The Crime Spree Continues?
Posted by Osagie Obasogie June 2, 2010
Biopolitical Times
Six months ago, David Evans at Bloomberg Markets wrote Big Pharma’s Crime Spree, a rather illuminating look at the pharmaceutical industry as a repeat offender in criminally advocating certain drugs for unapproved off-label use. Notably, Evans identified Pfizer as having recently paid the highest criminal fine in U.S. history – $1.19 billion – for instructing salespersons to illegally promote Bextra for unapproved uses. Evans noted, “Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.”
Despite huge fines, this criminal behavior may have continued. Two former hospital sales reps recently amended a complaint originally filed in 2005 that blew the whistle on Wyeth’s alleged practice of promoting Rapamune (a drug approved only for kidney transplants) for heart, liver, pancreas, and lung transplants. Wyeth is now owned by Pfizer; Rapamune reportedly led to $376 million in sales for Pfizer in 2008. The suit alleges:
Despite huge fines, this criminal behavior may have continued. Two former hospital sales reps recently amended a complaint originally filed in 2005 that blew the whistle on Wyeth’s alleged practice of promoting Rapamune (a drug approved only for kidney transplants) for heart, liver, pancreas, and lung transplants. Wyeth is now owned by Pfizer; Rapamune reportedly led to $376 million in sales for Pfizer in 2008. The suit alleges:
Wyeth trained and encouraged its sales representatives to market Rapamune for uses outside those listed on the FDA-approved label and to misrepresent and withhold clinical information regarding the safety and efficacy of Rapamune. As a result of Wyeth's wrongdoing, patients were put at risk of serious physical and financial harm, including: the disruption or discontinuation of stable treatment regimens; increased costs associated with treating side effects caused or exacerbated by Rapamune; life-threatening side effects such as anemia, bone marrow suppression, inhibited wound-healing, proteinuria, blood clots, leukopenia, thrombocytopenia, liver failure, pulmonary dehiscence; and death.But there’s a twist: Wyeth allegedly targeted African-Americans patients for the off-label use of this drug despite Blacks being considered a “high risk” population due to their immune systems’ “more vigorous” response towards transplanted organs. The suit notes
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.Wyeth also allegedly targeted SUNY Downstate Medical Center, another hospital that predominantly serves Blacks, for conversion studies, i.e. swapping patients from existing transplant drug regimens to Rapamune. The suit states:
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.This is definitely a case to keep an eye on.