Saturday, September 13, 2008

Holy Schatz!

I'm back after attending the 3rd Annual Psychotic Disorders Conference (1). One of the speakers was Corcept co-founder (and shareholder), and president of the APA (the bad APA, not the good APA), Alan F. Schatzberg (pictured right). His topic? "The Latest Treatment Approaches for Managing Psychotic Depression." Most of Schatzberg's work regarding his company's drug, Corlux, also known by its many aliases: mifepristone, RU-486 (special ops name), the abortion pill, has been well documented here (CL Psych), as well as by others, which can be accessed through the above-link.

Did he have any new or exciting data to present? No. It was like an Earth, Wind, and Fire concert, he was doing all his greatest hits. He began with the spectre of psychotic depression: it has similar neuropsychological deficits seen in schizophrenia (not quite true, but I'll humor him), it represents 15-18% of cases of major depression (that's in Europe by the way), and of course, who can forget his number hit, hypercortisolemia. Ah, the memories that one brings back. Anyway, after quickly blowing through various treatments (ETC, Symbyax, SSRI), and a quick primer on the HPA-axis, he moved onto mifepristone. First, he spoke about the Corcept 03 Study 2006. The lead author is DeBattista. You can read more about him and that study here (2). Did you read it? Good. So, did the Schatzmeister mention any of those criticisms? No. And where moving on...

Here is where I became confused, when he talked about Corcept study 06-PMD. The study concluded in 2007. You can read about the results here (3). The main findings were this, " 06, the last of the three Phase 3 trials, in March 2007. These results indicated that this study did not achieve statistical significance with respect to the primary endpoint, 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale, or BPRS PSS, at Day 7 and at Day 56." What Schatzy primarily focused on was Corcept's spin, which is found in the latter part of that release.

This is where it gets interesting. The PPT slides that Schatzberg showed while talking about this study had this reference at the bottom "Schatzberg AF et al., J Affective Disorders, 107:S40-41, 2008." What would one assume, when seeing that reference underneath the 06-PMD data? If you're an idiot like me, you'd assume that he was referring to a published study, or at least published data. He's not (4). It's an abstract, two paragraphs in lengths that summarize what he was going to talk about at a symposium; the content of which is identical to the lecture I saw (he's doing a greatest hits tour folks!). These data weren't even referenced in the abstract. So why list a reference at all? Because that allowed him to present unpublished data, from a negative trial, as if it were published data and to give it a positive spin. That's a neat trick..., and now watch him do it while drinking a glass of water...

At the end of the lecture, he gave contact information for a person at Stanford, so others could refer patients with PMD to a clinical trial for mifepristone at Stanford University, his place of employment. Because it's affiliated with Stanford, he is recused from working on this study (read these links regarding his position and his other influences , 5, 6).

To summarize, Dr. Schatzberg gave a lecture wherein he presented unpublished data from a company, which he has a major stake in, as if it were published data. Then, he made a request for referrals, for a clinical trial at his place of employment. Somehow, all this constitutes being recused. The best part is, I received 5.5 cme hours for attending this infomercial. And as usual, the representatives for Lilly, Teva, AstraZenca, Abbott, Janssen, and BMS where all present, which means my precious ink pen and note pad collection quadrupled in size.


keeping them honest said...

Great piece!

The Schatzberg-Stanford farce is dissected very well in a series of posts here:

Anonymous said...

Why did the American Psychiatric Association keep Schatzberg around after he was exposed as a carnival barker for Corcept?

APA has no shame.

Anonymous said...

Did Dr. Schatzberg comply with this disclosure policy? It doesn't seem so.

As a sponsor accredited by the Accreditation Council for Continuing Medical Education, the UC Davis Health System Office of Continuing Medical Education must ensure balance, independence, objectivity and scientific rigor in all individually or jointly sponsored educational activities. Speakers, moderators, panel members, and planning committee members participating in a sponsored activity are expected to disclose to the audience any significant financial interests or other relationships with manufacturers of commercial products and/or providers of commercial services that will be discussed in their presentations. The intent of this disclosure is not to prevent speakers with significant financial or other relationships from making presentations. Rather, disclosure allows listeners to determine if content is evidence based and free of commercial bias, and it demonstrates how speakers will resolve conflict when it exists. All presenters must agree to provide verbal disclosure prior to presentations. A complete disclosure statement and acknowledgment of commercial support for this program will be included in the syllabus provided at the activity.

NeuroPsych15 said...

All presenters, Dr. Schatzberg included, complied with the disclosure policy. They each spent all of 20 seconds on it, and each person said something along the lines of "I have to do here."

The main point about Dr. Schatzberg in this post, is that he was presenting information in a manner/format that created the impression that it was more legitimate than it was (i.e., peer reviewed, published). The corcept 03 study had a reference because it was a published study. The corcept 06 study had a reference, but it has nothing to do with the data, thus the false impression.