News Scan for Oct 01, 2014

Funds for new flu tests
Simvastatin for ARDS
Flawed FEMA system

Federal contracts aim at faster flu testing, better pandemic response

Large contracts for developing improved diagnostics for influenza in point-of-care settings have been awarded to two companies by the federal government's Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) announced today.

In general, the tests will allow faster differentiation of influenza from bacterial infections as well as differentiation of seasonal flu strains from novel ones in settings such as doctors' offices, clinics, and hospitals, HHS said in a news release. Above and beyond the day-to-day advantages they will allow in diagnosing individual flu cases, they could help boost preparedness for a flu pandemic.

Massachusetts-based Alere received a contract for $12.9 million over 3.5 years for developing iNAT Influenza A&B test, a simple, low-cost molecular test that will be able within 15 minutes to tell whether a patient has an infection caused by a seasonal type A or B flu.

Colorado-based InDevR's 2-year, $7.9 million contract, which has options for extension up to $14.7 over 4 years, is for development of the FluChip-8G test. This genetic test will be able to identify seasonal flu viruses as well as recognize novel strains within 4 hours, a detailed laboratory process that now takes days, HHS said.

BARDA Director Robin Robinson, PhD, said quick, accurate tests have other benefits. "Prescribing medication or other therapies in a more targeted way is good stewardship and will be critical to reducing the risk of antimicrobial resistance," he said in the release.
Oct 1 HHS press release


Study shows no benefit of simvastatin treatment in patients with ARDS

Despite promising findings in early-phase trials of statins for patients with acute respiratory distress syndrome (ARDS), a large multicenter study, the findings of which were published yesterday in the New England Journal of Medicine, found no benefit to simvastatin treatment in these patients.

The study group comprised 540 adult patients from 40 hospitals in the United Kingdom and Ireland who had experienced onset of ARDS within the previous 48 hours and were intubated and mechanically ventilated. They were well matched demographically and physiologically.

Patients were randomized to a treatment group of 259, who received 80 mg of enteral simvastatin daily for a mean of 10.2 + 7.1 days, and a control group of 281, who received placebo for a mean of 11.0 + 7.9 days. The study period ran from Dec 21, 2010, to Mar 13, 2014.

The mean ventilator-free days was not significantly different between groups. Likewise, a significant difference was not seen in days free of nonpulmonary organ failure.

Although overall adverse events, mostly elevated creatine kinase and hepatic aminotransferase levels, were significantly more common in the simvastatin group than the controls, the incidence of serious adverse events was similar in the groups. The authors conclude that their findings "do not support the use of simvastatin in the management of ARDS."
Sep 30 N Engl J Med study


OIG: FEMA's system for distributing emergency supplies not up to the task

The Federal Emergency Management Agency's (FEMA's) system for quickly delivering supplies such as food, water, blankets, and generators to people after a catastrophic disaster, is, according to a notice today from the Department of Homeland Security's (DHS's) Office of Inspector General (OIG), somewhat of a debacle itself.

FEMA's high-tech logistics system was developed over 9 years at a cost of more than $247 million, but so far it can't interface properly with its partners' and suppliers' systems, according to the notice, so tracking and locating emergency supplies is difficult.

Besides that problem, OIG found in its audit of FEMA that there are not enough trained employees at FEMA to operate the system.

OIG has made recommendations to FEMA for improvements. DHS Inspector General John Roth said, "One of FEMA's prime missions is to immediately provide survivors with three days' worth of basic emergency supplies. . . . As presently configured, this supply chain system is not up to that task."
Oct 1 OIG notice

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