Wednesday, October 22, 2014
Inquirer Daily News

Other pathogens also found in NIH room

WASHINGTON - Federal officials found more than just long-forgotten smallpox samples recently in a storage room on the National Institutes for Health campus in Bethesda, Md. The discovery included 12 boxes and 327 vials holding an array of pathogens, including the virus behind the tropical disease dengue and the bacterium that can cause spotted fever, according to the Food and Drug Administration, which oversees the lab in question.

"The fact that these materials were not discovered until now is unacceptable," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research (CBER), told reporters Wednesday. "We take this matter very seriously, and we're working to ensure that this doesn't happen again."

The disclosure came hours after Thomas Frieden, director of the Centers for Disease Control and Prevention, testified on Capitol Hill that researchers at the agency mishandled live anthrax and other deadly pathogens in a string of problems in recent years. "We missed a critical pattern," he told lawmakers. "And the pattern is an insufficient culture of safety."

Both the smallpox discovery and the previously undisclosed safety lapses at the CDC have sowed doubt about how the nation's premier public health and research institutions are safeguarding some of the most lethal organisms on Earth.

The vials of smallpox, a scourge that was eradicated decades ago after killing hundreds of millions in the 20th century alone, remain the most disturbing find this month inside the third-floor cold storage room in Building 29A. Those samples were flown to the CDC in Atlanta, and at least two have shown growth in tissue cultures, meaning they are viable, or alive.

On Wednesday, the FDA said that along with dengue and rickettsia, the bacterium that can cause spotted fever, the additional vials contained such microbes as influenza and Q fever, a bacterium that can cause complications with the heart, lungs, and liver. The samples were in well-packed, heat-sealed vials and showed no signs of leakage. No evidence exists that anyone has been exposed to the pathogens, the agency said.

"The reasons why these samples went unnoticed for this long is something that we're actively trying to understand," said Peter Marks, CBER's deputy director, adding that the boxes were in a seldom-accessed storage area.

Agency officials said 32 of the samples were destroyed at an NIH facility. An additional 279 were transferred to the Department of Homeland Security's National Biodefense Analysis and Countermeasures Center in Maryland. No additional smallpox samples were found.

The FDA said the collection "was most likely assembled between 1946 and 1964 when standards for work with and storage of biological specimens were very different from those used today."

The smallpox vials were labeled with a date - Feb. 10, 1954 - Frieden said last week, adding that it appeared that whoever left them at NIH "didn't do so out of malice."

The FDA said Wednesday that it was reviewing its safety protocols and digging through all other similar storage rooms, at its headquarters and nationwide, to make sure no more vials are tucked away in forgotten corners.

Frieden was summoned before a House Energy and Commerce subcommittee about last month's incident in which more than 80 CDC employees may have been exposed to live anthrax when samples were transferred from one lab to others. The agency said last week that there had been at least four other incidents in the last decade in which deadly pathogens were mishandled, including one in which employees mistakenly sent a sample contaminated with the deadly H5N1 influenza virus to government researchers in Georgia. None of those incidents had been previously disclosed.

Rep. Fred Upton (R., Mich.), noting that Frieden had made similar promises to improve safety and accountability in the wake of previous incidents, asked, "Why should we believe you this time that things are going to be different?"

Brady Dennis and Lena H. Sun Washington Post
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