* 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
* F. When U.S. troops were sent to the
Persian Gulf in 1994, DOD still did not have proof that
pyridostigmine bromide was safe for use as an antidote enhancer
* G. Pyridostigmine may be more dangerous in
combination with pesticides and other exposures
* H. The safety of the botulism vaccine was
not established prior to the Persian Gulf War
* I. Records of anthrax vaccinations are not
suitable to evaluate safety
* J. Army regulations exempt informed
consent for volunteers in some types of military research
* K. DOD and DVA have repeatedly failed to
provide information and medical follow-up to those who
participate in military research or are ordered to take
* 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
* A. Congress should deny the DOD request for
a blanket waiver to use investigational drugs in case of war or
threat of war
* B. FDA should reject any applications from
DOD that do not include data on women, and long-term follow-up
* C. Congress should authorize a centralized
database for all federally funded experiments that utilize human
* D. Congress should mandate all Federal
agencies to declassify most documents on research involving
* 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
IS MILITARY RESEARCH HAZARDOUS TO VETERANS' HEALTH? LESSONS
SPANNING HALF A CENTURY
During the last 50 years, hundreds of thousands of military
personnel have been involved in human experimentation and other
intentional exposures conducted by the Department of Defense
(DOD), often without a servicemember's knowledge or consent. In
some cases, soldiers who consented to serve as human subjects
found themselves participating in experiments quite different
from those described at the time they volunteered. For example,
thousands of World War II veterans who originally volunteered to
"test summer clothing" in exchange for extra leave time, found
themselves in gas chambers testing the effects of mustard gas
and lewisite. (Note 1) Additionally, soldiers were sometimes
ordered by commanding officers to "volunteer" to participate in
research or face dire consequences. For example, several Persian
Gulf War veterans interviewed by Committee staff reported that
they were ordered to take experimental vaccines during Operation
Desert Shield or face prison. (Note 2)
The goals of many of the military experiments and exposures were
very appropriate. For example, some experiments were intended to
provide important information about how to protect U.S. troops
from nuclear, biological, and chemical weapons or other
dangerous substances during wartime. In the Persian Gulf War,
U.S. troops were intentionally exposed to an investigational
vaccine that was intended to protect them against biological
warfare, and they were given pyridostigmine bromide pills in an
experimental protocol intended to protect them against chemical
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
Every year, thousands of experiments utilizing human subjects
are still being conducted by, or on behalf of, the DOD. Many of
these ongoing experiments have very appropriate goals, such as
obtaining information for preventing, diagnosing, and treating
various diseases and disabilities acquired during military
service. Although military personnel are the logical choice as
human subjects for such research, it is questionable whether the
military hierarchy allows for individuals in subordinate
positions of power to refuse to participate in military
experiments. It is also questionable whether those who
participated as human subjects in military research were given
adequate information to fully understand the potential benefits
and risks of the experiments. Moreover, the evidence suggests
that they have not been adequately monitored for adverse health
effects after the experimental protocols end.
Veterans who become ill or disabled due to military service are
eligible to receive priority access to medical care at VA
medical facilities and to receive monthly compensation checks.
In order to qualify, they must demonstrate that their illness or
disability was associated with their military service. Veterans
who did not know that they were exposed to dangerous substances
while they were in the military, therefore, would not apply for
or receive the medical care or compensation that they are
entitled to. Moreover, even if they know about the exposure, it
would be difficult or impossible to prove if the military has
not kept adequate records. It is therefore crucial that the VA
learn as much as possible about the potential exposures, and
that the DOD assume responsibility for providing such
information to veterans and to the VA.
A. CODES, DECLARATIONS, AND LAWS GOVERNING HUMAN EXPERIMENTATION
The Nuremberg Code is a 10-point declaration governing human
experimentation, developed by the Allies after World War II in
response to inhumane experiments conducted by Nazi scientists
and physicians. The Code states that voluntary and informed
consent is absolutely essential from all human subjects who
participate in research, whether during war or peace. The Code
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.
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 follow-up 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
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.
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
It is unknown how many people in the surrounding vicinity were
also exposed to potentially harmful agents used in open-air
tests at Dugway. In 1969, concerns were expressed at a
congressional hearing about the possible public health
implications of the VEE virus tested at Dugway. (Note 26)
Due to previous problems with dangerous organisms and chemicals,
Dugway has developed an active program of "simulant" testing.
According to the Department of Defense, simulants are harmless
organisms or chemicals which do not cause disease. However,
during 45 years of open-air testing, the Army has stopped using
a variety simulants when they realized they were not as safe as
previously believed. (Note 27)
E. RADIATION EXPOSURE
From 1945 to 1962, the United States conducted numerous nuclear
detonation tests: Crossroads (Bikini); Sandstone, Greenhouse,
and Ivy (Eniwetok Atoll); Castle (Bikini Atoll); Pacific Ocean
400 miles southwest of San Diego; Redwing and Hardtack I
(Eniwetok and Bikini Atolls); Argus (South Atlantic); and
Dominic (Christmas Island, Johnston Island, 400 miles west of
San Diego). (Note 28) The main goal was to determine damage
caused by the bombs; however, as a result, thousands of military
personnel and civilians were exposed to radioactive fallout.
Similar tests were conducted within the continental United
States, including sites in New Mexico and Nevada. (Note 29)
Veterans who participated in activities that directly exposed
them to radioactive fallout are referred to as "atomic
Data obtained on some military personnel who were exposed to
radioactive fallout were collected after these men were
unintentionally exposed. However, some atomic veterans believe
they were used as guinea pigs to determine the effects of
radiation from various distances, including those at ground
zero, on human subjects. Their suspicions are supported by a
1951 document from the Joint Panel on the Medical Aspects of
Atomic Warfare, Research and Development Board, Department of
Defense, which identified general criteria for bomb test-related
"experiments" and identified 29 "specific problems" as
"legitimate basis for biomedical participation."
The National Research Council's Committee on the Biological
Effects of Ionizing Radiation (BEIR) have prepared a series of
reports to advise the U.S. Government on the health consequences
of radiation exposure. (Note 31) The first of these reports was
not published until the late 1980's, decades after military
personnel were first exposed to ionizing radiation. For the last
13 years, the VA has provided free medical care to atomic
veterans who have disorders they believe to be caused by
ionizing radiation, even if there is no conclusive evidence of
the cause. (Note 32) In addition, the VA provides monthly
compensation to veterans who were exposed to ionizing radiation
during military service, who have illnesses that are believed to
be associated with their exposure. The lists of compensable
diseases have been revised as more research information has
become available. For example, on October 11, 1994, the VA
announced that tumors of the brain and central nervous system
would be considered for disability compensation for veterans
exposed to ionizing radiation. (Note 33)
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
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.
Working with the CIA, the Department of Defense gave
hallucinogenic drugs to thousands of "volunteer" soldiers in the
1950's and 1960's. In addition to LSD, the Army also tested
quinuclidinyl benzilate, a hallucinogen code-named BZ. (Note 37)
Many of these tests were conducted under the so-called MKULTRA
program, established to counter perceived Soviet and Chinese
advances in brainwashing techniques. Between 1953 and 1964, the
program consisted of 149 projects involving drug testing and
other studies on unwitting human subjects. (Note 38)
One test subject was Lloyd B. Gamble, who enlisted in the U.S.
Air Force in 1950. In 1957, he volunteered for a special program
to test new military protective clothing. He was offered various
incentives to participate in the program, including a liberal
leave policy, family visitations, and superior living and
recreational facilities. However, the greatest incentive to Mr.
Gamble was the official recognition he would receive as a
career-oriented noncommissioned officer, through letters of
commendation and certification of participation in the program.
During the 3 weeks of testing new clothing, he was given two or
three water-size glasses of a liquid containing LSD to drink.
Thereafter, Mr. Gamble developed erratic behavior and even
attempted suicide. He did not learn that he had received LSD as
a human subject until 18 years later, as a result of
congressional hearings in 1975. (Note 39) Even then, the
Department of the Army initially denied that he had participated
in the experiments, although an official DOD publicity
photograph showed him as one of the valiant servicemen
volunteering for "a program that was in the highest national
security interest." (Note 40)
According to Sidney Gottlieb, a medical doctor and former CIA
agent, MKULTRA was established to investigate whether and how an
individual's behavior could be modified by covert means. (Note
41) According to Dr. Gottlieb, the CIA believed that both the
Soviet Union and Communist China might be using techniques of
altering human behavior which were not understood by the United
States. Dr. Gottlieb testified that "it was felt to be mandatory
and of the utmost urgency for our intelligence organization to
establish what was possible in this field on a high priority
basis." Although many human subjects were not informed or
protected, Dr. Gottlieb defended those actions by stating,
"...harsh as it may seem in retrospect, it was felt that in an
issue where national survival might be concerned, such a
procedure and such a risk was a reasonable one to take." (Note
G. INVESTIGATIONAL DRUGS USED IN THE PERSIAN GULF WAR
Under the Food, Drug, and Cosmetics Act, all vaccines and
medical products must be proven safe and effective by the Food
and Drug Administration (FDA) in order to be sold and
distributed in the United States. This law also applies to
medical products used by the Department of Defense, even if
given to U.S. troops who are stationed in other countries.
FDA also regulates medical products that are proven safe and
effective for some uses or with specific doses, but not for
other uses or other doses. If the product is only sold at
certain doses and not others, its use at the non-approved dose
would be considered investigational. If the product is legally
available for sale at the same dosage, physicians can legally
prescribe it; however, manufacturers can not advertise it for
that purpose. Such "off label" use is also considered
investigational. So, for example, a drug may be proven safe and
effective to treat one kind of cancer, but be considered
investigational to treat a different disease.
Under current law, an unapproved vaccine or investigational use
of a drug could only be administered by the DOD under an
Investigational New Drug (IND) procedure. (Note 43) Under an IND,
any individual who is given the investigational product must
give informed consent, i.e., must be told of the potential risks
and benefits of the product, orally and in writing, and choose
freely whether or not to participate. In addition, the IND
requires that the medical product be distributed under carefully
controlled conditions where safety and effectiveness can be
When the Department of Defense began preparations for Desert
Shield and Desert Storm in 1990, officials were extremely
concerned that Iraq would use chemical and biological weapons
against the United States. Despite years of study and billions
of dollars, the DOD lacked drugs and vaccines that were proven
safe and effective to safeguard against anticipated chemical
nerve agents and biological toxins. Therefore, DOD officials
wanted to use a medication (pyridostigmine bromide) and vaccine
(botulinum toxoid) that they believed might protect against
chemical nerve agents and botulism. Because the safety and
effectiveness of pyridostigmine bromide and botulinum toxoid had
not been proven for their intended use, these products were
considered investigational drugs.
Pyridostigmine bromide is a chemical which enhances the
effectiveness of two drugs, atropine and 2-PAM, which are proven
effective for the treatment of nerve agent poisoning. (Note 44)
Pyridostigmine is also a nerve agent itself. Nerve agents exert
their biological effects by binding to, and inhibiting, the
enzyme acetylcholinesterase (AChE) which normally shuts off the
neurotransmitter, acetylcholine (ACh). When levels of ACh
increase, nerve impulses and organ activity increase. When nerve
and organ stimulation are excessive, death can result.
There are two major categories of nerve agents, carbamates and
organophosphate (OP) compounds. (Note 45) German scientists
developed many of the OP compounds for warfare agents and
pesticides in the 1930's and 1940's. Examples of warfare agents
include tabun, sarin, soman, and VX. Many organophosphates
permanently inhibit AChE. This permanent effect, which can only
be reversed when new enzymes are synthesized, makes OP warfare
agents extremely lethal.
Pyridostigmine bromide is a carbamate, rather than an OP
compound. (Note 46) Although it is a nerve agent, pyridostigmine
has a reversible effect which can protect the AChE from
permanently binding to OP compounds. When appropriate doses are
selected, pyridostigmine theoretically should not cause nerve
agent poisoning and should help protect against some lethal
Efficacy. Pyridostigmine only works when taken in combination
with other drugs and only if taken before exposure to nerve gas.
(Note 47) Two antidotes to nerve agents, atropine and
pyridine-2-aldoxime methochloride (2-PAM), are reportedly
enhanced if pyridostigmine has already been given. Atropine and
2-PAM were included in the nerve agent antidote kits (Mark I)
which were issued to U.S. troops in the Persian Gulf.
In research studies, animals given pyridostigmine, atropine, and
2-PAM were more likely to survive exposure to one chemical nerve
agent, soman, than those given only atropine and 2-PAM. However,
pyridostigmine is unable to enter and protect the brain, so that
animals exposed to soman can still suffer from convulsions
despite the pyridostigmine pretreatment. (Note 48) To protect
against brain damage from ongoing seizure activity, valium may
also be required following exposure to a warfare nerve agent.
Similarly, pyridostigmine may offer little protection against
the damage caused by nerve agents in the spinal cord. (Note 49)
Safety. Pyridostigmine bromide is approved by the FDA for
treating myasthenia gravis, a neurological disease characterized
by extreme weakness. This disease occurs when individuals
develop antibodies that prevent ACh from causing muscle impulses
at the neuromuscular junction. Therefore, treatment with
relative high doses of pyridostigmine increases ACh to levels
that are able to overcome the "block" created by the antibodies.
An analogy might be that of a fishing pond. The two ways to
increase the number of fish caught are to increase the number of
fishing poles or to increase the number of fish in the pond.
FDA and DOD officials claimed they were confident of the safety
of pyridostigmine as an antidote enhancer for chemical warfare
protection because it would be used at a much lower dose (Note
50) in combat than normally used for treating patients with
myasthenia gravis. However, normal patients and those with
myasthenia gravis may not respond similarly to the same dose of
pyridostigmine bromide. Whereas the dosage of pyridostigmine
bromide for patients with myasthenia gravis may reach 120 mg
every three hours, (Note 51) the dose for U.S. troops was only
30 mg every 8 hours. A good analogy is the use of insulin for
diabetes mellitus; very high doses of insulin are sometimes
necessary to treat diabetics, but similar doses could be fatal
for non-diabetic individuals.
Some scientists also question whether pyridostigmine is
completely safe even for treating patients with myasthenia
gravis. The proportion of patients with myasthenia gravis that
recover after surgical treatment (thymectomy) has decreased
since pyridostigmine therapy was introduced several decades ago.
(Note 52) Experts speculate that whereas the problems caused by
myasthenia gravis can be corrected by surgery, pyridostigmine
may cause immune damage to the neuromuscular junction that
cannot be corrected by surgery. Since the symptoms of
pyridostigmine damage would be similar to the symptoms of
myasthenia gravis, any damage from the pyridostigmine would be
extremely difficult if not impossible to diagnose.
In addition to its use for myasthenia gravis, pyridostigmine
bromide has been approved by FDA for use with surgical patients;
it is administered after surgery to reverse the effect of
anesthesia, which are neuromuscular blocking agents. The dose is
relatively small (15 mg) and not repeated. This treatment does
not provide relevant information about the safety of repeated
use of pyridostigmine by healthy individuals, since the dosage
is small and the patients have received neuromuscular blocking
The bromide that is included in pyridostigmine bromide pills is
known to sometimes cause problems referred to as "bromide
intoxication" when used for the treatment of myasthenia gravis.
(Note 53) Bromide intoxication may cause confusion,
irritability, tremor, memory loss, psychotic behavior, ataxia,
stupor, and coma. Some patients with bromide intoxication have a
skin disorder of the face and hands resembling acne. A 60 mg
tablet of the commercially available pyridostigmine bromide
contains 18.4 mg bromide (30.6 percent). (Note 54), (Note 55)
FDA has not approved pyridostigmine bromide for repeated use in
healthy individuals as an antidote enhancer or for any other
reason. Since it would be unethical to expose individuals to
potentially lethal chemical weapons in order to evaluate the
efficacy of pyridostigmine, this use has only been studied on
animals. The product is therefore an investigational drug when
used as an antidote enhancer for treating nerve gas poisoning.
Botulinum toxoid is an unapproved vaccine that is used to
protect laboratory workers and others who are likely to be
exposed to botulism. Botulism is caused by at least one of seven
neurotoxins produced by the bacteria Clostridium botulinum. When
home-canning of food was common, food poisoning was the most
common cause of botulism in the United States; the bacteria in
the food produces a toxin which is eaten. Today, the most common
form of botulism occurs in infants, since the bacteria that
produces the toxin can thrive in a baby's intestinal tract.
A botulism vaccine that is intended to protect against five of
seven neurotoxins (called A,B,C,D,E) is produced by the Michigan
Department of Health. This is called pentavalent toxoid. This
vaccine is not a licensed product and must be distributed as an
Investigational New Drug (IND).
Efficacy. Desert Shield began on August 8, 1990. Since the air
war did not begin until January 16, 1991, and the ground war
took place from February 24-27, 1991, the Pentagon had several
months to review the possible use of investigational drugs and
vaccines. In December 1990, the FDA advised the Department of
Defense that it would be unable to test the botulism vaccine for
efficacy, presumably because of limited time before the onset of
the war. The FDA agreed to test the vaccine for safety, but
these tests were not completed until late January 1991. At a
meeting of the Informed Consent Waiver Review Group (ICWRG) on
December 31, 1990, a representative of FDA's Center for
Biologics Evaluation and Research discussed the vaccine,
explaining that the existing supply was nearly 20 years old and
consisted of three lots, stored under continuous refrigeration.
(Note 56) Given the age of these vaccines, there were concerns
about their safety.
The recommended schedule for immunization with the pentavalent
vaccine includes a series of three initial injections at 0, 2,
and 12 weeks, followed by a booster 12 months after the first
injection. According to the Centers for Disease Control's Center
for Infectious Diseases, subjects given the vaccine did not have
detectable antitoxin titers after the first two shots in the
initial series, which means that they were unlikely to be
protected at week 2. (Note 57) If for any reason only two
immunizations can be given, at least 4 to 8 weeks should elapse
between injections if most individuals are to be protected
against the disease. (Note 58)
Safety. The Michigan Department of Health reported that 4.2
percent of patients reported a sore arm or other local reactions
to the initial series of three shots, and 12.1 percent had local
reactions to the booster shots. (Note 59) Almost 3 percent had
systemic reactions, such as general malaise, after either the
initial three shots or the booster shots. Because of the
relatively large percentage of adverse reactions, new lots of
the vaccine were manufactured in 1971. However, there is no
evidence that the newer lots produced fewer adverse reactions
than the older lots.
In her review of the DOD's application for use of botulinum
toxoid in the Persian Gulf, an FDA reviewer pointed out that in
1973, the Centers for Disease Control had considered terminating
the distribution of the vaccine because of the relatively large
number of individuals who had negative reactions to it. (Note
60) The FDA reviewer also pointed out that "there are no
efficacy data in humans" and that the dose for humans was an
estimate based on results from guinea pigs. In addition, potency
testing had suggested that the vaccine would not be effective
against two of the five botulism toxins.
According to the Michigan Department of Health, the effects of
the botulism vaccine on pregnant women had not been studied
prior to its use in the Persian Gulf War.
Anthrax vaccine is an FDA-approved vaccine that is considered
safe and effective for individuals whose skin may come in
contact with animal products such as hides, hair, or bones
likely to contain the anthrax infection. It is also recommended
for veterinarians and others who are likely to touch infected
animals. (Note 61) However, the vaccine's effectiveness against
inhaled anthrax is unknown. Unfortunately, when anthrax is used
as a biological weapon, it is likely to be aerosolized and thus
inhaled. Therefore, the efficacy of the vaccine against
biological warfare is unknown.
It appears that there is only one relevant animal study which
showed that anthrax vaccine apparently provided additional
protection against relapse in monkeys exposed to inhalation
anthrax and treated with antibiotics. (Note 62) Although the
results of this study suggest the vaccine might protect against
anthrax that has been sprayed, it is not sufficient to prove
that anthrax vaccine is safe and effective as used in the
Persian Gulf. The vaccine should therefore be considered
investigational when used as a protection against biological
The anthrax vaccine is given as three injections 2 weeks apart,
followed by three additional injections given 6, 12, and 18
months after the initial injection. If immunity is to be
maintained, subsequent booster injections of anthrax vaccine are
recommended at 1-year intervals. (Note 63) According to the
Interagency Task Force on Persian Gulf War Illnesses, one dose
provides some immunity in 85 percent of those individuals
vaccinated. (Note 64)
According to the Michigan Department of Public Health which
manufactures anthrax vaccine, it is not known whether anthrax
vaccine is safe for pregnant women or their offspring.
III. FINDINGS AND CONCLUSIONS
A. FOR AT LEAST 50 YEARS, DOD HAS KNOWINGLY EXPOSED MILITARY
PERSONNEL TO POTENTIALLY DANGEROUS SUBSTANCES, OFTEN IN SECRET.
The U.S. General Accounting Office issued a report on September
28, 1994, which stated that between 1940 and 1974, DOD and other
national security agencies studied hundreds of thousands of
human subjects in tests and experiments involving hazardous
substances. (Note 65) GAO stated that some tests and experiments
were conducted in secret. Medical research involving the testing
of nerve agents, nerve agent antidotes, psychochemicals, and
irritants was often classified. Additionally, some work
conducted for DOD by contractors still remains classified today.
For example, the Central Intelligence Agency (CIA) has not
released the names of 15 of the approximately 80 organizations
that conducted experiments under the MKULTRA program, which gave
psychochemical drugs to an undetermined number of people without
their knowledge or consent. According to the GAO report, the CIA
has not released this information because the organizations do
not want to be identified. (Note 66)
WORLD WAR II VETERANS
As recently as 1993, the Institute of Medicine of the National
Academy of Sciences reported that an atmosphere of secrecy still
existed regarding World War II testing of mustard gas and
lewisite. (Note 67) Although many documents pertaining to the
World War II testing programs were declassified shortly after
World War II ended, others remain "restricted" even today. In
addition to the classified or restricted documents, World War II
veterans who participated in the research were sworn to secrecy.
These classified documents and promises of secrecy have impeded
medical care for thousands of veterans during half of the last
For example, Rudolph R. Mills participated in gas chamber
experiments as an 18-year-old in 1945, one year after he joined
the U.S. Navy. (Note 68) He was sworn to secrecy and did not
learn until 46 years later that approximately 4,000 servicemen
were human subjects in mustard gas experiments conducted from
1942 through 1945 by the Chemical Warfare Service. Although his
health began to deteriorate even before his discharge from the
Navy in 1946, he did not learn that mustard gas might be
responsible for his physical problems until more than 40 years
At a May 6, 1994, hearing of the Senate Committee on Veterans'
Affairs, entitled "Is Military Research Hazardous to Veterans'
Health? Lessons from World War II, the Persian Gulf War, and
Today," Mr. Mills testified, "I had on an experimental mask and
the Navy was trying to determine if people wearing these masks
could communicate with each other. I was enticed to sing over
the intercom....No one ever told me that the mask became less
effective against the gas with each use....We were sworn to
secrecy....At the age of 43 I underwent a long series of
radiation treatments and later surgery to remove part of my
voice box and larynx....It didn't occur to me that my exposure
to mustard gas was responsible for my physical problems until
June 1991, when I read an article in my hometown newspaper."
John T. Harrison participated in Navy chemical tests in 1943 to
get an extra week pass. He was also sworn to secrecy. According
to written testimony submitted to the Senate Committee on
Veterans' Affairs by Mr. Harrison, "[I] was never warned or told
anything about the dangers of what [I] volunteered for....told
never to reveal what [I] did or where [I] was; if anyone asked
[I] was to say [I] was on rowing maneuvers." (Note 70) At the
time of his discharge from the military, he could not even
describe his exposures to a Navy doctor who was trying to
determine the cause of his severe respiratory illnesses.
Although Mr. Harrison has suffered from recurrent breathing
problems and has greatly diminished pulmonary function, he has
never received any compensation for his illness. According to
the VA and DOD, his medical and services records have been lost,
making it difficult to prove that his disability is
COLD WAR VETERANS
During the years immediately following World War II, military
personnel were intentionally exposed to radiation during the
testing of atomic bombs and during radioactive releases. While
it is unclear how many of these servicemembers were
intentionally exposed to what were known to be harmful levels of
radiation, there is clear evidence that in some cases military
personnel were ordered to locate themselves in areas of high
radioactive fallout. They were given no choice in the matter,
and they were not told of the potential risks of those
Similarly, military personnel were intentionally given
hallucinogenic drugs to determine the effects of those drugs on
humans. The servicemembers were not told that they would be
given experimental drugs, they had no choice of whether or not
to take them, and even after the unusual effects of the drugs
were obvious to researchers, the unwitting human subjects were
given no information about the known effects of the drugs. Even
if the DOD did not know about the potential long-term effects of
the drugs, that would not justify their failure to provide
information to thousands of servicemembers about the known
short-term effects of the drugs.
PERSIAN GULF WAR VETERANS
Persian Gulf veterans were also given investigational vaccines
and ordered not to tell anyone. In a Committee survey of 150
individuals who served in the military during the Persian Gulf
War (see Appendix), many of those surveyed indicated they were
ordered, under threat of Article 15 or court martial, to discuss
their vaccinations with no one, not even with medical
professionals needing the information to treat adverse reactions
from the vaccine. Similarly, 86 percent of the military
personnel who told the Committee that they were ordered to take
pyridostigmine bromide reported that they received no
information on what they were taking or the drug's potential
risks. According to a DOD study published in the Journal of the
American Medical Association, commanding officers and medical
personnel were also inadequately informed about the
investigational drugs; as a result, they were ill-prepared to
recognize or treat military personnel who experienced side
effects. (Note 71)
B. DOD HAS REPEATEDLY FAILED TO COMPLY WITH REQUIRED ETHICAL
STANDARDS WHEN USING HUMAN SUBJECTS IN MILITARY RESEARCH DURING
WAR OR THREAT OF WAR.
The major principle of all research ethics involving human
subjects, as described by the Nuremberg Code, the Declaration of
Helsinki, and the "Common Rule" of the U.S. Government, states
that the voluntary, competent, informed, and understanding
consent of the subject is absolutely essential, whether during
war or peace. (Note 72)
These standards are more than 50 years old. For example, the
Nuremberg Code was based on testimony of two U.S. physicians,
Drs. Leo Alexander and Andrew Ivy, who served as expert medical
witnesses for the Nazi crime prosecutors. The code was not the
outcome of an attempt to frame a new code of ethics, but rather
a description of criteria said to be widely accepted by the
medical profession at the time. (Note 73) Therefore, DOD
research during the 1940's was clearly conducted in an era when
researchers were well aware of ethical codes regarding the use
of human subjects.
The Department of Defense has violated these well-established
ethical principles each time soldiers are required to
participate in military research or take investigational drugs
or vaccines or are not adequately informed about the risks of
WORLD WAR II VETERANS
Many individuals were recruited for various military experiments
of mustard gas and lewisite under the guise of testing clothing,
without being warned beforehand that they would be exposed to
dangerous chemicals. Additionally, young servicemembers
frequently reported that they were enticed to volunteer for
experiments by being promised extra leave time from duty.
For example, in 1944, Nathan Schnurman was a 17-year-old sailor
who was recruited to test Navy summer clothing, in exchange for
a 3-day pass. Instead, he participated in the testing of gas
masks and clothing while he was locked in a gas chamber and
exposed to mustard gas and lewisite. Mr. Schnurman believes that
he was not really a volunteer since the research was
misrepresented. Additionally, Mr. Schnurman stated in written
testimony submitted to the Committee that "many were denied the
3-day pass, and many went to their graves without revealing this
story." (Note 74) Perhaps most outrageous, Mr. Schnurman was not
allowed to leave the gas chamber when he became violently ill.
Mr. Schnurman testified before the Committee on the Judiciary of
the U.S. House of Representatives that, "During my sixth
exposure in the chamber, I determined something was wrong. I
called to the corpsman, via an intercom, and informed him of my
condition, and what was happening and requested I be released
from the chamber, now. The reply, was `No' as they had not
completed the experiment. I became very nauseous. Again, I
requested to be released from the chamber. Again, permission was
denied. Within seconds after the denial, I passed out in the
chamber. What happened after that, I don't know. I may only
assume, when I was removed from the chamber, it was presumed I
was already dead." (Note 75)
John William Allen enlisted in the U.S. Navy in 1945 at the age
of 17. Immediately after boot camp, he volunteered to test
summer uniforms so he could go home before shipping out. His
test clothing consisted of one pair of pants, undershorts, a gas
mask, and a shirt that had been used in previous experiments and
was therefore impregnated with toxic chemicals. According to Mr.
Allen, the actual testing consisted of determining the amount of
sulfur mustard that would cause illness ("man-break" test), not
the testing of summer uniforms. He was exposed several times to
sulfur mustard and was removed from further exposure on May 5,
1945, when he passed out in the gas chamber. A physical
examination on May 14, 1945, revealed many wounds as the result
of exposure to mustard gas.
Mr. Allen stated in written testimony submitted to the
Committee, "The government has lied to us for 50 years over and
over again. If I would have been shot on the front lines at
least I would had it on my record and would have received
medical treatment." (Note 76)
PERSIAN GULF WAR VETERANS
Almost 50 years after World War II veterans were exposed to
unethical research, the Department of Defense again failed to
comply with the well- established ethical requirement that all
soldiers and civilians make an informed choice of whether or not
to use investigational medical treatment.
* 1. Military personnel were not given the opportunity to refuse
When the Department of Defense began preparations for Desert
Shield and Desert Storm in 1990, officials were extremely
concerned about the need to protect U.S. troops against chemical
and biological weapons that were believed to have been developed
by Iraq. However, the DOD lacked drugs and vaccines that were
proven safe and effective to safeguard against expected weapons,
such as soman and botulism.
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, or used by U.S. troops.
However, DOD officials were interested in using a botulinum
toxoid, which is a vaccine to prevent botulism, that was not
approved by FDA. They also wanted to use pyridostigmine bromide,
a medication to protect U.S. troops against chemical nerve
agents. Although approved by the FDA for treating patients with
a neurological disorder called myasthenia gravis, pyridostigmine
is not proven safe or effective for repeated use by healthy
persons under any circumstances, and is normally unavailable in
doses that would be likely to be safe for healthy individuals.
Under current law, the unapproved vaccine and the
investigational use of pyridostigmine for healthy individuals
could only be administered under an Investigational New Drug
(IND) procedure. (Note 78) 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.
In August 1990, the DOD contacted FDA to review regulatory
restrictions of DOD's plan to use pyridostigmine and botulinum
toxoid for U.S. troops in the Persian Gulf. The major focus of
the meeting was informed consent. The DOD sought a waiver of
requirements for informed consent for the use of pyridostigmine
bromide and botulinum toxoid, arguing that these investigational
products had well-established uses and were safe. They also
claimed that there were no reasonable alternatives. According to
minutes of the meeting, "FDA expressed some concern about
liability and the need to comply with the regulations," and
FDA's Deputy Director for Drug Review "pointed out the need to
establish an appropriate investigational framework to collect
observational data and evaluate the military medical products in
question." (Note 79)
In summary, DOD informed FDA that they did not want to abide by
informed consent regulations, and FDA officials pointed out that
pyridostigmine and botulinum toxoid were investigational and
that there are laws regulating how they can be used. DOD claimed
that "under the DOD directive the Secretary of Military
Departments [could] dictate the use of unapproved FDA regulated
products" in the Persian Gulf, but "DOD's current position is
that this not their primary choice at this time." (Note 80)
The issue was debated by the two agencies for several months.
Finally, at a meeting on December 31, 1990, an agreement was
reached. According to minutes of that meeting, DOD officials
agreed that the botulism vaccine would be administered by
trained individuals with a health care background, and that
information would be provided orally "at minimum, and in written
form if feasible, to all personnel receiving the vaccine." (Note
81) Officials from the DOD said that the feasibility of
distributing an information sheet would depend on many factors,
and would vary from location to location within the military
theater of operation. DOD officials "reiterated that at least
verbal [sic] information would be provided to each person
receiving the vaccine."
The FDA Informed Consent Waiver Review Group recommended that
pregnant women be excluded from receiving the vaccine and that
information about the vaccine be "posted at places where vaccine
is administered." However, DOD argued that pregnant women would
be at greater risk from exposure to botulism toxins than to the
vaccine, and FDA agreed that instead of excluding pregnant
women, a statement would be added to the information sheet
stating that, "If you are pregnant, it is not known if this
vaccine will hurt the unborn baby, however, most vaccines do
not." (Note 82)
In their application for a waiver, DOD described the safeguards
that would be in place regarding the distribution of the
botulism vaccine. In addition to oral warnings regarding the
vaccine, DOD promised that the soldiers would be observed for 30
minutes after receiving the vaccine, and if possible, they would
also be checked again 48 hours later. In addition, DOD claimed
that they would provide all three vaccine injections and stated
that all three were necessary to provide protection.
FDA granted the waiver on a temporary basis, concurring that
obtaining informed consent during wartime is not feasible in a
specific military operation involving combat or the threat of
combat. (Note 83) On January 8, 1991, Dr. David Kessler, FDA
Commissioner, wrote to the Assistant Secretary of Defense for
Health Affairs regarding the waiver for informed consent for
pyridostigmine. In his letter, Dr. Kessler agreed that since
there was "no available satisfactory alternative therapy" for
protection against organophosphorus nerve gas, he would "concur
with your assessment that informed consent is not feasible."
This agreement was apparently based on DOD officials' promise to
"provide and disseminate additional information to all military
personnel concerning the risks and benefits of pyridostigmine."
Although FDA agreed to waive informed consent for both the
pyridostigmine bromide and the botulism vaccine, the Assistant
Secretary of Defense for Health Affairs notified Dr. Kessler on
March 15, 1992, that "Central Command" had decided that the
vaccine would be administered on a voluntary basis. (Note 85)
However, based on interviews with 150 Persian Gulf War veterans
by Committee staff (Appendix), 88 percent of those who said they
received a botulism vaccine were told they had no choice.
According to the DOD, all 696,562 U.S. troops in the Persian
Gulf War were issued pyridostigmine bromide as a pretreatment
for nerve agent poisoning, and officials estimate that
approximately two-thirds took the drug for varying periods of
time. Of 150 who were interviewed by Committee staff, 73 took
pyridostigmine and 74 percent of them were told they could not
refuse to take it. Approximately 8,000 individuals received
botulinum toxoid in the Persian Gulf. Given the high proportion
who have reported that they had no choice, it appears that
hundreds of thousands of U.S. troops were ordered to take an
investigational drug or vaccine without having the opportunity
* 2. Military personnel were not informed about the risks of the
Although DOD officials convinced FDA they need not offer choice,
DOD had promised to provide extensive information about
potential risks orally and in writing. In addition to being
ordered to take an investigational product without informed
consent, most Persian Gulf War military personnel surveyed claim
they received no oral or written information about the drug or
vaccine, despite the DOD promises to FDA to provide information
about potential risks. These claims are supported by a survey
conducted by the Department of Defense following the Persian
Gulf War. Sixteen of 23 selected Persian Gulf War medical
personnel surveyed by the DOD indicated that no information on
the side effects of pyridostigmine bromide was provided to those
who were ordered to take the drug. (Note 86) These medical
personnel were responsible for 8,366 military personnel during
the Persian Gulf War.
There are two kinds of risks associated with lack of
information. One is a lack of trust. In the survey conducted by
Committee staff, 14 of 73 (19 percent) Persian Gulf War veterans
who had been ordered to take pyridostigmine bromide indicated
that they did not take all the pyridostigmine bromide they were
ordered to take, fearful that the drug was responsible for the
symptoms they experienced (Appendix). Because no one would
answer their questions about the safety and efficacy of the
pyridostigmine bromide, they feared they were receiving a
potentially harmful drug. Therefore, if pyridostigmine bromide
had been crucial for surviving nerve agent exposure, an unknown
number of individuals would have lacked protection because they
had received inadequate information about the drug.
The other risk is that even if serious side effects were rare,
they could have been treated if medical personnel were able to
diagnose the problem. For example, Carol Picou, a nurse who was
stationed in the Gulf for 5 months, had obvious side effects
from the pyridostigmine starting on the third day that she took
it. These side effects included incontinence, drooling, and
blurry vision, among others. The side effects became worse 1
hour after she took each pill. One day, she did not take the
pill as scheduled, and the side effects stopped; unfortunately,
her commanding officer ordered her to continue taking the pills,
and watched to make sure she swallowed them. She was ordered to
take the pills for 15 days. She now has many permanent medical
problems, including incontinence, muscle weakness, and memory
loss, that might have been avoided had she been allowed to stop
taking the pills. (Note 87)
Similarly, Lt. Col. Neil Tetzlaff had immediate side effects
when he started taking pyridostigmine bromide on the plane ride
over to Saudi Arabia. His nausea and vomiting became so severe
that he needed emergency surgery to repair a hole in his
stomach. When he became ill, the military doctor told him to
continue to take the pills, because the doctor apparently did
not know that nausea and vomiting were known side effects.
According to Tetzlaff's sworn testimony, the doctor acted as if
the pyridostigmine was as safe as a cough drop. (Note 88)
CIVILIANS IN THE GULF WAR
Numerous civilians have reported to Committee staff that they
also were given investigational drugs during the Persian Gulf
War without informed consent. For example, civilians who worked
for DOD contractors and news media personnel were apparently
instructed to take the pyridostigmine bromide tablets. They
usually were not told it was experimental or that the
pyridostigmine bromide was being administered in a regime that
was not proven efficacious or safe, and received no information
on potential side effects of the drug.
For example, according to journalists who covered the Gulf War,
some were given the pills by the U.S. military. Several of these
journalists experienced serious medical problems similar to
Persian Gulf War veterans. (Note 89) The Committee has also
received letters from civilians who are suffering from "Gulf War
syndrome" who report the widespread use of pyridostigmine by
civilians working for DOD during the Gulf War.
OTHER STUDIES OF PYRIDOSTIGMINE
Following the Committee's May 6, 1994, hearing, several
individuals who were in the Air Force during the 1980's
contacted Committee staff to report they had also received
pyridostigmine bromide without their consent. (Note 90) They
indicated that they did not volunteer for any research study,
were ordered to take the pyridostigmine pills as part of a
research project, and were ordered to report any side effects to
the flight surgeons. One individual estimated that several
hundred individuals in his squadron participated in the
pyridostigmine studies, and reported that the studies were
conducted over a period of at least 2 years.
The descriptions of these studies are disturbing because, if
accurate, they indicate that even during peacetime, the Air
Force totally ignored the requirements of informed consent that
are a central provision of the Nuremberg Code, the Declaration
of Helsinki, and the "Common Rule" which had been in effect in
at least some U.S. Government agencies at the time.
In addition to being unethical, these studies were reportedly
unscientific; there were apparently no safeguards to ensure that
the pilots took the pills or accurately reported the side
effects. Many pilots who participated in these studies were on
flight status; if they reported any side effects, they could
lose their flight pay. (Note 91) Obviously, this provided an
incentive for them not to report any side effects, since they
did not want to lose their flight pay. Similarly, those who
experienced side effects had an incentive to stop taking the
drug without notifying the researchers conducting the study.
Moreover, pilots who contacted the Committee staff reported that
many of their friends and colleagues did not take any of the
pills at all, and many of those who did take at least one pill
stopped taking them when they experienced headaches and other
side effects. Despite the pressure to obey orders, many of the
pilots apparently believed that they should not trust the
Pentagon regarding the safety of these experimental pills.
One member of the air crew who was given pyridostigmine as part
of these studies, Craig Crane, notified the Committee that he
now has memory loss, joint pain, sensitivity to chemicals, and
other symptoms that are commonly associated with Gulf War
syndrome, although he is only 32 years old and did not serve in
the Gulf War. He has left the Air Force because of his
disabilities. (Note 92)
C. DOD INCORRECTLY CLAIMS THAT SINCE THEIR GOAL WAS TREATMENT,
THE USE OF INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR WAS NOT
Despite the fact that pyridostigmine was an investigational drug
whose safety and effectiveness had not been proven to FDA, the
DOD claims that its use in the Persian Gulf War was prevention
and treatment, not research. For example, Dr. Edward Martin,
Acting Principal Assistant Secretary of Defense for Health
Affairs, stated at the Committee's hearing on May 6, 1994, that
"..investigational products were employed during the Persian
Gulf War as prophylactic treatments against biological and
chemical warfare agents. This was not research but direct
prevention and treatment." (Note 93) Additionally, John M.
Bachkosky, Deputy Director, Office of the Director of Defense
Research and Engineering, wrote to Sen. Rockefeller on May 19,
1994, that "[botulinum toxoid and pyridostigmine bromide] were
used for direct prevention and treatment and were not employed
as part of any research effort." (Note 94)
In a letter to Sen. Rockefeller dated November 17, 1994, DOD
continues to claim that its use of pyridostigmine was not
research. John Deutch, Deputy Secretary of Defense, wrote that,
"Although pyridostigmine and botulinum toxoid were classified as
investigational drugs as required by FDA regulations, they were
not used for experimental purposes in [Operation Desert Storm]
and the military personnel who received these products were not
experimental subjects." (Note 95) Mr. Deutch added that, "The
fact that these drugs were used for treatment purposes, not
research purposes, was clearly understood by all parties
involved and specifically approved by the courts in litigation
challenging the governments [sic] actions." Once again, it
appears that the DOD confuses the goals of using these medical
products with the process, which was clearly considered
investigational by FDA.
Dr. Arthur Caplan, who at the time he testified was Director of
the Center of Biomedical Ethics at the University of Minnesota,
addressed that issue at the May 6 hearing. He explained that the
fact that the goal is treatment and that DOD believed the
benefits of the pills and vaccines would outweigh the risks
"doesn't transform the use of experimental, innovative,
investigational agents into therapies. These agents were used,
as we have heard, in large populations for purposes other than
those for which they were originally designed in some cases, and
circumstances under which they had never before been tried out
in the desert. This seems to me to cinch the case that what took
place fell into the category of experimental, innovative and
investigational, and that makes them research." (Note 96)
Since the end of the Persian Gulf War, DOD has repeatedly
requested that the waiver of informed consent be made permanent,
arguing that "to not finalize it provides an arguable defect
under the Administrative Procedures Act and leaves both DOD and
FDA open to greater liability." (Note 97) To finalize the
interim rule would grant unrestricted use of investigational
drugs by military personnel, even though investigational status
means that efficacy and safety have not been proven. FDA has not
yet decided whether to concur with DOD's request.
D. DOD USED INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR IN
WAYS THAT WERE NOT EFFECTIVE.
The DOD persuaded FDA that informed consent should be waived
for pyridostigmine bromide and botulism vaccine because these
investigational products had been used safely in the past.
However, based on documents provided to the Committee staff, it
is doubtful that either of these products would have been
effective as used in the Persian Gulf War.
Pyridostigmine bromide, according to DOD, improves the
survival of animals exposed to soman and treated with atropine
and 2-PAM. However, pyridostigmine pretreatment makes
individuals more vulnerable to other nerve agents, such as VX
and sarin. (Note 98) The DOD scientists who studied
pyridostigmine and sarin therefore concluded that pyridostigmine
should only be used when the chemical warfare threat is soman.
The Pentagon, however, had no reason to believe that the
Iraqis were more likely to use soman rather than sarin.
According to a report by the Persian Gulf Veterans Coordinating
Board, Iraq had several chemical weapons, including sarin. (Note
100) Moreover, at a briefing for Senators and staff on November
10, 1993, Under Secretary of Defense John Deutch stated that the
Czechoslovakian military detected low levels of sarin in the
Saudi theater during the opening days of the air war against
Iraq. This statement was also made by Joseph Corrivean, U.S.
Army Foreign Science and Technology Center, on April 27, 1994,
at a National Institutes of Health workshop on "The Persian Gulf
Experience and Health."
Even if U.S. troops had been exposed to soman, it is unclear
that the pyridostigmine would have provided adequate protection
against nerve damage. When DOD began the second phase of
research on pyridostigmine, it was noted that the atropine and
2-PAM did not seem to save the lives of animals that were
exposed to soman. As a result, the dose of atropine was
increased to 0.40 mg/kg, which according to FDA, increased the
survival of Rhesus monkeys exposed to soman. (Note 101) However,
when the Department of Defense developed a treatment regimen for
U.S. troops during the Persian Gulf War, it was based on the
inadequate dose of atropine in the animal studies (0.096 mg/kg)
rather than the higher, effective dose. (Note 102) Therefore,
even if Persian Gulf soldiers had been exposed to soman, it is
questionable if the pyridostigmine pretreatment would have
provided any protection, since the dose of atropine was
In response to posthearing questions about this dosage
discrepancy from Sen. Rockefeller, the DOD stated "the dose of
atropine in the Mark I kit was established based exclusively on
safety, rather than on efficacy, considerations." (Note 103)
This statement suggests that hundreds of thousands of
servicemembers were put at risk by requiring them to take a drug
with known risks (pyridostigmine bromide) in a situation where
it might have done little good since the atropine dose in the
Mark I kits, 6 mg, was inadequate. Based on the monkey data, a
dose of 27 mg would have been required for a 150-pound man.
(Note 104) However, the side effects of only 2 mg of atropine in
a normal young person (without nerve-agent exposure) include
increased heart rate, decreased sweating, visual blurring, and
others. (Note 105) Apparently, DOD officials decided that the
high dosage required for protection would impair performance, so
they selected the much lower dosage, even though its
effectiveness was questionable. Although results for monkeys may
not be exactly comparable to those for humans, it seems unlikely
that humans would respond dramatically differently. It is
therefore likely that the dose of atropine in the Mark I kits
was inadequate for efficacy, and even with this very low dose
could have compromised the ability of servicemembers during war.
Botulism vaccine was given too late to U.S. troops to be of
any use had the Iraqis actually used biological warfare during
Desert Storm. At a briefing on April 20, 1994, DOD officials
informed Committee staff that botulism vaccine was not
administered to most military personnel in the Persian Gulf
until January 23, 1991, which was 7 days after the onset of the
air war. Approximately 8,000 individuals received the vaccine,
but most received only one or two inoculations. Because the war
ended on February 27, 1991, before the third injection was
scheduled to be given, it is unlikely that these soldiers were
adequately immunized. Moreover, because of the severe shortage
of the product, the remainder of those deployed received no
inoculations, and hence no protection against botulism.
According to the Department of Veterans Affairs, 696,562
individuals participated in Operation Desert Shield/Desert
Storm. Therefore, 99 percent of the military personnel deployed
would have received no protection due to the shortage of
botulinum toxoid, and the remaining 1 percent were probably not
protected because the vaccine distribution started too late.
Additionally, in December 1990, the FDA advised the
Department of Defense that it would be unable to test the
botulism vaccine for efficacy, presumably because of limited
time before the onset of the war. (Note 107) Therefore, in
addition to the limited supply of vaccine and late onset of
inoculations, efficacy of the existing supply was not determined
prior to the onset of the war.
Anthrax vaccine was given to approximately 150,000 military
personnel in the Persian Gulf. Anthrax vaccine is considered
effective for protecting against anthrax exposure of the skin;
however it is unclear whether it provides protection against
inhaling aerosolized anthrax. (Note 108) According to the
Department of Defense, in biological warfare the anthrax would
be sprayed, so the efficacy of the vaccine against aerosolized
anthrax would have been the relevant test. (Note 109) As stated
earlier in this report, the DOD has only one study indicating
that the vaccine might be useful against aerosolized anthrax,
but there are no data on humans.
E. DOD DID NOT KNOW WHETHER PYRIDOSTIGMINE BROMIDE WOULD BE
SAFE FOR USE BY U.S. TROOPS IN THE PERSIAN GULF WAR.
Committee staff reviewed all the clinical studies and related
research regarding pyridostigmine on healthy individuals which
DOD provided to FDA to support their IND and their NDA (new drug
approval) application. (Note 110) The number of human subjects
in most studies was less than 35; several studies included as
few as two or four individuals.
According to the materials that FDA provided to the
Committee, virtually all the studies excluded women. The lack of
studies on women is a problem, because dosage should be based on
the weight of the person taking the drug, and because some
scientists believe that pyridostigmine may affect men and women
differently. (Note 111), (Note 112) For example, women on birth
control pills may have different levels of AChE than other women
or men. Similarly, women in different stages of their
reproductive cycle respond differently to pyridostigmine. (Note
113) Since studies excluded women, there is no information on
the potential long-term side effects of pyridostigmine on
diseases unique to women (such as menstrual cycle irregularities
or breast cancer).
Because of the DOD researchers' concerns about serious
adverse reactions to pyridostigmine bromide, many of the studies
screened the men to determine whether they were hypersensitive
to pyridostigmine bromide before allowing their participation in
the experiment. In some cases they used test doses; in other
cases they asked questions regarding similar medications and
sensitivity to bromide. In many of the studies, patients were
excluded if they were taking any medications, since adverse
reactions could occur when pyridostigmine was administered with
other drugs (i.e., propranolol, birth control medications, or
anti-malarial drugs). In some studies, smokers were excluded; in
many studies, participants were told not to drink any alcoholic
beverages. Most research study participants were less than 35
years of age. In addition, individuals with abnormal blood
pressure, asthma, glaucoma, low serum AChE levels,
gastrointestinal disorders, urinary or intestinal blockage, or
hyperthyroidism, were excluded from the studies. (Note 114)
Despite these precautions, serious adverse reactions were
reported for several of the studies. For example, in one study,
pyridostigmine bromide was administered to a group of 28 active
duty Air Force pilots. (Note 115) One pilot experienced
respiratory arrest 91 minutes after swallowing the third in a
series of three 30-mg pyridostigmine tablets. This pilot had
shown no sensitivity to the test dose of pyridostigmine prior to
the study. In another study of 32 male subjects, one subject
lost consciousness following vision problems and headache. (Note
116) In other studies, abnormal liver tests, unusual
electrocardiograms, gastrointestinal disturbances, and anemia
were reported. (Note 117), (Note 118), (Note 119)
Results also showed that pyridostigmine impaired performance,
including tasks which require short-term memory, and prevented a
number of test subjects from exercising in hot environments
during the second or third day of treatment. A study of the
impact of pyridostigmine on swimming in cold water had to be
terminated when it was determined that its use caused severe
cramps that could cause drowning.
Research published in 1978 on neostigmine, a "close relative"
of pyridostigmine, found that the drug caused "profound
physiological, electrophysiological, and electron microscopic
disruption of nerve endings and muscles." Some of these changes
increased in severity over time with continued treatment. (Note
120) The author of that study believes this study has worrisome
implications for pyridostigmine.
In August 1990, just before U.S. troops were sent to the
Gulf, DOD scientists requested approval for a study of four men
that would evaluate the effects of pyridostigmine on vision.
This study was deemed urgent because of the situation in Kuwait,
and it was approved quickly. It is important to note that this
study, conducted just prior to the Gulf War, included extensive
safety precautions, including giving medical exams to the men
before giving the pyridostigmine. The researchers indicated that
pyridostigmine should not be given to individuals who had
bronchial asthma, peptic ulcer, liver, kidney, heart disease, or
hypersensitivity to pyridostigmine or related drugs. They
informed study volunteers that possible adverse side effects
include nausea, vomiting, slow heart rate, sweating, diarrhea,
abdominal cramps, increased salivation, increased bronchial
secretions, and pupil constriction. They also warned of other
side effects, including "weakness, muscle cramps, and muscle
twitches" and explained that, "Because of these side effects,
all subjects will be admitted to Lyster Army Hospital as
in-patients so that they will be medically monitored during
evening periods of nontesting. A drug will be available at the
test site to counteract the possible adverse side effects."
(Emphasis added) (Note 121) In addition, the Human Subjects
Committee that reviewed this study considered whether the
possibility of pyridostigmine causing death should be mentioned
in the informed consent form; after some discussion, it was
decided that such a warning was unnecessary since death was
In contrast to the extensive precautions taken before giving
pyridostigmine every 8 hours for 3 days to four volunteers, a
few months later approximately 400,000 U.S. soldiers were
ordered to take the same dosage of the drug for days, weeks, or
months, none of whom had been screened for any of the diseases
mentioned in the informed consent form given to the four men,
none of whom were warned about the risks associated with the
drug, and none of whom were given a choice of whether or not to
take it. Additionally, approximately 28,000 of the 400,000
receiving the pyridostigmine were women, who were required to
take an investigational drug that DOD had never tested on
healthy women. (Note 122)
The repeated claims by DOD and FDA at the Committee's May 6,
1994, hearing and at other times since the war that they were
sure pyridostigmine was perfectly safe as used is not consistent
with the concerns of DOD scientists regarding the potential
serious adverse reactions and drug interactions while conducting
research. It does not make sense that the researchers would
establish such elaborate safeguards when giving the drug to four
men, and then have none of those safeguards when giving the drug
to more than 400,000 U.S. troops, none of whom had been tested
for sensitivity to pyridostigmine, and most of whom were not
screened for medical problems or medication use that could
preclude the safe use of pyridostigmine. DOD researchers were
aware of the shortcomings of their research. For example, in
1989 William K. Prusaczyk suggested, "Because of the existing
incidence of asthma in soldiers in the U.S. Army," the medical
monitor believes that pyridostigmine should be studies on
individuals who have asthma. (Note 123)
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.
When U.S. troops were sent to the Persian Gulf in the fall of
1994 because of concern about Kuwait, the DOD considered the use
of pyridostigmine to protect against chemical weapons. However,
in the 3 years since the Persian Gulf War of 1991, the DOD had
not conducted studies that proved the safety of pyridostigmine
bromide for that use.
The safety of pyridostigmine was evaluated during and after
the Persian Gulf War. In one study, approximately 37 percent of
213 soldiers reported at least one severe symptom 24 hours after
beginning to take the 30-mg pyridostigmine tablets. (Note 124)
Additionally, the DOD conducted three surveys concerning the use
of pyridostigmine in Operation Desert Shield/Storm which were
reported in 1992. (Note 125) These surveys indicated that side
effects were frequently experienced by military personnel taking
pyridostigmine bromide. One published article, based on reports
from medical personnel providing care to 41,650 soldiers (6.5
percent women) who took pyridostigmine bromide in the Persian
Gulf, found that over half experienced gastrointestinal
disturbances. (Note 126) Urinary urgency and frequency,
headaches, nasal discharge, profuse sweating, and tingling of
hands and feet were reported to occur in a range of 5 to 30
percent. (Note 127) Several doctors who were interviewed for the
study expressed concerns that the dose for women may have been
In the 3 years that have elapsed since the Gulf War, the DOD
has apparently not conducted research on the safety of
pyridostigmine for healthy women. In early 1994, DOD submitted
an NDA (new drug approval) application to FDA, urging that FDA
determine that pyridostigmine bromide is safe and effective as
an antidote enhancer. The studies provided in that application
did not include women.
In the last few year, several studies have been published on
the effects of pyridostigmine on growth hormones of women and
men. In one study, three of the eight women who received one 120
mg dose of pyridostigmine bromide became so ill they had to be
excluded from the study. (Note 128) The entire study consisted
of eight women and eight men who received pyridostigmine in
single doses of 30, 60, or 120 mg. The women in the study
experienced more severe and prolonged symptoms than men,
especially at the 120 mg dose, such as severe abdominal cramps,
nausea, vomiting, asthenia, and muscle cramps. Three subjects
who received 120 mg had vision impairment that lasted several
hours. (Note 129)
In addition, none of the studies of pyridostigmine evaluated
the safety of pyridostigmine if taken over a period of weeks or
months, as was done in the Gulf War. Moreover, none of the
studies evaluated the long-term safety of pyridostigmine by
providing followup information about men who had taken the drug
Despite the Committee's hearing in May and numerous
television news magazine reports and newspaper articles
reporting our concerns about the safety of pyridostigmine, the
DOD has apparently not yet conducted any studies that provide
any more information than was previously available. (Note 130)
Several studies of pyridostigmine conducted by DOD under
conditions of heat and/or exercise have been published, but they
studied only four to seven young men. In one study of four men,
one man became so fatigued on the third day that he was told to
stop exercising; this problem was barely mentioned in the
published study, and the implication for soldiers during wartime
was not discussed. (Note 131)
G. PYRIDOSTIGMINE MAY BE MORE DANGEROUS IN COMBINATION WITH
PESTICIDES OR OTHER EXPOSURES.
In 1993, Dr. James Moss, a scientist at the U.S. Department
of Agriculture, conducted research on cockroaches that could
have important implications for Persian Gulf War veterans. (Note
132) He found that when pyridostigmine was used in combination
with a common insect repellent called DEET (diethyl-m-tolamide),
the DEET became almost seven times as toxic as when it was used
alone. Similarly, pyridostigmine became four times as toxic when
used in combination with DEET. (Note 133) DEET and many other
insect repellents and pesticides were widely used in the Gulf
War as protection against sand flies, scorpions, and other
pests. If individuals who took pyridostigmine bromide became
more vulnerable to pesticides, or those exposed to pesticides
became more vulnerable to pyridostigmine bromide, this could
explain the serious neurological symptoms experienced by so many
Gulf War veterans.
The results were similar but not as alarming for permethrin,
another insecticide that was used in the Gulf War. Permethrin
was used in the military uniforms, impregnating the fabric
before it was cut and sewn. In his cockroach studies, Dr. Moss
found that DEET became twice as toxic when used with permethrin.
Dr. Moss also studied the combination of DEET and
pyridostigmine with other toxic substances that were present in
the Gulf War, such as lindane (a treatment for lice) and a wide
range of insecticides. These substances also became more toxic
when used at the same time than when used individually. Even
caffeine was found to have a potential impact on the toxicity of
Dr. Moss believes his findings regarding cockroaches are
likely to be relevant to humans; however, more research is
needed to determine if humans would be similarly affected.
Nevertheless, his findings are consistent with concerns that
have been raised by military researchers, who have stated
publicly that carbamates such as pyridostigmine must never be
used after nerve agent exposure, presumably because the
pyridostigmine could further decrease AChE from nerve agent
poisoning. If military personnel were exposed to low levels of
nerve agents due to bombing of nerve agent stockpiles as
proposed by some, (Note 134) as well as numerous pesticides
procured by the Army, (Note 135) and pyridostigmine bromide, it
is likely that the combination could have been much more toxic
than any of those substances would have been individually.
Dr. Moss' findings regarding pesticides are also consistent
with a note in the Air Force records of Craig Crane, an Air
Force crewman who participated in a pyridostigmine experiment in
1986. According to a description of the pyridostigmine study
that was signed by medical personnel and included in Mr. Crane's
records, "There is no sensitivity to pesticides or recent
significant exposure." This medical notation suggests that Air
Force medical personnel were concerned about a possible
interaction between pyridostigmine and pesticides, and therefore
avoided including men who had been exposed to pesticides. (Note
Dr. Moss testified about his findings at the Committee's May
6, 1994, hearing, despite efforts by USDA to prevent him from
doing so. On June 31, 1994, his 3-year contract with USDA
expired, and it was not renewed. Dr. Moss' repeated efforts to
continue working at USDA were unsuccessful. Sen. Rockefeller
wrote to Secretary Espy in May, June, and July to ask how USDA
planned to continue Dr. Moss' research, but received no reply
until after a CBS Evening News story on the subject on October
14, 1994. Secretary Espy then wrote to Sen. Rockefeller saying
that the USDA had no plans to follow up on Dr. Moss' research,
but would ensure that the data were provided to DOD. (Note 137)
Although Dr. Moss made no accusations against USDA at the
Committee hearing, he has subsequently expressed his views that
he lost his job at USDA because of his research findings. He
also now reports that his supervisor warned him that he should
not discuss his research findings with anyone. Moreover, in an
internal USDA memo dated December 30, 1993, Dr. Moss stated that
he was advised to "keep quiet." (Note 138) USDA and the Johnson
Wax Company are the co-inventors of DEET, an ingredient in most
commercially available insecticides, such as Raid.
H. THE SAFETY OF THE BOTULISM VACCINE WAS NOT ESTABLISHED
PRIOR TO THE PERSIAN GULF WAR AND REMAINS UNCERTAIN.
At a meeting with DOD officials regarding informed consent in
December 1990, the FDA agreed to test the botulinum toxoid
(botulism vaccine) for safety. (Note 139) A representative of
FDA's Center for Biologics Evaluation and Research explained
that the existing supply of the vaccine was nearly 20 years old
and consisted of three lots, stored under constant
refrigeration. There was concern that the vaccine would break
down into toxic products due to prolonged storage. General
safety testing was performed by the FDA on all of the lots of
botulinum toxoid used in the Persian Gulf; however, the FDA did
not complete these tests until January 24, 1991, (Note 140)
after the war had started.
While the results of FDA's general safety testing were
encouraging, the problem with adverse reactions to the vaccine
were not resolved. In her review of the DOD's application for
use of the botulism vaccine in the Persian Gulf, an FDA reviewer
pointed out that in 1973, the Centers for Disease Control had
considered terminating its distribution because of adverse
reactions. (Note 141) New lots of the vaccine were manufactured
in 1971, but research was not conducted to determine whether the
newer lots produced fewer adverse reactions than the older lots.
Since no records were kept for most of the Gulf War soldiers
who received the vaccine, there is no new information about the
safety of the botulism vaccine resulting from its use by U.S.
troops. Therefore, its safety remains unknown.
I. RECORDS OF ANTHRAX VACCINE ARE NOT SUITABLE TO EVALUATE
Although anthrax vaccine had been considered approved prior
to the Persian Gulf War, it was rarely used. Therefore, its
safety, particularly when given to thousands of soldiers in
conjunction with other vaccines, is not well established.
Anthrax vaccine should continue to be considered as a potential
cause for undiagnosed illnesses in Persian Gulf military
personnel because many of the support troops received anthrax
vaccine, and because the DOD believes that the incidence of
undiagnosed illnesses in support troops may be higher than that
in combat troops. (Note 143)
Unfortunately, medical records and shot records of
individuals who served in the Persian Gulf frequently do not
report the vaccines they received. In some cases, anthrax was
recorded as "Vac-A." However, in many cases, veterans who
believe they received anthrax vaccinations did not have them
recorded in their medical records. According to testimony
received at the Committee hearing on May 6, 1994, vaccines were
recorded in separate vaccine records, for soldiers who had such
records with them and insisted that the information be recorded.
J. ARMY REGULATIONS EXEMPT INFORMED CONSENT FOR VOLUNTEERS IN
SOME TYPES OF MILITARY STUDIES.
Army regulation (AR) 70-25 provides guidelines for the use of
volunteers as subjects in military research. Section 3 describes
three exemptions whereby military researchers are exempt from
the provisions of these protective regulations (the following is
a direct quote from the regulation):
* a. Research and nonresearch programs, tasks, and tests
which may involve inherent occupational hazards to health or
exposure of personnel to potentially hazardous situations
encountered as part of training or other normal duties, e.g.,
flight training, jump training, marksmanship training, ranger
training, fire drills, gas drills, and handling of explosives.
* b. That portion of human factors research which involves
normal training or other military duties as part of an
experiment, wherein disclosure of experimental conditions to
participating personnel would reveal the artificial nature of
such conditions and defeat the purpose of the investigation.
* c. Ethical medical and clinical investigations involving
the basic disease process or new treatment procedures conducted
by the Army Medical Service for the benefit of patients. (Note
It is sometimes difficult to differentiate training from
research. For example, military personnel at the U.S. Chemical
School, Fort McClellan, AL, are currently exposed to nerve agent
poisons as part of their training, so that they will learn how
to cope with similar situations in combat. Soldiers who refuse
to participate or do not complete live agent training are
subject to reclassification in another military occupational
specialty and cannot graduate. (Note 146) To determine if the
students used correct procedures during the training exercise,
blood samples are obtained from some students before and after
the procedure, and are analyzed for red blood cell
cholinesterase to determine if the soldier was exposed to the
If the military collects data to determine how to better
train individuals, the "training" is then defined as
contributing information to generalizable knowledge, and is
hence "research." For the optimal protection of U.S. troops, one
would hope that training exercises are improved based on
reliable information. However, during the testing of new
training methods or equipment, exercises utilizing potentially
dangerous substances, such as chemical weapons, should be
considered research rather than training. Participants must be
fully apprised of the nature of the experiments and have the
opportunity to refuse without reprisal, in order to conform with
the Nuremberg Code and other ethical standards.
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.
A common theme voiced by military personnel who have
participated in military research or training exercises over the
last 50 years is the lack of information about the risks they
faced and the lack of medical followup. World War II veterans
frequently reported that they heard about the adverse health
effects of mustard gas and lewisite from newspapers and
television decades after they were exposed, not from the
Department of Defense or Department of Veterans Affairs.
Veterans and civilians who worked at the Dugway Proving Ground
and were exposed to a variety of biological and chemical
simulants began to question the association of poor health with
work as they compared information among themselves, not because
of information provided by military officials. Veterans who were
inside atomic clouds from atomic testing heard nothing at all
from their government after they returned home from duty.
Similarly, soldiers who unknowingly participated in military
research designed to test the effects of hallucinogens on human
behavior were never given information to explain their
hallucinations and suffered from severe psychological disorders
as a result. Even today, most of those who served in the Persian
Gulf indicate they have received no followup information about
the investigational drugs they received.
It is the responsibility of DOD and VA to identify and keep
track of veterans exposed to potentially dangerous substances so
that they can receive medical care if needed. Even in situations
where DOD believes an investigational drug is safe, such
followup is necessary to establish with certainty whether
exposures were safe, or whether they resulted in long- term side
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.
In the last year, Gulf War veterans have reported that
exposures during military service have resulted in miscarriages
and birth defects, as well as excruciating pain during sexual
intercourse. For example, at a Committee hearing on August 5,
1994, Kelli Albuck, the wife of a Gulf War veteran, described
the miscarriage and pregnancy problems she had experienced since
her husband returned from the Gulf War. She also described what
she called "burning semen" or "shooting fire." Mrs. Albuck
stated that many wives of Gulf War veterans complained that
their husbands' semen caused a burning sensation, and in her
case that the semen itself could cause a rash or blood blister
on her husband's leg or her skin. Steve Miller, an Army nurse
who also testified at that hearing, had no problems with burning
semen, but his son was born with extensive birth defects,
including having only one eye and one ear. The doctors told him
that the combination of severe birth defects was very unusual
and suggestive of a toxic exposure. Mr. Miller believes that his
son's birth defects could be related to his use of
investigational drugs or vaccines, perhaps in combination with
Similarly, many atomic veterans believe that infertility,
miscarriages, stillbirths, and birth defects resulted from
exposure to ionizing radiation.
Although these reports have received media attention for
years, the VA and DOD have not conducted research on these
questions, nor have they supported independent research.
Finally, 50 years after veterans were intentionally exposed to
ionizing radiation, the VA will be required by law to enter into
a contract with the Institute of Medicine (IOM), or a similar
independent agency, to evaluate whether it is feasible to
support research on the reproductive problems associated with
exposure to ionizing radiation. If the IOM determines that such
research is feasible, the VA and the Congress will then
determine whether such research should be funded. (Note 147)
In November 1994, President Clinton signed a law that would
require VA to conduct research on birth defects and miscarriages
among Gulf War families. A preliminary study will be required,
in which information about these reproductive outcomes will be
included in the Persian Gulf War Veterans' Health Registry. In
addition, VA will be required to include semen analysis and
other reproductive evaluations in a standard protocol used to
evaluate Gulf War veterans with mysterious illnesses.
M. THE FEDERAL GOVERNMENT HAS ALSO FAILED TO SUPPORT
SCIENTIFIC STUDIES THAT PROVIDE TIMELY INFORMATION FOR
COMPENSATION DECISIONS REGARDING MILITARY PERSONNEL WHO WERE
HARMED BY VARIOUS EXPOSURES.
For decades, military personnel who were injured from various
exposures have been denied compensation until scientific
evidence could support their claims for service-connected
disabilities. Although 60,000 military subjects were involved as
human subjects in testing programs involving mustard gas and
lewisite over 50 years ago, the initiation of a study to review
research regarding the long-term health consequences from these
military experiments did not occur until 1991, and the results
of the study were not published until 1993. (Note 148)
Similarly, the use of Agent Orange and other herbicides in
Vietnam has stimulated concern and controversy ever since the
United States began the military herbicide program in 1961, but
a comprehensive review and evaluation of available scientific
and medical information regarding the health effects of
herbicides and the contaminant dioxin was not conducted until it
was authorized by Congress in 1991. (Note 149) The Department of
Veterans Affairs has recently announced new rules for awarding
compensation for more Agent Orange-related diseases, three
decades after military personnel were exposed to the defoliant
in Vietnam. (Note 150)
Reports of the National Research Council's Committee on the
Biological Effects of Ionizing Radiation (BEIR), written to
advise the U.S. Government on the health consequences of
radiation exposure, frequently relied on mortality and morbidity
experiences of exposed individuals, some of which took decades
to accumulate. (Note 151) Information is continuing to be
gathered, which will be incorporated into future BEIR reports.
When investigational drugs and vaccines were given to
thousands of military personnel during the Persian Gulf War,
this provided an unprecedented opportunity to learn more about
the safety of those products. Unfortunately, no effort was made
to gather objective information, despite the fact that data
gathering is required as part of the IND process for
investigational drugs and vaccines. (Note 152) Any research that
is conducted years after the war is over will be less
scientifically valid and much more expensive as a result of the
lack of objective information gathered during the war about
which servicemembers took which drugs or vaccines, and the
adverse reactions that they experienced.
The Medical Follow-up Agency (MFUA) of the Institute of
Medicine will take 3 years to issue its final report on whether
there is a scientific basis for an epidemiological study on the
health consequences of service in the Persian Gulf. (Note 153)
If the MFUA determines such a study or studies should be
conducted, it will take several more years to gather the
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
Although hundreds of thousands of U.S. military personnel
have been involved in military research, their medical records
usually do not contain information about the studies they
participated in, or the investigational drugs or vaccines they
received. (Note 154) There are currently no standardized
guidelines imposed by either the DOD or VA to include a copy of
the informed consent form or research proposal in the medical
records of exposed human subjects.
Even if medical records contain relevant information
regarding health consequences from various investigations, these
medical records may be difficult to obtain. Of the 150
individuals who were interviewed for the Committee's survey, not
all respondents had tried to obtain their medical records, but
28 (19 percent) indicated that part or all of their medical
record were lost and 48 (32 percent) respondents indicated that
their medical records were incomplete or inaccurate (Appendix).
Some of those surveyed believed their records had been
deliberately altered or contained inaccurate information.
The VA Office of Inspector General recently investigated the
possible illegal removal of official documents from certain
veterans' appeals files assigned to two Board of Veterans'
Appeals attorneys. (Note 155) It is unknown whether such
intentional removal is a rare occurrence; clearly, any removal
of medical information would make it difficult and perhaps
impossible for a veteran to receive the medical care and
compensation that he or she is entitled to.
In addition to any intentional removal of information,
veterans' service medical records are difficult to find.
According to the U.S. General Accounting Office, veterans'
service medical records can potentially be in thousands of
locations. (Note 156) The DOD has attempted to simplify the
retrieval of medical records by modifying the route for medical
records of individuals who have left the military. The
simplified route was initiated for the Army in October 1992, for
the Navy in February 1994, and for the Air Force and Marines in
late 1994. Although the new procedures should simplify the
process, the GAO concluded that the possibility of misplaced
medical records remains because there are still thousands of
locations where records could be found within the new system.
O. DOD HAS DEMONSTRATED A PATTERN OF MISREPRESENTING THE
DANGER OF VARIOUS MILITARY EXPOSURES THAT CONTINUES TODAY.
According to Dr. Leonard Cole, professor at Rutgers
University, the DOD has denied the possibility of harm from
various exposures. However, in many instances the military
belatedly recognized that some exposures may be causing disease
and death. (Note 157) Such denial, however, delays the
availability of medical assistance to those harmed.
For example, the military has released chemicals and
biological agents through outdoor "open air" tests for over four
decades. Some of these supposedly safe chemicals and biological
agents, referred to as simulants, were also released over
populated areas and cities. (Note 158) Although scientific
evidence suggested that the tests may have caused illnesses to
exposed citizens, the Army repeatedly claimed that these
bacteria and chemicals were harmless until adverse health
effects convinced them to change the simulants used. The death
of Edward J. Nevin was associated with the release of one
simulant, Serratia marcescens, over San Francisco in 1950. (Note
159) A subsequent court trial revealed that on September 26 and
27, 1950, the Army sprayed Serratia marcescens from a boat off
the coast of San Francisco. (Note 160) On September 29, patients
at the Stanford University Hospital in San Francisco began
appearing with Serratia marcescens infections. Although the
judge denied the validity of the plaintiffs' claims that the
exposures were related to the death of Mr. Nevin, the trial
raised frightening questions about the selection of simulants.
Serratia marcescens is no longer used by the military as a
Dugway Proving Ground has been a site for "open air" testing
of chemical and biological agents for decades. The purpose of
the tests is to determine how the agents spread and survive, and
their effect on people and the environment. Earl Davenport is a
veteran who participated in tests at Dugway Proving Ground in
Utah, first as a military employee and later as a civilian
employee. He became ill in 1984 after being exposed to a
chemical simulant called DMMP (dimethyl methylphosphate). He had
been spraying the chemical into the path of a laser beam when a
sudden change in wind blew the chemical all over his face and
hair before he was able to put on a protective mask. Although he
was "wheezing and coughing" the next day, and his symptoms
lasted for weeks, the Dugway Army Hospital merely gave him cough
medicine and antibiotics. The Dugway Safety Office assured him
that the chemical was safe. However, by 1988, officials at
Dugway had reevaluated the stimulant's danger, and were becoming
concerned that DMMP could cause cancer and kidney damage. (Note
161) Mr. Davenport is currently attempting to obtain
compensation for his illness from the Department of Labor, since
his exposure occurred when he was employed at Dugway as a
In 1992, several military personnel from the Arizona National
Guard experienced chemical burns during a summer training
exercise at the Dugway Proving Grounds. According to two
physicians, a daughter from one of the guardsmen also received
chemical burns when she later handled her father's duffle bag.
One of these doctors, Dr. Michael Vance, was contacted by
military officials and encouraged to modify his written findings
on the possible cause of the daughter's injury. (Note 162) He
According to scientists and doctors from the University of
Utah, there is great concern over the potential health
consequences not only for military personnel who work and train
at Dugway, but also for civilians who live in a small town and
on an Indian reservation near the Proving Grounds. Moreover,
physicians from the Utah Medical Society have complained about
the lack of information provided to the medical community about
the agents that are used in Dugway, despite repeated requests.
According to Dr. Cole, the use of potentially harmful
chemical and biological agents continues at Dugway even today.
For example, he testified that the Army uses a simulant called
Bacillus subtilis, "which is fairly harmless in many natural
conditions, [but] is recognized as a potential source of
infection and can cause serious illness in some people when they
are exposed to it in large numbers and they inhale large numbers
of those microorganisms." (Note 164)
Dr. Cole also testified about the lack of informed consent at
Dugway in recent months. For example, in November 1993, a test
that was intended to evaluate whether chemical agents could
penetrate protective clothing used informed consent forms that
did not mention the chemicals. (Note 165)
IV. STAFF RECOMMENDATIONS
A. FDA SHOULD DENY THE DEPARTMENT OF DEFENSE REQUEST FOR A
"BLANKET WAIVER" TO USE INVESTIGATIONAL DRUGS WITHOUT INFORMED
CONSENT IN CASE OF WAR OR THREAT OF WAR.
If investigational drugs are deemed necessary for protection
or treatment, a waiver of informed consent should be sought only
on a case-by- case basis. While the military might order
individuals to take an investigational drug or use an
investigational device if it is clearly safe and potentially
efficacious, under no circumstances should the DOD fail to
inform individuals about the known short-term and long-term
risks prior to its administration.
In 1990, DOD applied to FDA for a waiver of informed consent,
claiming they would provide warnings orally and in writing
regarding the risks of pyridostigmine, even though they would
not give soldiers the choice of whether or not to take it.
According to reports from various sources, including DOD's own
study, DOD did not fulfill its promise. In addition, DOD
personnel apparently distributed these drugs to civilians
without any warnings. These failures and broken promises should
be sufficient to persuade FDA to reject the DOD request for a
blanket waiver, and should be taken into consideration any time
DOD applies for a waiver of informed consent. In addition, FDA
should investigate these problems and work with DOD to prevent
similar problems in the future.
In addition, third-party or "deferred" consent should not be
considered unless the individual receiving the drug is
physically or mentally incompetent to make an informed decision
on his/her behalf. If the DOD fails to obtain the necessary
waivers, or fails to adequately inform those receiving the
investigational products, DOD should be required to provide a
written explanation to the appropriate congressional committees.
B. FDA SHOULD REJECT IND AND NDA APPLICATIONS FROM DOD THAT
DO NOT INCLUDE DATA ON WOMEN AND LONG-TERM FOLLOWUP DATA.
When DOD submits an IND (investigational new drug)
application or NDA (new drug application) to FDA for any product
that they plan to use, they should always be required to include
women in their research, since it is likely that the product
will be used by women. On the basis of that requirement, FDA
should reject the currently pending NDA for pyridostigmine's use
as an antidote enhancer, which was submitted to FDA in early
At a Senate briefing in November 1994, Dr. Ruth Merkatz,
FDA's Associate Commissioner for Women's Health, stated that FDA
will always require data on women in future drug approval
applications, if the product under review is intended for use by
women. However, Dr. Merkatz was not specific about whether this
policy would apply to DOD.
In addition to data on women, it is increasingly clear that
drugs can have long-term adverse reactions that are not
immediately obvious. Given the responsibility of the Federal
Government to provide medical care to veterans who were harmed
during military service, DOD and FDA need to ensure that the VA
and the public are aware of any potential long-term adverse
reactions of any medical products that are given to military
In the case of pyridostigmine, a drug that DOD wants to have
the authority to use in future conflicts in the Persian Gulf and
elsewhere, FDA should immediately urge DOD to conduct the kinds
of research that is needed to prove its safety for future
military use, including research on its potentially toxic
effects when combined with insecticides and other chemical
agents that are commonly used by military personnel.
C. CONGRESS SHOULD AUTHORIZE A CENTRALIZED DATABASE FOR ALL
FEDERALLY FUNDED EXPERIMENTS THAT UTILIZE HUMAN SUBJECTS.
Currently, the U.S. Department of Agriculture maintains a
database which can identify the number of research grants
awarded for studying various species, such as beef and dairy
cattle, poultry, sheep, swine, and others. (Note 166) However, a
database which identifies the types of human subjects does not
Congress should authorize a database which would provide
crucial information on federally funded research utilizing human
subjects. Included in this database should be the amount of
Federal dollars spent on various research efforts and the type
of human subjects utilized, such as women, minorities, children,
prisoners, military personnel, and others.
Annual reports from the data collected should be provided to
Congress. Such information would enable legislators to
understand better the use of human subjects in federally
D. CONGRESS SHOULD MANDATE ALL FEDERAL AGENCIES TO DECLASSIFY
MOST DOCUMENTS ON RESEARCH INVOLVING HUMAN SUBJECTS.
Information involving human subjects in military research,
which remains classified for purported reasons of national
security, needs to be reevaluated and declassified whenever
possible. All Federal agencies should scrutinize classified
information and make information available which might benefit
individuals who participated in such research.
E. CONGRESS SHOULD REESTABLISH A NATIONAL COMMISSION FOR THE
PROTECTION OF HUMAN SUBJECTS, WITHOUT A TERM LIMIT, WHICH HAS
THE AUTHORITY TO INVESTIGATE POTENTIAL VIOLATIONS OF HUMANS
SUBJECTS' RIGHTS IN FEDERALLY FUNDED RESEARCH.
A National Commission should standardize Federal regulations
(45 CFR 46), and consider adding military personnel as a
vulnerable population. Policies for the conduct of research in
war or for the purposes of national security should receive
greater public debate. No existing regulations governing
military personnel should be finalized without such public
Congress should provide authorization and appropriations for
the National Commission, and require annual reports on potential
violations of human subjects' rights. The administrative body of
the Commission should consist of nine members, three appointed
by the majority party in Congress, three appointed by the
minority party in Congress, and three appointed by the executive
F. THE DEPARTMENT OF VETERANS AFFAIRS AND THE DEPARTMENT OF
DEFENSE SHOULD IMPLEMENT REGULAR SITE VISITS TO REVIEW THE
PERFORMANCE OF INSTITUTIONAL REVIEW BOARDS.
DOD and VA authorized site visits should include an
evaluation of military and VA research onsite, and a random
sample review of actual research and medical records, interviews
with human subjects, and signed consent forms to assure
investigator compliance. A mechanism should be in place whereby
human subjects can express concern over perceived or actual
violations of the informed consent contract. This mechanism
should allow human subjects to register complaints to a
regulatory agency and the National Commission, rather than
solely the investigator of the research project. All military
personnel and veterans involved in research should receive a
copy of the "Experimental Subject's Bill of Rights." (Note 167)
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.
The U.S. Supreme Court has interpreted the Feres Doctrine to
mean that soldiers "injured in the course of activity incident
to service" may not sue the Government for compensation. (Note
168) However, when inappropriate experimentation has resulted in
suffering for military personnel, this interpretation stands in
violation of established ethical standards, including the
Nuremberg Code, the Declaration of Helsinki, and the "Common
Rule." Congress should not apply the Feres Doctrine for military
personnel who are harmed by inappropriate experimentation when
informed consent has not been given.
The U.S. Supreme Court mentioned the Nuremberg Code in United
States v. Stanley in 1987. James Stanley, an Army serviceman,
volunteered to test the effectiveness of protective clothing and
equipment against chemical warfare in February 1958. (Note 169)
In the process, he unknowingly received LSD as part of an Army
study to determine the effects of the drug on humans. Although
Stanley suffered from periods of incoherence and memory loss for
years, he only learned in 1975 that he had participated in the
LSD study when the Army solicited his cooperation in a followup
study. Having been denied compensation for injury by the Army,
Stanley filed under the Federal Tort Claims Act. Justice Antonin
Scalia wrote the opinion for the Court, split 5 to 4. (Note 170)
Justice Scalia wrote that permitting Stanley to sue the Army
would disrupt the Army itself and "would call into question
military discipline and decision-making." However, Justice
Sandra Day O'Connor, writing for herself as one of the
dissenting judges, stated that the Feres doctrine bar
"surely cannot insulate defendants from liability for
deliberate and calculated exposure of otherwise healthy
military personnel to medical experimentation without their
consent, outside of any combat, combat training, or military
exigency..." (Note 171)
Justice O'Connor also commented on the Nuremberg Code in her
writing, stating that voluntary consent of the human subject is
absolutely essential, even for the U.S. military. It was, after
all, the U.S. military who played an instrumental role in the
criminal prosecution of the Nazi officials who experimented with
human beings during World War II.
Male respondents: 120 [80%]
Female respondents: 30 [20%]
Active duty servicemembers: 46 [31%]
Retired: 4 [3%]
Temporarily disabled retirement list: 2 [1%]
Active reservists: 46 [31%]
Veteran: 15 [10%]
Individual ready reserves: 10 [7%]
National Guard: 27 [18%]
Those ill since returning from Gulf: 136 [91%]
Those who had ill family members: 60 [40%]
Those who identified at least one investigational drug that they took:
Number of respondents who received anthrax: 68 [45%]
1 vaccination: 31 [46% of those who received anthrax]
2 vaccinations: 31 [46%]
3 vaccinations: 2 [ 3%]
Unknown number: 4 [ 6%]
Of those receiving anthrax vaccinations, those who:
received no oral or written information about the vaccine: 61 [90%]
were told they could not refuse it: 58 [85%]
described immediate side effects: 29 [43%]
Of the women receiving anthrax vaccination, those who received no
warning on risk if pregnant: 12/16 [75%]
Number of respondents who received botulinum toxoid: 17
1 vaccination: 10 [59% of those who received botulinum toxoid]
2 vaccinations: 3 [18%]
Unknown number: 4 [24%]
Of those receiving botulinum toxoid, those who:
received no oral or written information about the vaccine: 13 [76%]
were told they could not refuse it: 15 [88%]
described immediate side effects: 6 [35%]
Of the women receiving botulinum toxoid, those who received no warning
on risk if pregnant: 4/4 [100%]
Number of respondents who took pyridostigmine bromide: 73 [49%]
Of those taking pyridostigmine bromide, those who:
received no oral or written information on side effects: 63 [86%]
were told they could not refuse it: 54 [74%]
described immediate side effects: 38 [52%]
did not comply and take drugs when they were supposed to: 14 [19%]
Of the women receiving pyridostigmine bromide, those who received no
warning on risk if pregnant: 14/18 [78%]
OTHER SURVEY INFORMATION--
Number of respondents who received a vaccination but did not know what
it was: 25 [17%]
Number of respondents who received a drug but did not know what it was:
Number of respondents who have not received any information following
the Persian Gulf War concerning investigational drugs from either VA or
DOD: 128 [85%]
Concerning medical records:
Medical record is incomplete/inaccurate: 48 [32%]
Medical record [part or all] is missing/lost: 28 [19%]
25 MOST COMMON SYMPTOMS REPORTED
[number of respondents reporting]
Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Skin problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
rashes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Memory loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
blackouts, forgets where they are . . . . . . . . . . . . . . . . . . 5
Joint pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Headaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Personality changes . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Diarrhea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Muscle pain, weakness, spasms, tremors . . . . . . . . . . . . . . . . 29
Pain [back, shoulder, neck, etc] . . . . . . . . . . . . . . . . . . . 28
Trouble with vision . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Shortness of breath . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Sleep disturbances . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Hair loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Numbness [hands, fingers, feet] . . . . . . . . . . . . . . . . . . . . 19
Dental problems/bleeding gums . . . . . . . . . . . . . . . . . . . . . 18
Reproductive problems . . . . . . . . . . . . . . . . . . . . . . . . . 18
Bleeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Sores . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Chest problems [pain] . . . . . . . . . . . . . . . . . . . . . . . . . 12
Abdominal/stomach pain . . . . . . . . . . . . . . . . . . . . . . . . 12
Fever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Nausea/vomiting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Dizziness/staggering . . . . . . . . . . . . . . . . . . . . . . . . . 10
Sinus, nasal discharge . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sensitivity to light, smell, noise . . . . . . . . . . . . . . . . . . . 9
Children born with birth defects . . . . . . . . . . . . . . . . . . . . 7
Partners with reproductive problems . . . . . . . . . . . . . . . . . . 16
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.
3. Veterans at Risk, op. cit., p. 36.
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 Testing by the CIA, 1977," September 20-21, 1977, pp.
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.
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."
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.
12. 45 CFR 46 (Public Welfare), subparts B,C, and D, revised
October 1, 1991.
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.
14. Veterans at Risk, op. cit., pp. 3-4, 6-8, 50-52, 224-226.
15. Ibid., p. 65.
16. Ibid., p. 7.
17. 59 Federal Register 41,497-42,500 (August 18, 1994),
"Claims Based on Chronic Effects of Exposure to Vesicant
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.
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.
23. Ibid., pp. 6-7.
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.
25. Ibid., pp. 64-65.
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.
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.
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.
37. Gene Wars, op. cit., pp 50-51.
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
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."
42. Ibid., pp. 169-217.
43. 55 Federal Register 52,814-52,817 (December 21, 1990).
44. Sidell, F.R., "Clinical Considerations in Nerve Agent
Intoxication," Chemical Warfare Agents, Somani, S.M. (Ed.),
Academic Press, Inc., 1992, pp. 155-194.
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.
50. 55 Federal Register 52,814-52,817 (December 21, 1990).
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.
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,
55. Mestinon is the brand name for one form of pyridostigmine
bromide available in the United States.
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.
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.
61. Informational material for the use of anthrax vaccine
adsorbed, Michigan Department of Public Health, U.S. License No.
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.
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.
65. "Human Experimentation, An Overview on Cold War Era
Programs," U.S. General Accounting Office, September 28, 1994,
67. Veterans at Risk, op. cit., pp. 7-8.
68. Statement of Rudolph R. Mills, hearing before the
Committee on Veterans' Affairs, U.S. Senate, "Is Military
Research Hazardous to Veterans' Health? Lessons from World War
II, the Persian Gulf War, and Today," May 6, 1994; hereinafter
referred to as Hearing, May 6, 1994.
70. Hearing, May 6, 1994; John T. Harrison, written statement
submitted for the record.
71. Although the study was published in the Journal of the
American Medical Association, these results were not reported in
the published article. They are reported in an unpublished
report, Survey #1, Food and Drug Administration IND 23,509,
Operation Desert Storm/Shield, May 27, 1992.
72. The Nuremberg Code, op. cit.
73. "Annas, G.J. & Grodin, M.A. "The Nazi Doctors and the
Nuremberg Code," Human Rights in Human Experimentation, Oxford
University Press, 1992, p 152.
74. Hearing, May 6, 1994; Nathan J. Schnurman, written
statement submitted for the record.
75. Testimony of Nathan Schnurman, WWII veteran, mustard gas
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.
76. Hearing, May 6, 1994; John William Allen, written
statement submitted for the record.
77. Pyridostigmine is approved by the FDA at a one-time
dosage of 15 mg to reverse the effects of certain drugs given
78. 55 Federal Register 52,814-52,817 (December 21, 1990).
79. Memorandum for Record, August 30, 1990, submitted by
Craig R. Lehmann, Lt. Col., USAF, BSC; in Committee files.
80. FDA memorandum from Richard Klein and Ann Graham to
Stuart Nightingale, September 7, 1990; in Committee files.
81. Draft of minutes, meeting between officials of DOD and
FDA, December 31, 1990, provided by FDA to Committee; in
83. 55 Federal Register 52,814-52,817 (December 21, 1990).
84. Letter in Committee files.
85. Letter from Enrique Mendez, Jr., M.D., to David Kessler,
M.D., Commissioner, Food and Drug Administration, March 15,
1991; in Committee files.
86. Survey #1, Food and Drug Administration IND 23,509,
Operation Desert Storm/Shield, May 27, 1992.
87. Response to Committee survey completed by Carol Picou,
Persian Gulf War nurse; in Committee files.
88. Hearing, May 6, 1994; statement of Neil Tetzlaff, Persian
Gulf War veteran.
89. Memoranda describing phone conversations with journalists
are in Committee files.
90. Letters, summaries of phone conversations, and supporting
documents are in Committee files. These include an "Aircrew
Symptoms Checklist on AF Form 1666 (TEST) FEB 86, which
instructs the pilots to "[t]ake one (1) pyridostigmine bromide
tablet (30 mg) every eight (8) hours over a 24 hour period."
91. One of the men has provided records of these studies to
the Committee; although the records specify that all pilots
participating in the study were removed from flight status and
given informed consent about the risks of pyridostigmine, those
records are not consistent with the descriptions of the study
provided by the pilots who contacted the Committee. Moreover,
the records themselves do not include an informed consent form
or information about the risks of pyridostigmine.
92. Letter and medical records of Craig Crane are in
93. Hearing, May 6, 1994; statement of Dr. Edward Martin,
Acting Principal Assistant Secretary of Defense for Health
94. Letter from John M. Bachkosky, Deputy Director, Office of
the Director of Defense Research and Engineering, U.S.
Department of Defense, to Sen. John D. Rockefeller IV, Chair,
Senate Committee on Veterans' Affairs, May 19, 1994.
95. Letter from John Deutch, Deputy Secretary of Defense, to
Sen. John D. Rockefeller IV, Chair, Senate Committee on
Veterans' Affairs, November 17, 1994; in Committee files.
96. Hearing, May 6, 1994; statement of Arthur Caplan, Ph.D.
Dr. Caplan is now Director of the Center of Biomedical Ethics at
the University of Pennsylvania.
97. Minutes, Meeting (July 27, 1992) on Finalizing Interim
Rule on Waiver of Informed Consent, signed July 28, 1992, by
William H. Habig.
98. Koplovitz, I., Harris, L.W., Anderson, D.R., Lennox,
W.J., & Stewart, J.R. "Reduction by pyridostigmine pretreatment
of the efficacy of atropine and 2-PAM treatment of sarin and VX
poisoning in rodents," Fundamental and Applied Toxicology, Vol.
18, 1992, pp. 102-106.
99. Sidell, F.R., op. cit.
100. "Summary of the issues impacting upon the health of the
Persian Gulf veterans," Version 1.1: March 3, 1994.
101. The actual data from this study was not provided to our
Committee, and apparently not provided to FDA either.
102. IND Amendment, Reference to IND# 28480, March 28, 1988,
Letter from Thomas H. Gray, Chief, Operational Unit Training
Branch, Department of the Air Force, to Mr. David Banks,
Consumer Safety Officer, FDA.
103. Answers from the Department of Defense to followup
questions submitted by Sen. John D. Rockefeller IV, after the
Committee's May 6, 1994, hearing. The answers were received by
the Committee on September 19, 1994.
104. A 150-pound man weighs 68 kg; 68 x 0.4 = 27 mg.
105. Sidell, F.R., op. cit.
106. The administration of additional atropine some hours
after exposure to chemical weapons might have been helpful, but
it is not clear how many soldiers would have been fortunate
enough to receive medical treatment within hours of combat, or
how effective that later treatment would have been.
107. Minutes of Meeting of the Informed Consent Waiver Review
Group (ICWRG), Food and Drug Administration, December 31, 1990.
108. In a letter dated July 27, 1992, FDA asked whether an
IND should be required to test the anthrax vaccine against
109. Department of Defense briefing with staff of the Senate
Committee on Veterans' Affairs, 414 Russell Senate Office
Building, April 20, 1994. 110. A list of many of these studies
is in Appendix A.
111. Barbarino, A., Corsello, S.M., Tofani, A., et al.
"Sexual dimorphism of pyridostigmine potentiation of growth
hormone (GH)-releasing hormone- induced GH release in humans,"
Journal of Clinical Endocrinology and Metabolism, Vol. 73, No.
1, 1991, pp. 75-78.
112. O'Keane V. & Dinan, T.G. "Sex steroid priming effects on
growth hormone response to pyridostigmine throughout the
menstrual cycle," Journal of Clinical Endocrinology and
Metabolism, Vol. 75, No. 1, 1992, pp. 11-14.
114. These instructions are consistent over time, and were
included in many different studies between 1985-90. Copies are
in Committee files.
115. IND Amendment, 28 March 1988, IND 28,480.
116. IND Annual Report, 1987-1988, IND 23,509.
117. DAMD17-85-C-5133, Task Order 2, Kornhauser.
118. Israeli Journal of Medical Science, Vol. 27, 1991, pp.
119. Keeler, J.R., Hurst, C.G., & Dunn, M.A. "Pyridostigmine
used as a nerve agent pretreatment under wartime conditions,"
Journal of the American Medical Association, Vol. 266, No. 5,
1991, pp. 693-695.
120. Letter from the author of the published research, Dr.
Thomas Tiedt, to Sen. John D. Rockefeller IV, Chair, Senate
Committee on Veterans' Affairs, June 8, 1994; in Committee
121. Abbreviated Protocol, signed by Roger W. Wiley and
Darcelle Delrie, and other documents regarding "The Effects of
Pyridostigmine Bromide on Vision"; attached to a cover letter
from Martha H. Myers, Acting Chief, Human Use Review and
Regulatory Affairs Office, Department of the Army, August 15,
1990. Documents are in Committee files.
122. There are several studies of the effects of a one-time
dose of pyridostigmine on growth hormone in women, but the
conditions of these studies, including fasting and use during
one phase of the menstrual cycle, were not relevant to use of
pyridostigmine in the Gulf War.
123. to Protocol HURC #378," memorandum from William K.
Prusaczyk, research physiologist, October 23, 1989; in Committee
124. Sharabi, Y., Danon, Y., Berkenstadt, H., et al., "Survey
of symptoms following intake of pyridostigmine during the
Persian Gulf War," Israeli Journal of Medical Science, Vol. 27,
1991, pp. 656-658.
125. Information amendment from the Department of the Army to
FDA, IND 23509-pyridostigmine bromide-WR 270,710, May 27, 1992.
126. Keeler, J.R., et al., op. cit.
128. Barbarino, A., et al., op. cit.
129. All the men and women in the study were between 19-25
years old, were free of other medications, and were fasting; the
women were all in the luteal phase of their menstrual cycle.
130. Although the DOD does plan to follow up on research on
pyridostigmine and DEET conducted by Dr. James Moss (previously
with the Agricultural Research Service, USDA) by conducting a
study of rats, that research has not yet been initiated. Dr.
Moss' research is described in the next section of this report.
131. M.A. & Stephenson, L.A. "Cardiovascular and
thermoregulatory responses to repeated anticholinesterase
administration," Journal of Thermal Biology, Vol. 17, No. 6, pp.
132. Hearing, May 6, 1994; testimony of James Moss, Ph.D.,
researcher, Agricultural Research Service, U.S. Department of
Agriculture, Gainesville, FL.
133. Additional information about his results are provided in
Dr. Moss' answers to Sen. Rockefeller's posthearing questions,
included in the transcript of the Committee's May 6, 1994,
hearing, and in documents provided by Dr. Moss which are in the
134. "U.S. Chemical and Biological Warfare-related Dual Use
Exports to Iraq and Their Possible Impact of the Health
Consequences of the Persian Gulf War," a report of Sen. Donald
W. Riegle, Jr., Chair, and Sen. Alfonse M. D'Amato, ranking
Republican member, U.S. Senate Committee on Banking, Housing,
and Urban Affairs, May 25, 1994.
135. List of pesticides procured during Desert Shield/Storm
(acquired through the Federal supply system), information
submitted to the Senate Committee on Veterans' Affairs, April 6,
1994, from the Department of the Army, Office of the Surgeon
136. Hearing, May 6, 1994; document submitted for the record.
137. Correspondence between Secretary Espy and Senator
Rockefeller are in Committee files.
138. Hearing, May 6, 1994; document submitted for the record
by Craig Crane.
139. Minutes of Meeting of the Informed Consent Waiver Review
Group (ICWRG), Food and Drug Administration, December 31, 1990.
140. BBIND 3723, Food and Drug Administration, memorandum
from Lawrence A. D'Hoostelaere on "General safety testing of
botulinum toxoid," March 2, 1994.
141. Review by Ann Sutton, Vaccines and Allergenics, DBIND,
Food and Drug Administration, to the IND record, November 14,
142. Informational material for the use of pentavalent
(ABCDE) botulinum toxoid aluminum phosphate adsorbed, U.S.
Department of Health and Human Services, Centers for Disease
Control, Atlanta, Georgia, Revised May 1982, protocol #392.
143. Briefing, Maj. Gen. Ron Blanck, Commanding General,
Walter Reed Army Hospital, to Committee staff, 414 Russell
Senate Office Building, Washington, DC, February 4, 1994.
144. Hearing, May 6, 1994, testimony of the Rev. Dr. Barry
Walker, Persian Gulf War veteran.
145. Army Regulation 70-25, "Research and Development, Use of
Volunteers as Subjects of Research," Department of the Army,
Washington, DC, March 26, 1968.
146. Letter from Sara E. Lister, Assistant Secretary of the
Army, to Sen. John D. Rockefeller IV, Chair, Senate Committee on
Veterans' Affairs, June 15, 1994.
147. The two provisions described in this section are part of
Public Law 103-446, the Veterans' Benefits Improvement Act of
148. Veterans at Risk, op. cit.
149. Veterans and Agent Orange, Health Effects of Herbicides
Used in Vietnam, Institute of Medicine, National Academy Press,
Washington, DC, 1993.
150. News Release, Office of Public Affairs, Department of
Veterans Affairs, Washington, DC, June 13, 1994.
151. "Health Effects of Exposure to Low Levels of Ionizing
Radiation," op. cit.
152. Hearing, May 6, 1994; prepared statement of Robert J.
Temple, M.D., Director, Office of Drug Evaluation, Center for
Drug Evaluation and Research, Food and Drug Administration.
153. Public Law 102-585, 706, November 4, 1992, Agreement
with National Academy of Sciences for Review of Health
Consequences of Service during the Persian Gulf War.
154. "It is likely that a great majority of ground personnel
[in the Persian Gulf] received at least one dose and probably up
to the full 21 tablets [of pyridostigmine] dispensed," National
Institutes of Health Technology Assessment Workshop, "The
Persian Gulf Experience and Health," final statement issued June
22, 1994, p. 10. The workshop was held April 27-29, 1994.
155. News Release, Office of Public Affairs, Department of
Veterans Affairs, July 20, 1994.
156. B-257173, GAO letter to Senator John D. Rockefeller IV,
Chair, Senate Committee of Veterans' Affairs, on the location of
veterans' service medical records, May 4, 1994.
157. Hearing, May 6, 1994; testimony of Leonard A. Cole,
Ph.D., professor, Rutgers University.
159. San Francisco Chronicle, December 22, 1976, page 1.
160. Cole, L.A. Clouds of Secrecy, The Army's Germ Warfare
Tests Over Populated Areas, Rowman and Littlefield, 1988, pp.
161. Hearing, May 6, 1994; testimony of Earl P. Davenport,
veteran and former employee, Dugway Proving Ground.
162. Memorandum of phone interview with Dr. Michael Vance,
Good Samaritan Hospital, Phoenix, AZ, March 21, 1994; in
163. "UMA Seeks Health and Safety Controls at Dugway,"
Bulletin of the Utah Medical Society, May 1992, Vol. 40, No. 5,
p. 1; "UMA Joins Lawsuit Against Army," Bulletin of the Utah
Medical Society, June 1992, Vol. 40, No. 6, p. 1; in Committee
164. Hearing, May 6, 1994; testimony of Dr. Cole.
166. Phone interview, Patrick Casula, Office of Grants and
Program Systems, U.S. Department of Agriculture, October 12,
167. "Summary of Findings and Recommendations, Review of the
Office of Health and Environmental Research Program, Protection
of Human Research Subjects," Subcommittee of the Health and
Environmental Research Advisory Committee, U.S. Department of
Energy, May 1994.
168. Annas, G.J. & Grodin, M.A. "The Nazi Doctors and the
Nuremberg Code," Human Rights in Human Experimentation, Oxford
University Press, 1992, p. 209.
169. Ibid., pp. 212-214.
170. United States v. Stanley, 107 S. Ct. 3054 (1987), cited
in "The Nazi Doctors and the Nuremberg Code," Human Rights in
Human Experimentation, Annas, G.J. & Grodin, M.A., Oxford
University Press, 1992, pp. 212-214.
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