence of problems before abortion, this may just as well support the notion that women already suffering from mental health problems or who are victims of risk factors for this are more likely to establish pregnancies that they eventually would prefer to have terminated. Indeed, such a link was suggested by a large Danish study published last year in the highly ranked journal New England Journal of Medicine. This, in turn, may depend on a lot of different things, such as being placed in a dysfunctional psycho-social context (e.g. lack of a reliable partner, poverty, disorganised housing situation, et cetera). Hopefully, time will tell what quality Coleman's study actually possess in this respect and, in the case of deficiencies, that further studies are undertaken to investigate the issue.

However, even if it turns out that Coleman's results hold up to closer scrutiny, the sort of factors just mentioned make the interpretation of Coleman's practical recommendation made in the media quite odd, if not biased – just as the one reported about the reaction of many campaigners against liberal abortion legislation. For suppose that Coleman indeed is right in the strongest sense, is the most obvious conclusion then that we should move to restrict access to legal abortion? Actually not, since there is strong scientific support for the claim that such actions lead to no good (in particular, they do not prevent abortions). How about informing about the risk then? Well this looks more sensible, although, if the underlying explanation of abortion being a risk factor is that a certain portion of abortion seeking women are already burdened by mental health problems that threaten to become more serious if they are exposed to trauma of some kind, one may doubt the efficacy of such actions.

Instead, the practical conclusion that would seem to be gaining the most support would be this: Researchers like Coleman should rapidly proceed to develop instruments to identify those at risk, and abortion services should offer these women special post-abortion care and counseling, or even preventive actions before the procedure is undertaken that may serve to decrease the risk. If such an instrument proves difficult to develop, such care and counseling should become a standard ingredient of good clinical abortion practice all across the board. I must say that I find it a bit odd and worrying that Coleman's own practical suggestion does not focus on this. After all, if women's mental health is what you care about, practical implications should focus on actions directed at promoting that aim.

Torture as Treatment?

Despite the ugly track record of treatment of intellectually and cognitively disabled people over the centuries, I was actually quite shocked to learn about this apparently ongoing practice in the USA:

Eight states are sending autistic, mentally retarded, and emotionally troubled kids to a facility that punishes them with painful electric shocks.

Read more here.