The AstraZeneca Seroquel Strategic Plan in 2000 listed their five Key Claims: 1. at least as efficacious as other first line atypicals 2. more effective than haloperdol and chlorpromazine 3. effective at preventing depression and improving cognition 4. superior tolerability to typicals and first line atypicals 5. weight neutral, placebo-level EPS and prolactin levels, and […]
In an earlier series [seroquel IX: weighty matters…], we looked at how the weight gain data was handled before Seroquel was approved by the F.D.A. – mainly minimized and explained away [seroquel X: matters cerebral Serebral…]. Dr Lisa Arvanitis, Director of the Seroquel effort summed things up about weight gain in an email a month […]
I guess any story about historical events is like this one. We already know something about how it comes out, so we want more than a rehashing of the events that were on the front page – the "what" of the story. We’re interested in something more in the range of the "why?" In this […]
AstraZeneca came to bat swinging with a multi-pronged game plan: weight-neutral, placebo-like EPS, well-tolerated superior antipsychotic efficacy expanded indications • Clinical Trials with published studies • F.D.A. Approvals promoting off-label indications They should’ve known that they were going to lose 1. and 2. down the line from their own pre-approval trials [and they would]. I […]
Joe: I was looking over some of those trials we buried. Seroquel is kind of a lightweight in spite of all our hype, isn’t it? Jim: Yeah. I mean it’s well tolerated except for that pesky weight/diabetes thing, and it seems to calm people down, puts them to sleep. But it’s a softy as antipsychotics […]
Everyone knew what was wanted: a potent antipsychotic drug that did not have extrapyramidal symptoms. Clozapine had filled the bill, but brought along a couple of new possibilities – fatal agranulocytosis, weight gain, and glucose intolerance. So the race was on to find a clozapine-like variant without these deal-breakers. Zeneca hoped they had it in […]
After being approved by the FDA in 1997, Seroquel joined the ranks of the Atypical Antipsychotics used to treat Schizophrenia. After a time, the NIMH funded a large study to compare the Atypicals that included one of the first generation neuroleptics, Trilafon [perphenazine] – the CATIE study. That study’s primary outcome measure was simple: We […]
Defector admits to WMD lies that triggered Iraq war guardian.co.uk by Helen Pidd in Karlsruhe 15 February 2011 The defector who convinced the White House that Iraq had a secret biological weapons programme has admitted for the first time that he lied about his story, then watched in shock as it was used to justify […]
Okay, you win. I’ll say it. No, there was no real reason to approve Seroquel. I didn’t say it because I don’t think I would’ve been able to turn it down myself in 1997. It wasn’t really a different time, but we didn’t know it then. There were Speaker’s Bureaus, and ghost-written articles [and textbooks], […]
The availability of the story of Seroquel‘s trip to market is fortuitous in that it came in the early days of the Internet and widespread use of email. The html driven WorldWideWeb was introduced in 1994, and by the period in question [1996-1997] was quite the rage in corporate life. I doubt Zeneca‘s staff realized […]