Monday, April 16, 2007

The AstraZeneca Controversy Increases with More Proof of Questionable Practices

The AstraZeneca “Group of Seven” has just provided Question Authority with additional proof of questionable promotional practices in connection with selling of AstraZeneca’s cancer drug ARIMIDEX ® (anastrozole), used for postmenopausal women with hormone receptor-positive early breast cancer, against Novartis' FEMARA® (letrozole), used for treatment for postmenopausal women suffering from female hormone imbalance with early stage breast cancer.

First you need to know that according to AstraZeneca's policy for product promotion, "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."

You also need to know that when you compare two products, to do so you should have them in THE SAME TRIAL. You can’t take two separate trials and compare the performance of the drugs, since that is like deciding who is the fastest runner, comparing two runners in two separate races. If you have two runners with similar performance, such a comparison is meaningless.

But that is exactly how it was done within AstraZeneca.

The proof is a slide presentation developed by the same AstraZeneca distric sales manager who was also the editor for the infamous Mid-Atlantic Oncology “Zubeletter.” This slide presentation was forwarded to the AstraZeneca Mid-Atlantic Regional trainer. In the slide presentation, which you can download here, AstraZeneca compares Arimidex in one trial with Femara (letrozole) in another trial.

It is not clear if this presentation was shown to doctors, in fact, the district manager who developed this presentation appears to have understood that doing so would be inappropriate. How do we know this? Because she wrote to the training manger:

“Hey guys,

Below you'll find the updated BIG 1-98 presentation put together by [name redacted] and myself for your background use. Please make sure that you study this information thoroughly. Hopefully it will make understanding the benefits of Arimidex over letrozole a little easier for all of us. We really worked on simplifying all of the data for your use.

Please remember that this is for background use only and should not be used in front of or with customers.

Knowledge is Power!”"

The obvious question is, if this material can’t be used in front of a doctor . . . why should a rep “study this information thoroughly”? And why would knowledge about something you can't discuss be "Power?"

And there is more of interest in this presentation. Take a look at slide number 12 and how DELIGHTED the distric sales manager who wrote the presentation is! (Remember “It's like a bucket of money . . ?”)

Here’s what slide 12 says:

Comparing Cardiac events from NEJM [using AstraZeneca’s drug Armidex] vs. Cardiac events from JCO [using letrozole] is like watching miracles happen!

The slide continues:

“Grade 3-5 cardiac events (the serious ones) are SIGNIFICANTLY worse for letrozole!”

So in AstraZeneca parlance: Yahooo!!! More people are killed on the competitor! (At least if we use two different studies and not one head-to-head comparison in one study.)

Wow. So here we have direct violation of AstraZeneca formal policy to objectively compare two products. Because, in sales training AstraZeneca uses two separate studies to compare the drugs with each other . . . which is clearly inappropriate in this case.

Question to AstraZeneca: Was this just one district, or was it the entire Onocology sales force trained this way?

But there is more . . . this is not the first time AstraZeneca’s Oncology franchise is in trouble:

Armidex is a cancer drug, just like Zoladex. And Zoladex is the drug that got AstraZeneca into major trouble in 2003, when AstraZeneca pleaded guilty to a healthcare crime and agreed to pay $355 million to resolve criminal charges and civil liabilities in connection with its drug pricing and marketing practices with regard to Zoladex. (Zoladex is a drug used primarily for the treatment of prostate cancer.)

This settlement also forced AstraZeneca to sign a corporate integrity agreement, which they still have to abide by, and it also forced AstraZeneca to implement a strict code of conduct.

But this is not the end of this story. There is more:

The fact that AstraZeneca sales reps were officially requested to sell Armidex against Femara (letrozole) is right there in the template for 2007 objectives for the oncology sales representatives. You can download those objectives here.

This is what they say: "Product Initiative-Arimidex (1) Grow at expense of Femara"

Selling against Femara (letrozole) was MANDATORY. Failure to do so would mean a worse evaluation and lower pay-raise for reps. Can it get any clearer than that?


Anonymous said...

Checked in to see what the "big surprise" is. I'm not surprised and to start with, pedantic criticism does not invalidate PR's morning post w/r to Arimidex and AZ. Like I wrote yesterday, this is just Pharma SOP. This morning, the raloxifene representative was "sharing" the "remarkable breast cancer data" (I hadn't asked...) and wanted me to "give patients the benefit of significant hip fracture reduction too" (yeah, right...). I was also warned about "mandibular necrosis which is so frequent with the bisphosponates" (It's also in the raloxifene literature too, little sweetie...) These "policies" and "conduct agreements" are literally worthless pieces of paper. Who monitors the conduct and what are the penalties?

Anonymous said...

Mobius, is that you?