Justice joins whistleblower suit over off-label use of Wyeth transplant drug, often to blacks

Justice joins whistleblower suit over Wyeth drug

PHILADELPHIA — The Justice Department has joined a whistleblower lawsuit that accuses Wyeth Pharmaceuticals of promoting the off-label use of a transplant drug in high-risk black patients, children and others.

The Justice Department filed its motion to intervene Tuesday in the lawsuit over the immunosuppressant drug Rapamune.

Two former sales managers also charge in their recently unsealed 2005 lawsuit that Wyeth improperly promoted the drug for heart and lung transplant patients and gave doctors cash and gifts in encouraging its use.

They say Wyeth pushed doctors to add Rapamune to their patients’ delicate drug regimen, even in blacks and others at high risk of rejecting organ transplants.

The company thereby caused life-threatening side effects, illnesses including anemia, and even the deaths of some patients, the suit charged.

“Unfortunately, we live in an age when life-and-death medical decisions are being influenced by marketing agendas. And many times patients don’t know it,” the plaintiffs’ lawyer, Reuben Guttman, told The Associated Press.

According to Guttman, the Justice Department’s decision to join the case often indicates the government thinks the case has merit.

U.S. Attorney Zane Memeger of the Eastern District of Pennsylvania, who signed the motion along with other Justice Department officials, had no comment, his spokeswoman said.

Pfizer Inc., which acquired New Jersey-based Wyeth in 2009, said it is cooperating in the U.S. government review of Wyeth’s marketing of Rapamune.

“The health and safety of the patients using our medicines is our top priority. Wyeth is committed to ensuring that information provided to physicians on the uses, benefits and risks for Rapamune is consistent with its FDA-approved label,” the statement from New York City-based Pfizer said.

Wyeth ordered its staff to boost Rapamune sales even at hospitals in Philadelphia and New York despite their predominantly black patients, the suit said. Blacks are considered high-risk transplant patients because of different immune responses and dosage needs, the suit said.

The drug was approved for use in these high-risk patients, Pfizer said.

But Guttman said the company’s push to switch patients to Rapamune, which can only be used in combination with other drugs, increased their risk of complications.

Patients remain on the drug for life, at a cost that can reach up to $20,000 a year, the suit said.

The lawsuit is pending in federal court in Philadelphia.

Rapamune, first approved for use in 1999, was acquired by Pfizer last year as part of its $68 billion buyout of Wyeth.