Monday, February 19, 2007

Zyprexa Off Label Marketing (?): Part 2

Disclaimer: I want to make absolutely clear that I am not alleging a crime was committed regarding off-label marketing. I will discuss one of the now famous Zyprexa documents and provide my opinion as to its implications – that’s all I’m doing.

This document is titled: “ZYPREXA – Primary Care Strategy Implementation and Overview” and it was authored by Mike Bandick, brand manager for Zyprexa. All emphases from the document are mine unless noted.

The document states:

Position: Zyprexa: The safe, proven solution in mood, thought, and behavior disorders [emphasis in original]. We will emphasize safety to address barriers to adoption and merchandise the brand’s “Four years – Four million patients” base of experience. The word “solution” speaks to unmet medical need, and enables the PCP to take control of clinical situations that previously had led to referrals and/or poor outcomes. “Mental disorders” is intentionally broad and vague, providing latitude to frame the discussion around symptoms and behaviors rather than specific indications. We will position Zyprexa as the incremental next step in the PCP’s expanding clinical orbit: e.g., SSRI’s => 2nd generation antidepressants => safe, gentle psychotropics.

Later in the document, it is stated that:

The Zyprexa PCP strategy is designed to fit within the brand vision of broad spectrum efficacy.

There are a number of important points here. Discussion of “intentionally broad and vague” marketing of Zyprexa that provides “latitude” to “frame the discussion around symptoms and behaviors rather than specific indications” points to Lilly apparently marketing Zyprexa off-label. This ties in with another document that pointed toward Zyprexa possibly being marketed for conditions other than schizophrenia or bipolar disorder (see post here).

While PCPs see few patients with schizophrenia or bipolar disorder (especially bipolar I, which is much more impairing than bipolar II), they are certain to see patients who have some “symptoms” or “behaviors” that may overlap with schizophrenia or bipolar. For example, perhaps a male patient is unusually energetic and irritable, yet in no other way resembles an individual with bipolar disorder – does this individual have an “unmet medical need” for Zyprexa? Perhaps this patient is in need of a medication that provides “broad spectrum efficacy” across a wide variety of symptoms and behaviors, as opposed to “specific indications.”

Empowering PCP’s: It is also of note that Lilly appears to be positioning Zyprexa as “the incremental next step in the PCP’s expanding clinical orbit.” First it was PCPs prescribing more and more antidepressants (generally SSRIs) in the 1990’s, and now PCPs are perhaps to be empowered with the ability to prescribe atypical antipsychotics (Zyprexa, in this case) with the same degree of comfort that they now prescribe any other drug? Some of that is, of course, my inference, but it does seem that there was a concerted effort to make PCPs feel more comfortable in prescribing Zyprexa as opposed to making mental health specialty referrals.

The Safe, Proven Solution in Mood, Thought, and Behavior Disorders: To reiterate, this type of slogan really lends itself to off-label marketing. I cannot think of any other reason why Lilly could not have instead used the following: “The safe, proven solution in schizophrenia and bipolar disorder.” As for the issue of "safe," that assertion is also being questioned.

Dislaimer (in case you did not read this first one): Please note that I am not equipped to state whether Lilly’s marketing practices regarding Zyprexa were illegal, as the law seems to be pretty unclear on this point.

Of course, whether a practice is legal and whether it is ethical are two different things.

The document discussed in the post is document number 100589868 and it is available from Furious Seasons here.


Anonymous said...

There is also this from P.9 of
ZY1 00520636.TIF
"We are committed to positioning ZYPREXA as a broad-spectrum psychotropic to differentiate it from other antipsychotics, and to reflect its mood stabilizing properties…
We will be consistent and persistent in our customer communications— CME programs, symposia, publications, slide kits—to brand ZYPREXA as a broad spectrum psychotropic."

Anonymous said...

Why not a crime? Seems pretty criminal to me.

tyhe fact that the courts don't view corporate scientific misconduct/distortion of the pharmaceutical literature as a crime is by the bye.

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