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Wyeth Sued Over Rapamune Transplant Drug

Washington, DC: A whistleblower lawsuit has been filed by two former sales representives for Wyeth, alleging that the company, which is now owned by Pfizer, illegally promoted its kidney transplant drug Rapamune for use with other organ transplants, and targeted African American patients who are known to be a high-risk patient group due to their immune response to transplant, despite the lack of evidence to support its use in this population and notwithstanding the product labeling.

"Despite limited data on high-risk patients, Wyeth targeted transplant centers that catered primarily to African-American patients, typically in urban areas. In 2005, Wyeth's sales management selected Philadelphia's Einstein Medical Center as a center on which to focus a Wyeth marketing plan designed to rapidly increase or accelerate Rapamune sales in a 90 day period. Einstein's transplant patient population was approximately 75 percent African-American in 2005," the suit states.

The suit also states that Wyeth marketed Rapamune for an unapproved dosing regimen which it called "Conversion," despite the fact that it was never indicated for conversion use. In 2004, the FDA required Wyeth to place warnings in Rapamune's package insert pertaining to side effects of converting patients on other immunosuppressant regimens to Rapamune.

Additionally, the two former sales reps claim that Wyeth "openly encouraged and directed their entire Rapamune sales force" to promote the use of the drug among physicians involved in heart, lung, liver, pancreas and islet cell transplants, knowing that Rapamune did not have an FDA approval for those indications. The suit also claims that Wyeth offered doctors and hospitals kickbacks, in the form of speaker fees, grants and donations, in exhcange for off-label prescribing of Rapamune.

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Published on May-25-10


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