Celebrating the status quo at the University of Minnesota

If the University of Minnesota has felt any pressure to reform the way it oversees clinical research, it is certainly not betraying any evidence of it. From the gala send-off for the General Counsel, through the aggressive public statements of the Dean of the Medical School and the relentless public relations campaign for Charles Schulz, it has become plain that no plans for change are being contemplated. Just the opposite, in fact: the President of the university has made it clear that he wants more clinical trials and more partnerships with industry.

Given our scandal-plagued history, this is not really a surprise. Perhaps the petition calling for an investigation will eventually have an effect. In the meantime, however, the very same rules and oversight system that failed Dan Markingson will continue to fail other vulnerable patients.

What was missing at the Rotenberg celebration

It wasn’t all champagne and heartfelt tributes at the farewell ceremony for Mark Rotenberg last week.  Sure, there was a lot of expensive jewelry and tailored suits.  But there was also plenty of good-natured ribbing, not to mention some wacky video clips of office hijinks.  Who knew that university attorneys could dance the Macarena?

My favorite part of the ceremony came at the end, when the audience was treated to a PowerPoint presentation about how much money Mark Rotenberg had generated for the university. Yes, Rotenberg makes considerably more money than the Chief Justice of the United States Supreme Court. But when you look at that salary in larger economic terms, you see just what a terrific investment he has been.  Plus, as the audience was reminded, university attorneys could be making so much more money in the private sector.  Yet they have chosen public service.  (Pause here for cheers and applause.)

I might have missed it, but I saw no mention of secret agreements to bury research fraud or filing a “notice to assess costs”  for $57,000 against the mother of a suicide victim. 

Using the threat of involuntary commitment as a clinical trial recruitment tool

Yesterday I posted this question:

Have you been approached for enrollment in a research study while under an involuntary commitment order? When the Minnesota legislature passed Dan’s Law in 2009, it placed strict limits on the ability of psychiatrists to recruit mentally ill patients under involuntary commitment orders into drug studies. What is unclear is whether psychiatric researchers are actually complying with Dan’s Law. We would like to find out more. If you or anyone you know has been approached for enrollment in a research study while under a commitment order, I would be grateful if you could send an email to me (ellio023) at my gmail address. 

Judging from the response I have gotten the first day, using the threat of commitment to pressure patients into clinical trials may well be more common than I had feared.  If you or anyone you know has experienced this kind of pressure, please contact me.

Wendy Rogers: "Dan Markingson: a study in research misconduct"

Wendy Rogers of Macquarrie University writes:

"As someone who has worked in research ethics for many years, I feel that I have a pretty good understanding of how and where things go wrong in the research ethics review process. Such a process can never be perfect – human judgment is involved and there will inevitably be problems that slip through the net. However, the events surrounding Dan Markingson’s recruitment into an industry-sponsored trial of Seroquel (quetiapine) and his subsequent death are less an issue of what slips through the net and much more an indictment of the corrosive powers of commercial interests which make a mockery of the safety net of human research ethics review."

Read the rest in IJFAB.

Gary Greenberg, DSM-5 and the Book of Woe on the Brian Lehrer Show

HT One Boring Old Man

Have you been approached for enrollment in a research study while under an involuntary commitment order?

When the Minnesota legislature passed Dan’s Law in 2009, it placed strict limits on the ability of psychiatrists to recruit mentally ill patients under involuntary commitment orders into drug studies.   What is unclear is whether psychiatric researchers are actually complying with Dan’s Law.  We would like to find out more.  If you or anyone you know has been approached for enrollment in a research study while under a commitment order, I would be grateful if you could send an email to me (ellio023) at my gmail address. 

Carl Elliott

Newly posted documents from Markingson case on Scribd

On the weekend I posted some new documents about the death of Dan Markingson: the report of the State of Minnesota's Office of the Ombudsman for Mental Health and Mental Retardation, and the response of the Minnesota Board of Medical Practice to complaints lodged by Mary Weiss about Dr. Charles Schulz and Dr. Stephen Olson.