I have repeatedly teased about Dr. Trivedi’s difficulty finishing tasks. His IMPACTS study was never completed. In STAR*D, they never published their primary efficacy results. CO-MED came in way late and was decidedly negative. TMAP landed in a courtroom. But in EMBARC, his new genetics study, he didn’t even finish his web-site. Why, pray tell, […]
Record Breaking $327 Million Verdict Upheld in Janssen Case and Request for New Trial Denied Dec 21, 2011 The jury verdict in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson, Inc. has been upheld and requests for a new trial denied, affirming groundbreaking $327 million in civil penalties against […]
"There is a concern that in five, 10 years we won’t have anything really new for patients with major mental illnesses, and that would be absolutely a tragedy," said Dr. Alan Schatzberg, former president of the American Psychiatric Association. "It’s an unfortunate outcome that we are slowing drug development." Insight: Pharma asks the money question […]
I obviously thought that the article I reported on in my last post was important [what was that all about?…]. Yesterday was a clinic day, and in the spaces between, it came back to my mind. When I got home, I imported the table of the studies they included and graphed the RR [Response Rate] […]
Randomized, Placebo-Controlled Trials of Antidepressants for Acute Major Depression: Thirty-Year Meta-Analytic Review by Juan Undurraga and Ross J Baldessarini Neuropsychopharmacology [advance online publication] 14 December 2011 Abstract: Antidepressant–placebo response-differences [RDs] in controlled trials have been declining, potentially confounding comparisons among older and newer drugs. For clinically employed antidepressants, we carried out a meta-analytic review of placebo-controlled trials in acute, […]
I was looking around for some recent Tom Insel writing that was fully available on-line, and ended up at his Director’s Blog on the NIMH website. These are his December offerings with a plug for what’s coming next: Antidepressants: A complicated picture [December 06, 2011] Treatment Development: The Past 50 Years [December 14, 2011] "In […]
I spent a whole post on just a piece of a paragraph from Tom Insel’s and Linda Brady’s piece in Neuropsychopharmacology [Translating Discoveries into Medicine: Psychiatric Drug Development in 2011, Neuropsychopharmacology Reviews 2012 37:281–283.], but I saved the rest for special consideration: INTRODUCTION Recent reviews have described the crisis in central nervous system drug development, […]
As a young science-type, I think I accepted a hierarchical notion that academic research was the true science, and the clinician was the interface between that science and the patient. But during an academic research fellowship, my view began to change as I noticed that the people I most respected were the academics who were […]
The Whistle-Blower/State of Texas suit against Johnson&Johnson is approaching – January 9th, 2012 – not quite four weeks away. It was filed by Allen Jones in 2003, joined by the State of Texas in 2004, and has been slouching its way towards an Austin Courtroom ever since. I’ve covered and recovered this ongoing saga here, […]
Well, I missed that one by a mile [remarkable…]! I assumed the PHQ-9 was a MacArthur Foundation Production and failed to read the page that said it was a creation of Dr. Robert Spitzer, framer of the DSM-III, paid for by Pfizer who copyrighted it as part of a larger questionnaire – PRIME-MD. Here’s the […]