Between 1954 and 1973, more than 2,000 men entering military service as conscientious objectors participated in Project Whitecoat as medical research volunteers for the Army’s biological warfare defense program. An assessment of self-reported, current health status among 358 “exposed” individuals and 164 unexposed control subjects found no conclusive evidence that receipt of investigational agents was related to adverse health outcomes. No differences in current overall health, current exercise levels, self-reported symptoms, and self-reported medical conditions were seen between the study groups. Possible associations were seen between exposure to antibiotics or other biological agents and self-reported asthma (13.0% vs. 2.4%, relative risk [RR] = 6.00, 95% confidence interval [CI] = 1.03-34.90, p = 0.050), as well as between receipt of tularemia vaccine(s) and self-reported asthma (13.3% vs. 2.4%, RR = 6.15, 95% CI = 1.03-36.70, p = 0.049) and increased frequency/severity of headaches (35.6% vs. 18.3%, RR = 2.46, 95% CI = 0.99-6.15, p = 0.074). However, the size of the population under study was insufficient to assert with confidence that these statistical associations are real.

United States government efforts to counter the threat of biological weapons have their genesis in the War Bureau of Consultation, a commission of the National Academy of Sciences that was formed at the request of Secretary of War Harold Stimson in 1941.1,2 This group recommended the urgent creation of a program of research to address the problem of biological warfare and, in 1942, President Roosevelt authorized Mr. Stimson to establish the War Research Service as a unit of the Federal security Agency for this purpose. The War Research Service, headed by George Merck (president of Merck Pharmaceuticals), immediately undertook a program of study of biological agents, conducted with “utmost secrecy.”3

With increasing appreciation of the scope and complexity of a large-scale program of research and development in this area, the War Research Service requested that the U.S. Army Chemical Warfare Service assume responsibility. The initial site selected for the program was Edgewood Arsenal, near Aberdeen, Maryland. In 1943, a small National Guard airfield (Derrick Field) just outside Frederick, Maryland, was purchased by the War Department, and the hub of the operation was moved to the renamed Camp Detrick.

The Office of the Army Surgeon General was involved in the biological warfare research and development program from the time of its inception in 1941, but it was not directly responsible for any activities until 1956, when the U.S. Army Medical Unit at Camp Detrick was activated with a mission to evaluate the threat of biological warfare and to develop appropriate counter-measures.4 During the same year, Camp Detrick became Fort Detrick. From that time to the present, Fort Detrick has been the home of the nation’s biological warfare defense program. The Army Medical Unit was redesignated the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in 1969. The contributions of USAMRIID and its predecessor to military medical research and national security are legion, and the planned integration of USAMRIID with National Institutes of Health and Department of Homeland security programs through the formation of a national biodefense campus at Fort Detrick5 ensures its future leadership role in this area.

Project Whitecoat was the title given to an Army research program “to use human volunteers in medical studies to evaluate the effect of certain biological pathogens upon humans in an effort to determine the vulnerability to attack with biological agents” (W.S. Augerson, 1976, cited in Ref. 4, p 20). The objectives of the studies involved were to develop medical defenses against biological warfare and included techniques for rapid diagnosis, improved therapeutic and prophylactic agents, and development of vaccines against biological weapons and endemic disease threats. The program evolved after a series of meetings in 1954-1955 between representatives of the Army Surgeon General and the Seventh Day Adventist Church. With the background of the Church’s philosophy and practice of medical service and encouragement of noncombatancy and its longstanding cooperation with the military in health and medical practice, Project Whitecoat became an accepted and respected vehicle by which conscientious objectors could serve the nation.4 From its inception in 1954 to its termination in 1973, approximately 2,300 individuals participated in this program, more than 90% of whom were Seventh Day Adventists. The group participated in more than 135 clinical research studies involving exposure to live agents, receipt of investigational vaccines, and studies of metabolic and psychological effects of environmental- and infection-induced stress.4,6 Most volunteers participated in at least one project, whereas some participated in several. The current study was designed to assess the long-term effects on the health of these men resulting from their involvement in this vital program.