AZ Bucket of Money Scandal: 'Group of 7' Whistleblowers Emerges

Peter Rost has received an email from someone claiming to be part of a ‘Group of 7’ disgruntled employees of AZ who believe “the company continues to violate policies developed under the HHS OIG Corporate Integrity Agreement.” (See copy of the email below for details.)

Separately, fired Regional Sales Director Mike Zubillaga had a brief chat with Ed Silverman over at Pharmalot, where he revealed none-too-shockingly that “It's been an absolutely horrible week.” He did not say anything substantive about why he was fired.

Backstory: Zubillaga was fired with unusual speed by AZ after Zubillaga published an internal AZ cancer pamphlet in which Zubillaga likened cancer docs’ offices to big buckets of money that AZ reps should be digging their fists into.

First: Let’s remember that Rost has many enemies in the drug biz and that this email may yet turn out to be an elaborate hoax.

Caveats aside, let’s look at a couple of details. AZ is indeed operating under a CIA with the OIG.

Also: The most interesting allegation in the email is that Zubillaga’s newsletter contained a “directive to misbrand anastrozole by ‘selling against letrozole’ without approved material, head to head studies or data in our prescribing information.  The RSD's statements were crude, but not illegal.”

Is this true? The newsletter actually said: “I heard early in the year at the Miami Breast Conference what letrozole was doing with their strategy. We should have changed our strategy with our core messages earlier in regards to selling against letrozole.”

That statement suggests that AZ reps have indeed been “selling against letrozole” for some period prior to the publication of the newsletter.

So I looked up the FDA approvals for these two drugs to see if they are indeed competitors. Novartis’s letrozole (marketed as Femara) is for “Treatment of advanced breast cancer in postmenopausal women.” Whereas AZ’s anastrozole (marketed is Arimidex) is for “Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy,” which strikes me as a somewhat narrower indication.

If it turns out to be true that AZ was marketing a narrow-use drug as a rival for a broader-use competitor, “without approved material, head to head studies or data in our prescribing information,” then it will be interesting to see what the OIG has to say about that.

Am I wrong? Let me know at jedwards@brandweek.com.

The email follows after the jump.

>----Original Message Follows----
>From: REDACTED
>To: rostpeter@hotmail.com
>Subject: AstraZeneca's "Group of Seven"
>Date: Thu, 12 Apr 2007 10:09:23 +0900
>
>
>We are a group of 7 honest AstraZeneca employees scattered around
>headquarters and field sales.
>
>Our goal is for AstraZeneca to once again become an ethical pharmaceutical
>company.
>
>We have been reporting unethical behavior to the Code of Conduct hotline
>(888 244-1769) for years.  However, the company continues to violate
>policies developed under the HHS OIG Corporate Integrity Agreement.  We
are
>afraid that AZ is not properly notifying OIG of these reports, and have
>begun to copy OIG (800-447-8477)on everything we submit.
>
>For the most part, the policy violations that we see come from management,
>and resistance from underlings is met with swift retaliation.  Anonymity
is
>essential.
>
>Our main concern with the Mid-Atlantic Oncology Newsletter was actually
its
>directive to misbrand anastrozole by "selling against letrozole" without
>approved material, head to head studies or data in our prescribing
>information.  The RSD's statements were crude, but not illegal.
>
>We would like to encourage all workers to stand up and report unethical
>behavior by managers to the Code of Conduct hotline.  One of the first
>directives in our compliance policy is that you have a "duty to report"
>illegal activity.

Comments

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If this group really exists, it remains to be seen if they have any truly useful information or are just rattling the cage.

Would it have been a nice entrance into the world to post some really juicy information? Unfortunately, we'll have to wait and see if more substance follows.

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Anastrozole is an aromatase inhibitor, which means that it interrupts a critical step in the body's synthesis of estrogen. Some breast cancer cells require estrogen to grow, and eliminating estrogen suppresses their growth. After more than 5 years the group that received anastrozole had significantly better clinical results than the tamoxifen group. The trial suggested that anastrozole is the preferred medical therapy for postmenopausal women with localized breast cancer that is estrogen receptor(ER) positive.