On March 5, 2007, the US House of Representatives Committee on Oversight & Government Reform announced that it has sent letters to Boston Scientific Corporation (Natick, MA) and the Cordis Corporation (a Johnson & Johnson company, Miami, FL), requesting information on the companies' drug-eluting stents (DESs), which are the only FDA-approved DESs. The action is part of the committee's oversight of the marketing practices of the medical device industry. Specifically, the request is in response to the FDA Circulatory Systems Devices Panel meeting of December 7-8, 2006, that addresses issues related to the use of DESs.

On February 28, the committee Chairman, Henry A. Waxman (DÐCA), sent a letter to James Tobin, President & CEO of Boston Scientific, requesting that the company provide the committee with a broad range of scientific and marketing materials related to the development, regulatory approval, clinical trials, marketing, and sales of the Taxus paclitaxel-eluting coronary stents. On March 1, a similar request for all documents related to the development, approval, and marketing of the Cypher sirolimus-eluting coronary stents was sent to Cordis's Worldwide Franchise Chairman, Rick Anderson.

COMPREHENSIVE DOCUMENT REQUEST
The committee requested the following information from Boston Scientific and Cordis for the Taxus and Cypher stents, respectively:

  1. A list of all trials, studies, or reports initiated, supported, or sponsored by the company related to the stents, including those related to premarket approval applications; the names of the physicians involved in the trials, the number of trial participants, the date the trials were initiated, completed, or terminated, the reasons for any termination, and a summary of the trial's methodology, findings, and conclusions; all information about whether the company's marketing department provided funding or other support for these studies and whether any compensation or benefit (monetary or otherwise, such as support in creating manuscripts) was provided to any author, physician, or participant; all publications and abstracts that were published or presented at major medical meetings; and, an explanation for why any study was not published or presented.
  2. All documents relating to the development of the printed labels that accompanied the stents, including all communications within the company and with the FDA.
  3. All documents relating to the stents provided to the FDA advisory committee for the December 2006 meeting.
  4. Documents related to the stents from June 2002 (for Cordis's Cypher) and from March 2003 (for Boston Scientific's Taxus) to the present, including all presentations, training sessions, or materials given to employees, agents, speakers, or consultants who marketed or otherwise promoted the stents; all pamphlets, literature, and other information shown or given to physicians by sales representatives, and all related communications; any other communications given to health care providers regarding the safety and efficacy of the stents, including direct presentations to physicians; all documents related to adverse event data in the Swedish Coronary Angiography and Angioplasty Registry; all internal or external presentations or reports and related communication regarding continuing medical education; all presentations or reports and related communications regarding off-label use; all documents related to the presence of sales representatives in the cardiac catheterization suites; all documents related to financial support provided for nonprofit professional medical organizations or consumer/patient organizations; and, all marketing department correspondence with these organizations.

OFF-LABEL USE TO BE LOOKED INTO; NOT "INVESTIGATED"
On March 6, The Wall Street Journal reported that the committee is reviewing the off-label use of the devices. Approximately 60% of DESs are used off-label. Although physicians are allowed to prescribe off-label use of stents, the manufacturers may not encourage off-label use. Included in the request are all documents related to sales representatives' presence in cardiac catheterization labs and the literature that they distribute.

A spokeswoman for Mr. Waxman told The Wall Street Journal that the committee had not initiated a formal investigation and characterized the letters as a preliminary look at off-label use, "given the allegations that have been out there."

COMPANIES WILL COOPERATE
The companies must provide all material to the committee by March 21. The request letters can be accessed at the committee's Web site, www.oversight.house.gov. Both companies have stated that they will comply with the committee's request.

On March 5, Boston Scientific stated: "We look forward to providing the Committee the information it has requested. [W]e have beenÑand remainÑcommitted to providing physicians, patients, and loved ones the information they need to make informed treatment decisions."