Feds and 19 states seek status in suit against Pfizer

The federal government and 19 states have asked to join a whistleblower lawsuit against Pfizer Inc. that charges one of its subsidiaries with illegally promoting the off-label use of an organ-transplant drug and essentially experimenting on African-American patients without their knowledge.

Pfizer has denied all charges originally filed by two former Wyeth Pharmaceuticals sales representatives, Marlene Sandler and Scott Paris, against their former employer. by joining the suit, originally filed in 2005 under the U.S. false Claims Act, the federal and state governments could be repaid for any illegal medical charges related to off-label uses of the transplant drug Rapamune.

The former sales reps, as whistleblowers, also would get a portion of any settlement.

“The feds do not intervene in every whistleblower lawsuit,” noted the pharmaceutical blog Pharmalot, saying the governments’ intervention has bolstered the case against Pfizer.

Among the suit’s most explosive allegations is the sales reps’ contention that Wyeth – bought by Pfizer last year – targeted transplant centers used primarily by African-American patients for off-label use of Rapamune. Some commentators have likened the unapproved drug dosing to a 40-year experiment in Tuskegee, Ala., conducted by the U.S. Public Health Service that left African-American men with syphilis untreated for decades after a cure was known.

Edolphus “Ed” Towns, chairman of the House Committee on Oversight and Government Reform, launched an investigation of the suit’s allegations earlier this year.

Pfizer said Wednesday it is cooperating in government investigations of Rapamune marketing and supported federal intervention so the case can come to an orderly conclusion.

“The government’s intervention motion is an administrative step in this process, and was not caused by the addition of any new assertions to a complaint which does not include any factual allegations after 2007 – years prior to Pfizer’s acquisition of Wyeth,” spokesman Christopher Loder said in a statement.

Pfize said African-Americans have a higher probability than the general population that their bodies will reject transplanted organs. The company 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.”

Pfizer, which has research-and-development facilities in New London and Groton, faced a series of false Claims Act suits that were settled last year for a record $2.3 billion fine. it is currently operating under a Corporate Integrity Agreement that would place it at risk of being unable to sell drugs to the government if major marketing irregularities are proved, though observers said Pfizer likely could avoid so-called debarment by pointing out that the alleged violations occurred years before the company bought Wyeth.

The lawsuit against Wyeth and Pfizer claims that the Wyeth sales force offered hospitals donations as a form of kickback and gave doctors grants and speaker fees to encourage off-label use of Rapamune.

Feds and 19 states seek status in suit against Pfizer

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