For At Least 50 Years, DOD Has Intentionally
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 century.
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 later. 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."
(Note 69)
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 service-connected.
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 exposures.
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)
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 the experiments.
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
investigational drugs.
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. (Note 77)
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." (Note 84)
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 to refuse.
· 2. Military personnel were not informed about
the risks of the investigational drugs.
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)
DOD Incorrectly Claims That Since
Their Goal Was Treatment, The Use Of Investigational Drugs In The Persian
Gulf War Was Not Research
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.
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. (Note 99)
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 apparently inadequate.
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. (Note 106)
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.
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 unlikely.
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)
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 too high.
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 years earlier.
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)
Pyridostigmine May Be More Dangerous
In Combination With Pesticides And 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 other
substances.
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 136)
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.
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. (Note 142)
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.
Records Of Anthrax Vaccinations Are
Not Suitable To Evaluate Safety
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. (Note 144)
Army Regulations Exempt Informed
Consent For Volunteers In Some Types Of Military Research
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 145)
·
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 nerve agents.
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.
Army Regulations Exempt Informed
Consent For Volunteers In Some Types Of Military Research
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 effects.
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 pesticide
exposures.
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.
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 necessary data.
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
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.
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 simulant.
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 simulant'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 civilian.
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 refused.
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. (Note 163)
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)