Four months after two sales reps caused a sensation by charging that Wyeth (WYE) illegally promoted its Rapamune kidney transplant drug for use with other organs and targeted African-Americans, the federal government has filed a motion with a federal court to intervene, or join their whistleblower lawsuit.
In a document (pdf) filed Tuesday in US District Court in Philadelphia, the US Attorney for Pennsylvania and 19 states, along with the District of Columbia, wrote that “the United States has established good cause to intervene…” An accompanying memorandum, however, was filed separately under seal. Wyeth, by the way, is now part of Pfizer (NYSE:PFE).
“Our experience in cases where the government intervenes for cause is that is a term of art and it would mean, to us, the government has merit found in some or all of the relators’ allegations,” Reuben Guttman, who represents the whistleblowers, tells us. “We applaud the government’s decision to take a stand in this case and we hope through our joint efforts, we achieve our result so the medical community can fullly understand what happened here.” The feds do not intervene in every whistleblower lawsuit, which explains his optimism.
Pfizer is already operating under a Corporate Integrity Agreement and last year paid a $2.3 billion fine for off-label marketing of several drugs. However, as Pfizer has noted previously, the whistleblower suit was filed in 2005, suggesting the drugmaker believes it would be in jeopardy of violating the CIA only if violations occurred after Wyeth was purchased last year. Last March, Pfizer disclosed federal prosecutors in Oklahoma are conducting a criminal investigation into Rapamune marketing.
The former Wyeth hospital reps - Marlene Sanders and Scott Paris - contend in their suit that Wyeth management “openly encouraged and directed their entire Rapamune sales force” to promote Rapamune to docs practicing heart, lung, liver, pancreas, and islet cell transplants even though the drug was never approved for patients receiving transplants of these organs. Reps were provided off-label studies, abstracts and lists of studies to use when marketing Rapamune for off-label usage. And Wyeth allegedly offered doctors and hospitals kickbacks in the form of donations, grants and speaker fees to prescribe Rapamune off-label, they alleged (back story and lawsuit here).
As for the charges concerning African-Americans, Rapamune is supposed to be administered following a kidney transplant and used in conjunction with cyclosporine and corticosteroids. However, cyclosporine is supposed to be withdrawn after two to four months, because it can eventually poison the kidneys, although this step is not approved for African-Americans and other high-risk groups. African-Americans are considered high-risk because they exhibit more vigorous immune responses to transplants.
Wyeth managers were allegedly aware of limited data for Rapamune use in high-risk patients, but Wyeth targeted two hospitals with mostly African-American patients - Philadelphia’s Einstein Medical Center and New York’s SUNY Downstate Medical Center. Some hospitals complained to Wyeth Global Medical Affairs that patients were experiencing “very serious side effects,” but “nothing was done,” according to the suit. The FDA, by the way, warned against off-label use in 2004 and 2007.