CorporateCrimeinthePharmaceuticalIndustry Tagged:

*ModernMedicine

Thesordidbehaviouroftoday'spharmaceuticalcorporationshasbeenfurtherdemonstratedby DrJohnBraithwaite,nowaTradePracticesCommissioner,inhisdevastatingexpos,CORPORATE CRIMEINTHEPHARMACEUTICALINDUSTRY.

Internationalbriberyandcorruption,fraudinthetestingofdrugs,criminalnegligenceinthe unsafemanufactureofdrugsthepharmaceuticalindustryhasaworserecordoflawbreaking thananyotherindustry.Describingmanyexamplesofcorporatecrime,whichshowsthedepth andseriousnessofthecrimeprobleminthepharmaceuticalindustry,DrBraithwaite'srevealing studyisbasedonextensiveinternationalresearch,includinginterviewsof131seniorexecutives ofpharmaceuticalcompaniesintheUnitedStates,theUnitedKingdom,Australia,Mexicoand Guatemala.

Thebookshowshowpharmaceuticalmultinationalsdefytheintentoflawsregulatingsafetyof drugsbybribery,falseadvertising,fraudinthesafetytestingofdrugs,unsafemanufacturing processes,smugglingandinternationallawevasionstrategies.Atthetimeofresearchingthe subject,BraithwaitewasaResearchCriminologistattheAustralianInstituteofCriminologyanda FulbrightFellowaffiliatedtotheUniversityofCalifornia,IrvineandtheUnitedNationsCenteron TransnationalCorporations.

"Datafabricationissowidespread",saysDrBraithwaite,"thatitiscalled'making'inthe Japanesepharmaceuticalindustry,'graphiting'or'drylabelling'intheUnitedStates."Hefurther states:

"Pharmaceuticalcompaniesfacegreattemptationstomisleadhealthauthoritiesaboutthe safetyoftheirproducts.Itisamakeorbreakindustrymanycompaniesgetvirtuallyalltheir profitsfromjusttwoorthreetherapeuticwinners.MostofthedatathattheAustralianDrug EvaluationCommitteereliesuponindecidingquestionsofsafetyandefficacyisdatafromother countries,particularlytheUS.InquiriesintoscientificfraudintheUShaveshownthereisa

substantialproblemoffraudinsafetytestingofdrugsintheUS,justashasbeendocumentedin Japan."

Thebookreportsthatbetween1977and1980theUnitedStatesFoodandDrugAdministration havediscovered62doctorswhohadsubmittedmanipulatedordownrightfalsifiedclinicaldata. AstudyconductedbytheFDAhasrevealedthatoneinfivedoctorsinvestigated,whocarryout fieldresearchofnewdrugs,hadinventedthedatatheysenttothedrugcompanies,and pocketedthefees.Citingcaseexamples,DrBraithwaitestates:"Theproblemisthatmostfraud inclinicaltrialsisunlikelytoevenbedetected.Mostcaseswhichdocometopublicattention onlydosobecauseofextraordinarycarelessnessbythecriminalphysician..."

AccordingtoDrJudithJones,DirectoroftheDivisionofDrugExperienceattheFDA,ifthedata obtainedbyaclinicianprovesunsatisfactorytowardsthedrugbeinginvestigated,itisquitein orderforthecompanytocontinuetrialselsewhereuntilsatisfactoryresultsandtestimonialsare achieved.Unfavourableresultsareveryrarelypublishedandcliniciansarepressuredinto keepingquietaboutsuchdata.

Itisveryeasyforthedrugcompanytoarrangeappropriateclinicaltrialsbyapproachinga sympatheticcliniciantoproducethedesiredresultsthatwouldassisttheintendedapplicationof thedrug.Theincentiveforclinicalinvestigatorstofabricatedataisenormous.Asmuchas$1000 persubjectispaidbyAmericancompanies,whichenablessomedoctorstoearnupto$1million ayearfromdrugresearch,andinvestigatingcliniciansknowalltoowellthatiftheydon't producethedesireddata,thelossoffutureworkisinevitable.

byDrJohnBraithwaite PoisonousPrescriptions

byDrLisaLandymoreLim

"GiventhatapoisonisANYsubstancethatwhenintroducedintoorabsorbedbythebody injureshealthordestroyslife,mostoftoday'spharmaceuticalpreparations,becauseoftheir harmfuleffects,maybelabelledpoisonous."

TheaboveopeningtoPOISONOUSPRESCRIPTIONS(1994)givesthegistoftheauthor'sviewon allopathicdrugs.Aviewthatcouldnotbeeasilydismissedbyhealthauthorities,asDr LandymoreLim,aBritishscientist,iswellqualifiedbytheirownstandards.Shegraduatedin 1983fromtheSchoolofChemistryandMolecularSciences,UniversityofSussex,England,witha FirstClassHonoursdegreeinChemistrybyThesis.In1984shewasawardedastudyscholarship bytheSwedishInstitute,andhasworkedbrieflyfortheMedicalResearchCouncilattheNational InstituteforMedicalResearch,London,andattheDunnNutritionUnit,Cambridge.Concerned aboutpreventingdisease,LandymoreLimisnowanindependentconsultantandinvestigator, focusingontheharmfuleffectsofpharmaceuticaldrugsandotherchemicals.

POISONOUSPRESCRIPTIONS,whichevolvedfromtheauthor'sclinicalresearchconductedinthe UK,providesreaderswithaninsightintothepoisonousnatureofpharmaceuticaldrugs.The bookincludesinformationonanumberofcommonlyuseddrugsintheUnitedKingdomand otherindustrialisedcountries,payingparticularattentiontothosethatareroutinelypushed ontobabiesandyoungchildren.

Amongthenumerousotheradversereactionsthatareinherentlylinkedtoalldrugs,Landymore Lim'sinvestigationshavefoundthatdiabetesandasthmacanresultfromexposuretoantibiotics andothercommonlyusedpharmaceuticaldrugs.Tosupportherassertionssheprovidesample evidencefromhospitalrecordsandherownstudiesandsheexplainsclearlyandsimplythe complexmechanismsbehindthediabetesandasthmacausingpropertiesofchemicals.In dispellingtheauthorities'widelyheldmisconceptionthatdiabetesislargelyageneticdisorder LandymoreLimprovidesstatisticsandgraphsshowinghowtheincidenceofdiabetesin industrialisedcountrieshasdramaticallyincreasedinthelast40years,coincidingwiththerapid riseintheuseofdrugsduringthattimeperiod.

NodoubtthatifDrLandymoreLim'sinformationbreaksthroughtheMediacensorshipitwill sendshockwavesthroughthemedicalprofession.Wesupporthereffortsandurgeyoutoassist hergroup'songoingresearch.ThePreventionofDiseases&Disability(PODD)wouldliketohear fromanyoneinAustraliawhohassufferedfromanyseriousdrugrelatedconditiontobe includedonaregister. Vaccination:100YearsofOrthodoxResearchShowsthatVaccinesRepresentaMedicalAssault ontheImmuneSystem

byVieraScheibnerPh.D.

Thisbook(published1993)isaconcisesummaryoftheresultsoforthodoxmedicalresearch intovaccinesandtheireffects.Itaimstoinformmedicalprofessionals,parentsandthegeneral publicaboutshortandlongtermdangeroussideeffects,includingbraindamageanddeath,of vaccines;oftheineffectivenessofvaccinesinpreventinginfectiousdiseases,asshownby epidemicsinfullyvaccinatedpopulations;andthecausallinkbetweenDPTandpoliovaccines andcotdeath.

DrVieraScheibner,retiredPrincipalResearchScientistfortheNSWGovernmentwitha doctorateinNaturalSciences,haspublished3booksandsome90scientificpapersinrefereed scientificjournalsinAustraliaandoverseasduringherdistinguishedcareer.

Sheandherhusband,LeifKarlsson,anelectronicengineerspecialisinginpatientmonitoring systems,developedCotwatch,atruebreathingmonitorforbabies.Vaccinationprovedtobethe mostprominentstressfuleventtosoundthealarm.AmicroprocessorversionofCotwatch recordingbabies'breathingpatternspresentedtheeffectofvaccinationclearlyonthecomputer printoutsandthelinkbetweenvaccineinjectionsandcotdeathbecamepainfullyobvious.

Followingthisfinding,DrScheibnerstudiedsome30,000pagesofmedicalpapersdealingwith vaccination.Shefoundnoevidencethatvaccinesaresafeoreffective.Vaccinesarehighly noxious.Theycontainformaldehyde,aluminiumphosphate,thiomersal(mercurycompound), foreignproteins(antigens)andcontaminatinganimalproteinsandvirusesfromthetissuesused asgrowthmediumtoculturetheviralandbacterialcomponentsofvaccines.Noneofthese substancesshouldeverbeinjectedintohumanbeings.Theyerodetheimmunesystemandalter theimmunologicalresponsetodiseases.

Theappearanceofmanynew,autoimmunediseaseslikeasthma,affectingalarmingnumbersof children,childhoodleukaemia,andcancer,theenormousupsurgeintheincidenceofcerebral palsyandinfantileconvulsionsseeninchildrenofvaccinationageandnotbefore,shouldallbe takenasseriouswarnings.Infectiousdiseasescontractedattheappropriateageandallowedto runtheircoursearebeneficialbecausetheyservetoprimeandmaturethechild'simmune system.

Theoverwhelmingevidencefromthenumeroushumanclinicalandepidemiologicalstudies

citedbyDrScheibnerdemonstratesbeyondanydoubtthedangersandineffectivenessof vaccinationsandherbookisamostvaluablecontributiontowardsexposingthemythof vaccinations. DRUGCOMPANIESBRIBINGDOCTORS

Amajorreasonwhyhealthcareisinsuchashamblesisthatthemedicalestablishmenthas alloweditselftobeboughtoffbythepharmaceuticalindustry,whoseprimemotiveisprofit.In thebookDissentinMedicineNineDoctorsSpeakOut(1985),DrAlanLevinwrites:

"HealthcareintheUnitedStateshasbecomeamegabilliondollarbusiness.Itisresponsiblefor over12percentofthegrossnationalproduct.Revenuesfromthehealthindustry,which currentlyexceed$360billionayear,aresecondonlytothoseofthedefenseindustry.True profitsaremuchhigher.[In1991theUShadspent$750billiononhealthcare.Ithasbeen estimatedthatbytheyear2000,annualhealthcarecostsintheUSwillhaveincreasedtoat least1.5trilliondollars.(50)]Itisnotdifficult,then,toseewhythisindustryissoappealingto corporateinvestors.Manyindustrialistsdeterminedtoprofitfromhealthcareproductshave encounteredonemajorobstacle:Practicingphysiciansremaintheprimarydistributorsofhealth careproducts.Physicians,whohavetraditionallyexistedasindependententrepreneursdonot fiteasilyintothecorporatemindset.Ifcorporationsdidnothavecontrolovertheirdistributors (thephysicians)theywouldnotbeabletoguaranteeprofitstotheirstockholders....Thus,we neednotwonderwhyseniorexecutivesofmajorhealthcareorientedcorporationshave decidedtowoophysiciansintotheircamps.

"Pharmaceuticalcompanieshavecurriedthefavorofpracticingphysiciansformanyyears...As thecostofdevelopmentandmarketingofpharmaceuticalsincreased[duringthe1960's],the drugcompanieseffortstoattracttheallegianceofpracticingphysiciansintensified.

"Notonlydiddrugcompanyoperationcostsincreasemarkedly,buttherewardsofthe marketplacerosetremendously....Theincreaseinrevenuesbroughtcompetitionwhichledtoa nationwideincreaseindrugadvertising.Advertisementsinmedicaljournalsandpublic magazineswerepopularizedbycarefullycontrollednewsreleasesassociatedwith'medical breakthroughs.'

"Theseadvertisingefforts,whichbeganwithgiftstopracticingdoctorsandmedicalstudents,

havebecomeamassivecampaigntomoldtheattitudes,thoughts,andpoliciesofpracticing physicians.Drugcompanieshiredetailmentovisitphysicians'officesandtodistributedrug samples.Theydescribetheindicationsforthesedrugsandattempttopersuadephysiciansto usetheirproducts.Likeanyothersalesman,theydenigratetheproductsoftheircompetitors whileglossingovertheshortcomingsoftheirown.Detailmenhavenoformalmedicalor pharmacologicaltrainingandarenotregulatedbyanystateorfederalagencies.Despitetheir lackoftraining,thesesalesmenhavebeenveryeffective.Theirsalescampaignshavebeenso successfulwithintheUnitedStatesthattheaveragephysiciantodayhasvirtuallybeentrainedby thedrugdetailman.Thispracticehasledtowidespreadoveruseofdrugsbybothphysiciansin theireverydaypracticeandthelaypublic....Withtheexceptionofheroinandcocaine,85 percentofalldrugscurrentlyabusedinthestreetsaremanufacturedby'ethical'drug companies....Grosssalesforecastsfromthese'ethical'drugcompaniesdeliberatelyinclude profitsmadefromillicitsalestodrugpeddlers.

"Thedrugindustrywoosyoungmedicalstudentsbyofferingthemgifts,freetripsto 'conferences',andfree'educationalmaterial.'[Emphasisadded.]

Adoublepagearticletitled"$200m'bribe'tolureourdoctors",appearingintheSunHerald (August18,1992),reportedthat:

"Drugcompaniesspendamassive$200millioneveryyearinAustraliaonmarketingtheir products...Thatrepresentsalmost$10,000ayearspentattemptingtowooeachofAustralia's 21,000'activelyprescribing'GPs,accordingtoDrKenHarveyfromLaTrobeUniversity."

ThearticlecitedTheovanLieshout,secretaryoftheNSWDoctors'ReformSocietyassayingthat 50percentofdrugsonthemarketdidnotexist10yearsagoanddoctorshadnotlearned abouttheminmedicalschool.Busyphysiciansthereforerelymainlyondrugcompanysalesstaff totellthemaboutnewmedications.

AsreportedintheBulletin(March24,1991),DrKenHarveystated:"Thestudentsconcede concern.Theproblemis,afterfiveyearsoutinpractice,withsixdrugrepsaweekcomingin, theyhavegoneawayfromprescribingsensiblyandbyscientificnametoprescribingthebrand promotedbythelastrepwhowalkedin." UNIVERSITYSCIENTISTSTHEWILLINGPAWNS

Drugcompaniesemploymanymeansinbribingdoctorsandmedicalinstitutions.DrLevin writes:

"Youngphysiciansareofferedresearchgrantsbydrugcompanies.Medicalschoolsaregiven largesumsofmoneyforclinicaltrialsandbasicpharmaceuticalresearch.Drugcompanies regularlyhostlavishdinnerandcocktailpartiesforgroupsofphysicians.Theyprovidefunding fortheestablishmentofhospitalbuildings,medicalschoolbuildings,and'independent'research institutes.

"Thepharmaceuticalindustryhaspurposefullymovedtodevelopanenormousamountof influencewithinmedicalteachinginstitutions.Thismovewasgreatlyfacilitatedbyseveral factors.Thefirstwastheeconomicrecession,whichcausedamarkedconstrictioninfederal fundingforresearchprograms.Academicscientistslackedfundingforpetresearchprojects.The secondwasthetremendousinterestthatacademicscientistsheldinbiotechnology,thestock market,andthepossibilityofbecomingmillionairesovernight.Thethirdisthefactthat academicphysicianstendtolackrealclinicalexperience.Intheuniversity,thephysicianisan expertinesotericdisease,endstagedisease,andanimalmodelsofhumandisease.Heorshe haslittleornoexperiencewiththedaytodayneedsofthechronicallyillpatientorthepatient withveryearlysymptomsofseriousillness.Astheacademicphysiciandoesnotdependupon thegoodwillofthepatientforhisorherlivelihood,thepatient'swellbeingbecomesofminor considerationtohimorher.Allthesefactorsmaketheacademicphysicianaverypoorjudgeof treatmentefficacyandawillingpawnofhealthindustrialists.

"Pharmaceuticalcompanies,byenlistingtheaidofinfluentialacademicphysicians,havegained controlofthepracticeofmedicineintheUnitedStates.Theynowsetthestandardsofpractice byhiringinvestigatorstoperformstudieswhichestablishtheefficacyoftheirproductsor impugnthatoftheircompetitors....

"Practicingphysiciansareintimidatedintousingtreatmentregimeswhichtheyknowdonot work.Oneglaringexampleiscancerchemotherapy....

Yourfamilydoctorisnolongerfreetochoosethetreatmentmodalityheorshefeelsisbest foryou,butmustfollowthedictatesestablishedbyphysicianswhosemotivesandalliancesare

suchthattheirdecisionsmaynotbeinyourbestinterests.

DrAlanLevinisanAdjunctAssociateProfessorofImmunologyandDermatologyatthe UniversityofCalifornia.HeisaFellowoftheAmericanCollegeofEmergencyPhysicians,the CollegeofAmericanPathologists,andtheAmericanSocietyofClinicalPathologists.DrLevinis alsoarecipientoffellowshipsandawardsfromHarvardMedicalSchoolandothermedical institutions,andwasDirectorofvariousresearchlaboratories.

IvanIllichechoesLevin'slastcomment:"Themedicalestablishmenthasbecomeamajorthreat tohealth.Thedisablingimpactofprofessionalcontrolovermedicinehasreachedthe proportionsofanepidemic."(54) TheCotDeathCoverUp?

byDrJimSprott

THECOTDEATHCOVERUP?istheculminationofoverfifteenyearsofcotdeathresearchbythe author,ahighlyrespectedconsultingchemistandforensicscientistfromNewZealand.

In1986Sprottarrivedattheconclusionthatbabiesweresuccumbingtocotdeathbecauseof inadvertentgaseouspoisoningbyanextremelytoxicnervegasgeneratedbymicrobiological actiononsomethingwithinthebaby'scot,buthewasn'tabletoidentifythegas.Thenin1989 consultingscientistBarryRichardson,workingindependentlyinBritaincametothesame conclusionandinadditionidentifiedtheoffendinggases.Itwasnotlongbeforethetwo teameduptoworkonwhattheydescribeasthe"RichardsonHypothesis".

AccordingtoSprottthethreeidentifiedgasesthatweregeneratedfrommattressesonwhich babiesdiedofSIDSare"phosphine,arsineandstibine,allextremelytoxic'nervegases'.Theyare producedbytheactionoftheotherwiseharmlessfungusScopulariopsisbrevicaulison substancescontainingphosphorus,arsenicandantimony.Theseelementsareoftenpresentin cotandothermattresses."Theseodourlessbutintenselypoisonousgases,withtoxicitiesabout 100timesasgreatashydrogencyanide(prussicacid),actuponthebaby'snervoussystemto inhibitbreathingandheartfunction.

Theproblem,infact,hasbeenfirstidentifiedasfarbackasthe1880'swhenthemysteryof thousandsofunexpectedchilddeathsthroughoutWesternEuropeandtheUKwassolvedby ItalianchemistGosio.Hehaddiscoveredthatdeathswereduetoatoxicgas,arsineand/oralkyl homologuesgeneratedbythemicroorganismScopulariopsisbrevicaulis(thenknownas Penicilliumbrevicaules).Itacteduponcopperarsenate,usedingreenpigmentsinwallpaper, andarseniousoxide,usedasapreservativeinwallpaperglue.

THECOTDEATHCOVERUP?containsampleevidencesupportingSprottandRichardson's findings.Amongthemanygraphsitcontainsonethatdemonstratestherapiddropincotdeaths inBritainin19861994.Thegraph,basedonofficialstatistics,showsthatwhenthefindings werefirstmadepublicinmid1989theSIDSratestartedtofallimmediately,dropping35per centbythetimetheofficial"BacktoSleep"campaignwaslaunchedinDecember1991.Inthe period19891994,Britainsawastaggering70percentreductionintheSIDSrate.

Despitetheseremarkableresults,SprottandRichardsonwerefiercelyopposedbytheir respectivecountry'shealthauthoritiesandofficialSIDSgroups.Theirstruggleforofficial recognitionoftheirfindingsisreminiscenttothatofotherindependentSIDSresearcherssuchas DrArchieKalokerinosandDrGlenDettman,whohadprovedthatseveredepletionofachild's vitaminClevel,precipitatedbyvariousinsultsincludingchildhoodvaccinations,could predisposeittoSIDS.

Theauthorsaysthatthebookisnotaimedatacademics(althoughitsfirstclassmaterialshould sufficetheirsnobbery),butisaimedatparentsparentswhohavetosuffertheconsequencesof asystemthatputsthemandtheirbabieslastinthe"war"againstthishumantragedyknownas SIDS. BigPharma'sDeadlyExperiments

Anewlysurfacedreportallegesthatin1996,drugmonolithPfizergaveanunprovendrugto Nigerianchildrenandinfantssufferingfrommeningitiswithouttheauthorizationofthe Nigeriangovernment.CompletedfiveyearsagoandcomingtolightinaMay7WashingtonPost investigation,theconfidentialreport,writtenbyapanelofNigerianhealthexperts,concluded thatadministeringthedrugTrovanto100patientssufferingadeadlystrainofmeningitiswas "anillegaltrialofanunregistereddrug."Thedrugwasultimatelyshowntobeineffective.A lawsuitagainstPfizerclaimssomeofthechildreninthetrialdiedandotherssufferedbrain damage.

ThereportsurfacesasmoreandmoreclinicalresearchrelocatestotheGlobalSouthinorderto escapeburdensomeregulationschemesintheUnitedStatesandWesternEurope.AlterNethas obtainedanearlylookatabooktobepublishedlaterthisyearTheBodyHunters:Howthe DrugIndustryTestsItsProductsOntheWorld'sPoorestPatients(NewPress),byinvestigative journalistSoniaShahthatraisesthecurtainonatrendthat'sharmingpatientsandhealthcare systemswhileerodingthedevelopingworld'strustinconventionalmedicine.

Researchersneedingpatientsandfreerworkingconditionshaveforyearsfoundahoneypotin theworld'sslumsandshantytowns.Thefactthatpoor,desperatepatientsarewillingtotry anything,meanscompanieslikeGlaxoSmithKline,MerckandWyethcurrentlyconduct30 percentto50percentoftheirexperimentsoutsideWesternEuropeandtheUnitedStates,and plantoboostforeigntrialsby67percentthisyear,accordingtoUSAToday.Theirurgencyis understandable;Shah'sbooknotesthattogetasingledrugtomarket,drugcompaniesare forced"toconvincemorethan4,000patientstoundergo141medicalprocedureseachinmore than65separatetrials."

Clinicalinvestigatorsandthecompaniesbackingthemarguethatoverseastrialsgetdrugstoa luckyfewandleadtofastercuresforusall.ButShah,theauthorofCrude:TheStoryofOil, deftlytakesthatBigPharmamythtotask,tracinghowdrugtrialexportsruinthirdworldhealth caresystems,steerattentionawayfrompublichealthneedslikecleanwaterandsanitation,and ignorethehealthsafetyofsubjects.

Fromthehistoryofplacebocontrolstoamodernmapofhowloopholepronelawsinthe1980s pavedBigPharma'seasyway,Shahshowsthat"themainbusinessofclinicalresearchisnot enhancingorsavinglivesbutacquiringstuff:data"makingitanindustryinsteadofasocial service,asitwouldhavetheworldbelieve.Asanindustry,sheargues,theyshouldbedeniedthe regulatorywinksandnodsreservedforapublichealthentity.

Hearn:Whatstruckyouastheworstcaseofexcessorneglectyoufoundwhileresearchingthis book?

Shah:ItwasprobablythetrialIcoveredinZambia[involvingadrugtocombatcryptosporidium, adiarrheacausinginfection].Itwasstark,childrendying,littlekidsdying.ButfromwhatIcan

tellifthesekidshadreceivedantiretroviraltherapytheycouldhavesurvived.Buttheywereput intoatrialforadrugthatneverbenefitedthemortheirfamiliesorsiblingsbecausethedrug wassocompletelytargetedforotherpopulations,almostaluxurydrugforfightinganinfection thatinWesternchildrenmeansadayofdiarrhea.Itissomildinkidswhoarehealthythatlotsof peopledon'tevennoticeit.

Soforsuchaminorconditiontheytestedthedrugonpeoplewhowereso,sosick.Andinthe end,12kidsdied.

KellyHearn:Youwritethatbythelate1990s,pharmaceuticalcompanieshadgrownfrustrated withthepaceofacademichospitalsandresearchcenters,andchangedthecontractingfocusto "contractresearchorganizations,"privatecompaniesthatpromisetogetdrugtrialsdone quickly.Whatroledothesecompaniesplayintheschemeofdrugtrials,andtowhatdegreeare theyresponsibleforthegrowthinoverseastrials?

SoniaShah:Therearetwothings,apushandapull,thatforcetrialsoverseas.Thepushisa patientrecruitmentbottleneck.Mosttrialsdon'tmeetrecruitmentdeadlines,whetherit's becauseAmericansaren'tinterestedortheirprofilesarewrong.Oftentherightkindofpatients don'texistinenoughquantityintheU.S.,oriftheydotheydropoutoftrials.

Thebigpullisthecontractresearchorganizations(CROs).Ifanyoneisabodyhunter,it'stheCRO industry,anindustrythathaslargelyescapedpublicnotice,perhapsbecauseoftheweird,vague soundingmoniker,CRO.PublicCitizencalledthem,moreaccurately,"humanexperiment corporations."Theyare,though,justabusiness,andarenotanymorevenalthanotheractors involved.

Hearn:Likeyou,manyjournalistsandhealthexpertsIhaveinterviewedalmostinvariablysaythe FDAshouldrequirenewdrugstooutperformexistingonesratherthansimplyworkbetterthana placebo.GivenyoursenseoftheFDA'srulingculture,thegrowingpublicfrustrationwithdrug companies,Washington'scurrentpoliticalclimate,andsoon,isthererealhopeofthis happeninginthenextfewyears?

Shah:Ithinknot.Butthehistoryofregulationgoesinfitsandstartsbasedonscandals,horrible mistakeslikethalidomide,andthenregulationschangerapidly.Andwecan'tpredictdisasters,

somethingthatwillcomeintothelimelightandexposeacontroversy,somethingthatcan changeheadlines.TheFDAisvulnerabletoheadlines,topolitics.

Hearn:Whatarethemostdangerousstructuralimpactsoverseastrialscanhaveondeveloping countries'healthsystems?

Shah:Themainthingismisallocationofresources.You'retalkingaboutsuchascarcityinterms ofclinics,nurses,doctors,facilities,medicine,toolsandtime.Youhaveplaceswhereallthisisin shortsupplyandinthatsettingtheyhavethisfruitdangledinfrontofthemwe'llpayyouso manyhundredsperpatient,we'llgiveyounewtechnology,newMRImachines,etc.

Butwhatthismeansisthatdoctorsandnursesthereareperformingexperimentsfortreatments forthingslikediabetes,arthritis,erectiledysfunction.ThesethingsareimportantintheWestbut thesepeoplehavemalaria,cholera,andotherinfections.Inthatsense,theindustrysponsored trialsaredistortinghealthcare.

Partofalargertrend,asishappeninginplaceslikeIndiathathaveandwantmoreforeigntrials, istheriseofprivatized,twotieredhealthcarewherehightechfacilitiesandhighlyspecialized physiciansareavailableforthewealthy,butthepoorjusthavebasicservicethattheyhaveto payfor.InIndiaandinSouthAfrica,theyarebuildinghospitalsnotforpeoplewholivetherebut forforeigners.Doingtrialbusinessispartofthetrendtowardcreatingtwotieredsystemsin thesecountries,aprivateonefortherichandnothingforthepoor.

Hearn:Youtalkaboutthephrase"duetoethicalconcerns"appearingfrequentlyinbiomedical conversations.Younotethatitisalmost"exclusivelyreservedforbiomedicaltransgressions." Canyouexplain?

Shah:It'sjustthatyouneverhearitoutsidethesecirclesitseems.Ifyou'retalkingabout somethingunethical,youdon'tsay,"It'snotpossibleduetoethicalconcerns."Youdon'tsay,"It's notpossibletogaspeopleduetoethicalconcerns."Yousay,"Suchandsuchhappened,andit waswrong,immoralandillegal."

Hearn:Rep.TomLantosofCaliforniasaidaftertheWashingtonPost'scoverageoftheNigerian

reportthathewillofferabillmakingU.S.researchersgivefederalregulatorsdetailsoftests plannedindevelopingcountries.Whatdoyouthinkofthatidea,andwhataresomeofthe necessaryregulatorychangesforreininginthetransgressionsyouaddressinthebook?

Shah:Ithinkit'sababystepinrightdirection.Butmostimportant,thereneedstoberestraints andbreaksintheexportationofdrugtrials.It'snotpossibletoputinenoughoversightto protectthesesubjects,atthepresenttime.Restraintisnecessary.IwasgivingatalkattheFDA, andtheregulatorswantedtoknowwhattheycandotomakeitbetter.Whataboutanewrule thatsaysthereshouldbeanethicscommitteereviewinthiscountryandthecountrytakingthe trial?That'salreadytrueforNIHtrials.

Thatwouldbegood,butweknowfromNIHtrialsthatlotsofthingsfallthroughcracks,andthat justrequiringtheethicsreviewisnotsufficient.Anotherthingyoucoulddoisrequire verificationofinformedconsentandreallymakesurepeopleunderstandwhat'shappening,that theyfilloutformsortakequizzestoshowtheyunderstand.

Hearn:Youputhopeintotheriseofthenonprofitdrugcompanies.Whataresomeofthekey waystheycanhelp?

Shah:Idon'tthinkit'swrongtodotrialsindevelopingcountries.It'saboutwhatkindofdrugs thatarebeingdeveloped.Arethedrugsapublichealthpriority?Thosewhotakeontheburden ofexperimentationshouldenjoythefruitsofresearchratherthanwatchingthebenefitsgoonly toatinypercentageofwhite,overweightbaldmen.

Hearn:Havingnowwrittenabouttwooftheworld'smostpowerfulinterests,BigOilandBig Pharma,whatcommonthemesemerge?

Shah:What'sinterestingtomeistheyproducecommoditiesthatarepublicgoods.Society needsenergyandmedicine,butweletprivatecompaniesdoitforus.Andtheirgoalsareto enrichshareholders.Weneedthesethings,butwedecidetheresponsibilityforprovidingit shouldgotoforprofitentities.Thisdevelopsallkindsofdistortions.e

byKellyHearn,AlterNet.PostedJune9,2006.