NEWS SCAN: FDA warns egg producer, cholera in Sierra Leone, Ebola drug research pause, strep throat guidelines

Sep 10, 2012

Iowa egg producer warned about Salmonella, rule violations
The US Food and Drug Administration (FDA) has warned a company running Iowa egg farms linked to a 2010 nationwide Salmonella Enteritis (SE) outbreak that Salmonella Heidelberg has been found in two of its six barns in Clarion, Iowa, along with violations of new egg safety rules designed to curb SE, the Associated Press (AP) reported yesterday. The FDA detailed its findings in an Aug 14 warning letter addressed to Centrum Valley Farms, which took over management of farms owned by Jack DeCoster. DeCoster's Iowa operations were linked to the national outbreak, and he has been linked to repeated food safety violations. FDA officials inspected the Clarion facility from Apr 30 to May 4 and said Salmonella Heidelberg was also detected during the previous outbreak investigation and poses a public health threat. The FDA said the company has been working with the agency to address the situation. As an example of egg-rule violations, the FDA said the company's written plan didn't adequately cover environmental testing of pullet areas or measures to remove dust, feathers, and old feed from areas that tested positive for SE. It asked Centrum Valley Farms to respond to the concerns in 15 days. In a letter the company sent to the AP, it said the detection of Salmonella Heidelberg didn't mean the eggs were contaminated, but as a safeguard the company withheld them from market until they tested negative four times and were cleared by the FDA. The letter said the company has taken corrective actions and is working on a response to the FDA.
Sep 9 AP story
Aug 14 FDA warning letter

Cholera burden grows in Sierra Leone
With Sierra Leone's number of cholera cases and deaths rising, its health ministry and partners are stepping up response efforts, the World Health Organization (WHO) said Sep 8. So far 16,360 cases have been reported, an increase of 2,426 since the last update on Aug 30. The number of deaths has climbed to 255, up 23. The WHO said response efforts will emphasize detecting cases early and providing timely treatment. Infections are being managed in cholera treatment units and isolation areas. So far the outbreak has affected 12 of Sierra Leone's 13 districts, with about 60% of new cases reported from the western part of the country, where the capital Freetown is located. Last week United Nations groups, including the WHO, warned that cholera outbreaks in West Africa, including the one in Sierra Leone, could worsen during the rainy season.
Sep 8 WHO statement

DoD issues stop-work order for 2 Ebola drug candidates
A stop-work order from the US Department of Defense (DoD) has placed two developers of Ebola drugs in limbo, Nature News reported last week. Massachusetts-based Sarepta Therapeutics and Canada's Tekmira Pharmaceuticals, both of which are researching injectable drugs that interfere with Ebola virus replication, received a stop-work order Aug 2 from the DoD. The order prevents the companies from buying research supplies or changing the course of ongoing trials. The DoD plans to "evaluate each contractor's efforts independently to determine the plan for moving forward with the development of the best drug candidate possible," according to the story, but the now 5-week pause has created uncertainty as the disease has resurged in Uganda and the Democratic Republic of the Congo after no major global outbreaks since 2009. "The stop-work order is a big issue because you are taking two of the three most promising technologies off the table temporarily," said virologist Thomas Geisbert, PhD, of Tekmira. "The challenge we have with this virus is that it can be weaponized," added Chris Garabedian, president and CEO of Sarepta.
Sep 7 Nature News story

IDSA updates strep throat guidance
In updated guidelines today for treating streptococcal pharyginitis, the Infectious Diseases Society of America (IDSA) said most sore throats are caused by viruses and don't require antibiotics. After group A Streptococcus is confirmed with testing, patients should be treated with penicillin or amoxicillinÑif the patient is not allergicÑinstead of azithromycin or cephalosporin, according to an IDSA press release. The guidelines also recommend that children treated for recurrent strep throat not have their tonsils removed only to reduce the frequency of infections. Roughly 15 million Americans visit doctors each year for sore throats, and as many as 70% receive antibiotics, despite the fact that only 20% to 30% of children and 5% to 15% of adults have streptococcal infections, according to the IDSA. Patients who have a sore throat alongside cough, runny nose, hoarseness, and mouth sores likely have a viral throat infection and do not need to be tested for Streptococcus, the society said. Sore throats from streptococcal pharyginitis are more likely to come on suddenly, be accompanied by painful swallowing, and have a fever in the absence of viral sore throat symptoms. For those who test negative on a rapid test, the guidelines recommend follow-up throat culture for children and adolescents but not adults. Stanford Shulman, MD, lead author of the guidelines, said the revised guidance is aimed at avoiding inappropriate antibiotic use, which contributes to drug resistance, especially in the broader-spectrumÑand more expensiveÑmacrolides, including azithromycin.
Sep 10 IDSA press release
Sep 9 Clin Infect Dis clinical practice guidance

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