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DepartmentofVeteransAffairs
Report
REPORTTOSECRETARYOFTHEDEPARTMENTOFVETERANSAFFAIRS ONTHEASSOCIATIONBETWEENADVERSEHEALTHEFFECTS
AND EXPOSURE TOAGENTORANGE
CLASSIFIED
CONFIDENTIALSTATUS(1)
As ReportedbySpecialAssistant Admiral E.R.Zumwalt, Jr. May 5, 1990
NOTFORPUBLICATIONAND RELEASE TOTHEGENERAL PUBLIC
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 theScientific 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 studiesto 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, porphyriacutaneatarda 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 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 tocontain the contaminant TCDD or 2,3,7, 8-tetrachlorodibenzo-para-dioxin (i.e. dioxin), which isregarded 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 thefollowing objectives: 1) 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 trails2
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
1SeeCDCProtocolforEpidemiologicStudiesontheHealthofVietnamVeterans(November,1983), p.4(The CDCProtocolalso containsaliteraturereviewasof1983ofthehealtheffectsonanimalsand humansexposedtoherbicidesanddioxin,pp.63-78.Theliteraturereviewdocuments healthproblems suchaschloracne,immunological suppression,neurologicalandpsychologicaleffects,reproductive problemssuchasbirthdefects,carcinogeniceffectssuchassofttissuesarcomas,lymphomasand thyroidtumors,andvariousgastrointestinaldisorders);SeealsoGeneralAccountingOffice,"Reportby theComptroller General:HealthEffectsofExposuretoHerbicideOrangeinSouthVietnamShouldBe Resolved,"GAO-CED-79-22 at2 (April6, 1979) (hereinafterGAO Report,1979).
Dioxinisafamilyof chemicals(75 inall)thatdoes notoccurnaturally,nor isitintentionally manufacturedby anyindustry.Themosttoxicdioxiniscalled2,3,7,8 — TCDD. Dioxinsareproduced as byproductsof themanufactureof someherbicides( for example,2,4, 5—T),wood preservatives madefromtrichlorophenals,andsomegermicides.Dioxinsarealsoproducedby themanufactureof pulpandpaper,by thecombustionof wood inthepresenceof chlorine,by firesinvolvingchlorinated benzenesandbiphenyls(e.g.PCBs), by theexhaustof automobilesburningleadedfuel,andby municipalsolidwasteincinerators
2 SeeBruceMyers, "Soldierof Orange:TheAdministrative,Diplomatic,LegislativeandLitigatoryImpactof HerbicideAgentOrangeinSouthVietnam,"8 B.C.Env’t.Aff. L.Rev.159, 162 (1979).
3SeeGAO Report,1979 at2, 3 n.1;SeealsoMyers, 8 B.C.Env’tAff. L.Rev,at162. In contrast, civilianapplicationsof2,4,5—Tvariedfrom1 to4pounds peracre.
4GeneralAccountingOffice,‘Ground Troops inSouthVietnamWereinAreas Sprayedwith HerbicideOrange," FPCD 80-23, p.1 (November16, 1979).
Thebulkof AgentOrangeherbicidesusedinVietnamwerereportedlysprayedfrom"OperationRanch Hand" fixedwing aircraft.Smallerquantitieswereappliedfromhelicopters,trucks,riverboats,andby hand.Althoughvoluminousrecordsof RanchHand missionsarecontainedincomputerrecords, otherwiseknown as theHERBSandServiceHERBs tapes,asignificant,ifnotmajorsourceof exposure for ground forceswas fromnon— recorded,non RanchHand operations.6Widespreaduse of AgentOrangecoincidedwiththemassivebuildupof U.S. militarypersonnelin Vietnam,reachingapeakin 1969 andeventuallystoppingin1971.7 Thus, accordingtoanofficialof thethenVeterans Administration,itwas "theoreticallypossiblethatabout4.2 millionAmericansoldierscouldhavemade transientor significantcontactwiththeherbicidesbecauseof [theRanchHand Operation]."8
5LetterfromDr. JamesR.ClarytoSenatorTomDaschle(September9, 1988). Dr. ClaryisaformergovernmentscientistwiththeChemicalWeapons.Branch,.BW/CWDivision,Air ForceArmament DevelopmentLaboratory,EglinAPE, Florida.Dr. Clarywas instrumentalindesigningthe specificationsfor theA/A 45y-lspray tank(ADO 42) andwas alsothescientistwho preparedthe finalreporton RanchHand:HerbicideOperationsinSEA, July1979. AccordingtoDr. Clary:
Whenwe (militaryscientists)initiatedtheherbicideprograminthe1960’s, we wereaware of thepotentialfor damageduetodioxincontaminationintheherbicide.Wewereeven awarethatthe‘military6formulationhadahigherdioxinconcentrationthanthe‘civilian’ versionduetothelowercostandspeedof manufacture.However, becausethematerialwas tobeused on the‘enemy’,noneof us wereoverlyconcerned.Weneverconsidereda scenarioinwhich.our own personnelwould becomecontaminatedwiththeherbicide.And, ifwe had,we would haveexpectedour own governmenttogiveassistancetoveteransso contaminated.
Seealsonotes13, 73-75 andaccompanyingtextinfrafor additionalinformationof themanufacturer’s awarenessof thetoxicityof AgentOrange.
6Combatunits,suchas the‘Brown WaterNavy,’ frequentlyconducted"unofficial"sprayings of Agent Orangeobtainedfromoutof channel,andthusunrecordedsources. Additionally,asCommander,U.S. NavalForces, Vietnam,I was awarethatAgentOrangeissued toAlliedforceswas frequentlyused on unrecordedmissions.
7GAO Report1979, supra note1, at29. Seealsonote82 andaccompanyingtextinfrafor adiscussion of thecorrelationbetweenthesprayingof AgentOrangeandthehospitalizationof Vietnamsoldiersfor diseaseandnon-battlerelatedinjuries.
8HouseComm.onVeteran’sAffairs,95thCong.,2dSess.,Herbicide"AgentOrange".HearingsbeforetheSubcommitteeonMedicalFacilitiesandBenefits,(Oct.11,1978)(StatementofMaj.Sen. GarthDettingerUSAF, DeputySurgeon GeneralUSAF at12).
A. REASONS FOR PHASE OUT
Beginningas earlyas 1968, scientists,healthofficials,politiciansandthemilitaryitselfbeganto express concernsaboutthepotentialtoxicityof AgentOrangeanditscontaminantdioxintohumans.For instance,inFebruary1969 TheBioneticsResearchCouncilCommittee("BRC’) inareport commissioned by theUnitedStatesDepartmentof Agriculturefound that2,4,5-Tshowed a"significant potentialtoincreasebirthdefects."9Withinfour monthsaftertheBRCreport,Vietnamesenewspapers beganreportingsignificantincreasesinhumanbirthdefectsostensiblyduetoexposuretoAgent Orange.10
ByOctober,1969, theNationalInstituteof Healthconfirmedthat2,4,5—Tcouldcause malformationsandstillbirthsinmice,therebypromptingtheDepartmentof Defensetoannouncea partialcurtailmentof itsAgentOrangespraying.11
ByApril15, 1970, thepublicoutcryandmountingscientificevidencecausedtheSurgeon Generalof theUnitedStatestoissue awarningthattheuseof 2,4,5-Tmightbehazardousto"our health".12
On thesameday,theSecretariesof Agriculture,HealthEducationandWelfare,andtheInterior, stirredby thepublicationofstudiesthatindicated2,4,5-Twas ateratogen(i.e.causedbirthdefects), jointlyannouncedthesuspension of itsuse aroundlakes,ponds, ditchbanks, recreationareasand homesandcropsintendedfor humanconsumption.13 TheDepartmentof Defensesimultaneously announceditssuspension of alluses of AgentOrange.14
9Myers at166.
10 Id Whilebirthdefectsdidsignificantly increaseinSaigon,criticscontendthatSaigonwasnotan areawherethepreponderanceofdefoliationmissionswereflown andarguethatsuchincreasesweredue primarilytotheinfluxof U.S. medicalpersonnelwho keptbetterrecordsof birthdefects. SubsequentstudiesinVietnamconfirmtheincidenceofincreasedbirthdefectsamongcivilianpopulationsexposed toAgentOrange.Seee.g.Phuong,et.al."AnEstimateofReproductive AbnormalitiesinWomen InhabitingHerbicideSprayedandNon-herbicideSprayedAreasintheSouthofVietnam,152-198118Chemospere 843-846 (1989) (significant statistical difference between hydatidiform mole and congenitalmalformationsbetweenpopulationspotentiallyexposedandnotexposedtoTCDD);Phuong, et.al.,"AnEstimateofDifferencesAmongWomenGivingBirthtoDeformedBabiesandAmong ThosewithHydatidiformMoleSeenattheOB-GYNHospitalofHoChiMinhCityintheSouthof Vietnam,"18Chemosphere801-803(1989)(statisticallysignificantconnectionbetweenfrequencyof the occurrenceofcongenitalabnormalitiesand ofhydatidiformmolesand ahistoryofphenoxyherbicide exposure);Huong,et.al.,"AnEstimateoftheIncidenceofbirthDefects,Hydatidiform MoleandFetal DeathinUteroBetween1952and1985attheOB-GYNHospitalofHoChiMinhCity,Republicof Vietnam," 18Chemosphere805-810(l989)(sharpincreaseintherateoffetaldeathinutero, hydatidiformmole(withorwithoutchoriocarcinoma)andcongenital malformationsfromthepre1965-1975 period,suggestingpossibleassociationtophenoxyherbicideexposure).
11Myers at167
12 Id.
B.HEALTH STUDIES
As AgentOrangeconcernsgrew, numerousindependentstudieswereconductedbetween1974 and
1983 todetermineifalinkexistsbetweencertaincancerousdiseases,such as non-Hodgkin’s lymphoma andsoft-tissuesarcomas,andexposuretothechemicalcomponentsfound inAgentOrange.These
studiessuggestedjustsuch a link.
In 1974, for example,Dr. LennartHardellbeganastudywhicheventuallydemonstratedastatistically significantcorrelationbetweenexposuretopesticidescontainingdioxinandthedevelopmentof soft tissuesarcomas.15
In 1974, Axelson andSundellreportedatwo—foldincreaseof cancerinacohortstudyof Swedish railwayworkers exposedtoavarietyof herbicidescontainingdioxincontaminants.16
By1976, theOccupationalSafetyandHealthAdministration,establishedrigorous exposurecriteria for workers working with2,4, 5-T.117
13 Id.AlthoughDowChemicalCompany,theprimarymanufacturerof2,45-Tand2,4-D,deniedthis teratogenicity, Dow’sowntestsconfirmedthatwhendioxinwaspresentinquantitiesexceeding productionspecifications,birthdefectsdidoccur.See J.McCullough,Herbicides:EnvironmentalHealthEffects:VietnamandtheGenevaProtocol:Developments During1979,13(1970)(Congressional ResearchReportNo.UG447,70—303SP).Pressurefromindustrysubsequentlyledtosomerelaxation ofthe limitsplacedonthe 2,4,5—Tand 2,4—D.Theonlycurrentusesforthesechemicalsinthe United Statesareon rice,pastures,rangelandsandrightsof way.
14 Id.at167.SeealsoDowChemicalv.Ruckelshaus,477F.2d1317,1319 (8thCir.1973)(secretaries announcementquotedintheopinion).
15Hardell,L.andSandstrom,A."Case—control Study:SoftTissueSarcomasandExposureto PhenoxyaceticAcidsorChlorophenols,"39Brit.J.Cancer, 711—717(1979).Seealsonote89infrafor theconfirmingresultsof follow-upstudiesby Hardellandothers.
16Axelson andSundell,"HerbicideExposure,MortalityandTumorIncidence:An Epidemiological
Investigationon Swedish RailroadWorkers,"11 WorkEnv’t.Health21-28 (1974).
17U.S. OccupationalSafetyandHealthAdministration(1976), Air Contaminants;U.S. Code,Federal
Register29, Part1910.93 atp. 27
In 1977 theInternationalAgencyfor Researchon Cancer(IARC), whilecautioningthattheoverall datawas inconclusive,reportednumerousanomaliesandincreasedmortalityratesinanimalsand humansexposedto2,4-D or 2,4,5-T.18
In 1978, theEnvironmentalProtectionAgencyissuedanemergencysuspension of thesprayingof
2,4,5-Tinnationalforests afterfinding"a statisticallysignificantincreaseinthefrequencyof
miscarriages"amongwomenlivingnearforests sprayedwith2,4,5-T.19
18Withregardto2,4-D, theIARC found thefollowinganomalies:elevatedlevelsof cancerinrats; acuteandshort—termoraltoxicityinmice,rabbits,guineapigsandrats-—death,stiffness inthe extremities,incoordination,stupor, myotonia,andotherphysicalabnormalities;inmonkeys,injections causednausea,vomiting,lethargy,muscularincoordinationandheaddroop, fattydegenerationof the liver,spleen,kidneysandheart;foetalanomalyincreasesinsomespecies;post—birthdeathrates increasedinsome.species;highermortalityratesandmorphologicalalterationsinpheasantembryos and theirchickswhen sprayingtookplaceundersimulatedfieldconditions;highermortalityratesinrat pups ina3 generationexposure;genemutationafterexposuretohighconcentrations;chromosomal aberrationswhen culturedhumanlymphocyteswereexposed;increasedfrequencyof aberrant metaphases(2 to4 times)inmiceexposedtotoxicconcentrations.
In humanstheIARC found that:a23 yearoldfarmingstudent,asuicide,had6 gramsof 2,4-D inhis body, acutecongestionof allorgans, severedegenerationof ganglioncellsinthecentralnervoussystem;3 casesof peripheralneuropathyinhumanssprayedwith2,4-D withinitialsymptomsof nausea,vomiting,diarrhea,swellingandachingof feetandlegswithlatency,inindividualcases,paresthesiain theextremities,paininthelegs,numbness andachingof fingersandtoes,swellinginhandjoints,flaccid parapheresis;similarcasereportsinagricultureworkers sprayedby 2,4-D; workers associatedwith2,4—D developedsymptomsof somnolence,anorexia,gastralgia,increasedsalivation,asweettastein themouth,asensationof drunkenness, heavinessof thelegsandhyperacusea,rapidfatigue,headache,loss of appetite,painsintheregionof liverandstomach,weakness, vertigo,hypotension,bradycardia,dyspepticsymptoms,gastritis,liverdisfunction,changesinmetabolicprocesses..
Withregardto2,4,5—Vs effecton animalstheIARC found:itcanincreasethefrequencyof cleft palatesinsomestrainsof mice;fetalgrowth retardationmayalsobeobserved;cystickidneyswere observedintwo strainsof mice;inpurestavailableform,itinducedsomefetaleffectsandskeletal anomaliesinratsas wellas behavioralabnormalities,changesinthyroidactivityandbrainserotonin levelsintheprogeny;increasesinintrauterinedeathsandinmalformationsinrats;fetaldeathand teratogeniceffectsinSyriangoldenhamsters;chromosomalabnormalities.
TheIARC reportedin1977 withrespectto2,4,5-T’s effectson humansthat:workers exposedata factoryintheUSSR hadskinlesions,acne,liverimpairment,andneurasthenicsyndrome;similar findingswerereportedby Jerasneh,etal(1973, 1974) inafactoryinCzechoslovakiawhichin1965—68 produced76 casesof chloracne,2 deathsfrombronchogeniccancers.Someworkers hadporphyriacutaneatarda,urophryimuria,abnormallivertests,severeneurasthenia,depressionsyndrome,peripheralneuropathy;ina1975 accidentinWestVirginia,228 peoplewereaffected.Symptomsincludedchloracne,melanosis,muscularachesandpains,fatigue,nervousness, intolerancetocold;4 workers of50 affectedinasimilaraccidentintheNetherlandsin1963 diedwithin2 yearsandatleast10 stillhad skincomplaints13 yearslater.
19June1979CongressionalHearingsbeforeHouseCommerceCommittee.SubcommitteeonOversightandInvestigations,quotedin"HumanDiseaseLinkedtoDioxin: CongressCalls for2,4,5—TBanAfter DramaticHerbicide Hearings",28Bioscience 454(August1979).Thisstudy,otherwise knownasthe AlseaStudy,hasbeencitedasshowingthefirstcorrelationbetween2,4,5—T(andpresumablyits TCDD contaminant)andteratogeniceffectsinhumans.
In 1980, anotherprovocativemortalitystudyof workers involvedinanaccidentatanindustrialplantwhichmanufactureddioxincompoundssuggestedthat exposuretothesecompounds resultedinexcessivedeathsfromneoplasmsofthelymphaticand hematopoietictissues.20
On September22, 1980, theU.S. InteragencyWorkGroup toStudytheLong-termHealthEffectsof Phenoxy HerbicidesandContaminantsconcluded"thatdespitethestudies’limitations,theydo show a correlationbetweenexposuretophenoxyacidherbicidesandanincreasedrisk of developingsoft-tissuetumorsor malignantlymphomas."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 tobeincreasingconcernoverthe mountingevidenceof aconnectionbetweencertaincancer illnessesandexposuretodioxins.
20ZackandSuskind, "TheMortalityExperienceof WorkersExposedtoTCDDinaTrichlorophenol
Process Accident,"22 Journalof Medicine11—14 (1980).
21SeeU.S. InteragencyWorkgrouptoStudytheLong-TermHealthEffectsof Phenoxy Herbicidesand
Contaminants(September22, 1980) (executivesummary).
22 See...e.g."TheWeightof theEvidenceon theHumanCarcinogenicityof 2,4—D" (January1990) (Thisreport,sponsored by theNationalAssociationof WheatGrowers Foundationandagrantfromthe Industry TaskForceII on 2,4—D ResearchData,anassociationof manufacturersandcommercial formulatorsof 2,4—D, concludedthatthetoxicologicaldataon 2,4-D does notprovideastrong basis for predictingthat2,4-D iscarcinogenictohumans.Nevertheless,thepanelreviewingtheevidencedid concludethat"evidenceindicatesthatitispossiblethatexposureto2,4-D cancausecancerin humans.").
23ByOctober1, 1983, 9170 veteransfiledclaimsfor disabilitiesthattheyallegedwerecausedby exposuretoAgentOrange.TheVA deniedcompensationto7709 claimantson thegrounds thatthe claimeddiseaseswerenotserviceconnected.Onlyonediseasewas deemedassociatedwithservice relatedexposuretoAgentOrange,askinconditionknown as chloracne.SeeHouse ReportNo. 98-592, reprintedinU.S.Code Cong.Adm. News, 98thCong.2d Sess.,1984, at4452. SeealsoNehmerv.U.S. VeteransAdministration,712 F.Supp. 1404, 1407 (1989).
III. VETERANS’ DIOXIN AND RADIATION EXPOSURE COMPENSATION STANDARDS ACT OF 1984
Withtheincreasingvolumeof scientificliteraturegivingcredencetothebeliefof manyVietnam VeteransthatexposuretoAgentOrangeduringtheirmilitaryservicewas relatedtotheircontractionof severaldebilitatingdiseases--particularlynon-Hodgkin’s lymphoma,soft tissuesarcoma("STS") (malignanttumorsthatforminmusclefat,orfibrous connectivetissue)andporphyriacutaneatarda ("PCT") (deficienciesinliverenzymes)--VietnamVeteransrightfullysoughtdisabilitycompensation fromtheVeteransAdministration("VA").
TheVA determined,however,thatthevastmajorityofclaimantswerenotentitledtocompensation sincetheydidnothaveserviceconnectedillnesses.23As aconsequence,Congress attemptedtoalter dramaticallytheprocess governingAgentOrangedisabilityclaimsthroughpassageof theVeterans’ DioxinandRadiationExposureCompensationStandardsActof 1984 (hereinafterthe"Dioxin StandardsAct")24ToensurethattheVA provideddisabilitycompensationto veteransexposedtoherbicidescontainingdioxinwhileservinginVietnam,25Congress authorizedthe VA toconductrulemakingtodeterminethosediseasesthatwereentitledtocompensationas aresultof a service--relatedexposuretoAgentOrange.26
In promulgatingsuch rules,theDioxinStandardsActrequiredtheVA toappointaVeterans’ Advisory Committeeon EnvironmentalHazards(the"Advisory Committee")--composedof expertsin dioxin,expertsinepidemiology,andinterestedmembersof thepublic-- toreviewthescientificliterature on dioxinandsubmitperiodicrecommendationsandevaluationstotheAdministratorof the27
Such expertsweredirectedtoevaluatethescientificevidencepursuanttoregulationspromulgatedby theVA, andthereaftertosubmitrecommendations andevaluationstotheAdministratorof theVAon whether"sound scientificor medicalevidence" indicatedaconnectiontoexposuretoAgentOrangeandthemanifestationof variousdiseases.28
24Veterans’DioxinandRadiationExposureCompensationStandardsAct,Pub. L.98—542, Oct.24,
1984, 98 Stat.2727 (hereinaftertheDioxinStandardsAct).In passing theActCongress found that VietnamVeteranswere"deeplyconcernedaboutpossiblelongtermhealtheffectsof exposureto herbicidescontainingdioxin,"(Section2 (1)), particularlysince"(t)hereisscientificandmedical
uncertaintyregardingsuch long—termadversehealtheffects."(Section2 (2)). In respondingtothis
uncertainty,Congress mandatedthat"thorough epidemiologicalstudiesofthehealtheffectsexperienced by veteransinconnectionwithexposure. toherbicidescontainingdioxin"beconducted,(Section2(4)),
especiallyinlightof thefactthat"[t)hereissomeevidencethatchloracne,porphyriacutaneatarda,and soft tissuesarcomaareassociatedwithexposuretocertainlevelsof dioxinas found insome
herbicides."(Section2 (5)).
25Id. atSection3.
26Id. atSection5.
27Id. atSection6.
28 Id. atSection5.
Inrecognitionofthe uncertainstateofscientificevidenceand the inabilitytomakeanabsolutecausal connectionbetweenexposuretoherbicidescontainingdioxinandafflictionwithvariousrarecancer diseases,29CongressmandatedthattheVAAdministratorresolveanydoubtinfavoroftheveteran seekingcompensation.As statedintheDioxinStandardsAct:
Ithas alwaysbeenthepolicyoftheVeteransAdministrationandisthepolicyof theUnited States,withrespecttoindividualclaimsfor serviceconnectionof diseasesanddisabilities, thatwhen, afterconsiderationof alltheevidenceandmaterialof record,thereisan approximatebalanceof positiveandnegativeevidenceregardingthemeritsof anissue materialtothedeterminationof aclaim,thebenefitof thedoubtinresolvingeachsuch issue shallbegiventotheclaimant.30
A. NEHMER V. U.S. VETERANSADMINISTRATION
DespiteCongressionalintenttogivetheveteranthebenefitof thedoubt,andindirectoppositionto thestatedpurpose of theDioxinStandardsActtoprovidedisabilitycompensationtoVietnamVeteranssufferingwithcancer who wereexposedtoAgentOrange,theVA continuedtodenycompensationimproperlytoover31,000 veteranswithjustsuch claims.In fact,inpromulgatingtherulesspecifiedby DioxinStandardsAct,the VA notonlyconfoundedtheintentof theCongress, butdirectlycontradictedits-own established practice of grantingcompensableservice-connectionstatusfor diseaseson thelessershowing of a statisticalassociation,promulgatinginsteadthemorestringentrequirementthatcompensationdepends on establishingacauseandeffectrelationship.31
Mountingachallengetotheregulations,Veteransgroups prosecutedasuccessfullegalactionwhich found thattheVA had"both imposedanimpermissiblydemandingtestforgranting serviceconnection for variousdiseasesandrefusedtogivethe veteransthebenefitof thedoubtinmeetingthedemandingstandard."Nehmerv. U.S. VeteransAdministration,712 F. Supp. 1404, 1423 (1989) (emphasisinoriginal).rAs aresult,thecourtinvalidated theVA’s Dioxinregulationwhichdeniedserviceconnectionfor alldiseasesotherthanchloracne; ordered theVA toamenditsrules;andfurtherorderedthattheAdvisory Committeereassessits recommendationsinlightof thecourt’sorder.32
29 SeeNehmerv. U.S. VeteransAdmin.,712 F. Supp. 1404, 1408. (N.D. Cal.(1989). whereinthe courtfound afterreviewingthelegislativehistoryoftheAct"thatCongress intendedserviceconnection tobegrantedon thebasis of "increasedrisk of incidence"or a"significantcorrelation"betweendioxin andvariousdiseases," ratherthanonthebasis of acasualrelationship.
30SeeDioxinStandardsActatSection2 (23).
31Seee.g.38C.F.R.3.310(b)(compensationgrantedforcardiovasculardiseasesincurredbyveterans who sufferedamputationsof legsor feet);Nehmerat1418.
Thesignificanceof thedistinctionbetweenastatisticalassociationandacauseandeffectrelationship isintheburdenof proof thattheveteranmustsatisfyinordertobegrantedbenefits.A statistical association"meansthattheobservedcoincidenceinvariationsbetweenexposuretothetoxicsubstance andtheadversehealtheffectsisunlikelytobeachanceoccurrenceor happenstance,"whereasthecause andeffectrelationship"describesamuchstrongerrelationshipbetweenexposuretoaparticulartoxic substanceandthedevelopmentof aparticulardiseasethan‘statisticallysignificantassociation’does." Nehmer,712 F.Supp. at1416.(Continued on page 11)
Thus, on October2, 1989, theVA amended38 C.F.R.Part1, whichamongotherthingssetforth variousfactorsfor theSecretaryandtheAdvisory Committeetoconsiderindeterminingwhetheritis "atleastas likelyas not" thatascientificstudyshows a"significantstatisticalassociation"betweena particularexposuretoherbicidescontainingdioxinandaspecificadversehealtheffect.33Equally important,the regulationpermitstheSecretarytodisregardthefindingsof theAdvisory Committee,as wellas the standardssetforthat38 C.F.R.§1.17(d)anddetermineinhisownjudgmentthatthescientificandmedicalevidencesupports theexistenceofa"significantstatisticalassociation"betweenaparticularexposureandaspecific disease.38 C.F.R. § 1.17 (f).
TheSecretaryrecentlyexercisedhisdiscretionaryauthorityunderthisrulewhen hefound a significantstatisticalassociationbetweenexposuretoAgentOrangeandnon—Hodgkin’s lymphoma, notwithstandingthefailureof hisown Advisory Committeetorecommendsuch actioninthefaceof overwhelmingscientificdata.34
31(Continued from Page 10 )Thus, theregulationpromulgatedby theVA establishedanoverlyburdensomestandardby incorporatingthecausalrelationshiptestwithinthetextof theregulationitself.38 C.F.R. 1 3.311(d) ("(s] ound scientificandmedicalevidencedoes notestablishacauseandeffectrelationshipbetween dioxinexposure" andanydiseasesexceptsomecasesof chloracne)(emphasisadded).
32 Nehmer,712 F. Supp at1423.
3338 C.F.R. 1.17 (b) &(d). 38 C.F.R. 1.17 states:
(a)Fromtimetotime,theSecretaryshallpublishevaluationsof scientificor medicalstudiesrelatingto theadversehealtheffectsof exposuretoaherbicidecontaining2,3,7,8 tetrachlorodibenzo-p-dioxin (dioxin)and/orexposuretoionizingradiationinthe"Notices"sectionof theFederalRegister.
(b) Factorstobeconsideredinevaluatingscientificstudiesinclude:
(1) Whetherthestudy’s findingsarestatisticallysignificantandreplicable. (2) Whetherthestudyanditsfindingshavewithstoodpeerreview.
(3) Whetherthestudymethodologyhas beensufficientlydescribedtopermitreplicationof thestudy. (4) Whetherthestudy’s findingsareapplicabletotheveteranpopulationof interest.
(5) Theviews of theappropriatepanelof theScientificCouncilof theVeteran’Advisory Committeeon
EnvironmentalHazards.
(c)WhentheSecretarydetermines,basedon theevaluationof scientificor medicalstudiesandafterreceivingtheadviceof theVeteran’sAdvisory Committeeon EnvironmentalHazardsandapplyingthereasonabledoubtdoctrineas setforthinparagraph(d) (1) of thissection,thatasignificantstatisticalassociationexistsbetweenanydiseaseandexposuretoa herbicidecontainingdioxinor exposuretoionizingradiation,3.311aor 3.311b of thistitle,as appropriate,shallbeamendedtoprovideguidelinesfor theestablishmentof serviceconnection.
(d) (1) For purposes of paragraph(c)of thissectiona"significantstatisticalassociation"shallbe deemedtoexistwhen therelativeweightsof validpositiveandnegativestudiespermittheconclusion thatitisatleastas likelyasnotthatthepurportedrelationshipbetweenaparticulartypeof exposureand a specificadversehealtheffectexists.
(2) For purposes of thisparagraphavalidstudyisonewhich:
(i)Had adequatelydescribedthestudydesignandmethodsof datacollection,verificationand analysis;
(ii)Is reasonablyfreeof biases,such as selection,observationandparticipationbiases;however,if
biasesexist,theinvestigatorhasacknowledgedthemandso statedthestudy’s conclusionsthatthe biasesdo notintrudeupon thoseconclusions;and
(iii)Has satisfactorilyaccountedfor known confoundingfactors. (Continued on page 12)
B.. THEWORK OF THEVETERANS’ ADVISORY COMMITTEEONENVIRONMENTAL HAZARDS
Toassess thevalidityandcompetencyof thework of theAdvisory Committee,I askedseveral impartialscientiststo reviewtheAdvisory Committeetranscripts.Withoutexception,theexpertswho reviewedthework of theAdvisory Committeedisagreedwithitsfindingsandfurtherquestionedthevalidityof theAdvisory Committee’sreviewof studieson non—Hodgkin’s lymphomas.
For instance,adistinguishedgroup attheFredHutchinsonCancerResearchInstituteinSeattle, Washington,upon reviewingtheAdvisory Committeetranscripts,concluded"thatitisateast.,as likely as notthatthereisasignificantassociation(asdefinedby theSecretaryofVeteransAffairs) between (exposuretophenoxyacidherbicidesandnon-Hodgkin’s lymphoma.)"35 Thissamegroup further asserts thattheCommittee’swork was "not sensible"and"ratherunsatisfactory"initsreviewand classificationof thevariousstudiesitreviewed.Additionally,thesescientistsregardedDr. Lathrop’s views as "less thanobjective"andfeltthatthepossibilityexiststhat"his extremeviews (e.g.,inrespect totheroleof dose--response testing)mayhaveundulyaffectedtheCommittee’swork." Finally,the Hutchinsonscientistsarguethattheissue of chemical-specificeffects,inwhichanimalstudieshavebeensufficienttodemonstratethecarcinogenicityof dioxin,isanimportantfactor"not wellcons idered by theCommittee."(emphasisinoriginal)
33(Continued from Page 11)(3) For purposes of thisparagraphavalidpositivestudyisonewhichsatisfiesthecriteriain paragraph(d) (2) of thissectionandwhose findingsarestatisticallysignificantataprobabilitylevel
of .05 or less withproperaccountingfor multiplecomparisonsandsubgroups analyses.
(4) For purposes of thisparagraphavalidnegativestudyisonewhichsatisfiesthecriteriain paragraph(d) (2) of thissectionandhas sufficientstatisticalpower todetectanassociationbetweena
particulartypeof exposureandaspecificadversehealtheffectifsuch anassociationweretoexist.
(e)For purposes of assessing therelativeweightsof validpositiveandnegativestudies,otherstudies affectingepidemiologicalassessmentsincludingcaseseries,correlationalstudiesandstudieswith
insufficientstatisticalpower as wellas keymechanisticandanimalstudieswhicharefound tohave
particularrelevancetoaneffecton humanorgansystemsmayalsobeconsidered.
(f) Notwithstandingtheprovisionsof paragraph(d) of thissection,a"significantstatistical association"maybedeemedtoexistbetweenaparticularexposureandaspecificdiseaseif,inthe
Secretary’sjudgment,scientificandmedicalevidenceon thewholesupports such adecision.
34Afterreviewingnumerousscientificstudies,atleastfour of whichweredeemedtobevalidpositive indemonstratingthelink. betweenexposuretoherbicidescontainingdioxinandnon--Hodgkin’s lymphoma,theAdvisory Committeestillconcludedthat:
TheCommitteedoes notfindtheevidencesufficientatthepresenttimetoconcludethat there isasignificantstatisticalassociationbetweenexposuretophenoxyacidherbicidesand non—Hodgkin’s lymphoma.However, theCommitteecannotruleoutsuch anassociation.
TheSecretaryshouldbeinterestedtonotethatanew mortalitystudypositivelyconfirmsthatfarmers exposedtoherbicidescontaining2,4-D haveanincreasedrisk of developingnon-Hodgkin’s lymphoma. SeeBlair,"HerbicidesandNon-Hodgkin’s Lymphoma:New EvidenceFromaStudyof Saskatchewan Farmers," 82 Journalof theNationalCancerInstitute575--582 (1990).
35LettertoAdmiralZumwaltfromDr. RobertW.Day, Directorof theFred HutchinsonCancerResearchCenterof Seattle,Washington(Feb. 20, 1990).
A secondreviewerof theCommittee’.work, Dr. Robert Hartzman(consideredoneof theU.S. Navy’stopmedicalresearchers),effectivelyconfirmstheviews of theHutchinsongroup. Dr. Hartzmanstatesthat"thepreponderanceof evidencefromthepapers reviewed[by theAdvisory Committee)weighs heavilyinfavorof aneffectof AgentOrangeon increasedrisk for non—Hodgkin’s lymphoma."36 Dr. Hartzmanalsoatteststhat: aninadequateprocess isbeingused toevaluatescientificpublicationsfor use inpublicpolicy.The process uses scientific words like‘significantatthe5% level’andacommitteeof scientiststoproduce a decisionaboutaseriesof publications.Butinreality,theCommitteewas so tiedby theprocess, thata decisionwhichshouldhavebeenbasedon scientificdatawas reducedtovagueimpressions...Actually,if thereadingof therulesof validnegativefound inthetranscriptiscorrect(‘avalidnegativemustbe significantatthep=.05level’thatisstatisticallysignificanton thenegativeside)noneof thepapers reviewedarevalidnegatives.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 Veterans.38
A fourthreviewer,adistinguishedscientistintimatelyassociatedwithgovernmentsponsored studies on theeffectsof exposuretoAgentOrange,statesthesameconclusionsreachedby theotherreviewers:
Thework of theVeterans’Advisory Committeeon EnvironmentalHazards,as documented intheirNovember2, 1989 transcript,has littleorno scientificmerit,andshouldnotserveas abasis for compensationor regulatorydecisionsof anysort...
My analysisof theNHL articlesreviewedbythecommitteerevealsstrikingpatternswhich indicatetomethatitismuchmorelikelythannotthata statisticalassociationexists betweenNHL andherbicideexposure.
As thesevariousreviewerssuggest, theAdvisory Committee’sconclusionson therelationship betweenexposuretoAgentOrangeandnon—Hodgkin’s lymphomawerewoefullyunderstatedinlight of theclearevidencedemonstratingasignificantstatisticalassociationbetweenNHL andexposureto phenoxyacidherbicidessuch as AgentOrange.
36LettertoAdmiralZumwaltfromDr. R.J.HartzmanCapt.MC USN (March7, 1990).
37 Id. atp.3
38 SeeStellmanStellman,"A Selectionof Papers withCommentariesRelevanttotheScience InterpretationandPolicy:AgentOrangeandVietnamVeterans,’(March1, 1990) . Seealsonote51 and accompanyingtextinfrafor additionaldiscussionof theStellmans’work.
Perhaps moresignificantthantheCommittee’sfailuretosakesuch obviousfindingsisthedistressing conclusionof theindependentreviewersthattheCommittee’sprocessisso flawed as tobeuseless totheSecretaryinmakinganydeterminationon theeffectsof AgentOrange.Froma merereadingof Committeetranscripts,thesereviewersdetectedovertbiasintheCommittee’s evaluationof certainstudies.In fact,somemembersof theAdvisory CommitteeandotherVA officials have,evenbeforereviewingtheevidence,publiclydeniedtheexistenceof acorrelationbetween exposuretodioxinsandadversehealtheffects.40Thisblatantlackof impartialitylendscredencetothe suspicionthatcertainindividualsmayhavebeenundulyinfluencedintheirevaluationof various studies.Furthermore,such biasamongAdvisory committeememberssuggests thattheSecretaryshould, inaccordancewiththeDioxinStandardsAct,appointnew personneltotheAdvisory Committee.
III. THECDCSTUDIES
Werethefaultyconclusions,flawedmethodologyandnoticeablebiasof theAdvisory Committeean isolatedproblem,correctingthemisdirectionwould bemoremanageable.But,experiencewithother governmentalagenciesresponsiblefor specificallyanalyzingandstudyingtheeffectsof exposuretoAgentOrangestronglyhintsatadiscerniblepattern,ifnotoutrightgovernmentalcollaboration,todeny compensationtoVietnamVeteransfor disabilitiesassociatedwithexposuretodioxin.
A caseinpointistheCentersfor Diseasecontrol("CDC") . As concernsgrew followingthefirst studiesof humanexposuretoAgentOrange,Congresscommissionedalargescaleepidemiological study todeterminethepotentialhealtheffectsfor VietnamVeteransexposedtoAgentOrange.Initially, thisstudywas tobeconductedby theVA itself.Whenevidencesurfaced,however,of theVA’sfootdraggingincommencingthestudy(andinitialdisavowalof anypotentialharmfromexposureto AgentOrange),Congress transferredtheresponsibilityforthestudytotheCDC in1983. 41