For the past eight months, I have been trying unsuccessfully to get Serious Adverse Event reports for studies conducted by Stephen Olson and Charles Schulz, including a study of Seroquel XR for Borderline Personality Disorder. (See number 41 on this chart.) The General Counsel's office still won't let me see the SAE reports, but the study itself has just been published in the American Journal of Psychiatry. As expected, it's another experimercial for AstraZeneca. You can see Dr. Mickey Nardo's take on it here.
My question for the University of Minnesota IRB: what is an acceptable number of adverse events for a scientifically useless clinical trial?