WASHINGTON – Chairman Edolphus “Ed” Towns (D-NY) today launched an investigation into Wyeth Pharmaceuticals, Inc. amid reports alleging the company illegally promoted the kidney transplant drug Rapamune for treatments not approved by the Food and Drug Administration (FDA), and specifically targeted African-Americans in its promotional activities.
The Oversight Committee is investigating whether Wyeth, which was acquired by Pfizer in October 2009, “aggressively encouraged the use of Rapamune to prevent organ rejection following heart, lung, liver, pancreas, and islet cell transplants, without FDA approval.” The company reportedly did so despite the fact that the FDA approved the drug only to help prevent organ rejection after a kidney transplant.
As part of the inquiry, Chairman Towns has asked the company to provide internal documents, including reports detailing the side effects associated with Rapamune. In his letter to the CEO Jeffrey Kindler, Chairman Towns’ is also seeking to determine if “Pfizer or Wyeth, or any of their employees or agents engaged in off-label marketing or promotion of Rapamune” and if “Pfizer or Wyeth ever offered incentives to health care providers related to the use of Rapamune.”
“When patients seek medicinal therapy, they want to know the side effects and that the prescriptions offered to them have been FDA approved to treat their illness,” said Chairman Towns. “The most egregious problem here is that, unbeknown to the African Americans’ they allegedly targeted, their lives were placed at serious risk for life threatening ailments.”
Chairman Towns has expressed his commitment to holding companies accountable for their products, especially when those products pose serious health risks to the public. Just last month, the Oversight Committee held a hearing into popular infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare. Also underway, is an Oversight Committee investigation into Johnson and Johnson’s “phantom” recall of a certain type of Motrin and the Johnson & Johnson/McNeil plant that is now connected to the recall of four types of PediaCare, a popular children’s medication.
Towns concluded, “Numerous federal indictments have been handed down for pharmaceutical companies’ use of off-label drugs, and if true, this type of irresponsible experimentation is another example of big companies preying on vulnerable consumers. Unfortunately, these marketing techniques are reminiscent of Tuskegee all over again.”
The text of the letter follows.
June 11, 2010
Mr. Jeffrey Kindler
Chief Executive Officer
and Chairman of the Board
235 East 42nd Street
NY, NY 10017
Dear Mr. Kindler:
The Committee on Oversight and Government Reform is the principal oversight committee in the U.S. House of Representatives, with jurisdiction over “any matter.” Under Rules X and XI of the Rules of the House of Representatives, the Committee is investigating reports that Wyeth Pharmaceuticals, Inc., which was acquired by Pfizer in October 2009, marketed the prescription drug Rapamune for purposes that were not approved by the Food and Drug Administration. In addition, the Committee is investigating the allegation that certain Wyeth promotional activities involving Rapamune targeted African-American patients and may have placed them at far greater risk of harm.
As you know, Rapamune is approved by the FDA for use as a drug to prevent the immune systems of kidney transplant patients from rejecting their new organs. It is subject to specific instructions regarding when, how, and to whom the drug should be administered. However, it has been alleged that Wyeth aggressively encouraged the use of Rapamune to prevent organ rejection following heart, lung, liver, pancreas, and islet cell transplants, without FDA approval.
It has also been alleged that unapproved dosing regimens for Rapamune were promoted by Wyeth. According to former Wyeth employees, Wyeth allegedly encouraged physicians to switch patients from other medications and begin treatment with Rapamune at a later stage following a transplant than is approved by the FDA. Similarly, despite the FDA’s concerns and specific instructions regarding the drug’s use in kidney transplant patients at a high risk of organ rejection, such as African-Americans, the former employees claim that Wyeth may have targeted that population for the marketing of unapproved uses for Rapamune.
These are very serious allegations. Because of the seriousness of these issues, the Committee is investigating this matter further. To assist in our investigation, please provide the following information and records:
1. Have Pfizer or Wyeth, or any of their employees or agents, engaged in off-label marketing or promotion of Rapamune? If so, please explain in detail.
2. Have Pfizer or Wyeth, or any of their employees or agents encouraged off-label use of Rapamune? If so, please explain in detail.
3. Since January 1, 2000, did Wyeth target certain medical facilities for increased Rapamune sales? If so, please identify all such facilities and the dates they were targeted.
4. Since January 1, 2000, did Wyeth target certain medical facilities for Rapamune conversion, meaning switching patients from their existing transplant drugs to Rapamune? If so, please list all such medical facilities and the dates they were targeted for conversion.
5. Please provide copies of all written materials Pfizer and Wyeth have provided to healthcare providers regarding the safety or effectiveness of Rapamune when used for any purpose, or in any patient populations, other than that which has been explicitly approved by the FDA.
6. Please provide copies of all written material Pfizer and Wyeth have provided to healthcare providers that encourage conversion of transplant patients to Rapamune.
7. Please provide copies of all records pertaining to Pfizer or Wyeth arranging for physicians or other personnel to present to healthcare providers information on converting African-American patients to Rapamune.
8. Please provide copies of all records pertaining to complaints Pfizer or Wyeth have received from healthcare providers about Rapamune conversions.
9. Please provide copies of all records pertaining to reports Pfizer or Wyeth may have received from the Mayo Clinic regarding side effects from using Rapamune.
10. Have Pfizer or Wyeth ever offered incentives to health care providers related to the use of Rapamune? If so, please provide a detailed explanation, including a list of all such incentives, to whom they were offered, and the dates.
11. Please provide copies of any assessment of patient outcomes resulting from Pfizer's or Wyeth's encouragement of Rapamune use for any purpose other than that which has been explicitly approved by the FDA.
12. Please provide copies of all correspondence between Wyeth and Einstein Medical Center (Philadelphia) and SUNY Downstate Medical Center (Brooklyn) regarding Rapamune.
13. Have Pfizer or Wyeth been named as defendants in any criminal investigations or proceedings relating to Rapamune? If so, please provide a summary of the nature of all such investigations and proceedings, including the issues involved and the date, location, and disposition of the investigation or proceeding.
Please deliver the requested information and records to the Committee on Oversight and Government Reform, room 2157 Rayburn House Office Building, no later than 4:00 p.m. on Monday, June 28, 2010. To facilitate delivery and review, we prefer that the records be delivered in digital form. Please note that the terms “records” and “relating to” are defined in the attachment to this letter.
Should you have any questions regarding this request, please contact Jason Powell or Ryshelle McCadney of the Committee staff at (202) 225-5051.
Committee on Oversight and Government Reform
2154 Rayburn House Office Building
Washington, DC 20515
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