Department of Veterans Affairs

Report

REPORT TO TO SECRETARY OF THE DEPARTMENT OF VETERANS AFFAIRS

ON THE ASSOCIATION BETWEEN ADVERSE HEALTH EFFECTS

AND EXPOSURE TO AGENT ORANGE







As Reported by Special Assistant

Admiral E.R. Zumwalt, Jr.

May 5, 1990









1. INTRODUCTION

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

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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

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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)

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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

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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

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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

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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

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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.

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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

A. REASONS FOR PHASE OUT

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

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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

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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

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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.

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homes and crops intended for human consumption.13 The Department of Defense simultaneously announced its suspension of all uses of Agent Orange.14

B. HEALTH STUDIES

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

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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.

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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

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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

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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

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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.

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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

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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.").

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(

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

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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).

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(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

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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.

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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

A. NEHMER V. U.S. VETERANS ADMINISTRATION

Despite Congressional intent to give the veteran the benefit of the doubt, and in direct opposition to the stated purpose of

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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).

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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

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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).

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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

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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

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regulation permits the Secretary to disregard the findings of the Advisory Committee, as well as the standards set forth at 38

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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.

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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

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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).

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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

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35 Letter to Admiral Zumwalt from Dr. Robert W. Day, Director of the Fred Hutchinson Cancer Research Center of Seattle, Washington (Feb. 20, 1990).

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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

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36 Letter to Admiral Zumwalt from Dr. R.J. Hartzman Capt. MC USN (March 7, 1990).

37 Id. at p.3

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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

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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."

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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.

III. THE CDC STUDIES

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

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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) .

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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

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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].

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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

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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.

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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

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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).

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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

This message has been edited. Last edited by: SteveFiscus,

quote:

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.

Thank you Steve. As clearly stated in my book, the CDC proved it was ineffective in the 1980's! My book, found on my website "In Search of the Truth for Vietnam Combat Veterans" states the CDC failed to find 1,100 veterans nationwide, when I found more than 1,100 in Franklin County Ohio.

Outstanding post, thank you Steve