Oct 24, 2012
FDA documents voice doubts about voluntary approach on animal antibiotics
Internal Food and Drug Administration (FDA) documents obtained by an advocacy group show that the agency has some doubts about its voluntary strategy for reducing the use of antibiotics in food animals, according to the group, Public Employees for Environmental Responsibility (PEER). The voluntary approach, unveiled in April, encourages drug companies to change the labels of certain antibiotics to stop growth-promotion uses. PEER had asked the FDA for documentary evidence supporting its confidence in the voluntary strategy. The agency initially didn't respond, but recently provided documents under the threat of a lawsuit, according to PEER. The group, which posted some documents on its Web site, says they contradict rather than support the FDA's optimism about the voluntary strategy. One FDA memo says, "We recognize that the voluntary strategy has certain limitations in that (1) it lacks specifically defined/mandated timeframes, (2) its success is dependent on drug sponsors deciding it is in their best interest to work cooperatively with the agency, and (3) FDA collects insufficient data on drug use . . . to measure the effectiveness of the strategy." Another memo states that the FDA has "regulatory options" in case the voluntary approach doesn't work, but the agency blanked out the options in the document. PEER attorney Kathryn Douglass said in a press release, "In the foot-thick stack of materials FDA surrendered there is not a shred of evidence that industry is working to phase-out injudicious use of these drugs."
Oct 17 PEER press release
Apr 11 CIDRAP News story on FDA's voluntary strategy
Nursing-home hospitalization, death rates higher during norovirus outbreaks
A 2-year study of nursing homes in three states showed that hospitalization and death rates were significantly higher during norovirus outbreak periods than at other times, according to a report in the Oct 24/31 issue of the Journal of the American Medical Association (JAMA). In a retrospective cohort study, a team from the Centers for Disease Control and Prevention (CDC) and state health departments identified 308 Medicare-certified nursing homes in Oregon, Wisconsin, and Pennsylvania that had at least one norovirus outbreak in 2008 or 2009. A total of 407 outbreaks were reported, of which 293 were lab-confirmed, with a median 26 cases per outbreak. Reported hospitalizations and deaths were 67,730 and 26,055, respectively. Hospitalization rates per nursing home–year were 124.0 during outbreak periods versus 109.5 at other times, yielding a seasonally adjusted rate ratio of 1.09 (95% confidence interval [CI], 1.05-1.14). Likewise, mortality rates per nursing home–year were 53.7 during outbreak periods, compared with 41.9 at other times, for a rate ratio of 1.11 (95% CI, 1.05-1.18). The researchers found that the level of registered nurse (RN) staffing made a difference in the mortality rate. Homes with lower daily RN hours per resident (less than 0.75) had higher mortality during outbreaks, whereas those with higher hours had no increase in mortality. RN staffing was not found to be a factor in hospitalization rates, however.
Oct 24 JAMA report
Turtle turn-in program addresses Salmonella risks
In a move designed to stem Salmonella outbreaks linked to small-shell pet turtles, Petco, a pet supply retail chain based in San Diego, yesterday launched a turtle relinquishment program that it is sponsoring along with Concordia Turtle Farm, according to a company press release yesterday. Turtles with shells smaller than 4 inches relinquished at Petco stores will be shipped to Concordia Turtle Farm, where they will live and be cared for in the firm's ponds. The FDA has banned the sale and distribution of small turtles since 1975, but they are illegally sold through street vendors and other outlets. Thomas Edling, DVM, Petco's vice president of veterinary medicine, said in Petco's newsletter this spring that most of the turtles implicated in the outbreaks come from substandard breeding farms that don't use the latest egg disinfection, hatching, and growth technologies that are designed to curb Salmonella. The CDC recently reported that 219 people so far this year have been sickened in six Salmonella outbreaks linked to pet turtles.
Oct 23 Petco press release
May 23 Petco newsletter story
Oct 19 CIDRAP News Scan "US salmonellosis cases tied to pet turtles reach 219"