I just finished having a nice chat with one of the Group of 7 whistleblowers at AZ. He had several updates, including:
1. That this is not the first time that AZ has indulged in an improper promotional campaign in which reps were encouraged to compare Arimidex to Femara even though there was no data supporting such a comparison. An earlier campaign took place in 2000 and 2001 (see download at the end of this post). Internal sales slides show: "During 2000 and 2001 we talked about Femara on 61% of our sales calls." In fact, according to the slides, the company regretted not spending more time talking about the opposition.
Why is this a big deal? AZ's agreement with the OIG not to engage in comparison selling was not enacted until 2003. The Group of 7 believe this is a big deal because even though such an agreement was absent, such comparisons—when there is no data backing them—are still generally frowned upon by the FDA.
"The FDA would say there's no way in hell you can do that," the whistleblower told me. "For 2 years they campaigned off-label and then they turned around and did it again."
2. The OIG has not contacted the group even though "I've offered to give them any information they want" regarding AZ's violations of the corporate intergrity agreement that the company has signed with the OIG back in 2003.
3. He alleges that the salesforce trainer whose voice is on the roleplay tapes in which Armidex is compared to Femara (even though there is no data comparing the two) is the same AZ exec who hosted a phone conference with AZ sales reps earlier in May in which reps were given guidance on what they can and cannot do to promote Arimidex.
4. He gives "credit" to AZ management for not attempting to find the Group of 7 or retaliate against them. "There has not been a witchhunt...there seems to be an effort to clean this up."
5. He gave me another presentation slide which looks very much like a comparison of Arimedex vs. Letrozole (see second download at the end of this post.)
Bottom line: Now that AZ has fired two execs on this issue, the OIG's credibility is on the line. If it becomes known that the OIG doesn't bother to investigate violations of its own corporate integrity agreements, then there will be no incentive to follow them...and drug compoanies will stop bothering to fire execs who break them.
Why is this a big deal? AZ's agreement with the OIG not to engage in comparison selling was not enacted until 2003. The Group of 7 believe this is a big deal because even though such an agreement was absent, such comparisons—when there is no data backing them—are still generally frowned upon by the FDA.
Posted by: アニメ抱き枕 | June 16, 2011 at 01:59 AM