Wyeth Targeted "High Risk" Black Patients for Off-Label Kidney Drug Sales, Suit Claims

Last Updated May 24, 2010 3:32 PM EDT

Everyone knows that drug companies sometimes step over the line and market their drugs for unapproved or "off-label" purposes, but drug sales reps at Wyeth (later acquired by Pfizer (PFE)) allegedly combined that taboo with another -- targeting vulnerable black patients -- in their promotion of Rapamune, a kidney transplant drug, according to a whistleblower lawsuit. Two former sales reps claim that Wyeth targeted African American patients for unapproved use of Rapamune even though they didn't have data supporting its use in that population. Blacks are considered "high-risk" patients for kidney transplants because of their more vigorous immune response to new organs. Rapamune reduces immune response so patients don't reject their new kidneys.

Companies can emerge from some scandals unscathed, but accusations of racism can taint corporate reputations for years. (Just ask Texaco or Denny's.) So marketing efforts that target black consumers should be handled with special care. That wasn't done at Wyeth, according to the suit:

In 2005, Wyeth's sales management (headed by National Director of Transplant Sales Joe McCafferty) 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% African-American in 2005.
The suit claims that there is limited data on Rapamune use in black patients, who need a different dosing regimen than whites. Nonetheless, Wyeth targeted another hospital that primarily serves the black community for Rapamune "conversion." Conversion is the practice of switching a patient from their existing transplant drugs to Rapamune. The FDA has only ever approved Rapamune for first-line use in kidney patients, and since 2004 the drug has carried a black box warning against conversion. Even Wyeth's own internal studies did not show improved outcomes on Rapamune converted patients:
Wyeth management targeted SUNY Downstate Medical Center, whose patient population was in 2005 and still is predominantly African-American, for conversion protocols. Wyeth management arranged for Baltimore physician Dr. Walli to present to SUNY Downstate transplant staff his experiences in converting African-American patients to Rapamune, even though no approved data exists to show that conversion was safe or effective in high-risk patients. Dr. Walli reported some success with conversion in African-American patients.
He also disclosed, when questioned, that he found an organ rejection rate of approximately 50% among the African-American patients he tried to convert to Rapamune. When questioned about the outcomes of those African-American patients who had experienced organ rejection, Dr. Walli had no data to support this conclusion.
The bulk of Wyeth's alleged off-label conversion efforts targeted non-black patients, the suit claims. The consequences were serious: the suit claims one nephrologist at Columbia University Hospital stopped converting patients when too many died on Rapamune.

In 2005, the Mayo Clinic raised concerns with Wyeth that conversion patients were experiencing "very serious side effects from using Rapamune" but the company did nothing about it, the suit claims.

Kidney transplant patients are vulnerable to a range of infections, such as TB, as their immune systems are unable to fight off diseases. When doctors raised concerns over infections in kidney patients on Rapamune, Wyeth repeatedly blamed the surgeons who did the transplants, the suit claims. Here's one example:

Neal Wasserman, a Wyeth Transplant Science Liaison, represented to Robin Boardman, a pharmacist at Mt. Sinai Hospital, that hepatic artery thrombosis ("HAT") occurred in liver transplant patients primarily because of the surgical procedure itself and not because of the use of Rapamune after the surgery. Mr. Wasserman's representations directly contradict the FDA's Black Box warning, which states that "sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT."
Pfizer has yet to respond to the suit; the company did not immediately respond to a request for comment.