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Appendix B
Inventory of Chemical and Biological
Defense Technology, with
Gap and Overlap Analysis
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Gap And Overlap Analysis
A wide variety of sources were used in assembling the above inventory. The initial meeting of the committee in July of 1997 provided an overview of important organizations and R&D programs within the federal government. Follow-up with the briefers provided a more detailed list of projects and points of contact for technical information. The Office of Emergency Preparedness shared information on promising technology from its files, and of course the committee members themselves contributed both personal contacts and specific information from their own files and experience. The World Wide Web provided much information about both relevant commercial products and R&D activity, and the following databases were accessed and searched: National Technical Information Service, Defense Technical Information Center, Federal Research in Progress, Federal Conference Papers, Medline, MedStar, HSRProj.
Although we are still actively seeking additional information on many of the technologies already located, information on the products in the above inventory was distilled from a ProCite database of more than 430 records and entered into a series of databases, a description of which constitutes this gap and overlap analysis. In the process, we eliminated most products or R&D that did not explicitly address military chemical or biological agents or appear to be sufficiently generic in nature to encompass those agents without a major change. Exceptions were made only in categories in which there were very few or no products or R&D explicitly directed at chemical and biological weapons. We also excluded technology represented in our database by only a single experiment, journal article, or SBIR contract (i.e., we focus on products and R&D programs).
The overall organization of the inventory roughly parallels that of the interim report: Separate sections address detection (in the environment, and in patient fluids), detection of a covert attack in a population (Epidemiology), protection, decontamination, treatment, psychological effects, and computer software. The inventory has no sections on pre-incident intelligence or safe and effective patient extraction, because we uncovered no relevant products or research (we recognize that there is a great deal of intelligence activity devoted to prevention of terrorism, but our task is to address consequence managementour inclusion of a pre-incident intelligence section in the interim report was solely to make the point that whatever the readiness of the civilian medical community, any pre-incident warning will amplify effectiveness manyfold). An additional difference from the interim report organization is a section on computer models. The inventory includes a source for the products or the laboratory and PI performing the research, and a judgment about the product's state of development (availability).
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Detection
With 173 entries in the detector database, it became more manageable to divide the database into those detection devices intended for biological agents and those intended for chemical agents (there are 7 devices intended for both biological and chemical agents and these were included in each separate database).
Most of the funding for biodetection devices comes from the Department of Defense (56%), with 18% from commercial ventures. DoE, FDA, NASA, and TSWG account for the remaining 26%. With only 6 (out of 73) devices commercially available, 92% are in either the field testing stage (40%) or still in the laboratory (52%).
Where they are used. There are only 17 devices in the database that are explicitly intended for diagnostic purposes, that is, detecting biological agent in fluid or tissue samples from a patient. Most (85%) current devices are designed to detect biohazards in the environment (liquid, air, surface, or other). Seven devices in the inventory are designed to detect agent in either patients or the environment, and numerous others aimed at environmental monitoring or detection could be adapted to patient diagnostics, but not without considerable additional research.
What is needed. The most prevalent medium needed is liquid (44%), although 18 devices are designed to detect agent in the air. Twelve devices utilize either liquid or air samples. Twenty-eight items (40%) provide numeric estimates of agent concentration. A third (33%) of the biodetection devices do not provide a quantitative estimate of the pathogen detected, and another 27% of the devices provide no information whatsoever about quantification.
Speed and portability. According to the inventory, device portability is evenly distributed among hand-held, carriable by man, truck-loaded, or fixed. However, much of the newest research focuses on miniaturization of detectors. Fifty-nine percent of the devices in the inventory will provide results in a matter of minutes. Eight devices (11%) can or will detect agent in a matter of seconds.
How they work. There are basically two types of technology needed in a biodetection device: (1) detection technology and (2) reporting technology. Detection technology refers to the mechanism by which the device differentiates the target from other organisms or molecules. Reporting technology
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refers to the transduction mechanism that makes the detection event apparent to a human observer. Thirty percent of the devices in the inventory depend upon nucleic acid hybridization for detection, while 23% use antibody / antigen binding. The remaining devices use chemical reactions, the composition of agent (size, charge, mass), ligand / receptor binding, or more than one of these technologies. Forty-one percent of the reporting technology is optical, with other devices using technologies based on charge, color, mass, electrochemical reaction, or some combination.
There are 100 entries in the chemical detector inventory. Twenty-eight percent of the entries are funded by the Department of Defense and 56% by commercial companies. Other funders include DoE, EPA, NASA, and TSWG. Chemical detection devices are much more developed than their biological counterparts; 60% of the items in the inventory are commercially available, with only 13% still in the field testing stage and 16% in the laboratory. It is also worth noting that there are three commercial devices that are designed specifically for a civilian market.
Where they are used. The overwhelming majority (96%) of the chemical agent detectors are intended to detect agent in the environment, with only 4% designed to detect agent in patients.
What is needed. Forty-two percent of the devices provide a numerical estimate of agent concentration, but 47% only indicate the presence or absence of agent. There are four items in the inventory that will indicate a ''High" or "Low" concentration of agent.
Speed and portability. Ninety-two percent of the chemical detection devices in the inventory are able to provide information about agents within minutes or seconds (43% and 49%, respectively). Fifty-one percent are hand-held devices, 10% can be moved by one man, 12% can be moved by truck to the site of a suspected attack, and 23% are fixed in one location (e.g., a ship or a laboratory).
How they work. The detector technology used by 24% of these devices depends upon a chemical reaction. Other technologies used in the detection process are: agent composition (mass, charge, or size) absorption, ligand/receptor binding, mass (mass spectrometry, piezoelectric, surface acoustic wave, or multiple technologies). For the reporting phase of the sources, technologies include: charge (1%), color (12%), electrochemical
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(8%), atomic emission spectrum (1%), photo-acoustic (2%), surface acoustic wave (7%), or some combination or hybrid (8%) of these technologies.
Recognition of Signs and Symptoms in Patients (Diagnosis)
There are six products in this database. Three (the NBC indicator symptom matrix, Associates diagnostic software, and the Global Infectious Disease and Epidemiology Index [GIDEON]) are fully operational. The three Micromedex products (Poisindex, Drugdex, and Emergindex) are databases in use in poison centers and hospitals. Poisindex and Drugdex provide information on poisonous chemicals and drugs, while Emergindex is used for emergencies of unknown etiology. Only Emergindex is currently structured to provide diagnostic and treatment information based on signs and symptoms, but Micromedex is attempting to reengineer the other two databases to make this possible. At present, they require chemical or drug names as input.
The NBC indicator symptom matrix assumes that one of the traditional military chemical weapons is involved, and simply facilitates differential diagnosis among them. The other databases are larger in scope, but include some or all of the chemical or biological weapon agents.
Epidemiological Tools
The products in this database are potentially relevant in identifying outbreaks of disease in populations (as opposed to individual patients). There are 15 entries, 12 of which are operational at this time, the Emerging Infectious Disease Initiative of the CDC, which is a long-term project just getting under way, and the Global Public Health Intelligence of Health Canada, and the DoD's Global Emerging Infections Surveillance and Response System (DoD-GEIS) are two recently announced initiatives to be started in the near future.
Personal Protective Equipment
There are 63 entries in the personal protective equipment database. Of these, the vast majority (86%) of these products are designed to protect against both chemical and biological agents (8 are for chemicals only and one is for biological agents only). Many of the products are commercially available (44%), but 3 items are unique to the military. Also represented is equipment from 18 other countries. The U.S. Department of Defense (17 entries) and the multi-agency Technical Support Working Group (6 entries) sponsor laboratory research or field testing in this area. The type of equipment is evenly divided between protective clothing and breathing apparatus (both at 41%), with 11 entries that offer both types of protection.
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Decontamination
Seventy-eight percent of the 33 products in this database involve strictly chemical decontamination. The remaining products are designed to decontaminate either biological agents alone (13%), or both biological and chemical agents together (9%). Only 10 (31%) are commercially available. Three of these 10 items are focused on decontamination of people, 4 on equipment or materiel decon, and 3 might be used for decon of either people or inanimate objects. Twenty-two entries (69%) are currently in research and development, which is largely funded by government agencies. The Department of Defense funds 50%, the Department of Energy 32%, and the multiagency Technical Services Working Group 9% of the decontamination products listed as in research or field testing. Only 4 of the 22 R&D items in the inventory are focused on biological agent decontamination; 2 items pertain to both chemical and biological agents; and 13 focus on chemical agents. Thirty-six percent of the products being researched are potentially applicable to human decontamination; the remainder focus solely on decon of inanimate objects.
Treatment
Of the 128 treatment products in the inventory, 88 (69%) are intended for biological agents, leaving 40 (32%) for the treatment of chemical agents. Funding for treatment research is provided largely by DoD (43%) and commercial institutions (34%). NIH accounts for 18% of the funding, leaving only 5% of the funding from the Public Health Service.
The biological agents for which at least one treatment is being tested or is already available are: anthrax, brucella, C. botulinum, dengue, Ebola, EEE, Lassa, plague, Q-fever, ricin, SEB, smallpox, T-2 mycotoxin, tularemia, VEE, and WEE. Other entries involve broader treatments of more than one bacteria, virus, or toxin. Treatments for viruses, C. botulinum, and T-2 mycotoxin account for 35% of the treatment entries in the inventory (13%, 12%, and 10%, respectively)
Despite the abundant research on treatments of biological agents, most (65%) are in the preclinical stage of development. There are 13 (15%) INDs and 16 (19%) commercially available treatment products. There are 5 INDs for C. botulinum treatments, 1 for EEE, 1 for Q-fever, 1 for ricin, and 1 for smallpox. With the exception of tularemia, which has only one commercially available product and none in development, all of the agents listed above have at least one preclinical product under investigation. As
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might be expected, given the research status of most of the entries, there is no evidence or only partial evidence of efficacy in 53% of the treatment products. There is evidence of efficacy in animals in 21% of the entries, but only 3 (4%) entries with proven efficacy in humans.
The chemical agents considered for this inventory are: cyanide, nerve agents, phosgene, and vesicants. Out of the 40 treatment products in the inventory, 43% are for nerve agents, 30% for cyanide, 15% for vesicants, and 12% for phosgene. There is currently only one IND and it is for a cyanide treatment. As in biological treatments, most (53%) treatment products for chemical agents are in the preclinical stage of development; however, 35% of the chemical agent treatments are commercially available in the United States. There is animal evidence of efficacy in 68% of the entries, and 8 (20%) proven treatments in humans. The remaining products have no evidence or only partial evidence of efficacy.
Psychological Effects
This is a unique section of the inventory because the committee was unable to identify any "products" specifically connected with chemical or biological terrorism. The inventory thus focuses on information and resources regarding the psychological effects and treatment of trauma and disasters in general. There are 16 entries ranging from Web sites, to current studies, to publications. One entry focuses solely on rescue and health care workers; 4 solely on trauma victims themselves; and 2 focus on community-wide effects. The remaining seven include more than one of the above in their scopeusually victims and workers. Unfortunately, there is a dearth of information and resources about specific populations of victims such as the elderly, children, the disabled, and other special groups outside of the average adult male and female.
Computer Models
The 20 items in this database fall in two main categories: (1) information about agent transport, and (2) information about incident management. There are 10 models in each category. Most (13) are in beta testing, 4 are available for use at this time or are being used for purposes other than assisting authorities plan for responding to chemical or biological terrorism, and three are in the planning stage. The Department of Defense is funding 15 products, DoE 3, EPA 1, and 1 is funded by a commercial organization.