News Scan for Jun 05, 2015

Five Saudi MERS cases
;
NIH pharmacy lapses
;
Drug-resistant Shigella
;
Zika virus in Americas
;
Call for better lab biosecurity

Saudi Arabia reports 5 more MERS cases, including 3 in Hofuf

Saudi Arabia today reported five more MERS cases, including three in Hofuf, which has been a hot spot lately because of an apparent hospital outbreak.

Two of the three Hofuf patients, Saudi men ages 41 and 29 years, are healthcare workers who had contact with other MERS-CoV (Middle East respiratory syndrome coronavirus) patients, the Saudi Ministry of Health (MOH) reported. They are in stable condition.

The other Hofuf patient is a 58-year-old Saudi woman who is also in stable condition. Officials are investigating whether she had any contact with other MERS patients, the MOH said.

A World Health Organization (WHO) statement yesterday indicated that seven recent MERS patients in Hofuf picked up their infections while being treated in a hospital or while working there.

The other two new cases involve two non-Saudi men, a 55-year-old in Jeddah and a 58-year-old in Riyadh, both in critical condition, the ministry said. They are not healthcare workers and they had no contact with other MERS patients.

With the 5 cases, the MOH's MERS tally has reached 1,024, including 450 deaths and 563 recoveries. Two patients are in home isolation, and 9 remain under treatment.
Jun 5 MOH update

In other developments, the WHO filled in some details today on a MERS case reported recently in Oman. The patient, a 75-year-old man, owns a camel barn, where he has frequent contact with camels and their calves, the agency said. His case was first reported by the media on May 29.

The man fell ill on May 11, was hospitalized on May 25, tested positive 4 days later, and is in stable condition, the WHO reported. He has no underlying illnesses but is a heavy smoker. Officials are tracing his contacts and also investigating his camels.
Jun 5 WHO statement

 

Contamination, missteps prompt halt to NIH pharmacy operations

The National Institutes of Health (NIH) said yesterday it was suspending pharmaceutical operations at its Clinical Center in Bethesda, Md., after the discovery of fungal contamination in a drug ingredient led to the identification of serious manufacturing problems and violations of standard procedures.

In a press release, the NIH said two vials of albumin, used to administer interleukin in clinical studies, were found in April to have fungal contamination. Other vials from the same batch were administered to six patients, who have been notified and have remained free of infection so far, the agency said. It is not known whether those vials were contaminated.

The Food and Drug Administration (FDA), after receiving a complaint, inspected the NIH Pharmaceutical Development Section (PDS) between May 19 and 29 and found a number of deficiencies that require corrective action, the NIH said.

"This is a distressing and unacceptable situation," NIH Director Francis S. Collins, MD, PhD, said in the release. "The fact that patients may have been put in harm's way because of a failure to follow standard operating procedures in the NIH Clinical Center's Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible."

The FDA found building problems, including flaws in the ventilation system, and operational problems that included lapses in quality control, employee training, and compliance with standard procedures, the NIH said. The problems were found in the Clinical Center's Hospital Pharmacy and the Clinical Supply Manufacturing Facility, the FDA report shows.

Besides suspending PDS operations, the NIH said it is informing patients involved in affected clinical trials about the situation and working to secure other sources for the products. In addition, an outside group of experts will be appointed to make a thorough review and recommend corrective actions.

The news recalls the widespread outbreak of fungal infections that occurred in 2012 as a result of contaminated steroid drugs prepared by the now-defunct New England Compounding Center in Framingham, Mass. That outbreak sickened 751 people, killing 64, and led to changes in FDA oversight of compounding pharmacies.
Jun 4 NIH press release
Related
FDA report

 

CDC cautions about drug-resistant Shigella infections

The US Centers for Disease Control and Prevention (CDC) is alerting clinicians and other professionals of infections with Shigella strains resistant to ciprofloxacin and/or azithromycin, the antimicrobial agents most commonly used to treat shigellosis, a diarrheal disease.

The agency highlighted recent cases—most involving men who have sex with men (MSM)—and discussed prevention and response steps in a Health Alert Network (HAN) notice yesterday and a Morbidity and Mortality Weekly Report (MMWR) article today.

"Shigellosis is very contagious and can spread quickly through communities and across different segments of the population," the CDC said in its HAN notice.

The CDC highlighted three outbreaks:

  • Five confirmed cases of extremely drug-resistant (XDR) shigellosis have been identified with onset dates from Sep 7, 2014, through Apr 4 in Illinois, Montana, and Colorado. Four of the patients were MSM, and two are known to have experienced more than 14 days of diarrhea.
  • From May 2014 through April 2015, 179 cases with one of five highly-related pulsed-field gel electrophoresis (PFGE) patterns were identified in 34 states and Puerto Rico, and about half the patients reported international travel before illness. All 10 San Francisco isolates, and 89% of isolates overall, were resistant to ciprofloxacin. At least 19 patients are MSM, and a sub-outbreak in a childcare center made 16 people ill. This outbreak was detailed in an MMWR report in April.
  • Shigellosis with decreased susceptibility to azithromycin among MSM in Chicago and the Minneapolis/St. Paul area were involved in an outbreak from May 13 through December 8, 2014. Twenty-two isolates displayed highly similar PFGE patterns. All 22 patients were men, 15 of 17 with information said they were MSM, and 12 had HIV. This outbreak was detailed in today's MMWR report.

The HAN notice states, "CDC recommends meticulous handwashing and other hygiene practices to prevent shigellosis and encourages patients with symptoms of shigellosis such as diarrhea and fever to visit a healthcare provider. Clinicians should obtain stool cultures from patients suspected of having shigellosis, counsel patients about shigellosis prevention, and, when treatment is required, select drugs based on antimicrobial susceptibility test results."

It also lists prevention tips for MSM and those involved in childcare centers.
Jun 4 CDC HAN advisory
Jun 5 MMWR report

 

Zika virus infection reported in Dominican Republic

The Dominican Republic has become the second country in the Americas, after Brazil, to report an infection with Zika virus, a mosquito-borne pathogen that causes symptoms somewhat similar to dengue virus, according to a media report.

A 12-year-old girl in the Dominican city of Puerto Plata is hospitalized with the infection, according to a Jun 3 story in the newspaper El Nuevo Diario. A translation of the story was posted by ProMED-mail, the reporting service of the International Society for Infectious Diseases. The story did not say whether the girl had recently traveled internationally.

The report follows the confirmation by Brazil of 16 Zika virus cases on May 15, as noted by the European Centre for Disease Prevention and Control (ECDC) on May 26. That marked the disease's first documented appearance in the Americas.

Like dengue and chikungunya viruses, Zika virus is spread by Aedes mosquitoes. It causes an illness that is similar to dengue infection but is generally milder, according to a Pan American Health Organization (PAHO) alert issued May 7. The infection can be asymptomatic, and no fatal cases have been reported, PAHO said.

The agency said the most common symptoms include fever, non-purulent conjunctivitis, headache, muscle and joint pain, weakness, maculopapular rash, and lower-limb swelling. They last 4 to 7 days and are self-limiting. There is no specific treatment for the illness, only supportive measures.

Zika virus was discovered in rhesus monkeys in Uganda's Zika forest in 1947, according to PAHO. The first major outbreak of Zika virus fever occurred on the Micronesian island of Zap in 2007, the agency said. In late 2013, an outbreak involving about 10,000 cases occurred in French Polynesia.

The virus's arrival in the Americas recalls the appearance of the chikungunya virus in the Caribbean in December 2013. Since then, more than 1.4 million cases have been reported in many countries in the hemisphere, mainly in Latin America.
Jun 5 ProMED post
May 26 ECDC risk assessment
summary
May 25 ECDC
risk assessment
May 7 PAHO alert

 

Biodefense leaders call for bolstering lab biosecurity

Yesterday the co-chairs of the Blue Ribbon Study Panel on Biodefense (BRSPB) expressed grave concern over recent events involving US high-level biocontainment labs and USA Today's investigative report into these labs, according to a BRSPB news release.

The co-chairs, former Connecticut Sen. Joe Lieberman and former Pennsylvania Gov. Tom Ridge, called on the federal government to strengthen the nation's lab biosecurity.

"The state of oversight of U.S. biological research labs is extremely troubling," said Lieberman. "Every day, labs across America work with dangerous biological pathogens. Yet many state governments don't know about them, let alone have contingency plans for when these disease agents escape."

Ridge said the May 29 USA Today report "highlights a much larger weakness in biodefense policy. It is difficult enough to determine what bio threats our enemies may be developing overseas. So we must ensure that we strengthen federal biosecurity policy to reduce the risk of bioterrorism, biological warfare, and the illness and death caused by devastating outbreaks at home and abroad."

At least 51 labs in 17 US states, as well as facilities in South Korea, Australia, and Canada, recently received live Bacillus anthracis—which causes anthrax—from a US Army lab in Utah. And the USA Today report highlighted many shortcomings in high-containment US research labs, including a lack of adequate oversight.
Jun 4 BRSPB press release
Jun 3 CIDRAP News scan on anthrax breaches
May 29 CIDRAP News scan on USA Today report

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