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Aranesp Suit: What Did Amgen CEO Sharer Know (and Did He Read It in His Company's PowerPoint Slides)?

Amgen executives detailed their alleged Aranesp "overfill" kickback scheme in a set of PowerPoint slides and Excel spreadsheets, according to a lawsuit filed by the New York State Attorney General. The suit also describes an email in which colleagues of Amgen CEO Kevin Sharer asked for information on how Amgen changed the overfill levels on a competing drug, Epogen, that Amgen manufactured for Johnson & Johnson. The email indicates that the information -- which describes how Epogen's overfills were reduced when Aranesp hit the market -- was to be delivered to Sharer.

The allegations contain examples of drug company largess that we're all used to hearing:
... sham consultancy payments, and all-expense paid weekend retreats, among other things. Amgen and [International Nephrology Network] also conspired to induce providers to purchase Aranesp by paying medical providers bogus honoraria for attending all expense paid junkets that Amgen and INN referred to as Advisory Board meetings or weekend retreats.
The company allegedly over-filled each Aranesp vial by 16.8 percent to 19 percent. Physicians paid for the standard dose but were able to save the free extra anemia drug, and bill Medicare for its later use. The free extra drug thus functioned as an illegal kickback, the suit alleges.

The parts that Amgen will have the hardest time rebutting are the allegations drawn from the company's own internal materials. The AG found two PowerPoint slideshows that detailed the mechanics of the alleged overfill scheme, according to the suit:

At some point in 2008, an internal company recommendation was made to decrease the overfill amounts contained in Aranesp vials. An Amgen PowerPoint dated April 3, 2008, entitled "Overfill Reduction: Aranesp 1.0mL vials" recommends that the overfill amounts contained in Aranesp vials be decreased in two phases in order to reduce overfill amounts from 16.8% to 13%.

An Amgen PowerPoint presentation dated June 2, 2005, entitled "EPO Fill Volume" reports that overfill amounts contained in EPO were decreased in the fourth quarter 2002 from 16.8% to 14.4% for both single-use and multi-use vials.

If any physician asked Amgen about the overfill, a medical liaison would send them a letter in which its warning about the overfill functioned as an instruction on how to utilize it:
It is important to emphasize that Amgen cannot and will not condone unsafe practices that may be utilized to capture any overfill, such as the pooling of unused portions of single-dose preservative-free vials of Aranesp
Amgen also sent its reps "cost revenue models" in the form of Excel spreadsheets that showed reps how to calculate a doctor's profit from using overfilled Aranesp vials.

The smoking gun in the case, however, is an email replying to a request from colleagues of CEO Sharer about the overfill levels in Epogen, a competing drug that Amgen manufactured on behalf of J&J. The suit states:

... an email dated January 6, 2006 from Edwin Mar, Senior Manager of Medical Information, to Helen Torley, Vice President and General Manager of Nephrology, and Leslie Mirani, Vice President of Sales, states: "In regards to your request to provide EPOGEN overfill historical information to [CEO] Kevin Sharer, these are the information I have available so far regarding EPOGEN 1.0 mL vial fill volumes." The email goes on to provide the overfill amounts for Epogen from 1993 through January 2006:

(1993-Q4/2002) â€" 1.168 mL

(Q4/2002-Q1/2004) â€" 1.144 mL

(Q1/2004 â€" present) â€" 1.111 mL

Those dates and levels are significant because Aranesp was launched in 2001-2002. Put simply, as soon as Aranesp hit the market in overfilled vials, Amgen began reducing the overfill in J&J's Epogen.
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