News Scan for Jul 30, 2019

News brief

Consumer Reports probe finds Listeria on leafy greens in several stores

Leafy greens from several grocery store chains tested positive for Listeria bacteria, in an experiment conducted by Consumer Reports that's kicked off an investigation by the Food and Drug Administration (FDA).

Scientists with the organization tested 234 samples of fresh greens, and 6 of them tested positive for Listeria monocytogenes. The six samples included two bagged, pre-washed greens (both containing spinach), and four loose heads or bunches of green kale, green leaf lettuce, red leaf lettuce, and spinach. The samples came from Acme, Costco, Hannaford, and Whole Foods, and all were bought from Jun 3 to 19 in Connecticut, New Jersey, and New York.

"While it may not be surprising to find Listeria in a small percentage of leafy green products that are tested, it is always concerning to find bacteria that can make people sick in foods that aren’t meant to be cooked," says Karen Wong, MD, medical officer in the Centers for Disease Control and Prevention's (CDC's) Enteric Diseases Epidemiology Branch.

One strain seen in the sample collected from a "triple-washed" Nature's Place Organic Spinach Spring Mix was genetically linked to at least two listeriosis cases reported to the CDC.

"In response to CR's findings, the FDA initiated an inspection of the plant that produced Nature's Place Organic Spinach Spring Mix, the product that contained a strain of Listeria linked to two illnesses," Consumer Reports said.

The Consumer Reports study is not meant to result in any definitive food safety conclusions about supermarket produce, the authors said. But it does suggest that people susceptible to complications from Listeria, including pregnant women and the elderly, cook their greens before eating them.

"Unless there's an ongoing, known outbreak, for most people the nutritional benefits [of eating leafy greens] outweigh the potential contamination risks," said James. E. Rogers, PhD, director of food safety research and testing at Consumer Reports.
Jul 26 Consumer Reports story


FDA clears for marketing 4 new tests for Lyme diagnosis

Four previously cleared tests that can detect Lyme diseases are now cleared for market use, the FDA announced yesterday.

"Lyme disease can have a devastating impact on patients," said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "With today's action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients."

Traditional Lyme assays require a two-step process to detect the presence of antibodies against Borrelia burgdorferi, the bacterium that causes Lyme disease. The standard tests require both enzyme immunoassays (EIA) and Western blots results to confirm Lyme.

The new tests, manufactured by ZEUS Scientific, of Branchburg Township, New Jersey, will require only one step—a modified approach that uses only EIA technology-based tests, the FDA said.

The FDA said officials recorded 42,743 confirmed and probable Lyme cases in 2017, an increase of 17% from 2016. The disease can cause a range of symptoms from mild to debilitating, including rash, joint pain, and fever.
Jul 29 FDA
press release


Camel prion disease detected in Tunisian camels

A novel prion disease first reported in three dromedary camels in Algeria in 2018 has now been detected in dromedaries in Tunisia, the second country to be affected within a year, ProMED Mail, the online reporting system of the International Society for Infectious Diseases, reported yesterday.

The Tunisian detection and the latest information about the disease, called camel prion disease (CPD) and sometimes referred to as "mad camel disease", came from a presentation at the Mediterranean Animal Health Network meeting, held in Cairo on Jun 26 and 27. According to the meeting presentation, CPD is spreading rapidly in the Ouargla region of Algeria where the disease was first identified in older camels at a slaughterhouse.

The scientists who presented at the meeting also said preliminary results suggest that the CPD prion is different from scrapie and bovine spongiform encephalitis (BSE, or "mad cow disease").

A comment from the ProMED Mail moderator Arnon Shimshony, DVM, associate professor of veterinary medicine at Hebrew University of Jerusalem, notes that the area where CPD was first found in Algeria is about 174 miles from the Tunisian border.

In the initial report on the first detection in Algerian camels, published in April 2018 in Emerging Infectious Diseases, described disease-specific prion protein in brain tissues from symptomatic camels, including positive samples in lymph nodes, suggesting infection. The moderator also requested more details about the detections in Tunisia, including location, clinical signs, and ages and origins of affected camels.
Jul 29 ProMED Mail post
Apr 18, 2018, CIDRAP News story "'Mad camel' disease? New prion infection causes alarm"

Stewardship / Resistance Scan for Jul 30, 2019

News brief

Taco Bell to cut medically important antibiotics in beef supply by 25%

Taco Bell announced yesterday that it aims to reduce the amount of medically important antibiotics used in its US and Canadian beef supply chains by 25% by 2025.

The company said in a press release that as part of this new policy, it will favor suppliers that are reducing the use of antibiotics deemed by the World Health Organization (WHO) to be important to human health, and give preference to suppliers that increase veterinary oversight for treating sick animals. Taco Bell will also participate in the US Roundtable for Sustainable Beef and the Center for Disease Control and Prevention's Antimicrobial Resistance Challenge.

Taco Bell is the latest fast-food chain to commit to reducing medically important antibiotics in its beef supply chain. In December 2018, McDonald's announced it will work with its beef suppliers in the United States and nine other countries to cut the use of medically important antibiotics.

Although several fast-food chains have completely removed medically important antibiotics from their poultry supply chains in recent years, far fewer have committed to cutting antibiotics from their beef supply. Advocates for reduced antibiotic use in food-producing animals have been pushing the fast-food industry to make changes. 

"Fast food chains are seeing the writing on the wall: Customers want better beef," Lena Brook, director of food campaigns at the Natural Resources Defense Council (NRDC), said in a statement. "While its commitment leaves significant room for improvement, it's a move in the right direction and shows the pressure is on for competitors to take action."

According to the most recent report from the Food and Drug Administration, 42% of the medically important antibiotics sold for use in food-producing animals in the United States in 2017 were for cattle.

Taco Bell said it will report on its progress in 2022.
Jul 29 Taco Bell press release
Jul 29 NRDC press release


New antifungal shows promise in phase 2 trial

Biotechnology company Cidara Therapeutics yesterday reported positive topline results from a phase 2 trial of it antifungal candidate rezafungin.

According to a company press release, the results from the STRIVE B trial indicate the rezafungin, a novel echinocandin developed for treatment of invasive fungal infections, met all of its objectives for efficacy, safety, and tolerability in patients with candidemia and/or invasive candidiasis. The objective of the trial, which included 91 patients in the microbiological intention-to-treat population, was to compare the efficacy and safety of rezafungin administered once-weekly versus caspofungin dosed daily. Efficacy measures included clearance of Candida from the blood or other normally sterile sites, resolution of systemic signs of infection, investigator assessment of clinical response, and overall survival.

Topline results showed that patients treated with rezafungin had numerically improved outcomes compared to caspofungin across all efficacy measures, and was generally safe and well-tolerated.

"Rezafungin has the potential to be the first safe and effective once-weekly, first-line treatment option for patients with difficult-to-treat and deadly invasive Candida infections, and we believe this trial moves us one step closer to market," said Cidara president and chief executive officer Jeffrey Stein, PhD.

The FDA has designated rezafungin as a Qualified Infectious Disease Product and granted it Fast Track status for treatment of candidemia and invasive candidiasis.
Jul 29 Cidara Therapeutics press release


WHO AWaRe index adapted to improve stewardship in England

A paper today in the Journal of Antimicrobial Chemotherapy describes the creation of an antibiotic use index in England based on the WHO AWaRe index.

The AWaRe index was recently created by the WHO to classify key antibiotics into three categories: Access antibiotics that should be widely available, Watch antibiotics that should be monitored for toxicity concerns and/or resistance potential, and Reserve antibiotics that should be saved for complex, multidrug-resistant infections. The tool was developed to help nations evaluate and optimize antibiotic use, but national variations in antibiotic resistance and use require each country to ensure that the index is relevant for country-specific use.

To adapt the AWaRe index for use in English hospitals, researchers from Public Health England collected national-level antibiotic prescribing data from 2011 through 2016 to see which antibiotics from the WHO AWaRe index were commonly used in primary and secondary care. Antibiotics used in England but not included in the WHO AWaRe index were then added to an appropriate category following a workshop consensus exercise with national experts, and the methodology was tested using national antibiotic prescribing data.

In 2016, 46 of 108 antibiotics included within the WHO AWaRe index were routinely used in England, along with an additional 25 antibiotics that were not included in the WHO AWaRe index. WHO AWaRe-excluded and -included antibiotics were reviewed and reclassified according to the England-adapted AWaRE index, with justification by experts for each addition or alteration.

Applying the England-adapted AWaRe index, Access antibiotics accounted for the majority (60.9%) of prescribing in primary care, followed by Watch (37.9%) and Reserve (0.8%). In acute secondary care, Access antibiotics still accounted for most of the antibiotics used (49.7%), but Watch (46.9%) and Reserve (3.3%) antibiotics were used more frequently. There was an unexplained twofold variation in prescribing between hospitals within each AWaRe category, highlighting the potential for quality improvement.

"We recommend that countries should review the AWaRe categorizations in their country, potentially using similar methodology, and consider which antibiotics from each category should be moved into the relevant category based on resistance profiles and antibiotic use," the authors of the paper write. "Quality improvement methodology can then be applied to organizations to improve antimicrobial stewardship and, in particular, preserve antibiotics in the Watch and Reserve categories."
Jul 30 J Antimicrob Chemother article

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