US lawmakers launch inquiry into allegations Wyeth/Pfizer marketed Rapamune to African Americans for not-FDA-approved uses

The US House Oversight and Government Reform Committee, under the chairmanship of Representative Edolphus 'Ed' Towns (Democrat, New York), on Friday launched an investigation into Wyeth Pharmaceuticals (now part of global drugs behemoth Pfizer), citing reports alleging the company illegally promoted the kidney transplant drug Rapamune (sirolimus) for indications not approved by the Food and Drug Administration, and specifically targeted African-Americans in its promotional activities.

The Committee is investigating whether Wyeth '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 no later than June 28. In his letter to Pfizer chief executive 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.'