Human Experimentation and other Intentional Exposures conducted by the Department of Defense

For more information - this Page is referenced from The RATS BBS on a report by the Senate Committee on Veterans' Affairs of

Human Experimentation and other Intentional Exposures
conducted by the Department of Defense

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 , 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.

During the last 5O 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.

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.

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."

3 Similarly, hundreds of soldiers were subjected to hallucinogens in experimental programs conducted by the DOD in participation with, or sponsored by, the CIA.

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1 Veterans at Risk: The Health Effects of Mustard Gas and Lewisite, Pechura, C.M. & Rall, D.P. (Eds.) Institute of Medicine, National Academy Press, Washington, DC, 1993, p. 65.

2 In a survey of 150 Persian Gulf War veterans conducted by Committee staff, 15 of 17 military personnel receiving botulinum toxoid in the Gulf War were told they could not refuse the vaccination; 54 of 73 military personnel receiving pyridostigmine were told they could not refuse the drug.

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4,5 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.

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4 Testimony of Deanne Siemer, general counsel, Department of Defense, hearing before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, "Human Drug Testing by the CIA, 1977," September 20-21, 1977, pp. 157-168.

5 Testimony of Sidney Gottlieb, M.D., former CIA agent, hearing before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, "Human Drug Testing by the CIA. 1977," September 20-21, 1977, pp. 169-217.

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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.

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."

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..

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6 The Nuremberg Code, from Trials of War Criminals before the Nuremberg Military Tribunals, U.S. Government Printing Office, Washington, DC, 1948.

7 55 Federal Register 52,814-52,817 (December 21, 1990), "Informed Consent for Human Drugs and Biologics: Determinations that Informed Consent is Not Feasible."

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8 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

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.

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."

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.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.

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8 Declaration of Helsinki, in European and Nordic Regulations and Guidelines for Good Clinical practice, Pharmaco Dynamics Research, Inc., July 1990. The Declaration of Helsinki was amended at the Twenty-Ninth World Medical Assembly held in Tokyo, Japan, in 1975, the Thirty-Fifth World Medical Assembly held in Venice Italy in 1983, and the Forty-First World Medical Assembly held in Hong Kong in 1989.

9 Declaration of Helsinki, World Medical Association, in Biomedical Ethics, Third Edition Mappes T.A. & Zembaty, J.S., McGraw-Hill, Inc., 1991, pp. 211-213.

10 56 Federal Register 28,002-28,032 (June 18, 1991), "Federal Policy for the Protection of Human Subjects."

11 "Research Involving Human Subjects," statement of Robyn Y. Nishimi, Ph.D., Office of Technology Assessment, hearing before the Subcommittee on Energy, Committee on Science Space and Technology, U.S. House of Representatives, "Human Radiation, Experimentation, and Gene Therapy," February 10, 1994.

13 10 U.S.C. (Armed Forces) and 32 U.S.C. 980 (National Guard) put limits on the use of humans as experimental subjects.

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13 According to a report published by the Institute of Medicine (IOM) last year, approximately 60,000 military personnel Were used as human subjects in the 194O's to test two chemical agents, mustard gas and lewisite. Most of these subjects were not informed of the nature of the experiments and never received medical followup after their participation in the research.

14 Additionally, some of these human subjects were threatened with imprisonment at Fort Leavenworth if they discussed these experiments with anyone, including their wives, parents, and family doctors.

15 For decades, the Pentagon denied that the research had taken place, resulting in decades of suffering for many veterans who became ill after the secret testing. According to the 1993 IOM report, such denial by the DOD continues: "This committee discovered that an atmosphere of secrecy still exists to some extent regarding the WWII testing programs. Although many documents pertaining to the WWII testing programs were declassified shortly after the war ended, others were not."

16 Based on findings from the National Academy of Sciences, the Department of Veterans Affairs recently published a final rule to compensate veterans for disabilities or deaths resulting from the long- term effects of inservice exposure to mustard gas and other agents which blister the skin (these are called vesicants).

17 The final rule expands coverage to veterans exposed to mustard gas under battlefield conditions in World War I (WWI), those present at the German air raid on the harbor of Bari, Italy (WWII), and those engaged in manufacturing and handling vesicant agents during their military service. Thus, for the first time, VA will compensate certain veterans for illnesses which may have been caused by their exposure to vesicants over a century ago.

Many experiments that tested various biological agents on human subjects, referred to as Operation Whitecoat, were carried out at Fort Detrick, MD, in the 1950's. The human subjects originally consisted of volunteer enlisted men. However, after the enlisted men staged a sitdown strike to obtain more information about the dangers of the biological tests, Seventh-Day Adventists who were conscientious objectors were recruited for the studies.

18 Because these individuals did not believe in engaging in actual combat, they instead volunteered to be human subjects in military research projects that tested various infectious agents. At least 2,200 military personnel who were Seventh-Day Adventists volunteered for biological testing during the 1950's through the 1970's.

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17 Federal Register 41,497-42,500 (August 18, 1994), "Claims Based on Chronic Effects of Exposure to Vesicant Agents."

18 Gene Wars, Military Control Over the New Genetic Technologies, Piller, C. & Yamamoto, K.R., Beech Tree Books, William Morrow, New York, 1988, pp 44-45, 53.

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19 Unlike most of the studies discussed in this report Operation Whitecoat was truly voluntary. Leaders of the Seventh-Day Adventist Church described these human subjects as "conscientious participants," rather than "conscientious objectors," because they were willing to risk their lives by participating in research rather than by fighting a war.

20,21 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.

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.

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.

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 - was identified when the poisoned sheep were autopsied, which made it clear that the deaths were not caused by pesticides.

25 Eventually, the Department of Defense reimbursed the ranchers for their animals.

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21 At least one Seventh-Day Adventist Church has held reunions of those human subjects who participated in Operation Whitecoat. (Phone interview by Committee staff with Dr. Frank Damazo, Frederick, MD, March 21, 1994.)

22 Hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, "Environmental Dangers of Open-Air Testing of Lethal Chemicals," May 20-21, 1969.

24 Testimony of Dr. D.A. Osguthorpe, veterinarian and consultant to Utah State Department of Agriculture, hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, "Environmental Dangers of Open-Air Testing of Lethal Chemicals," May 20-21, 1969, pp 63-66.

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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.

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.

27 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).

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.

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

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26 Testimony of Hon. Richard D. McCarthy, a Representative in Congress from the State of New York, hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, "Environmental Dangers of Open-Air Testing of Lethal Chemicals," May 20-21, 1969, pp 6-7.

27 Cole, L.A., "Risk and biological defense program," Physicians for Social Responsibility Quarterly, Vol 2, No. 1, March 1992, pp. 40-50.

28 Compilation of Local Fallout Data From Test Detonations 1945-1962, extracted From DASA 1251, Vol I-Oceanic U.S. Tests, Contract No. DNA 001-79-C-0081, May 1, 1979, sponsored by the Defense Nuclear Agency.

30 Secret document, Department of Defense, Research and Development Board, Committee on Medical Sciences, Joint Panel on the Medical Aspects of Atomic Warfare, 8th Meeting, Washington, DC, February 24, 1951.

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30 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.

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.

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.

33 In addition to detonation testing, radioactive releases were also intentionally conducted at U.S. nuclear sites in the years following World War II. According to the U.S. General Accounting Office (GAO), at least l2 planned radioactive releases occurred at three U.S. nuclear sites during 1948-1952. These tests were conducted at Oak Ridge, TN; Dugway, UT; and Los Alamos, NM.

34 Additionally, a planned release occurred at Hanford, WA, in December 1949, which has been referred to as the Green Run test. It is not known how many civilians and military personnel were exposed to fallout from these tests.

In January 1994, the Clinton administration established a Human Radiation Interagency Working Group to coordinate a Government- wide effort to uncover the nature and extent of any Government- sponsored experiments on individuals involving intentional exposure to ionizing radiation. The working group represents the Administration's response to Secretary of Energy Hazel O'Leary's promise to comb Government files for information on hundreds of experiments conducted on people in the 1940's and 1950's.

To assist in identifying those people who may have been harmed by secret experiments utilizing ionizing radiation, the Clinton administration solicited complaints from possible victims by installing several telephone hotlines. As of September 1994, 86 percent of the 21,996 callers to the radiation hotline were veterans who believed they had participated in various radiation "experiments

References: ------------------------------------------------------------------------------------

31 "Health Effects of Exposure to Low Levels of Ionizing Radiation," BEIR V, National Research Council, National Academy Press, Washington, DC, 1990.

32 Letter from Hon. Jesse Brown, Secretary of Veterans Affairs, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans' Affairs, May 31, 1994.

33 News release, Office of Public Affairs, Department of Veterans Affairs, Washington, DC, October 11, 1994.

34 Nuclear Health and Safety, Examples of Post World War II Radiation Releases at U.S. Nuclear Sites," U.S. General Accounting Office, November 1993, GAO/RCED-94- 51FS.

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35 A VA advisory committee has concluded that activities other than atomic weapons tests and occupation force activities resulted in the exposure of veterans to ionizing radiation during their military service prior to 1970.

36 The committee concluded that the records for many individuals who were exposed to such activities are inadequate or inaccessible. Additionally, the committee concluded that information pertinent to military exposures is not always adequate to evaluate the health risks.

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.

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 1950 and 1964, the program consisted of 149 projects involving drug testing and other studies on unwitting human subjects.

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.

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."

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35 Information from the Office of the Assistant Secretary for Congressional Affairs, Department of Veterans Affairs, received at the Senate Committee on Veterans' Affairs, September 21, 1994; in Committee files.

36 Letter from Hon. Jesse Brown, Secretary of Veterans Affairs, to Sen. John D. Rockefeller IV, Chair, U.S. Senate Committee on Veterans' Affairs, May 26, 1994.

38 Statement of David Gries, Director, Center for the Study of Human Intelligence, CIA, hearing before the Subcommittee on Administrative Law and Governmental Relations, Committee on the Judiciary, U.S. House of Representatives, "Government - Sponsored Tests on Humans and Possible Compensation for People Harmed in the Tests," February 2, 1994.

39 Summary of testimony, Lloyd B. Gamble, LSD test subject, hearing before the Subcommittee on Administrative Law and Governmental Relations, Committee on the Judiciary, U.S. House of Representatives, "Government-Sponsored Tests on Humans and Possible Compensation for People Harmed in the Tests," February 2, 1994.

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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.

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.

42 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

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.

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41 Testimony of Sidney Gottlieb, M.D., former CIA agent, before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, "Human Drug Testing by the CIA, 1977," September 20-21, 1977, p. 169. Actual wording is "convert means," which we took to mean "covert means."

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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.

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.

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.

46 Although it is a nerve agent, pyridostigmine has a reversible effect which can protect the AChE form 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.

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 convulsions despite the pyridostigmine pretreatment.

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

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44 Sidell, F.R., "Clinical Considerations in Nerve Agent Intoxication," Chemical Warfare Agents, Somani, S.M. (Ed.), Academic Press, Inc., 1992, pp. 155-194.

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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

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,

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.

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 (l5 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.

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49 Das Gupta, S., Bass, K-N., Warnick, J.E. "Interaction of reversible and irreversible cholinesterase inhibitors on the monosynaptic reflex in neonatal rats," Toxicology and Applied Pharmacology, Vol. 99, 1989, pp. 28-36.

51 Drachman, D.B. "Medical Progress, review article: Myasthenia gravis," New England Journal of Medicine, Vol. 330, No. 25, June 23, 1994, pp. 1797-1810.

52 Scadding, G.K., Havard, C.W.H., Lange, M.J., & Domb, I. "The long term experience of thymectomy for myasthenia gravis," Journal of Neurology, Neurosurgery, and Psychiatry, Vol. 48, 1985, pp. 401-406.

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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.

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 l8.4 mg bromide (30.6 percent).

54,55 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 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

References: ------------------------------------------------------------------------------------

53 Wacks, I., Oster, J.R., Perez, G.O., & Kett, D.H. "Spurious hyperchloremia and hyperbicarbonatemia in a patient receiving pyridostigmine bromide therapy for myasthenia gravis," American Journal of Kidney Diseases, Vol. XVI, No. 1, July 1990, pp. 76-79.

55 Mestinon is the brand name for one form of pyridostigmine bromide available in the United State

End of References:----------------------------------------------------------------------------

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.

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.

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, an 12.1 percent had local reactions to the booster shots.

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.

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 Persian Gulf War. 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.

References: ------------------------------------------------------------------------------------

56 Minutes of meeting of the Informed Consent Waiver Review Group (ICWRG), Food and Drug Administration, December 31, 1990.

57 Ellis, R.J. Immunobiologic agents and drugs available from the Centers for Disease Control: Descriptions, recommendations, adverse reactions, and serologic response. Third Edition. Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA, March 1982.

58 Middlebrook, J.L. "Contributions of the U.S. Army to Botulinum Toxin Research," Botulinum and Tetanus Neurotoxins, Das Gupta, B.R., (Ed.), Plenum Press, New York, 1993, pp. 515-519.

59 Informational material for the use of pentavalent (ABCDE) botulinum toxoid aluminum phosphate adsorbed, Protocol #392, Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, May 1992.

60 Review by Ann Sutton to the IND record, November 14, 1990; in Committee files.

End of references: -----------------------------------------------------------------------------

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.

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.

63 According to the Interagency Task Force on Persian Gulf War Illnesses, one dose provides some immunity in 85 percent of those individuals vaccinated.

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.

References: -----------------------------------------------------------------------------

61 Informational material for the use of anthrax vaccine adsorbed, Michigan Department of Public Health, U.S. License No. 99, 1978.

62 Friedlander, A.M., Welkos, S.L., Pitt, M.L.M., et al. "Postexposure prophylaxis against experimental inhalation anthrax," Journal of Infectious Diseases, Vol. 167, 1993, pp. 1239-1242.

63 Anthrax vaccine adsorbed, package insert, Michigan Department of Public Health, Lansing, MI, 1978.

64 Summary of the issues impacting upon the health of Persian Gulf War veterans," Version 1.1, March 3, 1994.

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