By Brian Finlay – In 1989, the Food and Drug Administration approved a new product for treating severe neck pain and involuntary muscle spasms. Heralded as a breakthrough in therapeutic medicine, the drug would go on to be assessed for the treatment of a variety of conditions, including migraine headaches, lower back pain, and the debilitating effects of cerebral palsy and strokes. For the public health community, the potential seemed limitless. But while its medical applications expanded significantly, BOTOX® would not become a household name until a decade later when it became approved by the FDA for cosmetic use.
Since achieving regulatory approval, it and an array of other legitimate pharmaceutical products both in the development pipeline in the United States, or for sale around the globe, have been monitored by drug regulatory agencies as any other. But these products are unique, representing a growing trend in pharmaceutical research and development, and illustrating the unprecedented opportunities-and threats-posed by the biotechnological revolution.
Containing minute quantities of “select agents”-compounds or bacteria that can potentially be used to create biological weapons-these products, their precursor materials, and the expertise to fabricate them are as interesting to potential bioterrorists as they are to health care providers. In the case of BOTOX® and despite a lack of legal regulation, movement of the product from acquisition of raw materials through research and development and then to injection in a patient is closely monitored by its manufacturer, which has both the financial and security incentive to do so. Unfortunately, as additional corporate players enter this growing market, the lack of public health regulations on similar products is creating a greater susceptibility for misuse. Unaccustomed to the lens of national security, health regulatory agencies in the United States and around the globe have systematically failed to recognize the serious potential for the diversion and misuse of conotoxins, tetrodotoxins, ricin, and other agents of proliferation concern.
The development of legitimate pharmaceutical products using select agents is a microcosm of the complexities now challenging US and international security. While the world is, in many ways, far better off than it has ever been as a direct result of biotech innovation, the specter of nefarious diversion and use of this technology for harm is both clear and present.
Several real-world incidents have provided impetus for concern. The dissemination of anthrax through the US postal system one month after 9/11 was a wake-up call to the nation. In 2004, four people were hospitalized after a disgraced physician acquired raw botulinum toxin and injected it into himself and three of his colleagues. Miraculously, all four individuals survived. Most recently, the discovery of ricin in a Las Vegas hotel room in February has raised questions about the ease of access, development, and refinement of potentially deadly biological agents even within America’s borders.
Perhaps most distressingly, one British pharmaceutical company currently seeking FDA approval in the United States has distributed its product-containing botulinum toxin type A-across the Islamic Republic of Iran. While the acquisition of pharmaceutical products by the Iranian government is impossible to prevent, the company’s decision to seek regulatory approval and conduct clinical trials in that country certainly involved the sharing of critical dual-use information with a government that has been accused repeatedly of biological weapons development. While the motivations in this case involve profit rather than hostile intent, the willingness of legitimate foreign companies to share sensitive data with state sponsors of terrorism, and the ease in which biological agents were obtained in our own country, raise serious questions about our capacities to control sensitive biological agents, toxins, and know-how.
Taken together, these incidents highlight US vulnerabilities to bioterrorism that have not been given sufficient consideration among non-traditional security agencies in the US government-much less our friends and allies around the globe. They also reveal the looming challenge that there are major gaps in biological agent control measures, importation practices and supply chain security in the United States and around the world at a time when terrorist groups are showing growing interest in pursuing a biological weapons capability.
A formidable challenge of globalization is the inability of governments to effectively monitor and regulate emerging products and technologies-and the increasing commitment of non-state actors to exploit these advances for nefarious purposes. A new report by the Cooperative Nonproliferation Program at the Stimson Center entitled Old Plagues, New Threats, uses industry’s growing interest in dangerous pathogens and toxins as therapeutic pharmaceuticals as a case study. The report also illustrates the full life-cycle of opportunities and threats-from research and distribution to injection into patients of products derived from select agents.
Photo Credit: Christine Balderas/istockphoto.com
Brian Finlay co-directs the Cooperative Nonproliferation Program, a multifaceted project designed to accelerate existing efforts and design innovative new initiatives aimed at more rapidly and sustainably securing nuclear, biological, and chemical weapons, materials, and expertise.
Pharmaceutical Terrorism—The Bane Of Biotech
By Brian Finlay – In 1989, the Food and Drug Administration approved a new product for treating severe neck pain and involuntary muscle spasms. Heralded as a breakthrough in therapeutic medicine, the drug would go on to be assessed for the treatment of a variety of conditions, including migraine headaches, lower back pain, and the debilitating effects of cerebral palsy and strokes. For the public health community, the potential seemed limitless. But while its medical applications expanded significantly, BOTOX® would not become a household name until a decade later when it became approved by the FDA for cosmetic use.
Since achieving regulatory approval, it and an array of other legitimate pharmaceutical products both in the development pipeline in the United States, or for sale around the globe, have been monitored by drug regulatory agencies as any other. But these products are unique, representing a growing trend in pharmaceutical research and development, and illustrating the unprecedented opportunities-and threats-posed by the biotechnological revolution.
Containing minute quantities of “select agents”-compounds or bacteria that can potentially be used to create biological weapons-these products, their precursor materials, and the expertise to fabricate them are as interesting to potential bioterrorists as they are to health care providers. In the case of BOTOX® and despite a lack of legal regulation, movement of the product from acquisition of raw materials through research and development and then to injection in a patient is closely monitored by its manufacturer, which has both the financial and security incentive to do so. Unfortunately, as additional corporate players enter this growing market, the lack of public health regulations on similar products is creating a greater susceptibility for misuse. Unaccustomed to the lens of national security, health regulatory agencies in the United States and around the globe have systematically failed to recognize the serious potential for the diversion and misuse of conotoxins, tetrodotoxins, ricin, and other agents of proliferation concern.
The development of legitimate pharmaceutical products using select agents is a microcosm of the complexities now challenging US and international security. While the world is, in many ways, far better off than it has ever been as a direct result of biotech innovation, the specter of nefarious diversion and use of this technology for harm is both clear and present.
Several real-world incidents have provided impetus for concern. The dissemination of anthrax through the US postal system one month after 9/11 was a wake-up call to the nation. In 2004, four people were hospitalized after a disgraced physician acquired raw botulinum toxin and injected it into himself and three of his colleagues. Miraculously, all four individuals survived. Most recently, the discovery of ricin in a Las Vegas hotel room in February has raised questions about the ease of access, development, and refinement of potentially deadly biological agents even within America’s borders.
Perhaps most distressingly, one British pharmaceutical company currently seeking FDA approval in the United States has distributed its product-containing botulinum toxin type A-across the Islamic Republic of Iran. While the acquisition of pharmaceutical products by the Iranian government is impossible to prevent, the company’s decision to seek regulatory approval and conduct clinical trials in that country certainly involved the sharing of critical dual-use information with a government that has been accused repeatedly of biological weapons development. While the motivations in this case involve profit rather than hostile intent, the willingness of legitimate foreign companies to share sensitive data with state sponsors of terrorism, and the ease in which biological agents were obtained in our own country, raise serious questions about our capacities to control sensitive biological agents, toxins, and know-how.
Taken together, these incidents highlight US vulnerabilities to bioterrorism that have not been given sufficient consideration among non-traditional security agencies in the US government-much less our friends and allies around the globe. They also reveal the looming challenge that there are major gaps in biological agent control measures, importation practices and supply chain security in the United States and around the world at a time when terrorist groups are showing growing interest in pursuing a biological weapons capability.
A formidable challenge of globalization is the inability of governments to effectively monitor and regulate emerging products and technologies-and the increasing commitment of non-state actors to exploit these advances for nefarious purposes. A new report by the Cooperative Nonproliferation Program at the Stimson Center entitled Old Plagues, New Threats, uses industry’s growing interest in dangerous pathogens and toxins as therapeutic pharmaceuticals as a case study. The report also illustrates the full life-cycle of opportunities and threats-from research and distribution to injection into patients of products derived from select agents.
Photo Credit: Christine Balderas/istockphoto.com
Brian Finlay co-directs the Cooperative Nonproliferation Program, a multifaceted project designed to accelerate existing efforts and design innovative new initiatives aimed at more rapidly and sustainably securing nuclear, biological, and chemical weapons, materials, and expertise.