Healthy Skepticism Library item: 16641

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Edwards J
DOJ Blames Pfizer Management for Bextra Mess:
BNet 2009 Oct 16
http://industry.bnet.com/pharma/10004867/doj-blames-pfizer-management-for-bextra-mess-the-goal-was-to-avoid-getting-caught/

Full text:

The Department of Justice blamed Pfizer’s management for the $2.3 billion Bextra settlement by creating a “corporate culture” in which off-label promotion was encouraged, and where not going along was regarded as a “CLM” or career-limiting move.

The sentencing memo contains the now-familiar allegations of how the company promoted the painkiller off-label. But it also describes how Pfizer sponsored an “operate for cash” promotion, in which sales reps were rewarded for getting doctors to design Bextra protocols for post-surgery pain, even though it was not approved for that.

Pfizer’s statement is:

“Today’s hearing is the last step in a process to bring final closure to the settlement agreement with the U.S. Department of Justice that was announced on September 2, 2009. This agreement allows us to continue to focus on what we do best – discovering and developing innovative new medicines that improve patients’ lives.”

The sentencing memo was filed Oct. 9 in Massachusetts federal court. It was posted online by law firm Phillips & Cohen, who represented one of the whistleblowers in the case.

Here is a digest of new information described in the sentencing memo. It begins by noting that the off-label sales were pushed by management, not rogue reps or their district and regional managers:

Headquarters’ Marketing Plans: Pharmacia’s marketing team positioned Bextra for unapproved uses and dosages, commissioned market research to test its salesmaterials, and confirmed these unapproved messages.

The launch event was a trip:

Bextra was officially launched at a national meeting for sales representatives in Atlanta, Georgia from April 9-12, 2002. During this meeting, the sales force was given a vivid message of how to promote Bextra for the “power” position. They were inundated with displays of music, light shows, acrobats and dancers. The marketing managers led the entire audience in thrusting their fists into the air (the marketing symbol of Bextra) and pounding them against their upraised hands in unison to symbolize the power of Bextra and to “Power Up” the sales force. Ultimately, simulated large steel doors crash down on the stage, and the Bextra fist symbol crashed through the doors. The events from the launch demonstrates the sales frenzy that accompanied Bextra, as the company strove to make the drug reach “blockbuster” (billion dollar a year sales) status.

Pfizer also did research into other types of off-label pain that Bextra might be used for:

In March 2003, the problem was reflected very clearly in another market research report which explained that, with respect to the marketing material on primary dysmenorrhea (”PD”):

The PD page, while largely irrelevant in terms of patient population (”I don’t know nothin’ about birthin’ no babies”), supported Bextra’s acute pain relief message. It suggests that Bextra can be prescribed for pain relief other than arthritis. . . . It moves it in my mind to other types of pain, menstrual pain, maybe even nerve pain, headaches.

In terms of the “operate for cash” promotion, the memo states:

Many of these rewarded high-performing representatives, managers and districts with trips to places like the Carribean and Europe. One such contest, the aptly named “OPERATE FOR CASH” contest, specifically rewarded sales representatives for obtaining protocols and standing orders that included Celebrex and Bextra, and thus specifically rewarded the off-label promotion of Bextra.

The memo also goes into some detail as to where that $2.3 billion number came from:

Pharmacia’s net gain from the sales of Bextra was determined to be one billion, seven hundred ninety-one million dollars ($1,791,000, 000). This figure reflects the revenues from the sale of Bextra minus the costs of its production and distribution, based upon information provided by Pharmacia from its books and records. However, not all of the net gain was due to off-label sales of Bextra. Based upon data available from third party vendors, it appeared that approximately 43% of the sales were attributable to on-label uses for OA, RA and PD. Thus, 57% of the net gain, or one billion, twenty-one million dollars ($1,021,000,000), is attributable to off-label sales.

Of those off-label sales, some were generated spontaneously and not by Pfizer:

… a reasonable estimate of this “background” rate was 35% of the off-label sales. After applying this credit to the off-label sales number of one billion, twenty-one million dollars ($1,021,000,000), the parties determined that the pecuniary gain attributable to Pharmacia from its illegal conduct was six hundred sixty-four million dollars ($664,000,000).

Because Pfizer had signed a prior agreement with the DOJ, the punishment had to be increased:

The parties agreed that a 1.8 multiplier is the appropriate multiplier and the resulting fine of one billion, one hundred ninety-five million dollars ($1,195,000,000) represents a fair and reasonable penalty that achieves the goals of sentencing.

The memo states that off-label promotion of Bextra was management’s policy and the company’s corporate culture:

… the illegal conduct was pervasive throughout the company and stemmed from messages created at high levels within the national marketing team. The corporate culture contributed to causing the conduct and allowing it to continue. Sales employees explained that off-label promotion was tolerated and no big deal, even though they knew it was illegal. The goal was to avoid getting caught. Employees, including district managers, explained that they did not question their supervisors about the illegal conduct that they were being instructed to carry out, because to do so would be considered a “CLM” or “Career Limiting Move.” A CLM meant that an employee took an action that possibly ended his/her promotion potential or led to being disfavored by management and, ultimately, fired.

Finally, the settlement sets a record:

The criminal fine would be, to the best of the government’s knowledge, the largest criminal fine ever imposed against a defendant in any criminal proceeding.