THE CAFÉ study was published in the American Journal of Psychiatry in July 2007, and was funded by AstraZeneca. Its stated purpose was to compare AstraZeneca’s drug Seroquel (quetiapine) with other neuroleptic products. I have discussed the CAFÉ study here.
Two of CAFÉ’s participants committed suicide during the study period. Both had been randomly assigned to the quetiapine treatment. There are very strong indications that one of these individuals – Dan Markingson, who was enrolled in the study at the University of Minnesota site – was coerced into the study and, because of his psychotic state, was incapable of giving informed consent anyway. He was not doing well on the Seroquel, and his mother, Mary Weiss, made repeated attempts to have him withdrawn from the study and taken off the drug, but without success. In particular, Mary had expressed the belief that Dan was in danger of killing himself. AstraZeneca paid the University of Minnesota $15,648 for each study participant who completed the treatment course.
Carl Elliott, a bioethics professor at the University of Minnesota, has been drawing attention to this matter for a number of years, and has been critical of the university’s failure to take appropriate investigative action.
On October 18, Carl wrote an article, Getting by with a Little Help from Your Friends, detailing the latest chapter in this matter. In this article he exposes what I can only describe as an extraordinarily sordid network of conflicts of interest in the university’s review of Dan Markingson’s death. The article is detailed and compelling, and I urge my readers to take a look.
By way of context, it should be pointed out that the CAFÉ study was flawed from its inception. It was an AstraZeneca sponsored project whose apparent purpose was not to discover facts, but rather to rescue AZ’s drug, Seroquel, from the negative findings of CATIE, an earlier, NIMH-funded study.
The death of a patient or a research participant is the most serious adverse event that can occur in a study. Reputable medical facilities and research centers have procedures in place to prevent such deaths, and to investigate them thoroughly and properly if they do occur. Steps are routinely taken to ensure that conflicts of interest are not allowed to contaminate the findings. Against this background, the University of Minnesota’s response to Dan Markingson’s death did not meet even minimal standards for thoroughness and impartiality.
Carl Elliott has been arguing for transparency in this matter for several years, and his persistence has finally attracted some high-level interest. On October 21, he wrote an article on his website in which he reported that:
“Over one hundred seventy leading scholars in health law, bioethics and medical research have called on the University of Minnesota to investigate the 2004 death of a psychiatric research subject, charging that university administrators have ‘refused to publicly engage in a transparent, open, and critical assessment of what went wrong in this study.'”
You can see a copy of the letter that these individuals wrote here, with a list of signatories here. The letter is particularly interesting in that it provides an excellent summary of the main issues of the matter, as well as calling on the university’s senate to take appropriate action. Nine years after Dan’s suicide, we may finally see a genuine inquiry, assignment of responsibility, and the implementation of procedural safeguards against future similar occurrences.
But even as we take comfort in the fact that this letter has been written, it is troubling to note that psychiatry – the profession that initiated and carried out the study – is conspicuous by its absence in the call for corrective action.
The co-principal investigators in the CAFÉ study were Joseph P. McEvoy, MD and Jeffrey A Lieberman, MD, both of whom had been recipients of pharma dollars prior to the study. Neither of these psychiatrists has signed the letter calling for an impartial investigation of Dan Markingson’s death.
In fact, of the 177 signatories, only three are psychiatrists:
- David Healy, MD, Professor of Psychiatry, Bangor University, Wales
- Laurence Kirmayer, MD, Professor of Psychiatry, McGill University, Canada
- Alexander Tsai, MD, Assistant Professor of Psychiatry, Harvard University, Massachusetts
As a profession, psychiatry is not only fundamentally flawed and destructive, it is also extraordinarily lacking in anything resembling critical self-appraisal. As Dr. Lieberman, President of the APA, wrote on June 18, 2013, psychiatrists have the “…moral high ground…”, and “…must not be defensive…”
Psychiatry doesn’t just damage its victims, it damages its perpetrators. Psychiatrists are true believers. Most of them probably enter the profession with honorable intentions, but as they unquestioningly absorb the corrupted research and the dogma, and familiarize themselves with the drugs and the ECT, they lose sight of the humanity of their clients. They complete the initiation rites, and they are inducted into the fraternity. They accept willingly the mantle of psychiatric qualification from their teachers, and with it, the entire spurious and destructive ideology. If they initially see the negative side of psychiatry, they learn not to see it, and they soothe what’s left of their consciences with the mantra that the benefits of their products outweigh the risks.
What benefit did Dan Markingson derive from the CAFÉ study? By what complacent and perverted chain of “reasoning” did these psychiatrists manage to persuade themselves that the repeated warnings from Dan’s mother could be safely ignored?