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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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