News Scan for Aug 01, 2014

News brief

Poor phase 2 results lead Biota to suspend flu drug laninamivir

The neuraminidase inhibitor laninamivir, made by Biota Pharmaceuticals Inc. of Alpharetta, Ga., failed to perform better than a placebo at alleviating influenza symptoms in a phase 2 trial, the company said in a press release today, adding that it will no longer develop the drug.

The trial, involving 639 patients, tested 40-milligram (mg) and 80-mg doses of the inhaled drug. The median time to alleviate flu symptoms was 102.3 hours and 103.2 hours for the two doses, respectively, compared with 104.1 for the placebo.

In April the US Department of Health and Human Services told Biota it was pulling out of its contract worth up to $231 million to support the drug's development. The company's partner, Daiichi Sankyo of Tokyo, has been marketing laninamivir in Japan since 2010 using the brand name Inavir.

"It is disappointing that the rapid and significant onset of antiviral activity against the influenza virus that the two treatment arms demonstrated with LANI [laninamivir] did not translate into a meaningful reduction in the time to alleviate patient-reported influenza symptoms," Biota President and CEO Russell H. Plumb said in the release.

"We expect to complete a full analysis of additional clinical, safety, and pharmacokinetic data forthcoming from this trial over the next several months; however, at this time we do not have any plans to independently advance the development of LANI for the treatment of influenza and intend to evaluate next steps for the LANI program outside of Japan with our partner, Daiichi Sankyo."
Aug 1 Biota Pharmaceuticals press release

North Dakota reports H3N2 variant flu in state fair pigs

North Dakota health and agriculture officials reported yesterday that three pigs that were exhibited at the North Dakota State Fair tested positive for an H3N2 variant influenza virus (H3N2v). In a statement. health officials said the pigs appeared healthy when they arrived at the fair, then became ill and removed by their owners.

North Dakota's state fair was held in Minot from Jul 18 through Jul 26. The North Dakota Department of Agriculture said no human H3N2v illnesses have been found and that the detection is the first at a fair in the state.

From 2011 through 2013, 340 human illnesses were reported in 13 states, but none were from North Dakota. Nationally, no human H3N2v cases have yet been reported this year.
Jul 31 North Dakota Department of Health statement

NYC conducts massive no-notice emergency response drill

The New York City Health Department today conducted the largest no-notice emergency response exercise in the city's history to test its ability to dispense drugs in the event of a biological agent release or other public health emergency, the department said in a press release.

The exercise involved more than 1,500 staff members from 13 agencies and entailed setting up 30 temporary locations for quickly mass-dispensing medication in the event of a true emergency. Most staffers had no advance warning, "to better test and simulate a real emergency and response," the release said.

"This is a full-scale exercise," the release read, "meaning the Health Department is physically executing multiple elements of our response plan. By conducting the exercise in this way, the Health Department can review each piece of our emergency response plan and learn of critical gaps that can be corrected with additional planning or changes in policy."

"This exercise demonstrates our commitment to ensuring we have the capability and resources to protect the health and safety of all New Yorkers in times of crisis," said Oxiris Barbot, MD, the city's first deputy commissioner.
Aug 1 NYC Health Department press release
Health Department FAQ on the exercise

Report: Resistant gonorrhea isolates less prevalent in Europe

The percentage of European gonococci isolates that showed decreased susceptibility to the main antibiotic used in Europe declined substantially from 2011 to 2012, the latest year for which data are available, according to a report today from the European Centre for Disease Prevention and Control (ECDC).

Of 1,927 Neisseria gonorrhoeae isolates collected in 2012 from 20 European nations, only 3.9% showed reduced susceptibility to cefixime, which was down from 7.6% in 2011 and 8.7% in 2010.

Also, 14 countries in 2012 detected isolates with reduced susceptibility to cefixime, down from 17 in 2011. The report noted these levels of resistant isolates for lesser-used antibiotics: ciprofloxacin, 50.1%; azithromycin, 4.5%; and penicillin G, 13.0%. The percentages for those three drugs did not differ much from the year before.

The ECDC also found that gonorrhea infections that were less susceptible to cefixime were more likely to be found in patients younger than 25 years compared with older patients, which represents a shift.

The ECDC concluded in a news release, "Control of gonorrhoea relies on effective antimicrobial treatment. If existing agents would become less efficient the impact would be significant: with more than 47,000 reported cases in 2012, gonorrhoea is the second most frequently recorded sexually transmitted infection in Europe after chlamydia."
Aug 1 ECDC report
Aug 1 ECDC news release

Food Safety Scan for Aug 01, 2014

News brief

USDA declines to classify resistant Salmonella as meat adulterant

The US Department of Agriculture (USDA) has turned down a long-pending petition to declare antibiotic-resistant (ABR) Salmonella an adulterant in raw ground meat and poultry, saying there's not enough evidence to support the change.

The petition, filed by the Center for Science in the Public Interest (CSPI) in 2011, covers resistant strains of the Salmonella serotypes Hadar, Heidelberg, Newport, and Typhimurium. If these were deemed adulterants, the USDA would have to test for them and remove contaminated products from the food supply.

The USDA's Food Safety and Inspection Service (FSIS) explained its decision in a letter dated yesterday. As noted in the letter, the FSIS doesn't consider Salmonella an adulterant in ground meat and poultry because ordinary cooking generally kills it.

CSPI argued that ABR Salmonella is legally different from other Salmonella because it results from human action in the form of treating livestock with antibiotics, and that this lowers the bar for classifying it as an adulterant, the FSIS letter notes. But the FSIS responded that ABR Salmonella can exist in animals with no exposure to antibiotics, which it said undermines the distinction.

CSPI also argued that ABR Salmonella is dangerous because proper cooking often fails to heat food enough to kill the pathogen, the letter says. But the FSIS said there is no evidence that ABR strains are more heat-resistant than other strains.

The agency also said more data are needed on the infective dose of different Salmonella strains and whether ABR Salmonella causes more serious illness than susceptible strains.

Caroline Smith DeWaal, CSPI's food safety director, criticized the USDA decision in a statement yesterday.

"USDA's failure to act on antibiotic-resistant strains of Salmonella in the meat supply ignores vital information about the public health risk posed by these pathogens," she said. "Despite numerous examples of outbreaks linked to resistant pathogens, USDA leaves consumers vulnerable to illnesses that carry a much greater risk of hard-to-treat infections leading to hospitalization."
Jul 31 USDA letter
Jul 31 CSPI press release

CDC declares Foster Farms Salmonella chicken outbreak over

The Centers for Disease Control and Prevention (CDC) yesterday declared that a multistate Salmonella outbreak linked to Foster Farms chicken products that began in March 2013 is finally over after sickening at least 634 people.

The outbreak total marks a 13-case increase since the CDC's previous update, on Jul 4. Cases have been confirmed in 29 states and Puerto Rico. California reported by far the most cases, 490, followed by Arizona, with 25 (see CDC map below).

Illness-onset dates ranged from Mar 1, 2013, to Jul 11, 2014, and patients' ages varied from younger than 1 to 93 years, with a median of 18 years. Among 528 persons for whom information was available, 200 (38%) were hospitalized.

Fully 15% of case-patients developed blood infections, which is far higher than the typical 5% associated with Salmonella infections, the CDC said. No deaths were reported.

Of 350 patients with available information, 74% said they had eaten chicken prepared at home in the week before developing symptoms. And of those who could recall the brand of chicken, 152 (87%) of 175 said it was Foster Farms or a brand likely produced by Foster Farms, which is located in Livingston, Calif.

Authorities had isolated outbreak strains of Salmonella Heidelberg from patients' homes, and FSIS officials had identified six of the seven outbreak strains on raw chicken samples collected from the three Foster Farms establishments in California.

About a month ago Foster Farms recalled an undetermined amount of its chicken products because of possible Salmonella contamination.
Jul 31 CDC final outbreak notice
Jul 7 CIDRAP News scan on previous CDC update, chicken recall