Synthetic Biology and the Chem/Bio Threat
Synthetic biology, a set of technologies related to the design and fabrication of biological systems, poses an emerging hazard but also provides the tools to mitigate that hazard, according to a new DoD report to Congress on defense against chemical and biological (CB) weapons.
The new report “assesses DoD’s overall readiness to fight and win in a CB warfare environment.”
“Rapid advancements in technology are making it easier for an adversary, whether State or non-State, to develop chemical and biological weapons. This includes threats from non-State actor groups such as the Islamic State of Iraq and Syria (ISIS) and emerging threats like the misuse of synthetic biology.”
Although the technologies that comprise synthetic biology represent a growing threat, “we cannot look to constrain the technologies themselves as a means of risk mitigation, or we risk stalling our own research and development (R&D) programs that use those technologies to develop life-saving countermeasures.”
“Synthetic biology is critically important to the development of medical countermeasures (MCMs), detection technologies, materials for protective equipment, and other technologies with applicability to CBR [chemical / biological / radiological] defense,” the report said.
“The Department must be positioned to both leverage synthetic biology opportunities as well as address the potential for nefarious use of biotechnology, such as enhancing select agents or the engineering of novel pathogens.”
In fact, “the majority of CB [defense] programs utilize some aspect of synthetic biology. Current examples include the development of Filovirus vaccines and therapeutics, the development of the recombinant plague vaccine, novel approaches to overcome antibiotic resistance, and the rapid development of monoclonal antibody therapies.”
See Department of Defense 2017 Annual Report to Congress on Chemical and Biological Defense Program, March 2017, released under the Freedom of Information Act on May 25, 2017.
The Chemical and Biological Defense Program (CBDP) acquired nearly 200,000 smallpox vaccines and more than 500,000 anthrax vaccines, DoD reported. The military services distributed and administered them “as needed to support operations.”
The Program has also contributed to development of medical countermeasures against other CB threats.
“The CBDP-supported Ebola vaccine was granted Breakthrough Product Status by the FDA and European Medicines Agency (EMA),” the DoD report said. “This vaccine is the first to have demonstrated efficacy against Ebola in humans.”
However, funding constraints limit such progress. “The combination of evolving CB threats, reduced budgets, and uncertain fiscal futures forces the CBDP to focus its limited resources to address the highest priorities and greatest risks.” (See, relatedly, “Trump’s Proposed Budget Cuts Trouble Bioterrorism Experts” by Emily Baumgaertner, New York Times, May 28.)
The DoD report emphasized that “No individuals have been used as subjects of any CB agent tests in the United States since 1975.”
“Human biological agent testing ended on November 25, 1969, and human chemical agent testing ended on July 25, 1975. The Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) continues to work with the Department of Veterans Affairs to identify and locate previous human test subjects so they can receive appropriate attention.”
Report Details DoD Chem/Bio Defense Programs
Last year the Food and Drug Administration approved a new drug to be used as a countermeasure against Yersinia pestis, the biological agent that causes bubonic plague. The drug was developed with funding from the Department of Defense Chemical and Biological Defense Program (CBDP).
DoD described its research and development activities on defense against chemical and biological threats in a new 2016 annual report to Congress, which was released today under the Freedom of Information Act.
DoD’s work in this area is intended to provide “the necessary capabilities to deter, prevent, protect from, mitigate, respond to, and recover from” the use of chemical or biological (CB) agents in warfare.
“The DoD faces CB threats that are complex, diverse, and pose enduring risks to the Joint Force and Homeland,” the new report said. “The variety, origin, and severity of these threats continues to grow while resources shrink.”
DoD said it performed basic research in genetic engineering and nanoelectromechanical systems related to defense against CB threats, and supported the response to the Ebola outbreak in West Africa, among other initiatives.
Although DoD conducts or supports clinical trials of new medications, “No individuals have been used as subjects of any CB agent tests in the U.S. since 1975,” the reportsaid. “Human biological agent testing ended on November 25, 1969, and human chemical agent testing ended on July 25, 1975.”
But program safety is a continuing challenge. As previously reported, last year “the DoD became aware that viable Bacillus anthracis spores, believed to have been inactivated, had been shipped from a DoD laboratory. The DoD rapidly responded by implementing a moratorium on the production, handling, testing, and shipment of inactivated anthrax.”
The scope of chem/bio defense research is expected to shrink due to budget reductions. “The combination of evolving CB threats, reduced budgets, and uncertain fiscal futures forces the CBDP to focus its limited resources to address the highest priorities and greatest risks,” the report said. “This environment translates into increasingly complex program management decisions with no margins for error due to a lack of sufficient and predictable resources.”
The latest reported use of chlorine gas by Syrian government forces in the city of Aleppo is a reminder that chemical warfare is not simply a relic of a primitive past, but an actual reality today.
Examining Global Biosecurity Engagement Programs
Global biosecurity engagement programs are designed to prevent the harmful use of biological agents and pathogens. It is difficult to measure the effectiveness of these programs in improving biosecurity given that there have been relatively few attempts to misuse the life sciences. Metrics that focus on outputs (what was done) as opposed to outcomes (the impact of what was done) have not been helpful in determining how these efforts might be improved in the future. As a result, the goals of the programs have traditionally been more quantitative in nature – for example, increasing the number of agents secured and number of scientists engaged. Broadening the scope of biosecurity engagement metrics can help align program goals with a more qualitative approach that prioritizes the international partners’ global health security.
To understand how biosecurity engagement is conducted and evaluated, Michelle Rozo, Ph.D. candidate at Johns Hopkins University, interviewed more than 35 individuals in the United States and abroad (including government officials and their non-governmental partners) regarding current and future programs that can be used to create a cohesive, global health system approach to biosecurity. The results from the interviews are complied in an issue brief which also provides a strategy for policymakers to focus more on qualitative public health outcomes instead of quantitative security outputs. With this strategy, programs will cost less and be more effective in reducing global threats.