Seroquel Documents: "Buried" Studies And A Psychiatrist Who Claimed Patients Lost Weight On The Drug
As I mentioned elsewhere today, the major media has done a decent job of covering the Seroquel documents released by a federal judge last week. Bloomberg and the Wall Street Journal were first out of the chute on Friday, soon followed by the New York Times and the St. Petersburg Times. Most everyone has gotten the basic story out there now that the evidence from the documents is that AstraZeneca, Seroquel's maker, openly discussed "buried" studies of Seroquel (ie, less than positive studies of its drug), told sales reps to ignore evidence of diabetes and weight gain issues with the drug and tell the docs all was well, and was slow to warn the public about diabetes and weight gain concerns about the drug.
They also quoted AZ stating that it did all that it was required to do by the FDA.
But the St. Pete paper had the best article of all, since it got into a Chicago psychiatrist who wrote a paper asserting that Seroquel didn't cause patients to gain weight. AZ then made use of his claim--which the researcher's evidence may have supported, but which sure runs counter to what AZ knew otherwise, according to the Seroquel documents, and which sure runs counter to what many doctors and patients have observed in the real world--to create a marketing brochure of sorts.
"Among the documents was harsh criticism from an AstraZeneca executive of Dr. Michael J. Reinstein, a Chicago psychiatrist who was one of the company's paid consultants for Seroquel. In a note in October 2001, Georgia Tugend, U.S. brand manager for Seroquel, slammed the quality of research performed by the doctor's group."'Our clinical colleagues have significant and numerous issues in the past with the quality of research that this group has produced,' she said in the internal memo. 'There is little confidence that Good Clinical Practices can be adhered to.'"
"This is surprising because the documents also included a Seroquel marketing piece featuring Reinstein's research showing that the drug had led to weight loss in a patient.
"Reinstein said Friday that AstraZeneca paid him about $40,000 a year for 10 years to promote Seroquel among doctors. Reinstein, who said AstraZeneca ended his contract at the end of 2007, described the company's negative comments as 'sour grapes.'
"'We sent them criticism, saying they were not doing proper research, so of course they're not going to say we're wonderful,' he said. 'It's character assassination.'
"Though no longer on AstraZeneca's payroll, Reinstein said he still prescribes Seroquel.
"'Some patients gain weight, some stay the same, some lose weight,' he said. 'The results over time in terms of not gaining weight and not getting diabetes are better with Seroquel than with Zyprexa.'"
That's an interesting way of putting it, to be gentle about it. You may wonder about the $40,000 a year and ask yourself, "Why would AZ give $40,000 a year to a researcher it held in low esteem?" According to this document, Reinstein's group ran community mental health clinics where 1,000 patients a year were being prescribed Seroquel each year in the 1990s. While I don't know how much Seroquel sold for then, drugstore.com lists the 300 mg. size at $663.44 for 60 tablets, a month's supply in some cases. That would work out to $7.96 million a year from Reinstein's clinic alone and he's described, in the above document, as one of the five biggest Seroquel prescribers in the US at the time. I have no idea if there's any possible connection to the $40,000 a year
And, in the above document, you can see evidence that Reinstein and his colleagues were upset with AZ because it wouldn't fund a study of Seroquel at, drum roll, 1,600 mgs. a day for people diagnosed with schizophrenia. Seriously. That's roughly twice of the high end that you ever see anyone on with this drug, and you hope no one is ever on 800 mgs. for long.
Unless, of course, they lose weight at that dose. (Only joking.)
Posted by Philip Dawdy at March 2, 2009 12:03 AM
del.icio.us Digg it reddit
Posted via web from Jack's posterous
No comments:
Post a Comment