In March researchers at the U.S. Department of Agriculture received a shipment of what they thought was a relatively harmless strain of animal flu from the U.S. Centers for Disease Control and Prevention. It was, in fact, highly pathogenic H5N1 flu virus. Months later the researchers only began to suspect something was amiss when their experiments yielded results that they didn’t expect and couldn’t explain. The CDC, it turns out, had sent the deadly samples inadvertently.



The flu virus shipment was the third recent mistake by a government lab in handling dangerous pathogens. Last month a CDC lab prepared anthrax samples but failed to inactivate the bacterium. And 10 days ago six vials of smallpox, arguably the most dangerous known virus, were discovered in a box in an unsecured storage room at the National Institutes of Health (NIH) campus in Bethesda, Md.



The incidents are a “wake-up call” that raise “serious and troubling questions” and underscore potentially pervasive problems with oversight, reporting and adherence to safety protocols, said CDC Director Tom Frieden at a press conference. “Frankly, I’m angry about it,” he said. “These incidents should never have happened.”



The latest incident came to light as part of a dispatch from federal officials investigating the problems that led to some 75 federal employees’ potential exposure to live anthrax last month. The CDC announced today it is issuing an immediate halt on the transfer of all biological materials into or out of its high-level biosafety facilities pending a review by an advisory committee. The action will not extend to other agencies’ high-level labs.



The H5N1 flu incident, which the CDC discovered in the course of its post-anthrax investigation, entailed a relatively safe avian influenza being unintentionally contaminated at a CDC lab with a highly pathogenic H5N1 strain of influenza. On March 13 the CDC shipped that hazardous material to a facility operated by the Agriculture Department (USDA). Although the USDA lab in Athens, Georgia, was a high-level biosafety level 3 facility that required workers to shower in and out and wear respiratory protection, the lab was not supposed to have received that sample and did not have adequate clearance to handle that level of hazardous material. No workers are believed to have been exposed to the substance.



Frieden claimed that he did not hear about the incident until two days ago—an “unacceptable delay,” he says.



The recent anthrax debacle occurred June 5 when workers were preparing live Bacillus anthracis at a lab that did not follow mandated protocols to inactivate the bacterium. Because the anthrax was not properly killed, workers who received materials from that laboratory may have been unintentionally exposed to the deadly pathogen. No employees have become ill with anthrax symptoms. The CDC today said that it is possible that staff members were exposed to anthrax but “extremely unlikely.” “This is not the first time an event of this nature has occurred at CDC nor the first time it occurred from the [laboratory where the anthrax incident occurred],” the CDC noted in a new report, released today. The Centers are aware of four other such incidents in the past decade at the laboratory. The facility is now closed, the report notes.



On July 1 six-decade-old vials of smallpox virus that had been tucked away in a cold room were discovered at a U.S. Food and Drug Administration laboratory on the NIH campus. Smallpox was eradicated 35 years ago, yet two sites—one at the CDC and the other in Russia—are permitted to hold samples. The newly discovered vials were sent to the CDC for further testing. Frieden announced today that their testing has revealed that smallpox in at least two of the vials was alive and has been successfully grown in the lab—underscoring that smallpox is viable for decades. After the CDC completes its testing it will destroy all the samples, he says.



Some NIH employees have criticized the agency for not moving more quickly to tell its staff about the vials when they were discovered. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told National Public Radio’s Diane Rehm in an interview yesterday, “The most important thing to do was to get it secured and get it out of there to CDC, who could examine it and do the destruction.”



A House congressional panel this week announced plans to examine the smallpox and anthrax issues at a hearing next week where Frieden will be testifying.



The CDC report found that both a lackluster oversight system and inadequate standard protocols to document when biological agents are properly inactivated unnecessarily puts CDC employees at risk. In addition to the agency’s moratorium on the movement of biohazardous materials at biosafety level 3 and level 4 facilities, the agency also plans to establish a high-level working group that will report directly to Frieden. It will oversee improvements in safety on a lab-by-lab basis.



In addition, the CDC plans to establish an external advisory group for lab safety and has initiated its investigation into the H5N1 incident. It also plans to discipline anyone who knowingly violated protocols or failed to report a lab incident. “We have to work with these flu viruses, that is how we can understand them,” says Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “What’s more important is we have to be able to do this safely. That’s really the key piece. We don’t want to stop this work.” These incidents have “become a very dark cloud on lab science,” he says. But, “what I am really hopeful for is whatever happened with CDC will be viewed as the shot heard round the world and all laboratories will be looking at these issues. This could just as easily have been one of them.”



To minimize future risk, ideally, the CDC wants to limit the number of facilities working with highly pathogenic strains in the long term, Frieden says. But in the shorter term its large-scale improvements in safety and oversight will help insure the safety of agency employees and the communities where they are situated.





