Dan Weiss And GCP: A Case Study Summary

Dan Weiss & GCP
The reason of Dan’s death is clearly a result of market driven research & serious violations of GCP (Good Clinical Practice) guidelines, loose regulations & misconduct by The University of Minnesota’s (UMN) IRB (Institutional Review Board) & investigators in CAFÉ (Comparison of Atypicals in First Episode of Psychosis) study. The violations are as follows:
1) Dan Markingson wasn’t aware of his mental illness & was by all means incompetent to sign the consent form. The consent was taken in absence of Dan’s mother; furthermore, Dan was kept in the study despite his mother’s objection.
2) Dan was coerced into the study by threat of involuntary commitment to the University & was discharged from the hospital midway in his study,
Additional safeguards to protect the rights & welfare of mentally ill persons were not taken by IRB.
4) The CAFÉ study subjects weren’t disclosed nor re-consented when new information about serious risks about diabetes, weight gain from Seroquel was available during the study, which might affect subjects’ willingness to participate.
5) There was a lapse in proper documentation of consent forms & improper handling of the consent forms by the study coordinator Kenney. The response on the consent forms from different patients appeared identical as if they were photocopied & used as template. The only difference was the initials.
6) The CAFE study conveniently recruited patients with homicidal thoughts versus those with suicidal intentions. IRB did not act ethically to reject the protocol.
7) Mary conveyed her concern about Dan to Dr. Schulz & Kenney, The requests were unanswered at first & then inadequately answered. At no point, Kenney nor Dr. Olson inform the IRB about Mary’s concerns & Dan’s deteriorating condition which would eventually drive him to suicide, neither was he dropped from the study nor did they alter his
The UMN didn’t provide adequate medical care to Dan.
9) The investigator is responsible for regulatory violations resulting from inadequate supervision & improper task delegation to unqualified/untrained social worker Jeanne Kenney as study coordinator. Kenney made significant mistakes about a medical diagnosis & drug dosage, assessment of side effects, forged the initials of a physician on the medical chart & sometimes even assigned job to a social work intern. Dr. Schulz was listed on FDA form 1572, as a co-investigator & he hadn’t even read the consent form.
10) According to the Health Insurance Portability & Accountability Act (HIPAA), the investigators illegally released private health information of Dan to CAFÉ study sponsors & CRO for use in research without written consent from Dan.
11) The CAFÉ study design was biased to produce a favorable result for Seroquel. The sponsor enlisted Dr.Schulz to publicize the positive study while hiding negative study