Medical Device Daily Washington Editor
There is no such thing as a good cancer, but the epidemiology of colorectal cancer (CRC) suggests that it should be high on the list of diseases slated for a targeted attack. Hence, the National Institutes of Health published a report last week recommending a set of measures to improve screening for CRC, although the paper acknowledges that capacity is an issue.
The NIH paper reminds the reader that 150,000 Americans are diagnosed annually and that one third that number lose their lives each year. Screening rates for the population of interest – those aged 50 and older at average risk for the disease – rose sharply between 1997 and 2008, but the increase from 20%-30% at the beginning of that period to nearly 55% two years ago is seen as a positive trend in need of much more encouragement.
NIH asserts that screening for CRC is underused, but also argues that a registry is needed to evaluate the appropriate use of screening in general and the various modes for performing CRC check-ups. The NIH paper recommends that financial barriers – such as co-pays and other cost-sharing mechanisms – be eliminated and that studies be conducted to evaluate the various strategies for prompting screenings. However, the current capacity for the various modalties will support screening for those over the age of 50 only if fecal occult blood testing is the primary method for performing those checks.
The fecal occult blood test (FOBT) is perhaps the easiest way to screen, given the low invasiveness and current guidelines suggest annual screening via this method. Despite this, the NIH report says that colonoscopy is now "the most widely used screening test" despite recommendations that it be used only every five years, thanks in part to a coverage decision rendered by the Centers for Medicare & Medicaid Services in 2001. Prior to then, the NIH paper notes, FOBT and flexible sigmoid colonoscopy were the two dominant approaches, but the popularity of the latter was diminished by the CMS coverage decision regarding colonoscopy. NIH also notes, to no surprise, that the double-contrast barium enema "has fallen out of favor" since 2001 as well.
CT colonography is technologically ready for prime time, but CMS recently concluded that extant data do not support this technology's use as a screening tool, a decision that generated mixed reviews (Medical Device Daily, May 15, 2009). All the same, this modality is recommended for performance at five-year intervals after the age of 50, a frequency matching that for sigmoidoscopy and double-contrast barium enemas. The guidelines for colonoscopy call for such an exam once per decade, according to the American Cancer Society-U.S. Multi-Society Task Force. The U.S. Preventive Services Task Force (USPSTF) currently offers no recommendations for CT colonography or double-contrast enema, but essentially agrees with the ACS-led group on the other recommendations. USPSTF offers no recommendation fecal DNA exams, which the other group offers only a limited suggestion of testing at no specific intervals after the age of 50.
As for the capacity question, the NIH paper says that even if FOBT were more widely used, any positive results would have to be checked with colonoscopy, an observation that applies to the other first-line approaches as well. The document observes that there is "substantial uncertainty that current colonoscopy capacity would be sufficient" if the current screening guidelines were widely observed. By some accounts, this deficit could be made up within a decade, although sigmoidoscopy could largely fill in the gap in the interim.
NIH recommends an effort to track screening via "an infrastructure for capturing information," which could be modeled on the Breast Cancer Surveillance Consortium. The paper also suggests that research go toward establishing which factors are most effective at prompting patients and doctors to recommend and obtain a screening, and recommends that capacity be addressed with studies of demand and capacity "across geographic areas" as well as "research assessing various options for expanding the supply of providers."
BD joins recall bandwagon
Another firm has been hit by the recall bug and this time it's a household name, industry titan Becton Dickinson (BD; Franklin Lakes, New Jersey).
According to a Feb. 8 statement at the BD web site, the firm is pulling back "certain lots" of the firm's Q-Syte Luer infusion access devices and BD Nexiva closed intravenous catheter systems. The announcement states that use of the Q-Syte devices could trigger an embolism or trigger blood leakage or leakage of therapeutic fluids, "which may result in serious injury or death."
BD says that the recall of the Q-Syte was initiated in late October "after BD received complaints due to air entry through the bottom disk of the septum," and was expanded to the Nexiva because the Nexiva kits contain Q-Syte needles. The problem has been traced to "a manufacturing deviation" that BD is said to have corrected. Additional inspections have been conducted to confirm the corrections, and the total number of Q-Syte and Nexiva units under recall is roughly 5.7 million. The company is said to be investigating one report of a death and one of an injury said to be associated with the devices.
Spinal device firm is calling it quits
The economy is providing a severe shaking out for lots of industries, and the device industry is no exception. Disc Dynamics (Eden Prairie, Minnesota), a firm with 10 years and more than $65 million invested in spinal disc repair technology, reported it is closing its doors and selling off its assets. As of press time yesterday, the company's web site was no longer operating.
The company is said to have employed 32 people at the height of its fortunes, but started laying off employees toward the end of last year. The remaining three employees are tasked with selling assets, possibly including a patent related to the Dascor disc arthroplasty device. The idea for the Dascor is said to have originated with SpineTech (Edina, Minnesota).
The firm reported last year that its CEO, Steven Healy, had resigned to take over at Lumen Biomedical (Maple Grove, Minnesota), a firm he had served as a member of the board of directors (MDD, July 16, 2009). David Stassen of Split Rock Ventures (Eden Prairie, Minnesota) took over operations at that point.
Wire service reports state that the company's CFO, Keith Eastman, said the company "just ran out of money." The firm had completed its feasibility study for U.S. approval in July, but it is unclear as to whether FDA had approved a pivotal study for the Dascor.
Mark McCarty, 703-268-5690