Sunday, April 22, 2007

Secret AstraZeneca Audio Tapes: Violation of Corporate Integrity Agreement?

Question Authority has just obtained internal AstraZeneca training tapes (download below), which appear to confirm 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."

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.

The AstraZeneca whistleblower thinks that proof of this 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.

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 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".


HERE's the deal:

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.

And we're talking about a company which has been forced by the United States Department of Health and Human Services to follow certain procedures and ethics, based on their past crimes.

Basically through the documents and audio files published on this site, we've now shown that AstraZeneca sales, marketing and training have a coordinated campaign to sell against letrozole.


The OIG has been notified and will have to determine if this violates AstraZeneca's policy, which by definition also would be a violation of AZ's Corporate Integrity Agreement.


Anonymous said...

AZ can't even make the claim that Zube produced this all by himself. This tape is professionally produced. Someone else had to have had a hand in creating it.

Anonymous said...

AZ is looking more and more like "Little Britain" every day. Given Libby Purve's writing about "responsibility", is it too far off to see AZ as her next target? Peter, how about some YouTube segments of "Little Britain" on Question Authority?

Anonymous said...

AZ is sounding just like BMS, Merck, Lilly, Pfizer (especially), and the list goes on (as nearly everyone reading this post knows from their own experiences and witnessing of daily corruption while working in the industry) of drug companies pulling this crap.

Will long-term patient safety or protection of limited healthcare funds EVER matter to federal Courts, Prosecutors, or Legislators?

A slew of similar cases have already been settled (at least one already against AZ) and the U.S. Justice Dept. reports more than 500 similar cases currently under investigation and under seal involving more than 180 different drugs. And yet, to date, not one of those companies has been excluded from receiving govt. healthcare funds (that's always saved for some no longer relevant subsidiary of the real company to give the "appearance" that some business actually received this "death sentence"-- See any settlements between the occurrence of the irrelevant division of Serono that was then excluded from govt. programs in the Oct. 2005 settlement to as recent as the settlement with Pfizer over Genotropin in which Pharmacia was excluded from participating in govt. healthcare programs . . . "Ohhhh, Noooo! Please don't throw Pharmacia-- a now non-existent company-- in the Briar Patch, Mr. O.I.G.! That would be the worst thing Pfizer could possibly have happen to it (Says Jeff Kindler to the new General Counsel chuckling to themselves all the way to the door before they can get outside and finally explode in real laughter at how stupid and gullible the Inspector General and Fed. Prosecutors who really think they've made a change in the industry with this "tough" settlement negotiation-- See Statement from Boston U.S.Attorney, Michael Sullivan and HHS/OIG-- that excluded a non-existent company from govt. healthcare funds and that fined a company less than $40 million (only a small fraction-- cost of doing business-- of the Company's MUCH larger gain in profits from the illegal activity over so many years).

Are you kidding me? If I was Pfizer I would have gladly paid $430 million in the Neurontin settlement in order to keep the more than $8 billion that was netted through the illegal conduct. And honestly, what gambler wouldn't take those odds and what investor wouldn't invest for that kind of return? And the feds really think that these little slaps on the wrist are going to change something???

If they really want to change the industry as U.S. Attorney Sullivan says, they need to start indicting C.E.O.s and sending management to jail while recouping the FULL "up to three times the damages" plus "civil fines of $5,500 to $11,000 for each violation" that the federal false claims act actually authorizes. If they won't do that, they need to instead exclude the REAL company-- All of Astra Zeneca and any and all of its subsidiaries, past, present and future, in this case-- from any and all participation in any government funded healthcare program, period . . . . just as U.S. law also allows. THEN, we actually would see a true change in how all other businesses operated, and a true change in the industry's practices from that day forward. But this current wrist-slapping, cost-of-doing business practice is a joke!

Nevertheless, this info. on AZ is hard-hitting stuff, Doc! I don't know how you got a hold of it all, but Thanks for doing so and for making it known to the world when the mainstream media outlets (sponsored in every third commercial by another drug company) always fail to really divulge details or truth to us about what's going on, and about what is influencing our doctors' prescribing habits too frequently. I'm appreciative to you both as a patient, and as a taxpayer, and as someone who knows the inside of the drug industry all too well. Keep up the good work!!!