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Pfizer Hit With Huge Fine, Whistleblowers Reap Millions

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Washington, DCThe world's largest pharmaceutical company was hit yesterday with the largest fine ever levied against a drug manufacturer for unlawful activity. Meanwhile a collection of six whistleblowers will take home $102 million for their role in ensuring the pharma juggernaut was held accountable.

PharmaceuticalsOne individual, Gulf War veteran and former Pfizer sales rep John Kopchinski of Texas, will take home $51.5 million as his share in the qui tam lawsuit. Appalled by Pfizer's tactics with regard to the marketing and promotion of Bextra, Kopchinski filed the qui tam lawsuit in 2003 and served as the lead plaintiff. His actions sparked federal and state probes that led to Wednesday's agreement by Pfizer to pay $2.3 billion in civil and criminal penalties. Pfizer also agreed to plead guilty to a felony charge for promoting Bextra and 12 other drugs for unapproved uses and dosages.

In a news release issued Wednesday, the Justice Department cited Pfizer for promoting "the sale of Bextra for several uses and dosages that the (US Food and Drug Administration-FDA) specifically declined to approve due to safety concerns."

Pharmacia & Upjohn Company, a Pfizer subsidiary, agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for "misbranding Bextra with the intent to defraud or mislead."

Pfizer was also found to have illegally promoted the anti-psychotic drug Geodon, antibiotic Zyvox and anti-epilepsy drug Lyrica.

Only doctors have the authority to prescribe drugs for use other than that for which they have been approved by the FDA. It is illegal for a manufacturer to promote, to a doctor or to anyone, a drug for off-label use.

According to CNN, the Justice Department cited Pfizer sales reps for creating 'sham' requests from physicians asking for information about unapproved uses of certain drugs. The information was then mailed to doctors. Pfizer was also accused of entertaining doctors at resorts, where they were encouraged to prescribe its drugs. Kickbacks were made available to healthcare providers in exchange for prescribing drugs such as Lipitor, Viagra and Zoloft.

The settlement is considered historic not only in view of the size of the financial penalty, but also for the requirement for Pfizer to conduct yearly audits and certify its compliance. Protocols will be developed to allow for the reporting of questionable behavior on the part of sales reps, and Pfizer will post information online listing payments and gifts to doctors.

Health and Human Services Secretary Kathleen Sebelius called the agreement "the most comprehensive corporate integrity agreement that a drug company has ever signed in the United States."

For whistleblower John Kopchinski and his young family the agreement marks the end of a long road. He was fired by Pfizer in March 2003 at the age of 39. At the time he was making $125,000 a year, only to wind up living off his retirement fund before landing a job with an insurance company for $40,000 a year. Kopchinski told Reuters that he was fired shortly after raising concerns with the company over its practices. At the time he had an infant son and his wife was pregnant with twins.

With his $51.5 million share of the settlement, Kopchinski no longer has to worry about sending his kids to college. He also told Reuters that his decision to blow the whistle on Pfizer was rooted in principles stemming from his stint in the military.

"In the Army I was expected to protect people at all costs," Kopchinski said in a statement. "At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.

"I couldn't do that."



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