So I’m taking a break from the Egyptian Revolution and watching one of my daughter’s friends on the Grammy’s, but on the side of my mind, I’m working up a resentment that we don’t get to see a scattergram of the patient’s weight gain plotted as a function of when they dropped out of Trial […]
Note: The graphics in this post are from three F.D.A. documents and one on the psychrights site. The tables from the F.D.A. documents have been reformatted to be readable, but the substance is unaltered. Click the graphic to see the original. I haven’t altered the graphics from the psychrights document because that document itself is […]
Zeneca submitted eight studies to the F.D.A. in their final approval request. Only four were considered for efficacy, but the other four were considered in the F.D.A.’s evaluation for safety. These studies involved years, a lot of money, multiple investigators and staff, and a large cohort of Schizophrenic patients [2788]. This Table is from the […]
What follows is a pre-DSM III version of the illness, Schizophrenia, being treated in these studies we are currently examining: We don’t know what Schizophrenia is, but it is a disease in the word’s original meaning – "dis-ease." The typical course was described by Eugene Bleuler at the turn of the twentieth history and remains […]
We all know how the F.D.A. Approval comes out. Seroquel was approved in September of 1997 and turned into a megablockbuster for AstraZeneca and for the Patients [and their Lawyers] who sued [and will continue to sue] them. But let’s continue to look carefully at Trial 0013, the one that brought the approval home for […]
One might think from the way this series is going that the next thing would be Trial 0013, the last Clinical Trial submitted to the F.D.A., but in the Clinical Trial world of evidence-based medicine, all is not what it seems to be. And in this story, there’s something missing – Trial 0015. What is […]
In another life long ago, I was an N.I.H. Fellow in "hard science" and as part of my Fellowship, they offered a chance to get a Master’s Degree in Statistics. I was young with lots of energy, so I took all the courses, but I never got it because you had to submit a paper, […]
Moving along. Trial 0008 was Zeneca‘s most successful trial for Seroquel, published in a more widely distributed journal. I’ve included the abstract in part because it describes the actual dosing schedule for Seroquel omitted from the F.D.A. statistical report. Quetiapine in patients with schizophrenia. A high- and low-dose double-blind comparison with placebo Archives of General […]
Well, my first seroquel II was premature so I pulled it. Like AstraZeneca itself, I rushed to market before I knew exactly how I wanted to go through the FDA Approval document. This is Version 2.0. What’s new in Version 2.0, you ask? First off, there are a couple of buttons scattered around that pop-up […]
As a practitioner I never used to pay a lot of attention to Clinical Trial data. I assumed that if the FDA approved a drug, it meant that it was effective and that it added something to the drug armamentarium we already had. Back in the days when I was actively involved with treating psychotic […]