Epidemiological Studies of Morbidity among Gulf War Veterans: A Search for Etiologic Agents and Risk Factors
Action: Naval Health Research Center (NHRC), San Diego, CA, and VA.
Purpose: To conduct epidemiologic studies of symptoms, hospitalizations, and birth outcomes among large cohorts of active duty Gulf War veterans. DoD, in close coordination with VA and the Centers for Disease Control and Prevention (CDC), has initiated a research program which entails epidemiological studies of morbidity among Gulf War veterans and control groups. A series of epidemiological studies is being conducted of active duty personnel who were deployed to the Gulf compared to troops who served elsewhere. These studies will include detailed personal interviews and physiologic testing of approximately 2,250 Seabees (1500 Gulf War vets and 750 military personnel not deployed to the Persian Gulf), and analyses of hospitalization and birth records of over 1.2 million service members. These studies will involve both cohort and nested case-control designs, yielding risk factor analyses of symptoms/signs, hospitalizations, and birth outcomes.
Status: Ongoing. The first group of Seabees was surveyed in September, 1994. Initial analysis of hospital and birth outcome data has begun.
Results: Not available at this time.
Coordination: DoD, VA, CDC, and the University of California.
Comparative Mortality Among US Military Personnel Worldwide During Operations Desert Shield and Desert Storm
Action: Division of Preventive Medicine, Walter Reed Army Institute of Research
Purpose: The objectives of this study were to: 1) characterize the disease and non-battle injury (DNBI) mortality experience of US military personnel during Desert Shield/Desert Storm; and 2) determine whether US military personnel deployed to Southwest Asia (SWA) had a higher rate of death than US military personnel who were not.
Status: Complete. Cause-specific mortality rates among all persons on active duty in the US Armed Forces (including activated Reservists and National Guardsmen) over a one-year interval that included the Persian Gulf War were calculated using casualty reports. Death rates among active duty servicemembers deployed to SWA at any time during this period were compared to rates for all servicemembers on active duty but not deployed to SWA.. Each death was characterized as to have been most likely caused by disease or trauma. Trauma deaths were additionally classified as due to unintentional (accidental) injury, battle injury, self-inflicted injury, or homicide.
Results: Report in preparation.
Coordination: DoD, VA, and HHS.
DoD Funded Environmental Research
Action: Two research projects are being implemented, one involving the U.S. Army Medical Research Detachment/U.S. Naval Medical Research Institute Detachment, Wright Patterson AFB, OH, and another involving a broad agency announcement (advertised in Congressional Daily) from the Army Medical Research and Materiel Command of funds to support research involving low level chemical agent exposure (still in process).
Purpose: The study at Wright Patterson AFB has been initiated and will evaluate the physiologic and behavioral effects in rodents of insecticides, jet fuel, and kerosene heater emissions, and will look for the formation of biological markers to these exposures. The effects of JP4 diesel fuel and other combustion products, as well as possible interactions with pesticides, pyridostigmine and stress, will be evaluated. For the broad agency announcement, five different research proposals were received and evaluated by the American Institute of Biologic Science, a non-governmental institute. A final decision on a contract is in process.
Status: Ongoing. The study at Wright Patterson AFB is scheduled to begin in early 1995.
Results: Not available at this time.
Coordination: DoD, VA, HHS
Environmental Toxicology Studies: Health Consequences of the Exposure of Persian Gulf Force Members to the Fumes of Burning Oil
Action: U.S. Army Environmental Hygiene Agency (USAEHA), Armed Forces Institute of Pathology, U.S. EPA, HHS, National Oceanic and Atmospheric Administration.
Purpose: To conduct a series of studies in environmental and toxicologic pathology relating to possible exposure to burning oil in the Persian Gulf.
Status: Ongoing. Studies were conducted in the Persian Gulf from May through December 1991.
Results: Report prepared.
Final Report -- Kuwait Oil Fire Health Risk Assessment,, No. 3926-L192-91, 5 May -
3 December 1991 (1994). USAEHA. Aberdeen Proving Ground, MD.
Coordination: DoD, VA and HHS.
Study of Effects of Smoke Inhalation
Action: U.S. Army Medical Research and Materiel Command.
Purpose: Conduct studies in animal models to define the pathology resulting from smoke inhalation.
Status: Ongoing. A rodent model is being developed to define and characterize the pathology resulting from smoke inhalation under controlled conditions. A related sheep model is also being explored. This work predates Operations Desert Shield/Storm and is a necessary adjunct to research on clinical burn care. The current inhalation injury models are expected to be able to supply data addressing the acute toxicity of various components of smoke, as well as the effectiveness of standard and novel medical countermeasures in the amelioration of smoke inhalation injury.
Results: Not available at this time.
Coordination: DoD, VA.
Follow-up, Psychological Studies of Veterans from Hawaii and Pennsylvania Deployed in Operations Desert Shield/Storm
Action: Department of Military Psychiatry, WRAIR, and VA (VAMC Honolulu and VAMC Pittsburgh).
Purpose: To identify psychological consequences and risk factors of deployment to the Persian Gulf during Operations Desert Shield/Storm. In response to Congressional action, H-10437, which directs the Honolulu VAM&ROC to collaborate with DoD in an attempt to track all ODS veterans residing in Hawaii. Congressional mandate required the following: 1) Identification of ODS veterans living in Hawaii; 2) administration of a number of instruments (Brief symptom Inventory, Impact of Events Scale, Combat Exposure Scale) to each veteran; 3) provide orientation sessions to ODS veterans and their families; 4) provide in-depth debriefings to ODS veterans and their families, if requested; and, 5) complete congressional reporting requirements.
Status: Ongoing. Questionnaires were administered in the Persian Gulf to five military divisions and after the war to active duty and reserve Army, Navy, and Air Force personnel in Hawaii and Pennsylvania. Further follow-up studies are planned of military personnel initially evaluated while deployed to the Persian Gulf. Also, a case-control study is planned with VA (Pittsburgh VAMC) to compare patients enrolled in the VA registry and DoD CCEP with military personnel who were not deployed to the Persian Gulf.
Results: Report prepared.
U.S. Army Medical Research, Development, Acquisition and Logistics Command. The General Well-Being of Gulf War Era Service Personnel from the State of Pennsylvania and Hawaii: A Survey (1994).
Coordination: DoD, VA and HHS.
Operational Stress and Human Performance
Action: U.S. Army Medical Research and Materiel Command.
Purpose: Extend and elaborate on work conducted under "Continued
Psychological Studies of Veterans from Hawaii and Pennsylvania Deployed in Operations Desert Shield/Storm," which is described above. Identify psychological consequences and risk factors of deployment during Operations Desert Shield/Storm in a wider range of military populations.
Status: Ongoing.
Results: Not available at this time.
Coordination: DoD, VA.
Combat Stress Diagnosis
Action: U.S. Army Medical Research and Materiel Command.
Purpose: Develop a diagnostic algorithm for field combat stress diagnosis. Identify mechanisms of and pharmaceutical countermeasures for combat stress effects. Emphasis is on rapidly acting countermeasures which cold be administered far forward, and which would allow the stress casualty to remain on duty.
Status: Ongoing. Determined key stressors operating among mortuary affairs personnel in the Persian Gulf War and at the Dover Air Force Base Mortuary. Currently evaluating pharmaceutical countermeasures to combat stress in validated animal models of stress. Pharmaceutical countermeasures must be free of unwanted side effects, such as sedation or impairment of memory or performance.
Results: Not available at this time.
Coordination: DoD, VA.
Research Studies of the Health Effects of Embedded Fragments of Depleted Uranium (DU).
Action: U.S. Army Medical Research and Materiel Command (USAMRMC).
Purpose: As a result of friendly-fire accidents, approximately two dozen U.S. Persian Gulf war veterans may have embedded DU fragments. There is currently no information about the long-term health consequences of this exposure, including the effects of radiation and heavy metal toxicity. This information is needed as a basis for the most appropriate medical management of DU fragments injuries and to decide if these injuries should be treated differently than the management of other embedded metal fragments.
Status: Ongoing. Two studies were funded by the USAMRMC following advertisement by a Broad Agency Announcement. By the end of FY 1997, a study by the Armed Forces Radiobiological Research Institute (AFRRI) will determine: 1) the extent of localized tissue inflammatory responses and damage; 2) toxicological effects of DU on the nervous system, including effects on motor activity, memory, and nerve conduction; 3) long-term toxicological effects on kidney function; and, 4) the distribution of uranium in various tissues over time. By the end of FY 1998, a second study by the Inhalation Toxicology Research Institute (ITRI, Albuquerque, NM) will determine: 1) if there is reason to believe that DU will increase the carcinogenic potential of metal fragments, and 2) the timecourse and significance of urinary concentrations of uranium in individuals with embedded fragments. Both the AFRRI and ITRI studies will be conducted using rodent models.
Results: Not available at this time.
Coordination: DoD, DOE, VA.
Leishmaniasis Diagnostics Research
Action: U.S. Army Medical Research and Development Command.
Purpose: To develop a reliable serologic assay and skin test for leishmania infection.
Status: Ongoing. Rapid diagnostic tests for identifying leishmania infection are being pursued. Initial characterization studies are being conducted to gather data for submission of an Investigational New Drug (IND) application by the third quarter of FY 1995 for a skin test to detect leishmania infection. This skin test is considered the best candidate for screening populations to detect past leishmania infection. A rapid, simple, non-invasive diagnosis of leishmania infection would aid in the evaluation of both symptomatic and asymptomatic veterans. Studies are planned for evaluating the skin test in Gulf war veterans already diagnosed with leishmaniasis. Also, a polymerase chain reaction (PCR)-based blood test for leishmania infection is being pursued and will aid in identification of active infection among veterans with positive skin tests.
Results: Not available at this time.
Coordination: DoD, VA and HHS.
Retrospective Studies Involving Military Use of Pyridostigmine as a Pretreatment for Nerve Agent Poisoning
Action: U.S. Army Medical Research and Materiel Command.
Purpose: Obtain safety data for pending New Drug Application to the FDA.
Status: Complete.
Results: Three surveys have been completed, one each by the U.S. Army Medical Material Development Activity, the U.S. Army Aeromedical Research Laboratory, and the U.S. Navy. These reports were submitted to the Food and Drug Administration, May 21, 1992 as Amendment #29 to Investigational New Drug Application 23,509.
Coordination: DoD, FDA and VA.
DoD Sponsored Research of Pyridostigmine and Synergism Between Various Chemical
Agents Present during the Gulf War
Action: DoD, U.S. Army Medical Research and Materiel Command and U.S. Army Environmental Hygiene Agency.
Purpose: To evaluate any possible acute sequelae from exposure to pyridostigmine in combination with other chemicals present during the Gulf war, including insecticides, DEET, permethrine.
Status: Ongoing. Research was begun October 1, 1994. Using the research conducted by the Army Environmental Hygiene Agency on acute toxicity of DEET and permethrine on rats, pyridostigmine will be evaluated for synergistic effects.
Results: Not available at this time.
Coordination: DoD and VA.
DoD Sponsored Research of Male/Female Differential Tolerances to Pyridostigmine Bromide
Action: U.S. Army Medical Research and Material Command.
Purpose: To evaluate the tolerances of pyridostigmine, 30mg, every 8 hours for 21 days; to evaluate multiple dose kinetics; and, to evaluate the effect of weight in males and females.
Status: Ongoing. Protocol to be conducted at South Florida Research Corporation.
Results: Not available at this time.
Coordination: U.S. Army, VA.
Retrospective Survey of Troops Who Received Clostridium Botulinum Toxoid in the Gulf War
Action: U.S. Army Medical Research and Development Command.
Purpose: To conduct a retrospective survey of troops who received clostridium botulinum toxoid in the Gulf War.
Status: Complete. Post-deployment surveys were completed by a total of 121 service members who were vaccinated with clostridium botulinum toxoid during the Persian Gulf war.
Results: This data was collected in accordance with the Investigational New Drug (IND) application for Botulinum Toxoid on file with the U.S. Food and Drug Administration (FDA) and was provided to the FDA in the BB-IND 3723, Pentavalent Botulinum Toxoid Annual Report, Serial No. 006, dated October 8, 1991.
Coordination: DoD, FDA, and VA.
Forward Deployment Diagnosis of Infectious Diseases
Action: U.S. Army Medical Research and Materiel Command
Purpose: To develop simple diagnostic assays suitable for forward deployed preventive medicine teams and Area Medical Laboratories.
Status: Ongoing. Rapid and simple diagnostic tests are being developed to permit the identification of the causes of infection outbreaks before they reach the epidemic state. Serological assays are being developed for typhus fever, dysenteries caused by shigellosis and other bacteria, and leptospirosis. Tests utilizing polymerase chain reaction (PCR) technology are being explored for diagnosing dengue fever. Fluorescent assays for malaria and other parasitic diseases are under investigation.
Results: Not available at this time.
Coordination: DoD.
Evaluation of Military Working Dogs Who Participated in Operations Desert Shield/Storm
Action: DoD Working Dog Center, Lackland Air Force Base, San Antonio, TX
Purpose: To help identify any infectious diseases or environmental exposures that may be related to human illnesses reported by Gulf War veterans.
Status: Ongoing.
Results: Not available at this time.
Coordination: DoD, VA, and HHS.
DoD Comprehensive Clinical Evaluation Program (CCEP)
Action: DoD, Health Affairs/Pentagon, and VA.
Purpose: The DoD CCEP is intended to provide an in-depth medical evaluation and care of DoD beneficiaries who are experiencing illnesses which may be related to service in the Persian Gulf. A uniform case assessment protocol was developed in close collaboration with VA and was implemented by both DoD and VA to evaluate individuals with unexplained illnesses after Persian Gulf service. The initial step toward diagnosis of medical problems possibly related to Gulf service is the Phase 1, Persian Gulf Registry examination. For those individuals whose health problems require further evaluation, a comprehensive consultative/diagnostic evaluation follows. The initial findings of the DoD CCEP have been evaluated by a special committee of the National Academy of Sciences, IOM, which will continue to evaluate the CCEP.
Status: Ongoing. The DoD CCEP is in progress and greater than 12,000 veterans and their family members have been entered into the database.
Results: Initial reports of CCEP activities released in December 1994 by DoD and IOM.
Coordination: DoD, VA, HHS.
Epidemiologic Assessment of Suspected Outbreak of an Unknown Disease Among Veterans of Operation Desert Shield/Storm at the Request of the 123d Army Reserve Command, Ft. Benjamin Harrison, IN
Action: U.S. Army Medical Research and Development Command.
Purpose: To conduct medical examinations and in-depth surveys of 79 soldiers with symptoms or concerns potentially linked to service in the Persian Gulf.
Status: Complete.
Results: Investigation complete in April 1992; report available from the Army Surgeon General.
Coordination: DoD, VA and HHS.
Epidemiologic Assessment of Suspected Outbreak of an Unknown Disease Among Veterans of Operation Desert Shield/Desert Storm at the Request of the Naval Reserve Mobile Construction Battalion 24, Asheville, NC, and Columbus, GA
Action: U.S. Navy Environmental and Preventive Medicine Unit #2, Portsmouth, VA.
Purpose: To conduct in-depth, epidemiologic surveys of reservists Seabees with symptoms or concerns potentially linked to service in Operations Desert Shield/Storm.
Status: Complete. Initial evaluation complete; further epidemiologic research is planned by the Naval Health Research Center, San Diego, CA, of active duty Seabees.
Results: Not available at this time.
Coordination: DoD, VA and HHS.
Defense Science Board Task Force
Action: Sponsored by the Under Secretary of Defense (Acquisition), DoD.
Purpose: To review all available intelligence and reports of detection of chemical agents and toxins during Operations Desert Shield/Desert Storm and the post-war period; and, to review scientific and medical evidence related to exposure to nerve agents at low levels and their long-term health effects. A similar review was conducted for possible industrial pollutants and other potential causes for the health problems of Persian Gulf Veterans.
Status: Complete.
Results: The membership of the Task Force was composed of distinguished scientists representing leading universities, non-governmental organizations, and governmental agencies. Numerous meetings were held over a four-month period by the Task Force which received briefings from experts in chemical and biological weapons, intelligence, occupational health, environmental medicine, infectious diseases, and other medical fields. Trips to military laboratories specializing in chemical and biological defense issues also were made. A final report was presented in June 1994 (available from Office of the Under Secretary of Defense for Acquisition and Technology, Washington, DC) which stated that "there is insufficient epidemiological evidence at this time to support the concept of any coherent syndrome," and there is "no scientific or medical evidence that either chemical or biological warfare was deployed at any level against us, nor that there were any exposures of US service members to chemical or biological warfare agents in Kuwait or Saudi Arabia."
Coordination: DoD, VA and HHS.