5
Medical Chemical and Biological Countermeasures: Specific Findings and Recommendations

INTRODUCTION

Medical defense against chemical and biological warfare agents is critically important in preserving combat effectiveness of naval forces. Medical defense has great commonality across all of the Services—the affected asset in all cases is the individual Service member, not a weapon system or a logistics facility. While the level of threat may differ, individuals’ medical defense needs are the same whether personnel are stationed on a forward-deployed aircraft carrier, at an airbase, or at a home port. This chapter reemphasizes the need to differentiate clearly between the response to chemical agents and the response required to wage an effective medical defense against biological agents. Exposure to chemical agents is quickly detectable because the toxic effects are rapid; there are also specific medical responses available for some of the agents. In contrast, biological attacks will most certainly be silent and will not present an immediate, concentrated mass casualty situation. Biological warfare defense is clearly the most challenging from a medical perspective, and, not surprisingly, the committee found the greatest gaps between that threat and our capacity to manage the consequences of an attack.

Medical defense for naval forces must be viewed holistically and should recognize the importance of individual service members, corpsmen, and health care providers as the main elements of the medical defense equation. The Navy medical command is responsible for both Navy and Marine Corps medical defense. As will be discussed, there is a limited number of drugs, vaccines, and



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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats 5 Medical Chemical and Biological Countermeasures: Specific Findings and Recommendations INTRODUCTION Medical defense against chemical and biological warfare agents is critically important in preserving combat effectiveness of naval forces. Medical defense has great commonality across all of the Services—the affected asset in all cases is the individual Service member, not a weapon system or a logistics facility. While the level of threat may differ, individuals’ medical defense needs are the same whether personnel are stationed on a forward-deployed aircraft carrier, at an airbase, or at a home port. This chapter reemphasizes the need to differentiate clearly between the response to chemical agents and the response required to wage an effective medical defense against biological agents. Exposure to chemical agents is quickly detectable because the toxic effects are rapid; there are also specific medical responses available for some of the agents. In contrast, biological attacks will most certainly be silent and will not present an immediate, concentrated mass casualty situation. Biological warfare defense is clearly the most challenging from a medical perspective, and, not surprisingly, the committee found the greatest gaps between that threat and our capacity to manage the consequences of an attack. Medical defense for naval forces must be viewed holistically and should recognize the importance of individual service members, corpsmen, and health care providers as the main elements of the medical defense equation. The Navy medical command is responsible for both Navy and Marine Corps medical defense. As will be discussed, there is a limited number of drugs, vaccines, and

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats antidotes to support medical chemical warfare (CW) or biological warfare (BW) defense. Training is currently the most obvious weakness for the Navy in the area of medical defense, and improvements in training will offer the greatest return on investment. Vaccines could provide the most comprehensive defense against BW agents, but the Navy should be under no illusions that a stream of effective approved vaccines will become available in the near term to mid-term. In the absence of adequate supplies of effective vaccines, casualties must be anticipated, but observant sailors, corpsmen, clinicians, and commanders working with modern diagnostic tools will allow early medical interventions to save lives and preserve warfighting strength. Recognition of symptoms and pre-incident intelligence should be the earliest input into efficient, distributed disease reporting and analysis systems to allow effective and timely medical defensive measures to be taken. In this chapter, the committee presents findings and recommendations that run the spectrum from near-term, nontechnical initiatives, to technical and operational shortfalls, to interdepartmental, policy-level issues that can only be addressed through initiatives by the Secretary of the Navy and above. These findings and recommendations focus on three general areas: Medical training. Medical training remains a critical determinant of success in medical defense and an area in which senior leadership can be most effectively applied. It is also an area in which Navy medical personnel are significantly lagging behind their counterparts in other Services. Enhanced training of naval personnel, medical and—as noted for operations—non-medical, represents the highest-payoff, near-term investment that can be made by the naval Services, and the committee urges that it be done now. Training is not without costs, but the costs are relatively low. Moreover, without better training, the equipment and medical countermeasures provided by the technology developers cannot provide the levels of effectiveness for which they are designed. Technical and operational shortfalls. Many of the technical and some of the operational shortfalls in naval medical capabilities are the result of overreliance on the Joint Chemical and Biological Defense (CBD) Program.1 The committee’s leading recommendation for addressing these issues is to define the nature of the shortfalls in terms of naval-specific requirements. This analysis involves the full range of developmental activities, as discussed for operations: doctrine, organization, training, materiel, leadership, personnel, and facilities (commonly referred to as “DOTMLPF” analysis). This kind of analysis and 1   Due to their expanded scope of chemical and biological defense associated with the war on terrorism, the Department of Homeland Security and the Department of Health and Human Services, especially in the area of vaccines, may impact the Joint CBD Program. The committee believes, however, that its recommendations remain applicable, although the Department of the Navy should follow closely and leverage these activities as much as possible.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats formalization of naval requirements should be undertaken by the naval Services doctrine and warfare development centers, the Navy Warfare Development Command (NWDC) and the Marine Corps Combat Development Command (MCCDC), informed and supported by qualified medical personnel. (Specific information with respect to drugs and vaccines, diagnostics, and disease reporting is provided later in this chapter.) Medical policy issues. Embedded in the acquisition programs of DOD and the Joint CBD Program for both vaccines and laboratory diagnostics is the requirement for Food and Drug Administration (FDA) certification of drugs, devices, and vaccines. According to current DOD policy, the FDA provides the standards for the safety and efficacy of systems that are used to protect military personnel. FDA certification for BW and CW medical systems is problematic because objective clinical trials involving humans cannot be conducted on the diseases or injuries produced by CW or BW agents. The committee noted two major shortfalls in the development programs of the Services and the Medical Defense part of the Joint CBD Program: (1) the certification of critical laboratory reagents and (2) the slow progress toward certification of drugs and vaccines against BW pathogens. These shortfalls continue despite evidence that the FDA commissioner has shown increasing willingness to modify the certification systems unique to BW and CW. He has recently provided relief from some of the documentation requirements on “orphan” drugs or vaccines that are only effective against BW pathogens. The commissioner has also recently signed a letter authorizing the use of adequate animal studies to meet the efficacy rule. Yet the Joint CBD Program has been slow to act on those “openings” to shorten development and approval times. Liaison and cooperation between the Department of Health and Human Services and the Department of Defense must be continuously exercised to facilitate ways of establishing safety and efficacy in systems designed for military use. This kind of dialogue cannot be assumed to represent the Navy’s interests or needs. The committee recommends that the Secretary of the Navy champion those issues within which large gaps in capabilities expose sailors and Marines to unnecessary risk. The committee’s findings and recommendations are presented in four sections: “Medical Training for Casualty Management,” “Technical and Operational Shortfalls: Drugs and Vaccines,” “Technical and Operational Shortfalls: Medical Diagnostics,” and “Disease Reporting and Analysis.” Medical policy issues specific to each area are addressed in the respective sections. MEDICAL TRAINING FOR CASUALTY MANAGEMENT Medical training is an important basis for successful defense against chemical or biological attack. Training needs are broad: how to recognize the signs of an attack, how to protect medical forces from contamination, how to contain

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats contagious infections, including when and how to quarantine personnel, how to diagnose and manage patients, and how to maintain and access records of personnel exposed to CW or BW on a long-term basis. This section deals with the comprehensive training of Navy health care providers in the medical aspects of chemical or biological attacks. Because there are important differences between chemical and biological attacks with respect to procedures and health impacts, comprehensive training in both areas is essential. For the purpose of this section, CW and BW are discussed together except for topics in which distinctions need to be drawn. Medical Chemical and Biological Countermeasures Finding: Navy Deficiencies in Chemical and Biological Medical Defense Training While specific medical training needs vary, overall the Navy is severely deficient in many areas of chemical and biological medical defense training. Several changes will be needed to rectify the problems. Some of these changes will run counter to current Navy culture and practices and will therefore require directives or orders from the Chief of Naval Operations (CNO) or other appropriate authority to implement them. Training Requirements As stated in a recent General Accounting Office report, “There is no mechanism—either joint or within a service—for defining the medical NBC [nuclear, biological, and chemical] training requirements to support medical readiness.”2 It is difficult to establish what medical resources and facilities will be needed to respond to CW or BW situations that have not been previously encountered. Thus, tools are limited for estimating numbers of expected casualties, the mixes of medical specialty skills needed to treat casualties, and the types of equipment and facilities to handle, decontaminate, and treat casualties. Planning instruments, such as the Medical Analysis Tool (software used by the combatant commanders for identifying medical requirements to support war plans), do not adequately estimate the types of injuries and illnesses that a chemical or biological warfare attack would generate. Therefore, the estimated personnel needs generated by the software may not reflect the true mix of skills required to meet a specific situation. For this reason there is a greater requirement for military medical personnel to possess a diverse set of skills so that they can cope with many different possible scenarios. This need is especially relevant to the situation faced by Navy ships at sea, since importing new expertise in a given set of 2   General Accounting Office. 2001. Chemical and Biological Defense: DOD Needs to Clarify Expectations for Medical Readiness, GAO-02-38, Washington, D.C., October 19.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats circumstances in any timely way may not be possible. The only effective way to meet the needs for an extensive set of specialized CW and BW medical skills with a limited number of individuals is to invest these skills in the available medical personnel by placing a high priority on chemical and biological casualty diagnosis and management training and by making this training mandatory. Available Chemical and Biological Medical Defense Courses The Navy does not have a comprehensive chemical or biological casualty management training program, although there is ample opportunity for the training of Navy Medical Corps officers and health care providers through other organizations. The Army has the most extensive set of such training programs of any of the Services. The Chemical Casualty Care Division of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) provides training in chemical weapons casualty care. The U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) provides extensive instruction in biological weapons casualty care. These two institutes jointly administer and teach courses under the sponsorship of the Army Medical Department Center and School. The flagship course is titled Medical Management of Chemical and Biological Casualties (MCBC). The MCBC course was designed to train physicians, but it is open to physician’s assistants, nurses and, with instructor approval, senior medics and Medical Corps officers for all of the Armed Services. The course and selected components of the course are available in several formats. The most intensive version is a 6 1/2-day on-site course covering the principles, management, and treatment of chemical and biological warfare injuries. It combines lectures with clinical laboratory and hands-on field training. A limited number (560) of training slots per year is currently available. To meet a growing demand both within and outside the Services, off-site training options that are exportable on CDs have been developed or, at selected locations, are available for distance learning via satellite broadcast. A new course, Field Management of Chemical and Biological Casualties (FCBC), began in 1999. The focus of this course is on pre-hospital emergency treatment and casualty decontamination. It is available in both on-site and off-site versions. The USAMRICD television course Medical Response to Chemical Warfare and Terrorism has been viewed (at least in part) by about 3,500 military personnel who registered for the course. The institute has also developed several distance learning products in this area. In FY 1999, the Navy began offering a 1-day course, Navy Familiarization Course in the Medical Management of Chemical, Biological, Radiological and Environmental Casualties, that focuses on first-responder and medical support personnel. The course provides informatinon the chemical, biological, radiologi-

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats cal, and environmental (CBRE) threat and appropriate medical response. The Navy also has a 3-day Chemical, Biological, Radiological and Environmental Casualty Care Management Course. This 3-day course is designed specifically for clinical providers, including physicians, nurses, physician’s assistants, nurse practitioners, dentists, and independent-duty hospital corpsmen who might provide front-line or rear-echelon treatment to CBRE casualties. The course covers CBRE medical management and includes an interactive tabletop exercise involving one or more of the potential agents. The courses are conducted at the Naval Environmental and Preventive Medicine Units at Norfolk, Virginia; San Diego, California; Pearl Harbor, Hawaii; Sigonella, Italy; or on-site at the requesting command. In contrast to the limited time allocated for medical chemical and biological training, the Navy provides a 12-day course for non-medical chemical and biological issues, entitled Shipboard Chemical, Biological and Radiological Defense Operations and Training Specialist. This course provides basic to advanced chemical, biological, and radiological defense (CBR-D) training for enlisted personnel (E5 through E9, source ratings of damage controlman, hull maintenance technician, and hospital corpsman). Graduates of the course are prepared to conduct CBR-D training at commands and aboard ship and to advise on the integration of CBR-D operations into a normal command organization. This course is conducted by the Naval Construction Training Center Detachment at Fort Leonard Wood, Missouri. Readiness of Medical Personnel The availability of training courses does not by itself ensure that the Navy has reached an adequate level of chemical and biological medical defense readiness. The measure of readiness should include whether or not sufficient medical personnel have received training and provide objective evidence that this training has been effective. Navy doctrine provides for the regular evaluation of ships’ operational readiness and training. However, within this framework, the chemical and biological medical defense training requirement to support medical readiness is inadequately defined. The Navy does require that personnel deploying to field hospitals learn decontamination procedures, but little else in the way of chemical and biological medical defense training is mandatory for physicians, physician’s assistants, nurses, medics, or corpsmen. Chemical and biological medical defense training courses are largely voluntary. This lack of required training is reflected in the relatively small numbers of Navy health care providers who have received chemical and biological medical defense training. In some cases, individual health care personnel can augment formal training by taking personal initiative and studying the many resources available for self-instruction, as exemplified by a corpsman aboard the USS Kauffman who demonstrated this level of bottom-up initiative during a visit by members of the committee. Such initiative and interest are not universal, however.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats On the basis of data provided to the committee by both Army and Navy medical record holders, the committee estimates that overall participation by Navy health care providers in any training is poor. The MCBC course provides the most comprehensive training of all the available courses and should represent the minimum acceptable level of training for medical corps officers. From the same data, only a small percentage of Navy active duty officers have taken this course in comparison to a much larger percentage of the Army active duty officers.3 Reporting There is no centralized internal training and competency database for the Navy analogous to the one maintained by the Joint Commission on Accreditation of Health Care Organizations for civilian medical care. Consequently, there are no available accurate data on medical personnel trained in chemical and biological defense to support the development of compilations of medical skill availability for war planning and ship staffing. The staffing of a ship’s medical department will therefore be uneven with respect to training and competency. The committee’s findings can be summarized in three succinct statements: Participation by Navy Medical Corps officers in training for chemical and biological casualty treatment is unacceptably low, although training courses are available. Chemical and biological casualty training is not mandatory for Navy health care providers and is voluntary or discretionary on the part of commanders. The Navy has no objective tests for skills proficiency after training. The Army has tested its medics and found that NBC skills were unacceptably low.4 In the absence of Navy data, the readiness of Navy personnel to treat chemical and biological casualties is unknown but suspect. The Navy does not track the chemical and biological medical defense training or proficiency of health care providers. This lack of information limits the ability of the combatant commanders to accurately forecast medical skills needed and availability of trained personnel to support war plans. This limitation translates to the possibility that poorly prepared personnel will have life-anddeath responsibilities aboard ship in the event of a chemical or biological attack. 3   U.S. General Accounting Office. 2001. Chemical and Biological Defense, DOD Needs to Clarify Expectations for Medical Readiness, GAO-02-38, Washington, D.C., October. 4   The Army conducted an evaluation of the proficiency of its medical first-responders (medics). Their readiness to treat NBC casualties was lowest of all the skills evaluated (16 percent passed a cognitive test with a grade of 70 percent or better). Hands-on skills were not tested in this evaluation. There are no equivalent data for the Navy.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Medical Chemical and Biological Countermeasures Recommendation: Improving Medical Readiness In parallel with the recommendations of Chapter 3 in this report for achieving operational readiness, the Navy should establish a training and exercise program and an accompanying reporting system in order to achieve chemical and biological medical defense readiness. Since the Navy does not have its own comprehensive training program for the medical management of chemical and biological warfare casualties, Navy health care personnel should be directed to enroll in and complete the CW and BW courses on medical management offered by USAMRICD and USAMRIID, respectively. This direction should apply to all Navy health care providers, from corpsmen to physicians. The Navy should provide scheduling and funding for this training. The committee recommends that specific goals leading to at least 60 percent trained personnel within 2 years be adopted. The CNO should direct that training in chemical and biological medical defense and casualty management be mandatory and that no corpsman or physician should be deployed prior to completion of the appropriate course(s). Compliance can be ensured by incorporating requirements for proficiency in medical chemical and biological training in operational-readiness inspections prior to deployment. The Navy’s health care providers should be regularly tested for proficiency in the diagnosis and treatment of chemical and biological warfare casualties. To implement this requirement, fleet commanders should be directed to include the medical readiness of ships with regard to CW and BW medical defense into the periodic reports of readiness and training (i.e., Status of Resources and Training System (SORTS)) so that the capacity of a ship to handle the consequences of chemical or biological attack can be evaluated. A capably trained and proficient health care provider will save lives. The Navy should develop a program to track chemical and biological medical defense training and proficiency to allow medical personnel and skills to be adequately accounted for in war planning and ship staffing. TECHNICAL AND OPERATIONAL SHORTFALLS: DRUGS AND VACCINES This section reviews chemical and biological medical defense products currently available to naval and Marine forces. In addition, it discusses future products in advanced development and the medical technology base. The process used for military medical product development is reviewed, and a critical assessment of the process is presented.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Medical Chemical Defense Current Treatments With the exception of toxic industrial chemicals (TICs) and a small number of novel chemical agents, there is a limited number of chemical warfare agents (see Appendix B, “Agents and Effects,” for a summary description). Some of these agents have been weaponized by potential adversaries and, in some cases, used in warfare. Much is known about their physical and toxicological properties. The effective employment of these classical agents produces nearly immediate pathophysiological effects by relatively well-understood mechanisms. Physical protection is the first and most important line of defense, followed by decontamination, antidote therapy, or both. There are no plans to replace physical protection with a broad-spectrum, pre-exposure drug. In reality, there are only five military CW medical products fielded for U.S. forces. Four are for use as nerve agent therapeutics and one is a skin decontaminant resin device. Each is known to be safe and effective. All Navy personnel should be familiar with and trained in the use of these products and, when deployed, should have access to them in adequate quantity. Box 5.1 describes currently available medical products. BOX 5.1 Current Medical Treatments for Chemical Warfare Agents Nerve Agents The treatment for nerve agent poisoning recommended by the U.S. military involves the use of three therapeutic drugs: atropine, pralidoxime, and diazepam. Atropine counteracts many of the effects caused by the inhibition of acetylcholinesterase. Pralidoxime chloride (2-PAM), one in a family of drugs that reactivates the nerve agent-inhibited cholinesterase, is administered with atropine. Diazepam, an anticonvulsant, is administered in severe cases of nerve agent intoxication to control seizures and thereby minimize brain injury. Atropine, 2-PAM, and diazepam are packaged in autoinjectors issued to U.S. military personnel for self- or buddy-aid. Atropine and 2-PAM by themselves have limited efficacy against the nerve agent soman (GD); thus, naval personnel are supposed to be provided supplies of the nerve agent pretreatment pyridostigmine bromide (NAPPB). PB is administered on the orders of the commanding officer when a creditable future threat of exposure to GD exists. As is the case with other nerve agents, atropine and 2-PAM are administered post-exposure. Vesicants Included in the category of vesicants are sulfur mustard, lewisite, and phosgene oxime. Mustard has been used on modern battlefields—for example, in the Iran–Iraq conflict—and it is considered a likely chemical agent to be employed

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats against U.S. forces in a future war. Currently there is no effective antidote or treatment for mustard injury. Chemical protective ensembles are effective barriers if worn properly, and the chemical filters in the current mask are effective against mustard vapor. Should skin exposure occur, immediate decontamination of exposed skin areas is the only means of preventing tissue injury. For skin decontamination, U.S. military doctrine prescribes the use of 0.5 percent sodium hypochlorite followed by soap and water. The resin-based M291 kit is effective for small-area skin exposures. The Food and Drug Administration considers this product, developed by the Army Medical Department in cooperation with a commercial partner, a medically regulated product. One of the major problems associated with skin exposure to mustard is that signs of exposure such as pain and redness often do not appear for hours. By the time signs appear, the damage is done and the resulting injuries to the skin, eyes, and airways can only be treated with conventional supportive therapy. The clinical effects of lewisite are similar to those of mustard. However, unlike mustard, lewisite liquid or vapor produces irritation and pain upon contact. As with mustard, immediate decontamination will limit lewisite’s damage to skin or eyes. A specific antidote for the systemic effects of the agent exists in the form of British Anti-Lewisite (BAL). BAL must be used under medical supervision owing to its own toxic properties. There is no need to have this antidote far forward, and it can be kept in modest quantities because of the minimum threat from lewisite. In both liquid and vapor forms, phosgene oxime is highly corrosive and penetrates clothing and rubber readily; and, like lewisite, it produces severe pain upon contact. Like mustard, phosgene oxime has is no antidotal therapy. Cyanide Amyl nitrite, sodium nitrite, and sodium thiosulfate are commercially available in standard doses in the Pasadena Cyanide Antidote Kit. This kit is not widely distributed in Department of Defense medical channels. No antidote kits are provided to naval personnel far forward. However, should a person be exposed to a lethal dose of the agent and not receive therapy immediately, death is certain. Phosgene Although phosgene is not currently believed to be a significant threat to naval personnel, it is still a ubiquitous toxic industrial chemical. Pulmonary edema is the most serious consequence of inhalation exposure. At present, there are no proven pharmacological interventions for phosgene-induced pulmonary injury. As with the vesicants, rapid removal from the source is essential. Physical exertion during the latent period following exposure may precipitate signs and symptoms; thus, rest and airway management are essential in the medical management of phosgene exposure. Treatments Under Development Two new medical products are currently in advanced stages of development in the Joint Service Medical Chemical Defense Science and Technology Program: a topical skin protectant and a multichambered autoinjector. The topical skin protectant is a barrier ointment that will significantly delay the penetration of

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats chemical agents to the skin. This item is neither to be used on large areas of the body nor designed to take the place of gloves; rather, it is designed to improve the efficiency of the current chemical protective ensemble. Specifically, it is to be used around the neck, wrists, and ankles where there are weaknesses in the seals owing to body movement. This medical device is regulated by the FDA. The multichambered autoinjector is simply a device that will allow a nerve agent victim to administer both the atropine and the 2-PAM through a single needle. This medical device is also FDA-regulated and while each of the drugs contained in the device is approved separately, the combination delivery system requires additional FDA testing. Both of these products have spent at least a decade in development but are not expected to be fielded during the next several years. A number of potential advances in medical chemical defense are being pursued in the science and technology base. Some research efforts are looking at commercially available pharmaceuticals, such as an advanced anticonvulsant, that may be useful for the purpose of stopping and preventing nerve agent– induced seizures. It is important to point out that while a number of currently approved drugs may be effective, many years of research are required to meet FDA standards for an indication, or use, that the drug was not originally approved for. The best example of this problem is PB (pyridostigmine bromide). This drug, used safely in humans for another indication, requires that DOD request a special exception from FDA to allow its use as an investigational drug. Additionally, FDA requires that the efficacy of the product be shown in human subjects. This, of course, is impossible with chemical agents and requires enormous efforts to find surrogate endpoints for efficacy in animals that can be extrapolated to humans receiving the drug. Also within the Joint Service Medical Chemical Defense Science and Technology Program technology base are programs to develop broad-spectrum enzyme scavengers that will provide pre-exposure protection against CW agents. These scavengers are forms of human cholinesterases and will require the administration of a non-self-generated protein or gene therapy to develop levels that are protective. This next-generation antidote for nerve agents and for many of the other CW agents will not be available for at least a decade or more. Another nextgeneration medical product, the reactive topical skin protectant discussed above, has the potential to be developed more rapidly once the first iteration of the product currently in advanced development meets all regulatory requirements and is acceptable to operational forces. Medical Biological Defense Medical countermeasures to biological agents include pre-exposure vaccination and pre- or post-exposure drug therapy.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Recognizing the challenges that any of these alternative approaches faces, the committee believes that some assessment of different approaches should nonetheless be made. The committee’s review of the Joint CBD Program’s Critical Reagents Program suggests that FDA certification of the reagents used in many of the advanced military diagnostic systems lags behind technological development. There remains an impression with the committee, gained from looking into this area and into the vaccine programs, that the level of dialogue with the FDA is below a level at which efficient pathways to certification are going to be realized any time in the near future. Finally, the current systems under development, with rare exceptions, assume that the role of laboratory diagnostics is to provide confirmation of the clinical patterns observed by the physician or hospital corpsman. It assumes that sufficient clinical evidence exists to warrant laboratory sampling and that sufficient pathogen load exists to make the individual clinically ill. A priori, this assumption gives away much of the initiative to the perpetrator of biological warfare. The committee’s findings suggest that there is an opportunity to redirect some of the Navy’s basic research into investigating technologies that can identify incipient infection in individuals exposed to a BW pathogen before they manifest symptoms of infection. Given the suspicion of exposure (from warning sensors or an index case), this “pre-clinical” (or pre-symptomatic) phase represents a window of opportunity for making early treatment decisions that may be affected by mission requirements, limited supplies, or other non-medical issues that impact on the commander’s decision-making processes. Medical Chemical and Biological Countermeasures Recommendation: Operational Diagnostic Improvements at Hand Implement existing instructions and make use of environmental and preventive medicine units for introducing new equipment. The Chief of Naval Operations should require that fleet commanders review relevant instructions governing the medical readiness of ships with regard to biological warfare diagnostics. Ideally, this readiness review should result in new periodic reports of readiness and training (i.e., Status of Resources and Training System (SORTS)) and be more reflective of the capacity of a ship to handle the consequences of biological warfare. This recommendation is a low-cost, highpayoff action with a short implementation schedule. In addition, fleet commanders, wherever possible, should exercise the forward-deployable medical laboratories and direct that the lessons learned be incorporated into fleet instructions governing the equipping of medical facilities afloat and the training of their personnel. This laboratory represents an ideal testbed for defining the utility and “fieldability” of new diagnostic technologies.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Medical Chemical and Biological Countermeasures Recommendation: Current and New Technical Developments in Diagnostics Assess current equipment against naval requirements and establish research and development efforts where gaps in effectiveness exist. A number of actions are recommended both for assessing the direction of the current Joint CBD Program with regard to the specific needs of naval forces and for focusing some basic research in more promising directions. More specifically: The Chief of Naval Operations should direct a review of Joint Chemical and Biological Defense Program and Department of Defense lead agent investments in existing technologies and modify, as necessary, Navy operational requirements documents to serve the needs of the fleet and naval station end users. As is apparent from other parts of this report, there is a downside in assuming that joint systems will result in robust Service capabilities. Navy ships and marine operating environments can place unique demands on the design of equipment. A piece of laboratory equipment that would be entirely compatible with an Army table of organization and mission has more than a small chance of failing to become an operational capability on a Navy vessel. The Chief of Naval Operations should direct the chief of the Bureau of Medicine and Surgery to report on the status of the Critical Reagents Program and to make recommendations for CNO action for accelerating the regulatory activity surrounding the reagents that are necessary for the laboratory diagnostic gear earmarked for the fleet. The Chief of Naval Research (CNR) should consider Navy funding of technologies for laboratory diagnostics that support a broader technology base for ELISA (immunoassay) and polymerase chain reaction to drive down crossreactivity and false positives and to assess alternative techniques that may not have the inherent shortcomings of these approaches. The Chief of Naval Research should assess the adequacy of investigations into the means of identifying individuals who have been exposed to but are not yet clinically ill from a biological warfare pathogen. This task will require the investment of basic science dollars in the fundamental biology of pathogen invasion, infection, and host response. If gaps are identified, the CNR should champion increased investment by the Joint CBD Program in such research tailored to BW agents. While this is a potentially large scientific endeavor, the DOD program can build on significant investment by the National Institutes of Health and others on pre-symptomatic diagnosis techniques and tailor the most promising approaches to BW agents.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Clinical Diagnostics Clinical diagnostics traditionally represents the activity of physicians who must make the diagnosis of disease and injury on the basis of history, physical examination, and supporting laboratory data (in this case laboratory diagnostics). In the case of ships at sea, this role is often assumed by independent duty corpsmen. For disease outbreaks, the process consists of physical observation and correlation of data. Historically, the public health model of disease identification and mitigation has often been characterized by full laboratory confirmation of the putative pathogen before effective countermeasures are instituted. Less common, where public health is affected on a large scale, officials use “warnings or indicators” of disease and act early (often without the time for confirmation of findings) to head off the spread of dangerous diseases. The most common example of this proactive stance toward disease is the periodic surveillance of Far East stocks of chickens and waterfowl that may represent a reservoir of Asian influenza virus. Any change in the health of these animals that indicates the likelihood of spread to humans results in immediate actions (culling and slaughter) to prevent the spread of a contagion that could result in a human influenza pandemic. In this instance, the public health officers “get out in front” of more conservative means of human disease monitoring to lower the threshold for effective action to mitigate or eliminate the disease. The point to be made is that traditional clinical diagnosis, unless modified and advanced to a set of early, fundamental indicators of incipient disease, is likely to be “too little, too late” to prevent casualties and loss of life from biological warfare attacks. Medical Chemical and Biological Countermeasures Finding: The Lack of Practice of Clinical Diagnosis Training programs are available through the Department of the Army for both physicians and paramedical personnel in the diagnosis and management of CW and BW casualties. As noted in the section “Medical Training for Casualty Management,” above, there is no evidence that a minimum standard has been set for the training of fleet medical departments. Of equal importance for taking action, there was no evidence presented to the committee that efforts have been made to train commanders in the common language of epidemiology. The process of gaining some level of understanding of the language of infectious diseases (or chemical casualties, for that matter) currently depends on the interest and experience of the commander and the skill of those Navy Medical Department personnel who provide advice and counsel. The development of a more robust and widely useful approach for the fleet is hampered by the fact that there is no medical officer representation at the Navy Warfare Development Command.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats This lack, in turn, limits progress in the development of concepts of operation and experimentation in areas in which emerging threats or new operational doctrines have a medical diagnostic component. Medical Chemical and Biological Countermeasures Recommendation: CONOPS Development Coupled with Clinical Diagnosis The Navy Warfare Development Command should develop gaming and operational concepts, coupled with clinical diagnosis, for biological warfare attacks. This recommendation further expands the recommendation in Chapter 3 (see the section “Operational Recommendation: Roles for NWDC and MCCDC”). The Commander, Fleet Forces Command, should define a role for NWDC in the development of war games or seminars that exercise decision making by commanding officers faced with the consequences of biological warfare attack. The exercise of these war games should include ways to further refine the relationship between medical diagnostics (the detection of clinical disease) and the decision-making process of the ship’s commanding officer or the battle group commander. Said another way, medical diagnostics is another piece of information flowing to the operational commander. If the data supplied to the commander are not helpful in making decisions about the best employment of the unit, the systems need to be reengineered to fit the need. Assigning a senior medical officer who has fleet experience to serve as the principal originator of new concepts in medical diagnostics would be a minimal step. In fact, the Navy Medical Department has made considerable investment in physicians trained in epidemiology and infectious diseases. It is recommended that such an officer with sufficient fleet experience and training in infectious diseases be selected by the Bureau of Medicine and Surgery so that he or she can provide the nexus for concept generation and experimentation. Medical Chemical and Biological Countermeasures Finding: Consequences and Impact of Exposure A serious and generally overlooked issue is that of long-term consequences for the health care system of victims exposed to chemical or biological weapons. Lacking an understanding of any long-term or recurring symptoms of exposure, health care professionals in the military are not in a position to provide adequate treatment or post-injury support. The committee raises the issue as a general concern but does not have a particular recommendation to make beyond raising the need for the Department of Defense to invest in the research necessary to characterize such effects in order to provide both immediate and longer-term treatments.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats DISEASE REPORTING AND ANALYSIS A near-real-time disease reporting process coupled to an efficient and automated epidemiological analysis system would significantly improve the Navy’s ability to defend and operate under chemical and, especially, biological warfare conditions. Medical Chemical and Biological Countermeasures Finding: Lack of Disease Reporting System Among Naval Forces The Navy does not have a comprehensive health incident reporting system. The committee did not receive any information suggesting that the Navy has advanced beyond the “daily report of the sick” for naval vessels. There may be some ad hoc arrangements, particularly in amphibious ready groups, by which data are collected and shared, but there is no evidence of a system to facilitate sharing medical data within the battle groups. During a visit to Norfolk, Virginia, the committee was given the impression that each ship commander independently establishes his or her requirements for medical disease reporting. In some instances the captain is notified within 24 hours of any encounters in the sick bay, and in other instances the reports may be weekly or only at the discretion of the corpsman providing the first-line health care. Indications were that the larger the ship and hence the more sophisticated the medical capability, the more likely that the medical contingent functioned relatively independently of the ship captain unless an emergent situation developed. Many medical facilities ashore participate in local community disease reporting systems, but this too is not uniform practice. Thus, the current level of health surveillance in the Navy, especially among its surface ships, is insufficient to detect early symptoms of biological and/or chemical exposure. There is evidence that a few Marine bases have achieved some level of a civilian–military joint venture in health service support, particularly in disaster situations. Such practices are also followed by other naval installations (notably, nuclear shipyards) in regard to radiation health and by a few Navy hospitals. However, even if put in place, a health surveillance system will only be effective if its health care providers are properly trained in its use and interpretation—and the committee has already noted the shortcomings in medical training in general. Such variations in reporting are not acceptable in an era of significant and ongoing threats of biological or chemical attack. In this environment, it is essential that the ship or base commander and the medical personnel be aware of the threat and mutually supportive of one another in dealing with the threat.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Medical Chemical and Biological Countermeasures Recommendation: Establishing a Disease Reporting System Implement a routine disease reporting system. The committee recommends that the Navy implement a system of disease reporting which requires that any complex of signs and symptoms occurring in shipboard personnel above a predetermined threshold of indications be reported to the captain within hours. It is the committee’s view that such a system should be implemented if the Navy is to meet its responsibilities to protect, consistent with mission accomplishment, the lives of Navy personnel. The ultimate goal should be a single system of disease reporting that encompasses all aspects of Navy operations, deployed and shore-based. The elements of such a system need to include the initial capture of data in real time by monitoring key indicators gathered from patient encounters on a daily basis. All reported signs and symptoms that fit criteria indicating possible chemical or biological attack should be immediately reported to a unit commander. The commander should report data to a larger database at the battlegroup level, which collects data from several units on a daily basis. At the battlegroup level there should exist not only additional collection and analysis capability, but the expertise to provide consultation to individual units to confirm diagnoses. The battle group would, in turn, transmit the data to a Navy-wide CONUS-based database monitoring global developments. At the CONUS level, additional analysis and intervention capability would be available to address the situation. Ideally, the Navy system would then communicate the data and analysis to a single national registry, which would correlate developments from the military and civilian communities. Medical Chemical and Biological Countermeasures Finding: Successful Reporting Systems There are examples of successful military and civilian initiatives to identify fundamental warnings and indicators, collect the data, and analyze and merge them into systems capable of assessing the significance of seemingly random clinical observations. Beyond these, the Navy’s particular development needs should be minimal. The best military example of such an initiative that the committee is aware of is the Air Force’s progress in monitoring diseases in Southwest Asia. Originally developed as a project of the Defense Advanced Research Projects Agency, Desert Care One uses database management systems to log data from individual clinic visits to Air Force field medical units in Southwest Asia. Data such as presenting complaint, temperature, time to onset of disease, and initial laboratory findings are recorded into the central database. Computer analysis establishes a “normal” background activity level. Any specific findings above

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats the background level are analyzed for their significance. If a predetermined threshold of activity is exceeded, the Air Force dispatches a medical contact team to investigate the cause of the change. The result of these efforts has been some surprisingly early interventions in the course of human disease. In one instance, the system led investigators to a source of contaminated food before illness progressed to the level of deterioration in mission readiness. In the civilian community, large city health departments are beginning to use similar real-time analysis of visits to emergency rooms and clinics to gain some time advantage over the outbreak and spread of disease. Another successful system has been established in the commercial cruise industry. In that industry, the guideline is that any recurring symptom complexes be reported promptly to the ship captain. Further, any time that similar signs or symptoms occur in 1 percent of the ship’s population, the situation must be reported immediately to the corporate office. The corporate office is responsible for providing the needed range of medical and risk management consultation to deal effectively with the problem. Should the level of similar signs and symptoms exceed 2 percent of the presumed at-risk population, the cruise ship company is required to report the findings to the Centers for Disease Control and Prevention of the Department of Health and Human Services. (See also footnote 29 in Chapter 2.) Medical Chemical and Biological Countermeasures Recommendation: Standards for Disease Reporting Build a routine disease reporting system based on the Air Force prototype and adopt “best practices” from the commercial world. In the case of deployed naval forces, it is the committee’s recommendation that the Navy build on the Desert Care One prototype developed by the Air Force and implement the system with guidelines similar to those of cruise industry. In a deployed situation, the medical contingent with the most personnel and expertise in the battle group, usually on the aircraft carrier, should replace the corporate office and be notified at a predetermined threshold. The carrier medical department would maintain the registry of all suspicious occurrences within the battle group and would be staffed and equipped to provide consultation and sophisticated diagnostic and treatment advice to the smaller units. To assist in this responsibility, a large ship’s medical department could be the keeper of a forwarddeployable, preventive medicine unit that would be used to help confirm the presence of a biological warfare pathogen. Marines afloat should be managed in the same way, with the same reporting requirements as those for Navy personnel. Once Marines are deployed on shore, guidelines for reporting medical conditions should be maintained insofar as possible, depending on the intensity of combat.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats The committee both appreciates that it is recommending significant changes to the traditional Navy concept of each ship’s functioning independently in the medical arena and takes seriously the difficult nature of cultural and behavioral change. The committee is convinced, however, that the recommended changes are fully justified by the serious nature of biological and/or chemical attack. Particularly in the case of biological attack, time is of the essence. For example, describing a biological attack on a U.S. Navy guided-missile destroyer, the morbidity and mortality rate increases rapidly with each passing day between exposure and diagnosis. In order to preserve life, there must be made every effort to make a diagnosis before the onset of clinical disease. To accomplish this task, the Navy must ensure that adequate preventive medicine and detection capabilities are made available in order to strengthen laboratory capabilities and integrate information collection. In addition, epidemiological resources will be required to facilitate appropriate analysis, investigation, and consultative feedback to deployed units. The Navy should also take responsibility for transmitting information to larger national and, if developed, international data collection and analysis centers. In the United States, the Centers for Disease Control and Prevention is taking the lead for homeland security in this area, and it would be a logical referral site for analysis and further consultative help. As noted above, commercial cruise lines are mandated to report to the CDC when an incidence rate reaches 2 percent of the presumed at-risk population. Thus, the CDC would become the ultimate national registry of suspicious medical data for both the civilian and military communities. Medical Chemical and Biological Countermeasures Recommendation: Shore Installations and Bases Ensure that all shore installations and bases are included in the disease reporting system. The disease reporting and analysis system outlined above should be mirrored in the ports, at shore installations, and at bases. Depending on the size of the base and the sophistication of the health care contingent, any recurring signs and symptoms should be reported promptly to the base commander. Early reporting should be at the discretion of the concerned provider, but mandatory reporting at the 1 and 2 percent incidence levels, as described above, should be accepted procedure. It is important that the information flow to the base commander despite the fact that, particularly on larger bases, the medical commander also reports to the Navy’s Bureau of Medicine and Surgery and ultimately to the Surgeon General of the United States. In a scenario involving a biological or chemical attack, the base and the surrounding civilian community are inseparable. In order to provide the best

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats protection and care to both base and civilian communities in such circumstances, there need to be seamless reporting, analysis, and mobilization of resources. It seems to the committee that having the integration effort led by the base commander makes the most sense, since the base is a more likely target for attack. It should therefore be the responsibility of the base commander to assure that the base and civilian response to a biological or chemical attack is maximally coordinated. In the case of disease reporting, information should be shared when the first report is made to the base commander and regularly thereafter, until the crisis has passed. Communication should be continuous and efforts coordinated throughout the crisis. For that to happen, a concerted effort must be made to bring together the leadership from both sides of the base fence in a series of regularly scheduled meetings to plan the reporting and response system and then to regularly exercise it. The committee was made aware of the significant progress in fielding such a system at the Marine Corps base at Camp Lejeune and its surrounding community, Onslow County, North Carolina. The system was initiated because of concern for the possibility of an explosive release of toxic material. It effectively coordinates first-responders and those providing backup medical intervention. A similar system is being developed between the Marine Corps base at Camp Pendleton, California, and the surrounding communities in San Diego County. The committee sees no reason why similar programs tailored to community needs should not be developed at every CONUS Navy or Marine Corps base. A FINAL WORD ON TRAINING Although a more extensive discussion of training appears earlier in this chapter and in Chapter 3, the committee emphasizes here that it does not see any scientific or technological breakthroughs in the near term that will significantly alter current capabilities for diagnosing and treating biological or chemical attack victims. Therefore, the system will remain highly dependent on the performance of alert and well-trained individuals who have taken part in exercises focused on what can and should be done when a biological or chemical attack is suspected. To underpin the current system, it is important that biological and chemical attack scenarios be used in training exercises and war games to raise awareness of these threats. Further, the Navy should institutionalize training in risk communication for all commanders and health personnel. Since it is imperative that all personnel have heightened awareness, the Navy should introduce training in selected aspects of the chemical and biological threat, risk awareness, and risk communication to all Navy personnel within a short time of their induction into the Service.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats SUMMARY Box 5.3 provides a summary of the findings and recommendations in this chapter. Recommendations are directed to the Navy’s operational medicine leadership (Bureau of Medicine and Surgery) to prioritize and enlist key support organizations, both within the Navy and in the Joint CBD Program, for implementation. BOX 5.3 Summary of Findings and Recommendations on Medical Chemical and Biological Countermeasures Drugs and Vaccines Findings There are five fielded products for medical chemical warfare (CW) defense—four nerve agent therapeutics and one skin decontaminant. A topical skin protectant and a multichambered autoinjector are close to being fielded. Less mature are broad-spectrum enzyme scavengers and reactive topical skin protectants to provide pre-exposure protection against a wide range of agents. Two vaccines are approved for use against biological warfare (BW) agents—smallpox and anthrax—but both have limited availability. With the exception of smallpox, next-generation candidates to replace the two current vaccines (smallpox and anthrax), and vaccines for botulism, tularemia, and Venezuelan equine encephalomyelitis will not be approved and available until the end of the decade at the earliest, hampered in part by the normal process for new drug approval and by the risk-averse nature of lead agencies within the Department of Defense. Post-exposure antibiotic therapies for plague and anthrax are generally effective if administered within a day or so after exposure. There is no approved therapy for smallpox, but cidofavir and possibly vaccinia-immune globulin (VIG) are showing some promise. Stores of chemical antidote kits and antibiotics may be out of date and/or insufficient to treat all who might be exposed onboard ships, according to anecdotal evidence provided to the committee. Stocks at shore installations tend to suffer the same—or worse—shortfalls. Recommendations for the Navy Ensure that all deployments include adequate stores of current chemical and biological medical countermeasures. Push the Joint Vaccination Acquisition Program into a more aggressive development path for new and more effective vaccines and drugs (e.g., smallpox therapeutics). Even with aggressive engagement, do not rely on vaccinations or more effective chemical warfare agent antidotes to become available in the near term to midterm.

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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Medical Diagnostics Findings The Navy’s Bureau of Medicine and Surgery and the fleet have begun efforts to develop training packages and medical concepts of operations and to field improved equipment to Navy ships, but these changes have not yet been reflected in formal instructions and directives governing the readiness status of Navy ships. An overlooked resource to support experimentation, doctrine development, training, and disease surveillance are the forward-deployable medical laboratories that are assembled and maintained by the forward-deployable, environmental and preventive medicine units (FD-EPMUs). These laboratories are expeditionary, hardened for field use, and represent the first step toward a minimal equipment set for advanced laboratory diagnostics. Almost all of the clinical diagnostics systems either under development or fielded for the military are based on one or both of two relatively well-understood technologies. Both need further work to drive down false-positive indications. Almost all clinical diagnostics systems are based on confirmation of the clinical patterns observed by the diagnostician as opposed to approaches that identify incipient infection before symptoms are manifested (anthrax spore inhalation being an exception). Success with pre-symptomatic diagnosis would greatly reduce the treatment regimen and negative mission impacts. Recommendations for the Navy Implement existing instructions and make use of environmental and preventive medicine units for introducing new equipment. Review all Joint CBD Program efforts to assess how well they will meet operational requirements in the maritime environment. Assess the status of the Critical Reagents Program for fielded diagnostic equipment to accelerate approvals. Pursue development paths for advanced diagnostics to reduce false positives characteristic of the two leading approaches. Undertake fundamental research in developing the basis for pre-symptomatic diagnosis. Develop gaming and operational concepts, coupled with clinical diagnosis, for biological warfare attacks. Disease Reporting And Analysis Findings The Navy lacks a comprehensive health incident reporting system. Some ad hoc systems may exist, but they will not serve either fleet or shore installation operations well in the event of a major chemical or biological attack. Examples of successful reporting systems can be found in both civilian (e.g., the commercial cruise industry) and other military (e.g., the Air Force) communities. Recommendation for the Navy Develop and implement a routine disease reporting system, built on the Air Force prototype and best practices from the commercial world—for the fleet, shore installations, and bases.