I’ve always wondered how Dr. Martin Keller, then the recently named Chairman of Psychiatry at Brown [1989], got involved in a study of Paxil in adolescents. He’s neither a Child nor Adolescent psychiatrist. Paxil had been approved for MDD in adults by the FDA in December 1992, and the proposal for what would become Study […]
In medical school, statistics wasn’t the most popular of courses, but as a math major, I thought it was pretty wonderful [having taken the other kind of math]. The professor was really good, but long suffering. Years later, I was in a research fellowship taking a Master’s in statistics, and he was one of the […]
Study 329 has an extensive literature of its own familiar to most people with any interest in the relationship between the pharmaceutical industry and acadenic psychiatry. For the moment, I’d like to hold my focus on the raw data finally posed this month [the Appendices below]: The top four entries are summaries released after the […]
This is how the Adverse Events were presented in the article: the well known CV Effects for Imipramine; the annoying dry mouth from Imipramine’s anticholinergic effects; and a little something in the Nervous System section under Paroxetine. In the text, things look a bit more ominous though it’s a little hard to parse out what […]
Once the data’s in, one is invariably tempted to play with it – find new things, maybe make it look better. There are some conventions to keep data play in bounds. In a hypothesis driven study like Study 329, one is asked to state the hypothesis and to declare the outcome variables that will prove […]
NOTE: "Out of curiosity, I looked back using the Healthy Skepticism Archive to see the timeline of Study 329. The proposal to do the study is dated December 5, 1992, and the study protocol is dated April 17, 1994. The study itself went on from 1994-1998 – a comment from the first pass at the […]
Here are the raw results from GSK’s Paxil Study 329 – the HAM-D scores from each subject for Placebo [left] and Paroxetine [right]: I’ve transferred the data from the GSK site to a spreadsheet [downloadable]. In the table below, the only manipulation is that the mean values are in the ‘least squares mean’ format used […]
Oh what a tangled web we weave, When first we practise to deceive! Sir Walter Scott In the last post, I was talking about the need for the raw data from clinical trials to be posted after discovering that the STUDY 329 was finally available. The format is tough, an image based pdf file. […]
I ran across something quite by accident that surprised me. I was chasing down a copy of the GSK Plea Agreement, and I found myself on the GSK site looking at a page that said Paroxetine and pediatric and adolescent patients. I’d been there before. It purported to be about their clinical trials. When I […]
http://www.justice.gov/opa/documents/gsk/us-complaint.pdf the charges involving Paxil and Study 329 are on pages 3 through 19… http://www.justice.gov/opa/documents/gsk/plea-agreement.pdf If you have the time, it’s instructive to read through the DOJ complaint. It’s thorough and factual. I wrote Dr. Drell [below] and received a response that the American Academy of Child and Adolescent Psychiatry is currently "vetting" the issue […]