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 site?
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?