MRMC Review 2006

Defense Medical Logistics and the Army Medical Department

By Patrick Byrne
Medical logistics has undergone significant transformation to improve the efficiency and effectiveness of the medical supply chain. Several initiatives have been undertaken jointly by the Military Health System (MHS) in partnership with the Defense Logistics Agency (DLA) and are distinguished by a shift to commercial industry rather than government depots for national-level support, the adoption of industry best business practices for information and distribution management, and the development of a DoD standard automated information system under the Defense Medical Logistics Standard Support (DMLSS) program. Medical logistics has become a truly joint enterprise with all military services using common business processes and IT solutions for most medical logistics functions.

The Army Medical Department, however, is unique among the services in its responsibilities for theater medical logistics support that routinely include support to other services as well as the Department of State and designated multinational partners. The AMEDD must also field and sustain a multifunctional health service support system that is capable of supporting a campaign-quality Army with highly sophisticated medical capabilities distributed across broad land areas. Meeting the logistical demands of providing the appropriate medical materiel to project and sustain the medical force using the most modern business practices available is a major mission of the U.S. Army Medical Research and Materiel Command.

MRMC executes these responsibilities through three subordinate commands, the U.S. Army Medical Materiel Agency, the U.S. Army Medical Materiel Center, Europe, and the U.S. Army Medical Information Technology Center. It also works in close coordination with two other Army theater medical logistics centers, the 16th Medical Logistics Battalion in Korea and the U.S. Army Medical Materiel Center, Southwest Asia, supporting U.S. Central Command.

Present Situation

Operations Enduring and Iraqi Freedom confirmed the need for distribution management capabilities at the theater level that are far beyond those normally provided by individual medical treatment facilities that are successfully supported across the MHS by the DMLSS application. It also demonstrated the limitations of stand-alone applications and servers, especially in the synchronization of medical logistics data associated with the predominantly commercial products obtained directly from commercial sources using medical prime vendors and other DLA industry partners.

Operational forces were also found to need simple and reliable means of performing customer-level medical logistics functions without the need to maintain powerful yet cumbersome servers and systems, and to obtain information on product availability and shipment status without having to learn how to use and maintain a complicated logistics application. In short, solutions were needed that would promote ease of use for customers, improve availability and accuracy of medical logistics information, and enable the most complex processes to be accomplished in locations outside the maneuver area where the necessary expertise can be concentrated.

Medical Logistics Transformation

In June 2004, the commanding general of USAMRMC initiated a comprehensive strategy to transform Army medical logistics in order to better support theater requirements for medical force projection and sustainment. The objectives of this strategy are to:

• Integrate and synchronize all theater medical supply chain management activities under single, end-to-end process management.
• Simplify processes in the theater, accomplishing the most complex processes at the highest level possible, for example, in safe havens.
• Apply best business processes to provide the right products at lowest total delivered cost.

Three important initiatives make it possible for MRMC to achieve these objectives:

Policy Transformation: DoD Directive 5101.9 designates DLA as the DoD Executive Agent for Medical Materiel (MMEA), making it the DoD agency responsible for orchestrating end-to-end medical supply chain support to combatant commands.

A major element of this initiative has been the formal incorporation of Army medical logistics organizations into the DLA operational architecture as Theater Lead Agent for Medical Materiel (TLAMM). The TLAMM manages theater-level distribution for the HSS system on behalf of the executive agent, receiving materiel directly from industry and providing direct support to theater customers. These TLAMM designations build upon a highly successful partnership between the AMEDD and DLA that allows designated AMEDD organizations to operate with the support of the DLA Defense Working Capital Fund. This partnership has existed since 2000, and leverages the capabilities of both Army and DLA to achieve seamless, endto- end medical materiel distribution directly from commercial sources to operational customers in the theater. The implementation of MMEA and the designation of TLAMMs formalizes this partnership into a policy framework that is now included in joint doctrine for Health Service Support.

Technology Transformation: MRMC is developing a theater-level medical logistics solution by leveraging its successful SAP-based Enterprise Resource Planning initiative originally developed in partnership with DLA for the management of medical assemblages. The Theater Enterprise-Wide Logistics System (TEWLS) is a BMMP-approved, phased implementation of a single enterprise solution using commercial off-the-shelf software. It will support the development, production and ultimate theater sustainment of medical assemblages that are the basic building blocks of operational medical capabilities. TEWLS will support the operation of all Army organizations serving as TLAMM, and provide materiel management within a single operational instance for tactical Army medical logistics companies. Upon completion in Fiscal Year 2007, TEWLS will migrate into the DMLSS program as the DMLSS theater-level solution for medical supply chain management.

Organizational Transformation: The full realization of an enterprise solution will require the establishment of new organizational responsibilities and relationships. Army medical logistics organizations that traditionally have managed independently using stand-alone, legacy systems and servers will have to be functionally integrated to the enterprise solution. Most of these units currently operate under different commands using their own procedures. Organizational responsibilities for the management of enterprise processes, especially catalog update and new item entry, will have to be established and streamlined to be responsive to theater requirements worldwide. MRMC is working with the AMEDD Combat Developer and U.S. Forces Command to develop the necessary operational concepts and organizational alignments to enable separate Army medical logistics units to successfully manage a synchronized, end-to-end supply chain.

The Road Ahead

HSS is dependent upon medical materiel to provide effective health care. The urgency and complexity of medical requirements under demanding operational environments are met with increased expectations of military leaders as well as American families for nothing less than the best medical care under any conditions. MRMC is uniquely positioned with the requisite expertise and synergy in its medical logistics, information technology and research capabilities to play a key role in the development of DoD capabilities for world-class medical logistics. ♦

Combat Casualty Care Research Program

By Colonel Robert Vandre
For more than 150 years, 20 percent of U.S. soldiers wounded in battle have died before they reached a medical treatment facility. Today that figure is below 14 percent. What made the difference? Starting with Afghanistan and continuing to the present, the U.S. military has fielded a steady stream of new technologies and procedures. Interceptor body armor stops high-speed projectiles and greatly reduces chest injuries. Army medics are now far better trained and must be emergency medical technician Level-B certified.

The Department of Defense fielded two new bandaging technologies for stopping bleeding, the chitosan bandage, manufactured by HemCon, and QuikClot, manufactured by Z-Medica. The chitosan bandage is made from shrimp shells and sticks to the wounded area, sealing it much like a tire patch. QuikClot is made up of dessicant granules that absorb water from blood, thereby concentrating the blood’s clotting factors and encouraging rapid clotting to stop the bleeding. Both products have been highly effective, and there are nearly 100 reports from the field where those technologies have been able to stop bleeding that normal bandages have not been able to control. The U.S. military also fielded a new tourniquet system called the Combat Application Tourniquet. About 200,000 of these tourniquets have been fielded.

The three services, in collaboration with Captain Frank Butler, former command surgeon for the U.S. Special Operations Command, developed new tactical combat casualty care guidelines that have become the standard of care for medics. These guidelines modify the advanced trauma life support recommendations that are taught in the civilian community to make them more applicable to the military environment. Some major differences are treating active bleeding before checking the airway, routinely placing tourniquets, and using hypotensive resuscitation in patients who are actively bleeding. This is contrary to the civilian practice of giving large volumes of resuscitation fluid early on.

In hypotensive resuscitation, if patients are actively bleeding, medics do not give them resuscitation fluids until they lose consciousness. Military research has shown that administering IV fluids increases blood pressure, which dislodges clots that have already formed and also increases the rate of bleeding. Obviously, these are complications medical professionals want to avoid in actively bleeding patients. The Combat Casualty Care Research Program also showed that Hextend is the best resuscitation fluid for hypotensive resuscitation, and the use of Hextend has been incorporated into tactical combat casualty care.

To allow medics to bring blood products far forward on the battlefield, researchers developed the Golden Hour blood transport container that can keep four bags of red cells at 10 degrees C for 72 hours with no electricity or wet ice. This container is being used in theater on evacuation missions where red blood cells may be of help to the wounded patients.

Through an extensive collaboration with Israeli partners, the Combat Casualty Care Research Program promoted the first use of recombinant activated Factor VII (rFVIIa) for the treatment of severe surgical bleeding in trauma patients. rFVIIa stops bleeding in trauma patients when their own clotting mechanisms are not working properly. As a result of this collaboration, rFVIIa is now being used in major trauma centers throughout the world and has been used on more than 400 wounded patients in Iraq. This is a remarkable, life-saving drug with tremendous applicability to the civilian trauma patient population as well as military patients. Currently the drug’s maker, Novo Nordisk, is pursuing clinical trials to gain a trauma indication for this drug with the Food and Drug Administration. After that is received, the Combat Casualty Care Research Program expects that medics will be able to use rFVIIa far forward so that it can be applied immediately after a soldier is wounded. Program officials hope that this drug will slow down bleeding enough so that soldiers who receive it will be able to survive long enough to be evacuated to surgery.

In the past year, the Combat Casualty Care Research Program partnered with industry to discover a potent new neuroprotective drug that shows great promise in reducing the effects of penetrating head injury. Researchers’ studies in rats were so encouraging that the company, Neuren, has decided to use the results to steer their next human clinical trial. If the drug performs in humans as well as it has in animal models, it will revolutionize the care of soldiers with head injuries and will give medics a real tool to treat head injuries.

So far, the program’s studies are showing that nothing is as good for treating blood loss as replacing it with whole blood. The problem is that medics cannot carry it because it must be refrigerated. As a result combat casualty-care researchers are teaming with the Navy and the Defense Advanced Research Projects Agency to develop a fleet of freeze-dried blood products that can be used in lieu of whole blood. The Army is actively developing freeze-dried plasma and hopes to have a product available within five years. Plasma is the liquid part of blood that contains the majority of its clotting factors and is highly desirable for early resuscitation of patients. Currently it exists on the battlefield only in a frozen form and, as such, cannot be given any place but at field hospitals.

DARPA and the Navy have both pursued freezedried platelets, another clotting product. The Army has also developed a process to allow red blood cells to be kept refrigerated for up to eight weeks, 33 percent longer than they can currently be stored. Army researchers are working now to get funding to push this product through advanced development and FDA certification. Army researchers are also participating in clinical trials of a hemoglobin- based oxygen carrier, which will act as a temperature-stable substitute for red cells.

As a result of military medicine’s great success in saving lives, the services have a much larger percentage of patients who need rehabilitative services. Many of them have damaged or missing limbs. To better repair these wounds, the Combat Casualty Care Research Program is conducting research on regenerative medicine with a goal of being able to use a patient’s own stem cells to regenerate lost or damaged tissue and thereby restore function.

Through the Combat Casualty Care Research Program’s efforts, the death rate on the battlefield is greatly reduced. Technologies still under development show promise to reduce that rate even more, while also reducing the terrible morbidity associated with the wounds of war. The command’s researchers are changing history. ♦

Medical Chemical and Biological Defense Research Program

By Colonel Harry Slife
Future battlefields are expected to be at least as dangerous as any of the past or any that were anticipated during the Cold War. Although treaties and agreements forbidding the use of chemical and biological weapons were milestones in arms control, they make no provision for monitoring and compliance. Such weapons remain significant threats to U.S. and allied forces. The terrorist attacks of September 11, the anthrax letters that followed, the stockpiles of chemical weapons found in Iraq after the 1990-91 Gulf War, the use of these weapons in the Iran-Iraq War, and the 1995 nerve gas attack in the Tokyo subway are vivid reminders of the potential risk and threat to both servicemembers and civilians from these weapons.

Through the medical chemical and biological defense research efforts conducted at U.S. Army Medical Research and Materiel Command laboratories, several key medical capabilities in chemical defense and biological defense are being fielded to enhance personnel survivability.

Medical Chemical Defense Research

The mission of the U.S. Army Medical Research and Materiel Command’s Medical Chemical Defense Research Program is to preserve combat effectiveness by providing timely medical countermeasures in response to joint service chemical warfare defense requirements.

Research and product development supporting pretreatment, treatment, diagnostics and clinical management of the chemical casualty are the keys to continuing discovery and fielding of medical countermeasures to chemical warfare agents. Successful ongoing programs in or nearing acquisition status include an advanced anticonvulsant system and an improved nerve agent treatment system with an improved oxime for treatment of nerve agent exposure, and a stoichiometric nerve agent pretreatment (bioscavenger increment I). Active programs in the command’s technology base include research to investigate the effects of low-level exposure to chemical warfare agents, research to develop medical countermeasures against vesicants and nontraditional agents, research on nerve agent neuroprotection, and enhancements to the nerve agent pretreatment (bioscavenger increments II and III).

Critical advancements have been made in all areas of medical chemical and biological defense research, particularly in the area of nerve agent countermeasures. Nerve agents can be fatal to the unprotected warfighter. Survivors may have recurring seizures and longterm brain damage. Through joint research and development, the nerve agent threat has been substantially reduced by the fielding of numerous products:

• Soman Nerve Agent Pretreatment Pyridostigmine, a pretreatment drug, can be administered orally to troops under risk of chemical warfare attack without degrading their performance.

• Mark I Nerve Agent Antidote Kit provides the soldier with the nerve agent antidote atropine and an oxime, 2-pralidoxime chloride.

• Antidote Treatment Nerve Agent Autoinjector is an improvement over the Mark I Nerve Agent Antidote Kit.
 
• Convulsant Antidote for Nerve Agent— diazepam in an autoinjector— is used as an adjunct therapy for nerve agent poisoning to protect against seizureinduced brain injury and to enhance survival.

• Medical Aerosolized Nerve Agent Antidote is an aerosolized atropine that can be rapidly administered far forward to casualties for the control of respiratory effects of nerve agents.

• Skin Exposure Reduction Paste against Chemical Warfare Agents is a topical pretreatment that forms a film barrier on the skin and augments mission-oriented protective posture gear by preventing or delaying the penetration of a wide variety of chemical warfare agents, including the blistering agent sulfur mustard.

Medical Biological Defense Research

The mission of the command’s Medical Biological Defense Research Program is to ensure the sustained effectiveness of U.S. forces in a biological warfare environment and to deter the use of these weapons by maintaining a strong medical defensive posture.

Vaccines and pretreatment drugs for biological threat agents and toxins are designed to prevent casualties in the event of a biological warfare attack. Diagnostic tests and reagents are developed to diagnose disease in the event of actual exposure to biological agents. Antitoxins and therapeutic drugs are designed to treat casualties, prevent deaths, and expedite return to duty after exposure.

Technologies in advanced development include vaccines against Venezuelan equine encephalitis, plague, a bivalent (A and B) recombinant botulinum vaccine, a recombinant protective antigen as a next-generation anthrax vaccine for inhaled anthrax, and medical diagnostic systems (reagents, protocols and devices) for biological warfare threats and endemic infectious diseases. Several technologies maturing to the point where they are being considered for transition to advanced development include:

• A combined Venezuelan equine encephalitis, eastern and western equine encephalitis vaccine.

• Vaccines against staphylococcal enterotoxin and ricin toxin exposure.

Research is ongoing to develop multiagent vaccines that would provide the capability for immunizing the warfighter against multiple biological threats with a single vaccine, development of vaccines against Marburg and Ebola viruses, pursuing needle-free delivery methods for recombinant protein vaccines, and development of a comprehensive, integrated diagnostic system that combines nucleic-acid-based and immunodiagnostic-based platforms. Ongoing research efforts are also directed toward identifying and fully characterizing therapeutics against viral, bacterial and toxin threats.

The most likely route of dissemination of a biological warfare agent on the battlefield is through small-particle aerosols; therefore, researchers continue to develop, refine and validate equipment and experimental models used to study airborne infection and disease prevention. If exposure and illness occur, rapid diagnosis is essential for proper treatment and medical management. Field-deployable, rapid assays are being developed for diagnosis of biological warfare agent exposure.

Training

In addition to research and development, training military and civilian health care professionals in the diagnosis and treatment of chemical and biological warfare agent exposure is a command priority.

MRMC provides education and training to officers and enlisted persons from all services who will be the doctors, nurses and medics that will treat the warfighter exposed to chemical and biological warfare agents. In addition, this information is periodically broadcast via satellite to first responders around the world who would likely be tending to casualties exposed to chemical and biological warfare agents in the event of a terrorist action. The command’s experts also provide technical support to law enforcement agencies and counter-terrorism initiatives.

Looking to the Future of Medical Chemical and Biological Defense

The criticality of the Department of Defense’s medical chemical and biological defense mission, providing medical solutions to sustain the force in chemical and biological warfare environments, is matched only by the veracity with which it is approached. Emphasis includes rigorous scientific research, development of advanced products for chemical and biological defense, and training of both awareness and management of medical chemical- and biological-related events. The command’s laboratories are a critical link in the overall medical chemical and biological research, development, test and evaluation process, serving as the resource for product testing in animals with live biological warfare agent or undiluted chemical warfare agent thereby linking product research to product development. Ultimately the goal is to preserve total warfighter effectiveness, a vision to which the Medical Chemical and Biological Defense Program and U.S. Army Medical Research and Materiel Command is deeply committed and invested. ♦

Military Operational Medicine Research Program

By Lieutenant Colonel Carl Hover, MSC
In a typical Army mission, modern soldiers may encounter overheating from the extreme desert temperature of Southwest Asia; muscle fatigue from carrying more than 100 pounds of equipment—the infamous soldier load; sleep deprivation from continuous, several-day missions; anxiety from the concern of family members thousands of miles away; information overload generated by the rapid operational tempo and the increasing output of sophisticated high-tech equipment systems; and the emotional trauma of war.

Recognizing these and other stressors, the Military Operational Medicine Research Program is a Department of Defense program that builds the super warfighter. The program’s objective is to enhance the warfighters’ performance in training and on the battlefield in the face of those stressors that degrade operational performance. It studies the soldier as a biomedical system and develops models and medical products to sustain the warfighter in optimal mental and physical health.

Protection of Drinking Water

An example of one of the program’s successful efforts is in the area of water protection. Every installation and military operation is dependent on the availability of clean water. Water is one of our most valuable natural resources, and it requires significant resources to produce and distribute water across the theater of operations. In the United States, 47 percent of Americans get their primary water supply from surface waters, which are highly susceptible to contamination. Such contamination can originate from any of several sources, such as petroleum product spills, agricultural runoff, industrial processes, ineffective wastewater treatment and even deliberate introduction of toxic substances to the source water.

Ensuring that contaminants are not present in drinking water can be difficult. Using conventional chemical analyses to perform comprehensive contaminant testing is very expensive and time-consuming. Using traditional methods for monitoring simple water quality characteristics, such as residual chlorine and turbidity, while inexpensive, will not detect the majority of toxic chemicals. Furthermore, analytical chemistry techniques cannot directly measure toxicity.

Using the concept of the canary in the coal mine, the U.S. Army has developed a system that uses fish to monitor toxicity: the intelligent Aquatic Biomonitoring System, or iABS. Fish are natural integrators of water quality conditions and respond to a wide range of unsuspected toxic chemicals or chemical mixtures.

Eight fish are held in chambers under flowthrough conditions and continuously sense the water to provide an early warning of potential toxic hazards. Much like an electrocardiogram, electrodes above and below each fish passively monitor the electrical signals generated as the fish breathe and move in the chamber. An expert system monitors these signals for deviations from normal behavior along with water characteristics, such as pH, dissolved oxygen, conductivity and temperature, and alarms when the fish display excessive stress. In these instances, the expert system takes action to automatically capture a water sample for detailed chemical analyses and also notifies appropriate individuals via phone or e-mail. Technicians can then remotely access the system for an off-site evaluation and to determine if additional action is required.

Although not practical for evaluating field water production, the iABS is a low-maintenance, compact and portable biomonitoring system that is suitable for fixed facilities and rear areas where high-volume water production occurs. The system is used in a variety of applications, from protection of source water and dechlorinated product water to monitoring wastewater treatment discharge. The system has been validated for multiple classes of chemicals and is now a commercially available product from the Intelligent Automation Corporation (IAC Corp., Huntsville, Ala.).

Expanding upon the success of the iABS, efforts within the U.S. Army Center for Environmental Health Research are now directed toward incremental development of smaller, more portable, and easily sustainable environmental sentinel biomonitor, or ESB, systems. These systems will utilize novel cell- and tissue-based systems to meet Army requirements in a variety of operating scenarios, from tactical water purification systems, through incorporation into the Future Combat System family of vehicles, to handheld systems for individual soldier use.

Biomarker Discovery

U.S. Army Center for Environmental Health Research also engages in research directed toward the discovery of biomarkers of exposure, effect and susceptibility to non-weaponized, military-relevant chemicals (MRCs), such as pesticides, fuels and agricultural chemicals. Again, the emphasis is on developing the medical models to protect soldiers. The center conducts research and development on new methods and technologies for environmental health surveillance and risk assessment of MRCs. The biomarkers discovery program uses genomic (gene-based) and proteomic (protein-based) technologies to identify biomarkers (gene expression products measurable in easily accessible biological samples such as blood) that indicate exposures and/or effects from MRCs. One goal of this work would be the identification of biomarkers, which would then be incorporated into a biomonitoring platform to assess and manage risks from MRCs.

Force Health Protection

As a result of lessons learned from medical issues raised during the 1991 Gulf War deployment, new studies in force health protection are expanding on previous research and expertise in the program. These efforts focus on optimizing the soldier to better withstand deployment health threats; methods to baseline soldier health and performance that will be useful in fitness for duty and return to duty assessments; new inquiries into safety of materiel, especially when combined stressors and previously unforeseen physiological interactions may alter safe exposure limits; and rapid and effective health monitoring to provide the earliest possible detection of a change in health status for individuals and groups.

From some of these new studies, exercise training is emerging as a potent neuroprotectant that can substantially shift threshold susceptibility to toxic chemical exposures as well as prevent symptoms of chronic multi-symptom illnesses. The neurophysiological basis of these benefits is being examined in a new research initiative on the neurobiology of exercise. Physical activity and fatness are interrelated, with some mediation of the health and performance impacts of excessive abdominal fat through regular physical activity. Excessive fat is associated with Type 2 diabetes and consequent deficits in cognition and mood, as well as increased risks of injury, possibly explaining some of the rapid increase in soldier disability discharges for osteoarthritis. The U.S. Army Institute for Environmental Health Research is examining the effects of deployment on muscle, fat and bone changes, as well as fitness and recovery interventions through several pre- and post-deployment studies.

There is a popular perception that a preand post-deployment blood sample would provide all the necessary data to determine a change in health status of soldiers as a consequence of their deployment exposures and experiences. The neuropsychological symptoms experienced by Gulf War veterans are not typically detected by any known changes in blood measures.

The Military Operational Medicine Research Program has developed and continues to validate a simple and robust battery of neuropsychological tests that could be administered to every service member periodically to detect meaningful changes in health and performance. A current pre- and post-deployment study conducted by the U.S. Army Institute of Environmental Medicine and Veterans Affairs researchers highlights the importance of individual baselines and effects of deployment on the neuroplastic brain. These studies are important to being able to distinguish adverse effects from what may be adaptive or transient responses. Other studies on state-ofthe- art neuroimaging with magnetic resonance spectroscopy are examining symptom complaints and neurophysiological associations.

Prior to the Gulf War, there was little consideration of safety threshold for chemicals, such as permethrin, DEET and chlorpyrofos, in combinations, especially in environments with heat, respirable fine sand, and psychological stress overlays. There had been virtually no consideration to health effects of low-level chemical threat agents or depleted uranium munitions. The Military Operational Medicine Research Program has actively pursued understanding important fundamental interactions, such as the effects of psychological stress on reduced thresholds for toxic chemical susceptibility, with in vitro, animal, human and epidemiological studies. Current studies at the U.S. Army Research Institute of Environmental Medicine and through extramural partners are focused on accurate assessment of the fate and effect of jet fuel and permethrin exposures in militarily relevant environments.

The Millennium Cohort Study and Total Army Injury and Health Outcomes Database are beginning to produce important information on the health status of service members with the opportunity to detect or rule out associations with occupational and deployment exposures. Prominent extramural scientists are also conducting a huge basic research project funded by special Congressional interest appropriations. These state-of-the-art investigations will provide the basis for understanding how neurophysiological systems interact at the level of the brain to integrate perceptions of external stressors, other physiological responses to stressors, and experience and consequences of training, nutritional and fitness status, and resultant health and performance outcomes. ♦
 

Topical Treatment for Cutaneous

By Lynn W. Kitchen, M.D., M.P.H.
Among the numerous ongoing medical materiel development efforts of the U.S. Army Medical Research and Materiel Command, one of the most challenging is the project to develop, license and field a new drug to treat cutaneous leishmaniasis. Leishmaniasis is a parasitic disease transmitted by sand flies, small biting insects similar to mosquitoes, which are commonly found in areas where U.S. forces operate.

Development of a treatment for leishmaniasis is one of the U.S. Army Medical Research and Materiel Command’s best examples of the bench to bedside acquisition programs that underscore the command’s mission to deliver new products to the warfighter. The success of the program thus far is directly attributable to good teamwork by a dedicated group of professionals with diverse specialties working together to respond in a timely manner to an emerging requirement using limited resources. This effort has quickly become the model for all of the command’s drug and vaccine development projects.

Leishmaniasis comes in two varieties— visceral and cutaneous—the latter resulting in skin lesions that vary in size from small pimplelike eruptions to large opens sores 3 or 4 inches in diameter. Although these lesions will generally heal in time without treatment, that healing can take many months or even years and the resulting scars are often disfiguring. The visceral form is more serious, but fortunately much less common (only five cases in U.S. forces in the last five years), and when it does appear it can usually be treated quickly and cured with a licensed drug.

Unfortunately, the cutaneous form of leishmaniasis has become all too familiar to U.S. military physicians in recent years, and there is still no Food and Drug Administration-licensed drug to effectively treat the disease. According to Colonel Alan Magill, one of the DoD’s top experts in tropical diseases, there have been about 2,000 cases of the disease in U.S. forces deployed in support of operations Iraqi Freedom and Enduring Freedom since the start of operations. The occurrence of the disease was not unexpected because cutaneous leishmaniasis has been common in that part of the world for centuries; however, the large numbers of U.S. soldiers who quickly became infected was not anticipated and rapidly became a detractor to the combat effectiveness of deployed units and a burden on the medical system.

Because cutaneous leishmaniasis is a disease rarely seen in the United States, it can easily be misdiagnosed or confused with other tropical skin problems. Furthermore, the lack of an easy, field expedient method for diagnosing the disease exacerbates the problem because the diagnosis cannot be confirmed within the timeframe necessary to make a treatment decision. As a result, soldiers suspected to have a cutaneous leishmaniasis infection have been evacuated to the United States where the only treatment for the disease is available.

Current treatment involves 10-20 days of intravenous administration of the drug called Pentostam that can be administered only at the Walter Reed or Brooke Army Medical Centers. Although highly effective, Pentostam is also inherently toxic, and patients typically experience significant side-effects. For many, treatment with Pentostam may seem worse than the disease. And since the drug is only available at these two hospitals, Magill estimates that so far cutaneous leishmaniasis has cost the U.S. taxpayer roughly “in the neighborhood of $40 million” considering the costs of evacuation, treatment, and lost duty time. Obviously an alternative method of dealing with this disease is required.

The U.S. Army Medical Research and Materiel Command has been working on just such an alternative. Colonel Max Grogl, an Army parasitologist working at the Walter Reed Army Institute of Research, had been developing a cream based on two antibiotics—paromomycin and gentamicin— that could be applied topically to cutaneous leishmaniasis lesions. In early testing, this new topical showed significant efficacy against cutaneous leishmaniasis and was envisioned as a nearideal replacement for Pentostam as the first-line treatment for this disease. When licensed, it could be used in theater to treat most infected soldiers and obviate the need to evacuate the vast majority of cases for treatment, affording a cost-avoidance of tens of millions of dollars.

However, because of the relatively low incidence of cutaneous leishmaniasis in U.S. forces prior to 2001, coupled with the general shortage of funding for development items and the heavier emphasis on providing more immediate countermeasure for other higher-profile diseases such as malaria and dengue, this project had been moving at a snail’s pace toward obtaining FDA approval. That all changed when U.S. forces entered Iraq and soldiers with cutaneous leishmaniasis began arriving at treatment centers regularly and in large numbers. Suddenly, topical paromomycin (or simply the Topical) became an urgently needed product.

The development effort for the Topical has recently been re-energized following an award of a two-year, $1.9-million project under the Defense Acquisition Challenge Program. Products funded under this program can be developed and fielded in a relatively short period of time with a boost of funding. As part of this effort, a contract was awarded to Teva Pharmaceuticals (USA), now the largest generics drug company in the world, which agreed to develop and produce a new formulation of the Topical and ultimately submit the license application to the FDA.

The final piece of the development puzzle was to find a place to field test the drug. Prior to licensure, the FDA requires that the drug be tested in a population with the disease to prove that it is both safe and effective. Through the efforts of the development team, a field site was established in Tunisia, a country whose population has long suffered from cutaneous leishmaniasis.

Indeed, the Tunisians have been especially eager and valuable collaborators because they also view the Topical as the first highly effective, easy to use, and potentially inexpensive means of treating this ancient disease that most seriously affects their children, the most susceptible population in Tunisia. The development team is currently seeking to partner with non-governmental organizations, such as the World Health Organization and the Drugs for Neglected Diseases Initiative, to ensure the drug will be available to the Tunisian population when it is finally licensed. The amount of goodwill that has been established during this collaboration is priceless. ♦

Vision Forward: An Integrated Future
The path to the future medical force is being paved with IM/IT capabilities.

By Pamela Simpson
As commanding general of the U.S. Army Medical Research and Materiel Command and Fort Detrick, Md., Major General Eric Schoomaker is dedicated to streamlining, integrating, and transforming the future medical force. And, he is making progress.

One of MRMC’s core capabilities is information management/information technology (IM/ IT) development, and its subordinate command, the U.S. Army Medical Information Technology Center (USAMITC), located at Fort Sam Houston, Texas, is executing an enterprise IM/IT strategy that is helping Army medicine lead the way in modernization.

Foundational Technologies

Much of USAMITC’s enterprise focus is on centrally managing the technologies that form the basis for medical information interchange for the U.S. Army Medical Department (AMEDD).

USAMITC implemented and maintains the U.S. Army Medical Command’s (MEDCOM’s) operating environment: the AMEDD Active Directory (AD) Forest. A forest refers to a grouping of domains for the purpose of sharing information, while maintaining network security and integrity. The AMEDD AD Forest provides the authentication and security infrastructure for MEDCOM’s global enterprise consisting of 300 servers, spanning 65 sites and supporting 70,000 users.

Through six global messaging centers, USAMITC centrally manages information services such as electronic mail, mobile devices (e.g., BlackBerry services), data sharing and access to applications. AD strengthens security compliance, establishes the foundation for a net-centric and integrated joint enterprise, and leverages IT dollars for MEDCOM. AD balances the centralization of enterprise-wide engineering initiatives with the needs of local administrators to manage site-specific requirements. It is the basis for all key enterprise applications.

Network Operations Security

USAMITC also ensures the network security and connectivity for the AMEDD by operating the Medical Network Operations Security Center (MEDNOSC).

Monitoring is provided 24/7 to mitigate any operational vulnerabilities of MEDCOM’s medical networks, and to maintain the MEDCOM corporate Virtual Private Network (VPN) architecture and offer security engineering assistance and support to Army military treatment facilities worldwide.

USAMITC interfaces with system owners, security engineers, and information assurance personnel across the MEDCOM, Military Health System (MHS), the U.S. Army Network Command, and the Defense Information Systems Agency to maintain the perimeter defense infrastructure, configurations, and communication protocols critical for enterprise network security.

Integrating Help Desks

One of USAMITC’s major roles is to incorporate common IM/IT capabilities. The U.S. Army Surgeon General’s IT Enabler Strategy is one of USAMITC’s roadmaps. Given the thrust of this strategy—enterprise management, centralization, service and standardization—taking a look at centralizing the numerous help desks’ activities within the AMEDD and the MHS was a natural progression.

With so many disparate help desks, there are currently no standards or processes to manage work tickets, problem resolution, and knowledge management.

USAMITC is conducting an integrated help desk pilot that studies the people, processes and technologies in the formation of an integrated help desk. The pilot joins the Carl R. Darnall Army Medical Center at Fort Hood, Texas, USAMITC, the MHS help desk, and IBM in a virtual help desk environment.

The pilot has already highlighted ways to streamline how help desk tickets are handled, enable IT staff to track and resolve recurring issues, and provide 24/7 help for users, including some self-service options. The pilot will be completed in Fiscal Year 2007 and will assist the enterprise in determining: 1) the feasibility of integrating help desk services, and 2) the best system design to serve the needs of AMEDD and other DoD customers.

Toward Joint Medical Collaboration

From the battlefield to the Veterans Administration, continuity and availability of medical information and applications are vital to the care of our servicemembers and their families as well. Patients being served across the Military Health System will benefit one day from the Active Directory Collaboration Forest.

USAMITC is currently enabling clinicians at the Walter Reed Army Medical Center in Washington, DC, and the National Naval Medical Center at Bethesda, Md., to share access of USAMITC’s Surgery Scheduling System. The user-friendly system streamlines how operating rooms and staff are scheduled, provides patient demographics, and assists with reporting.

As the Collaboration Forest pilot continues, USAMITC will build on the lessons learned to continue its work with the DoD and sister services to expand joint access to other medical applications. In the future, the Joint Medical Collaboration Forest could grow to include such medical partners as Veterans Affairs and the Centers for Disease Control and Prevention.

Integrating AHLTA

USAMITC works closely with the Military Health System to integrate the Armed Forces Health Longitudinal Technology Application (AHLTA), as well as other MHS systems, into AMEDD health care facilities. AHLTA, the military’s electronic health record, has been fully deployed in 33 of 36 AMEDD sites, and the balance will be completed by summer’s end.

In addition to this deployment, USAMITC is also supporting the MHS in its efforts to enhance the electronic medical record to include dental and inpatient capabilities.

Medical Force of the Future

In line with Schoomaker’s vision to become the backbone of the joint biomedical research and materiel community, USAMITC will continue to: 1) manage foundational technologies, 2) safeguard a secure medical network operating environment and 3) seek collaborative ventures.

As the joint medical community moves toward information sharing and IM/IT standardization across the services, USAMITC is leading the Army in providing IM/IT solutions to meet this joint medical mission.

The yellow brick road to the future medical force is being paved with IM/IT. This particular Emerald City is not simply green, but is fully capable of transforming to shades of purple. ♦

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