Pfizer Exec: Company Approved of Off-Label Bextra Promotion

Mary Holloway, the Pfizer regional manager who was sentenced last week for her role in a rogue operation that promoted Bextra for off-label uses such as post-operative pain, had the support of her superiors, she told Massachusetts federal district court. In fact, Pfizer’s off-label Bextra promotion was widespread within the company, approved of by the company, and generally “part of the Pfizer culture,” Holloway’s lawyer said.

The Bextra scandal resulted in a $2.3 billion settlement with the government; the settlement’s existence was announced the same day as Pfizer’s merger with Wyeth and was thus eclipsed in media coverage at the time.

One of Holloway’s off-label messages, for which she was fined $75,000 and given two years’ probation, was for using Bextra to enable joint replacement patients to get walking faster, thus avoiding deep-vein thrombosis. Holloway’s lawyer wrote to the judge (download her sentencing memo here):

The DVT Message was responsibly developed after consultation with prominent clinicians, including a Pfizer consultant. In April 2002, Pfizer, through Ms. Holloway, presented a $100,000 research grant to a consultant whose Pfizer-sponsored research focused on the use of COX-2 inhibitors, instead of narcotics, for postoperative pain control in joint replacement patients.

Indeed, the company publicized such findings. In February 2002, Pfizer issued a press release boasting that a new study suggested that Bextra was an effective morphine-sparing analgesic in knee replacement surgery.

You can read that press release here. Holloway’s action won praise at the company:

As a clear sign of corporate endorsement, two of Ms. Holloway’s superiors complimented her for the presentation. Moreover, one Pfizer Medical Director in attendance wrote to another Medical Director that “Mary Holloway was awesome” at the meeting.

This collection and dissemination of protocols was not limited to Ms. Holloway’s Northeast region, but took place across the various sales regions.It was part of the Pfizer culture.

Holloway paints herself as a victim of her own honesty:

There is some irony in the fact that to date, Ms. Holloway has been singled out as the lone Pfizer sales manager to be charged with off-label promotion of Bextra. When Ms. Holloway heard in September 2004 that three sales representatives in one of her districts had deleted information from their computers, she immediately reported this information to her direct superior. Indeed, Ms. Holloway’s good-faith action in reporting to her supervisor that employees in her region had allegedly deleted information from their computers likely led to the government investigation that focused on her region.

That’s only partially true. In fact, another sales manager, Thomas Farina, was also convicted in the scheme. Holloway trained and encouraged a staff of 100 reps to promote Bextra for unapproved uses, the DOJ said.

Her sentencing memo includes letters of praise and recommendation from many of her colleagues at Pfizer, which you can download here. Meanwhile, on Cafe Pharma, memories appear to be very short …

• Previous BNET coverage of Bextra:
• Document Shows Rogue Bextra Operation Inside Pfizer
• Pfizer District Sales Manager Guilty of Altering Off-Label Celebrex Documents
• Federal Prosecutor Warns Drug Companies on Off-Label Promotion: “This Must Stop”
• How Pfizer Hid a $2.3 Bill. Bextra Settlement in Plain Sight
• Pfizer’s Wyeth Buy Eclipses $2.3 Bill. Bextra Troubles; 19,000 Layoffs to Come