Since the attacks of September 11, 2001 and the subsequent dissemination of anthrax through the United States postal system, bioterrorism prevention and response strategies have received unprecedented attention. Beyond the obvious security challenge of global terrorism, perhaps no other threat has approached the level of concern or complexity than has the widespread recognition of emerging infectious diseases as a global threat to security. Bioterrorism strategies have been developed and strengthened alongside those to combat infectious diseases and include US domestic regulation to control access to high-consequence pathogens and toxins, as well as multilateral measures which seek to prevent the unlawful development and use of biological materials, technology and weapons.
The existing strategies are a beginning. But as research and development in the life sciences advances, so too must our strategies to manage the misuse of that research. With the vast majority of innovation occurring in the private sector, new partnerships with the biotechnology and pharmaceutical industries are more critical to national security than at any other point in history.
In February 2006, the Managing Across Boundaries Program at the Stimson Center undertook an examination of the myriad issues surrounding the misuse of biologics in our country and abroad. There has been extensive research on dual-use pathogens and toxins. But there has been far less on the role of the growing biologics industry in future opportunities for bioterrorism, and the vulnerabilities associated with our inability to track dual-use biological agents and toxins used in the manufacture of medical and pharmaceutical products, including those related to counterfeiting, reimportation, diversion and misuse.
The deadly implications of counterfeit drugs are well understood to be a central challenge to the integrity of public health systems around the globe, as well as a direct threat to our individual health and welfare. What is less understood is that the profits from this sinister crime are increasingly being co-opted by an array of organized criminal groups and terrorist entities as a means by which to fund their nefarious operations around the world.
From a public health perspective, there is much to celebrate among the many competing health care reform proposals that have been offered on Capitol Hill. Yet one underlying and potentially worrisome subtext to almost all existing reform options is a continued lack of recognition of the growing link between public health and national security. Legislative decisions being made today on health care reform could have a deleterious impact on US efforts to address the growing threat of bioterrorism.
The benefits of biotechnology have brought unprecedented advances in global development. But a formidable challenge of globalization is governments’ inability to effectively monitor and regulate these emerging technologies–and the increasing commitment and wherewithal of non-state actors to use these advances for hostile purposes. This report uses as a case study industry’s growing interest in dangerous pathogens and toxins as therapeutic pharmaceuticals. It illustrates the full life-cycle of threats and opportunities from research to distribution to injection into patient of products derived from select agents.
Recommendations from Old Plagues, New Threats
|Protecting the Homeland: A Comprehensive Plan for Cradle-to-Grave Tracking of Dangerous Pathogens and Toxins|
SECURING BULK MATERIAL
Develop and implement a system to track the distribution of bulk biological materials produced domestically or imported from foreign manufacturers.
Ensure that manufacturing and distribution facilities/institutions that possess, use and transfer pathogenic micro-organisms and toxins have adequate biosecurity measures in place to safeguard against theft and diversion.
ENSURING SECURITY DURING RESEARCH, DEVELOPMENT AND PRODUCTION
|Public health and biosecurity strategies must account for new trends in the pharmaceutical industry, particularly with respect to the use of select agents. Anti-counterfeiting strategies need to be tightened and better coordinated. Pedigree requirements for pharmaceutical products should be standardized across the country and ultimately across the globe, and due to their unique characteristics, particular attention should be given to those products which bear or contain select biological agents and toxins. Relevant industry representatives should be involved in the development of these standards.|
TRACKING FINISHED PRODUCT
|Given the deficiencies in current tracking systems in the US and the emerging threat posed by products that are, bear or contain select agents, a need for a solution is clear. The potential use of biological agents and toxins to incite mass panic in the United States should motivate government officials to utilize all means available to track, trace and secure the movement of both raw toxin and prescription products.|