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Waxman's
Congressional Committee Requests Clinical and Marketing Information About Drug-Eluting Stents from Boston Scientific and Cordis |
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"Concerns about the safety and off label use of drug-eluting cardiac stents were raised by a recent FDA panel. As part of the Committee's ongoing oversight of the medical device industry's research and marketing practices, I am writing to request information about these concerns and drug-eluting cardiac stents." The information requested was wide-ranging, encompassing all trials, studies and reports in which the companies were involved, both within and outside of the U.S., including not only the results, but any compensation paid to physicians or institutions. Much of this information (with the exception of the compensation data) previously has been presented at various meetings and is available from a variety of sources. However, Waxman has also requested all materials relating to the marketing of these devices, including support for medical education programs and support provided to nonprofit professional medical organizations or consumer/patient organizations, such as the Cardiology Research Foundation (CRF), the Transcatheter Cardiovascular Therapeutics (TCT) meeting, which is organized by CRF, and the Society for Cardiovascular Angiography (we assume Congressman Waxman meant the Society for Cardiovascular Angiography and Interventions or SCAI). Although both stent companies had been asked by the FDA to present clinical data about drug-eluting stents and late stent thrombosis at the December panel meeting, this is the first time that an official body has requested stent marketing information -- and specifically marketing information relating to the largest annual meeting of interventional cardiologists -- the TCT. Boston Scientific Corporation immediately issued a press release with the following statement:
Cordis also sent out an email stating that they would cooperate with the Committee. Waxman didn't give the companies much time. He requested that the information be delivered by March 21 -- a little over two weeks from now.
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