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.
Briefly, in November 2003 a mentally ill young man named Dan Markingson was recruited by psychiatrists at the University of Minnesota into a profitable, industry-funded study of antipsychotic drugs. His doctors used the threat of involuntary commitment to force Dan, who was mentally incapable of giving informed consent, into the study over the objections of his mother, Mary Weiss.
For months Weiss tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself, to no avail. On May 8, 2004, Dan committed suicide.
The sildenafil online Trip Won’t Be Any Longer Than normal. The generic cialis feeling of making love or sex will definitely drives people crazy. For women viagra order that, the medicine should be found in cheap. Autism is denoted as the spectrum of disorders in a child regarding social interactions and communication; the child affected with autism finds it difficult to understand simple logics and therefore suffers communication barriers. levitra 60 mg about levitra 60 mg Carl Elliott has been writing on this case for a long period, as has Howard Brody.
I recommend their excellent analyses: Carl Elliott, “Making a Killing,” in Mother Jones, this piece by Howard Brody, and finally a referenced summary of the Dan Markingson investigation with links to court documents can be found here.
Finally, while I am ambivalent about the plethora of online petitions that come into my email inbox on a daily basis, I feel that this is one that deserves support. Mary Weiss (the mother of Dan Markingson) and others have started a petition to Minnesota Governor Mark Dayton, asking for an external investigation into the events surrounding Dan’s death.
Thanks, Wendy, for posting this. I would just add that there have been a number of alarming developments since my 2010 article in Mother Jones. Last fall, the Minnesota Board of Social Work found that the study coordinator for the CAFE study in which Dan died had falsified the initials of physicians on study records, dispensed drugs without medical training, failed to warn subjects of new drug risks, and failed to respond to the warnings of Dan’s mother that he was in danger of killing himself. Because she was also the study coordinator on other research studies, this finding raises the possibility that other subjects have also been harmed or mistreated.
In addition, some bizarre irregularities with study records have emerged. I would recommend having a look at these links:
Controversy over U of M clinical trial has heated up again
http://www.minnpost.com/second-opinion/2013/03/controversy-over-u-m-clinical-trial-has-heated-again
Dan Markingson’s 2004 suicide: ‘Corrective Action’ issued to former U of M employee
\http://blogs.citypages.com/blotter/2012/11/dan_markingsons_suicide_jean_kenney.php
You’re right Carl – the developments are inexorable and alarming. Thanks for those – I’d hoped that your 2010 article and the petition would put people on the trail, so links to those new developments are very welcome.