FDA found more than smallpox vials

Health & Science
FDA found more than smallpox vials in storage room

By Brady Dennis July 16 at 4:57 PM

Federal officials on Wednesday revealed they found more than just long-forgotten smallpox samples in a storage room on the National Institutes for Health campus in Bethesda. The discovery actually included 12 boxes and 327 vials holding an array of dangerous pathogens, including the tropical disease dengue and the bacteria that can cause spotted fever, according to the Food and Drug Administration, which oversaw 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 vials containing smallpox, a scourge responsible for hundreds of millions of deaths, clearly remain the most troubling toxin found inside the third-floor cold storage room in Building 29A earlier this month. Those samples where flown to the Centers for Disease Control and Prevention, where at least two have shown growth in tissue cultures, meaning the samples are viable, or alive.



The administrative building of the National Institutes of Health in Bethesda, Md: Hundreds of other potentially dangerous pathogens were in forgotten boxes on NIH campus. (J. Scott Applewhite/Associated Press)
By Brady Dennis July 16 at 4:57 PM

Federal officials on Wednesday revealed they found more than just long-forgotten smallpox samples in a storage room on the National Institutes for Health campus in Bethesda. The discovery actually included 12 boxes and 327 vials holding an array of dangerous pathogens, including the tropical disease dengue and the bacteria that can cause spotted fever, according to the Food and Drug Administration, which oversaw 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 vials containing smallpox, a scourge responsible for hundreds of millions of deaths, clearly remain the most troubling toxin found inside the third-floor cold storage room in Building 29A earlier this month. Those samples where flown to the Centers for Disease Control and Prevention, where at least two have shown growth in tissue cultures, meaning the samples are viable, or alive.

Still, the FDA’s disclosure Wednesday about the quantity and nature of other samples that were found underscored questions about the government’s ability to properly account for the amount of potentially-deadly pathogens in its own labs.

“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. “Our goal is to understand what happened and take the appropriate actions to make sure something like this never happens again.

The FDA said that in addition to dengue and rickettsia, which can cause spotted fever, the vials contained such organisms such as influenza and Q fever, a bacteria that can cause complications with the heart, lungs and liver.

Agency officials said 32 of the samples were destroyed at an NIH facility. Nearly 300 were transferred to the Department of Homeland Security’s National Bioforensic Analysis Center. No additional smallpox samples were found.

The FDA said investigators from numerous agencies are working to figure out the origins of the samples discovered in Building 29A, but that 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 themselves were labeled with a date — Feb. 10, 1954 — CDC director Thomas Frieden said last week, adding that whoever left them at NIH “didn't do so out of malice.”

Wednesday’s disclosure came hours after Frieden himself traveled to Capitol Hill to explain how researchers at the agency mishandled live anthrax and other deadly pathogens in a string of mishaps in recent years. “We missed a critical pattern,” Frieden told lawmakers. “And the pattern is an insufficient culture of safety.”

FDA officials said the hundreds of samples found earlier this month were stored in glass, heat-sealed vials that were well packed and showed no signs of leakage, and that no evidence exists that anyone has been exposed to the pathogens.

The FDA said Wednesday that it is in the process of reviewing its protocols and plans to put in place measures to ensure that potentially hazardous samples are not overlooked in the future. In the meantime, agency are digging through all other similar storage rooms to make sure no more surprise vials are tucked away in forgotten corners.

Researchers work in a cell culture unit: The first vaccine against dengue fever, from France's Sanofi, provided moderate protection in a large clinical study, but questions remain as to how well it can help fight the world's fastest-growing tropical disease. (Robert Pratta/Reuters)

“The commissioner has asked that we sweep common cold storage facilities,” Marks said, “not just on the main campus but also satellite facilities around the country.”

Lena Sun contributed to this report



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