Friday, April 13, 2007

Open letter to OIG, from AstraZeneca "Group of Seven"

I have received this open letter to the Office of Inspector General from the same person who provided the AstraZeneca Oncology Newsletter to me, which resulted in the termination of Regional Sales Director Mike Zubillaga.

The letter contains allegations by these individuals and the only independent corroboration available is the newsletter, which states “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 AstraZeneca reps have indeed been “selling against letrozole” for some period prior to the publication of the newsletter, which may have been contrary to AstraZeneca policy.

There is at this time no other independet verification of any of these allegations, however, AstraZeneca may be able to verify if a report containing these allegations, number ASTR 06110001, has been filed and AstraZeneca would also be able to confirm if they filed the appropriate report within 30 days with the OIG, per the obligations spelled out in AstraZeneca's Corporate Integrity Agreement.

The information below would appear to meet the definition of a "reportable event" and if AstraZeneca has not reported this information they may be in breech of their Corporate Integrity Agreement, which may have various consequences, from fines, to exclusion from federal healthcare programs.

See also Brandweek story here, with additional information.

Certain personal information has been redacted:


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 Agreement

[Personal information redacted]

Summary and Chronology of Events:

Early November 2006 – At an oncology district meeting for the [Redacted] territories held in [Location and Name 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 data).
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, [Name 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 [Name Redacted] actions were sanctioned by AstraZeneca and that we have no other alternative but to contact OIG directly and publicly.

This is where the letter ends, but the story doesn't end here.

Here is AstraZeneca's policy for product promotion.

And this is what it says:

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."

This means Astra reps discuss and compare anastrozole to letrozole without good, rigorous studies to back up any claims they may make. Since those don't exist, this also means that the infamous Oncology Newsletter is proof that AstraZeneca may have violated its own policy.

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