Medical Device Daily Washington Editor

Federal prosecutors have charged a second sales representative of Stryker (Kalamazoo, Michigan) or its subsidiaries with misbranding of a medical device, but the case is being handled by a prosecutor whose office has been reprimanded for failure to disclose potentially exculpatory information to counsel for the defense.

Justin Demming of Ohio has pleaded guilty to promoting a device to doctors outside labeled indications while Darnell Martin of Chicago, who represented Stryker Biotech (Hopkinton, Massachusetts), was charged with and pled guilty to similar charges last year.

The names of the employers of the two sales representatives were said to have been redacted from court documents, but in the case of Martin, "those same records and publicly available federal Food and Drug Administration records make it clear the company is Stryker Biotech," according to a story appearing in the Nov. 19, 2008, edition of the Boston Business Journal. According to a Feb. 10 story in the same publication, "various references make it clear [Demming] worked for Stryker."

Martin will be sentenced May 13 and faces a prison term of up to eight years and fines of $260,000 while Demming could be jailed for three years and fined $250,000. Demming's sentence will be determined June 3, according to BBJ.

The Demming case is being handled by the office of the federal prosecutor that has been reprimanded for withholding vital evidence in at least nine cases. According to the Boston Globe, U.S. District Court Judge Mark Wolf is threatening to sanction a prosecutor in the U.S. Attorney's office in Massachusetts for withholding evidence from counsel for the defense, alleging that such activity in that office dates back to the early 1990s. The current U.S. Attorney for Massachusetts, Michael Sullivan, was appointed by the Bush administration earlier this decade and is expected to be replaced by the Obama Department of Justice. His predecessor, Jeffrey Auerhahn, was appointed by the Clinton White House in a clean sweep of all U.S. Attorneys during the Clinton years.

Stryker spokesman Pat Anderson said he was not familiar with Demming and declined to comment on the matter.

No coverage of CT screens for CRC

The Centers for Medicare & Medicaid Services has proposed not to cover screening for colorectal cancer (CRC) with computerized tomography (CT) to the disappointment of many. The agency took up the matter May 19, 2008, and posted the memo on its web site on Tuesday, eight days early.

CMS's proposed decision memo states that the repeated exposure to X-radiation is a concern, as was also expressed by a number of those who commented during the open comment period. Another of the impediments to coverage is that "the mean age of participants in [the supporting studies] ... was considerably younger than the Medicare aged population," thus calling generalizeability of the study data into question. CMS also noted that CT colongraphy does not effectively pick up polyps smaller than 6 mm in length, and that because surgeons typically remove polyps of all sizes during optical examinations, little is known about the natural history of colon polyps.

Durado Brooks, MD, chief of the division of prostate and colon cancer at the American Cancer Society (ACS; Washington) told Medical Device Daily that ACS is "disappointed that CMS will not cover CT colonography for the Medicare population," but acknowledged that there is a gap in the understanding of how polyps evolve. He said that the current view is that only about 10% of all polyps become cancerous, but he also said that there is little long-term follow-up data to confirm or rebut that view. At present, medical science sees polyps of 10mm in length as high-risk for cancer.

"We still see CTC as appropriate technology, and it would be a useful addition" to a physician's armamentarium, Brooks said.

In an e-mailed statement sent by Aimee Frank, director of public relations for the American Gastroenterological Association (AGA; Bethesda, Maryland), the association voices its support for coverage for CT screening "if CMS were to require, as a condition of coverage the establishment of procedure standards, mandated physician completion of a CTC certification program, and clearly defined appropriate cross-specialty episodes of care." The statement also notes that while AGA agrees "that the limitations of CTC cannot be ignored," the organization nonetheless "support[s] CTC and other screening tests if patients and their physicians believe that test is the appropriate one for them."

House passes nanotechnology bill

A committee in the House of Representatives passed a bill Wednesday that would reauthorize the agency that is responsible for coordinating federal nanotechnology research, but the National Nanotechnology Initiative Amendments Act – essentially a duplicate of a bill by the same name that was offered in 2008 – passed in the House but made no headway in the Senate last year.

According to Congressional Quarterly, most of the provisions in H.R. 554 did not create a stir, but the call for more multi-agency initiatives – and the corollary expense – drew fire from the committee's GOP members. Roy Blunt (R-Missouri) is quoted as saying that because of the bill, nanotechnology will "look like ... old science compared to the new technology of spending money."

In a Feb. 11 statement posted at the committee web site, Rep. Bart Gordon (D-Tennessee), the committee chairman and the bill's primary sponsor, said "there is no doubt that the potential of this technology is vast," adding that the bill will "foster commercialization while ensuring public health and safety."

According to a summary of the bill at the Thomas Library of Congress web site, the bill would require that the National Nanotechnology Coordination Office develop a database describing any projects dealing with environmental health and safety, and would make formal a nanotechnology advisory panel to assess the ethical, legal and environmental aspects of National Nanotechnology Initiative projects.

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