Weekend Update! See my story here for latest details, including AZ confirming an internal probe, Zook move not related, more details on the Group of 7. Not mentioned in my story because I was in a rush: The OIG told me today it's been fielding a lot of media calls on AZ and that it won't comment specifically on whether it's looking into AZ. However, the rep said, typically the OIG tracks down every complaint made ... Now read on!
The AZ Bucket of Money scandal is starting to unfold at a faster pace. First, in what I’m sure is just an unfortunate coincidence, AZ’s global marketing evp Marty Nicklasson has left the company. Ed at Pharmalot thinks his duties will be taken on by Tony Zook (pictured). Zook is currently the evp for North America. Again, rotten timing all round, AZ.
Second, anonymous people claiming to be the AZ Group of 7 have sent me AZ’s “Standards for Engaging in Product Promotion.” Guess what? They appear to prohibit AZ reps from even talking to doctors about rival products. (See download below for the full monty.)
That’s a huge red flag because, as I mentioned earlier, fired AZ regional sales director Mike Zubillaga wrote in an internal newsletter that “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.” AZ’s drug isn’t letrazole, it’s anastrozole; the two drugs have different indications.
Third, Peter Rost—who has been leading the charge on this in a way that is most irritating for us professional journalists who, you know, would like to be able to check the facts ‘n’ stuff before writing—has shared with me some more email he got from the Group of 7. (See the full emails after the jump.)
Apparently, the whistleblowers alerted AZ internally to their complaints as much as five months ago—but nothing was done.
More inflammatory: The Group of 7 accuses one AZ exec (not Zook or Nicklasson) of attempting to organize an off-label push for Faslodex, and a counter-detailing effort against letrozole, and that the whole thing would be done without any kind of paper trail or voicemail records.
I should emphasize at this point that these are unfounded allegations, which is why the emails are presented here in a slightly redacted form.
Lastly, the Group of 7 claims that they sent a letter to the OIG alerting the government to all of this last month.
Clearly, AZ has a lot of questions to answer at this point. May I suggest that a little transparency and humility will get the company through this crisis faster than a batten-down-the-hatches approach? Just a thought.
Sent: Thursday, April 12, 2007 7:23 PM
Subject: Open Letter to OIG: AstraZeneca Code of Conduct Report # ASTR
An Open Letter To:
Office of Inspector General (OIG)
Department of Health and Human Services
330 Independence Ave., SW
Washington, DC 20201
From: The AstraZeneca 'Group of Seven'
Subject Company: AstraZeneca Pharmaceuticals & their Corporate Integrity
Subject Individual: [REDACTED]
690 Lee Rd, Wayne, PA 19087-5647, 800 937-1664
Summary and Chronology of Events:
Early November 2006 - At an oncology district meeting for the Pittsburgh &
Harrisburg territories held in Bedford, PA [REDACTED] instructed his
pharmaceutical reps to:
1) Solicit requests from physicians for a visit from a Regional Scientific
Manager (Medical Science Liaison) to discuss the off-label use of
Faslodex/fulvestrant injection after an aromatase inhibitor (for which we
are not indicated).
2) Solicit requests from physicians for a visit from a Regional Scientific
Manager (Medical Science Liaison) to discuss the serious cardiovascular side
effects of our competitor Femara/letrozole (for which we have no comparative
3) Repeatedly and emphatically instructed those present NOT to use email or
voicemail when communicating these solicited off-label requests, but to use
cell phones instead so as not to leave a permanent record of this activity.
Mid November 2006 - We called the AstraZeneca Code of Conduct hotline at 888
244-1769 and filed Report Number ASTR 06110001.
Mid December 2006 - Shortly after it became known that someone called the
Code of Conduct hotline about the meeting, [REDACTED] demoted the
district manager and dissolved the district (despite some of the best sales
in the country). We suspect retaliation.
April 10, 2007 - Despite persistent follow up with the Code of Conduct
hotline every two weeks for five months, AstraZeneca provided NO RESPONSE AT
ALL to our report. Unfortunatly, this led us to believe that [REDACTED]'s actions
were sanctioned by AstraZeneca and that we have no other alternative but to
contact OIG directly and publicly.
The following message was in my email in-box (firstname.lastname@example.org) this morning:
On 4/13/07 7:52 AM, [EMAIL REDACTED] wrote:
You are getting very close to the truth. Anastrozole sales have flatlined and letrozole's market share is growing. This is motivation for management to violate their own policies:
Attached is the AZ policy for product promotion. Pay close attention to these sections:
5.1.1 Conformance to Full Prescribing Information
"Any claim made ORALLY that does not conform to the product's full prescribing information, may render the product MISBRANDED and could jeopardize AZ's ability to market that particular product. Also, statements extending claims or minimizing risks may expose AZ to product liability claims. Therefore, AZ employees must stay strictly within approved claims and never minimize any of the risks associated with the use of any AZ product."
Translation: AZ reps can't talk about letrozole because it's not in anastrozole's prescribing information.
5.1.2 Promotional Materials
"Promotional Materials Must Be eSTaR-approved Prior to Use: All materials used in promotion – including reprints, referenced texts, patient education pieces, display/exhibit materials and reminder items – must have prior approval through the eSTaR process."
Translation: AZ reps can't show physicians anything about letrozole because they have no approved material to work with.
5.1.3 Comparisons with Competitive Products
"Employees May Not Initiate Any Discussion Involving Comparisons With Competitive Products Unless Specifically Instructed To Do So:
In such case, approved materials and training will be provided to the employee. As with all product discussions, all such product comparisons may be made only in the context of an objective, balanced presentation. The benefits of one product and the shortcomings of another may not be singled out."
Translation: AZ reps can't initiate a discussion to compare anastrozole to letrozole.
Rhetorical Question: How can AZ reps sell against letrozole if they can't initiate a discussion, talk about it or show physicians anything?