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ClinicalTrialsinDevelopingCountries

KassandraMartin

English12
Mrs.Whedon
4March2016


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Theymademesignbecausetheysaiditwasessentialforthevaccinations.Theydidnot
tellusthattheyaremakinguspartofthedrugtrials.(GlobalNews)Thisisarealityformany.
Pharmaceuticalcompaniesareseekingoutpoorregionstodotheseclinicaltrials.Thetreatment
ofthepoorisawfullyunethical,andformanyreasons.Forinstance,theyobtainnorealconsent
fromthepatients,andarenottruthfulwhenaskingforit.Theydontexplainanythingtothese
volunteers,sotheyarenotwellinformedoftherisksandwhatwillbehappeningduringthese
trials(Anand).Thisisnotjusthappeninginoneplace,eitheritshappeningallovertheworldin
developingcountries.Argentinahashaditsshareofvictims,andmanyhavelostfamily,even
babies,tothiscause.Indiaisalsoagotoplaceforthesetrials,andherealso,these
pharmaceuticalcompaniesseekoutpooranduneducatedpeopleandfamilies,gettingunclear
consent.In2011,morethan438peoplediedinclinicaltrialsinIndia.Peoplearelosingtheir
livesandlovedonestotheseclinicaltrials.Somesaythattheyofferedthemselvesuptothis
possibility,butsomebelievethatwiththewaytheclinicaltrialwasperformedandsetup,they
hadnowayofknowingitwasevenapossibility(LloydRoberts).
Aclinicaltrialisdescribedas
anyresearchstudythatprospectivelyassignshuman
participantsorgroupsofhumanstooneormorehealthrelatedinterventionstoevaluatethe
effectsonhealthoutcomes(WorldHealthOrganization).Onewayofresearchingthisistotest
newdrugsonwillinghumansubjects(Stefan).Heresthething,notallclinicaltrialsarebad!
ManyclinicaltrialsareperformedrighthereinAmerica,andmanyotherdevelopedcountries!
However,manypeoplelivinginthesepoorregionshavestoriesabouttheunjusttreatmentthey
havefacedwhenbeingdraggedintotheseclinicaltrials.PoorIndiansarenotreceivingthesame


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amountofcarethatanAmericanwouldreceiveiftheyweretopartakeinaclinicaltrial,for
instance.
PharmaceuticalcompanieslikeJohnson&Johnson,Pfizer,andGlaxoSmithKlinearethe
bignamesbehindthesetestsandtrials.Theyhavedrugstheywanttotest,andsosometimesthey
willhirelocaldoctorsorphysicianstorunthetestsandtrials.Occasionally,theyseekoutpeople
whoarealreadyillwithsomething,withpromisesoffixingtheproblem,onlytotestadrugthat
maynotevenworkonthem.Usually,thesevictimsareverypooranduneducated(Anand).
Theseclinicaltrialsindevelopingcountriesarebothunethicalandexploitative.
Thisisaglobalsituation.Thisisnotaonetimehappening,oronlytakesplaceinone
area.TheearliestcasetookplaceinNigeria.In1996,theyhadAfricasworstevermeningitis
outbreakthecontinenthadeverseen.Pfizerwenttheretotestadrugformeningitis.Outofthe
200kids,11died,andseveralothershadlastingbadsideeffects.
Butlateritwasclaimedthat
Pfizerdidnothaveproperconsentfromparentstouseanexperimentaldrugontheirchildrenand
questionswereraisedoverthedocumentationofthetrial.Legalactionfiledagainstthecompany
allegedthatsomereceivedadoselowerthanrecommended,leavingmanychildrenwithbrain
damage,paralysisorslurredspeech
.
(Smith).Thusbegana15yearlegalbattle.Unfortunately,
thesametypeofeventsarestilloccurringtoday,20yearslater.
Morerecently,Argentinahadasimilaroccurrencewithunethicalclinicaltrials.GSK
cametothecountryhopingtotestadrugthatwasmeanttohelptreatmeningitis,otitis,and
pneumonia.Inavideoarticletitled
HumanLabRatsExploitingtheworld'spoorforclinical
trials,awomannamedSusannagaveherstory.Herbaby,notevenayearoldyet,becameill
withpneumonia.Whensomedoctorsfoundout,theypushedandpushedhertobepartofthis


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clinicaltrial.Afterhersongotveryill,andaftershehadhadenoughoftheirpushing,shecaved.
Shesignedthepapers.Shehadnoideawhattheriskswouldbe,becausetheconsentformswere
allinenglishandshedidntspeakthelanguage.Shortlyafter,hersondied.Themedicationdid
nothingfortheboy,andwithnotreatment,itkilledhim.13otherfamiliessufferedthesamefate
withtheirownbabies.
Indiahasbecomeagotolocationfortheseclinicaltrials.Whenaskingamedical
professionalaboutwhythatis,shestated
Theyhavealotofpoorpeoplewhoaredesperateto
makemoneyanddesperateforhealthcareandtheydon'tunderstand.Theyarepoorlyeducated.
InIndia,youareeitherreallyrichorreallypoor
(Martin).
Onespecificstoryisaboutaman
namedAJ,andhissmallfamily(hiswifeandoneson).Whentakinghissontothedoctors,they
askedhimtosignaconsentformforessentialvaccinationsthatyoureceiveasababy.Acouple
dayslater,whentheirsonstartedgettingwhitepatchesalloverhisbody,theyfoundoutthatthe
consentformwasactuallyforaclinicaltrialofpoliodrug.Theyhadnoidea,becausethedoctors
werenothonestaboutit,anddidnotevencaretomentionthatthatwaswhattheconsentform
wasactuallyfor.Thenowtoddlerissufferingsomedevelopmentalproblems(Journeyman).
Between1948and2000,almostnoclinicaltrialsweretakingplaceinthesepoorregions.
However,in2008,thenumbersskyrocketed.Thenumberofdevelopingcountriesparticipating
intheseclinicaltrialstripled.Thereweremanytransitionalcountriestakingpartinthose
numbers,likeBrazil,China,India,Mexico,andSouthAfrica
(SciDevNet).
Therearemanyreasonsthesepharmaceuticalcompaniespickthesetypeoflocations.
Threespecificonesarethattheyarecheaper,faster,andeasier.Theexchangerateisafactor,
andhowanAmericandollarisworthwaymoreinothercountries,sothatsonereasonits


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cheaper.Itsalsocheaper,becausethesepoorfamiliesarewillingtotakeless(ifthe
pharmaceuticalcompaniesactuallycompensatethem,sometimestheydont).Itsfasterbecause
theydontexactlyfollowprotocolintheseothercountries,sotheycangetitdoneasfastasthey
like,andtheydonttakethetimetohavesafetyprecautionsliketheywouldhere.Lastly,itis
easier,becausethesepoorandsickpeoplecooperate,becausetheybelievethattheyareactually
receivingtreatmentforanillness(Anand).
Notallpharmaceuticalcompaniespracticetheseclinicaltrialsinsuchanunethicalway.
Infact,GSKafewyearsagomadeacommitmenttopublishclinicalstudyresearchfromthepast
20years!Theyare
claiming[it]willfurthertransparency,aidfutureresearch,andprotect
patientsfrommisinformation(Kelly).However,othercompanieshavenotevenmerelytriedto
makeachange,orpubliclystateanythingaboutwhathasbeenhappeningbehindcloseddoorsin
thesedevelopingcountries.Infact,GlobalNewstriedtotalkwiththoseinvolved,beingitthe
actualpharmaceuticalcompany,orthelocaldoctorsrunningthetrial.Noonecooperated.The
pharmaceuticalcompaniesgaveonlybriefstatementsclaimingtheyhavedonenothingwrong,
Forinstance,Johnson&Johnsontestedanulcerdrugonalittleboywithbothmentaland
physicaldisabilities.Themotherhadnoeducation(itdidnothelpthatsheandmanyothers
claimedtheconsentandinformationformswereonlyinEnglish),andcouldnotanswersimple
questionsaboutclinicaltrials,sotheconsentwasunclear,andshedidnotunderstandthatthey
weredoingatestonhim,nottreatment.WhenGlobalNewsaskedtospeaktosomeoneincharge
atJohnson&Johnson,theyonlysentbackthisstatement,Allofourclinicaltrialsareguidedby
ourEthicalCodefortheConductofResearchandDevelopment.Theprocessesusedtomanage
thispediatrictrialatthesiteinIndore,wereapprovedbythehospitalsethicscommitteepriorto


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initiation,andthepatientswereprovidedmaterialsandexplanationsofthetrialintheirnative
language(GlobalNews).
Withtheseclinicaltrialsinthedevelopingworldcomeafewpros.Likestatedearlier,it
ismuchcheaper,faster,andeasiertodotheseclinicaltrialsindevelopingcountries.The
protocolandregulationsarenotasstrict,whichcanbeaproandacon,butforthedoctorsand
pharmaceuticalcompanies,itisapro!Theycanhavesomewiggleroomabouthowtheyperform
thetrial,wheretheydothetrial,andwhoperformsitinthisparticularregion(Clark).Theres
alsoahugepossibilityofactuallyhelpingthesepeople!Thecompaniescouldgethugeanswers
toquestionsaboutthedrug.Thesepoorerpeoplearealsousuallycleanslatesbecausethey
havenevertakenmedicationforanythingbecausetheycouldnotaffordit(Miller).
However,therearemanymoreconstotalkabout.Throughmanyofthesestories,you
cangetaclearpictureofwhatthepresentconcernsare.Evenifthepersonorfamilygives
consent,manytimestheydonotunderstandwhattheyareconsentingto.Theformsmightbein
English,sotheycannotunderstand,orarejusttoouneducatedtounderstandit.Thecompanies
arenotbeingveryhonest,andarenotexplainingwelltothepatientswhattherisksare.They
alsofailtoexplainthatthesearejustclinicaltrials,notactualtreatmentthatisguaranteedto
work.Theymightthinkitistreatmentorvaccines.Theythengetthrownintoclinicaltrials
withoutevenknowingit.Manydoctorsalsoreallypushthemtojoinortosigntheirchildup,and
likeSusannasstory,willcontinuallycometoyourdoorstepaskingthemaboutit(Journeyman).
Inothercases,theyhaveemptypromisesoftreatments,andgettingthepatienthelp,andwhen
thedrugdoesntwork,orthecompanygetstheiranswers,theyleaveanddontcontinuetotreat


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them.Sometimestheysaythatitstooexpensivetocontinuethat.Attheendoftheday,theyare
notaccuratelyrecordingtheirdata(Kelly).
Thesolutionsthatcouldbeathandareverysimple.Firstofall,weshouldbeeducating
andcompensating!Thecompaniesbeprovidingsomewayforthesepatientstofullyunderstand
thewholetestandtrial,aswellastherisksthatmightcomealong.
I'magainstitbecause
patientsarenotwellinformedonwhat'sgoingtohappentothemandthere'snoregulationofit
sotheycanbeharmedbyitandthere'snoaccountabilityforthecompaniesdoingthetrial
(Martin).
Thelocaldoctorsshouldbesettingthemdownandexplainingeverysingledetailofthe
trial,andhavingnecessary,lengthyconversations.Lastly,compensationissomethingthatshould
begivenout,andsometimesthatsnothappening.
Theyshouldbewillingparticipants,butthat
theyshouldbecompensatedinsomeway(Martin).
Volunteeringyourtime,andespeciallyyour
health,ishuge!Thesepeopledefinitelydeservesomethingforthat.
Anothersolutionistobeareliablecompany.Ifthatmeanshiringatranslatortohelp
themreadconsentandotherinformationformssothattherearenoquestionslefttobe
unanswered,thensobeit!Notheyshouldnot.Theyshouldhavetohiresomeonewhospeaks
thelanguagesothattheycanexplainwhattheyaredoingandwhattheconsequencesareand
theyshouldgivethemaresourcesothatifsomethinghappenstheycanreceivecare,likea
numberorclinicforwhenadversereactionsoccur

(Martin).
Theycouldalsohelpthem
understandthedoctorsiftheydonotuselocaldoctorstorunthetrials.Pharmaceutical
companiesshouldbebeinghonest.Thatmeansnosecrets,andtellingthemrightawaythatitisa
clinicaltrial,andthatitstestingadrug,andthatitmaynotworkandthattheremaybe
sideeffects.Italsomeanstellingthemeverydetailofthetrial,aswellastherisks!Andlast,but


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notleast,donotpushit.No(thefirsttime!)meansno.Byallmeans,theyshouldbeexplaining
whattheyareadvocatingfor,ortryingtogetvolunteersfor,butiftheywantnopartin,they
shouldbewalkingawayandfindsomeoneelse.Itsonethingtokeeptheoptionopentothose
whoinitiallysaidno,butitsacompletelydifferentthingwhentheykeepcomingtoapatients
housetocontinuetokeepaskingandpushingthemtodoit!Whenspeakingtoamedical
professional,shehadthistosayaboutthetopicYes,theyshouldhavetodoitthesameasthey
wouldhere.Here,theyhavetoscreenthecandidate,andwatchthemthewholetimethetestis
goingon,andthentheygetcompensated!Whywouldtheyevendothesetestsiftheyaren't
collectingdataappropriate?(Martin).Thatisanotherthingtothinkabout,dothingsonlyifyou
areallowedtodothemheretoo!
Aftergoingovertheresearchandthestoriesaboutthistopic,hopesariseforafuturewith
noexploitationofanotherhumanbeingandforhonestandfairclinicaltrials.Afutureforapoor
familymaylookbrightiftheyfindthemselvesinaclinicaltrialthatishonest,ethical,can
receivecompensationfrom,andcanbettertheirownthrivingcommunitywithbenefitsfromsaid
company!Asadevelopednation,wemustkeepinmindtheyarenotlabratsandtheyarenot
lowerthanus.Beforebetteringthemselves,thesecompaniesfirstfocusshouldbeonactually
helpingpeople.Shouldntthatalwaysbeourfocus?


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Miller,Talea."ExplosiveGrowthinForeignDrugTestingRaisesEthicalQuestions."
PBS
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Smith,David."PfizerPaysouttoNigerianFamiliesofMeningitisDrugTrialVictims."
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Guardian
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(TheHindu)


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(
"AkhaHumanRightsCartoonAkha.org.")

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