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OPERATION: WHITECOAT

Fort Detrick was visited by 300 men, families, guests who were associated with the original Whitecoat program.


They gathered at the Frederick Seventh-Day Adventist Church in Frederick, Maryland on Sept. 19-21. As part of the event , they visited Fort Detrick for briefings and a tour of the post.


 

 During World War II, the Allies feared biological attacks from the Germans and the Japanese, whom they suspected of running extensive development programs. “Not many people can understand the mindset of 1941, when we were attacked by the Japanese,” says Camp Detrick Historian Norm Covert. “The entire nation was at war, so we had a real mission to protect our nation.” In 1942 Franklin Roosevelt sanctioned a top-secret biological weapons testing program in the United States that would last 27 years ? well into the cold war. Experimenting on thousands of animals and fully-informed Army recruits, American scientists proved it was possible to produce effective weapons of mass destruction at a fraction of the cost of a nuclear bomb. “It took a little thought, but not much, to realize that to pioneer a cheap weapon of mass destruction is exactly what the United States should never do,? says biologist Matthew Meselson. On November 25, 1969, President Richard Nixon ended America’s offensive bioweapons program.

Operation Whitecoat served as a model for the ethical use of human subjects in research, according to Col. Arthur O. Anderson, M.D., chief of USAMRIID's Office of Human Use and Ethics. In particular, the process of "informed consent"--by which research subjects become familiar with the purpose and scope of a study to understand the risks involved before agreeing to participate--was successfully implemented from the program's inception.

  Each medical investigator prepared a protocol that was extensively reviewed and modified to comply with each of the 10 ethical principles of the Nuremberg Code. When the committee determined that ethical requirements and scientific validity were assured, it was approved by Army officials. Next, potential volunteers were briefed as a group on the approved protocol and attended a project interview with the scientist where they could ask questions about the study. Informed consent documents would be signed after an obligatory waiting period that ranged from 24 hours to four weeks, depending on the presumed risks of the study. The volunteer was encouraged to discuss the study with family members, clergy and his personal physician before making a final decision.

BENEFITS OF WHITECOAT RESEARCH

Several vaccines were developed as a result of Operation Whitecoat, according to project records. Many of these vaccines are used today by industry and laboratory workers, including USAMRIID personnel who receive special immunizations to work in Biosafety Level 3 containment laboratories. Licensed vaccines (approved by the Food and Drug Administration) include those for yellow fever and hepatitis. Investigational new drug vaccines, used under approved clinical protocols for research or immunization of laboratory personnel, include those for Q fever, Venezuelan equine encephalitis, Rift Valley fever and tularemia.

Research conducted during the Whitecoat years at Fort Detrick also contributed to the development of equipment and procedures that established the standard for laboratory biosafety throughout the world. Biological safety cabinets with laminar flow hoods, "hot suites" with differential air pressure to contain pathogens, decontamination procedures, prototype fermentors, incubators, refrigerated centrifuges, particle sizers and other types of specially fabricated laboratory equipment provided enormous value to the scientific community and to the pharmaceutical industry.

Operation Whitecoat tests were done under the cloud of the Cold War and at a time when people rarely scrutinized workings of the government. It was a time when the government conducted some dubious experiments, such as the infamous Tuskegee experiments in which scientists studied the progression of syphilis in untreated poor black men.


Col. Arthur Anderson, who signs off on all research conducted today at Fort Detrick, Md., the home of the United States Army Medical Research Institute of Infectious Diseases, says the program was "a model for medical, ethical research for humans."


Whitecoat volunteers were given a consent form at the Texas medic school where they were first approached, Anderson says.


In total, about 150 studies of the diagnosis prevention, and treatment of various diseases were completed during the Whitecoat years. Volunteers were exposed to disease-causing agents, such as Q fever and tularemia, under strict protocols to study immunity to disease and conduct drug therapy studies, according to Anderson. Later studies of staphylococcal enterotoxins were included among the high risk exposures. Whitecoat volunteers also participated in safety and immunogenicity studies of inactivated or attenuated vaccines designed for protection against Venezuelan equine encephalitis, plague, tularemia, Q fever, Rocky Mountain spotted fever and Rift Valley fever.


 On Jan. 25, 1955, the first Whitecoat volunteers were exposed with the use of the one-million-liter sphere commonly known as the "Eight Ball." This research device, which is still standing at Fort Detrick, was designed to allow simultaneous exposure of humans and laboratory animals to carefully controlled numbers of organisms by the aerosol, or inhalation, route.


Over the next two months, the minimal infectious dosage to be employed in human field trials was determined, as was the effectiveness of the Q fever vaccine in protecting volunteers exposed under carefully controlled laboratory conditions using a cloud chamber. After completion of this second phase of the study, preparation for phases III and IV was initiated. Phase III was a field study using animals, while phase IV would expose humans to a Q fever aerosol under field conditions that mimicked a biological warfare event. These studies were conducted at Dugway Proving Ground, Utah.


The tests THE MILITARY AND THE SDA CHURCH

Operation Whitecoat ended in 1973 when the draft was eliminated, but the need to progress in development of medical countermeasures resulted in establishment of the Medical Research Volunteer Subject program during the period of the "All Volunteer Army." Essentially, this program was identical to Operation Whitecoat in that the Medical Research Volunteer Subjects were Soldier trainees in 91B combat medic training school at Fort Sam Houston, Texas, when they were recruited to serve. Unlike the Whitecoats, the Medical Research Volunteer Subjects were not Seventh-Day Adventists nor were they conscientious objectors subject to the draft. The Medical Research Volunteer Subject program continued under Anderson's oversight after he was appointed chairman of the USAMRIID Human Use Committee in 1975.

Program ending

Members of Operation Whitecoat (with several family members) at the 35th anniversary celebration in 2003 at the Frederick, Md., Seventh-day Adventist Church.



Photo: courtesy of Pacific Press© all right reserved


SOURCES:  USAMRIID (The United States Army Medical Research Institute for Infectious Diseases) North American Division of SDA Chaplaincy Ministry Adventist Pacific Press Magazine PBS USA TODAY