U.S. steps into drug whistle-blowers case

The U.S. Justice Department intervened Tuesday in a case of two whistle-blowers who have accused Wyeth Pharmaceuticals of illegally promoting the kidney-transplant drug Rapamune for unapproved uses.

Among the suit's allegations are claims that Wyeth targeted African American transplant patients, and that Wyeth used speaking fees and grants to reward doctors who prescribed the drug for unapproved uses, such as liver, lung, and heart transplants.

According to the suit, Wyeth, which was bought by Pfizer Inc. last year, promoted the drug's unapproved uses to doctors at a number of Philadelphia-area transplant centers, including Temple University Hospital, the Hospital of the University of Pennsylvania, and Einstein Medical Center. The suit notes that 75 percent of Einstein's transplant patients are African American, a population for which there was little data on the possible negative effects of the drug.

"As a result of Wyeth's wrongdoing, patients were put at serious physical and financial harm," the suit alleged.

Pfizer said Tuesday that it was cooperating with the government's review of Wyeth's promotion of Rapamune.

In a statement, the company said Rapamune "was never contraindicated for African-American patients or other high risk populations," and that it was approved in 1999 "for the prophylaxis of organ rejection in patients receiving kidney transplants, including low, moderate and high risk patients."

The suit was originally filed in 2005 by two former Wyeth sales representatives, who contended that Wyeth encouraged its sales team to market Rapamune for treatments beyond kidney transplants, which is the Food and Drug Administration's only approved use for the drug.

While doctors are permitted to use drugs for treatments beyond those approved by the FDA, drug makers are barred from promoting such uses.

For five years, the suit was sealed while the Justice Department investigated its merits, as is the practice in whistle-blower cases, according Reuben Guttman, the lawyer representing the sales reps, Marlene Sandler and Scott Paris.

Sandler and Paris stand to collect a portion of whatever funds are recovered on behalf of Medicare, Medicaid or other government-funded health-insurance programs that paid for Rapamune prescriptions.

The Justice Department's motion entering the case did not explain its rationale. Charles Miller, spokesman for the department, said such motions were filed when the department had determined there was merit in some or all of the allegations.