Seroquel's BOLDERs

In what strikes me as an important post, CL Psych, is calling into question how a recent study on Seroquel's use in bipolar disorder arrived at the degree of positive effects experienced by the research subjects. Or more properly how the researchers calculated those effects. If I am not incorrect, this study, known as BOLDER II, was the basis (or one of the bases) of Seroquel's recent FDA approval for bipolar depression (company press release here). That approval, in essence, now allows AstraZeneca to market Seroquel as a mood stabilizer. Or do a lot of nudging of clinicians such as one I wrote about recently.

For example, see the AstraZeneca website www.isitreallydepression.com. I have also recently noted that AZ is trialing Seroquel for several other DSM diagnoses, anxiety, depression (as opposed to bipolar depression), and PTSD among them. The company is also testing it in children as young as four-years-old.

I'll let CL Psych's post speak for itself. Except to say that the gist of his concern is that researchers used what s/he considers an unusual statistical method to calculate effects of taking the drug on depression. Prompted by that post and conversations with others who read this site, I emailed Dr. Michael Thase, a professor of psychiatry at Pitt, who was lead author on the study and asked him several questions about the stats.

Thase responded that he would check in with the project statistician and get back with me. Later, he suggested that I write a letter to the editor of the Journal of Clinical Psychopharmacology, and that the study team would respond there where people who read the original study can read his group's explanation. I appreciate Thase's prompt response. Sounds fine to me and in keeping with academic debate and so on. But i'll be surprised if the journal would take a letter from a patient seriously.

One concern of mine, however, is that results of the BOLDER II study have blasted all over the Internet. There are almost 700 references to it on the 'Net, including this one. Would an academic debate in the pages of the journal generate similar attention?

Heck, maybe it's time for these types of discussions to start happening online instead. Maybe next time.