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Towns Announces Inquiry into Allegations Wyeth Marketed Rapamune to African Americans for Purposes Unapproved by the FDA PDF Print

For immediate release: Friday, June 11, 2010
Contact: Oversight and Government Reform Press Office, (202) 225-5051

Chairman Towns Announces Inquiry into Allegations Wyeth Marketed Rapamune to African Americans for Purposes Unapproved by the FDA

WASHINGTON – Chairman Edolphus “Ed” Towns (D-NY) today launched an investigation into Wyeth Pharmaceuticals, Inc. amid reports alleging the company illegally promoted the kidney transplant drug Rapamune for treatments not approved by the Food and Drug Administration (FDA), and specifically targeted African-Americans in its promotional activities.

The Oversight Committee is investigating whether Wyeth, which was acquired by Pfizer in October 2009, “aggressively encouraged the use of Rapamune to prevent organ rejection following heart, lung, liver, pancreas, and islet cell transplants, without FDA approval.” The company reportedly did so despite the fact that the FDA approved the drug only to help prevent organ rejection after a kidney transplant.

As part of the inquiry, Chairman Towns has asked the company to provide internal documents, including reports detailing the side effects associated with Rapamune. In his letter to the CEO Jeffrey Kindler, Chairman Towns’ is also seeking to determine if “Pfizer or Wyeth, or any of their employees or agents engaged in off-label marketing or promotion of Rapamune” and if “Pfizer or Wyeth ever offered incentives to health care providers related to the use of Rapamune.”

“When patients seek medicinal therapy, they want to know the side effects and that the prescriptions offered to them have been FDA approved to treat their illness,” said Chairman Towns. “The most egregious problem here is that, unbeknown to the African Americans’ they allegedly targeted, their lives were placed at serious risk for life threatening ailments.”

Chairman Towns has expressed his commitment to holding companies accountable for their products, especially when those products pose serious health risks to the public. Just last month, the Oversight Committee held a hearing into popular infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare. Also underway, is an Oversight Committee investigation into Johnson and Johnson’s “phantom” recall of a certain type of Motrin and the Johnson & Johnson/McNeil plant that is now connected to the recall of four types of PediaCare, a popular children’s medication.

Towns concluded, “Numerous federal indictments have been handed down for pharmaceutical companies’ use of off-label drugs, and if true, this type of irresponsible experimentation is another example of big companies preying on vulnerable consumers. Unfortunately, these marketing techniques are reminiscent of Tuskegee all over again.”

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Documents and Links

Letter from Chairman Towns to Pfizer CEO Jeffrey Kindler

 

Committee On Oversight and Government Reform

U.S. House of Representatives | 2157 Rayburn House Office Building | Washington, D.C. 20515 | (202) 225-5051