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Pfizer Probed By House Oversight Committee

From Day, The (New London, CT) (June 15, 2010)

Jun. 14--The chief investigative committee of the U.S. House said Monday it will be probing illegal promotion of Pfizer Inc.’s transplant drug Rapamune that one congressman likens to the government's infamous Tuskegee experiments on African-American syphilis patients.

Edophus "Ed" Towns, chairman of the House Committee on Oversight and Government Reform, said in a letter to Pfizer chief executive Jeffrey B. Kindler that he wants to know more about the Rapamune controversy that surfaced in a lawsuit unsealed last month.

Among other allegations, the suit said Wyeth Pharmaceuticals -- bought by Pfizer last year -- targeted transplant centers used primarily by African-American patients for off-label use of Rapamune.

"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," Towns, a Democrat who represents New York's 10th District, said in a press statement.

But Pfizer said Rapamune, first approved in 1999, has been used in a broad range of patients, including African Americans, who are considered to be a high-risk group because of the higher probability that their bodies will reject transplanted organs.

"At the time of approval, FDA requested Wyeth to agree to a post-marketing commitment to study the drug in the high-immunologic risk patient population (of which African-Americans are often members) to determine whether higher dosing regimens would be beneficial," Pfizer's Wyeth subsidiary said in a statement. "Based on this further study, in 2007 FDA authorized the inclusion of additional dosing information in Rapamune's label for its use in treatment of high immunologic risk patients."

Pfizer stressed that, "At no time was the product contraindicated for this population, nor has the label contained any limitations on its use with adult African-American patients."

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Posted: June 2010