|
|
Department of Veterans Affairs |
Report
ON THE ASSOCIATION BETWEEN ADVERSE HEALTH EFFECTS
AND EXPOSURE TO AGENT ORANGE
CLASSIFIED
CONFIDENTIAL STATUS (1)
As Reported by Special Assistant
Admiral E.R. Zumwalt, Jr.
May 5, 1990
|
|
NOT FOR
PUBLICATION AND RELEASE TO THE
GENERAL PUBLIC |
On October 6, 1989 I was appointed as special
assistant to Secretary Derwinski of the Department of Veterans Affairs to
assist the Secretary in determining whether it is at least as likely as not
that there is a statistical association between exposure to Agent Orange and a
specific adverse health effect.
As special assistant, I was entrusted with
evaluating the numerous data relevant to the statistical association between
exposure to Agent Orange and the specific adverse health effects manifested by
veterans who saw active duty in Vietnam. Such evaluations were made in
accordance with the standards set forth in Public Law 98-542, the Veterans’
Dioxin and Radiation Exposure Compensation Standards Act and 38 C.F.R. 1.17,
regulations of the Department of Veterans Affairs concerning the evaluation of
studies relating to health effects of dioxin and radiation exposure.
Consistent with my responsibilities as special
assistant, I reviewed and evaluated the work of the Scientific Council of the
Veterans’ Advisory Committee on Environmental Hazards and commissioned
independent scientific experts to assist me in evaluating the validity of
numerous human and animal studies on the effects of exposure to Agent Orange and/or
exposure to herbicides containing 2,3,7,8 tetrachlorodibenzo-para-dioxin (TCDD
or dioxin). In addition, I reviewed and evaluated the protocol and standards
employed by government sponsored studies
2
to
assess such studies’ credibility,
fairness and consistency with generally accepted scientific practices.
After reviewing the scientific literature
related to the health effects of Vietnam Veterans exposed to Agent Orange as
well as other studies concerning the health hazards of civilian exposure to
dioxin contaminants, I conclude that there is adequate evidence for the
Secretary to reasonably conclude that it is at least as likely as not that
there is a relationship between exposure to Agent Orange and the following
health problems: non—Hodgkin’s lymphoma, chloracne and other skin disorders,
lip cancer, bone cancer, soft tissue sarcoma, birth defects, skin cancer,
porphyria cutanea tarda and other liver disorders, Hodgkin’s disease,
hematopoietic diseases, multiple myeloma, neurological defects, auto—immune
diseases and disorders, leukemia, lung cancer, kidney cancer, malignant
melanoma, pancreatic cancer, stomach cancer, colon cancer,
nasal/pharyngeal/esophageal cancers, prostate cancer, testicular cancer, liver
cancer, brain cancer, psychosocial effects and gastrointestinal diseases.
I further conclude that the Veterans’ Advisory
Committee on Environmental Hazards has not acted with impartiality in its
review and assessment of the scientific evidence related to the association of
adverse health effects and exposure to Agent Orange.
In addition to providing evidence in support of
the conclusions stated above, this report provides the Secretary with
3
a review of the
scientific, political and legal efforts that have occurred over the last decade
to establish that Vietnam Veterans who have been exposed to Agent Orange are in
fact entitled to compensation for various illnesses as service-related
injuries.
II. AGENT
ORANGE USAGE IN
VIETNAM
Agent Orange was a 50:50 mixture of 2,4-D and
2,4,5-T. The latter component, 2,4,5-T, was found to contain the contaminant
TCDD or 2,3,7, 8-tetrachlorodibenzo-para-dioxin (i.e. dioxin), which is
regarded as one of the most toxic chemicals known to man.1
From 1962 to 1971 the United States military
sprayed theherbicide Agent Orange to accomplish the following objectives: 1)
______________________
1 See CDC Protocol for
Epidemiologic Studies on the Health of Vietnam Veterans (November, 1983), p. 4
( The CDC Protocol also contains a literature review as of 1983 of the health
effects on animals and humans exposed to herbicides and dioxin, pp. 63-78. The
literature review documents health problems such as chloracne, immunological
suppression, neurological and psychological effects, reproductive problems such
as birth defects, carcinogenic effects such as soft tissue sarcomas, lymphomas
and thyroid tumors, and various gastrointestinal disorders) ; See also General
Accounting Office, "Report by the Comptroller General: Health Effects of
Exposure to Herbicide Orange in South Vietnam Should Be Resolved,"
GAO-CED-79-22 at 2 (April 6, 1979) (hereinafter GAO Report, 1979).
Dioxin is a family of chemicals (75 in all) that
does not occur naturally, nor is it intentionally manufactured by any industry.
The most toxic dioxin is called 2,3,7,8 — TCDD. Dioxins are produced as
byproducts of the manufacture of some herbicides ( for example, 2,4, 5—T), wood
preservatives made from trichlorophenals, and some germicides. Dioxins are also
produced by the manufacture of pulp and paper, by the combustion of wood in the
presence of chlorine, by fires involving chlorinated benzenes and biphenyls
(e.g. PCBs), by the exhaust of automobiles burning leaded fuel, and by
municipal solid waste incinerators
4
defoliate
jungle terrain to improve observation and prevent enemy ambush; 2) destroy food
crops; and 3) clear Vegetation around military installations, landing zones,
fire base camps, and trails 2
Unlike civilian applications of the components
contained in Agent Orange which are diluted in oil and water, Agent Orange was
sprayed undiluted in Vietnam. Military applications were sprayed at the rate of
approximately 3 gallons per acre and contained approximately 12 pounds of 2,4-D
and 13.8 pounds of 2,4,5-T.3
Although the military
dispensed Agent Orange in concentrations 6 to 25 times the manufacturer’s
suggested rate, "at that time the Department of Defense (DOD) did not
consider herbicide orange toxic or dangerous to humans and took few precautions
to prevent exposure to it."’ Yet, evidence readily suggests that at the
time of its use experts knew that Agent Orange was harmful to military
personnel.5
__________________
2 See Bruce Myers, "Soldier of Orange:
The Administrative, Diplomatic, Legislative and Litigatory Impact of Herbicide
Agent Orange in South Vietnam," 8 B. C. Env’t. Aff. L. Rev. 159,
162 (1979).
3 See GAO Report, 1979 at 2, 3 n.1; See also Myers, 8 B.C. Env’t Aff. L. Rev, at 162. In contrast, civilian applications
of 2,4,5—T varied from 1 to 4 pounds
per acre.
4 General Accounting
Office, ‘Ground Troops in South Vietnam Were in Areas Sprayed with Herbicide
Orange," FPCD 80-23, p.1 (November 16, 1979).
5 Letter from Dr. James
R. Clary to Senator Tom Daschle (September 9, 1988). Dr. Clary is a former
government scientist with the Chemical Weapons. Branch,. BW/CW Division, Air
Force Armament Development Laboratory, Eglin APE, Florida. Dr. Clary was
instrumental in designing the specifications for the A/A 45y-l spray tank (ADO 42) and was also the scientist who
prepared the
5
The
bulk of Agent Orange herbicides used in Vietnam were reportedly sprayed from
"Operation Ranch Hand" fixed wing aircraft. Smaller quantities were
applied from helicopters, trucks, riverboats, and by hand. Although voluminous
records of Ranch Hand missions are contained in computer records, otherwise
known as the HERBS and Service HERBs tapes, a significant, if not major source
of exposure for ground forces was from non— recorded, non Ranch Hand
operations.6
Widespread use of Agent Orange coincided with
the massive buildup of U.S. military personnel in Vietnam, reaching a peak in
_________________
final report on Ranch Hand: Herbicide Operations
in SEA, July 1979. According to Dr. Clary:
When we (military
scientists) initiated the herbicide program in the 1960’s, we were aware of the
potential for damage due to dioxin contamination in the herbicide. We were even
aware that the ‘military6 formulation had a higher dioxin
concentration than the ‘civilian’ version due to the lower cost and speed of
manufacture. However, because the material was to be used on the ‘enemy’, none
of us were overly concerned. We never considered a scenario in which. our own
personnel would become contaminated with the herbicide. And, if we had, we
would have expected our own government to give assistance to veterans so
contaminated.
See also notes 13, 73-75 and accompanying text
infra for additional information of the manufacturer’s awareness of the
toxicity of Agent Orange.
6 Combat units, such as the ‘Brown Water Navy,’ frequently conducted
"unofficial" sprayings of Agent Orange obtained from out of channel,
and thus unrecorded sources. Additionally, as Commander, U.S. Naval Forces, Vietnam, I was aware that Agent Orange issued to Allied
forces was frequently used on unrecorded missions.
6
1969
and eventually stopping in 1971. 7 Thus, according to an official of
the then Veterans Administration, it was "theoretically possible that
about 4.2 million American soldiers could have made transient or significant
contact with the herbicides because of [the Ranch Hand Operation]." 8
Beginning as early as 1968, scientists, health
officials, politicians and the military itself began to express concerns about
the potential toxicity of Agent Orange and its contaminant dioxin to humans.
For instance, in February 1969 The Bionetics Research Council Committee
("BRC’) in a report commissioned by the United States Department of
Agriculture found that 2,4,5-T showed a "significant potential to increase
birth defects." 9 Within
four months after the BRC report, Vietnamese newspapers began reporting
significant increases in human birth defects ostensibly due to exposure to
Agent Orange.10
______________
7 GAO Report 1979, supra note 1, at 29. See
also note 82 and accompanying text infra for a discussion of the correlation
between the spraying of Agent Orange and the hospitalization of Vietnam
soldiers for disease and non-battle related injuries.
8 House Comm. on
Veteran’s Affairs, 95th Cong., 2d Sess., Herbicide "Agent Orange".
Hearings before the Subcommittee on Medical Facilities and Benefits, (Oct.
11, 1978) (Statement of Maj. Sen. Garth Dettinger USAF, Deputy Surgeon General
USAF at 12).
9 Myers at 166.
10 Id
While birth defects did significantly increase in Saigon, critics contend that
Saigon was not an area where the preponderance of defoliation missions were
flown and argue that such increases were due primarily to the influx of U.S.
medical personnel who kept better records of birth defects. Subsequent
7
By
October, 1969, the National Institute of Health confirmed that 2,4,5—T could
cause malformations and stillbirths in mice, thereby prompting the Department
of Defense to announce a partial curtailment of its Agent Orange spraying.11
By April 15, 1970, the public outcry and
mounting scientific evidence caused the Surgeon General of the United States to
issue a warning that the use of 2,4,5-T might be hazardous to "our
health". 12
On the same day, the Secretaries of Agriculture,
Health Education and Welfare, and the Interior, stirred by the publication of
studies that indicated 2,4,5-T was a teratogen (i.e. caused birth defects),
jointly announced the suspension of its use around lakes, ponds, ditch banks,
recreation areas and
__________________
studies in Vietnam
confirm the incidence of increased birth defects among civilian populations
exposed to Agent Orange. See e.g. Phuong, et. al. "An Estimate of
Reproductive Abnormalities in Women Inhabiting Herbicide Sprayed and
Non-herbicide Sprayed Areas in the South of Vietnam, 152-1981 18 Chemospere
843-846 (1989) (significant statistical difference between hydatidiform mole
and congenital malformations between populations potentially exposed and not
exposed to TCDD); Phuong, et. al., "An Estimate of Differences Among Women
Giving Birth to Deformed Babies and Among Those with Hydatidiform Mole Seen at
the OB-GYN Hospital of Ho Chi Minh City in the South of Vietnam," 18 Chemosphere 801-803 (1989) (statistically
significant connection between frequency of the occurrence of congenital
abnormalities and of hydatidiform moles and a history of phenoxyherbicide
exposure); Huong, et. al., "An Estimate of the Incidence of birth Defects,
Hydatidiform Mole and Fetal Death in Utero Between 1952 and 1985 at the OB-GYN
Hospital of Ho Chi Minh City, Republic of Vietnam," 18 Chemosphere
805-810 (l989) (sharp increase in the rate of fetal death in utero,
hydatidiform mole (with or without choriocarcinoma) and congenital
malformations from the pre 1965-1975 period, suggesting possible association to
phenoxyherbicide exposure).
11 Myers at 167
12 Id.
8
homes
and crops intended for human
consumption.13 The Department of Defense simultaneously announced
its suspension of all uses of Agent Orange.14
As Agent
Orange concerns grew, numerous independent studies were conducted between 1974
and 1983 to determine if a link exists between certain cancerous diseases, such
as non-Hodgkin’s lymphoma and soft-tissue sarcomas, and exposure to the
chemical components found in Agent Orange. These studies suggested just such a
link.
In 1974, for example, Dr. Lennart Hardell began
a study which eventually demonstrated a statistically significant correlation
between exposure to pesticides containing dioxin and the development of soft
tissue sarcomas.15
_________________________
13
Id. Although Dow Chemical
Company, the primary manufacturer of 2,45-T and 2,4-D, denied this
teratogenicity, Dow’s own tests confirmed that when dioxin was present in
quantities exceeding production specifications, birth defects did occur. See J.
McCullough, Herbicides: Environmental Health Effects: Vietnam and the Geneva
Protocol: Developments During 1979, 13 (1970) (Congressional Research
Report No. UG 447, 70—303SP). Pressure from industry subsequently led to some
relaxation of the limits placed on the 2,4,5—T and 2,4—D. The only current uses
for these chemicals in the United States are on rice, pastures, rangelands and
rights of way.
14
Id. at 167. See also Dow
Chemical v. Ruckelshaus, 477 F.2d 1317, 1319 (8th Cir. 1973) (secretaries
announcement quoted in the opinion).
15 Hardell, L. and
Sandstrom, A. "Case—control Study: Soft Tissue Sarcomas and Exposure to
Phenoxyacetic Acids or Chlorophenols," 39 Brit. J. Cancer, 711—717
(1979). See also note 89 infra for the confirming results of
follow-up studies by Hardell and others.
9
In
1974, Axelson and Sundell reported a two—fold increase of cancer in a cohort
study of Swedish railway workers exposed to a variety of herbicides containing
dioxin contaminants.16
By 1976, the Occupational Safety and Health
Administration, established rigorous exposure criteria for workers working with
2,4, 5-T.1 17
In 1977 the International Agency for Research on
Cancer (IARC), while cautioning that the overall data was inconclusive,
reported numerous anomalies and increased mortality rates in animals and humans
exposed to 2,4-D or 2,4,5-T.18
________________________
16 Axelson and Sundell,
"Herbicide Exposure, Mortality and Tumor Incidence: An Epidemiological
Investigation on Swedish Railroad Workers," 11 Work Env’t. Health 21-28
(1974).
17 U.S. Occupational Safety and Health
Administration (1976), Air Contaminants; U.S. Code, Federal Register 29, Part
1910.93 at p. 27
18 With regard to 2,4-D, the IARC found the
following anomalies: elevated levels of cancer in rats; acute and short—term
oral toxicity in mice, rabbits, guinea pigs and rats-—death, stiffness in the
extremities, incoordination, stupor, myotonia, and other physical
abnormalities; inmonkeys, injections caused nausea, vomiting, lethargy,
muscular incoordination and head droop, fatty degeneration of the liver,
spleen, kidneys and heart; foetal anomaly increases in some species; post—birth
death rates increased in some. species; higher mortality rates and
morphological alterations in pheasant embryos and their chicks when spraying
took place under simulated field conditions; higher mortality rates in rat pups
in a 3 generation exposure; gene mutation after exposure to high
concentrations; chromosomal aberrations when cultured human lymphocytes were
exposed; increased frequency of aberrant metaphases (2 to 4 times) in mice
exposed to toxic concentrations.
In humans the IARC found that: a 23 year old
farming student, a suicide, had 6 grams of 2,4-D in his body, acute congestion
of all organs, severe degeneration of ganglion cells in the central nervous
system; 3 cases of peripheral neuropathy in humans sprayed with 2,4-D with
initial symptoms of nausea, vomiting, diarrhea, swelling and aching of feet and
legs with latency, in individual
cases, paresthesia in the extremities, pain in the legs, numbness and aching of
fingers and toes, swelling in hand joints, flaccid
10
In
1978, the Environmental Protection Agency issued an emergency suspension of the
spraying of 2,4,5-T in national forests after finding "a statistically
significant increase in the frequency of miscarriages" among women living
near forests sprayed with 2,4,5-T.19
In 1980, another provocative mortality study of
workers
_____________________
parapheresis; similar case reports in
agriculture workers sprayed by 2,4-D; workers associated with 2,4—D developed
symptoms of somnolence, anorexia, gastralgia, increased salivation, a sweet
taste in the mouth, a sensation of drunkenness, heaviness of the legs and
hyperacusea, rapid fatigue, headache, loss of appetite, pains in the region of liver
and stomach, weakness, vertigo, hypotension, bradycardia, dyspeptic symptoms,
gastritis, liver disfunction, changes in metabolic processes..
With regard to 2,4,5—Vs effect on animals the
IARC found: it can increase the frequency of cleft palates in some strains of
mice; fetal growth retardation may also be observed; cystic kidneys were
observed in two strains of mice; in purest available form, it induced some
fetal effects and skeletal anomalies in rats as well as behavioral
abnormalities, changes in thyroid activity and brain serotonin levels in the
progeny; increases in intrauterine deaths and in malformations in rats; fetal
death and teratogenic effects in Syrian golden hamsters; chromosomal
abnormalities.
The IARC reported in 1977 with respect to 2,4,5-T’s
effects on humans that: workers exposed at a factory in the USSR had skin
lesions, acne, liver impairment, and neurasthenic syndrome; similar findings
were reported by Jerasneh, et al (1973, 1974) in a factory in Czechoslovakia
which in 1965—68 produced 76 cases of chloracne, 2 deaths from bronchogenic
cancers. Some workers had porphyria cutanea tarda, urophryimuria, abnormal
liver tests, severe neurasthenia, depression syndrome, peripheral neuropathy;
in a 1975 accident in West Virginia, 228 people were affected. Symptoms
included chloracne, melanosis, muscular aches and pains, fatigue, nervousness,
intolerance to cold; 4 workers of 50 affected in a similar accident in the
Netherlands in 1963 died within 2 years and at least 10 still had skin complaints
13 years later.
19
June 1979 Congressional Hearings before House Commerce Committee.
Subcommittee on Oversight and Investigations, quoted in "Human Disease
Linked to Dioxin: Congress Calls for 2,4,5—T Ban After Dramatic Herbicide
Hearings", 28 Bioscience 454 (August 1979). This study, otherwise known as
the Alsea Study, has been cited as
showing the first correlation between 2,4,5—T (and presumably its TCDD
contaminant) and teratogenic effects in humans.
11
involved in an
accident at an industrial plant which manufactured dioxin compounds suggested
that exposure to these compounds resulted in excessive deaths from neoplasms of
the lymphatic and hematopoietic tissues. 20
On September 22, 1980, the U.S. Interagency Work
Group to Study the Long-term Health Effects of Phenoxy Herbicides and
Contaminants concluded "that despite the studies’ limitations, they do
show a correlation between exposure to phenoxy acid herbicides and an increased
risk of developing soft-tissue tumors or malignant lymphomas."21
To be sure, there remain skeptics who insist
that the studies failed in one respect or another to establish a scientifically
acceptable correlation.22 Yet, it can fairly be said that the general attitude
both within and outside the scientific community was, and continues to be
increasing concern over the mounting evidence of a connection between certain
cancer
___________________
20 Zack and Suskind,
"The Mortality Experience of Workers Exposed to TCDD in a Trichlorophenol
Process Accident," 22 Journal of Medicine 11—14 (1980).
21 See U.S. Interagency
Workgroup to Study the Long-Term Health Effects of Phenoxy Herbicides and
Contaminants (September 22, 1980) (executive summary).
22 See...e.g. "The Weight of the Evidence on
the Human Carcinogenicity of 2,4—D" (January 1990) (This report, sponsored
by the National Association of Wheat Growers Foundation and a grant from the
Industry Task Force II on 2,4—D Research Data, an association of manufacturers
and commercial formulators of 2,4—D, concluded that the toxicological data on
2,4-D does not provide a strong basis for predicting that 2,4-D is carcinogenic
to humans. Nevertheless, the panel reviewing the evidence did conclude that
"evidence indicates that it is possible that exposure to 2,4-D can cause cancer in humans.").
12
illnesses and
exposure to dioxins.
III. VETERANS’ DIOXIN AND RADIATION EXPOSURE COMPENSATION
STANDARDS ACT OF 1984
With the increasing volume of scientific
literature giving credence to the belief of many Vietnam Veterans that exposure
to Agent Orange during their military service was related to their contraction
of several debilitating diseases -- particularly non-Hodgkin’s lymphoma, soft
tissue sarcoma ("STS") (malignant tumors that form in muscle fat, or
fibrous connective tissue) and porphyria cutanea tarda ("PCT")
(deficiencies in liver enzymes) --Vietnam Veterans rightfully sought disability
compensation from the Veterans Administration ("VA").
The VA determined, however, that the vast
majority of claimants were not entitled to compensation since they did not have
service connected illnesses. 23
As a consequence, Congress attempted to alter dramatically the process
governing Agent Orange disability claims through passage of the Veterans’
Dioxin and Radiation Exposure Compensation Standards Act of 1984
________________________
23 By October 1, 1983,
9170 veterans filed claims for disabilities that they alleged were caused by
exposure to Agent Orange. The VA denied compensation to 7709 claimants on the
grounds that the claimed diseases were not service connected. Only one disease
was deemed associated with service related exposure to Agent Orange, a skin
condition known as chloracne. See House Report No. 98-592, reprinted in
U.S.Code Cong. & Adm. News, 98th Cong. 2d Sess.,1984, at 4452. See also Nehmer
v. U.S. Veterans Administration, 712 F.Supp. 1404, 1407 (1989).
13
(hereinafter the "Dioxin Standards
Act") 24 To ensure
that the VA provided disability compensation to veterans exposed to herbicides
containing dioxin while serving in Vietnam,25 Congress authorized
the VA to conduct rulemaking to determine those diseases that were entitled to
compensation as a result of a service--related exposure to Agent Orange.26
In promulgating such rules, the Dioxin Standards
Act required the VA to appoint a Veterans’ Advisory Committee on Environmental
Hazards (the "Advisory Committee") -- composed of experts in dioxin,
experts in epidemiology, and interested members of the public -- to review the
scientific literature on dioxin and submit periodic recommendations and
evaluations to the Administrator of the 27 Such experts were directed to evaluate the scientific evidence
pursuant to regulations promulgated by the VA, and thereafter to submit
recommendations
___________________
24 Veterans’ Dioxin and Radiation Exposure
Compensation Standards Act, Pub. L. 98—542, Oct. 24, 1984, 98 Stat. 2727
(hereinafter the Dioxin Standards Act). In passing the Act Congress found that
Vietnam Veterans were "deeply concerned about possible long term health
effects of exposure to herbicides containing dioxin,"(Section 2 (1)),
particularly since "(t)here is scientific and medical uncertainty
regarding such long—term adverse health effects." (Section 2 (2)). In
responding to this uncertainty, Congress mandated that "thorough
epidemiological studies of the health effects experienced by veterans in
connection with exposure . to herbicides containing dioxin" be conducted,
(Section 2(4)), especially in light of the fact that "[t)here is some
evidence that chloracne, porphyria cutanea tarda, and soft tissue sarcoma are
associated with exposure to certain levels of dioxin as found in some
herbicides." (Section 2 (5)).
25 Id. at Section 3.
26 Id. at Section 5.
27 Id. at Section 6.
14
and
evaluations to the Administrator of the VA on whether "sound scientific or
medical evidence" indicated a connection to exposure to Agent Orange and
the manifestation of various diseases.28
In recognition of the
uncertain state of scientific evidence and the inability to make an absolute
causal connection between exposure to herbicides containing dioxin and
affliction with various rare cancer diseases,29 Congress mandated
that the VA Administrator resolve any doubt in favor of the veteran seeking
compensation. As stated in the Dioxin Standards Act:
It has always been the
policy of the Veterans Administration and is the policy of the United States,
with respect to individual claims for service connection of diseases and
disabilities, that when, after consideration of all the evidence and material
of record, there is an approximate balance of positive and negative evidence
regarding the merits of an issue material to the determination of a claim, the benefit of the doubt in resolving
each such issue shall be given to the claimant. 30
Despite Congressional intent to give the veteran
the benefit of the doubt, and in direct opposition to the stated purpose of
_____________________
28 Id. at Section
5.
29 See Nehmer v. U.S.
Veterans Admin., 712 F. Supp. 1404, 1408. (N.D. Cal. (1989). wherein the
court found after reviewing the legislative history of the Act "that
Congress intended service connection to be granted on the basis of
"increased risk of incidence" or a "significant
correlation" between dioxin and various diseases," rather than on the
basis of a casual relationship.
30 See Dioxin Standards
Act at Section 2 (23).
15
the
Dioxin Standards Act to provide disability compensation to Vietnam Veterans
suffering with cancer who were exposed to Agent Orange, the VA continued to
deny compensation improperly to over 31,000 veterans with just such claims. In
fact, in promulgating the rules specified by Dioxin Standards Act, the VA not
only confounded the intent of the Congress, but directly contradicted its- own
established practice of granting compensable service-connection status for
diseases on the lesser showing of a statistical association, promulgating
instead the more stringent requirement that compensation depends on
establishing a cause and effect relationship.31
Mounting a challenge to the regulations,
Veterans groups prosecuted a successful legal action which found that the VA
had "both imposed an impermissibly demanding test for grantingservice
connection for various diseases and refused to give the
___________________
31 See e.g. 38 C.F.R.
3.310(b) (compensation granted for cardiovascular diseases incurred by veterans
who suffered amputations of legs or feet); Nehmer at 1418.
The significance of the distinction between a
statistical association and a cause and effect relationship is in the burden of
proof that the veteran must satisfy in order to be granted benefits. A
statistical association "means that the observed coincidence in variations between exposure to the toxic
substance and the adverse health effects is unlikely to be a chance occurrence
or happenstance," whereas the cause and effect relationship
"describes a much stronger relationship between exposure to a particular
toxic substance and the development of a particular disease than ‘statistically
significant association’ does." Nehmer, 712 F.Supp. at 1416.
Thus, the regulation promulgated by the VA
established an overly burdensome standard by incorporating the causal
relationship test within the text of the regulation itself. 38 C.F.R. 1
3.311(d) ("(s] ound scientific and medical evidence does not establish a cause
and effect relationship between dioxin exposure" and any diseases
except some cases of chloracne) (emphasis added).
16
veterans
the benefit of the doubt in meeting the demanding standard." Nehmer v.
U.S. Veterans Administration, 712 F. Supp. 1404, 1423 (1989) (emphasis in
original). As a result, the court invalidated the VA’s Dioxin regulation which
denied service connection for all diseases other than chloracne; ordered the VA
to amend its rules; and further ordered that the Advisory Committee reassess
its recommendations in light of the court’s order.32
Thus, on October 2, 1989, the VA amended 38
C.F.R. Part 1, which among other things set forth various factors for the
Secretary and the Advisory Committee to consider in determining whether it is
"at least as likely as not" that a scientific study shows a
"significant statistical association" between a particular exposure
to herbicides containing dioxin and a specific adverse health effect.33 Equally
important, the
_________________
32 Nehmer, 712 F. Supp at
1423.
33 38 C.F.R. 1.17 (b) & (d). 38 C.F.R.
1.17 states:
(a) From time to time, the Secretary shall publish evaluations of scientific or
medical studies relating to the adverse health effects of exposure to a
herbicide containing 2,3,7,8 tetrachlorodibenzo-p-dioxin (dioxin) and/or
exposure to ionizing radiation in the "Notices" section of the Federal
Register.
(b) Factors to be considered in evaluating scientific studies include:
(1) Whether the study’s findings are statistically significant and replicable.
(2) Whether the study and its findings have withstood peer review.
(3) Whether the study methodology has been sufficiently described to permit
replication of the study.
(4) Whether the study’s findings are applicable to the veteran population of
interest.
(5) The views of the appropriate panel of the Scientific Council of the
Veteran’ Advisory Committee on Environmental Hazards.
(c) When the Secretary determines, based on the evaluation of
17
regulation
permits the Secretary to disregard the findings of the Advisory Committee, as
well as the standards set forth at 38
____________________
scientific or medical studies and after
receiving the advice of the Veteran’s Advisory Committee on Environmental
Hazards and applying the reasonable doubt doctrine as set forth in paragraph
(d) (1) of this section, that a significant statistical association exists
between any disease and exposure to a herbicide containing dioxin or exposure
to ionizing radiation, 3.311a or 3.311b of this title, as appropriate, shall be
amended to provide guidelines for the establishment of service connection.
(d) (1) For purposes of paragraph (c) of this section a "significant
statistical association" shall be deemed to exist when the relative
weights of valid positive and negative studies permit the conclusion that it is
at least as likely as not that the purported relationship between a particular
type of exposure and a specific adverse health effect exists.
(2) For purposes of this paragraph a valid study is one which:
(i) Had adequately described the study design and methods of data collection,
verification and analysis;
(ii) Is reasonably free of biases, such as selection, observation and
participation biases; however, if biases exist, the investigator has
acknowledged them and so stated the study’s conclusions that the biases do not
intrude upon those conclusions; and
(iii) Has satisfactorily accounted for known confounding factors.
(3) For purposes of this paragraph a valid positive study is one which
satisfies the criteria in paragraph (d) (2) of this section and whose findings
are statistically significant at a probability level of .05 or less with proper
accounting for multiple comparisons and subgroups analyses.
(4) For purposes of this paragraph a valid negative study is one which
satisfies the criteria in paragraph (d) (2) of this section and has sufficient
statistical power to detect an association between a particular type of
exposure and a specific adverse health effect if such an association were to
exist.
(e) For purposes of assessing the relative weights of valid positive and
negative studies, other studies affecting epidemiological assessments including
case series, correlational studies and studies with insufficient statistical
power as well as key mechanistic and animal studies which are found to have
particular relevance to an effect on human organ systems may also be
considered.
(f) Notwithstanding the provisions of paragraph (d) of this section, a
"significant statistical association" may be deemed to exist between
a particular exposure and a specific disease if, in the Secretary’s judgment,
scientific and medical evidence on the whole supports such a decision.
18
C.F.R. § 1.17 (d) and
determine in his own judgment that the scientific and medical evidence supports the existence of a "significant
statistical association" between a particular exposure and a specific
disease. 38 C.F.R. § 1.17 (f).
The Secretary recently exercised his
discretionary authority under this rule when he found a significant statistical
association between exposure to Agent Orange and non—Hodgkin’s lymphoma,
notwithstanding the failure of his own Advisory Committee to recommend such
action in the face of overwhelming scientific data.34
B. . THE WORK OF THE VETERANS’ ADVISORY
COMMITTEE ON ENVIRONMENTAL HAZARDS
To assess the validity and competency of the
work of the Advisory Committee, I asked several impartial scientists to
______________________
34 After reviewing numerous scientific
studies, at least four of which were deemed to be valid positive in
demonstrating the link . between exposure to herbicides containing dioxin and
non--Hodgkin’s lymphoma, the Advisory Committee still concluded that:
The Committee does not
find the evidence sufficient at the present time to conclude that there is a
significant statistical association between exposure to phenoxy acid herbicides
and non—Hodgkin’s lymphoma. However, the Committee cannot rule out such an
association.
The Secretary should be interested to note that a new mortality study positively
confirms that farmers exposed to herbicides containing 2,4-D have an increased
risk of developing non-Hodgkin’s lymphoma. See Blair, "Herbicides and
Non-Hodgkin’s Lymphoma: New Evidence From a Study of Saskatchewan Farmers,"
82 Journal of the National Cancer Institute 575--582 (1990).
19
review the Advisory Committee transcripts.
Without exception, the experts who reviewed the work of the Advisory Committee
disagreed with its findings and further questioned the validity of the Advisory
Committee’s review of studies on non—Hodgkin’s lymphomas .
For instance, a distinguished group at the Fred
Hutchinson Cancer Research Institute in Seattle, Washington, upon reviewing the
Advisory Committee transcripts, concluded "that it is at east., as likely
as not that there is a significant association (as defined by the Secretary of Veterans Affairs) between (exposure
to phenoxy acid herbicides and non-Hodgkin’s lymphoma.)" 35 This same
group further asserts that the Committee’s work was "not sensible"
and "rather unsatisfactory" in its review and classification of the
various studies it reviewed. Additionally, these scientists regarded Dr.
Lathrop’s views as "less than objective" and felt that the
possibility exists that "his extreme views (e.g., in respect to the role
of dose--response testing) may have unduly affected the Committee’s work."
Finally, the Hutchinson scientists argue that the issue of chemical-specific
effects, in which animal studies have been sufficient to demonstrate the carcinogenicity
of dioxin, is an important factor "not well cons idered by the
Committee." (emphasis in original)
A second reviewer of the Committee’. work, Dr.
Robert
_____________________
35 Letter to Admiral Zumwalt from Dr. Robert
W. Day, Director of the Fred Hutchinson Cancer Research Center of Seattle,
Washington (Feb. 20, 1990).
20
Hartzman
(considered one of the U.S. Navy’s top medical researchers), effectively
confirms the views of the Hutchinson group. Dr. Hartzman states that "the
preponderance of evidence from the papers reviewed [by the Advisory Committee)
weighs heavily in favor of an effect of Agent Orange on increased risk for
non—Hodgkin’s lymphoma."36 Dr. Hartzman also attests that:
an inadequate process is being used to evaluate
scientific publications for use in public policy. The process uses scientific
words like ‘significant at the 5% level’ and a committee of scientists to
produce a decision about a series of publications. But in reality, the
Committee was so tied by the process, that a decision which should have been
based on scientific data was reduced to vague impressions... Actually, if the
reading of the rules of valid negative found in the transcript is correct (‘a
valid negative must be significant at the p=.05 level’ that is statistically
significant on the negative side) none of the papers reviewed are valid
negatives. 37
A third reviewing team, Dr. Jeanne Hager
Stellman, PhD (Physical Chemistry) and Steven D. Stellman, PhD (Physical
Chemistry), also echo the sentiments expressed by the Hutchinson Group and Dr.
Hartzman on the validity of the Committee’s proceedings and conclusions. In
fact, the Stellmans’ detailed annotated bibliography and assessment of numerous
cancer studies relevant to herbicide exposure presents a stunning indictment of
the Advisory Committee’s scientific interpretation and policy judgments
regarding the link between Agent Orange and Vietnam
________________
36 Letter to Admiral
Zumwalt from Dr. R.J. Hartzman Capt. MC USN (March 7, 1990).
37 Id. at p.3
21
Veterans . 38
A fourth reviewer, a distinguished scientist
intimately associated with government sponsored studies on the effects of
exposure to Agent Orange, states the same conclusions reached by the other
reviewers:
The work of the
Veterans’ Advisory Committee on Environmental Hazards, as documented in their
November 2, 1989 transcript, has little or no scientific merit, and should not
serve as a basis for compensation or regulatory decisions of any sort...
My analysis of the NHL
articles reviewed by the committee reveals striking patterns which indicate to
me that it is much more likely than not that a statistical association exists
between NHL and herbicide exposure.
As these various reviewers suggest, the Advisory
Committee’s conclusions on the relationship between exposure to Agent Orange
and non—Hodgkin’s lymphoma were woefully understated in light of the clear
evidence demonstrating a significant statistical association between NHL and
exposure to phenoxy acid herbicides such as Agent Orange.
Perhaps more significant than the Committee’s
failure to sake such obvious findings is the distressing conclusion of the
independent reviewers that the Committee’s process is so flawed
_________________
38 See Stellman &
Stellman, "A Selection of Papers with Commentaries Relevant to the Science
Interpretation and Policy: Agent Orange and Vietnam Veterans,’ (March 1, 1990)
. See also note 51 and accompanying text infra for additional
discussion of the Stellmans’ work.
39 A
copy of the anonymous reviewer’s analysis can be madeavailable for the
Secretary’s personal .inspection and review. In another paper, this same source
stated: "I estimate that the Vietnam Veterans are experiencing a 40% to
50% increase in sarcomas and non--Hodgkin’s lymphoma rates."
22
as
to be useless to the Secretary in making any determination on the effects of
Agent Orange. From a mere reading of Committee transcripts, these reviewers
detected overt bias in the Committee’s evaluation of certain studies. In fact,
some members of the Advisory Committee and other VA officials have, even before
reviewing the evidence, publicly denied the existence of a correlation between
exposure to dioxins and adverse health effects.40 This blatant lack
of impartiality lends credence to the suspicion that certain individuals may
have been unduly influenced in their evaluation of various studies.
Furthermore, such bias among Advisory committee members suggests that the
Secretary should, in accordance with the Dioxin Standards Act, appoint new
personnel to the Advisory Committee.
Were the faulty conclusions, flawed methodology
and noticeable bias of the Advisory Committee an isolated problem, correcting
the misdirection would be more manageable. But, experience with other
governmental agencies responsible for specifically analyzing and studying the
effects of exposure to
___________________________
40 For instance, Dr.
Lawrence B. Hobson (Director, Office of Environmental Medicine, Veterans Health
Services and Research Administration), claims that TCDD ‘presents no threat
from the exposures experienced by the veterans and the public at large,"
and virtually accuses scientists who find that such health effects do exist to
be nothing more than witch doctors. See Hobson, ‘Dioxin and Witchcraft"
presented at the 5th InternatiOnal Symposium on Chlorinated Dioxins and Related
Compounds (September 1985) .
23
Agent
Orange strongly hints at a discernible pattern, if not outright governmental
collaboration, to deny compensation to Vietnam Veterans for disabilities
associated with exposure to dioxin .
A case in point is the Centers for Disease
control ("CDC") . As concerns grew following the first studies of
human exposure to Agent Orange, Congress commissioned a large scale
epidemiological study to determine the potential health effects for Vietnam
Veterans exposed to Agent Orange. Initially, this study was to be conducted by
the VA itself. When evidence surfaced, however, of the VA’s footdragging in
commencing the study (and initial disavowal of any potential harm from exposure
to Agent Orange), Congress transferred the responsibility for the study to the
CDC in 1983. 41
Unfortunately, as hearings before the Human
Resources and Intergovernmental Relations Subcommittee on July 11, 1989
revealed, the design, implementation and conclusions of the CDC study were so
ill conceived as to suggest that political pressures once again interfered with
the kind of professional, unbiased review Congress had sought to obtain.42
The Agent Orange validation study, for example,
a study of
_______________________
41 See 135 Congressional
Record, Statement of Senator Tom Daschle (November 21, 1989); See also
Agent Orange Hearings at p.37.
42 Oversight Review
of CDC’s Agent Orange Study: Hearing Before the Human Resources and Intergovernmental
Relations Subcommittee of the Committee on Government Overations House of
Representatives, 101st Cong., 1st Sess. at p. 71 and 330 (1989)
[hereinafter cited as Agent Orange Hearing].
24
the
long—term health effects of exposures to herbicides in Vietnam, was supposedly
conducted to determine if exposure could, in fact, be estimated.43 After
four years and approximately $63 million in federal funds, the CDC concluded
that an Agent Orange exposure study could not be done based on military
records. 44 This conclusion was based on the results of blood tests
of 646 Vietnam Veterans which ostensibly demonstrated that no association
existed between serum dioxin levels and military— based estimates of the likelihood of exposure
to Agent Orange.45 Inexplicably, the CDC then used these
"negative" findings to conclude that not only could an exposure study
not even be done, but that the "study" which was never even conducted
proves that Vietnam Veterans were never exposed to harmful doses of Agent
Orange.
Even more disturbing, when the protocol for this
"study" and the blood test procedures were examined further, there
appeared to be a purposeful effort to sabotage any chance of a meaningful Agent
Orange exposure analysis. For , the original protocol for the Agent Orange
exposure study understandably called for subject veterans to be tracked by
company level
______________________
43 Id. at 37; See
also, Protocol for Epidemiologic Studies of the Health of Vietnam Veterans,
Centers for Disease Control, Public Health Service, U.S. Department of Health
and Human Services (November, 1983).
44 Agent Orange Hearings at 13 (Statement of
Dr. Vernon Houk).
45 Id. at 12—13.
25
location.46 By tracking company level
units of 200 men, rather than battalions of 1,000 men, the location of men in
relation to herbicide applications would be known with greater precision,
thereby decreasing the probability that study-subjects would be misclassified
as having been or not been exposed to Agent Orange.
However, in 1985 the CDC abruptly changed the
protocol to have battalions, rather than companies, serve as the basis for
cohort selection and unit location. 47 By the CDC’s own admission, changing the protocol to track
veterans on the broader batta1ion basis effectively diluted the study for the
simple reason that many of the 1,000 men in a battalion were probably not
exposed to Agent Orange. Why then did the CDC change the protocol in 1985?
According to Dr. Vernon Houk, Director of the
Center for Environmental Health and Injury control, the department within the
CDC responsible for conducting the Agent Orange study, the protocol was changed
because the CDC concluded that company— specific records were unreliable and
contained too many gaps of information. As a result, military records could simply
not be used to assess exposure.48
_____________________________
46 Id. at 4l.
47 Id. at 38.
48 Agent Orange Hearing:
Testimony of Dr. Vernon Houk at 38-40 and 69. Dr. Houk sports an unbounded
skepticism for the health hazards of dioxin. He recently endorsed the lessening
of the dioxin dumping standard in the State of Georgia at a rate 500 times more
lenient than EPA recommended guidelines. See Letter from Dr. Vernon N. Houk to Leonard Ledbetteber,
Commissioner Georgia Department of Natural Resources (November 27, 1989).
26
Richard
Christian, the former director of the Environmental Study Group of the
Department of Defense ("ESG") testified that not only was this
conclusion false, but that he had personally informed the CDC that adequate
military records existed to identify company—specific movements as well as
spray locations.49 Furthermore, in a February 1985 report to the
Congressional Office of Technology Assessment, the CDC reported that in
analyzing 21 of 50 detailed computer HERBs tapes developed by the ESG on
company movements that it was possible to correlate the exposure data to areas
sprayed with Agent Orange with consistent results.50 Indeed, a peer
reviewed study sponsored by the American Legion conclusively demonstrated that
such computerized data could be used to establish a reliable exposure
classification system essential to any valid epidemiologic study of Vietnam
Veterans.51
In addition to altering the protocol from
company units to battalions, the CDC further diluted the study by changing the
protocol on the length of time study subjects were to have served in Vietnam.
Whereas the original protocol required subjects to have served a minimum of 9
months in combat companies, the CDC reduced the minimum to 6 months.
Furthermore, the CDC eliminated
_____________________
49 Agent Orange Hearing,
Testimony of Richard Cheristian at 41.
50 Interim Report, Agent
Orange Study: Exposure Assessment: Procedures and Statistical Issues. See
Also American Legion Magazine
Special Issue, "Agent Orange" (1990) at p. 12.
51 Agent Orange Hearing
155-220 (Testimony of Steven and Jeanne Stellman); American Legion and Columbia
University Vietnam Experience Study, Environmental Research (December,
1988).
27
from
consideration all veterans who served more than one tour in Vietnam. Finally,
while the original protocol called only for subjects who served in Vietnam from
1967 to 1968, the years that Agent Orange spraying was at its height, the CDC
added an additional 6 months to this time period. The net effect of these
various changes was seriously to dilute the possibility that study subjects
would have been exposed to Agent Orange, which in turn would impair any
epidemiological study’s ability to detect increases in disease rate.52
Although the above
referenced problems cast serious suspicion on the work of the CDC, perhaps its
most controversial
__________________
52 Agent Orange Hearing at 46-49. This
"dilution effect" is considered the classic flaw in epidemiological
study design. most epidemiologists would try to optimize the chances of
observing an effect by including, rather than excluding, the subjects who are
most likely to have been exposed to the suspected disease causing agent. This
statistical ability to observe an effect if one is present is generally referred
to as the "statistical power" of a given study.
When the CDC chose to
generalize exposure to Agent Orange to groups of veterans who were less likely,
rather than more likely, to be exposed, the power of the study was diluted. For
example, if we assume that 1 out of every 5 men who served in Vietnam was
exposed to Agent Orange, any possible effects of the exposure will be diluted
when the 4 non—exposed men are averaged in. If we assume further that exposure
to Agent Orange caused a doubling of the incidence of cancers among the 20% of
men exposed, the effect would largely be obscured since 80% of the group being
studied would not have been sprayed with Agent Orange and would thus have a
normal background rate of cancer. Consequently, only exceptionally large
increases in the cancer rate would be discovered and or reach statistical
significance in a study group so diluted
from the outset. See Agent Orange Hearing at 149 (Testimony of John F. Sommer,
Jr., Director National Veterans Affairs and Rehabilitation commission the
American Legion).
See also
Agent Orange Legislation and Oversight: Hearing Before the Committee on
Veterans’ Affairs, United States Senate, 100th Cong.,(May 12, 1988) (Testimony
of Dr. Joel Nichalek) at pp. 65, 66 and 668.
28
action
was to determine unilaterally that blood tests taken more than 20 years after a
veteran’s service in Vietnam were the only valid means of determining a
veteran’s exposure to Agent Orange. In addition, Dr. Houk further
"assumed" that the half—life for dioxin in the blood was seven years.
53 When the underlying data for Houk’s assumptions were recently
reviewed, however, 11 percent of the blood tests were invalid (i.e. study
subjects had higher values of dioxin in their blood in 1987 than in 1982 even
though the subjects had no known subsequent exposure to dioxin) and the half
lives of dioxin in the remaining study subjects ranged from a low of 2 to a
high of 740 years! 54 Yet
despite this tremendous variance in the data and the high incidence of false
results, Houk and the CDC concluded, rather remarkably, that a large scale
exposure study was simply not possible since "negative" blood tests
appeared to "confirm" that study subjects were not even exposed to
Agent Orange.
Such conclusions are especially suspect given
the fact that scientists have consistently cautioned against the use of blood
tests as the sole basis for exposure classification. Although blood and adipose
tissue tests can be used to confirm that
___________________
53 Agent Orange Hearing
at 59. Dr. Houk’s assumption was based on a study of only 36 former Ranch
Handers (members of "Operation Ranch Hand," the Air Force herbicide
defoliation program) who had volunteered blood samples in 1982 and 1987.
54 American Legion Magazine Reprint
"Agent Orange" at 12 See also Agent Orange Hearing at p. 67
(testimony of Dr. Houk revealed that the senior-statistician on the Agent
Orange project believed that the dioxin blood analysis was so flawed there is a
substantial likelihood that there is no correlation between the exposure scores
and the blood levels).
29
Vietnam
veterans were heavily exposed to Agent Orange and the contaminant dioxin55,
even the CDC’s own researchers have unequivocally stated that "much more
has to be learned about the kinetics of dioxin metabolism and half-life before
current levels can be used to fully explain historic levels of exposure."56
While the CDC’s changes in protocol have been
"justified", however unreasonably, on the basis of
"scientific" explanations57, what cannot be justified is
the evidence of political interference in the design, implementation and
drafting of results of the CDC study by Administration officials rather than
CDC scientists. As early as 1986, the Subcommittee on Oversight and
Investigations of the Committee on Energy and Commerce documented how untutored
officials of the Office of Management and Budget (0MB) interfered with and
second-guessed the professional judgments of agency scientists and
multidisciplinary panels of outside peer review experts
____________________
55 See Kahn, "Dioxins and Dibenzofurans
in Blood and Adipose Tissue of Agent Orange Exposed Vietnam Veterans and
Matched Controls," 259 Journal of the American Medical Association
1661 (1988). This report found that "Vietnam veterans who were heavily
exposed to Agent Orange. exceeded matched control subjects in both blood, and
adipose tissue levels of 2,3,7, 8—tetrachlorodibenzo-p— dioxin (TCDD) but not
in the levels of the 12 other 2,3,7,8-substituted dioxins and dibenzofurans
that were detected. Since only TCDD among these compounds was present in Agent
Orange but all are present in the population of the industrialized world, it is
likely that the elevated TCDD levels arose from wartime exposure."
56 Patterson, "Levels of
Polychlorinated Dibenzo-p-dioxins and Dibenzofurans in Workers Exposed to
2,3,7,8 --tetrachlorodibenzo-p—dioxin,. 16 American Journal of Industrial
Medicine 135, 144 (1989).
57 See generallv,
Agent Orange Hearing (Testimony of Dr. Vernon Houk) at 44--50.
30
effectively
to alter or forestall CDC research on the effects of Agent Orange, primarily on
the grounds that "enough" dioxin research had already been done.58
These Agent Orange Hearings revealed additional examples of political
interference in the CDC~s Agent Orange projects by members of the White House
Agent Orange Working Group.59
Dr. Philip 3. Landrigan, the former Director of
the Environmental Hazards branch at the CDC, upon discovering the various
irregularities in CDC procedures concluded that the errors were so egregious as
to warrant an independent investigation not only of the methodology employed by
the CDC in its validation study, but also a specific inquiry into what actually
transpired at the Center for Environmental Health of the CDC.60
With these suspicions in mind, it should come as
no surprise that those familiar with the CDC~s work found little credence in
the conclusions reached by the CDC in its recently released Selected Cancers
Study. Even though the CDC has previously stated that it believes exposure to
Agent Orange is impossible to assess, it found no difficultly in reporting to
the press upon the release of the
Selected Cancers Study that exposure to Agent
___________________
58 OMB Review of CDC
Research: Impact of the Paperwork Reduction Act; A Report Prepared for the
Subcommittee on Oversight and Investigations of the Coumittee on Energy and
Commerce, 99th Cong. 2nd Sess. (October 1986).
59
See Agent Orange Nearing at 49-54 (Testimony of Dr. Vernon Houk).
60
Agent Orange Hearing at 229 and 330
31
Orange
does not cause cancer. This conclusion was reached despite the fact that the
CDC made no effort to determine, through military records or blood/adipose
tissue tests, if study subjects were, indeed, exposed to dioxins; nor did the
CDC attempt to verify exposure to Agent Orange of those study subjects who
actually contracted cancerous diseases. In fact, according to scientists who
have made preliminary reviews of the CDC’s findings, the statistical power of
any one cancer grouping, with the exception of non—Hodgkin’s lymphoma, was so
low as to make any conclusion virtually impossible.
Unfortunately, political interference in
government sponsored studies associated with Agent orange has been the norm,
not the exception. In fact, there appears to have been a systematic effort to
suppress critical data or alter results to meet preconceived notions of what
alleged scientific studies were meant to find.61 As recently as
March 9, 1990 Senator Daschle disclosed compelling evidence of additional political
interference in the Air Force Ranch Hand study, a separate government sponsored
study meant to examine the correlation between exposure to Agent Orange and
harmful health effects among Air Force veterans who participated in Agent
Orange spraying
61 See generallv
Agent Orange Nearing; Congressional Record, S 2550 (March 9, 1990); Congressional
Record, (November 21, 1989) (Statements of Senator Thomas Daschle).
32
missions
under Operation Ranch Hand. As Senator Daschle explained:
In January 1984, the scientists
in charge of the Ranch Hand Study issued a draft baseline morbidity report that
described some very serious health problems in the Ranch Hand veterans and
stated that the Ranch Handers, by a ratio of five to one, were generally less
well than the veterans in the control group. The opening sentence of the draft
report’s conclusion was clearly stated: "It is incorrect to interpret this
baseline study as ‘negative.’
After
the Ranch Hand Advisory Committee, which operates under the White House Agent Orange
Working Group of the Domestic Policy Council, got its hands on the document,
the final report was changed in some very important ways. Most notably, the
table and exposition explaining that the Ranch Handers were generally less well
than the controls was omitted, and the final conclusion was altered
substantially. The statement that the baseline study was not negative was
completely omitted and the study was described as "reassuring." 62
By altering the study’s conclusion, opponents of
Agent Orange compensation were able to point to "irrefutable proof"
that Agent Orange is not a health problem: if those veterans most heavily
exposed to Agent Orange did not manifest any serious health problems, they
argued, then it could safely be deduced that no veteran allegedly exposed to
Agent Orange in smaller doses could have health problems. Yet, when Senator
Daschle questioned Air Force scientists on why discrepancies existed between an
Air Force draft of the Ranch Hand Study and the final report actually released
to the press, the answers suggested not merely disagreements in data
evaluation, but the perpetration of fraudulent conclusions. In a word, the
major premise was badly
_______________________
62 See Congressional
Record S 2550 (March 9, 1990)
33
flawed.
For example, in 1987 Ranch Hand scientists
confirmed to Senator Daschle that an unpublished birth defects report shows
that birth defects among Ranch Hand children are double those of children in
the control group and not "minor" as originally reported in l984.63
This increase in birth defects takes on added
significance when one considers that the original CDC birth defects study,
which found no increase in birth defects, merely examined birth defects as
reported on birth certificates, rather than as reported by the child’s parent
or physician. The CDC never recorded hidden birth defects, such as internal
organ malformations and other disabilities that only became apparent as the
child developed. Consequently, it is very likely that the CDC’s negative findings
on birth defects were also vastly understated.64
In addition to elevated birth defects, Ranch
Handers also showed a significant increase in skin cancers unrelated to
overexposure to the sun as originally suggested in the 1984 report. Air Force
scientists also admitted that Air Force and White House Kanagement
representatives were involved in
____________________
63
Congressional Record, (November 21, 1989) (Statement of Senator Thomas
Daschle).
64 The CDC birth defects
study was confined to Vietnam Veterans located in the Atlanta, Georgia region.
The study was not an Agent Orange birth defects study since no effort was made
to determine whether the veterans had even been exposed to Agent orange. See
notes 10 and 18 supra for additional information on birth defects.
34
scientific
decisions in spite of the study’s protocol which prohibited such involvement.65
On February 23, 1990, the Air Force released a
follow-up morbidity report on the Ranch Handers. That report, "1987
Followup Examination Results," described statistically significant
increases in health problems among Ranch Handers including: all cancers —— skin
and systemic combined, both verified and suspected; skin cancers alone;
hereditary and degenerative neurological diseases and other problems. The Air
Force-concluded, however, that these and other problems cannot necessarily be
related to Agent Orange/dioxin exposure, as they do not always show a
"dose-response" relationship — particularly since the exposure index
used in the data analysis "is not a good measure of actual dioxin
exposure." 66
With this conclusion, the Air Force for the
first time officially acknowledged that the conclusions reached in its original
1984 Ranch Hand study are not simply moot, but that the Ranch Hand study is
not, at this date, an Agent Orange study at all since dioxin exposure could not
be determined reliably in the first place. In other words, the Air Force could
just as easily have concluded that the health problems associated with the
Ranch Handers were not necessarily related to eating beer nuts.
_________________________
65 Congressional
Record, S 2551 (March 9, 1990) (Statement of Senator Daschle).
66 Wolfe,
St. al., Air Farce Health Study and Epidemiologic Investigation of Health
Effects in Air Force Personnel Following Exposure to Herbicides (Feb. 1990) at
p. vi.
35
For
the Air Force to have made the statement in 1990 of no evidence of a link
between exposure to Agent Orange and the cancer problems experienced by Ranch
Handers is, as Senator Daschle notes, "patently false."67.
Although not yet conclusive, what the Ranch Hand and CDC studies demonstrate is
that there is evidence of a link between health problems and dioxin exposures
which may become definitive when a new and reliable exposure index is used to
evaluate the data.
As stated by Dr. James Clary, one of the
scientists who prepared the final Ranch Hand report:
The current literature
on dioxin and non--Hodgkin’s lymphoma and soft tissue sarcoma can be
characterized by the following:
1. It underestimates (reduced
risk estimates) the effect of dioxins on human tissue systems. As additional
studies are completed we can expect to see even stronger correlations of dioxin
exposure and NHL/STS.
2. Previous studies
were not sensitive enough to detect small, but statistically significant
increases in NHL/STS. As time progresses, and additional evidence is
forthcoming, it will be increasingly difficult for anyone to deny the
relationship between dioxin exposure and NHL/STS
Shamefully, the deception, fraud and political
interference that has characterized government sponsored studies on the health
____________________________
67 Congressional
Record 5. 2551 (March 9, 1990). See also Letter from Maj. Gen. James G. Sanders, U.S.A.F. Deputy
Surgeon General to Senator Thomas Daschle (February 23, 1990).
68 Letter from Dr. James
Clary to Senator Tom Daschle (September 9, 1988).
36
effects
of exposure to Agent Orange and/or dioxin has not escaped studies ostensibly
conducted by independent reviewers, a factor that has only further compounded
the erroneous conclusions reached by the government.
For instance, recent litigation against the
Monsanto corporation revealed conclusive evidence that studies conducted by
Monsanto employees to examine the health effects of exposure to dioxin were
fraudulent. These same fraudulent studies have been repeatedly cited by
government officials to deny the existence of a relationship between health
problems and exposure to Agent Orange. According to court papers:
Zack and Gaffey, two Monsanto employees,
published a mortality study purporting to compare the cancer death rate amongst
the Nitro workers who were exposed to Dioxin in the 1949 explosion with the
cancer death rate of unexposed workers. The published study concluded that the
death rate of the exposed worker was exactly the same as the death rate as the
unexposed worker. However, Zack and Gaffey deliberately and knowingly omitted 5
deaths from the exposed group and took 4 workers who had been exposed and put
these workers in the unexposed group, serving, of course, to decrease the death
rate in the exposed group and increase the death rate in the unexposed group.
The exposed group, in fact, had 18 cancer deaths instead of the reported 9
deaths (P1. Ex. 1464), with the result that the death rate in the exposed group
was 65% higher than expected (emphasis in original)69.
____________________
69 Brief of
Plaintiffs-appellees in Kemner. et. al. v. Monsanto Company, No.
5--88--0420 (5th Dist., Illinois Appellate Court) (Oct. 3, 1989) (as the facts
were proven at trial, the appeal only considered appealable matters of law).
Plaintiff’s brief refers to Zack and Gaf fey, "A Mortality Study of
Workers Employed at the Monsanto Company Plant in Nitro, WV,. man Environmental
Risks of Chlorinated Dioxins and Related Compounds (1983) pp. 575--591. It
should be noted that the Advisory Committee classified this report as
"negative" in evaluating compensation for NHL
The brief also states that another study of the
workers exposed in the 1949 accident was also fraudulent (e.g. R.R. Suskind
37
Similarly, recent evidence also suggests that
another study heavily relied upon by those opposed to Agent Orange compensation
to deny the existence of a link between dioxin and health effects was falsified.
Three epidemiologic studies and several case report studies about an 1953
industrial accident in which workers at a BASF plant were exposed to dioxins
concluded that exposure to TCDD did not cause human malignancies.70 A
reanalysis of the data that comprised the studies, all of which was supplied by
the BASF company itself, revealed that some workers suffering from chloracne
(an acknowledged evidence of exposure to dioxin) had actually been placed in
the low--exposed or non--exposed cohort groups. Additionally, 20 plant
supervisory personnel, not believed to have been exposed, were placed in the
exposed group.
When the 20 supervisory personnel were removed
from the exposed group, thereby negating any dilution effect, the reanalysis
revealed statistically significant increases in cancers of the respiratory
organs (lungs, trachea, etc.) and
_________________________
and V.S. Hertzberg, "Human Health Effects
of 2,4,5-T and Its Toxic Contaminants," Journal of the American Medical
Association, Vol. 251, No. 18 (1984) pgs. 2372-2380.) The study reported
only 14 cancers in the exposed group and 6 cancers in the unexposed group.
Trial records conclusively demonstrated, however, that there were 28 cancers in the group that had been
exposed to dioxins, as opposed to
only 2 cancers in the unexposed group.
70
See e.g. Thiess, Frentzel-Beyme, Link, "Mortality Study of Persons
Exposed to Dioxin in a Trichlorophenol Process Accident that occurred in the
BASF AG on November 17 , 1953", 3 American Journal of Industrial
Medicine 179—189 (1982)
38
cancers
of the digestive tract.71 According to the scientist who conducted
this study, "t)his analysis adds further evidence to an association
between dioxin exposure and human malignancy."72
Recent evidence also reveals that Dow Chemical,
a manufacturer of Agent Orange was aware as early as 1964 that TCDD was a
byproduct of the manufacturing process. According to Dow’ s then medical
director, Dr. Benjamin Holder, extreme exposure to dioxins could result in
"general organ toxicity" as well as "psychopathological"
and "other systemic" problems. 73 In fact, a
_______________________
71 Friedemann Rohleder,
"Dioxins and Cancer Mortality Reanalysis of the BASF Cohort,"
presented at the 9th International Symposium on Chlorinated Dioxins and Related
Compounds, Toronto, Ontario (Sept. 17-22, 1989). BASF recently published a
study in an attempt to refute the allegations that the original studies related
to the accident were fraudulent. See Zobier, Messerer & Huber,
"Thirty Four Year Mortality Follow Up of BASF Employees, 62 Occupational
Environmental Health 139-157, (Oct. 19, 1989). While the company states
that "there was no significant increase in deaths from malignant
neoplasms," the study does conclude that:
There was, however, a
significant excess for all cancers combined among the chloracne victims 20 or
more years after initial exposure when an excess would be most likely to occur.
In addition, there is the notable finding on one case of liver cancer without
cirrhosis in a worker with an exceptionally high level of TCDD in the blood.
Id. at 155. See also
id. at 139 ("In general,
our results do not appear to support a strong association between cancer
mortality and TCDD, but they do suggest that some hazard may have been
produced.) (emphasis added) and 149 ("Although TCDD blood levels were
available for only 5 of the 10 subjects, the three highest levels were found in
subjects with liver cancer, leucosis and Merkell—cell carcinoma of the
skin.").
72 Wanchinski, "New
Analysis Links Dioxin to Cancer," New Scientist, (Oct. 28, 1989) p.
24.
73 See L. Casten,
Patterns of Secrecy: Dioxin and Agent Qrange (1990) (unpublished
manuscript detailing the efforts of government and industry to obscure the
serious health consequences of exposure to dioxin).
39
recent
expert witness who reviewed Dow Chemical corporate documents on behalf of a
plaintiff injured by exposure to dioxin who successfully sued Dow74 states
unequivocally that "the manufacturers of the chlorphenoxy herbicides have
known for many years about the adverse effects of these materials on humans who
were exposed to them."75
Despite its poor
record in carrying out its responsibility to ascertain the health effects of
exposure to Agent Orange, the CDC has been candid in some of its findings. As
early as 1983, for instance, the CDC stated in the protocol of its proposed
Agent Orange Studies "(t)hat the herbicide contaminant TCDD is considered
to be one of the most toxic components known. Thus any interpretation of
abnormal findings related to 2,4,5—T must take into consideration the presence
of varying or undetermined
_________________
74 Peteet v. Dow
Chemical Co., 868 F.2d 1428 (5th Cir. 1989) cert...denied
110 S.Ct. 328 (1989).
75 Letter from Daniel
Teitelbaum, M.D., P.C. to Admiral E.R. Zumwalt, Jr. (April 18, 1990). Dr
Teitelbaum additionally states:
What I do think...may bear on the Agent Orange
issue, is the fact that in review of Dow’s 2,4-D documentation I found that
there are significant concentrations of potentially carcinogenic materials
present in 2,4-D which have never been made known to the EPA, FDA, or to any
other agency. Thus, in addition to the problem of the TCDD which, more likely
than not, was present in the 2,4,5--T component of Agent Orange, the finding of
other dioxins and closely related furans and xanthones in the 2,4--D
formulation was of compelling interest to me.
40
amounts of TCCD." 76
In 1987, after first being leaked by the New
York Times, a VA mortality study was released indicating a 110 percent
higher rate of non-Hodgkin’s lymphoma in Marines who served in heavily sprayed
areas as compared with those who served in areas that were not sprayed. 77
The study also found a 58 percent higher rate of lung cancer among the same
comparative groups . 78
Also in 1987, a second VA study found a
suggestive eight-fold increase in soft tissue sarcoma among veterans most
likely to
___________________________
76 CDC Protocol, see
note 1 supra The CDC went on to state that a wide variety of health effects
have been observed following the administration of TCDD to experimental animals
including soft tissue sarcomas and lymphoma1 nasal and
nasopharyngeal cancers, birth defects, changes in thymus and lymphoid tissues,
and other numerous cancers. Additionally, the CDC acknowledged the toxic
effects of occupational exposure to dioxin, including evidence that exposure
"may be associated with an increased risk of soft tissue sarcoma and
lymphoma" and perhaps nasal and nasopharyngeal cancers.
77 Breslin, et. al.
"Proportionate Mortality Study of U.S. Army and U.S. Marine Corps Veterans
of the Vietnam War," Veterans Administration (1987).
78
Id. Some scientists, including the Advisory Committee have attempted to
denigrate these significant findings on the basis that Army personnel did not
show similar results. The explanation for this lack of comparative Army
findings is directly attributable to the dilution effect caused by including
logistics personnel as part of the Army study. Marines were studied as a
separate group. The Marine’s logistical support personnel (i.e. the Navy), were
not included. Thus, the increased cancers among Marines were clearly associated
with field exposure to Agent Orange.
The Army study, on the
other hand, combined field personnel with personnel on logistics assignments
who were unlikely to have been exposed to Agent Orange. As a result, the Army
findings were drastically diluted. Additionally, Army personnel generally
engaged the enemy and returned to base, whereas Marines consistently remained
in areas presumably sprayed by Agent Orange to provide medical, health and
engineering assistance to the local population. Such "pacification"
efforts gave Marines additional opportunities to be exposed to dioxins.
41
have
been exposed to Agent Orange.79
A proportionate mortality study of deaths in
pulp and paper mill workers in New Hampshire from 1975 to 1985 showed that one
or more of the exposures experienced by such workers (dioxin is a byproduct of
pulp and paper production) posed a "significant risk" for cancers of
the digestive tract and lymphopoietic tissues . 80
Another case control study of farmers in Hancock
County, Ohio, showed a "statistically significant" rise in Hodgkin’s
disease and non-Hodgkin’s lymphoma. Although the study speculates that exposure
to phenoxy herbicides may be the cause of such elevated cancers, the study
recognizes that, given the size of its cohort, the only credible conclusion
that can be drawn is that it "adds to the growing body of reports linking
farming and malignant lymphoma, particularly NHL." 81
A study of disease and non—battle injuries among
U.S. Marines in Vietnam from 1965 to 1972 showed a significantly higher rate of
first hospitalizations for Marines stationed in Vietnam as opposed to Marines
stationed elsewhere, particularly
_____________________
79 Kang, et. al.,
"Soft-Tissue Sarcoma and Military Service in Vietnam: A Case Control
Study," 79 Journal of the National Cancer Institute 693 (October,
1987). The increases were not statistically significant as reported.
Nonetheless, the results are remarkable.
80 E · Schwartz, "A
Proportional Mortality Ratio of Pulp and Paper Mill Workers in New
Hampshire," 45 British Journal of Industrial Medicine, 234—238
(1988).
81 Dubrow, Paulson &
Indian, "Farming and Malignant Lymphoma in Hancock county, Ohio," 45 British
Journal of Industrial Medicine 25—28 (1988).
42
for
neoplasms, diseases of the blood and blood forming organs and diseases of the
circulatory and respiratory systems.82 Of particular significance is
the fact that the rate of first hospitalization for disease and non—battle
injuries among Vietnam personnel rose steadily, reaching a peak in 1969, while
the rate of non—Vietnam personnel remained relatively constant.83 This
rise in hospitalization for non—combat injuries coincides exactly with the
increased use of Agent Orange, reaching a peak in 1969, and declining
thereafter until its elimination in 1971.
In a recently published article entitled
"2,4--D, 2,4,5 --T, and 2,3,7,8 --TCDD: An Overview", the authors
acknowledge that at least three weaknesses in research related to dioxins are
sufficient to cast doubt on the validity of any study. 84 The
___________________________
82 Palinkas & Coben,
"Disease and Non—Battle Injuries Among U.S. Marines in Vietnam, 153 Military
Medicine 150 (March, 1988).
83 Id. at 151. It should
be noted that the year of greatest combat activity, as measured by the number
of personnel wounded in action, 1968, had the smallest disease and non-battle
injury vs. wounded in action ratio. Id. at 152.
84 Lilienfeld and Gallo
"2,4-D, 2,4,5—T and 2,3,7,8-TCDD An Overview," Epidemiologic
Review, Vol. II (1989). Three major criteria must be considered in
evaluating the numerous epidemiologic studies of phenoxy herbicides and
2,3,7,8-TCDD: 1) the accuracy of exposure assessment; 2) the studies’
statistical power; and 3) the adequacy of follow-up. Problems in any one of the
three areas leaves the study open to criticism and subject to manipulation.
For instance, in retrospective studies, various
proxies of exposure to herbicides and 2,3,7,8,—TCDD have been used such as
military service in Vietnam or residence in an area in which the herbicides
were sprayed. The weakness in such an approach is that unless the proxy
corresponds to exposure, the "exposed group" is diluted with the
individuals who have NOT been exposed, thereby reducing the magnitude of the
strength of the association. In fact, such reduction may be of such a degree as
to preclude detection of any
43
authors
report that while the data on soft tissue sarcoma and phenoxy acids are too
inconsistent to allow for any comment at this time, there is evidence of a
strong association between STS and the suspect chemicals in 2 of the 8 studies
analyzed in their article. Furthermore, the birth defect studies analyzed
"suggest that adverse reproductive effects can be caused by (dioxin) . 85
Recent studies in Vietnam continue to show
statistically significant reproductive anomalies and birth defects among women,
and children of women presumably exposed to Agent Orange spraying.86
____________________
of a serum marker for 2,3,7,8-TCDD by Kahn may
provide the means of identifying persons who have been exposed.
Furthermore, studies concerning Agent Orange
have nearly all been conducted in the past decade. This 10 year latency period
is generally thought to be insufficient for many cancers to be clinically
detected .
85 Id.
86 See note 10 supra.
It should be noted that as early as 1977 information about Agent Orange’s potential
for genetic damage was known to the VA. For example, a "NOT FOR
RELEASE" VA document expressly noted Agent Orange’s "high
toxicity" and "its effect on newborn, deformed children —— similar to
the thalidomide situation." See L. Casten, Patterns of Secrecy note
73 supra at Department of Veteran Affairs p.4. Similarly, in March of 1980,
Senator Tom Daschle and Rep. David Bonior received an anonymous memorandum
written on VA stationery which stated:
chemical agents
2,4,5-T and 2,4-D commonly known as Agent Orange and Agent Blue, are mutagenic
and teratogenic. This means they intercept the genetic DNA message processed to
an unborn fetus, thereby resulting in deformed children being born. Therefore,
the veteran would appear to have no ill effects from the exposure but he would
produce deformed children due to this breakage in his genetic chain.... .
.Agent Orange is 150,000 times more toxic than organic arsenic.
Id. See also Wolfe &
Lathrop, "A Medical
Surveillance Program for Scientists Exposed to Dioxins and Furans," Human
and Environmental Risks of Chlorinated Dioxins and Related Compounds,
707—716 (1983)
44
In the December 1,
1989, issue of Cancer, a study of the
cancer risks among Missouri farmers found elevated levels of lip and bone
cancer as well as nasal cavity and sinuses, prostrate, non-Hodgkin’s lymphoma
and multiple myeloma. Smaller elevations, but elevations nonetheless, were
found for cancers of the rectum, liver, malignant melanoma, kidney and
leukemia. According to the authors, evidence of the cause for the elevated
risks for these illnesses "may be strongest for a role of agricultural
chemicals, including herbicides, insecticides and fertilizers." 87
Both the U.S.
Environmental Protection Agency (EPA) and the International Agency for Research
on Cancer (IARC) have concluded that dioxin is a "probable human
carcinogen." 88
In a work entitled
"Carcinogenic Effects of Pesticides" to be issued by the National
Cancer Institute Division of Cancer Etiology, researchers conclude that while
confirmatory data is lacking there is ample evidence to suggest that NHL, STS,
colon, nasal and nasopharyngeal cancer can result from exposure to phenoxy
herbicides .
A just released case
control study of the health risks of exposure to dioxins confirmed previous findings
that exposure to
________________________
(Proceedings of
International Symposium on Chlorinated Dioxins and Related Compounds,
Arlington, VA, October 25—29, (1981)). The article explains the possible
mechanism for paternally transmitted birth defects.
87 Brownson, et. al.
"Cancer Risks Among Missouri Farmers," 64 Cancer 2381, 2383
(December 1, 1989) .
88 Agency for Toxic
Substances and Disease Registry, pp. 7,, 61—68, 94 reprinted in Rachel’s
Hazardous Waste News # 173 (March 21, 1990)
45
phenoxyacetic
acids or chlorophenols entails a statistically significant increased risk (i.e.
1.80) for soft tissue sarcoma.89
As recently as
February 28, 1990 an additional study found that farmers exposed to various
herbicides containing 2,4—D may experience elevated risks for certain cancers,
particularly cancers of the stomach, connective tissue, skin, brain, prostate,
and lymphatic and hematopoietic systems."90
This week a scientific
task force, after reviewing the scientific literature related to the potential
human health effects associated with exposure to phenoxyacetic acid herbicides
and/or their associated contaminants (chlorinated dioxins) concluded that it is
at least as likely as not that exposure to Agent Orange is linked to the
following diseases: non—Hodgkin’s lymphoma, soft tissue sarcoma, skin
disorders/chloracne, subclinical hepatotoxic effects (including secondary
coproporphyrinuria and chronic hepatic porphyria), porphyria cutanea tarda,
reproductive and developmental effects, neurologic
_________________________
89 Eriksson, Hardell
& Adami, "Exposure to Dioxins as a Risk Factor for Soft Tissue
Sarcoma: A Population--Based Case--Control study," 82 Journal of the
National Cancer Institute 486—490 (March 21 1990) . It should be noted that
in this study the median latency for phenoxyacetic acid and chlorophenols
exposure was 29 and 31 years respectively, thereby suggesting that many of the
veterans who are at risk have not yet manifested symptoms of STS.
90 Blair,
"Herbicides and Non-Hodgkin’s Lymphoma: New Evidence From a Study of
Saskatchewan Farmers," 82 Journal of the National cancer
46
effects
and Hodgkin’s disease.91
On the same day that
this scientific task force reported a statistically significant linkage between
exposure to the dioxins in Agent Orange and various cancers and other
illnesses, the Environmental Protection Agency reported that the cancer risk
posed by the release of such a "potent carcinogen" as dioxin in the
production of white paper products is "high enough to require tighter controls
on paper mills."92
As many of the studies associated with Agent
Orange and dioxins attest, science is only at the threshold of understanding
the full dimension of harmful toxic effects from environmental agents on
various components of the human immune system. 93 In
_________________________
91 Report of the Agent Orange Scientific
Task Force of the American Legion, Vietnam Veterans of America, and the
National Veterans Legal Services Project, reported by McAllister, "Viet
Defoliant Linked to More Diseases, Washington Post, May 1, 1990 at AS,
col. 4. The report also found that there are other disorders for which there is
evidence suggesting an association with exposure to Agent Orange, but for which
statistically significant evidence is not currently available. Those diseases
include: leukemias, cancers of the kidney, testis, pancreas, stomach, prostate,
colon hepatobiliary tract, and brain, psychosocial effects, immunological
abnormalities, and gastrointestinal disorders.
92 Weisskopf, "EPA
Seeking to Reduce Dioxin in White Paper: Cancer Risk Said to Justify Mill
Restrictions," Washington Post, May 1, 1990 at AS, col. 1.
93 A recent report in
the Washington Post suggests that there is an inherent uncertainty in trying to
measure the dangers posed by the chemicals humans eat, drink and breathe. Since
human experimentation is impossible to assess the effect of varied doses of a
chemical on human health, scientists are ultimately required
47
fact,
a whole new discipline — immunotoxicology — has developed to explore further
the effects of environmental chemicals on human health and to relate animal
test results to humans.94
Immunotoxicology has
established, however, at a minimum that at least three classes of undesirable
effects are likely occur when the immune system is disturbed by environmental
exposure to chemicals such as dioxin, including: 1) immunodeficiency or
suppression; 2) alteration of the host defense mechanism against mutagens and
carcinogens (one theory is that the immune system detects cells altered by
mutagens or other carcinogenic trigger and destroys these cells. Thus, an
impaired immune system may not detect and destroy a newly forming cancer); and
3) hypersensitivity or allergy to the chemical antagonist. Because of dioxin’s
ability to be both an immunosuppressant and a carcinogen, as early as 1978
immunologists were suggesting that "(a) gents such as TCDD.. .may be far
more dangerous than those possessing only one of these properties."95
While scientists are
not in agreement, some immunotoxicologists argue that one molecule of a
carcinogenic agent, like dioxin in the right place and at the right time can
____________________________
to speculate or guess
as to the health effects of a given chemical to the human body. See Measuring
Chemicals’ Dangers: Too Much Guesswork?" Washington Post, March 23,
1990.
94 Silbergeld &
Gaisewicz, "Dioxins and the Ah Receptor," 16 American Journal of
Industrial Medicine 455, 468—69 (1989).
95 Inadvertent
Modification of the Immune Response — The Effect of Foods, Drugs, and
Environmental Contaminants; Proceedings at the Fourth FDA symposium; U.S. Naval
Academy (August 28-30, 1978), p. 78.
48
cause
the human immune system to turn on itself, manifesting such breakdowns in the
form of cancer. Indeed, even some courts have accepted this theory of causation
in matters specifically related to exposure to dioxin.96
With additional evidence from Vietnam suggesting
that Agent Orange contaminants have the ability to migrate away from actual
spray locations via river channels and the food chain, the opportunity for a
Vietnam Veteran to have been exposed to dioxin contaminant molecules increases
significantly.97
It cannot be seriously disputed that any large
population exposed to chemical agents, such as Vietnam Veterans exposed to
Agent Orange, is likely to find among its members a number who will develop
malignancies and other mutagenic effects as a result of being exposed to
harmful agents.
To be sure, decisions today with regard to the
seriousness of Agent Orange health effects must be made while the science of
___________________________
96 See Peteet V. Dow
Chemical Co. , 868 F.2d 1428, 1433 (5th Cir. 1989) cert denied 110 S.Ct.
328 (1989).
97 See e.g.
Schecter, et. al., "Levels of 2,3,7,8—TCDD in Silt Samples Collected
Between 1985—86 From Rivers in the North and South of Vietnam," 19
Chemosphere 547—550 (1989) (suggestive findings that the predominant dioxin
isomer in Agent Orange has moved into downstream rivers in the South of
Vietnam); Olie, et. al., "Chlorinated Dioxin and Dibenzofuran Levels in
Food and Wildlife Samples in the North and South of Vietnam," 19 Chemosphere
493-496 (1989) (food and wildlife specimens in South Vietnam had a higher
relative abundance of 2,3,7,8-TCDD suggesting contamination from Agent Orange);
Schecter, et · al. "Chlorinated Dioxin and Dibenzofuran Levels in Food
Samples Collected Between 1985—87 in the North and South of Vietnam," 18 Chemosphere
627—634 (1989) (Agent Orange contaminants, specifically 2,3,7,8-TCDD found at relatively
elevated levels in food and wildlife samples 15-2 5. years after environmental
contamination with compound in South of Vietnam
49
immunotoxicology is in its infancy. After having
evaluated and considered all of the known evidence on Agent Orange and dioxin
contaminants, it is evident to me that enough is known about the current trends
in the study of dioxins, and their linkage with certain cancers upon exposure,
to give the exposed Vietnam Veteran the benefit of the doubt.
This benefit of the doubt takes on added
credence given two separate means for determining exposure to Agent Orange — 1)
HERBs and Service HERBs tapes establishing troop location for comparison with
recorded Ranch Hand spraying missions; and 2) blood testing from living Veterans,to
ascertain elevated dioxin levels. The inexplicable unwillingness of the CDC to
utilize this data has had the effect of masking the real increase in the rate
of cancers among the truly exposed. There is, in my opinion, no doubt that had
either of these methods been used, statistically significant increased rates of
cancer would have been detected among the Veterans for whom exposure can still
be verified.
Since science is now able to conclude with as
great a likelihood as not that dioxins are carcinogenic directly and indirectly
through immunosuppression, and since a large proportion of those exposed to
dioxin can be so ascertained, I am of the view that the compensation issue for
service—related illnesses associated with exposure to Agent Orange should be
resolved in favor of Vietnam Veterans in one of the two following ways:
50
Alternative
1:
Any Vietnam Veteran, or Vietnam Veteran’s child
who has a birth defect, should be presumed to have a service—connected health
effect if that person suffers from the type of health effects consistent with
dioxin exposure and the Veteran’ s health or service record establishes 1)
abnormally high TCDD in blood tests; or 2) the veteran’s presence within 20
kilometers and 30 days of a known sprayed area (as shown by HERBs tapes and
corresponding company records); or 3) the Veteran’ s presence at fire b se
perimeters or brown water operations where there is reason believe Agent Orange
have- occurred.
Under this alternative compensation would not be
provided for those veterans whose exposure came from TCDD by way of the food
chain; silt runoff from sprayed areas into unsprayed waterways; some unrecorded
U.S. or allied Agent Orange sprayings; inaccurately recorded sprayings; or
sprayings whose wind drift was greater than 20 kilometers. Predictably,
problems generated by the foregoing oversights, the mass of data to be analyzed
as claims were filed, and the known loss of many service records would
invalidate many veterans’ legitimate claims
Alternative
2:
Any Vietnam Veteran or child of a Vietnam
Veteran who experiences a TCDD—like health effect shall be presumed to have a
service—connected disability. This alternative is admittedly
51
broader than the first, and would provide
benefits for some veterans who were not exposed to Agent Orange and whose
disabilities are not presumably truly service—connected. Nevertheless, it is
the only alternative that will not unfairly preclude receipt of benefits by a
TCDD exposed Vietnam Veteran.
Furthermore, this alternative is consistent with
the Secretary’s decision regarding the Service—connection of non— Hodgkin’s
lymphoma, as well as legal precedent with respect to other diseases presumed by
the Department of Veterans Affairs to be connected to one or more factors
related to military service (i.e. veterans exposed to atomic radiation and
POW’s with spastic colon).
I have also given
considerable thought to which health effects are to be presumed likelier than
not to be related to TCDD exposure and therefore service—connected. Any such
determination must be made in light of: 1) the review of the scientific
literature, including animal studies where human data does not exist or has
been manipulated; 2) the inappropriate processes of the Veterans Advisory
Committee on Environmental Hazards; 3) the past political manipulations of
Ranch Hand and CDC studies; and 4) the recent discoveries of manipulation by
scientists hired by chemical manufacturers of dioxin contaminants to evaluate
the potentially best epidemiological data concerning TCDD’s effects on humans.
My evaluation of the evidence has been made with
just such
52
considerations in mind. Additionally, I have
conferred with several experts in the field. After evaluating all the
evidence and material of record, I am convinced that there is better than
"an approximate balance of positive and negative evidence" on a
series of Agent Orange related health effects.
It can, in my judgment, be concluded, vith a
very high degree of confidence, that it is at least as likely as not that the
following are caused in humans by exposure to TCDD: non—Hodgkin’ s lymphoma,
chloracne and other skin disorders, lip cancer, bone cancer, soft tissue
sarcoma, birth defects, skin cancer, lung cancer, porphyria cutanea tarda and
other liver disorders, Hodgkin’s disease, hematopoietic diseases, multiple
myeloma, neurological defects and auto—immune diseases and disorders.
In addition, I am most comfortable in concluding
that it is at least as likely as not that liver cancer,
nasal/pharyngeal/esophageal cancers, leukemia, malignant melanoma, kidney
cancer, testicular cancer, pancreatic cancer, stomach cancer, prostate cancer,
colon cancer, brain cancer, psychosocial effects, and gastrointestinal disease
are service-- connected.
I have separated the two foregoing subsets
subjectively only because there is somewhat more data to support the former
than the latter. Nonetheless, immunological and toxicological theory supports
both subsets and fully justifies, in my view, the inclusion of both subsets of
the foregoing health effects in determining a service--connected injury.
53
Such
a resolution of the embarrassingly prolonged Agent Orange controversy would be
on the order of decisions to compensate U.S. soldiers who contracted cancer
after exposure to radiation from atomic tests and U.S. soldiers involved,
without their knowledge, in LSD experiments. With the scientific basis now
available for it to be stated with confidence that it is at least as likely as
not that various health effects are related to wartime exposure to Agent
Orange, there is the opportunity finally to right a significant national wrong
committed against our Vietnam Veterans.
RECOMENDATIONS
1. That the Secretary undertake a prompt
reevaluation of the compensation decision impacting on Vietnam Veterans exposed
to Agent Orange in light of accumulating scientific evidence that discredits
earlier "findings" of an insufficient linkage between dioxin
contaminants in Agent Orange and rare disease, such as cancer illnesses.
2. To the extent that the Secretary deems it
necessary to use the Veterans’ Advisory Committee on Environmental Hazards to
assist in his reevaluation, the current members should be dismissed -— having
demonstrated a disturbing bias in their review to date of the scientific
literature related to Agent Orange and dioxin -- and new members should be
appointed in accordance with Section G of the Veterans’ Dioxin and Radiation
Exposure Compensation Standards Act, including persons with recognized
scientific and medical expertise in fields pertinent
54
to
understanding the health effects of exposure to dioxin. The Committee meeting
currently scheduled for May 16th and May 17th should be cancelled.
3. That the Secretary in making his decision
regarding Agent Orange compensation for Vietnam Veterans do so on the basis of
his independent evaluation of the existing scientific and medical evidence on
the health effects of exposure to dioxins, as cataloged and discussed in this
Report, and in full recognition that the standard to be applied -- as mandated
by both Congress and the courts -- requires the resolution of doubts as to a
number of cancers linked to dioxins in favor of the Vietnam Veterans.
55
PAGE
