In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”
Back in the early 2000s, the University of Minnesota’s Department of
Psychiatry was having so much trouble getting research subjects that
Quintiles, a Contract Research Organization, had put it on
probation. Perhaps the department’s difficulty convincing subjects to
sign up for trials should not have been a surprise, given its alarming history of research scandals. Yet
by December 2003, the Department had managed a 180-degree turn. In
fact, it had become so successful in getting subjects into trials that
Quintiles had profiled it in a CAFÉ study webcast. How did the
Department manage to become such an aggressively successful recruiting
A hint emerges in this document from
the lawsuit against the University of Minnesota brought by Mary Weiss
over the suicide of her son, Dan Markingson. The document, dated April
14, 2003, is labeled “CAFÉ Study Coordinator Teleconference,” and it
mentions a number of strategies for recruiting subjects.
First, the document references a discussion of “ways to utilize
subjects for multiple studies.” The phrase “multiple studies” should
set off a red flag. Enrolling severely mentally ill subjects in multiple
industry-funded studies was exactly the strategy of former University
of Minnesota psychiatrist Faruk Abuzzahab, who was eventually found to
be responsible for the deaths and injuries of 46 patients.
Second, the document discusses a “newly-added 16 bed psychosis
specialty unit” where all nurses and staff are “supportive of research”
and “all patients are reviewed for possible research candidacy.” Every
patient? Remember, patients with psychotic illnesses are among the most
vulnerable patients in the hospital. Because of their thought
disorders, they are often unable to understand and appreciate the risks
of research. Yet according to this document, every patient on the
psychosis unit is evaluated for his or her suitability for research
studies — and perhaps even multiple studies. How exactly do the
Minnesota psychiatrists accomplish this?
Apparently one way is to have research staff “attend morning report
before inpatient rounds take place,” in order to “identify any possible
subjects who might be eligible for studies.” Yet again, this statement
should raise alarm bells. Morning report is a time for discussing the
care of patients, where private medical information is revealed. Why
should research staff working for pharmaceutical companies and Contract
Research Organizations be given privileged access to the private health
information of hospitalized patients? Of course, privacy violations
were at the heart of Mike Howard’s complaint about Stephen Olson to the
Board of Regents, which was dismissed by the General Counsel.
This is an alarming document, but even more alarming is the fact that
nobody at the University of Minnesota is willing to look into the
issues it raises – not the Board of Regents, not the Research Subject
Advocate, not the Research Integrity Officer, and not the Research
Ethics Consultation Service. At the very least someone should be asking
the question: how do we know that the suicide of Dan Markingson in the CAFÉ study was an isolated case?
Note: This was originally posted on January 17, 2013. As we continue our call-in campaign and other actions in coming weeks, I will be reposting other older posts, as a reminder of all the unanswered questions surrounding the Markingson case.