PROJECT 112, THE GERSTLE RIVER PROJECT, FORT GREELEY ALASKA:
'In the early 1970's, the Gerstle River Test Site at Fort Greely became a matter of controversy for Alaskan politicians in Washington, D.C. The discovery that the U.S. Army had conducted chemical and biological tests at Fort Greely initiated an intense investigation. Numerous articles appeared in local papers, federal releases, and national television accusing the U.S. Army of being responsible for the deaths of various animals in Delta Junction, Alaska, approximately 10 miles from Fort Greely. Newspaper articles also accused the U.S. Army of being responsible for the paralysis of two children in Fairbanks, Alaska, and an outbreak of tularemia in Vermont in 1968, in addition to many other accusations. There has been no evidence or scientific proof to link the Alaska tests with any of the above accusations'. Old habits die hard and once again people are asking for explanations.
'Earth-covered ammunition storage magazines are overgrown with natural grasses, Kentucky Bluegrass, and Artca Red Fescue. The goal is to camouflage the nature of the facility from aerial observation and four or five more years of undisturbed growth will complete the program'. And yet, '..the Team cannot vouch for the accuracy of the data'. How can anyone be sure that all nuclear, chemical and biological weapons have been removed from the area. They can not, nor do they care to find out. Many of the symptoms I experience are the same symptoms experienced by the Gulf War Veterans, yet I was never there. Before moving to Ft. Greely I was an extremely healthy and vibrant person who never had any need to visit a physician. Now I am a sick 29 year old housewife and mother of four. Shall I, like a hypocrite, go with my family to church every Sunday and turn my back on this issue? To the contrary, every stone must be overturned. This type of knowledge requires responsibility and is an extremely delicate matter. Before her transfer back to the lower 48, my girlfriend confided that she had ovarian cancer. She told me that it had spread so quickly that she had only months to live. Her face of anguish haunts me. My husband, John, has for many years now discouraged me from trying to find out exactly what happened on Ft. Greely. He is a veteran and the idea that the military would do anything like this is almost like blasphemy to him. As a patriotic American, it is not my intention to disgrace the military in any way, rather, as a Christian woman, I feel a moral obligation to have this matter addressed and investigated further.
It is especially important that the military be held accountable before they pull out in the year 2001 and leave the Delta Junction community and the state of Alaska with this mess. Up to this date they have not been forthright in their findings concerning the human health situation and environmental contamination. Those who passed through Fort Greely may be suffering and dying without even realizing why.
Don Jenkins recalls, "Come to think of it, that is all we ever treated people on Greely for: headache and nausea with accompanying flu like symptoms. Besides that, we treated soldiers for broken bones which were the result of training exercises. For a three month period of time we had a real problem on Greely and were very worried. Everyone was coming in with these symptoms. We did not treat them, just ensured they did not become dehydrated."
Mr. Jenkins is extremely ill these days. He served his nation in the Gulf and then on Greely. Don was told that he is by far the sickest man to come out of the Fox Trot 122 Main Support Battalion and it is no wonder. The variety of symptoms he experiences include: gastrointestinal problems, loose bowel syndrome, headaches, chronic fatigue, swelling of lymph nodes with those on the right side of his neck very pronounced, respiratory problems, extreme joint pain and weakness, and stabbing pains due to noticeable liver swelling. For his meritorious duty, he has been rewarded with slaps in the face by our government and has no cheek left to turn.
John Vitek also has the Gulf War Syndrome. His stay on Greely had been brief. John has been consulting physicians ever since returning from Alaska for aches in his joints, muscle spasms, headaches, memory loss, ringing in the ears and stiff necks due to lymph node swelling . No one has been able to diagnose him. After relaying this information to him, he said, "Thank you. It is such a comfort to know why I am ill. Thank you so much".
Heather Breece still experiences chronic fatigue and just feels sick all of the time.
Jason Kelly said, "One thing I do recall about my health on Ft. Greely is that I was always tired and worn down. All day long in the clinic I felt tired and worn down. I always remember that". After Jason left Ft. Greely, he returned to feeling healthy again.
My husband, John received 12 hours of sleep a night while on Ft. Greely and never woke up feeling refreshed. Today he is in good health.
The U.S. Army may have slowed me down by inflicting this disease upon me, but I have not been stopped, nor will I stop until their reckless actions of nuclear, chemical and biological weapons testing have been stopped. How many times must the face of humanity be slapped before he rises up and cries, "JUSTICE!"? America, we lived and worked on a nuclear, chemical and biological weapons playground. Today many of us are ill. It is just this simple. Our government has perpetrated The Gulf War Illness upon this nation's people. Today I am calling for a revolution of Truth in this country. I am calling every good American to arms. Arm yourself with Truth. Truth is our government's greatest enemy. Truth shall prevail every time. It is only when we are once again armed with Truth that our nation will be great. As these words leave you now, sing to yourself the words of "America the Beautiful"… and weep.
UPDATE: After contacting Laura Cuozzo and realizing that innocent people were still being subjected to the aftereffects of nuclear, chemical and biological testing, I was contacted by representatives of the Canadian Parliament. They are now asking serious questions involving the experiments, which may have a direct effect on the caribou migration into Alaska and throughout the northwest. To satisfy my curiosity about the health effects on the civilian residents of Delta Junction, I contacted Delta Junction City Hall, the Public Health Nurse, the one local physician and several others. They confirmed to me that the incidence of rare tumors and cancers appears to be much higher than that found in the general population. Bolio Lake no longer has any fish in it and several areas on the base are totally off limits.
It is because of the real American Patriot's such as Laura Cuozzo and magazines like the Free American that we are still able to disclose information vital to the health and well being of all Liberty loving Americans. We must be our own advocates and research these issues as if our very lives depend upon them---BECAUSE THEY DO. We have heard ad nauseam of the experiments conducted on unwitting American children, the mentally retarded, prisoners and also the military. It is time the experiments be revealed, individuals be justly compensated and prosecution be pursued with regard to those who have perpetrated these illnesses and diseases on the very people the Constitution, Declaration of Independence, the Bill of Rights and the Nuremberg Code was designed to protect.
If you have information on this or any other experiments regarding nuclear, biological or chemical testing, please contact the American Gulf War Veterans Association:
3506 Highway 6 So. #117, Sugarland, Tx. 77478-4401, 1-800-231-7631
There can be a million lies; there is only one truth. We will continue to bring you the truth.
For God and Country,
Joyce Riley vonKleist & Dave vonKleist
FROM: 40 Years of Government Sponsored Ecological Terrorism
Joyce Riley vonKleist, RN BSN
Captain, USAF, inactive reserve
When beginning an investigation of any kind, one must accept the inevitability that when going through the process of "leaving no stone unturned", the resulting scatter of insects lead to other stones. Such is the case when it comes to the investigation of nuclear, chemical and biological exposures and the research and development of these insidious weapons of mass destruction.
While researching the history behind the Gulf War experiments, I have been stunned almost on a daily basis by the revelations of other experiments conducted by the Department of Defense and the CIA on the American civilian and military population. Our most recent discovery is the that the Department of the Army was conducting biological, chemical and nuclear experiments at Ft. Greeley, Alaska and the town of Delta Junction, Alaska.
The documentation for the information that follows was taken from a 60-page report that included maps, photos and charts I received in a brown manila envelope entitled:
INSTALLATION ASSESSMENT OF GERSTLE RIVER TEST SITE:
RECORDS EVALUATION REPORT NO. 105, VOLUME 1
Department of the Army Office of the Project Manager for
Chemical Demilitarization and Installation Restoration
Aberdeen Proving Ground, Maryland 21010
FOR OFFICIAL USE ONLY
INSTALLATION ASSESSMENT OF GERSTLE RIVER TEST SITE
RECORDS EVALUATION REPORT NO. 105
DEPARTMENT OF THE ARMY
OFFICE OF THE PROJECT MANAGER
CHEMICAL DEMILITARIZATION AND INSTALLATION RESTORATION
ABERDEEN PROVING GROUND, MARYLAND 21010
FOR OFFICIAL USE ONLY
The Records Research Team wishes to thank the various military and civilian agencies that have cooperated with it and provided the information contained herein. In particular, the cooperation of the present and former employees at Fort Greely is especially appreciated.
A special note of thanks is extended to Captain James Verney and Captain David Moss, of the U.S.A. Cold Regions Test Center, who served as points of contact for this assessment. They provided excellent liaison, working closely with the Team in arranging interviews and in locating the documents needed for assessment.
Appreciation is also given to Mr. Bert Johns, of Dugway Proving Ground, who accompanied the Team to Fort Greely. He was in charge of test operations for Deseret Test Center from 1962 to 1967 and had intimate knowledge of test and surveillance operations conducted at the Gerstle River Test Site during this period.
During August 1976, a Records Research (R/R) study was conducted at Fort Greely to estimate possible contamination at the Gerstle River Test Site by chemical, biological, and radiological material, and to assess the possibility of contaminants migrating beyond the boundaries of the installation
As a result of the records search survey, it was discovered that the same organization which conducted the chemical agent tests at the Gerstle River area also conducted biological agent tests at the Delta Creek area of Fort Greely, Alaska. It was decided to include the Delta Creek data in this report so that it could be permanently documented.
The approach used by the R/R Team included (1) the evaluation of available documents on the operations at the Gerstle River Test Site and a literature search conducted at other Government agencies including the Department of Defense Explosive Safety Board (DDESB), the U.S. Army Environmental Hygiene Agency (AEHA), the U.S. Geological Survey, the U.S. Department of Agriculture, the Defense Documentation Center (DDC), and the National Technical Information Service (NTIS), and (2) interviews with key personnel including present and former employees of U.S. Army Cold Regions Test Center (CRTC) Fort Greely and Dugway Proving Ground.
Based on the evaluation of available information, the following findings are presented:
1. The records and personnel interviews indicate that contaminant migration at the Gerstle River Test Site is not a problem since (a) the decontamination procedures used before burial of scrap test materials were thorough and complete, and (b) the soil and moisture characteristics at the site are such that even if contaminants were present, leaching of contaminants into the groundwater is unlikely. The Test Site is located in a remote area with no adjacent home sites. The land is unsuitable for agricultural purposes.
2. Records covering incoming material for the 1953 - 1958 time frame are incomplete. An accurate accounting on all material shipped into the Gerstle River area for function and surveillance testing is not available. However, interviews with responsible personnel indicate that all munitions subjected to surveillance testing were properly demilitarized. Although all rounds drawn for functional tests were reportedly accounted for with the possible exception of one 155mm round, it is considered possible that other unexploded ordnance munitions and submunitions may be found at the Gerstle River Test Site.
3. The records indicate that the Gerstle River Test Site is not contaminated by radiological or biological agent materials. A deep well was prepared and instrumented for use as a radiological material disposal well, but it was never used for this purpose.
4. Two fenced disposal pits are located in the Gerstle River Test Site. These pits were opened in 1970 and contain residue and removed from all known disposal pits in the Gerstle River area. The pits were closed in 1971 after receiving scrap material from pits near Blueberry Lake. Over 400 truckloads of material (dirt plus refuse) were placed in the two pits. Refuse included scrap metal, test vehicles. grid instrumentation, protective clothing, and uncontaminated garbage. The refuse was decontaminated by incineration and chemical treatment before burial.
5. The records indicate that the Delta Creek area of Fort Greely was used for biological agent testing from 1962 through 1967. Ecological studies were conducted at Delta Creek after testing was completed to assure that active biological materials did not remain at the site,
Based on available records, it is concluded that a preliminary survey of the Gerstle River Test Site is not required.
Whether or not the property is retained, consideration should be given to opening the two disposal pits at the Gerstle River Test Site, examining the decontaminated rubble, and moving it to Fort Greely for disposal in the normal manner prescribed for industrial waste. If the Gerstle River Test Site remains in Army possession, consideration should be given to the removal of the warning signs and fences around the pit areas since these only attract the attention of unauthorized curiosity seekers. The area perimeter fences should remain intact to discourage penetration of the area by unauthorized personnel.
Should it be decided to "excess" the Gerstle River Test Site property, it is recommended that the area be swept by an explosive ordnance disposal team to remove large shrapnel fragments and possible UXO’s. One 155 mm HE round was reported to have malfunctioned in this area and it is possible that other UXO’s are present since during one of the cleanup operations, three live rounds were discovered.
103d Congress, 2d Session - COMMITTEE PRINT - S. Prt. 103-97
IS MILITARY RESEARCH HAZARDOUS TO VETERANS' HEALTH?
[DUH....DO CATS LICK FUR?]
LESSONS SPANNING HALF A CENTURY
A STAFF REPORT PREPARED FOR THE
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
DECEMBER 8, 1994
JOHN D. ROCKEFELLER IV, West Virginia, Chairman
Committee on Veterans' Affairs,
Washington, DC, December 8, 1994
During the last few years, the public has become aware of several examples where U.S. Government researchers intentionally exposed Americans to potentially dangerous substances without their knowledge or consent. The Senate Committee on Veterans' Affairs, which I have been privileged to chair from 1993-94, has conducted a comprehensive analysis of the extent to which veterans participated in such research while they were serving in the U.S. military. This resulted in two hearings, on May 6, 1994, and August 5, 1994.
This report, written by the majority staff of the Committee, is the result of that comprehensive investigation, and is intended to provide information for future deliberations by the Congress. The findings and conclusions contained in this report are those of the majority staff and do not necessarily reflect the views of the members of the Committee on Veterans' Affairs.
This report would not have been possible without the dedication and expertise of Dr. Patricia Olson, who, as a Congressional Science Fellow, worked tirelessly on this investigation and report, and the keen intelligence, energy, and commitment of Dr. Diana Zuckerman, who directed this effort.
John D. Rockefeller IV, Chairman
* A. Codes, declarations, and laws governing human experimentation
* B. Mustard gas and lewisite
* C. Seventh-Day Adventists
* D. Dugway Proving Ground
* E. Radiation exposure
* F. Hallucinogens
* G. Investigational drugs
III. Findings and conclusions
* A. For at least 50 years, DOD has intentionally exposed military personnel to potentially dangerous substances, often in secret
* B. DOD has repeatedly failed to comply with required ethical standards when using human subjects in military research during war or threat of war
* C. DOD incorrectly claims that since their goal was treatment, the use of investigational drugs in the Persian Gulf War was not research
* D. DOD used investigational drugs in the Persian Gulf War in ways that were not effective
* E. DOD did not know whether pyridostigmine bromide would be safe for use by U.S. troops in the Persian Gulf War
* F. When U.S. troops were sent to the Persian Gulf in 1994, DOD still did not have proof that pyridostigmine bromide was safe for use as an antidote enhancer
* G. Pyridostigmine may be more dangerous in combination with pesticides and other exposures
* H. The safety of the botulism vaccine was not established prior to the Persian Gulf War
* I. Records of anthrax vaccinations are not suitable to evaluate safety
* J. Army regulations exempt informed consent for volunteers in some types of military research
* K. DOD and DVA have repeatedly failed to provide information and medical follow-up to those who participate in military research or are ordered to take investigational drugs
* 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
* M. The Federal Government has failed to support scientific studies that provide timely information for compensation decisions regarding military personnel who were harmed by various exposures
* 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
* O. DOD has demonstrated a pattern of misrepresenting the danger of various military exposures that continues today
* A. Congress should deny the DOD request for a blanket waiver to use investigational drugs in case of war or threat of war
* B. FDA should reject any applications from DOD that do not include data on women, and long-term follow-up data
* C. Congress should authorize a centralized database for all federally funded experiments that utilize human subjects
* D. Congress should mandate all Federal agencies to declassify most documents on research involving human subjects
* E. Congress should reestablish a National Commission for the Protection of Human Subjects
* F. VA and DOD should implement regular site visits to review Institutional Review Boards
* G. The Feres Doctrine should not be applied for military personnel who are harmed by inappropriate human experimentation when informed consent has not been given
Appendix -- Survey of 150 Persian Gulf War Veterans
IS MILITARY RESEARCH HAZARDOUS TO VETERANS' HEALTH? LESSONS SPANNING HALF A CENTURY
During the last 50 years, hundreds of thousands of military personnel have been involved in human experimentation and other intentional exposures conducted by the Department of Defense (DOD), often without a servicemember's knowledge or consent. In some cases, soldiers who consented to serve as human subjects found themselves participating in experiments quite different from those described at the time they volunteered. For example, thousands of World War II veterans who originally volunteered to "test summer clothing" in exchange for extra leave time, found themselves in gas chambers testing the effects of mustard gas and lewisite. (Note 1) Additionally, soldiers were sometimes ordered by commanding officers to "volunteer" to participate in research or face dire consequences. For example, several Persian Gulf War veterans interviewed by Committee staff reported that they were ordered to take experimental vaccines during Operation Desert Shield or face prison. (Note 2)
The goals of many of the military experiments and exposures were very appropriate. For example, some experiments were intended to provide important information about how to protect U.S. troops from nuclear, biological, and chemical weapons or other dangerous substances during wartime. In the Persian Gulf War, U.S. troops were intentionally exposed to an investigational vaccine that was intended to protect them against biological warfare, and they were given pyridostigmine bromide pills in an experimental protocol intended to protect them against chemical warfare.
However, some of the studies that have been conducted had more questionable motives. For example, the Department of Defense (DOD) conducted numerous "man-break" tests, exposing soldiers to chemical weapons in order to determine the exposure level that would cause a casualty, i.e., "break a man." (Note 3) Similarly, hundreds of soldiers were subjected to hallucinogens in experimental programs conducted by the DOD in participation with, or sponsored by, the CIA. (Note 4), (Note 5) These servicemembers often unwittingly participated as human subjects in tests for drugs intended for mind-control or behavior modification, often without their knowledge or consent. Although the ultimate goal of those experiments was to provide information that would help U.S. military and intelligence efforts, most Americans would agree that the use of soldiers as unwitting guinea pigs in experiments that were designed to harm them, at least temporarily, is not ethical.
Whether the goals of these experiments and exposures were worthy or not, these experiences put hundred of thousands of U.S. servicemembers at risk, and may have caused lasting harm to many individuals.
Every year, thousands of experiments utilizing human subjects are still being conducted by, or on behalf of, the DOD. Many of these ongoing experiments have very appropriate goals, such as obtaining information for preventing, diagnosing, and treating various diseases and disabilities acquired during military service. Although military personnel are the logical choice as human subjects for such research, it is questionable whether the military hierarchy allows for individuals in subordinate positions of power to refuse to participate in military experiments. It is also questionable whether those who participated as human subjects in military research were given adequate information to fully understand the potential benefits and risks of the experiments. Moreover, the evidence suggests that they have not been adequately monitored for adverse health effects after the experimental protocols end.
Veterans who become ill or disabled due to military service are eligible to receive priority access to medical care at VA medical facilities and to receive monthly compensation checks. In order to qualify, they must demonstrate that their illness or disability was associated with their military service. Veterans who did not know that they were exposed to dangerous substances while they were in the military, therefore, would not apply for or receive the medical care or compensation that they are entitled to. Moreover, even if they know about the exposure, it would be difficult or impossible to prove if the military has not kept adequate records. It is therefore crucial that the VA learn as much as possible about the potential exposures, and that the DOD assume responsibility for providing such information to veterans and to the VA.
A. CODES, DECLARATIONS, AND LAWS GOVERNING HUMAN EXPERIMENTATION
The Nuremberg Code is a 10-point declaration governing human experimentation, developed by the Allies after World War II in response to inhumane experiments conducted by Nazi scientists and physicians. The Code states that voluntary and informed consent is absolutely essential from all human subjects who participate in research, whether during war or peace. The Code states:
The person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health and person which may possibly come from his participation in the experiments. (Note 6)
There is no provision in the Nuremberg Code that allows a country to waive informed consent for military personnel or veterans who serve as human subjects in experiments during wartime or in experiments that are conducted because of threat of war. However, the DOD has recently argued that wartime experimental requirements differ from peacetime requirements for informed consent. According to the Pentagon, "In all peacetime applications, we believe strongly in informed consent and its ethical foundations.....But military combat is different." (Note 7) The DOD argued that informed consent should be waived for investigational drugs that could possibly save a soldier's life, avoid endangerment of the other personnel in his unit, and accomplish the combat mission.
More than a decade after the development of the Nuremberg Code, the World Medical Association prepared recommendations as a guide to doctors using human subjects in biomedical research. As a result, in 1964 the Eighteenth World Medical Assembly met in Helsinki, Finland, and adopted recommendations to be used as an ethical code by all medical doctors conducting biomedical research with human subjects. This code, referred to as the Declaration of Helsinki, was revised in 1975, 1983, and 1989. (Note
It differs from the Nuremberg Code in certain important respects. The Declaration of Helsinki distinguishes between clinical (therapeutic) and nonclinical (nontherapeutic) biomedical research, and addresses "proxy consent" for human subjects who are legally incompetent, such as children or adults with severe physical or mental disabilities. (Note 9) Proxy consent for legally competent military personnel who participate in military research is not considered appropriate under the Nuremberg Code or the Declaration of Helsinki.
On June 18, 1991, the Federal Government announced that 16 U.S. governmental agencies would abide by a set of regulations, referred to as the "Common Rule," designed to protect human subjects who participate in federally funded research. (Note 10) The provisions of the "Common Rule," first promulgated for the Department of Health and Human Services (DHHS) in 1974, described how federally funded research involving human subjects shall be conducted. However, local Institutional Review Boards (IRB's) may revise or exclude some or all consent elements if the research exposes subjects to no more than "minimal risk," meaning "that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (Note 11) IRB's vary greatly in their interpretation of the risks of daily life.
There are three provisions governing research funded by DHHS that are intended to protect vulnerable populations, such as pregnant women and fetuses, prisoners, and children. (Note 12) There are no special Federal regulations to protect military personnel when they participate as human subjects in federally funded research, despite logical questions about whether military personnel can truly "volunteer" in response to a request from a superior officer.
Current law prevents the Department of Defense from using Federal funds for research involving the use of human experimental subjects, unless the subject gives informed consent in advance. This law applies regardless of whether the research is intended to benefit the subject. (Note 13)
D. DUGWAY PROVING GROUND
Dugway Proving Ground is a military testing facility located approximately 80 miles from Salt Lake City. For several decades, Dugway has been the site of testing for various chemical and biological agents. From 1951 through 1969, hundreds, perhaps thousands of open-air tests using bacteria and viruses that cause disease in human, animals, and plants were conducted at Dugway. (Note 22) For example, antigens produced by animals that had come in contact with Venezuelan equine encephalomyelitis (VEE), a disease usually found in horses, were later found in animals around Dugway. Prior to the identification of these substances in the Dugway vicinity, VEE had only been identified in the rat population in Florida. Such a finding suggested that VEE had been used in the open-air tests at Dugway or within laboratories, and transferred to the nearby animal population. (Note 23)
In 1968, approximately 6,400 sheep died following the intentional release of a deadly nerve gas from a plane. According to a veterinarian who evaluated the sick and dying sheep, there was little doubt that the sheep had been poisoned with nerve gas. (Note 24) The sheep and other animals in the area had depressed cholinesterase levels, suggesting organophosphate nerve poisoning. Initially, the Department of Defense denied any responsibility for the accident, stating that the sheep died from organophosphate pesticides sprayed on a nearby alfalfa field. However, the nerve agent VX was identified when the poisoned sheep were autopsied, which made it clear that the deaths were not caused by pesticides. (Note 25) Eventually, the Department of Defense reimbursed the ranchers for their animals.
It is unknown how many people in the surrounding vicinity were also exposed to potentially harmful agents used in open-air tests at Dugway. In 1969, concerns were expressed at a congressional hearing about the possible public health implications of the VEE virus tested at Dugway. (Note 26)
Due to previous problems with dangerous organisms and chemicals, Dugway has developed an active program of "simulant" testing. According to the Department of Defense, simulants are harmless organisms or chemicals which do not cause disease. However, during 45 years of open-air testing, the Army has stopped using a variety simulants when they realized they were not as safe as previously believed. (Note 27)
E. RADIATION EXPOSURE
From 1945 to 1962, the United States conducted numerous nuclear detonation tests: Crossroads (Bikini); Sandstone, Greenhouse, and Ivy (Eniwetok Atoll); Castle (Bikini Atoll); Pacific Ocean 400 miles southwest of San Diego; Redwing and Hardtack I (Eniwetok and Bikini Atolls); Argus (South Atlantic); and Dominic (Christmas Island, Johnston Island, 400 miles west of San Diego). (Note 28) The main goal was to determine damage caused by the bombs; however, as a result, thousands of military personnel and civilians were exposed to radioactive fallout. Similar tests were conducted within the continental United States, including sites in New Mexico and Nevada. (Note 29) Veterans who participated in activities that directly exposed them to radioactive fallout are referred to as "atomic veterans."
Data obtained on some military personnel who were exposed to radioactive fallout were collected after these men were unintentionally exposed. However, some atomic veterans believe they were used as guinea pigs to determine the effects of radiation from various distances, including those at ground zero, on human subjects. Their suspicions are supported by a 1951 document from the Joint Panel on the Medical Aspects of Atomic Warfare, Research and Development Board, Department of Defense, which identified general criteria for bomb test-related "experiments" and identified 29 "specific problems" as "legitimate basis for biomedical participation."
The National Research Council's Committee on the Biological Effects of Ionizing Radiation (BEIR) have prepared a series of reports to advise the U.S. Government on the health consequences of radiation exposure. (Note 31) The first of these reports was not published until the late 1980's, decades after military personnel were first exposed to ionizing radiation. For the last 13 years, the VA has provided free medical care to atomic veterans who have disorders they believe to be caused by ionizing radiation, even if there is no conclusive evidence of the cause. (Note 32) In addition, the VA provides monthly compensation to veterans who were exposed to ionizing radiation during military service, who have illnesses that are believed to be associated with their exposure. The lists of compensable diseases have been revised as more research information has become available. For example, on October 11, 1994, the VA announced that tumors of the brain and central nervous system would be considered for disability compensation for veterans exposed to ionizing radiation. (Note 33)
Working with the CIA, the Department of Defense gave hallucinogenic drugs to thousands of "volunteer" soldiers in the 1950's and 1960's. In addition to LSD, the Army also tested quinuclidinyl benzilate, a hallucinogen code-named BZ. (Note 37) Many of these tests were conducted under the so-called MKULTRA program, established to counter perceived Soviet and Chinese advances in brainwashing techniques. Between 1953 and 1964, the program consisted of 149 projects involving drug testing and other studies on unwitting human subjects. (Note 38)
One test subject was Lloyd B. Gamble, who enlisted in the U.S. Air Force in 1950. In 1957, he volunteered for a special program to test new military protective clothing. He was offered various incentives to participate in the program, including a liberal leave policy, family visitations, and superior living and recreational facilities. However, the greatest incentive to Mr. Gamble was the official recognition he would receive as a career-oriented noncommissioned officer, through letters of commendation and certification of participation in the program. During the 3 weeks of testing new clothing, he was given two or three water-size glasses of a liquid containing LSD to drink. Thereafter, Mr. Gamble developed erratic behavior and even attempted suicide. He did not learn that he had received LSD as a human subject until 18 years later, as a result of congressional hearings in 1975. (Note 39) Even then, the Department of the Army initially denied that he had participated in the experiments, although an official DOD publicity photograph showed him as one of the valiant servicemen volunteering for "a program that was in the highest national security interest." (Note 40)
According to Sidney Gottlieb, a medical doctor and former CIA agent, MKULTRA was established to investigate whether and how an individual's behavior could be modified by covert means. (Note 41) According to Dr. Gottlieb, the CIA believed that both the Soviet Union and Communist China might be using techniques of altering human behavior which were not understood by the United States. Dr. Gottlieb testified that "it was felt to be mandatory and of the utmost urgency for our intelligence organization to establish what was possible in this field on a high priority basis." Although many human subjects were not informed or protected, Dr. Gottlieb defended those actions by stating, "...harsh as it may seem in retrospect, it was felt that in an issue where national survival might be concerned, such a procedure and such a risk was a reasonable one to take." (Note 42)
G. INVESTIGATIONAL DRUGS USED IN THE PERSIAN GULF WAR
Under the Food, Drug, and Cosmetics Act, all vaccines and medical products must be proven safe and effective by the Food and Drug Administration (FDA) in order to be sold and distributed in the United States. This law also applies to medical products used by the Department of Defense, even if given to U.S. troops who are stationed in other countries.
FDA also regulates medical products that are proven safe and effective for some uses or with specific doses, but not for other uses or other doses. If the product is only sold at certain doses and not others, its use at the non-approved dose would be considered investigational. If the product is legally available for sale at the same dosage, physicians can legally prescribe it; however, manufacturers can not advertise it for that purpose. Such "off label" use is also considered investigational. So, for example, a drug may be proven safe and effective to treat one kind of cancer, but be considered investigational to treat a different disease.
Under current law, an unapproved vaccine or investigational use of a drug could only be administered by the DOD under an Investigational New Drug (IND) procedure. (Note 43) Under an IND, any individual who is given the investigational product must give informed consent, i.e., must be told of the potential risks and benefits of the product, orally and in writing, and choose freely whether or not to participate. In addition, the IND requires that the medical product be distributed under carefully controlled conditions where safety and effectiveness can be evaluated.
When the Department of Defense began preparations for Desert Shield and Desert Storm in 1990, officials were extremely concerned that Iraq would use chemical and biological weapons against the United States. Despite years of study and billions of dollars, the DOD lacked drugs and vaccines that were proven safe and effective to safeguard against anticipated chemical nerve agents and biological toxins. Therefore, DOD officials wanted to use a medication (pyridostigmine bromide) and vaccine (botulinum toxoid) that they believed might protect against chemical nerve agents and botulism. Because the safety and effectiveness of pyridostigmine bromide and botulinum toxoid had not been proven for their intended use, these products were considered investigational drugs.
Pyridostigmine bromide is a chemical which enhances the effectiveness of two drugs, atropine and 2-PAM, which are proven effective for the treatment of nerve agent poisoning. (Note 44) Pyridostigmine is also a nerve agent itself. Nerve agents exert their biological effects by binding to, and inhibiting, the enzyme acetylcholinesterase (AChE) which normally shuts off the neurotransmitter, acetylcholine (ACh). When levels of ACh increase, nerve impulses and organ activity increase. When nerve and organ stimulation are excessive, death can result.
There are two major categories of nerve agents, carbamates and organophosphate (OP) compounds. (Note 45) German scientists developed many of the OP compounds for warfare agents and pesticides in the 1930's and 1940's. Examples of warfare agents include tabun, sarin, soman, and VX. Many organophosphates permanently inhibit AChE. This permanent effect, which can only be reversed when new enzymes are synthesized, makes OP warfare agents extremely lethal.
Pyridostigmine bromide is a carbamate, rather than an OP compound. (Note 46) Although it is a nerve agent, pyridostigmine has a reversible effect which can protect the AChE from permanently binding to OP compounds. When appropriate doses are selected, pyridostigmine theoretically should not cause nerve agent poisoning and should help protect against some lethal chemical warfare.
Efficacy. Pyridostigmine only works when taken in combination with other drugs and only if taken before exposure to nerve gas. (Note 47) Two antidotes to nerve agents, atropine and pyridine-2-aldoxime methochloride (2-PAM), are reportedly enhanced if pyridostigmine has already been given. Atropine and 2-PAM were included in the nerve agent antidote kits (Mark I) which were issued to U.S. troops in the Persian Gulf.
In research studies, animals given pyridostigmine, atropine, and 2-PAM were more likely to survive exposure to one chemical nerve agent, soman, than those given only atropine and 2-PAM. However, pyridostigmine is unable to enter and protect the brain, so that animals exposed to soman can still suffer from convulsions despite the pyridostigmine pretreatment. (Note 48) To protect against brain damage from ongoing seizure activity, valium may also be required following exposure to a warfare nerve agent. Similarly, pyridostigmine may offer little protection against the damage caused by nerve agents in the spinal cord. (Note 49)
Safety. Pyridostigmine bromide is approved by the FDA for treating myasthenia gravis, a neurological disease characterized by extreme weakness. This disease occurs when individuals develop antibodies that prevent ACh from causing muscle impulses at the neuromuscular junction. Therefore, treatment with relative high doses of pyridostigmine increases ACh to levels that are able to overcome the "block" created by the antibodies. An analogy might be that of a fishing pond. The two ways to increase the number of fish caught are to increase the number of fishing poles or to increase the number of fish in the pond.
FDA and DOD officials claimed they were confident of the safety of pyridostigmine as an antidote enhancer for chemical warfare protection because it would be used at a much lower dose (Note 50) in combat than normally used for treating patients with myasthenia gravis. However, normal patients and those with myasthenia gravis may not respond similarly to the same dose of pyridostigmine bromide. Whereas the dosage of pyridostigmine bromide for patients with myasthenia gravis may reach 120 mg every three hours, (Note 51) the dose for U.S. troops was only 30 mg every 8 hours. A good analogy is the use of insulin for diabetes mellitus; very high doses of insulin are sometimes necessary to treat diabetics, but similar doses could be fatal for non-diabetic individuals.
Some scientists also question whether pyridostigmine is completely safe even for treating patients with myasthenia gravis. The proportion of patients with myasthenia gravis that recover after surgical treatment (thymectomy) has decreased since pyridostigmine therapy was introduced several decades ago. (Note 52) Experts speculate that whereas the problems caused by myasthenia gravis can be corrected by surgery, pyridostigmine may cause immune damage to the neuromuscular junction that cannot be corrected by surgery. Since the symptoms of pyridostigmine damage would be similar to the symptoms of myasthenia gravis, any damage from the pyridostigmine would be extremely difficult if not impossible to diagnose.
In addition to its use for myasthenia gravis, pyridostigmine bromide has been approved by FDA for use with surgical patients; it is administered after surgery to reverse the effect of anesthesia, which are neuromuscular blocking agents. The dose is relatively small (15 mg) and not repeated. This treatment does not provide relevant information about the safety of repeated use of pyridostigmine by healthy individuals, since the dosage is small and the patients have received neuromuscular blocking agents.
The bromide that is included in pyridostigmine bromide pills is known to sometimes cause problems referred to as "bromide intoxication" when used for the treatment of myasthenia gravis. (Note 53) Bromide intoxication may cause confusion, irritability, tremor, memory loss, psychotic behavior, ataxia, stupor, and coma. Some patients with bromide intoxication have a skin disorder of the face and hands resembling acne. A 60 mg tablet of the commercially available pyridostigmine bromide contains 18.4 mg bromide (30.6 percent). (Note 54), (Note 55)
FDA has not approved pyridostigmine bromide for repeated use in healthy individuals as an antidote enhancer or for any other reason. Since it would be unethical to expose individuals to potentially lethal chemical weapons in order to evaluate the efficacy of pyridostigmine, this use has only been studied on animals. The product is therefore an investigational drug when used as an antidote enhancer for treating nerve gas poisoning.
Botulinum toxoid is an unapproved vaccine that is used to protect laboratory workers and others who are likely to be exposed to botulism. Botulism is caused by at least one of seven neurotoxins produced by the bacteria Clostridium botulinum. When home-canning of food was common, food poisoning was the most common cause of botulism in the United States; the bacteria in the food produces a toxin which is eaten. Today, the most common form of botulism occurs in infants, since the bacteria that produces the toxin can thrive in a baby's intestinal tract.
A botulism vaccine that is intended to protect against five of seven neurotoxins (called A,B,C,D,E) is produced by the Michigan Department of Health. This is called pentavalent toxoid. This vaccine is not a licensed product and must be distributed as an Investigational New Drug (IND).
Efficacy. Desert Shield began on August 8, 1990. Since the air war did not begin until January 16, 1991, and the ground war took place from February 24-27, 1991, the Pentagon had several months to review the possible use of investigational drugs and vaccines. In December 1990, the FDA advised the Department of Defense that it would be unable to test the botulism vaccine for efficacy, presumably because of limited time before the onset of the war. The FDA agreed to test the vaccine for safety, but these tests were not completed until late January 1991. At a meeting of the Informed Consent Waiver Review Group (ICWRG) on December 31, 1990, a representative of FDA's Center for Biologics Evaluation and Research discussed the vaccine, explaining that the existing supply was nearly 20 years old and consisted of three lots, stored under continuous refrigeration. (Note 56) Given the age of these vaccines, there were concerns about their safety.
The recommended schedule for immunization with the pentavalent vaccine includes a series of three initial injections at 0, 2, and 12 weeks, followed by a booster 12 months after the first injection. According to the Centers for Disease Control's Center for Infectious Diseases, subjects given the vaccine did not have detectable antitoxin titers after the first two shots in the initial series, which means that they were unlikely to be protected at week 2. (Note 57) If for any reason only two immunizations can be given, at least 4 to 8 weeks should elapse between injections if most individuals are to be protected against the disease. (Note 58)
Safety. The Michigan Department of Health reported that 4.2 percent of patients reported a sore arm or other local reactions to the initial series of three shots, and 12.1 percent had local reactions to the booster shots. (Note 59) Almost 3 percent had systemic reactions, such as general malaise, after either the initial three shots or the booster shots. Because of the relatively large percentage of adverse reactions, new lots of the vaccine were manufactured in 1971. However, there is no evidence that the newer lots produced fewer adverse reactions than the older lots.
In her review of the DOD's application for use of botulinum toxoid in the Persian Gulf, an FDA reviewer pointed out that in 1973, the Centers for Disease Control had considered terminating the distribution of the vaccine because of the relatively large number of individuals who had negative reactions to it. (Note 60) The FDA reviewer also pointed out that "there are no efficacy data in humans" and that the dose for humans was an estimate based on results from guinea pigs. In addition, potency testing had suggested that the vaccine would not be effective against two of the five botulism toxins.
According to the Michigan Department of Health, the effects of the botulism vaccine on pregnant women had not been studied prior to its use in the Persian Gulf War.
Anthrax vaccine is an FDA-approved vaccine that is considered safe and effective for individuals whose skin may come in contact with animal products such as hides, hair, or bones likely to contain the anthrax infection. It is also recommended for veterinarians and others who are likely to touch infected animals. (Note 61) However, the vaccine's effectiveness against inhaled anthrax is unknown. Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled. Therefore, the efficacy of the vaccine against biological warfare is unknown.
It appears that there is only one relevant animal study which showed that anthrax vaccine apparently provided additional protection against relapse in monkeys exposed to inhalation anthrax and treated with antibiotics. (Note 62) Although the results of this study suggest the vaccine might protect against anthrax that has been sprayed, it is not sufficient to prove that anthrax vaccine is safe and effective as used in the Persian Gulf. The vaccine should therefore be considered investigational when used as a protection against biological warfare.
The anthrax vaccine is given as three injections 2 weeks apart, followed by three additional injections given 6, 12, and 18 months after the initial injection. If immunity is to be maintained, subsequent booster injections of anthrax vaccine are recommended at 1-year intervals. (Note 63) According to the Interagency Task Force on Persian Gulf War Illnesses, one dose provides some immunity in 85 percent of those individuals vaccinated. (Note 64)
According to the Michigan Department of Public Health which manufactures anthrax vaccine, it is not known whether anthrax vaccine is safe for pregnant women or their offspring.
III. FINDINGS AND CONCLUSIONS
A. FOR AT LEAST 50 YEARS, DOD HAS KNOWINGLY EXPOSED MILITARY PERSONNEL TO POTENTIALLY DANGEROUS SUBSTANCES, OFTEN IN SECRET.
The U.S. General Accounting Office issued a report on September 28, 1994, which stated that between 1940 and 1974, DOD and other national security agencies studied hundreds of thousands of human subjects in tests and experiments involving hazardous substances. (Note 65) GAO stated that some tests and experiments were conducted in secret. Medical research involving the testing of nerve agents, nerve agent antidotes, psychochemicals, and irritants was often classified. Additionally, some work conducted for DOD by contractors still remains classified today. For example, the Central Intelligence Agency (CIA) has not released the names of 15 of the approximately 80 organizations that conducted experiments under the MKULTRA program, which gave psychochemical drugs to an undetermined number of people without their knowledge or consent. According to the GAO report, the CIA has not released this information because the organizations do not want to be identified. (Note 66)
COLD WAR VETERANS
During the years immediately following World War II, military personnel were intentionally exposed to radiation during the testing of atomic bombs and during radioactive releases. While it is unclear how many of these servicemembers were intentionally exposed to what were known to be harmful levels of radiation, there is clear evidence that in some cases military personnel were ordered to locate themselves in areas of high radioactive fallout. They were given no choice in the matter, and they were not told of the potential risks of those exposures.
Similarly, military personnel were intentionally given hallucinogenic drugs to determine the effects of those drugs on humans. The servicemembers were not told that they would be given experimental drugs, they had no choice of whether or not to take them, and even after the unusual effects of the drugs were obvious to researchers, the unwitting human subjects were given no information about the known effects of the drugs. Even if the DOD did not know about the potential long-term effects of the drugs, that would not justify their failure to provide information to thousands of servicemembers about the known short-term effects of the drugs.
PERSIAN GULF WAR VETERANS
Persian Gulf veterans were also given investigational vaccines and ordered not to tell anyone. In a Committee survey of 150 individuals who served in the military during the Persian Gulf War (see Appendix), many of those surveyed indicated they were ordered, under threat of Article 15 or court martial, to discuss their vaccinations with no one, not even with medical professionals needing the information to treat adverse reactions from the vaccine. Similarly, 86 percent of the military personnel who told the Committee that they were ordered to take pyridostigmine bromide reported that they received no information on what they were taking or the drug's potential risks. According to a DOD study published in the Journal of the American Medical Association, commanding officers and medical personnel were also inadequately informed about the investigational drugs; as a result, they were ill-prepared to recognize or treat military personnel who experienced side effects. (Note 71)
B. DOD HAS REPEATEDLY FAILED TO COMPLY WITH REQUIRED ETHICAL STANDARDS WHEN USING HUMAN SUBJECTS IN MILITARY RESEARCH DURING WAR OR THREAT OF WAR.
The major principle of all research ethics involving human subjects, as described by the Nuremberg Code, the Declaration of Helsinki, and the "Common Rule" of the U.S. Government, states that the voluntary, competent, informed, and understanding consent of the subject is absolutely essential, whether during war or peace. (Note 72)
These standards are more than 50 years old. For example, the Nuremberg Code was based on testimony of two U.S. physicians, Drs. Leo Alexander and Andrew Ivy, who served as expert medical witnesses for the Nazi crime prosecutors. The code was not the outcome of an attempt to frame a new code of ethics, but rather a description of criteria said to be widely accepted by the medical profession at the time. (Note 73) Therefore, DOD research during the 1940's was clearly conducted in an era when researchers were well aware of ethical codes regarding the use of human subjects.
The Department of Defense has violated these well-established ethical principles each time soldiers are required to participate in military research or take investigational drugs or vaccines or are not adequately informed about the risks of the experiments.
C. DOD INCORRECTLY CLAIMS THAT SINCE THEIR GOAL WAS TREATMENT, THE USE OF INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR WAS NOT RESEARCH.
Despite the fact that pyridostigmine was an investigational drug whose safety and effectiveness had not been proven to FDA, the DOD claims that its use in the Persian Gulf War was prevention and treatment, not research. For example, Dr. Edward Martin, Acting Principal Assistant Secretary of Defense for Health Affairs, stated at the Committee's hearing on May 6, 1994, that "..investigational products were employed during the Persian Gulf War as prophylactic treatments against biological and chemical warfare agents. This was not research but direct prevention and treatment." (Note 93) Additionally, John M. Bachkosky, Deputy Director, Office of the Director of Defense Research and Engineering, wrote to Sen. Rockefeller on May 19, 1994, that "[botulinum toxoid and pyridostigmine bromide] were used for direct prevention and treatment and were not employed as part of any research effort." (Note 94)
In a letter to Sen. Rockefeller dated November 17, 1994, DOD continues to claim that its use of pyridostigmine was not research. John Deutch, Deputy Secretary of Defense, wrote that, "Although pyridostigmine and botulinum toxoid were classified as investigational drugs as required by FDA regulations, they were not used for experimental purposes in [Operation Desert Storm] and the military personnel who received these products were not experimental subjects." (Note 95) Mr. Deutch added that, "The fact that these drugs were used for treatment purposes, not research purposes, was clearly understood by all parties involved and specifically approved by the courts in litigation challenging the governments [sic] actions." Once again, it appears that the DOD confuses the goals of using these medical products with the process, which was clearly considered investigational by FDA.
Dr. Arthur Caplan, who at the time he testified was Director of the Center of Biomedical Ethics at the University of Minnesota, addressed that issue at the May 6 hearing. He explained that the fact that the goal is treatment and that DOD believed the benefits of the pills and vaccines would outweigh the risks "doesn't transform the use of experimental, innovative, investigational agents into therapies. These agents were used, as we have heard, in large populations for purposes other than those for which they were originally designed in some cases, and circumstances under which they had never before been tried out in the desert. This seems to me to cinch the case that what took place fell into the category of experimental, innovative and investigational, and that makes them research." (Note 96)
Since the end of the Persian Gulf War, DOD has repeatedly requested that the waiver of informed consent be made permanent, arguing that "to not finalize it provides an arguable defect under the Administrative Procedures Act and leaves both DOD and FDA open to greater liability." (Note 97) To finalize the interim rule would grant unrestricted use of investigational drugs by military personnel, even though investigational status means that efficacy and safety have not been proven. FDA has not yet decided whether to concur with DOD's request.
D. DOD USED INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR IN WAYS THAT WERE NOT EFFECTIVE.
The DOD persuaded FDA that informed consent should be waived for pyridostigmine bromide and botulism vaccine because these investigational products had been used safely in the past. However, based on documents provided to the Committee staff, it is doubtful that either of these products would have been effective as used in the Persian Gulf War.
Pyridostigmine bromide, according to DOD, improves the survival of animals exposed to soman and treated with atropine and 2-PAM. However, pyridostigmine pretreatment makes individuals more vulnerable to other nerve agents, such as VX and sarin. (Note 98) The DOD scientists who studied pyridostigmine and sarin therefore concluded that pyridostigmine should only be used when the chemical warfare threat is soman. (Note 99)
The Pentagon, however, had no reason to believe that the Iraqis were more likely to use soman rather than sarin. According to a report by the Persian Gulf Veterans Coordinating Board, Iraq had several chemical weapons, including sarin. (Note 100) Moreover, at a briefing for Senators and staff on November 10, 1993, Under Secretary of Defense John Deutch stated that the Czechoslovakian military detected low levels of sarin in the Saudi theater during the opening days of the air war against Iraq. This statement was also made by Joseph Corrivean, U.S. Army Foreign Science and Technology Center, on April 27, 1994, at a National Institutes of Health workshop on "The Persian Gulf Experience and Health."
Even if U.S. troops had been exposed to soman, it is unclear that the pyridostigmine would have provided adequate protection against nerve damage. When DOD began the second phase of research on pyridostigmine, it was noted that the atropine and 2-PAM did not seem to save the lives of animals that were exposed to soman. As a result, the dose of atropine was increased to 0.40 mg/kg, which according to FDA, increased the survival of Rhesus monkeys exposed to soman. (Note 101) However, when the Department of Defense developed a treatment regimen for U.S. troops during the Persian Gulf War, it was based on the inadequate dose of atropine in the animal studies (0.096 mg/kg) rather than the higher, effective dose. (Note 102) Therefore, even if Persian Gulf soldiers had been exposed to soman, it is questionable if the pyridostigmine pretreatment would have provided any protection, since the dose of atropine was apparently inadequate.
In response to posthearing questions about this dosage discrepancy from Sen. Rockefeller, the DOD stated "the dose of atropine in the Mark I kit was established based exclusively on safety, rather than on efficacy, considerations." (Note 103) This statement suggests that hundreds of thousands of servicemembers were put at risk by requiring them to take a drug with known risks (pyridostigmine bromide) in a situation where it might have done little good since the atropine dose in the Mark I kits, 6 mg, was inadequate. Based on the monkey data, a dose of 27 mg would have been required for a 150-pound man. (Note 104) However, the side effects of only 2 mg of atropine in a normal young person (without nerve-agent exposure) include increased heart rate, decreased sweating, visual blurring, and others. (Note 105) Apparently, DOD officials decided that the high dosage required for protection would impair performance, so they selected the much lower dosage, even though its effectiveness was questionable. Although results for monkeys may not be exactly comparable to those for humans, it seems unlikely that humans would respond dramatically differently. It is therefore likely that the dose of atropine in the Mark I kits was inadequate for efficacy, and even with this very low dose could have compromised the ability of servicemembers during war. (Note 106)
Botulism vaccine was given too late to U.S. troops to be of any use had the Iraqis actually used biological warfare during Desert Storm. At a briefing on April 20, 1994, DOD officials informed Committee staff that botulism vaccine was not administered to most military personnel in the Persian Gulf until January 23, 1991, which was 7 days after the onset of the air war. Approximately 8,000 individuals received the vaccine, but most received only one or two inoculations. Because the war ended on February 27, 1991, before the third injection was scheduled to be given, it is unlikely that these soldiers were adequately immunized. Moreover, because of the severe shortage of the product, the remainder of those deployed received no inoculations, and hence no protection against botulism.
According to the Department of Veterans Affairs, 696,562 individuals participated in Operation Desert Shield/Desert Storm. Therefore, 99 percent of the military personnel deployed would have received no protection due to the shortage of botulinum toxoid, and the remaining 1 percent were probably not protected because the vaccine distribution started too late.
Additionally, in December 1990, the FDA advised the Department of Defense that it would be unable to test the botulism vaccine for efficacy, presumably because of limited time before the onset of the war. (Note 107) Therefore, in addition to the limited supply of vaccine and late onset of inoculations, efficacy of the existing supply was not determined prior to the onset of the war.
Anthrax vaccine was given to approximately 150,000 military personnel in the Persian Gulf.
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