Military Human Experimentation
Congressional Committee Report 103-97
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 FRANK H. MURKOWSKI, Alaska
GEORGE J. MITCHELL, Maine STROM THURMOND, South Carolina
BOB GRAHAM, Florida ALAN K. SIMPSON, Wyoming
DANIEL K. AKAKA, Hawaii ARLEN SPECTER, Pennsylvania
THOMAS A. DASCHLE, South Dakota JAMES M. JEFFORDS, Vermont
BEN NIGHTHORSE CAMPBELL, Colorado
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
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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
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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...
[The file ends here, with much left out...]
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