Pfizer has agreed to pay nearly $491 million to settle civil and criminal charges that Wyeth, which the drugmaker purchased four years ago, spent a decade promoting the Rapamune kidney transplant drug for a variety of unapproved uses, and these resulted in false claims submitted to federal healthcare programs.
The lawsuits drew considerable attention because the drugmaker was accused of targeting African-Americans, a high-risk patient group. Wyeth managers were allegedly aware of limited data for Rapamune use in such patients, but deliberately targeted two hospitals with mostly African-American patients – Philadelphia’s Einstein Medical Center and New York’s SUNY Downstate Medical Center.
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 However, cyclosporine is supposed to be withdrawn after two to four months, because it can eventually poison the kidneys, although this step was not approved for African-Americans and other high-risk groups.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. Read more