By RADHA CHITALE
ABC News Medical Unit
Sept. 3, 2009

At $2.3 billion, it’s a record-breaking settlement that includes the largest fine ever levied in U.S. history, but drug industry experts say that the hefty sum Pfizer agreed to Wednesday will do little to curb highly profitable, unethical marketing behaviors by some companies. The sum folds in civil and criminal penalties related to illegal prescription drug marketing, bringing the investigation of the pharmaceutical behemoth by the U.S. Department of Justice to a close.

Associate Attorney General Tom Perrelli, center, Health and Human Services Secretary Kathleen Sebelius, left, and Assistant Attorney General for the Civil Division Tony West, take part in a news conference to announce Pfizer will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions on Wednesday, September 2, 2009 in Washington.

The settlement includes $1.3 billion in criminal fines related to promoting the arthritis and menstrual pain drug Bextra for uses and in doses not approved by the FDA, putting patients at increased risk for heart attack and stroke. Pfizer voluntarily removed Bextra from the market in 2005.

But promoting off-label drug use to physicians is commonplace. Ethics experts and policy makers say more stringent government oversight is necessary, but that as long as the profits are bigger than the penalties, drug companies are unlikely to revise their marketing model.

“This suit shows that Pfizer controlled what physicians and consumers believed to be the effectiveness and safety of Bextra in ways not supported by the real science Pfizer had done and was not approved by the FDA,” said Dr. Jon Abramson, a pharmaceutical safety and ethics expert at the Harvard Medical School. “Those are the necessary ingredients of blockbuster drugs.”

Pharmacia and Upjohn Company, Inc., a subsidiary of Pfizer, will plead guilty to one criminal count of violating the U.S. Food, Drug, and Cosmetic Act in promoting off-label Bextra use.

Lavish Trips for Prescribing Doctors

Part of Pfizer’s marketing campaign included lavish “consultant meetings” in exotic locations that physicians were paid up to $1,500 to attend, in the hopes that they might increase the number of prescriptions they wrote, according to a lawsuit filed by John Kopchinski, a former Pfizer sales representative.

“At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives,” Kopchinski said, in a statement. “I couldn’t do that.”

Department of Health and Human Services Secretary Kathleen Sebelius called the settlement today “historic,” not only because of its size but because Pfizer agreed to a Corporate Integrity Agreement, which she said would offer some transparency in how the company researches and markets its drugs, including what kind of financial incentives the company offers doctors who prescribe Pfizer drugs.