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Secret AstraZeneca Audio Tapes: Violation of Corporate Integrity Agreement?

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An AstraZeneca anonymous whistleblower has just provided internal AstraZeneca training tapes (download below), which appear to indicate that AstraZeneca may be in violation of its Corporate Integrity Agreement with the Office of Inspector General of the United States Department of Health and Human Services. If such a violation is confirmed, it could in a worst case scenario result in exclusion of AstraZeneca from selling drugs to the Federal Government.

Here's the background:

AstraZeneca has been forced to sign a Corporate Integrity Agreement (CIA) with the OIG of HHS, based on past sins and violations. Among the many provisions of this CIA, AstraZeneca employees have to comply with AstraZeneca's own policies and procedures.

The AstraZeneca's policy for product promotion states that "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."

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The only way to make a balanced comparison between two products is to have a well designed, double-blind, randomized trial WITH THE TWO DRUGS IN THE SAME TRIAL.

But that doesn't seem to bother AstraZeneca; a company for which the lack of comparative trials is a mere nuisance, easily corrected with slick selling.

Proof of this, according to the AstraZeneca whistleblower, is two audio tracks from the "Arimidex/Faslodex," "Pharmaceutical Sales Specialist Objection Handler for the Tablet PC," which is a CD that was mailed to the AZ oncology sales force in January 2007.

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Two of the audio tracks show exactly how to sell AZ's Arimidex against Novartis' letrozole (brand name FEMARA), by minimizing the efficacy message of letrozole, WITHOUT HAVING ANY COMPARATIVE DATA.

Click on the links below to download and listen to the drug company training conversations with a doctor:

Track 7 - Here a sales rep targets a physician who uses letrozole from Novartis. She gets the doc to talk about her use, then proceeds to minimize letrozole efficacy because Novartis used "sub-group analysis" that is "fraught with difficulty" and that the authors say "use caution when interpreting this analysis" in their BIG 1-98 trial.

Track 15 - Similar. Strategy is to generate a conversation about letrozole and then minimize the efficacy of letrozole in node positive patients by bashing the Novartis BIG 1-98 trial because of bad "sub group analysis".

SO HOW DOES THIS WORK? HOW CAN ASTRAZENECA USE NON-EXISTENT COMPARATIVE DATA TO DISS THE COMPETITION?

HERE's the deal:

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1. AstraZeneca has an Arimidex versus tamoxifen study called ATAC.
2. Novartis has a letrozole versus tamoxifen study called BIG 1-98.
3. There are no studies of Arimidex versus letrozole.

Both training examples show exactly how oncology reps can:

1) Get the doctor to start talking about letrozole and then compare it to Arimidex without a head to head study.
2) Minimize the efficacy of letrozole by slamming their trial.
3) Imply that Arimidex efficacy is better than letrozole WITHOUT ANY COMPARATIVE DATA. Remember, we're talking CANCER patients here, not restless leg syndrome.

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Peter Rost M.D. Peter Rost, M.D., is a former Vice President of Pfizer. He is the author of "The Whistleblower, Confessions of a Healthcare Hitman" and "Killer Drug." He also writes the daily Pharma Law Blog and the Pharma Expert Witness (more...)
 
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