Healthcare Business News

CDC faces torrent of criticism over anthrax, other mishaps

By Steven Ross Johnson
Posted: July 16, 2014 - 3:15 pm ET

Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, on Wednesday called incidents involving the mishandling of dangerous biological materials at federal research laboratories a “pattern of safety issues” that was missed and vowed to correct the “insufficient culture of safety” that apparently developed at the agency regarding the use of such pathogens.

Frieden was in Washington speaking before the House Energy and Commerce subcommittee on the recent safety lapses discovered at CDC labs involving such biological agents as anthrax and deadly strains of avian influenza virus.

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Committee members from both sides of the aisle took turns criticizing the CDC for a number of safety breaches that have occurred over the past decade. The most recent occurrence involved live anthrax that was unknowingly shipped from one CDC lab to another, potentially exposing more than 80 employees to the deadly pathogen.

Operations at two agency laboratories have been temporarily halted and the transfer of all biological materials in or out of labs has been suspended until a full review has been completed, Frieden said.

“The CDC is supposed to be the gold standard of the U.S. public health system and it has been tarnished,” said subcommittee chairman Rep. Tim Murphy (R-Pa.). “We rely on CDC to protect us and uphold the highest standards of safety, but the recent anthrax event and newly disclosed incidents have raised very serious questions about CDC's ability to safeguard properly selected agents in its own labs.”

Details about the incident was disclosed by the CDC in a report released last week, where several missteps related to the storage, use, transfer and sterilization of biological agents were cited.

In a memo released Monday (PDF), lawmakers detailed the findings of a separate investigation conducted by the U.S. Food and Drug Administration's Animal and Plant Health Inspection Service, which discovered a series of safety issues that included missing anthrax containers, the transfer of live anthrax that was put in zip-close plastic bags and deadly biomaterial that was stored in easily accessible, unlocked refrigerators in unsecure areas.

The CDC since has identified four other incidents of safety breaches that have occurred over the past decade. An occurrence that took place six weeks ago but was reported only last week involved a nonpathogenic form of bird-flu virus that was mistakenly contaminated with a pathogenic strain of H5N1 influenza and then shipped to another CDC laboratory.

Such events have raised broader questions over a seeming lack of national standards and oversight regarding the use of biological materials in light of the increased use of such agents in labs throughout the country over the decade.

“Since 2001, there have been an increasing number of bio-safety laboratories across the whole government in six or seven different agencies,” Nancy Kingsbury, managing director of Applied Research and Methods for the U.S. Government Accountability Office, said before the congressional panel. “No one entity has been charged with (developing) a strategic (safety) plan.”

In written testimony submitted to the committee (PDF), Kingsbury stated the need for a more unified strategy. Lab bio-safety has been the topic of a number of reports the GAO has issued in past years, which called on a government plan to develop requirements for laboratories using such agents.

Follow Steven Ross Johnson on Twitter: @MHsjohnson

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