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         MindNet Journal - Vol. 1, No. 71
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         V E R I C O M M / MindNet         "Quid veritas est?"
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    Research: Darrell Bross

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    MILITARY HUMAN EXPERIMENTATION PROTOCOL

    U.S. Government, Committee on Veterans' Affairs

    December 1994

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    Military Human Experimentation Protocol

    103d Congress, 2d Session - COMMITTEE PRINT - S. Prt. 103-97

    IS MILITARY RESEARCH HAZARDOUS TO VETERANS' HEALTH? 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

    DENNIS DeCONCINI, Arizona
    GEORGE J. MITCHELL, Maine
    BOB GRAHAM, Florida
    DANIEL K. AKAKA, Hawaii
    THOMAS A. DASCHLE, South Dakota
    BEN NIGHTHORSE CAMPBELL, Colorado
    FRANK H. MURKOWSKI, Alaska
    STROM THURMOND, South Carolina
    ALAN K. SIMPSON, Wyoming
    ARLEN SPECTER, Pennsylvania
    JAMES M. JEFFORDS, Vermont

    Jim Gottlieb, Chief Counsel/Staff Director
    John H. Moseman, Minority Staff Director/Chief Counsel
    Diana M. Zuckerman, Professional Staff Member
    Patricia Olson, Congressional Science Fellow

    FOREWORD

    U.S. Senate, 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

    CONTENTS

    I. Introduction

    II. Background

    *  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 followup 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

    IV. Recommendations

    *  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 followup 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

    I. INTRODUCTION

    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.

    II. BACKGROUND

    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 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. (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)

    B. MUSTARD GAS AND LEWISITE

    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 1940'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. (Note
    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. (Note 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." (Note 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). (Note
    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 half a century
    ago.

    C. SEVENTH-DAY ADVENTISTS

    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. (Note 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. (Note 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. (Note 20), (Note 21)

    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

    ATOMIC VETERANS

    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." (Note 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. (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)

    RADIATION RELEASES AT U.S. NUCLEAR SITES

    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 12 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. (Note
    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.

    OTHER EXPOSURES TO IONIZING RADIATION

    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." (Note 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. (Note 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.

    F. HALLUCINOGENS

    Working with the CIA, the Department of Defense gave
    hallucinogenic drugs to thousands of "volunteer" soldiers in the
    1950's and 1960's...

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