Findings & Conclusions
H. THE SAFETY OF THE BOTULISM VACCINE WAS NOT ESTABLISHED PRIOR TO THE PERSIAN GULF WAR AND REMAINS UNCERTAIN. At a meeting with DOD officials regarding informed consent in December 1990, the FDA agreed to test the botulinum toxoid (botulism vaccine) for safety. (Note 139) A representative of FDA’s Center for Biologics Evaluation and Research explained that the existing supply of the vaccine was nearly 20 years old and consisted of three lots, stored under constant refrigeration. There was concern that the vaccine would break down into toxic products due to prolonged storage. General safety testing was performed by the FDA on all of the lots of botulinum toxoid used in the Persian Gulf; however, the FDA did not complete these tests until January 24, 1991, (Note 140) after the war had started. While the results of FDA’s general safety testing were encouraging, the problem with adverse reactions to the vaccine were not resolved. In her review of the DOD’s application for use of the botulism vaccine in the Persian Gulf, an FDA reviewer pointed out that in 1973, the Centers for Disease Control had considered terminating its distribution because of adverse reactions. (Note 141) New lots of the vaccine were manufactured in 1971, but research was not conducted to determine whether the newer lots produced fewer adverse reactions than the older lots. (Note 142) Since no records were kept for most of the Gulf War soldiers who received the vaccine, there is no new information about the safety of the botulism vaccine resulting from its use by U.S. troops. Therefore, its safety remains unknown.
Findings & Conclusions
I. RECORDS OF ANTHRAX VACCINE ARE NOT SUITABLE TO EVALUATE SAFETY.
Although anthrax vaccine had been considered approved prior to the Persian Gulf War, it was rarely used. Therefore, its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established. Anthrax vaccine should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel because many of the support troops received anthrax vaccine, and because the DOD believes that the incidence of undiagnosed illnesses in support troops may be higher than that in combat troops. (Note 143)
Unfortunately, medical records and shot records of individuals who served in the Persian Gulf frequently do not report the vaccines they received. In some cases, anthrax was recorded as “Vac-A.” However, in many cases, veterans who believe they received anthrax vaccinations did not have them recorded in their medical records. According to testimony received at the Committee hearing on May 6, 1994, vaccines were recorded in separate vaccine records, for soldiers who had such records with them and insisted that the information be recorded. (Note 144)
Findings & Conclusions
J. ARMY REGULATIONS EXEMPT INFORMED CONSENT FOR VOLUNTEERS IN SOME TYPES OF MILITARY STUDIES.
Army regulation (AR) 70-25 provides guidelines for the use of volunteers as subjects in military research. Section 3 describes three exemptions whereby military researchers are exempt from the provisions of these protective regulations (the following is a direct quote from the regulation):
a. Research and nonresearch programs, tasks, and tests which may involve inherent occupational hazards to health or exposure of personnel to potentially hazardous situations encountered as part of training or other normal duties, e.g., flight training, jump training, marksmanship training, ranger training, fire drills, gas drills, and handling of explosives.
b. That portion of human factors research which involves normal training or other military duties as part of an experiment, wherein disclosure of experimental conditions to participating personnel would reveal the artificial nature of such conditions and defeat the purpose of the investigation.
c. Ethical medical and clinical investigations involving the basic disease process or new treatment procedures conducted by the Army Medical Service for the benefit of patients. (Note 145)
It is sometimes difficult to differentiate training from research. For example, military personnel at the U.S. Chemical School, Fort McClellan, AL, are currently exposed to nerve agent poisons as part of their training, so that they will learn how to cope with similar situations in combat. Soldiers who refuse to participate or do not complete live agent training are subject to reclassification in another military occupational specialty and cannot graduate. (Note 146) To determine if the students used correct procedures during the training exercise, blood samples are obtained from some students before and after the procedure, and are analyzed for red blood cell cholinesterase to determine if the soldier was exposed to the nerve agents.
If the military collects data to determine how to better train individuals, the “training” is then defined as contributing information to generalizable knowledge, and is hence “research.” For the optimal protection of U.S. troops, one would hope that training exercises are improved based on reliable information. However, during the testing of new training methods or equipment, exercises utilizing potentially dangerous substances, such as chemical weapons, should be considered research rather than training. Participants must be fully apprised of the nature of the experiments and have the opportunity to refuse without reprisal, in order to conform with the Nuremberg Code and other ethical standards.
Findings & Conclusions
K. DOD AND DVA HAVE REPEATEDLY FAILED TO PROVIDE INFORMATION AND MEDICAL FOLLOWUP TO THOSE WHO PARTICIPATE IN MILITARY RESEARCH OR ARE ORDERED TO TAKE INVESTIGATIONAL DRUGS.
A common theme voiced by military personnel who have participated in military research or training exercises over the last 50 years is the lack of information about the risks they faced and the lack of medical followup. World War II veterans frequently reported that they heard about the adverse health effects of mustard gas and lewisite from newspapers and television decades after they were exposed, not from the Department of Defense or Department of Veterans Affairs. Veterans and civilians who worked at the Dugway Proving Ground and were exposed to a variety of biological and chemical simulants began to question the association of poor health with work as they compared information among themselves, not because of information provided by military officials. Veterans who were inside atomic clouds from atomic testing heard nothing at all from their government after they returned home from duty.
Similarly, soldiers who unknowingly participated in military research designed to test the effects of hallucinogens on human behavior were never given information to explain their hallucinations and suffered from severe psychological disorders as a result. Even today, most of those who served in the Persian Gulf indicate they have received no followup information about the investigational drugs they received.
It is the responsibility of DOD and VA to identify and keep track of veterans exposed to potentially dangerous substances so that they can receive medical care if needed. Even in situations where DOD believes an investigational drug is safe, such followup is necessary to establish with certainty whether exposures were safe, or whether they resulted in long- term side effects.
Findings & Conclusions
L. THE FEDERAL GOVERNMENT HAS FAILED TO SUPPORT SCIENTIFIC STUDIES THAT PROVIDE INFORMATION ABOUT THE REPRODUCTIVE PROBLEMS EXPERIENCED BY VETERANS WHO WERE INTENTIONALLY EXPOSED TO POTENTIALLY DANGEROUS SUBSTANCES.
In the last year, Gulf War veterans have reported that exposures during military service have resulted in miscarriages and birth defects, as well as excruciating pain during sexual intercourse. For example, at a Committee hearing on August 5, 1994, Kelli Albuck, the wife of a Gulf War veteran, described the miscarriage and pregnancy problems she had experienced since her husband returned from the Gulf War. She also described what she called “burning semen” or “shooting fire.” Mrs. Albuck stated that many wives of Gulf War veterans complained that their husbands’ semen caused a burning sensation, and in her case that the semen itself could cause a rash or blood blister on her husband’s leg or her skin. Steve Miller, an Army nurse who also testified at that hearing, had no problems with burning semen, but his son was born with extensive birth defects, including having only one eye and one ear.
The doctors told him that the combination of severe birth defects was very unusual and suggestive of a toxic exposure. Mr. Miller believes that his son’s birth defects could be related to his use of investigational drugs or vaccines, perhaps in combination with pesticide exposures.
Similarly, many atomic veterans believe that infertility, miscarriages, stillbirths, and birth defects resulted from exposure to ionizing radiation.
Although these reports have received media attention for years, the VA and DOD have not conducted research on these questions, nor have they supported independent research. Finally, 50 years after veterans were intentionally exposed to ionizing radiation, the VA will be required by law to enter into a contract with the Institute of Medicine (IOM), or a similar independent agency, to evaluate whether it is feasible to support research on the reproductive problems associated with exposure to ionizing radiation. If the IOM determines that such research is feasible, the VA and the Congress will then determine whether such research should be funded. (Note 147)
In November 1994, President Clinton signed a law that would require VA to conduct research on birth defects and miscarriages among Gulf War families. A preliminary study will be required, in which information about these reproductive outcomes will be included in the Persian Gulf War Veterans’ Health Registry. In addition, VA will be required to include semen analysis and other reproductive evaluations in a standard protocol used to evaluate Gulf War veterans with mysterious illnesses.
Findings & Conclusions
M. THE FEDERAL GOVERNMENT HAS ALSO FAILED TO SUPPORT SCIENTIFIC STUDIES THAT PROVIDE TIMELY INFORMATION FOR COMPENSATION DECISIONS REGARDING MILITARY PERSONNEL WHO WERE HARMED BY VARIOUS EXPOSURES.
For decades, military personnel who were injured from various exposures have been denied compensation until scientific evidence could support their claims for service-connected disabilities. Although 60,000 military subjects were involved as human subjects in testing programs involving mustard gas and lewisite over 50 years ago, the initiation of a study to review research regarding the long-term health consequences from these military experiments did not occur until 1991, and the results of the study were not published until 1993. (Note 148)
Similarly, the use of Agent Orange and other herbicides in Vietnam has stimulated concern and controversy ever since the United States began the military herbicide program in 1961, but a comprehensive review and evaluation of available scientific and medical information regarding the health effects of herbicides and the contaminant dioxin was not conducted until it was authorized by Congress in 1991. (Note 149) The Department of Veterans Affairs has recently announced new rules for awarding compensation for more Agent Orange-related diseases, three decades after military personnel were exposed to the defoliant in Vietnam. (Note 150)
Reports of the National Research Council’s Committee on the Biological Effects of Ionizing Radiation (BEIR), written to advise the U.S. Government on the health consequences of radiation exposure, frequently relied on mortality and morbidity experiences of exposed individuals, some of which took decades to accumulate. (Note 151) Information is continuing to be gathered, which will be incorporated into future BEIR reports.
When investigational drugs and vaccines were given to thousands of military personnel during the Persian Gulf War, this provided an unprecedented opportunity to learn more about the safety of those products. Unfortunately, no effort was made to gather objective information, despite the fact that data gathering is required as part of the IND process for investigational drugs and vaccines. (Note 152) Any research that is conducted years after the war is over will be less scientifically valid and much more expensive as a result of the lack of objective information gathered during the war about which servicemembers took which drugs or vaccines, and the adverse reactions that they experienced.
The Medical Follow-up Agency (MFUA) of the Institute of Medicine will take 3 years to issue its final report on whether there is a scientific basis for an epidemiological study on the health consequences of service in the Persian Gulf. (Note 153) If the MFUA determines such a study or studies should be conducted, it will take several more years to gather the necessary data.
Findings & Conclusions
N. PARTICIPATION IN MILITARY RESEARCH IS RARELY INCLUDED IN MILITARY MEDICAL RECORDS, MAKING IT IMPOSSIBLE TO SUPPORT A VETERAN’S CLAIM FOR SERVICE-CONNECTED DISABILITIES FROM MILITARY RESEARCH.
Although hundreds of thousands of U.S. military personnel have been involved in military research, their medical records usually do not contain information about the studies they participated in, or the investigational drugs or vaccines they received. (Note 154) There are currently no standardized guidelines imposed by either the DOD or VA to include a copy of the informed consent form or research proposal in the medical records of exposed human subjects.
Even if medical records contain relevant information regarding health consequences from various investigations, these medical records may be difficult to obtain. Of the 150 individuals who were interviewed for the Committee’s survey, not all respondents had tried to obtain their medical records, but 28 (19 percent) indicated that part or all of their medical record were lost and 48 (32 percent) respondents indicated that their medical records were incomplete or inaccurate (Appendix). Some of those surveyed believed their records had been deliberately altered or contained inaccurate information.
The VA Office of Inspector General recently investigated the possible illegal removal of official documents from certain veterans’ appeals files assigned to two Board of Veterans’ Appeals attorneys. (Note 155) It is unknown whether such intentional removal is a rare occurrence; clearly, any removal of medical information would make it difficult and perhaps impossible for a veteran to receive the medical care and compensation that he or she is entitled to.
In addition to any intentional removal of information, veterans’ service medical records are difficult to find. According to the U.S. General Accounting Office, veterans’ service medical records can potentially be in thousands of locations. (Note 156) The DOD has attempted to simplify the retrieval of medical records by modifying the route for medical records of individuals who have left the military. The simplified route was initiated for the Army in October 1992, for the Navy in February 1994, and for the Air Force and Marines in late 1994. Although the new procedures should simplify the process, the GAO concluded that the possibility of misplaced medical records remains because there are still thousands of locations where records could be found within the new system.
Findings & Conclusions
O. DOD HAS DEMONSTRATED A PATTERN OF MISREPRESENTING THE DANGER OF VARIOUS MILITARY EXPOSURES THAT CONTINUES TODAY.
According to Dr. Leonard Cole, professor at Rutgers University, the DOD has denied the possibility of harm from various exposures. However, in many instances the military belatedly recognized that some exposures may be causing disease and death. (Note 157) Such denial, however, delays the availability of medical assistance to those harmed.
For example, the military has released chemicals and biological agents through outdoor “open air” tests for over four decades. Some of these supposedly safe chemicals and biological agents, referred to as simulants, were also released over populated areas and cities. (Note 158) Although scientific evidence suggested that the tests may have caused illnesses to exposed citizens, the Army repeatedly claimed that these bacteria and chemicals were harmless until adverse health effects convinced them to change the simulants used. The death of Edward J. Nevin was associated with the release of one simulant, Serratia marcescens, over San Francisco in 1950. (Note 159) A subsequent court trial revealed that on September 26 and 27, 1950, the Army sprayed Serratia marcescens from a boat off the coast of San Francisco. (Note 160) On September 29, patients at the Stanford University Hospital in San Francisco began appearing with Serratia marcescens infections. Although the judge denied the validity of the plaintiffs’ claims that the exposures were related to the death of Mr. Nevin, the trial raised frightening questions about the selection of simulants. Serratia marcescens is no longer used by the military as a simulant.
Dugway Proving Ground has been a site for “open air” testing of chemical and biological agents for decades. The purpose of the tests is to determine how the agents spread and survive, and their effect on people and the environment. Earl Davenport is a veteran who participated in tests at Dugway Proving Ground in Utah, first as a military employee and later as a civilian employee. He became ill in 1984 after being exposed to a chemical simulant called DMMP (dimethyl methylphosphate). He had been spraying the chemical into the path of a laser beam when a sudden change in wind blew the chemical all over his face and hair before he was able to put on a protective mask. Although he was “wheezing and coughing” the next day, and his symptoms lasted for weeks, the Dugway Army Hospital merely gave him cough medicine and antibiotics. The Dugway Safety Office assured him that the chemical was safe. However, by 1988, officials at Dugway had reevaluated the simulant’s danger, and were becoming concerned that DMMP could cause cancer and kidney damage. (Note 161) Mr. Davenport is currently attempting to obtain compensation for his illness from the Department of Labor, since his exposure occurred when he was employed at Dugway as a civilian.
In 1992, several military personnel from the Arizona National Guard experienced chemical burns during a summer training exercise at the Dugway Proving Grounds. According to two physicians, a daughter from one of the guardsmen also received chemical burns when she later handled her father’s duffle bag. One of these doctors, Dr. Michael Vance, was contacted by military officials and encouraged to modify his written findings on the possible cause of the daughter’s injury. (Note 162) He refused.
According to scientists and doctors from the University of Utah, there is great concern over the potential health consequences not only for military personnel who work and train at Dugway, but also for civilians who live in a small town and on an Indian reservation near the Proving Grounds. Moreover, physicians from the Utah Medical Society have complained about the lack of information provided to the medical community about the agents that are used in Dugway, despite repeated requests. (Note 163)
According to Dr. Cole, the use of potentially harmful chemical and biological agents continues at Dugway even today. For example, he testified that the Army uses a simulant called Bacillus subtilis, “which is fairly harmless in many natural conditions, [but] is recognized as a potential source of infection and can cause serious illness in some people when they are exposed to it in large numbers and they inhale large numbers of those microorganisms.” (Note 164)
Dr. Cole also testified about the lack of informed consent at Dugway in recent months. For example, in November 1993, a test that was intended to evaluate whether chemical agents could penetrate protective clothing used informed consent forms that did not mention the chemicals. (Note 165)
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