Chapter IV. Technology Development
Army Science and Technology Master Plan (ASTMP 1997)


Q. Medical and Biomedical Science and Technology

1. Scope

Military medical and biomedical science and technology programs are a unique national resource focused to yield superior capabilities for medical support and services to U.S. armed forces. Unlike other national and international medical science and technology investments, military medical research is concerned with preserving the combatant's health and optimizing mission capabilities despite extraordinary battle, nonbattle, and disease threats. It is also unlike most of the more widely visible Army modernization programs because its technology is incorporated into service men and women rather than into the systems they use. This technology area is vital to the human capability dimension of all Joint Warfighting Capabilities. Weapons systems developers exploit capabilities to mitigate system hazards, improve soldier survivability, and optimize operator-system interface. Because of its special and unique nature, international treaty and convention require military medical research to be conducted for the benefit of mankind. Additionally, many activities and products are regulated by the U.S. Food and Drug Administration (FDA).

The Army medical and biomedical science and technology program is divided into five technology sub-areas: Infectious Diseases of Military Importance; Medical Biological Defense; Medical Chemical Defense; Army Operational Medicine, and Combat Casualty Care. Each sub-area focuses on a specific category of threat to the health and performance of soldiers. The first four technology sub-areas emphasize the prevention of battle and non-battle injury and disease, while the Combat Casualty Care Research Program emphasizes far-forward treatment. Prevention research programs provide both medical material (e.g., vaccines, drugs, and applied medical systems) and biomedical information. Combat Casualty Care provides medical and surgical capabilities tailored to military medical needs for resuscitation, stabilization, evacuation, and treatment of all battle and non-battle casualties. Each technology sub-area has objectives that respond to the National Military Strategy.

The National Defense Act of FY94 consolidated chemical and biological defense (CBD) programs, including both Warfare and Medical, under OSD management. The medical CBD programs are discussed here, while the warfare CBD programs are addressed in Section E, Nuclear, Chemical, and Biological Defense, of this chapter.

2. Rationale

Individual service men and women are the most important, and the most vulnerable, components of military systems and mission capabilities. Disease and non-battle injury typically far outweigh battle-related injury as the greatest cause of casualties among military forces. Regional, life-threatening, or incapacitating disease epidemics both limit and constrain military deployment alternatives. Widespread sickness and injury are mission aborting; high casualty and death rates are warstoppers. The current force structure is confronted with an expanded potential for large-scale regional conflicts, proliferation of weapons of mass destruction, and ready availability of advanced conventional weapons, as well as more diverse and highly complex missions characterized by continuous, high-tempo operations. These more dangerous challenges are coupled with enduring threats of disease, harsh climates, operational stress, and injury. These realities mandate a sustained commitment to robust investment in medical re search programs (Figure IVQ1).

Figure IV-Q-1. Future Medical Technologies

3. Technology Subareas

a. Infectious Diseases of Military Importance

Goals and Time Frames

The goals of the Military Infectious Disease Research Program are primarily to protect soldiers from incapacitating infectious diseases by the development of vaccines and disease-preventing drugs and secondarily to develop effective drug treatments. Infectious diseases pose a significant threat to operational effectiveness. Most Americans lack natural immunity to diseases endemic abroad. Prevention of epidemic infections in deployed forces is a force multiplier. Immunization prior to deployment is the preferred medical countermeasure to infection because it reduces logistical requirements in the theater of operations. Chemoprophylaxis is a proven method of protecting the military population from malaria. Sepsis following surgical wound infection is a major cause of death in battle casualties. Lost training days due to respiratory infections and meningitis increase the cost of mobilization. Human Immunodeficiency Virus (HIV) infection is a leading cause of death among young people of military age.

A vaccine to protect troops against infectious hepatitis was fielded (FY95). New antimalarial drugs will be fielded to replace drugs rendered ineffective by the global development of parasite resistance (FY97). An improved drug for the treatment of cutaneous and visceral leishmaniasis will replace the highly toxic and marginally effective compound currently available (FY97). Improved arthropod repellents will protect soldiers from insects carrying lethal parasitic, viral, and rickettsial diseases (FY97). Oral vaccines will immunize soldiers against incapacitating dysentery caused by shigella species (FY98). Antibodies will provide protection against sepsis resulting from the common bacterial wound infections (FY98).

Major Technical Challenges

Many diseases which were feared killers only a few years ago have been subdued, largely through vaccination and public health advances. The first diseases to yield were those in which vaccination induces permanent immunity. New diseases (such as HIV, Lyme disease, Legionnaire's disease) emerged to take their place while previously successfully treated diseases developed resistance to formerly effective drugs. The focus of market-driven pharmaceutical development has been on diseases important in the industrial world. Infections prominent in many strategically significant areas of the world do not receive attention comparable to the extent of the populations affected. Thus, fundamental insight into the biology of the infectious organism and human response to infection must be developed through Army supported research. Drug and vaccine development requires the use of animal models of human infections to validate their efficacy. In many cases, such as malaria, the species of parasite which will infect laboratory animals is not the same species as that affecting humans. Furthermore, the course of infection in animals may not produce the symptoms important in human disease.

Specific technical challenges are listed below:

b. Medical Chemical and Biological Defense

Effective FY94, as a result of Public Law 103-160, the National Defense Authorization Act for Fiscal Year 1994, the medical chemical and biological defense research programs were consolidated under a single office of OSD with the Army serving as Executive Agent.

Goals and Time Frames

The primary goal of the Medical Biological Defense Research Program (MBDRP) is to ensure the sustained effectiveness of U.S. armed forces operating in a biological warfare (BW) environment. Specific objectives of the program are: To prevent casualties by the use of medical counter measures (e.g., vaccines, toxoids, and pretreatment drugs); to diagnose exposure to a BW agent; and to use chemotherapeutics and immunotherapeutics to prevent lethality, and maximize return to duty.

The MBDRP is developing vaccines that will protect at least 80 percent of the immunized personnel against an aerosol challenge and will induce minimum reactogenicity in soldiers when immunized. Safety and efficacy in pre-clinical studies using animal models will be demonstrated for the following vaccines: second generation Anthrax vaccine (FY96); Venezuelan equine encephalitis vaccine (FY96); second generation Botulinum Toxin vaccine (FY98); Plague vaccine (FY98); Eastern equine encephalitis vaccine (FY98); Brucellosis vaccine (FY99); second generation Ricin vaccine (FY00); and the second generation Staphylococcal Enterotoxin B vaccine (FY00). After these successful transition milestones, initial clinical trials will be conducted.

Major Technical Challenges

The development of new vaccines requires both close examination of the biological threat agent to determine the pathogenic mechanism of the disease and development of vaccine strategies to counteract these mechanisms. Strategies for vaccine development must embrace new knowledge regarding the human immune system. This includes information about generation of immunity; the preservation of immunological memory; and the regulation or modulation of immune functions, including enhancement and suppression.

New candidate vaccines must be both safe and efficacious. These criteria are regulated by the Food and Drug Administration (FDA). Ethically it is not possible to test the efficacy of a biological warfare vaccine in humans, however extensive safety and immunogenicity studies are conducted in these development programs.

Therefore, this testing must be conducted in model systems. Animal models do not currently exist for many of the BW agents. The use of existing animal models is limited by the desire to decrease or eliminate the use of animals for vaccine development.

Specific technical challenges are listed below:

c. Medical Chemical Defense

 

Effective FY94, as a result of Public Law 103-160, the National Defense Authorization Act for Fiscal Year 1994, the medical chemical and biological defense research programs were consolidated under a single office of OSD with the Army serving as Executive Agent.

Goals and Time Frames

The mission of the Medical Chemical Defense Research Program is to preserve combat effectiveness by timely provision of medical countermeasures in response to joint service chemical warfare defense requirements. This goal is accomplished via three objectives: To maintain technological capability to meet present requirements and counter future threats; provide individual level prevention and protection to preserve the fighting strength; and provide medical management of chemical casualties, to enhance survival and expedite and maximize timely return to duty.

By FY96, demonstrate the safety and efficacy for a Milestone 1 transition (demonstration and validation phase) to advanced development for a methemoglobin former for pretreatment of cyanide. Demonstrate by FY96 safety and efficacy sufficient for a Milestone 0 transition (concept exploration and definition) of an advanced anticonvulsant component for the warfighter/buddy-use nerve agent antidote. By FY99, develop biotechnology based chemical agent prophylaxes that provide protection against battlefield concentrations of CW agents without operationally significant physiological or psychological side effects. Demonstrate by FY99 safety and efficacy sufficient for a Milestone 0 transition of a reactive component for a topical skin protectant (providing protection against penetration) that will detoxify both vesicant and nerve agent. By FY00, demonstrate safety and efficacy of a candidate medical countermeasure against the vesicant agents sufficient for a Milestone 0 transition decision. By FY02, demonstrate safety and efficacy sufficient for a Milestone 0 transition decision of an advanced skin /wound decontamination system for decontaminating chemically contaminated wounds.

Major Technical Challenges

Developing a pretreatment, protectant, or antidote which is both effective against chemical warfare agents and safe for human use is critical. Candidate countermeasures must demonstrate the desired protection without detrimental side effects. These evaluations depend on animal models to identify those candidates with the highest potential to successfully demonstrate both safety and efficacy in warfighters.

Specific technical challenges are listed below:

d. Army Operational Medicine

Goals and Time Frames

The goals of the Army Operational Medicine Research Program are to protect soldiers from environmental injury and materiel/system hazards; shape medically-sound safety and design criteria for military systems; sustain individual and unit health and performance under operational stresses, especially continuous and sustained operations (CONOPS/SUSOPS); and quantify performance criteria and soldier effectiveness in order to improve operational concepts and doctrine.

The modern warfighter will require the full range of human physical and mental capability to survive and prevail in future military operations. By FY96, predictive models will be developed to estimate the level of performance degradation from nonincapacitating laser eye injury. By FY97, performance enhancing rations involving an optimal carbohydrate mix and other components such as caffeine, tyrosine and choline will prevent neurochemical deficits and sustain soldier cognitive function during CONOPS in environmental extremes. Antioxidant pretreatments will be tested for the ability to protect soldiers against muscle damage produced by blast overpressure or sustained physical effort (FY98). Flat panel displays will be designed to reduce the effects of visual cortical distortions and disorientation in rotary-wing aviators and command ground vehicle crewmembers (FY98). By FY98, melatonin, a hormone which acts as a master synchronizer of body rhythms and a natural sleep inducer, will be operationally tested for ability to prevent symptoms of jet-lag and fatigue in soldiers deploying across time-zones and in night operations. Specific physical and psychological training strategies will be developed to harden selected individuals to operate continuously without performance deficit or injury for 72 hours (FY98).

Major Technical Challenges

Developing strategies and products to protect, sustain and enhance soldier performance requires the development and application of scientific data and knowledge. Strategies and products must remain effective in various combinations and in realistic operational tests. One example is sleep management. Strategies that combine the use of pharmaceutical agents, naturally occurring hormones (such as melatonin), timing of bright lights, and feeding schedules are needed. Various combinations of these factors must be explored in order to develop the best sleep management strategies for the most realistic operational scenarios.

Specific technical challenges are listed below:

e. Combat Casualty Care

Goals and Time Frames

The goal of this program is to save lives far-forward. This goal will be achieved by improving the delivery of far-forward resuscitative care, minimizing lost duty time from minor battle and non-battle injuries, reducing unnecessary evacuations, and decreasing the resupply requirements of all forward echelons of care. Near-term objectives include general improvements in currently approved treatments, techniques, solutions, etc. Specifically, by FY96, develop small-volume resuscitation solutions such as hypertonic saline dextran (HSD). Such solutions will reduce the logistics tail by at least threefold for the 5 to 10% of casualties requiring HSD. By FY96 produce an intraosseous, blood vessel infusion device for the rapid administration of resuscitation solutions, which will enable prompt vascular access in those casualties in profound shock. The program will also provide a microencapsulated antibiotic to improve drug concentrations at the required tissue site, without overwhelming the entire body by FY96. Mid-term goals include introduction of capabilities to physiologically monitor combat casualties from the instant they are wounded (FY99), development of improved diagnostic algorithms, introduction of minimally invasive "smart catheters" for the determination of blood chemistries on the far-forward battlefield (FY01), development and fielding of oxygen free radical scavengers to minimize the damage to cells and tissue caused by the rigors of combat trauma, as well as products to reduce blood loss following injury. Longer lived blood preservatives are scheduled for transition during this period (FY97-01), as are improved medications for the treatment of thermally injured tissue.

Major Technical Challenges

Technical challenges include understanding and overcoming the toxicity of oxygen-carrying hemoglobin solutions, development of battery power and computing capability necessary to support the demands of the computer-aided diagnostic sensor/computer interface system, overcoming the problem of applying local hemostatic agents (e.g., fibrin glues) to the wet surfaces of a hemorrhaging wound, and miniaturizing all of the equipment necessary to induce suspended animation far-forward.

4. Roadmap of Technology Objectives

The roadmap of technology objectives for Medical and Biomedical S&T are shown in Table IV-Q-1, below.

Table IV-Q-1. Technical Objectives for Medical and Biomedical Science and Technology