NEWS SCAN: IV fluids and HUS, E coli DNA test, varicella vaccine and mortality, FDA research needs

Jul 25, 2011

Study: Early IV fluids help protect kids with HUS
Researchers who observed the clinical course of 50 children who were hospitalized with Escherichia coli O1057:H7 infections and hemolytic uremic syndrome (HUS), a potentially fatal complication, found that early intravenous (IV) fluid therapy helped protect kidneys. Their analysis, published Jul 22 in Archives of Pediatric and Adolescent Medicine, involved children younger than 18 at 11 pediatric hospitals in the United States and Scotland from July 2007 until Dec 2008. In their review of the care that the children received, oligoanuria was present in 84% (21) of 25 children who weren't given IV fluids in the first 4 days of treatment but only 52% (13) of the 25 who did receive early IV fluids. The group concluded that IV volume expansion is an underused intervention that could decrease renal failure in patients at risk for HUS. Christina Ahn Hickey, MD, first author of the study and third-year pediatrics resident at Washington University School of Medicine in St. Louis, said in a press release that to ensure that kidneys get enough blood flow, clinicians need to get sodium-containing fluid directly to the blood vessels. In an editorial note that accompanied the study, the journal said it published the findings quickly ahead of print, given the important public health implications in light of Europe's sprout-related E coli outbreak.
Jul 22 Arch Pediatr Adolesc Med abstract
Jul 22 Washington University press release

Company unveils DNA testing system for 7 pathogenic E coli strains
Neogen Corp., based in Lansing, Mich., announced on Jul 21 that it has launched a testing system that can rapidly detect Escherichia coli O157:H7 and six other pathogenic E coli strains that pose food safety hazards: O26, O45, O103, O111, O121, and O145. In a press release the company said initially it will provide next-day results from enriched food samples submitted to its GeneSeek laboratory in Lincoln, Neb. It said the system uses mass spectrometry–based multiplexing to develop DNA "bar codes" for bacteria that can be compared to target E coli strains, which produces a result sooner than conventional culture methods and allows a more sensitive detection limit than other rapid pathogen detection methods. James Herbert, chairman and chief executive officer of Neogen, said in the statement, "As recent worldwide food recalls have clearly shown, regulators and the food industry need a rapid, DNA-definitive test for bacterial pathogens. NeoSeek provides that DNA-definitive test result."
Jul 21 Neogen press release

Varicella vaccine led to impressive decline in mortality
The annual average mortality rate for varicella (chicken pox) declined by 88% overall and by 97% for individuals younger than 20 years in the first 12 years of varicella vaccine availability, according to a study in Pediatrics. These results cover mainly the 1-dose regimen adopted when the vaccination program began in 1995; with the current 2-dose regimen, “There is potential that these most severe outcomes of a vaccine-preventable disease could be eliminated,” say the authors. Data were obtained from the US National Center for Health Statistics; age-adjusted and age-specific mortality rates for the years 2002 through 2007 were calculated and trends since the prevaccine years were evaluated. Mortality dropped from 0.41 per million population in 1990-94 to 0.05 per million in 2005-07. Data for the first 6 years of varicella vaccination (1995-2001), published previously, showed a 66% overall decline in deaths attributed to varicella as the underlying cause and a 75% decline for those younger than 20.
Jul 25 Pediatrics article

FDA report outlines research and science needs
The US Food and Drug Administration (FDA) today released a report that spells out the science and research needs of its Center for Drug Evaluation and Research (CDER), which among a wide range of topics addresses regulatory science advancements that will be required to evaluate new bioterrorism countermeasures. The report is open for review and public comments for the next 60 days, according to an FDA press release. Janet Woodcock, MD, director of CDER, said in a press release, "Communicating our science and research needs represents an important step in stimulating research and fostering collaborations with our external partners." On its report Web page the FDA said the report is the first step toward setting priorities that will guide its science and research agenda. For example, one section of the 24-page report addresses the need to develop animal models to evaluate new countermeasures for potential bioterrorism threats. It says the models are also needed to test combinations of drugs and assess dosing. In late 2009, Health and Human Services Secretary Kathleen Sebelius called for a major review of the nation's medical countermeasure program after delays in production of 2009 H1N1 vaccine left most of the nation unprotected against the virus until after the second wave of cases had peaked. One of the needs identified in that review, released in Aug 2010, was to strengthen regulatory science at the FDA to facilitate more rapid approval of cutting-edge technologies. The report's goals included identifying animal models and surrogate measures of product efficacy, expanding the ability to pre-qualify mobile or convertible manufacturing facilities, and improving potency, sterility, and stability assays.
Jul 25 FDA press release
Jul FDA regulatory science needs report
Jul 25 Federal Register notice
Aug 19, 2010, CIDRAP News story "HHS sees greater federal role in building biodefense tools"

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