Healthy Skepticism Library item: 17819

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Wyeth Marketing Targeted Blacks Illegally: Lawsuit
Pharmalot 2010 May 24
http://www.pharmalot.com/2010/05/wyeth-targeted-blacks-with-illegal-marketing-lawsuit/

Full text:

A pair of former hospital sales reps filed a whistleblower suit alleging Wyeth, which is now owned by Pfizer, illegally promoted its Rapamune kidney transplant drug for use with other organs and targeted African-Americans, even though this is a high-risk patient group, according to the product labeling. The suit was filed by Marlene Sandler and Scott Paris in 2005, but was recently unsealed and an amended complaint was filed today (see the suit).
In arguing their case, the former reps contend 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, according to the suit. Reps, in fact, 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.
By way of background, the suit notes the FDA never approved Rapamune when other immunosuppressive drugs are given to the patient at the time of transplant and the patient is later switched or converted to Rapamune, a practice Wyeth refers to as “conversion.” Indeed, the FDA even issued a warning against this practice in 2004 and an update was issued in 2007. Yet Wyeth marketed Rapamune in combination with other drugs not mentioned in the labeling, the suit charges.
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 However, cyclosporine is supposed to be withdrawn after two to four months, because it can eventually poison the kidneys, although this step is not approved for African-Americans and other high-risk groups.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.
“Despite limited data on high-risk patients, Wyeth targeted transplant centers that catered primarily to African-American patients, typically in urban areas. In 2005, Wyeth’s sales management 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 percent African-American in 2005.”
Wyeth also instructed reps to use journal articles, including one published in Transplantion in July 2002 RANSPLANTATION July 2002 to off-label market Rapamune to African-Americans for combinations that were not approved by the FDA. The study describes the outcomes of 56 African-American transplant
recipients and showed equivalent results compared to whites studied measuring acute rejection, graft
survival, and patient survival, but the combinations of Rapamune examined in this study were not
approved in the Rapamune package insert, the suit states.
Elsewhere, the lawsuit charges an internal Wyeth spreadsheet from around 2002 called “Grants In Aid” indicates about 35 separate Rapamune trials were approved for docs among Wyeth’s four Rapamune sales districts. While Wyeth only provided free drugs for some studies, most were paid and some docs or hospitals received between $300,000 to $400,000. The Grants In Aid document indicates about $7 milllion was spent at that time for the studies.
Hat tip to Bnet