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Doubt is their Product

Doubt is their Product

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Published by Derek Colanduno
Doubt as a product and service.
Doubt as a product and service.

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Published by: Derek Colanduno on Apr 16, 2011
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07/27/2011

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ewscientificchallengesaremorecomplexthanunderstandingthehealthrisksofachemicalordrug.Investigatorscannotfeedtoxiccompoundstopeopletoseewhatdosescausecancer.Insteadlaboratoryresearchersrelyonanimaltests,andepidemiologistsexaminethehumanexposuresthathaveal-readyhappenedinthefield.Bothtypesofstudieshavemanyuncertainties,andscientistsmustextrapolatefromtheevi-dencetomakecausalinferencesandrecommendprotectivemeasures.Becauseabsolutecertaintyisrarelyanoption,reg-ulatoryprogramswouldnotbeeffectiveifsuchproofwererequired.Governmentofficialshavetousethebestavailableevidencetosetlimitsforharmfulchemicalsanddeterminetheofpharmaceuticals.Uncertaintyisaninherentproblemofscience,butmanu-factureduncertaintyisanothermatterentirely.Overthepastthreedecades.jndustrygroupshavefrequentlybecomeinvolvedintheinvestigativeprocesswhentheirinterestsarethreatened.
If,
forexample,studiesshowthatacompanyisexposingitsworkerstodangerouslevelsofacertainchemical,thebusinesstypicallyrespondsbyhiringitsownresearcherstocastdoubtonthestudies.Or
if
apharmaceuticalfiI'mfacesquestionsaboutthesafetyofoneofitsdrugs,itsexecutivestrumpetcompany-sponsoredtrialsthatshownosignificanthealthriskswhileignoringorhidingotherstudiesthataremuchlessreassuring.Thevilificationofthreateningresearchas"junkscience"andthecorrespondingsanctificationofindustry-commissionedresearchas"soundscience"hasbecomenothinglessthanstan-dardoperatingprocedureinsomepartsofcorporateAmerica.In1969anexecutiveatBrown
&
Williamson,acigarettemakernowownedbyR.].ReynoldsTobaccoCompany,un-wiselycommittedtopapertheperfectsloganforhisindustry'sdisinforrnationcampaign:"Doubtisourproductsinceitisthebestmeansofcompetingwiththe'bodyoffact'thatexistsinthemindofthegeneralpublic."
In
recentyears,manyotherindustrieshaveeagerlyadoptedthisstrategy.Corporationshavemountedcampaignstoquestionstudiesdocumentingtheadversehealtheffectsofexposuretoberyllium,lead,mercury,
96
SCIENTIFICAMERICAN
vinylchloride,chromium,benzene,benzidine,nickel,andalonglistofothertoxicchemicalsandmedications.Whatismore,CongressandtheadministrationofPresidentGeorgeW.Bushhaveencouragedsuchtacticsbymakingiteasierforprivategroupstochallengegovernment-fundedresearch.Al-thoughinsomecases,companiesbelegitimatearguments,theoverallresultisdisturbing:manycorporationshavesuccessfullyavoidedexpenseandinconveniencebyblock-ingandstallingmuchneededforpublichealth.betweenindustryandscienceisthecontroversyThislightweightmetalisvitaltotheproductionofnuclearwarheadsbecauseitincreasestheyieldofthethecoldwar,theU.S.nuclearwe:'ponsconsumerofthesubstance.used
to
makeelectronicsthemetalisalsoextremelyamountscancausechronicberylliumadebilitatingail-mentthatscarsthelungs.Victimshaveincludednotjustthemachinistswhoworkedwiththemetalbutotherssim-plyinthevicinityofthemillingandforveryshortperiods.Oneaccountantworkingforafewweekseachyearinanofficenearwhereberylliumwasbeingprocessed.CBDhasalsobeendiagnosedinpeoplelivingnearberylliumfactories.Asassistantsecretaryofenergyforenvironment,safetyandhealthfrom1998to2001,Iwasthechiefsafetyofficerforthenuclearweaponscomplex,responsibleforprotectingthehealthofworkersatproductionandresearchfacilitiesaswellasforsafeguardingthesurroundingcommunitiesandenvi-ronment.WhenPresidentBillClintonappointedme,theDe-partmentofEnergy'sexposurestandardforberylliumhadnotchangedsince1949,someyearsafterthesubstance'shealthdangershadbecomeclear.Inresponsetoacrisisinvolvingmanysickworkersandcommunityresidents,twoscientistsworkingwiththeAtomicEnergyCommissionestimatedwhat
JUNE2005
 
,ucn,",uc
tobeasafe
IPUP__
l"iX7n
permeterofair-whileinataxicabontheirwaytoameeting.ThethepredecessortheDOE,thenimplementedthetaxicabstandard.WhentheOccupationalSafetyandHealthAdministrationwasestablishedin1971toprotectthehealthofwork-ersintheprivatesector,it,too,adoptedthetaxicabstandardberyllium.Overthefollowingdecades,however,itbecamedearthatworkersexposedtoberylliumlevelswellbelowthestandardwerefallingsick.Inthe19908theDOEandOSHAbeganthetime-consuminglegalprocessofchangingtheirex-posurelimitsforberyllium.BrushWellman,thenation'slead-ingproducerofthemetal,hiredExponent,aMenloPark,Calif.,consultingfirmspecializinginproductdefense.SharingauthorshipwithBrushWellman'sscientists,theseconsultantswroteaseriesofpaperssuggesting
it
waspossiblethatthesize,surfaceareaandnumberofberylliumparticlesmaybemoreimportantthanpreviouslythoughtinthedevelopmentofCBD.alsoraisedthehypothesisthatskinexposurecouldplayaroleindiseaserisk.Theconsultantsconcludedthatthecurrentstandardforberylliummightnotbeprotectivebutthatmoreresearchwasrequiredbeforechangingit.Afterreviewingallthestudiesandtakingtestimonyfromandindependentscientists,theDOEleadershipinthelateryearsoftheClintonadministrationdecidedthatalthoughmoreresearchisalwaysdesirable,thedepartmenthadmorethanenoughinformation
to
warrantimmediateimplementa-tionofastricterstandardforberyllium.Weissuedanewrule,reducingtheacceptableworkplaceexposurelevelbyafactorof10.Althoughwecouldnotprovethatthelowerlimitwouldeliminatethehealthrisks,wechosealevelthatwebelievedwouldpreventmostcasesofCBDandthatwasalsotechno"logicallyfeasible.Thisnewstandard,however,appliesonlytoDOEworkers;workersintheprivatesector,whofallunderOSHA'sumbrella,donotenjoythesameprotection.In
1998
OSHAdeclareditsintention
to
followDOE'slead,butthreeyearslatertheagencydroppedthatinitiative.InNovember2002theagencyimplicitlyacceptedtheindustry'sargumentsbyissuingacallforadditionaldataontherelationofberylliumdiseaseto,amongotherthings,thesize,surfaceareaandnum-berofparticlesandtheextentofskincontact.Thatiswheremattersstandtoday.Asithappens,mostscientistsbelievethatberylliumalsoincreasestheriskoflungcancer;severalstudiesconductedbyepidemiologistsattheCentersforDiseaseControlandPreven-tionsupportthisconclusion.In2002,however,statisticiansfromanotherproduct-defensefirm,RothAssociatesinRock-ville,Md.,andtheUniversityofIllinoispublishedareanalysisofalO-year-old
CDC
study.Bychangingsomekeyparameters,theauthorsraisedtheestimatesforthebackgroundrateof
98
SCIENTIFICAMERICAN
longerstatisticallysignificant,accomplished,whereasthe
ULJIJU~1";~U.HHH"'5
U~li"l1JU"
intosignificance-isextremelydifficult.)NGKMetals,aprodu:s;erofresearch.Thenewanalysis
co!ogy,
apeer-reviewedjournal=-notoneepidemiologybut
t'lP"f'-l·pv,p".rp!1
nonetneiess-vanonowtoursitsstudyasevidenceThispatternisnotuniquetotheberylliumindustry.Manyothercompaniesthatproducehazardouschemicalshavehiredresearcherstodisputeandreanalyzedatashowingadversehealtheffects.Theirconclusionsarealmostalwaysthesame:theevidenceisambiguous,soregulatoryactionisunwarrant-ed.Outofthealmost3,000chemicalsproducedinlargequan-tities(morethanonemillionpoundsannually),OSHAenforc-esexposurelimitsforfewerthan500.Inthepast10yearstheagencyhasissuednewstandardsforagrandtotaloftwochemicals;thevastmajorityoftheothersarestill"regulated"byvoluntarystandardssetbefore1971,whenthenewlycreatedagencyadoptedthemuncriticallyandunchanged.Newsciencehashadnoimpactonthem.IconcludethatsuccessiveOSHA
JUNE2005
 
administratorshavesimplyrecognizedthatestablishingnewstandardsissotime-andlabor-intensive,andwillinevitablycallforthsuchorchestratedoppositionfromindustry,thatitisnotworthexpendingtheagency'slimitedresourcesontheeffort.Emphasizinguncertaintyonbehalfofbigbusinesshasbe-comeabigbusinessinitself.Theproduct-defensefirmshavebecomeexperiencedandsuccessfulconsultantsinepidemiol-ogy,biostatisticsandtoxicology.Infact,itisnowunusualforthesciencebehindanyproposedpublichealthorenvironmen-talregulation
not
tobechallenged,nomatterhowpowerfultheevidence.Currentlyrepresentativesofindoortanningsa-lonsarehardatworkdisparagingthedesignationofultravio-letradiationasacauseofskincancer.Furthermore,thede-nialofscientificevidenceandtheinsistenceonanimpossiblecertaintyarenotlimitedtobusinessinterests.Forinstance,somezealousenvironmentalistsremainadamantlyopposed
to
foodirradiation-theuseofgammarays,x-raysorelectronbeamstokillmicrobesinmeatsandproduce-eventhoughthebenefitsofthepracticegreatlyoutweightherisks.
THEPOWEROFCOMPANIES
toinfluenceanddistortre-searchisalsostronginthepharmaceuticalindustry.ConsidertheFoodandDrugAdministration'sbelatedclampdownonphenylpropanolamine(PPA),theover-the-counterdrugthatwaswidelyusedasadecongestantandappetitesuppressantfordecades.Reportsofhemorrhagicstrokesinyoungwomen
whohadtakenaPPA-containing1970s.Overthenext20years,thePPA'ssafety,butthetradeassociationmanufacturers-includingtis),Wyethand
cerns,
employingscientistsandmarket.Eventuallya
r,)jmn,j''',m
thecompaniestoselectanandfundanepidemio-logicalstudywhosedesignwouldbebyboththemanufacturersandthe
FDA.
TheychosetheYaleUniversitySchoolofMedicine;in1999theconfirmedthatPPAcauseshemorrhagicstroke.Didthemanufacturerswithdrawthewhichbythenhadannualsalesofmorethan$500million?No.InsteadtheyturnedtotheWeinbergGroup,aproduct-defenseconsultingfirmbasedinWashington,D.C.,toattackthestudyandhadtheirattorneysputtheresearchersthroughgruelinglegalde-positions.DavidA.Kessler,formerheadofthe
FDA
andnowdeanoftheUniversityofCaliforniaatSanFranciscoSchoolofMedicine,said,"Withtheamountofhassleandharassmentthat[theYalescientists]hadtoendure,I'msurethenexttimethey'reaskedtoundertakesomethinglikethis,they'llwonderifit'sworththecost."The
FDA
finallyadvisedmanufacturerstostopmarketingPPAinNovember2000.Theagencyesti-matesthatthechemicalcausedbetween200and500strokesayearamong18-to49-year-oldpeople.Orconsiderrofecoxib,morecommonlyknownasVioxx,thedrug'spa
rt
of
N
ovar-agency'scon-PPAonthe
SCIENTIFICAMERICAN
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