Medical Device Daily

A congressional committee has launched a probe concerning the “off-label” use of drug-eluting stents (DES) and drugs, focusing on the commonly-accepted practice allowing doctors to use or prescribe medical products outside FDA-approved applications.

Congressman Henry Waxman (D-California) disclosed Monday that he sent letters last week to two medical device makers and three drug manufacturers requesting information concerning their marketing practices.

Waxman, chair of the House Committee on Oversight and Government Reform, said he sent the letters as part of the committee’s look at the research and marketing practices of the medical device and pharmaceutical industries. Whether Waxman plans to undertake an all-out investigation or simply exert some minor oversight muscle has yet to be determined.

Boston Scientific (Natick, Massachusetts) and Cordis (Miami Lakes, Florida), the DES-manufacturing unit of Johnson & Johnson (New Brunswick, New York), confirmed that they received letters concerning the safety and off-label use of their DES products — Taxus and Cypher. The two companies have the only DES systems approved by FDA.

The drug makers that received the letters are Eli Lilly and Co. (Indianapolis), over its anti-psychotic drug Zyprexa; AstraZeneca (London), over it anti-psychotic drug Seroquel; and Cephalon (Frazer, Pennsylvania) over its drug Actiq, a narcotic lollipop, and Fentora, a narcotic lozenge.

Circumstantially, news of the letters comes just before a meeting that the FDA is holding today in Washington. The meeting is in conjunction with Cardiovascular Revascularization Therapies (CRT) 2007 for an extensive review of DES devices, including sessions on clinical trials, risks and benefits, and a variety of other regulatory and clinical issues.

While the session will delve into inclusion and exclusion criteria, the agenda does not call for any discussion of advertising and promotion. CRT 2007 bills the event as “the first cardiology meeting to address the implications of the recommendations made by the FDA panel following its December meeting.” (Editor’s note: Medical Device Daily will offer coverage of the first day’s sessions in a subsequent issue.)

The companies receiving the letters pledged cooperation with the committee request.

Boston Scientific said in a statement, “We look forward to providing the committee the information it has requested. As the leading maker of drug-eluting stents in the United States, we have been — and remain — committed to providing physicians, patients and loved ones the information they need to make informed treatment decisions.”

Waxman requested information about trials and other studies related to the stents after an FDA panel raised concerns about DES safety in December (MDD, Dec. 11 & 12, 2007).

The panel recommended that labels for the devices, sold in the U.S. by Cordis and Boston Scientific, should note that sicker patients who receive stents to treat blocked arteries face a higher chance of developing potentially deadly blood clots than those with simple blockages.

The panel concluded the benefits outweighed the risks for appropriate patients and called for more research.

Last September, Boston Scientific said it found a slightly higher risk of blood clotting in patients implanted with its DES devices compared with older bare-metal stents.

In a copy of the letter sent to Boston Scientific that was obtained by Medical Device Daily, Waxman requested that the company provide information on, among other things, “whether any compensation or benefit, monetary or otherwise, was provided to any author, physician, or participant involved in the Taxus trials.”

Waxman also requested that the Boston Scientific furnish the committee with “all documents relating to the development of the printed label that accompanied Taxus stents.” He added that this should include “all communications with the FDA and those within your company.”

The letter also requested that the company furnish all documents related to adverse event data related to the Swedish Coronary Angiography and Angioplasty Registry.

The data from the 20,000-patient Swedish Registry, which was published in the New England Journal of Medicine last month (MDD, Feb. 14, 2007), showed an increased risk of death in patients implanted with a DES compared to a BMS up to three years after implantation.

In a statement of response back in February, Boston Scientific criticized this study, saying that the data did not come from patients randomized to DES or BMS devices. It said that, instead, the study tracked patients from a national database and that the DES-implanted patients were sicker.

In an article in the Wall Street Journal, a spokeswoman for Waxman was quoted as saying that the committee hadn’t initiated a formal investigation and characterized the letters as a preliminary look at off-label use, “given the allegations out there.”

Last month, the Centers for Medicare & Medicaid Services said it too was examining off-label use of DES, but disavowed the WSJ’s assertions that a reduced coverage decision was eminent (MDD, Feb. 7, 2007). While it said it was not planning changes in DES coverage policies “at the present time,” it said it was continuing to look at the evidence concerning the devices.

In a research report, Prudential Equity Group (New York) senior med-tech analyst Larry Beigelsen wrote that the letters likely will not result in any major device safety legislation or a rewrite of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) reauthorization this year nor threaten the passage of MDUFMA this year. However, he did not rule out the possibility that negative headline attention to the issue on Capital Hill “could translate into legislation further down the road.”

Beigelsen also noted that Waxman could hold oversight hearings that could “generate additional negative publicity for DES and potentially exert further negative downward pressure on usage.”

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