FDA reports finding vials of other pathogens along with smallpox
In the wake of finding smallpox vials in a storage area earlier this month and a congressional hearing today on federal lab biosecurity (see related story), the US Food and Drug Administration (FDA) said the earlier discovery also included more than 300 vials of pathogens such as influenza and dengue viruses, as well as vaccinia, the smallpox vaccine.
The agency also said in a press release that it is in the process of scouring all its cold storage areas to ensure no other unreported pathogens are lurking.
"The investigation [into the smallpox find] found 12 boxes containing a total of 327 carefully packaged vials labeled with names of various biological agents such as dengue, influenza, Q fever, and rickettsia," the FDA said. "Upon the discovery of these vials on July 1, 2014, FDA employees followed standard protocol and turned them all over to the appropriate NIH safety program officials, who in turn transferred them to the appropriate investigative agencies, as per standard protocols."
The FDA did not specify the influenza strain or strains found. As noted previously, six of those vials were labeled "variola," which causes smallpox, and were transferred to a high-containment lab at the Centers for Disease Control and Prevention (CDC).
"In addition," the FDA noted, "32 samples were destroyed following inventory at the NIH facility, including 28 labeled as normal tissue and four labeled as 'vaccinia,' the virus used to make the smallpox vaccine. To be clear, vaccinia does not cause smallpox. These vials represented no value to forensic sciences and were destroyed according to standard protocols."
The remaining 279 samples were transported to the US Department of Homeland Security's National Bioforensic Analysis Center for safekeeping, the FDA said, adding, "The FDA received confirmatory information about the samples yesterday, thus permitting public disclosure of this additional information."
The vials were most likely collected between 1946 and 1964, and there was no evidence that anyone was exposed to the pathogens they contained, the agency said. Calling the lapse in lab security "clearly unacceptable," the FDA said it has begun a thorough search of all common cold storage areas and is reviewing its policies and procedures.
Jul 16 FDA news release
Experts puzzled by increase in shingles cases
For unclear reasons, shingles cases have been rising in the United States, despite the availability of a vaccine, according to experts quoted recently in the Sacramento Bee.
Cases have been increasing steadily since the 1990s, Ben Balatbat, MD, an infectious-disease specialist and chairman of the Internal Medicine Department at Mercy Medical Group in Sacramento, told the newspaper.
Rafael Harpaz, MD, a CDC medical epidemiologist, said shingles infections have been rising in most age-groups, not just in people older than 60 and those with weakened immune systems, according to the story.
Shingles, caused by the varicella zoster virus, occurs only in those who have had chickenpox or, less commonly, the chickenpox (varicella) vaccine, the story notes. After lying dormant for years, the virus can attack nerve cells, causing pain that is often severe. Unlike chickenpox, shingles can hit a person more than once.
The shingles vaccine cuts the risk of disease in half and reduces the chance of complications, but most people don't receive it, the story notes. Balatbat said the injection is expensive and often not covered by insurance. Pharmacies in the Sacramento area said they sell it for $200 to $250 a dose.
The FDA has approved the vaccine for people 50 and older, and the CDC recommends it for those 60 and older. Because of the age-group recommendation, many insurance companies don't cover it for those younger than 60, the story said.
Harpaz and colleagues found that young people are the only age-group in which shingles is not increasing, the story said. It didn't define the specific age range.
About 1 million shingles cases occur in the United States annually, and nearly 1 of 3 people will get the disease in their lifetime, according to the CDC.
Jul 14 Sacramento Bee story
CDC information on shingles
USDA proposes record-keeping rule for makers of ground beef
The US Department of Agriculture's Food Safety and Inspection Service (FSIS) issued a proposed rule today that would require all retail outlets that grind their own beef to keep records of their meat sources to enable efficient tracing in case of a foodborne disease outbreak.
"The improved traceback capabilities that would result from this proposal will prevent foodborne illness by allowing FSIS to conduct recalls of potentially contaminated raw ground products in a timelier manner," said USDA Deputy Under Secretary for Food Safety Brian Ronholm in an FSIS news release.
The rule specifies that records to be kept include bills of sale, invoices, bills of lading, and receiving and shipping papers. Records must also include "the name or description of the livestock or article, the net weight of the livestock or article, the number of outside containers, the name and address of the buyer or seller of the livestock or animal, and the date and method of shipment."
"FSIS has concluded that recordkeeping by retail facilities that grind raw beef to date, has not been sufficiently effective," the agency said in the release. "This proposal is in keeping with the agency's latest efforts to target its food safety prevention tools at areas that will have the most significant public health impact." It specified the Salmonella Action Plan introduced in December 2013 as an example.
The public will be allowed to comment on the rule for 60 days after it is posted in the Federal Register.
Jul 16 proposed rule
Jul 16 FSIS news release
Experts: Chikungunya likely to remain a problem in Americas
Chikungunya is likely in the Americas to stay, at least for a time, according to leading US government scientists, and it might have parallels with an outbreak in the 1820s that at the time was blamed on dengue, a similar mosquito-borne disease.
The scientists, from the National Institute of Allergy and Infectious Diseases (NIAID), wrote a perspective article today in the New England Journal of Medicine on the current outbreak, which is now approaching 400,000 cases. Anthony Fauci, MD, NIAID director, and David M. Morens, MD, senior advisor to Fauci, compare the chikungunya epidemic to when dengue first gained a US foothold in 2008.
In addition to a similarity in the mode of infection—typically via the bite of an Aedes aegypti mosquito—chikungunya and dengue produce a similar clinical picture. The main distinguishing feature is the debilitating joint pain associated with chikungunya, which often recurs even a year after infection. Chikungunya also has a low incidence of asymptomatic infection, which can surpass 50% with dengue.
Morens and Fauci note that chikungunya may well have caused a pandemic that involved parts of the Western Hemisphere in the 1820s. Historians first attributed the outbreak to dengue because chikungunya was unknown at the time.
"The course of the burgeoning [current chikungunya] epidemic in populations not previously exposed to alphaviruses offers little room for optimism: the growing number of imported cases in the Americas raises concerns about possible future local transmission," they write.
"The possibility that the Western Hemisphere may actually have experienced a chikungunya pandemic in the past is hardly reassuring."
Without effective medication or a vaccine, they write, the outbreak must be addressed with standard public health steps such as mosquito control and avoidance. And, they add, we can only hope that the epidemic declines and the virus leaves the hemisphere, something it may have done nearly two centuries ago.
Jul 16 N Engl J Med perspective
