Pfizer Accused of Using Unapproved Drugs on High Risk Black Patients
Two former hospital sales representatives have filed suit against the world’s largest pharmaceutical company for encouraging the sale of an unapproved drug to “high-risk” black patients.
Marlene Sandler and Scott Paris originally filed suit against Pfizer and Wyeth in 2005, and the file was unsealed last week. It reveals shocking allegations against the pharmaceutical company.
Sandler and Paris claim that Wyeth, which is now owned by Pfizer, promoted the sale of Rapamune, a kidney transplant drug which generated $376 million in sales in 2008, as a med for heart, lung, liver, and pancreas transplants. Rapamune was never approved for those procedures and the Food and Drug Administration warned against such off-label use of Rapamune in 2004 and 2007.
The practice of off-labeling (misleading consumers on the proper usage of medication) by pharmaceutical companies has lead to many settlements and federal charges.
In this particular case they suit alleges Wyeth targeted African-American patients for unapproved use of the drug “even though they didn’t have data supporting its use in that population,” reports BNet.com. “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.”
According to the Huffington Post, Wyeth targeted hospitals with a large African-American population like Philadelphia’s Einstein Medical Center and New York’s SUNY Downstate Medical Center.
When doctors at Mount Sinai Medical Center in New York expressed concerns about using Rapamune as part of a specific regimen, Wyeth brought in a paid physician, Dr. Staurt Flechner to talk them into continuing the use of the drug. Flechner billed the company for an honorarium of $2,000 or prorated $15,000.
In addition to the lawsuit, federal prosecutors have launched a criminal investigation into Wyeth’s promotion and marketing of Rapamune. More details to come as the story continues to develop.