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House to scrutinize marketing of stents

Boston Scientific will submit internal files

Mar 6, 2007 | Boston Globe

As part of a federal inquiry into drug and medical-device marketing, Boston Scientific Corp. was asked by Congress last week to submit to investigators internal documents, marketing plans, and clinical data related to its top-selling product, the Taxus drug-coated stent.

In a letter sent to Boston Scientific chief executive Jim Tobin , Representative Henry Waxman , chairman of the chief investigative committee of the House of Representatives, requested information about whether the Natick company's marketing department funded any clinical studies on Taxus stents, whether it paid any of the studies' authors or doctors, and whether it withheld the results of any Taxus studies.

Waxman , a California Democrat, sent an identical letter to Cordis Corp. , the division of Johnson & Johnson that makes the only competing drug-coated stent in the United States. The letters cited "concerns about the safety and off-label use" of the stents, which were the subject of a two-day Food and Drug Administration hearing in December.

Both companies issued statements saying they planned to cooperate with Waxman's request.

Since their introduction in 2003, drug-coated coronary stents have become the fastest-selling medical device in history, bringing in about $5 billion a year for Boston Scientific and Johnson & Johnson, which is based in New Jersey. The tiny wire-mesh tubes are implanted to hold open cleared heart arteries.

The companies used powerful marketing campaigns to launch their products for use instead of an older generation of bare-metal stents. Recent data shows that while drug-coated stents can decrease the rate at which patients need to return for new heart procedures, they also slightly raise the risk of long-term clotting over the older, cheaper stents.

Waxman's letter cited the December FDA hearing, at which a panel of experts combed through a wide array of data on the benefits and risks of drug-coated stents. The panelists concluded that stents were safe and effective when used on the subset of heart patients for which they were initially approved, but they raised a flag of caution over the large number of patients who receive drug-coated stents despite falling outside those guidelines.

The letter came from the House Committee on Oversight and Government Reform, which Waxman chairs.

His request focuses on how the companies marketed their stents, asking for records of sales-training, presentations to doctors, and "all internal or external presentations or reports relating to off-label use." It also asks for a record of their funding of cardiology societies and events.

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