Official Cites Progress in WMD Countermeasure Development

Dale Klein, assistant secretary for nuclear, chemical and biological defense programs, testified before the House Subcommittee on National Security, Emerging Threats and International Relations on the department's efforts to develop and acquire countermeasures to weapons of mass destruction. The subcommittee is part of the House Committee on Government Reform.

In his prepared statement, Klein described the process by which DoD identifies, prioritizes, develops and acquires countermeasures to current and future threats.

Klein said DoD's strategy focuses on robust and agile capabilities. "This strategy drives a top-down, competitive process that enables the secretary to balance risk across the range of complex threats facing military personnel, to balance risk between current and future challenges, and to balance risk within fiscal constraints," he said.

Key capabilities within the chemical and biological defense program are structured within the operational elements he described as "Sense, Shape, Shield and Sustain."

"Sense includes advanced remote sensing, standoff detection and identification systems," he explained. "Shape includes battlespace management, including modeling and simulation and the communication and decision systems to make appropriate responses and plans. Shield includes collective and individual protection and preventive medicines, such as vaccines. Sustain includes capabilities for decontamination and medical diagnostics and therapeutics."

Klein cited several examples of progress, beginning with the Food and Drug Administration's approval in 2003 of using pyridostigmine bromide to increase survival exposure to soman nerve poisoning. Four months ago, Klein said, the FDA approved the DoD vaccinia immunoglobulin used to treat adverse events following smallpox immunization. In March, he added, a contract award was made for developing a chemical agent, bioscavenger, for a pre- or post-exposure treatment of nerve-agent exposure, and this year clinical trials will begin for a multivalent botulinum vaccine for stereotypes A and B, a plague vaccine, as well as a vaccine for Venezuelan equine encephalitis.

"It's important to note that some of the medical countermeasures currently being developed through the National Institute of Allergy and Infectious Diseases for the national stockpile had their technology basis in programs which initially began in the Department of Defense," he said. "Examples of this are the next-generation anthrax vaccine and cell culture-derived smallpox vaccine."

Based on a recent DoD study that indicates the need for a long-term investment strategy, Klein said, senior officials agreed to increase the investment for WMD countermeasures by $2.1 billion for fiscal 2006 through 2011. The increase includes $1.3 billion for the chemical and biological defense program, as well as an additional $100 million for biological warfare medical countermeasure initiatives.

"These medical countermeasures initiatives will apply transformational approaches which leverage our genomics, proteomics and systems biology data exploitation," he said.

Klein said DoD chemical and biological defense program activities are informally coordinated with the Department of Health and Human Services, the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention.

"A critical aspect of interagency coordination is DoD support for Project BioShield," he said, "a program to speed the development of new vaccines and treatments against biological agents that could be used in a terrorist attack on the United States.

"The first project that DoD may be able to transition to the Department of Health and Human Services under Project BioShield is a plasma-derived bioscavenger for pre- and post- exposure treatments of nerve agent exposure," Klein continued. "The department has already awarded an initial contract for Phase 1 clinical trials, at which point DHHS would be expected to assume advanced development through FDA licensure under the BioShield authority." The chemical and biological defense program budget provides a balanced investment strategy which includes procurement of capabilities to protect U.S. forces in the near term, investment in advanced development to protect U.S. forces in the mid term, and investment in the science and technology base to protect U.S. forces in the far term and beyond, Klein said.

"As we look to the future, our main concern is a bio-engineered threat to our men and women in uniform," he told the legislators. "Our main task continues to be to provide the best technology to the warfighter in the most expeditious and most efficient manner possible."