PraiseforDeathbyMedicine

“Anyonewithahorseinthehealthcareraceissuretobeintriguedandprovoked.”PublishersWeekly

“Theauthormakeseffectiveuseofheadline-grabbingstatisticsandshockinganecdotalevidencefromawiderangeofmedicalsources....[He]wantedthisvehicletodrivehomehismessage.Anditcertainlydoes.”

KarlKunkel,ForeWord“DeathbyMedicineisawellarguedreadforthehealthcaredebatethatoffersamoretothepoint

healthcarereformidea.”MidwestBookReview

“ThisauthoritativebookcitespublishedresearchdemonstratingthattheAmericanmedicinesystemistheleadingcauseofdeathandinjuryintheUS....”

PositiveHealthOnline“MostLiveLighterreadersknowthere’ssomethingfishywithconventionalmedicineandsothey’ve

turnedtonaturalhealthalternatives.NowwithGaryNull’snewestbook,DeathbyMedicine,wehavesolidproofthattoday’smedicalworldneedsdrasticchange.”

LiveLighter.org

TheAward-WinningFilmDocumentaryDeathbyMedicine

Fromtheaward-winningdirectorofVaccineNation,TheDruggingofourChildren,PrescriptionforDisaster,GulfWarSyndrome:KillingOurOwn,andAIDSInc.comesthelatestfilmofcriticalsocialimportance:DeathbyMedicine.

DeathbyMedicinetakesahardlookatthedominantmedicalparadigmcontributingtoAmerica’shealthcrisis.BasedonGaryNull’sgroundbreakingbookbythesamenameaboutthehundredsofthousandsofinjuriesanddeathscausedbyconventionalmedicine,thisdocumentaryexaminesthemedical–industrialcomplexandtheinfluenceofdrugrepresentatives;thepharmaceuticalindustry’susurpationofthenation’smedicalschools,research,andpeer-reviewedscientificjournals;thefalsifieddrugtrials;thepowerofprivateinsurancefirmsandthelobbyingofourlegislators;andthecomplicityoffederalhealthagencieswhichallowthistohappen.Theresultisamedicalsystemnolongerbasedonsoundscience.Whyistherealackofoversightbythegovernmentregulatoryagencieswhileprivate-interestlobbyistscalltheshotsfornationalhealthcare?

FromFDAandFBIraidsoncherryfarmerstothehallsofCongress,thefilmdocumentsthehostileattackonthenaturalhealthindustry.AmercenaryhealthcaresystemandthefailuresofajustandfairhealthcarepolicyhaslefttheUSasthe37th-besthealthcaresystemintheworld.TheAmericanmedicalsystemisbroken,utterlycorruptedbymoney,andnolongerfoundedonscientificfact.Theansweristocreateanentirelynewmedicalparadigm—ahealthier,moreholisticsystemthatisconcernedwithpeople’shealthratherthanstockprices,careers,andreputations.

FilmFestivalAwardsDeathbyMedicine

CANADAFILMFESTIVAL

RisingStarAwardHOBOKENINTERNATIONALFILMFESTIVAL

BestDocumentaryHONOLULUFILMFESTIVAL

GoldKahunaAwardLASVEGASFILMFESTIVAL

GoldenAceAwardLITCHFIELDHILLSFILMFESTIVAL

ExtraordinaryAchievementinDocumentaryFilmmakingOFFICIALBESTOFFEST

OfficialBestofFestAwardSKYFESTVFESTIVAL

HonorableMentionWORLDFEST–HOUSTON

GoldRemiAward

DeathbyMedicine

byGaryNull,PhDMartinFeldman,MD;DeboraRasio,MD;andCarolynDean,MD,ND

DISCLAIMERIdeasandinformationinthisbookarebasedupontheexperienceandtrainingoftheauthorandthescientificinformationcurrently

available.Thesuggestionsinthisbookaredefinitelynotmeanttobeasubstituteforcarefulmedicalevaluationandtreatmentbyaqualified,licensedhealthprofessional.Theauthorandpublisherdonotrecommendchangingoraddingmedicationorsupplementswithoutconsultingyourpersonalphysician.Theyspecificallydisclaimanyliabilityarisingdirectlyorindirectlyfromtheuseofthisbook.

PraktikosBooksP.O.Box118MountJackson,VA22842888.542.9467info@praktikosbooks.comDeathbyMedicine,RevisedPaperbackEdition©2011byNutritionInstituteofAmerica.Allrightsreserved.PrintedintheUnitedStates

ofAmerica.Nopartofthisbookmaybeusedorreproducedinanymannerwhatsoeverwithoutwrittenpermissionexceptinthecaseofbriefquotationsusedincriticalarticlesandreviews.

PraktikosBooksareproducedinalliancewithAxiosPress.EbookISBN:978-1-60766-010-1

1Introduction

Somethingiswrongwhenregulatoryagenciespretendthatvitaminsandnutritionalsupplementsaredangerous.Manyinthemedia,withoutscientificbasis,denigratetheuseofsupplements,yetthese“vitamincritics”ignorepublishedstatisticsshowingthattherealhazardisgovernment-sanctionedmedicine.

Inmanyrespects,however,theseregulatoryagenciesactastheirowncritics.Thegovernmentisnotblindtoitsowndeficienciesinhealthcaredelivery.TheInstituteofMedicine,apartoftheUnitedStatesNationalAcademyofSciences,states:

HealthcareintheUnitedStatesisnotassafeasitshouldbe....Amongtheproblemsthatcommonlyoccurduringthecourseofprovidinghealthcareareadversedrugeventsandimpropertransfusions,surgicalinjuriesandwrong-sitesurgery,suicides,restraint-relatedinjuriesordeath,falls,burns,pressureulcers,andmistakenpatientidentities[allofwhichexact]theircostinhumanlives.1TheInstituteofMedicineevenrefersto“thenation’sepidemicofmedicalerrors,”manyofwhich

involveadversedrugreactions(ADRs).TheUSFoodandDrugAdministration(FDA)saysthat“ADRsareoneoftheleadingcausesofmorbidityandmortalityinhealthcare.”2

ArchivesofInternalMedicinepublished“ASpecialArticle”byCurtD.Furberg,MD,PhD,etal.,called“TheFDAandDrugSafety:AProposalforSweepingChanges.”Thesection“ProblemswiththeCurrentSystem”begins:“WeseeeightmajorproblemswiththecurrentsystemofassessmentandassuranceofdrugsafetyattheFDA.”ThefirstofthesesaysthattheinitialreviewforapprovaloftenfailstodetectseriousADRs:“AstudybytheUSGeneralAccountabilityOffice(GAO)concludedthat51%ofallapproveddrugshadatleastoneseriousADRthatwasnotrecognizedduringtheapprovalprocess.”3

Theironyisthatsafer(andlessexpensive)preventivealternativesareoftenattackedorstrategicallyridiculedbyregulatorypowers,even—orperhapsespecially—whenproveneffective.Thiscondescendingstancetowardalternativesmaybefueledbytheirrelativelackofsideeffectsinacompetitivemarketplace.

Untilrecently,healthresearcherscouldciteonlyisolatedstatisticstomaketheircaseaboutthedangersofconventionalmedicine.Noonehadeveranalyzedandcompiledallthepublishedliteraturedealingwithinjuriesanddeathscausedbygovernment-protectedmedicine.

Agroupofresearchersmeticulouslyreviewedthestatisticalevidence,andtheirfindings,includedinthisbook,areabsolutelyshocking.InDeathbyMedicine,wewillpresentcompellingevidencethattoday’shealthcaresystemfrequentlycausesmoreharmthangood.

Thisfullyreferencedbookrevealsanumberofstartlingfacts:

Thenumberofpeoplehavingin-hospital,adversereactionstoprescribeddrugsannually:approximately2.2million

Thenumberofunnecessaryand/orinappropriateantibioticsprescribedannually:approximately45millionperyear4,5

Thenumberofunnecessarymedicalandsurgicalproceduresperformedeachyear:7.5millionThenumberofpeopleunnecessarilyhospitalizedeachyear:8.9million

Themoststunningstatistic,however,isthatthetotalnumberofdeathscausedbyconventionalmedicineisnearly800,000peryear.ItisnowevidentthattheAmericanmedicalsystemistheleadingcauseofdeathandinjuryintheUS.Bycontrast,thenumberofdeathsattributabletoheartdiseasein2005,themostrecentyearforwhichfinaldataisavailable,is652,091,whilethenumberofdeathsattributabletocanceris559,312.6“Itisestimatedthat...565,650menandwomenwilldieofcancerofallsitesin2008,”accordingtotheNationalCancerInstitute,aprojectedincreaseof6,338cancerdeaths.7

WedecidedtopublishDeathbyMedicinetocallattentiontothefailureoftheAmericanmedicalsystem.Byexposingthesegruesomestatisticsinpainstakingdetail,weprovideabasisforcompetentandcompassionatemedicalprofessionals,suchasthecourageousDr.DavidGraham,torecognizetheinadequaciesoftoday’ssystemandatleastattempttoinstitutemeaningfulreforms.

OnNovember18,2004,DavidJ.Graham,MD,MPH,AssociateDirectorforScienceandMedicineintheFDA’sOfficeofDrugSafety,testifiedbeforetheUSSenate.Dr.GrahamgraduatedfromtheJohnsHopkinsUniversitySchoolofMedicine,andtrainedinInternalMedicineatYaleandinadultNeurologyattheUniversityofPennsylvania.Afterthis,hecompletedathree-yearfellowshipinpharmaco-epidemiologyandaMastersinPublicHealthatJohnsHopkins,withaconcentrationinepidemiologyandbiostatistics.8Hiseducationandextensiveexperiencequalifyhimtoofferanexpertopiniononpharmaceuticaldrugs.

Dr.Graham,whohadspenttwentyyearsworkingattheFDA,toldtheSenate:Duringmycareer,IbelieveIhavemadearealdifferenceforthecauseofpatientsafety.My

researchandeffortswithinFDAledtothewithdrawalfromtheUSmarketofOmniflox,anantibioticthatcausedhemolyticanemia;Rezulin,adiabetesdrugthatcausedacuteliverfailure;Fen-PhenandRedux,weightlossdrugsthatcausedheartvalveinjury;andPPA(phenylpropanolamine),anover-the-counterdecongestantandweightlossproductthatcausedhemorrhagicstrokeinyoungwomen.

MyresearchalsoledtothewithdrawalfromoutpatientuseofTrovan,anantibioticthatcausedacuteliverfailureanddeath.IalsocontributedtotheteameffortthatledtothewithdrawalofLotronex,adrugforirritablebowelsyndromethatcausesischemiccolitis;Baycol,acholesterol-loweringdrugthatcausedseveremuscleinjury,kidneyfailureanddeath;Seldane,anantihistaminethatcausedheartarrhythmiasanddeath;andPropulsid,adrugfornight-timeheartburnthatcausedheartarrhythmiasanddeath....

IhavedoneextensiveworkconcerningtheissueofpregnancyexposuretoAccutane,adrugthatisusedtotreatacnebutcancausebirthdefectsinsomechildrenwhoareexposedinuteroiftheirmotherstakethedrugduringthefirsttrimester.Duringmycareer,Ihaverecommendedthemarketwithdrawaloftwelvedrugs.Onlytwooftheseremainonthemarkettoday—AccutaneandArava,adrugforthetreatmentofrheumatoidarthritisthatIandaco-workerbelievecausesanunacceptablyhighriskofacuteliverfailureanddeath.9TheLosAngelesTimesreportedthatwitnessestoldtheSenatepanelthat

Merck&Co.andtheFoodandDrugAdministrationknewbeforetheagencyapprovedthecompany’sVioxx®painkillerin1999thatthedrugcouldhaveseriousadverseeffectsontheheart....ButtheFDAgaveitsapprovalwithoutresolvingtheconcerns,andVioxx®wasaggressivelymarketedtopointupitspainreliefqualities,notitsrisks.10TestifyingaboutMerck’sVioxx®,Dr.Grahamstates:

Today...you,we,arefacedwithwhatmaybethesinglegreatestdrugsafetycatastropheinthehistoryofthiscountryorthehistoryoftheworld.WearetalkingaboutacatastrophethatIstronglybelievecouldhave,shouldhave,beenlargelyorcompletelyavoided.Butitwasn’t,andover100,000Americanshavepaiddearlyforthisfailure.Inmyopinion,theFDAhaslettheAmerican

peopledown,andsadly,betrayedapublictrust.11InthesamewaytheFDAattemptstoquashvitamins,theyallegedlyattemptedtosuppressscientific

research,presumablytokeepVioxx®andotherdrugsafloat,accordingtoDr.Graham.“NotonlydidtheFDAignoreknownrisksfromVioxx®andrelateddrugsbut...ittriedtopreventGrahamandothersfrompublicizingtheirownresearchthatprovedtheextentoftheserisks.”12

Whenitcomestonewmedications,AttorneyBlakeBaileyobserves:TheFDA...usesthestudiesofthecompanieswhostandtogainbillionsofdollarsandare

underintensepressuretobeatacompetingcompanytomakeittothemarketwithasimilarproduct.ManyofthescientistsandmedicaldoctorsgotoworkforthesecompaniesafteratenurewithFDA.13Dr.Grahammadeitclearinhistestimonythat,throughouthiscareer,hehadonlyworkedforthe

FDA,notforanycompanies.CommitteeChairmanCharlesE.Grassley(R–Iowa)saidhewasconcernedthattheFDA“hasa

relationshipwithdrugcompaniesthatistoocozy.”14Sen.JeffBingaman(D–NewMexico)saidtheproblemwaswithintheFDA’sownculture:“The

culturewithintheFDA,beingonewherethepharmaceuticalindustry,whichtheFDAissupposedtoregulate,isseenbytheFDAasitsclientinstead.15

InGraham’sview,thedrugsafetyproblemsbeganin1992withthepassageofalawaimedatgettinglifesavingdrugsontothemarketfaster.Tospeedupapprovals,thelawforcedpharmaceuticalcompaniestofootmostofthebillforthereviewprocess.ThatlefttheFDA“capturedbyindustry,”saysGraham.“Hewhopaysthepipercallsthetune.”16

EdwardJ.Markey(D–Massachusetts)notedthata2006surveyconductedbytheUnionofConcernedScientistsreportedthat18.4%ofFDAscientistssurveyedreportedthattheyhadbeenaskedtoinappropriatelyexcludeoraltertechnicalinformationortheirconclusionsinanFDAscientificdocument.17TheAmericanSocietyofHealth-SystemPharmacistsreportsthatGrahamtestified“inFebruary

[2007]that,haditnotbeenfortheprotectionofSen.CharlesGrassley(R–Iowa),FDAwouldhavefiredhimforpubliclyspeakingoutabouthisconcernsaboutVioxx®andotherdrugs.”18

Dr.Grahamsays,“Youneedtoweedthegardenpatchofdrugsthataren’tdoingwhatthey’resupposedtodo.TheFDAhasnotbeenverygoodaboutthat;itlikestocultivatealltheseweeds.”19Dr.Graham“namedfiveotherdrugswhosesafetyissuspect,andnotedthat‘theFDAascurrentlyconfiguredisincapableofprotectingAmericaagainstanotherVioxx®.20

Manymediasourcespresentatthehearing,suchastheLosAngelesTimesandMedscapeMedicalNews,21reportthatGrahamthenadded,“Wearevirtuallydefenseless,22butthissentencedoesnotappearinthefinaltranscriptandmayhavebeenstrickenfromtherecord.Onereportbegins,“TheAmericanpublicis‘virtuallydefenseless’ifanothermedicationsuchasVioxx®provestobeunsafeafteritisapprovedforsale,agovernmentdrugsafetyreviewertoldacongressionalcommittee.”23

YettheFDAcrusadestopreventusfromtakingdandelionroot.Naturalmedicineisundersiege,aspharmaceuticalcompanylobbyistsurgelawmakerstodeprive

Americansofthebenefitsofdietarysupplementsandbioidenticalhormones.Drug-companyfrontgroupshavelaunchedslanderousmediacampaignstodiscreditthevalueofhealthylifestyles.TheFDAcontinuestointerferewiththosewhooffernaturalproductsthatcompetewithprescriptiondrugs.

Theseattacksagainstnaturalmedicineobscurealethalproblemthatuntilnowwasburiedinthousandsofpagesofscientifictext.Inresponsetothesebaselesschallengestonaturalmedicine,hereisanindependentreviewofthequalityof“government-approved”medicine.TosupporttheboldclaimthatconventionalmedicineisAmerica’snumberonekiller,everycountinthisindictmentofUSmedicineis

validatedbypublished,peer-reviewedscientificstudies.ThestartlingfindingsfromthismeticulousstudyindicatethatconventionalmedicineistheleadingcauseofdeathintheUnitedStates.

Whatyouareabouttoreadisastunningcompilationoffactsthatdocumentsthatthosewhoseektoabolishconsumeraccesstonaturaltherapiesaremisleadingthepublic.Nearly800,000Americansdieeachyearatthehandsofgovernment-sanctionedmedicine,whiletheFDAandothergovernmentagenciespretendtoprotectthepublicbyharassingthosewhooffersafealternatives.

Adefinitivereviewofmedicalpeer-reviewedjournalsandgovernmenthealthstatisticsshowsthatAmericanmedicinefrequentlycausesmoreharmthangood.

Eachyearatleast2.2millionUShospitalpatientsexperienceadversedrugreactions(ADRs)toprescribedmedications.24TheFDAacknowledgesthat,comparedwithdatafromtheInstitutesofMedicine,studies

conductedonhospitalizedpatientpopulationshaveplacedmuchhigherestimatesontheoverallincidenceofseriousADRs.Thesestudiesestimatethat6.7%ofhospitalizedpatientshaveaseriousadversedrugreactionwithafatalityrateof0.32%.25

Iftheseestimatesarecorrect,thentherearemorethan2,216,000seriousADRsinhospitalizedpatients,causingover106,000deathsannually....ThesestatisticsdonotincludethenumberofADRsthatoccurinambulatorysettings.Also,itisestimatedthatover350,000ADRsoccurinUSnursinghomeseachyear.26TheexactnumberofADRsisnotcertainandislimitedbymethodologicalconsiderations.However,whateverthetruenumberis,ADRsrepresentasignificantpublichealthproblemthatis,forthemostpart,preventable.27In1995,Dr.RichardBesserofthefederalCentersforDiseaseControlandPrevention(CDC)

estimatedthenumberofunnecessaryantibioticsprescribedannuallyforviralinfectionstobe20million;in2003,Dr.Besserspokeintermsoftensofmillionsofunnecessaryantibioticsprescribedannually.28,29

In2005,Dr.PhilipTierno,directorofclinicalmicrobiologyandimmunologyatNewYorkUniversityMedicalCentersaidthateachyear“about90millionantibioticprescriptionsarewrittenandabouthalfofthoseareeitherunnecessaryorinappropriate,whichistheleadingcauseofantibioticresistanceinAmerica.”30

InOctober2008,Dr.LauriHicks,medicaldirectoroftheCDC’sGetSmart:KnowWhenAntibioticsWorkprogram,warns:“Antibioticoveruseisaseriousproblemandathreattoeveryone’shealth.”TheCDCreports,“Upperrespiratorytractinfections[are]usuallycausedbyviruses[and]can’tbecuredwithantibiotics.Yeteachyear,healthcareprovidersintheUSprescribetensofmillionsofantibioticsforviralinfections.”Dr.Hicksexplains,“Takingantibioticswhenyoudon’tneedthemornotasprescribedincreasesyourriskofgettinganinfectionlaterthatresistsantibiotictreatment.”31

TheCDCannouncedthattobringattentiontothisincreasingproblem,theyinitiatedaGetSmartAboutAntibioticsWeekin2008,acampaigntoeducatethepublic32and,byimplication,tosensitizephysicianstothedangerofover-prescribing,apracticethathasbeenbuildingwithimpunityformanyyears,butwhichcannolongerbereadilytolerated.

Approximately7.5millionunnecessarymedicalandsurgicalproceduresareperformedannuallyintheUS,33,34whileapproximately8.9millionAmericansarehospitalizedunnecessarily.35–38TheInstituteofMedicineestimatesthatnearly100,000patientsdieinhospitalseachyearduetomedicalerrors.Thisisthreetimesthenumberwhodieonthehighways.39

Deathsfromnosocomialinfections—thatis,infectionsthatarearesultoftreatmentinahospitalorahealthcareserviceunit,appearing48hoursormoreafterhospitaladmissionorwithin30daysafterdischarge—rosefrom88,000in199740,41to99,000peryearin2002.42AccordingtotheCDC,inAmericanhospitalsalone,healthcare-associatedinfections(HAIs)accountforanestimated1.7millioninfectionsand99,000associateddeathseachyear.”43Therewere

33,269HAIsamongnewbornsinhigh-risknurseries,19,059amongnewbornsinwell-babynurseries,417,946amongadultsandchildreninICUs,and1,266,851amongadultsandchildrenoutsideofICUs.

Ofthe99,000associateddeaths,

35,967wereforpneumonia,30,665forbloodstreaminfections,13,088forurinarytractinfections,8,205forsurgicalsiteinfections,and11,062forinfectionsofothersites.44

AsshowninTable1,theestimatedtotalnumberofiatrogenicdeaths—thatis,deathsinducedinadvertentlybyaphysicianorsurgeonorbymedicaltreatmentordiagnosticprocedures—intheUSannuallyisatleast581,926.ItisevidentthattheAmericanmedicalsystemisitselftheleadingcauseofdeathandinjuryintheUS.Bycomparison,approximately652,091Americansdiedofheartdiseasein2005,while559,312diedofcancer.45

Themortalitycostsaloneexceed$215billionayear.“HealthcarecostsintheUnitedStatesaregrowingatanunsustainablerate,”accordingtoSenatorRonWyden,whoservesontheSenate’sFinanceCommittee,SubcommitteeonHealthcare.46

TheNationalCoalitiononHealthcarereportsthatannualhealthcarespendingintheUShasbeenincreasingtwotofivetimestherateofinflationsince2000.47In2006,Americansspentmorethan$2.2trilliononhealthcare.48

Table1:EstimatedAnnualMortalityandCostofMedicalIntervention

Condition

Deaths

Cost

Author

HospitalAdverseDrugReactions

106,000+

$2billion+

Lazarou,49Suh,50FDA51

HospitalMedicalErrors

98,000

$2billion

IOM,52–54

HospitalBedsores

17,160

$90billion

Xakellis,55Barczak,56HealthGrades57

HospitalInfections

88,000

$5billion+

CDC,58Weinstein,59MMWR60

NursingHomes/Malnutrition

4,630

-----------

CoalitionforNursingHomeReform61ConsumerAffairs62

OutpatientAdverseDrugReactions

199,000

77billion

Starfield,63,64Weingart65

UnnecessarySurgicalProcedures

37,136

$30billion

HCUP,66,67Leape68

Surgery-Related

32,000

$9billion

AHRQ,perZahnandMiller69

Total

581,926+

$215billion+

Totalhealthcarespendingwas$2.4trillioninboth2007and2008,or$7,900perperson,whichrepresented17percentofthegrossdomesticproduct(GDP).70That’sabout4.3timestheamountspentonnationaldefense.71Thetotalwasprojectedtoreach$3.1trillionin2012.72

TheNationalCoalitiononHealthcarefurtherstates:Itisestimatedthatwehavespentasanationnearly16trilliondollarsonhealthcaresince2000,

butthisexpenditurehasnotresultedindemonstrablybetterqualityofcareorbetterpatientsatisfactioncomparedtoothernations.73JasonLazarou,MSc,estimated106,000annualdrugerrorsinhisgroundbreaking1998reportinthe

JournaloftheAmericanMedicalAssociation;74theInstituteofMedicineestimated98,000annualmedicalerrors.ButifweuseDr.LucianL.Leape’s1997medicalanddrugerrorrateof3million75multipliedbythe14%fatalityrateheusedin1994,76wefindthatthenumberofdeathswouldbeincreasedby216,000,foratotalof797,926deathsannually,asshowninTable2.

Table2:EstimatedAnnualMortalityandCostofMedicalIntervention

Condition

Deaths

Cost

Reference

HospitalADR/mederror

420,000

$28billion

Leape,77NPSF78

HospitalBedsores

17,160

$90billion

Xakellis,79Barczak,80HealthGrades81

HospitalInfection

88,000

$5billion+

CDC,82Weinstein,83MMWR84

NursingHome/Malnutrition

4,630

-----------

CoalitionforNursingHomeReform85

Outpatients

199,000

$77billion

Starfield,86,87Weingart88

UnnecessaryProcedures

37,136

$30billion

HCUP,89Leape90

Surgery-Related

32,000

$9billion

AHRQ*,91

Total

797,926

$239billion+

*perZahnandMiller

“Inthepast,medicinewas‘simple,relativelysafe,andineffective’...buttodaymedicineiscomplicated...whichhasmadeitlesssafe,anditisstillineffective,”accordingtoDr.Leape.92Emergencymedicinehelpsmany.

Unnecessarymedicalevents,includingpointlesshospitalization,areimportantinouranalysis.Theseeventsareamongthemostlamentableinallofmedicine.Theyareusuallypreventable.Anyinvasiveinappropriatemedicalprocedureputsapatientatriskforaniatrogeniccascadeofinjuries,possiblydeath.Unfortunately,causeandeffectgounmonitored.“Atleast150times[inthesevenyearsbetween1996and2003],surgeonsinAmericanhospitalshaveoperatedonthewrongarm,leg,eyeorotherbodypart.”

Donotimaginethathospitalsviewedasrolemodelsforresearchandfineclinicalcareareperfect.MemorialSloan–KetteringCancerCenterinNewYorkCity“advertisesthatitdeliversthebestcancercareanywhere.Butin1995,itschiefneurosurgeonoperatedonthewrongsideofapatient’sbraininpartbecauseofamix-upinX-rays....Lapsesinbasicqualitychecksandordinarystandardsofpatientcareledtomostofthemishaps.”93

Thefiguresonunnecessaryeventsrepresentpeoplewhoarethrustintoadangeroushealthcaresystem.Eachofthese16.4millionlivesisbeingaffectedinwaysthatcouldhavefatalconsequences.Simplyenteringahospitalcouldresultinthefollowing:

In16.4millionpeople,a2.1%chance(affecting344,400)ofaseriousadversedrugreaction94

In16.4millionpeople,a5–6%chance(affecting902,000)ofacquiringanosocomialinfection95

In16.4millionpeople,a4–36%chance(affectingbetween656,000and5.9million)ofhavinganiatrogenicinjury(medicalerrororadversedrugreactions)96

In16.4millionpeople,a17%chance(affecting2.8million)ofaprocedureerror97

Table3:Estimated10-YearDeathRatesfromMedicalIntervention

Condition

10YearDeaths

Reference

HospitalAdverseDrugReaction

1,060,000+

Lazarou,98FDA99

HospitalMedicalError

980,000

IOM100–102

HospitalBedsores

1,150,000

Xakellis,103Barczak104

HospitalInfection

880,000

CDC,105Weinstein106

NursingHome/Malnutrition

1,090,000

CoalitionforNursingHomeReform107

Outpatients

1,990,000

Starfield,108,109Weingart110

UnnecessaryProcedures

371,360

HCUP111

Surgery-related

320,000

AHRQ*,112

Total

7,841,360+

*perZahnandMiller

Thesestatisticsrepresentaone-yeartimespan.Workingwiththemostconservativefiguresfromourstatistics,weprojectthefollowingten-yeardeathrates(Table3).

Ourestimatedten-yeartotalof7.95millioniatrogenicdeathsismorethanallthecasualtiesfromallthewarsfoughtbytheUSthroughoutitsentirehistory.Ourprojectedfiguresforunnecessarymedicaleventsoccurringoveraten-yearperiodarealsostriking.ThefiguresinTable4showthatanestimated164millionpeople—morethanhalfofthetotalUSpopulation—receiveunneededmedicaltreatmentoverthecourseofadecade.

Table4:EstimatedTen-YearUnnecessaryMedicalEvents

UnnecessaryEvents

10-yearNumber

IatrogenicEvents

Hospitalization

89million113–116

17million

Procedures

75million117

15million

Total

164million

32million

2MedicallyInducedDeath:TheEquivalentofSixJumbo

JetsFallingOutoftheSkyEachDay

Neverbeforehavecompletestatisticsonthemultiplecausesofiatrogenesisbeencombinedinonebook.Medicalscienceamassestensofthousandsofpapersannually,eachrepresentingatinyfragmentofthewholepicture.Tolookatonlyonepieceandtrytounderstandthebenefitsandrisksislikestandinganinchawayfromanelephantandtryingtodescribeeverythingaboutit.Youhavetostepbacktoseethebigpicture,aswehavedonehere.Eachspecialty,eachdivisionofmedicine,keepsitsownrecordsanddataonmorbidityandmortality.Wehavenowcompletedthepainstakingworkofreviewingthousandsofstudiesandputtingthepiecesofthepuzzletogether.

IsAmericanMedicineWorking?UShealthcarespendingreached$1.6trillionin2003,representing14%ofthenation’sgross

nationalproduct.118Whenspendingroseto$2.4trillionperyearin2007,itwouldrepresent17%ofthegrossdomesticproduct.119Consideringthisenormousexpenditure,whichoccurredin2008aswell,weshouldhavethebestmedicineintheworld.Weshouldbepreventingandreversingdisease,anddoingminimalharm.Carefulandobjectivereview,however,showswearedoingtheopposite.Becauseoftheextraordinarilynarrow,technologicallydrivencontextinwhichcontemporarymedicineexaminesthehumancondition,wearecompletelymissingthelargerpicture.

Medicineisnottakingintoconsiderationthefollowingcriticallyimportantaspectsofahealthyhumanorganism:

stress,andhowitadverselyaffectstheimmunesystemandlifeprocesses;insufficientexercise;excessivecalorieintake;highlyprocessedanddenaturedfoods,grownindenaturedandchemicallydamagedsoil;andexposuretotensofthousandsofenvironmentaltoxins.

Insteadofminimizingthesedisease-causingfactors,wecausemoreillnessthroughmedicaltechnology,diagnostictesting,overuseofmedicalandsurgicalprocedures,andoveruseofpharmaceuticaldrugs.Thehugedisserviceofthistherapeuticstrategyistheresultoflittleeffortormoneybeingspentonpreventingdisease,asevidencedbyeffortstocurtailuseofeffectivevitaminsandsupplements.Therecentarticle,“USSpends$700BilliononUnnecessaryMedicalTests,”whichappearsontheHealthcareEconomistwebsite,reflectsthestateofourtechno-mednation:

PeterOrszag,directoroftheCongressionalBudgetOffice,estimatesthat5percentofthenation’sgrossdomesticproduct—$700billionperyear—goestotestsandproceduresthatdonotactuallyimprovehealthoutcomes....TheunreasonablyhighcostofhealthcareintheUnitedStatesisadeeplyentrenchedproblemthatmustbeattackedatitsroot.”ThisquotationcomesfromaProgressivePolicyInstitute(PPI)report.Thereislittledoubtthatmuchofhealthcareisunnecessaryoratleastisnotworthwhileinthecost-benefitsense.120Moreover,

SomemedicalexpertssaytheAmericandevotiontothenewest,mostexpensivetechnologyisanimportantreasonthattheUnitedStatesspendsmuchmoreonhealthcarethanotherindustrializednations...withoutprovidingbettercare....[A]RandCorporationstudyestimatedthatone-thirdormoreofthecarethatpatientsinthiscountryreceivecouldbeoflittlevalue.Ifthatisso,hundredsofbillionsofdollarseachyeararebeingwastedonsuperfluoustreatments.

[Thereis]amuchlargertrendinAmericanmedicine....Afaithininnovation,oftendrivenby[quick]financialincentives,encouragesAmericandoctorsandhospitalstoadoptnewtechnologiesevenwithoutproofthattheyworkbetterthanoldertechniques....Theproblemisnotthatnewertreatmentsneverwork.Itisthatoncetheybecomeavailable,[toooftenprematurely,]theyareoftenusedindiscriminately,intheabsenceofstudiestodeterminewhichpatientstheywillbenefit....Andsometimes,thenewtechnologiesproveharmful....[Some]doctorsinprivatepracticewhoowntheir[CT]scanners,usethetestsaggressively...[asifitwere]anewtoyintheoffice121—endangeringasymptomaticpatientsforwhomthescanmaybeinappropriate.

HealthInsuranceTodeterminewhetherAmericanmedicineisworking,wealsoneedtoknowifenoughpeoplehave

accesstotheAmericanhealthcaresystem.TheNationalCoalitiononHealthcarereports,“Nearly46millionAmericans,or18percentofthepopulationundertheageof65,werewithouthealthinsurancein2007,thelatestgovernmentdataavailable.”122AsofSeptember2007,oneoutofthreeAmericanswereuninsured.123,124Thisnumberisapttorisesharplyfor2008and2009becausesomanyAmericansarelosingtheirjobsintherecession.

Thenumberofuninsuredchildrenin2007was8.1million—or10.7percentofallchildrenintheUS....Thelargemajorityoftheuninsured(80percent)arenativeornaturalizedcitizens....Thenumberofuninsuredrose2.2millionbetween2005and2006andhasincreasedbyalmost8millionpeoplesince2000....

Astudyfoundthat29percentofpeoplewhohadhealthinsurancewere“underinsured”withcoveragesomeagertheyoftenpostponedmedicalcarebecauseofcosts.Nearly50percentoverall,and43percentofpeoplewithhealthcoverage,saidtheywere“somewhat”to“completely”unpreparedtocopewithacostlymedicalemergencyoverthecomingyear.125TheNationalCoalitiononHealthcareadvises,

Gettingeveryonecoveredwillsavelivesandmoney.Theimpactsofgoinguninsuredareclearandsevere.Manyuninsuredindividualspostponeneededmedicalcarewhichresultsinincreasedmortalityandbillionsofdollarslostinproductivityandincreasedexpensestothehealthcaresystem.126TheLosAngelesTimesalmostwaxespoeticabouthealthcareinsuranceasjournalistRicardo

Alonso-Zaldivarobserves,“Somepeoplemarryforlove,someforcompanionship,andothersforstatusormoney.Nowcomesanotherreasontogethitched:healthinsurance.”127

Apollof2,003adultsreleasedonApril27,2008(onthecuspofoureconomicrecession)bytheKaiserFamilyFoundationfoundthat“7%ofAmericanssaidtheyorsomeoneintheirhouseholddecidedtomarryinthelastyearsotheycouldgethealthcarebenefitsviatheirspouse.”Notsurprisingly,“Thosewhocitedhealthinsuranceasafactorindecidingtomarrytendedtohavemodestincomes.About6in10wereinhouseholdsmakinglessthan$50,000ayear,saidMollyannBrodie,whodirectsKaiser’sopinionresearch.”Whatsurprisedresearcherswasthatsuchcostshadbecomeafactorinmarriagedecisions.“Weshouldhaveaskedaboutdivorce,”saidDrewE.Altman,presidentoftheKaiserFamilyFoundation,“joking.”128

TheInstituteofMedicinefoundthatthe41millionAmericanswithnohealthinsurancehaveconsistentlyworseclinicaloutcomesthanthosewhoareinsured,andareatincreasedriskfordyingprematurely.129

Compoundingtheproblemistheissueofinsurancefraud.Whendoctorsbillforservicestheydonotrender,adviseunnecessarytests,orscreeneveryoneforararecondition,theyarecommittinginsurancefraud.TheUSGAOestimatedthat$12billionwaslosttofraudulentorunnecessaryclaimsin1998,andreclaimed$480millioninjudgmentsinthatyear.In2001,thefederalgovernmentwonornegotiatedmorethan$1.7billioninjudgments,settlements,andadministrativeimpositionsinhealthcarefraudcasesandproceedings.130

UnderreportingofIatrogenicEventsAslittleas5%andnomorethan20%ofiatrogeniceventsareeverreported.131–135Thisimpliesthat

ifmedicalerrorswerecompletelyandaccuratelyreported,wewouldhaveanannualiatrogenicdeathtollmuchhigherthan794,936.In1994,Leapesaidhisfigureof180,000medicalmistakesresultingindeathannuallywasequivalenttothreejumbojetcrasheseverytwodays.136Ourconsiderablyhigherfigureisequivalenttosixjumbojetsfallingoutoftheskyeachday.

Whatwemustdeducefromthisreportisthatmedicineisinneedofcompleteandtotalreform—fromthecurriculuminmedicalschoolstoprotectingpatientsfromexcessivemedicalintervention.Itisobviousthatwecannotchangeanythingifwearenothonestaboutwhatneedstobechanged.Thisreportsimplyshowsthedegreetowhichchangeisrequired.

Wearefullyawareofwhatstandsinthewayofchange:powerfulpharmaceuticalandmedicaltechnologycompanies,alongwithotherpowerfulgroupswithenormousvestedinterestsinthebusinessofmedicine.Theyfundmedicalresearch,supportmedicalschoolsandhospitals,andadvertiseinmedicaljournals.Withdeeppockets,theyenticescientistsandacademicstosupporttheirefforts.Suchfundingcanswaythebalanceofopinionfromprofessionalcautiontouncriticalacceptanceofnewtherapiesanddrugs.Youhaveonlytolookatthepeoplewhomakeupthehospital,medical,andgovernmenthealthadvisoryboardstoseeconflictsofinterest.

Forexample,a2003studyfoundthatnearlyhalfofmedicalschoolfacultywhoserveoninstitutionalreviewboards(IRBs)toadviseonclinicaltrialresearchalsoserveasconsultantstothepharmaceuticalindustry.137Thestudyauthorswereconcernedthatsuchrepresentationcouldcausepotentialconflictsofinterest.Inanewsrelease,Dr.ErikCampbell,theleadauthor,wrote,“Ourpreviousresearchwithfacultyhasshownusthattiestoindustrycanaffectscientificbehavior,leadingtosuchthingsastradesecrecyanddelaysinpublishingresearch.It’spossiblethatsimilarrelationshipswithcompaniescouldaffectIRBmembers’activitiesandattitudes.”138Thepublicismostlyunawareoftheseinterlockinginterests.(Formoreonthis,seechapter8,“MedicalEthicsandConflictofInterestinScientificMedicine.”)

Governmentmedicaladvisorsplayaroleinadequatereportingofiatrogenicevents.TheFDAannouncedinMarch2007:

Expertadviserstothegovernmentwhoreceivemoneyfromadrugordevicemakerwouldbebarredforthefirsttimefromvotingonwhethertoapprovethatcompany’sproductsundernewrules...fortheFDA’spowerfuladvisorycommittees.Indeed,suchdoctorswhoreceivemorethan$50,000fromacompanyoracompetitorwhoseproductisbeingdiscussedwouldnolongerbeallowedtoserveonthecommittees,thoughthosewhoreceivelessthanthatamountintheprioryearcanjoinacommitteeandparticipateinitsdiscussions.A“significantnumber”oftheagency’spresentadviserswouldbeaffectedbythenewpolicy,saidtheFDAactingdeputycommissioner,RandallW.Lutter,thoughhewouldnotsayhowmany.139

TheFirstStudyofIatrogenesis

Dr.LucianL.Leapeopenedmedicine’sPandora’sboxinhis1994paper,“ErrorinMedicine,”whichappearedintheJournaloftheAmericanMedicalAssociation(JAMA).140HenotedthatSchimmelreportedin1964that20%ofhospitalpatientssufferediatrogenicinjury,witha20%fatalityrate.In1981,Steelreportedthat36%ofhospitalizedpatientsexperiencediatrogenesis,witha25%fatalityrate,andadversedrugreactionswereinvolvedin50%oftheinjuries.In1991,Bedellreportedthat64%ofacuteheartattacksinonehospitalwerepreventableandweremostlyduetoadversedrugreactions.

LeapefocusedontheHarvardMedicalPracticeStudypublishedin1991,141whichfounda4%iatrogenicinjuryrateforpatients,witha14%fatalityrate,in1984inNewYorkState.Fromthe98,609patientsinjuredandthe14%fatalityrate,heestimatedthatintheentireUS,180,000peopledieeachyearpartlyasaresultofiatrogenicinjury.

WhyLeapechosetousethemuchlowerfigureof4%injuryforhisanalysisremainsinquestion.Usinginsteadtheaverageoftheratesfoundinthethreestudieshecites(36%,20%,and4%)wouldhaveproduceda20%medicalerrorrate.Thenumberofiatrogenicdeathsusinganaveragerateofinjuryandhis14%fatalityratewouldbe1,189,576.

Leapeacknowledgedthattheliteratureonmedicalerrorsissparseandrepresentsonlythetipoftheiceberg,notingthatwhenerrorsarespecificallysoughtout,reportedratesare“distressinglyhigh.”Hecitedseveralautopsystudieswithratesashighas35–40%ofmisseddiagnosescausingdeath.Healsonotedthatanintensivecareunitreportedanaverageof1.7errorsperdayperpatient,and29%ofthoseerrorswerepotentiallyseriousorfatal.

Leapecalculatedtheerrorrateintheintensivecareunitstudy.First,hefoundthateachpatienthadanaverageof178“activities”(staff/procedure/medicalinteractions)aday,ofwhich1.7wereerrors,whichmeansa1%failurerate.Thismaynotseemlikemuch,butLeapecitedindustrystandardsshowingthatinaviation,a0.1%failureratewouldmeantwounsafeplanelandingsperdayatChicago’sO’HareInternationalAirport;intheUSPostalService,a0.1%failureratewouldmean16,000piecesoflostmaileveryhour;andinthebankingindustry,a0.1%failureratewouldmean32,000bankchecksdeductedfromthewrongbankaccount.

Atthesametime,Leapeacknowledgedthelackofreportingofmedicalerrors.Medicalerrorsoccurinthousandsofdifferentlocationsandareperceivedasisolatedandunusualevents.Butthemostimportantreasonthattheproblemofmedicalerrorsisunrecognizedandgrowing,accordingtoLeape,isthatdoctorsandnursesareunequippedtodealwithhumanerrorbecauseofthecultureofmedicaltrainingandpractice.

Doctorsaretaughtthatmistakesareunacceptable.Medicalmistakesarethereforeviewedasafailureofcharacterandanyerrorequalsnegligence.Nooneistaughtwhattodowhenmedicalerrorsdooccur.LeapecitesMcIntyreandPopper,whosaidthe“infallibilitymodel”ofmedicineleadstointellectualdishonestywithaneedtocoverupmistakesratherthanadmitthem.

TherearenoGrandRoundsonmedicalerrors,nosharingoffailuresamongdoctors,andnoonetosupportthememotionallywhentheirerrorharmsapatient.Leapehopedhispaperwouldencouragemedicalpractitioners“tofundamentallychangethewaytheythinkabouterrorsandwhytheyoccur.”Ithasbeenalmostadecadesincethisgroundbreakingwork,butthemistakescontinuetosoar.

In1995,aJAMAreportnoted,“OveramillionpatientsareinjuredinUShospitalseachyear,andapproximately280,000dieannuallyasaresultoftheseinjuries.Therefore,theiatrogenicdeathratedwarfstheannualautomobileaccidentmortalityrateof45,000andaccountsformoredeathsthanallotheraccidentscombined.”142

Ata1997pressconference,LeapereleasedanationwidepollonpatientiatrogenesisconductedbytheNationalPatientSafetyFoundation(NPSF),whichissponsoredbytheAmericanMedicalAssociation(AMA).LeapeisafoundingmemberofNPSF.Thesurveyfoundthatmorethan100millionAmericanshavebeenaffecteddirectlyorindirectlybyamedicalmistake.Forty-twopercentwereaffecteddirectly

and84%personallyknewofsomeonewhohadexperiencedamedicalmistake.143Atthispressconference,Leapeupdatedhis1994statistics,notingthatasof1997,medicalerrorsin

inpatienthospitalsettingsnationwidecouldbeashighas3millionandcouldcostasmuchas$200billion.Leapeuseda14%fatalityratetodetermineamedicalerrordeathrateof180,000in1994.144In1997,usingLeape’sbasenumberof3millionerrors,theannualdeathratecouldbeashighas420,000forhospitalinpatientsalone.

OnlyaFractionofMedicalErrorsAreReportedIfthemedicalsystemwereabank,youwouldn’tdeposityourmoneyhere,becausetherewouldbeanerroreveryone-in-twotoone-in-threetimesyoumadeatransaction.

STEPHENPERSELL,MD,NORTHWESTERNUNIVERSITY’SFEINBERGSCHOOLOFMEDICINE145

In1994,Leapesaidhewaswellawarethatmedicalerrorswerenotbeingreported.146AstudyconductedintwoobstetricalunitsintheUKfoundthatonlyaboutonequarterofadverseincidentswereeverreported,toprotectstaff,preservereputations,orforfearofreprisals,includinglawsuits.147

AnanalysisbyWaldandShojaniafoundthatonly1.5%ofalladverseeventsresultinanincidentreport,andonly6%ofadversedrugeventsareidentifiedproperly.TheauthorslearnedthattheAmericanCollegeofSurgeonsestimatesthatsurgicalincidentreportsroutinelycaptureonly5–30%ofadverseevents.Inonestudy,only20%ofsurgicalcomplicationsresultedindiscussionatmorbidityandmortalityrounds.148

Fromthesestudies,itappearsthatallthestatisticsgatheredonmedicalerrorsmaysubstantiallyunderestimatethenumberofadversedrugandmedicaltherapyincidents.Theyalsosuggestthatourstatisticsconcerningmortalityresultingfrommedicalerrorsmaybeinfactconservativefigures.

AnarticleinPsychiatricTimes(April2000)outlinesthestakesinvolvedinreportingmedicalerrors.149Theauthorsfoundthatthepublicisfearfulofsufferingafatalmedicalerror,anddoctorsareafraidtheywillbesuediftheyreportanerror.Thisbringsuptheobviousquestion:whoisreportingmedicalerrors?Usuallyitisthepatientorthepatient’ssurvivingfamily.Ifnoonenoticestheerror,itisneverreported.

JanetHeinrich,anassociatedirectorattheUSGeneralAccountabilityOfficeresponsibleforhealthfinancingandpublichealthissues,testifiedbeforeaHousesubcommitteehearingonmedicalerrorsthat“thefullmagnitudeoftheirthreattotheAmericanpublicisunknown”and“gatheringvalidandusefulinformationaboutadverseeventsisextremelydifficult.”Sheacknowledgedthatthefearofbeingblamed,andthepotentialforlegalliability,playedkeyrolesintheunderreportingoferrors.

ThePsychiatricTimesnotedthattheAMAstronglyopposesmandatoryreportingofmedicalerrors.150Ifdoctorsarenotreporting,whataboutnurses?Asurveyofnursesfoundthattheyalsofailtoreportmedicalmistakesforfearofretaliation.151

NoImprovementinErrorReportingA2003surveyisallthemoredistressingbecausethereseemstobenoimprovementinerror

reporting,evenwithalltheattentiongiventothistopic.Dr.DorotheaWildsurveyedmedicalresidentsatacommunityhospitalinConnecticutandfoundthatonlyhalfwereawarethatthehospitalhadamedicalerror-reportingsystem,andthatthevastmajoritydidnotuseitatall.Dr.Wildsaysthisdoesnotbodewellforthefuture.Ifdoctorsdonotlearnerrorreportingintheirtraining,theywillneveruseit.Wildaddsthaterrorreportingisthefirststepinlocatingthegapsinthemedicalsystemandfixingthem.152

Intheirarticle,“UnderreportingofMedicalErrorsAffectingChildrenIsaSignificantProblem,ParticularlyamongPhysicians,”theAgencyforHealthcareResearchandQuality(AHRQ)reportsthatastudyin2004publishedinthejournalPediatricsdiscoveredthatmostmedicalerrorsmadebynursesand

physicianstreatingchildrenareneverreported.153,154OnFebruary17,2008,IndianaUniversitySchoolofMedicineairedarevealingradiointerview

withLaurisKaldjian,MD,PhD,oftheDept.ofInternalMedicineandPrograminBiomedicalEthicsattheUniversityofIowa’sRoyJ.andLucilleA.CarverCollegeofMedicine.Theprogramwascalled,“DoctorsDon’tReportMedicalErrors.”Aquestionisposed:

Let’ssayyou’readoctor—aheartsurgeon.Andyoumakeamistake.Maybeyouprescribethewrongmedicine.Maybeyoucutsomethingyou’renotsupposedto.Anditmightnotbeabigdeal.Butthenagain,itmight.Thequestionis:doyouadmityourmistakeandreportittothehigherups?

LaurisKaldjiandirectsthebioethicsprogramattheUniversityofIowa.Accordingtohisrecentstudy,theanswertothatquestionisprobablyno.Mostdoctorshesurveyedagreeintheorythat’sit’sagoodthingtoreportmedicalerrors.Butfewactuallydoit.155Dr.Kaldjian’sreportonmedicalerrorsappearsintheJanuary14,2008,issueoftheArchivesof

InternalMedicine.

MedicalErrorsaGlobalIssueAfive-countrysurveypublishedintheJournalofHealthAffairsfoundthat18–28%ofpeoplewho

wererecentlyillhadsufferedfromamedicalordrugerrorintheprevioustwoyears.Thestudysurveyed750recentlyilladults.Thebreakdownbycountryshowedthepercentagesofthosesufferingamedicalordrugerrorwere18%inBritain,23%inAustraliaandinNewZealand,25%inCanada,and28%intheUS.156

PublicSuggestionsonIatrogenesisInatelephonesurvey,1,207adultsrankedtheeffectivenessofthefollowingmeasuresinreducing

preventablemedicalerrorsthatresultinseriousharm.157Followingeachmeasureisthepercentageofrespondentswhorankedthemeasureas“veryeffective.”

Givingdoctorsmoretimetospendwithpatients(78%)Requiringhospitalstodevelopsystemstoavoidmedicalerrors(74%)Bettertrainingofhealthprofessionals(73%)Usingonlydoctorsspeciallytrainedinintensivecaremedicineonintensivecareunits(73%)Requiringhospitalstoreportallseriousmedicalerrorstoastateagency(71%)Increasingthenumberofhospitalnurses(69%)Reducingtheworkhoursofdoctorsintrainingtoavoidfatigue(66%)Encouraginghospitalstovoluntarilyreportseriousmedicalerrorstoastateagency(62%)

Variousinitiativesareunderwaytoaddresstheseproblems.ThePatientSafetyandQualityImprovementActof2005158“wasenactedinresponsetogrowingconcernaboutpatientsafetyintheUnitedStates....ThegoaloftheActistoimprovepatientsafetybyencouragingvoluntaryandconfidentialreportingofeventsthatadverselyaffectpatients.”159Thesuccessofthislegislationwilldependinlargepartuponthewillingnessofhealthcareproviderstorevealerrorsofcolleagues,aswellastheirowninachallengingmedicalenvironmentthatreverestheconceptofaccuracy.

AnewspecialtyinmodernmedicinethatisdevelopinginpartfromthefocusontheneedforimprovedqualityofhospitalcareisHospitalMedicine.Ittrainsphysiciansas“hospitalists”todevotethemselvestothesafetyofhospitalpatients.Thesewouldbethedoctorsreferredtoabovewhoare“speciallytrainedinintensivecaremedicineonintensivecareunits.”Thesewouldalsobethephysicianswhoaretheretorelievedoctorsintraining,whichwouldallowdoctors’shiftstobereducedinordertocombatfatigueandreduceerrors.In2009,TheAmericanBoardofHospitalMedicine(ABHM),was

foundedasthefirstboardofcertificationforHospitalMedicineinNorthAmerica.Thespecializedtrainingof“hospitalists”andtheincreaseintheirfuturenumbersmayenablethemtospendmoretimewithpatients,whichappearstobeaprioritywiththepublic.Therearealsocampaignstoincreasethenumberofhospitalnursesandtoeducatethemregardinghospitalerrors.

3ProblemswithDrugs

Prescriptiondrugsconstitutethemajortreatmentmodalityofscientificmedicine.Withthediscoveryofthe“germtheory,”medicalscientistsconvincedthepublicthatinfectiousorganismswerethecauseofillness.Findingthe“cure”fortheseinfectionsprovedmuchharderthananyoneimagined.Fromthebeginning,chemicaldrugspromisedmuchmorethantheydelivered.Butfarbeyondnotworking,thedrugsalsocausedincalculablesideeffects.Thedrugsthemselves,evenwhenproperlyprescribed,havesideeffectsthatcanbefatal,asLazarou’sstudy160showed.Buthumanerrorcanmakethesituationevenworse.

OnDecember10,2007,theheadlineread:“TheQuaidTwins‘FightingforTheirLives’:DennisandKimberlyQuaidKeepVigilasTheirNewbornsStruggletoSurviveaDevastatingHospitalErrorthatResultedinanOverdoseofBloodThinner”:

ThetwinswerehospitalizedatCedars-Sinai[MedicalCenterinL.A.]duetostaphinfections....AtthehospitalonNov.18,[2007,]theywereallegedlyamongthreepatientsgiven1,000timestherecommendeddoseofheparin,adrugusedtopreventIVcathetersfromclotting.Thedosagewashighenoughtocauseseverebleedinganddeathifleftuntreated.161Infantcare,famousparents,renownedhospital.“Howcouldsuchathinghappen?”youmayask.That

iswhatthePatientSafetyandQualityImprovementActof2005isinplacetodiscover.Drugiatrogenesismayalsoincludeanesthesia.Fatalanesthesiaerrorsstilloccur.Major

complicationsofspinalsandepiduralsincludedamagetonervesorthespinalcordbyinfection(meningitisandabscess),bleedingandbloodclots(hematoma),directdamagetothenerves(needleinjuryorchemicalinjury)andpoorbloodsupplytothespinalcord(ischemia).Allcancausepermanentnerveinjuryincludingparalysis.Afurthercomplicationoccurswhena“drugswitch”or“routeswitch”occurs:eitherthewrongdrugisdeliveredasanepiduralorspinal(drugswitch)oradrugthatshouldhavebeenadministeredintravenouslyisusedinasanepiduralorspinal,orviceversa(routeswitch).Thesensitivityofthenervoussystemandthetypeofdrugsusedmeansthesemistakescanbefatal.162

Althoughanesthesiaisconsideredverysafe,itisnotriskfree....Uncommoncomplicationsincludechestinfectionsanddifficultybreathing,damagetoteeth,lipsortongue,andawarenessundergeneralanesthesia....Therareandveryrarecomplicationsofanesthesiaincludedamagetotheeyes,seriousallergicreactionstomedications,nervedamage,equipmentfailureanddeath....

Deathscausedsolelybyanesthesiaareveryrare,andareusuallytheresultofseveralseriouscomplicationstogether[suchasallergies],yourpreviousmedicalconditions,yourbodysize,yoursurgicalprocedure,andyourhabitslikesmoking,[allofwhichmay]influencetherisksofcertaincomplications....Riskcannotbecompletelyavoided,butthecombinationofyouranesthesiaprofessional’straining,modern[sterilized]equipmentusedtodeliveranesthesiaandmonitoryourcondition,andmodernmedicationshavemadeanesthesiaamuchsaferprocedureinrecentyears.163

MedicationErrorsAsurveyofa1992nationalpharmacydatabasefoundatotalof429,827medicationerrorsin1,081

hospitals.Medicationerrorsoccurredin5.22%ofpatientsadmittedtothesehospitalseachyear.Theauthorsconcludedthatatleast90,895patientsannuallywereharmedbymedicationerrorsintheUSasawhole.164

A2002studyshowsthat20%ofhospitalmedicationsforpatientshaddosageerrors.Nearly40%oftheseerrorswereconsideredpotentiallyharmfultothepatient.Inatypical300-bedhospital,thenumberoferrorsperdaywas40.165

Problemsinvolvingpatients’medicationswereevenhigherthefollowingyear.Theerrorrateinterceptedbypharmacistsinthisstudywas24%,makingthepotentialminimumnumberofpatientsharmedbyprescriptiondrugs417,908.166

AdverseDrugReactionsTheLazaroustudy167analyzedrecordsforprescribedmedicationsfor33millionUShospital

admissionsin1994.Itdiscovered2.2millionseriousinjuriesduetoprescribeddrugs;2.1%ofinpatientsexperiencedaseriousadversedrugreaction,4.7%ofallhospitaladmissionswereduetoaseriousadversedrugreaction,andfataladversedrugreactionsoccurredin0.19%ofinpatientsand0.13%ofadmissions.Theauthorsestimatedthat106,000deathsoccurannuallyduetoadversedrugreactions.

Usingacostanalysisfroma2000studyinwhichtheincreaseinhospitalizationcostsperpatientsufferinganadversedrugreactionwas$5,483,costsfortheLazaroustudy’s2.2millionpatientswithseriousdrugreactionsamountedto$12billion.168,169

SeriousadversedrugreactionscommonlyemergeafterFDAapprovalofthedrugsinvolved.Thesafetyofnewagentscannotbeknownwithcertaintyuntiladrughasbeenonthemarketformanyyears.170

Morerecentstudiesonadversedrugreactionsshowthatthefiguresmaybeincreasing.A2003studyfollowed400patientsafterdischargefromatertiarycarehospitalsetting(requiringhighlyspecializedskills,technology,orsupportservices).Seventy-sixpatients(19%)hadadverseevents.Adversedrugeventswerethemostcommon,at66%ofallevents.Thenextmostcommoneventwasprocedure-relatedinjuries,at17%.171

InaNewEnglandJournalofMedicinestudy,analarmingoneinfourpatientssufferedobservablesideeffectsfromthemorethan3.34billionprescriptiondrugsfilledin2002.172OneofthedoctorswhoproducedthestudywasinterviewedbyReutersandcommented,“Withthese10-minuteappointments,it’shardforthedoctortogetintowhetherthesymptomsarebotheringthepatients.”173

WilliamTierney,whoeditorializedontheNewEnglandJournalstudy,wrote,“Giventheincreasingnumberofpowerfuldrugsavailabletocarefortheagingpopulation,theproblemwillonlygetworse.”Thedrugswiththeworstrecordofsideeffectswereselectiveserotoninreuptakeinhibitors(SSRIs),nonsteroidalanti-inflammatorydrugs(NSAIDs),andcalcium-channelblockers.

Reutersalsoreportedthatpriorresearchhassuggestedthatnearly5%ofhospitaladmissions(over1millionperyear)aretheresultofdrugsideeffects.Butmostofthecasesarenotdocumentedassuch.Thestudyfoundthatoneofthereasonsforthisfailureisthatinnearlytwothirdsofthecases,doctorscouldnotdiagnosedrugsideeffectsorthesideeffectspersistedbecausethedoctorfailedtoheedthewarningsigns.

In2004,theworldpharmaceuticalmarketdid$550billioninsales;theUSmarketaccountedfor48%ofthattotal,whichwas$248billion.TheUSsoldnearlyhalfoftheworld’stotalofprescriptiondrugs.174

UnderreportingofSideEffectsStandardmedicalpharmacologytextsadmitthatrelativelyfewdoctorseverreportadversedrug

reactionstotheFDA.175Thereasonsrangefromnotknowingsuchareportingsystemexiststofearofbeingsued.176Yetthepublicdependsonthistremendouslyflawedsystemofvoluntaryreportingbydoctorstoknowwhetheradrugoramedicalinterventionisharmful.

Pharmacologytextsalsowilltelldoctorshowharditistoseparatedrugsideeffectsfromdisease

symptoms.Treatmentfailureismostoftenattributedtothediseaseandnotthedrugordoctor.Doctorsarewarned,“Probablynowhereelseinprofessionallifearemistakessoeasilyhidden,evenfromourselves.”177

Itmaybehardtoaccept,butitisnotdifficulttounderstandwhyonlyoneintwentysideeffectsisreportedtoeitherhospitaladministratorsortheFDA.178

Ifhospitalsadmittedtotheactualnumberoferrorsforwhichtheyareresponsible,whichisabouttwentytimeswhatisreported,theywouldcomeunderintensescrutiny.179

JerryPhillips,associatedirectoroftheFDA’sOfficeofPostMarketingDrugRiskAssessment,confirmsthisnumber.“Inthebroaderareaofadversedrugreactiondata,the250,000reportsreceivedannuallyprobablyrepresentonly5%oftheactualreactionsthatoccur.”180Dr.JayCohen,whohasextensivelyresearchedadversedrugreactions,notesthatbecauseonly5%ofadversedrugreactionsarereported,thereareinfact5millionmedicationreactionseachyear.181

MedicatingOurFeelingsPatientsseekingamorejoyfulexistenceandrelieffromworry,stress,andanxietyarefrequently

swayedbythemessagesendlesslydisplayedonTVandbillboards.Often,insteadofgainingrelief,theyfallvictimtothemyriadiatrogenicsideeffectsofantidepressantmedication.

Moreover,awholegenerationofantidepressantusershasbeencreatedfromyoungpeoplegrowinguponRitalin®.Medicatingyoungpeopleandmodifyingtheiremotionsmusthavesomeimpactonhowtheylearntodealwiththeirfeelings.Theylearntoequatecopingwithdrugsratherthanwiththeirinnerresources.Asadults,thesemedicatedyouthreachforalcohol,drugs,orevenstreetdrugstocope.

AccordingtoJAMA,“Ritalin®actsmuchlikecocaine.”182Today’smarketingofmood-modifyingdrugssuchasProzac®andZoloft®makesthemnotonlysociallyacceptable,butalmostanecessityintoday’sstressfulworld.

YoucannotturnonTVwithouthearingapitchfordrugsforsocialanxiety,depression,orlethargy.Notethatwhentheytellyouthesideeffects,theyoftenshowapastoralsceneofbeauty,orajoyfulactivity,atthesametime,soyouwillequatetheobligatorywarningofdangerwithapleasantmemory.

Doctors(notjustconsumers)arebombardedwithpsychoactivepharmaceuticalpropaganda,sotheywillprescribecertaindrugproducts:

In2006moneyfromthepharmaceuticalindustryaccountedforabout30percentofthe[AmericanPsychiatric]Association’s$62.5millioninfinancing.Abouthalfofthatmoneywenttodrugadvertisementsinpsychiatricjournalsandexhibitsattheannualmeeting,andtheotherhalftosponsorfellowships,conferencesandindustrysymposiumsattheannualmeeting.183

TelevisionDiagnosisToreachthewidestaudiencepossible,drugcompaniesnolongersimplytargetmedicaldoctorswith

theirmarketingofantidepressants.By1995,drugcompanieshadtripledtheamountofmoneyallottedtodirectadvertisingofprescriptiondrugstoconsumers.Themajorityofthismoneyisspentonseductivetelevisionads.From1996to2000,spendingrosefrom$791milliontonearly$2.5billion.184This$2.5billionrepresentsonly15%ofthetotalpharmaceuticaladvertisingbudget.

Whilethedrugcompaniesmaintainthatdirect-to-consumeradvertisingiseducational,Dr.SidneyM.WolfeofthePublicCitizenHealthResearchGroupinWashington,DC,arguesthatthepublicoftenismisinformedabouttheseads.185Peoplewantwhattheyseeontelevisionandaretoldtogototheirdoctorsforaprescription.Doctorsinprivatepracticeeitheracquiescetotheirpatients’demandsforthesedrugsorspendvaluabletimetryingtotalkpatientsoutofunnecessarydrugs.

Dr.Wolferemarksthatoneimportantstudyfoundthatpeoplemistakenlybelievethatthe“FDA

reviewsalladsbeforetheyarereleasedandallowsonlythesafestandmosteffectivedrugstobepromoteddirectlytothepublic.”186

In2004,pharmaceuticalmanufacturersspentanestimated$4.15billionondirect-to-consumeradvertising,accordingtoIMSHealth.187Therearethosewhosurmisethatconsumersarepayingfortheseexpensiveadswhentheybuymedicationsthatcostmuchmorethantheyareworth.

Afindingofanationalsurveyof643physiciansbyHarvard’sDr.JoelWeissman,etal.,foundthat“direct-to-consumeradvertising(DTCA)ledpatientstoseekunnecessarytreatments.”188

In2004,Americansspent$188.5billiononprescriptionmedications,whichwasmorethan4½timesthe$40.3billionspentin1990.189

Dr.DavidGrahamoftheFDA’sCenterforDrugEvaluationandResearchwarns:Direct-to-consumeradvertisingingeneralisagreatdisservicetotheAmericanpeople.Wesee

wonderfuladsofpeopledemonstratingtheirhealth,whetherthey’reskatingacrosstheiceordoingtheirTaiChi.MadisonAvenueknowsthatapictureisworthathousandwords,sotheyconveyanimage,amessage,anditmakesanimpressiononpatientsandonphysicians.Itcreatesneedsordesireswheretherereallyisn’taneedoradesire.

TherewasarecentstudyintheJournalofTheAmericanMedicalAssociationthatshowedthatifpatientsmentionedadrugthatthey’veseenontelevisiontotheirphysiciantheyweremuchmorelikelytobeprescribedthatdrugbythedoctor.Drugcompaniesknowthis.That’swhytheydoit....Clearly,direct-to-consumeradvertisingdoesnotservetheAmericanpeoplewell.190

HowDoWeKnowDrugsAreSafe?Anotheraspectofscientificmedicinethatthepublictakesforgrantedisthetestingofnewdrugs.

Drugsgenerallyaretestedonindividualswhoarefairlyhealthyandnotonothermedicationsthatcouldinterferewithfindings.Butwhenthesenewdrugsaredeclared“safe”andenterthedrugprescriptionbooks,theyarenaturallygoingtobeusedbypeoplewhoareonavarietyofothermedicationsandhavealotofotherhealthproblems.Thenanewphaseofdrugtestingcalled“post-approval”comesintoplay,whichisthedocumentationofsideeffectsoncedrugshitthemarket.

Inoneverytellingreport,thefederalgovernment’sGeneralAccountabilityOffice“foundthatofthe198drugsapprovedbytheFDAbetween1976and1985...102(or51.5%)hadseriouspost-approvalrisks....Theseriouspost-approvalrisks[included]heartfailure,myocardialinfarction,anaphylaxis,respiratorydepressionandarrest,seizures,kidneyandliverfailure,severeblooddisorders,birthdefectsandfetaltoxicity,andblindness.”191

NBCNews’sinvestigativeshowDatelinewonderedifyourdoctorismoonlightingasadrugcompanyrepresentative.Afterayear-longinvestigation,NBCreportedthatbecausedoctorscanlegallyprescribeanydrugtoanypatientforanycondition,drugcompaniesheavilypromote“off-label”—thatis,frequentlyinappropriateanduntestedusesofthesemedications—eventhoughthesedrugsareapprovedonlyforthespecificindicationsforwhichtheyhavebeentested.192

Theleadingcausesofadversedrugreactionsareantibiotics(17%),cardiovasculardrugs(17%),chemotherapy(15%),andanalgesicsandanti-inflammatoryagents(15%).193

DrugsPolluteOurWaterSupplyWehavereachedthepointofsaturationwithprescriptiondrugs.Everybodyofwatertestedcontains

measurabledrugresidues.Thetonsofantibioticsusedinanimalfarming,whichrunoffintothewatertableandsurroundingbodiesofwater,areconferringantibioticresistancetogermsinsewage,andthesegermsalsoarefoundinourwatersupply.Flusheddownourtoiletsaretonsofdrugsanddrugmetabolitesthatalsofindtheirwayintoourwatersupply.Wehavenowaytoknowthelong-termhealthconsequences

ofingestingamixtureofdrugsanddrug-breakdownproducts.Thesedrugsrepresentanotherlevelofiatrogenicdiseasethatweareunabletocompletelymeasure.194–202

DrugCompaniesFinedPeriodically,theFDAfinesadrugmanufacturerwhenitsabusesaretooglaringandimpossibleto

coverup.InMay2002,theWashingtonPostreportedthatSchering–PloughCorp.,themakerofClaritin®,wastopaya$500millionfinetotheFDAforquality-controlproblemsatfourofitsfactories.203TheindictmentcameafterthePublicCitizenHealthResearchGroup,ledbyDr.SidneyWolfe,calledforacriminalinvestigationofSchering–Plough,chargingthatthecompanydistributedalbuterolasthmainhalerseventhoughitknewtheunitsweremissingtheactiveingredient.

TheFDAtabulatedinfractionsinvolving125products,or90%ofthedrugsmadebySchering-Ploughsince1998.Besidespayingthefine,thecompanywasforcedtohaltthemanufactureof73drugsorsufferanother$175millionfine.Schering–Plough’snewsreleasestoldanotherstory,assuringconsumersthattheyshouldstillfeelconfidentinthecompany’sproducts.

ThislargesettlementservedasawarningtothedrugindustryaboutmaintainingstrictmanufacturingpracticesandhasgiventheFDAmorecloutindealingwithdrugcompanycompliance.AccordingtotheWashingtonPostarticle,afederalappealscourtruledin1999thattheFDAcouldseizetheprofitsofcompaniesthatviolate“goodmanufacturingpractices.”Sincethattime,AbbottLaboratorieshaspaida$100millionfineforfailingtomeetqualitystandardsintheproductionofmedicaltestkits,whileWyethLaboratoriespaid$30millionin2000tosettleaccusationsofpoormanufacturingpractices.

4ProblemswithSpecificClassesofDrugs

Antibiotics

AccordingtoWilliamAgger,MD,directorofmicrobiologyandchiefofinfectiousdiseaseatGundersenLutheranMedicalCenterinLaCrosse,WI,30millionpoundsofantibioticsareusedinAmericaeachyear.204Ofthisamount,25millionpoundsareusedinanimalhusbandryand23millionpoundsareusedtotrytopreventdiseaseandpromotegrowth.Only2millionpoundsaregivenforspecificanimalinfections.Dr.Aggerremindsusthatlowconcentrationsofantibioticsaremeasurableinmanyofourfoodsandinvariouswaterwaysaroundtheworld,muchofitseepinginfromanimalfarms.

Aggercontendsthatoveruseofantibioticsresultsinfood-borneinfectionsthatareresistanttoantibiotics.Salmonellaisfoundin20%ofgroundmeat,buttheconstantexposureofcattletoantibioticshasmade84%ofsalmonellaresistanttoatleastoneantisalmonellaantibiotic.Diseasedanimalfoodaccountsfor80%ofsalmonellosisinhumans,or1.4millioncasesperyear.Theconventionalapproachtocounteringthisepidemicistoradiatefoodtotrytokillallorganismswhilecontinuingtousetheantibioticsthatcreatedtheprobleminthefirstplace.Approximately20%ofchickensarecontaminatedwithCampylobacterjejuni,anorganismthatcauses2.4millioncasesofillnessannually.Fifty-fourpercentoftheseorganismsareresistanttoatleastoneanti-Campylobacterantimicrobialagent.

Denmarkbannedgrowth-promotingantibioticsbeginningin1999,whichcuttheirusebymorethanhalfwithinayear,from453,200to195,800pounds.AreportfromScandinaviafoundthatremovingantibioticgrowthpromotershadnoorminimaleffectonfoodproductioncosts.Aggerwarnsthatthecurrentcrowded,unsanitarymethodsofanimalfarmingintheUSsupportconstantstressandinfection,andaregearedtowardhighantibioticuse.

IntheUS,over3millionpoundsofantibioticsareusedeveryyearonhumans.Withapopulationof284millionAmericans,thisamountisenoughtogiveeveryman,woman,andchild10teaspoonsofpureantibioticsperyear.AggersaysthatexposuretoasteadystreamofantibioticshasalteredpathogenssuchasStreptococcuspneumoniae,Staphylococcusaureus,andvariousEnterococci,tonameafew.

AlmosthalfofpatientswithupperrespiratorytractinfectionsintheUSstillreceiveantibioticsfromtheirdoctors,205whichisinappropriateinmostcases.InGermany,theprevalenceofsystemicantibioticuseinchildrenaged0–6yearswas42.9%.206

DataobtainedfromnineUShealthinsurersonantibioticusein25,000childrenfrom1996to2000foundthatratesofantibioticusedecreased.Antibioticuseinchildrenagedthreemonthstounderthreeyearsdecreased24%,from2.46to1.89antibioticprescriptionsperpatientperyear.Forchildrenagedthreetoundersixyears,therewasa25%reduction,from1.47to1.09antibioticprescriptionsperpatientperyear.Andforchildrenaged6tounder18years,therewasa16%reduction,from0.85to0.69antibioticprescriptionsperpatientperyear.207Despitethesereductions,thedataindicatethatonaverage,everychildinAmericareceives1.22antibioticprescriptionsannually.

GroupAbeta-hemolyticstreptococciistheonlycommoncauseofsorethroatthatrequiresantibiotics,withpenicillinanderythromycintheonlyrecommendedtreatment.Ninetypercentofsorethroatcases,however,areviral.Antibioticswereusedin73%oftheestimated6.7millionadultannualvisitsforsorethroatintheUSbetween1989and1999.Furthermore,patientstreatedwithantibioticswereprescribednon-recommendedbroad-spectrumantibioticsin68%ofvisits.Thisperiodsawasignificantincreaseintheuseofnewer,moreexpensivebroad-spectrumantibioticsandadecreaseinuse

oftherecommendedantibioticspenicillinanderythromycin.208Antibioticsbeingprescribedin73%ofsorethroatcasesinsteadoftherecommended10%resultedinatotalof4.2millionunnecessaryantibioticprescriptionsforsorethroatsalonefrom1989to1999.

InSeptember2003,theCDCre-launchedaprogramstartedin1995called“GetSmart:KnowWhenAntibioticsWork.”209This$1.6millioncampaignisdesignedtoeducatepatientsabouttheoveruseandinappropriateuseofantibiotics.Mostpeopleinvolvedwithalternativemedicinehaveknownaboutthedangersofantibioticoverusefordecades.Finally,thegovernmentisfocusingontheproblem,yetitisspendingonlyaminisculeamountofmoneyonaniatrogenicepidemicthatiscostingbillionsofdollarsandthousandsoflives.TheCDCwarnsthat90%ofupperrespiratoryinfections,includingchildren’searinfections,areviralandthatantibioticsdonottreatviralinfection.Morethan40%ofprescriptionsforantibioticswritteneachyearinphysicians’officesareinappropriate.210,211Usingantibioticswhennotneededcanleadtothedevelopmentofdeadlystrainsofbacteriathatareresistanttodrugs.212

TheCDC,however,seemstobeblamingpatientsformisusingantibioticseventhoughtheyareavailableonlybyprescriptionfromphysicians.AccordingtoDr.RichardBesser,thenheadofthe“GetSmart”programtoeducatepatientsaboutproperantibioticuse,“Programsthathavejusttargetedphysicianshavenotworked.Direct-to-consumeradvertisingofdrugsistoblameinsomecases.”Bessersaystheprogram“teachespatientsandthegeneralpublicthatantibioticsarepreciousresourcesthatmustbeusedcorrectlyifwewanttohavethemaroundwhenweneedthem.Hopefully,asaresultofthiscampaign,patientswillfeelmorecomfortableaskingtheirdoctorsforthebestcarefortheirillnesses,ratherthanaskingforantibiotics.”213

Whatconstitutesthe“bestcare”?TheCDCdoesnotelaborateandignoresthelatestresearchonthedozensofnutraceuticalsthathavebeenscientificallyproventotreatviralinfectionsandboostimmune-systemfunction.Willdoctorsrecommendgarlic,vitaminC,lactoferrin,elderberry,vitaminA,zinc,orDHEA?Probablynot.TheCDC’scommonsenserecommendationsthatmostpeoplefollowanywayincludegettingproperrest,drinkingplentyoffluids,andusingahumidifier.

Thepharmaceuticalindustryclaimsitsupportslimitingtheuseofantibiotics.ThedrugcompanyBayersponsorsaprogramcalled“OperationCleanHands”throughanorganizationcalledLIBRA.214TheCDCalsoisinvolvedintryingtominimizeantibioticresistance,butnowhereinitspublicationsisthereanyreferencetotheroleofnutraceuticalsinboostingtheimmunesystem,ortothethousandsofjournalarticlesthatsupportthisapproach.Thistunnelvisionandrefusaltorecommendtheavailablenon-drugalternativesisunfortunatewhentheCDCisdesperatelytryingtocurbtheoveruseofantibiotics.

TheAHRQreportsthatcurrently,“ThemostcommonHAI[healthcare-associatedinfection]agentismethicillin-resistantStaphylococcusaureus(MRSA).”215

NSAIDSItisnotonlytheUSthatisplaguedbyiatrogenesis.Asurveyofmorethan1,000Frenchgeneral

practitioners(GPs)testedtheirbasicpharmacologicalknowledgeandpracticeinprescribingNSAIDs,whichrankfirstamongcommonlyprescribeddrugsforseriousadversereactions.ThestudyresultssuggestthatGPsdonothaveadequateknowledgeofthesedrugsandareunabletoeffectivelymanageadversereactions.216

Across-sectionalsurveyof125patientsattendingspecialtypainclinicsinSouthLondonfoundthatpossibleiatrogenicfactorssuchas“over-investigation,inappropriateinformation,andadvicegiventopatientsaswellasmisdiagnosis,over-treatment,andinappropriateprescriptionofmedicationwerecommon.”217

In2003,J.S.Hochman,MD,ExecutiveDirectoroftheNationalFoundationfortheTreatmentofPain,referringtoNSAID-relateddeathsasa“silentepidemic,”wrote:

Ithasbeenestimatedconservativelythat16,500NSAID-relateddeathsoccuramongpatientswithrheumatoidarthritisorosteoarthritiseveryyearintheUnitedStates.Thisfigureissimilartothenumberofdeathsfromtheacquiredimmunodeficiencysyndromeandconsiderablygreaterthanthenumberofdeathsfrommultiplemyeloma,asthma,cervicalcancer,orHodgkin’sdisease.218Over66,000peoplewerekilledovera10-yearperiodduringtheVietnamWar.Morepeopleare

killedbyNSAIDsinoneyear(16,500deaths)thanwerekilledinanytwoyearsoftheVietnamWar.Intenyears,NSAIDSkills165,000people.NSAIDSkills2.5timesasmanypeopleinaten-yearperiodaswerekilledinthetenyearsoftheVietnamWar.

In2003,theBritishMedicalJournalwarnedthatwomenwhotookNSAIDs—“painkillerslikeAdvil®,Motrin®,andNaprosyn®—hadan80percenthigherriskofmiscarriagethanwomenwhoavoidedthesemedications.”219“Theriskincreasedifsuchpainkillersweretakenshortlybeforeorafterconception,orforlongerthanoneweek.”220

OnSeptember30,2004,Merckannounced“avoluntaryworldwidewithdrawalofVioxx®(Rofecoxib),itsarthritisandacutepainmedication.”MerckannouncesvoluntaryworldwidewithdrawalofVioxx®221“duetosafetyconcernsofanincreasedriskofcardiovascularevents(includingheartattackandstroke)inpatientsonrofecoxib.RofecoxibisaprescriptionCOX-2selective,non-steroidalanti-inflammatorydrug(NSAID)thatwasapprovedbytheFDAinMay1999.”222“Itwaslaterapprovedforthereliefofthesignsandsymptomsofrheumatoidarthritisinadultsandchildren.”223Thismeansthatchildrenwereexposedtothisdangerousdrug.

TheLancetcarriedthefollowingarticleinitsfirstissueofDecember2004,“Riskofcardiovasculareventsandrofecoxib:cumulativemeta-analysis,”whichfindsthat“rofecoxibshouldhavebeenwithdrawnseveralyearsearlier.Thereasonswhymanufactureranddruglicensingauthoritiesdidnotcontinuouslymonitorandsummarizetheaccumulatingevidenceneedtobeclarified.”224

TheNSAID“Vioxx®waswithdrawnafterevidencecametolightthatitalmostdoubledtheriskofheartattacksandstrokeinpeoplewhohadbeentakingitfor18months.”225FDAresearcherDr.DavidGraham,testifyingbeforetheUSSenate,estimated88,000to138,000AmericanshadheartattacksorstrokesasasideeffectfromVioxx®.“Ofthese,”Grahamsaid,“30–40%probablydied.”226“Thatwouldbeanestimated27,000to55,000preventabledeathsattributedtoVioxx®.”227

Dr.GrahamcontinueshisSenatetestimony,“Iftherewereanaverageof150to200peopleonanaircraft,thisrangeof88,000to138,000wouldbetheroughequivalentof500to900aircraftdroppingfromthesky.Thistranslatesto2–4aircrafteveryweek,weekinandweekout,forthepast5years.”228

CancerChemotherapyIn1989,GermanbiostatisticianUlrichAbel,PhD,wroteamonographentitled“Chemotherapyof

AdvancedEpithelialCancer.”Itwaslaterpublishedinshorterforminapeer-reviewedmedicaljournal.229Abelpresentedacomprehensiveanalysisofclinicaltrialsandpublicationsrepresentingover3,000articlesexaminingthevalueofcytotoxicchemotherapyonadvancedepithelialcancer.

Epithelialcanceristhetypeofcancerwithwhichwearemostfamiliar,arisingfromepitheliumfoundintheliningofbodyorganssuchasthebreast,prostate,lung,stomach,andbowel.Fromthesesites,cancerusuallyinfiltratesadjacenttissueandspreadstothebone,liver,lung,orbrain.Withhisexhaustivereview,Abelconcludedthereisnodirectevidencethatchemotherapyprolongssurvivalinmostpatientswithadvancedcarcinoma.

AccordingtoAbel,“Manyoncologiststakeitforgrantedthatresponsetotherapyprolongssurvival,anopinionwhichisbasedonafallacyandwhichisnotsupportedbyclinicalstudies.”OveradecadeafterAbel’sexhaustivereviewofchemotherapy,thereseemsnodecreaseinitsuseforadvancedcarcinoma.Forexample,whenconventionalchemotherapyandradiationhavenotworkedtoprevent

metastasesinbreastcancer,high-dosechemotherapy(HDC)alongwithstem-celltransplant(SCT)isthetreatmentofchoice.InMarch2000,however,resultsfromthelargestmulti-centerrandomizedcontrolledtrialconductedthusfarshowedthat,comparedtoaprolongedcourseofmonthlyconventional-dosechemotherapy,HDCandSCTwereofnobenefit,230withevenaslightlylowersurvivalratefortheHDC/SCTgroup.

SeriousadverseeffectsoccurredmoreoftenintheHDCgroupthaninthestandard-dosegroup.Onetreatment-relateddeath(within100daysoftherapy)wasrecordedintheHDCgroup,butnonewasrecordedintheconventionalchemotherapygroup.Thewomeninthistrialwerehighlyselectedashavingthebestchancetorespond.

Unfortunately,noall-encompassingfollow-upstudysuchasDr.Abel’sexiststoindicatewhethertherehasbeenanyimprovementincancer-survivalstatisticssince1989.Infact,researchshouldbeconductedtodeterminewhetherchemotherapyitselfisresponsibleforsecondarycancersinsteadofprogressionoftheoriginaldisease.Wecontinuetoquestionwhywell-researchedalternativecancertreatmentsarenotused.

Untilnow,theextenttowhichchemotherapytorturesyoungpatients,formerlythoughttobestrongenoughtowithstandthetoxicity,wasunknown.

OnAugust16,2006,HarvardMedicalSchool-affiliatedDrs.MichaelJ.Hassett,A.JamesO’Malley,JulianaR.Pakes,JosephP.Newhouse,andCraigC.Earlepublished,“FrequencyandCostofChemotherapy-RelatedSeriousAdverseEffectsinaPopulationSampleofWomenWithBreastCancer”intheJournaloftheNationalCancerInstitute.231Theauthorsacknowledgethat“breastcanceristhemostcommonindicationforchemotherapyamongwomenintheUnitedStates,andchemotherapydrugsaretheleadingcauseofseriousdrug-relatedadverseeffectsamongwomenwithbreastcancer,”buttheauthorssuggestthatstudiesinolderwomencannotbeextrapolatedtothegeneralpopulation.This,therefore,isthefirststudyofchemotherapy-relatedseriousadverseeffectsinapopulation-basedsampleofyoungerwomenwithbreastcancer.12,239women63yearsofageoryoungerwithnewlydiagnosedbreastcancerparticipatedinthestudy.(“Adrug-relatedseriousadverseeffecthasbeendefinedasanyuntowardmedicaloccurrencethatisrelatedtodruguseandresultsindeathorsignificantdisability/incapacity,requireshospitaladmissionorprolongationofexistinghospitalstay,orislifethreatening.”)Severaloftheadverseeffectsare:

dehydrationorelectrolytedisorders(potentiallyfatal);fatigue;dizziness;nausea;diarrhea;emesis;bronchitis(potentiallyfatal);pneumonia(potentiallyfatal);flu(potentiallyfatal);kidneyinfection(potentiallyfatal);otherinfections(potentiallyfatal);shock(potentiallyfatal);fever;malnutrition;anemia(potentiallyfatal);deep-veinthrombosisorpulmonaryembolism(potentiallyfatal);fracturesanddislocations;

emphysema(potentiallyfatal);asthma(potentiallyfatal);renalfailure(potentiallyfatal);thyroiddisorders,includinggoiter(potentiallyfatal);andheadaches,includingmigraines.

Priortothisstudy,itwasbelievedthatwomenoverage65couldbeexpectedtohavecomorbidconditionsthatwouldmakethemmoresusceptibletoadversesideeffectsofchemotherapy,butthattheyoungerpopulationcouldsurvivethetoxicity.Theauthorsconcludethat“breastcancerchemotherapymaycausemorepatientsufferingandhigherhealthcarecoststhanpreviouslyestimated.”232

Theyemphasizethatclinicaltrialsofnewdrugsareofteninadequatetoaccuratelyshowexperiencesofthegeneralpopulation.Theywarn:

Althoughclinicaltrialsofnewdrugtherapiesprovidesomeinformationregardingthenumberandnatureofseriousadverseeffects,reportsofthesecomplicationsarefrequentlyinadequateandmaynotaccuratelyreflecttheexperiencesofthegeneralpopulation.Indeed,recentandwidelypublicizedcaseshavedemonstratedthatseriousadverseeffectsthatarenotfullyappreciatedduringearlyclinicaltrialscanappearafteradrugisapprovedbytheUSFoodandDrugAdministration(FDA)andusedbythepublic.Infact,onestudyofseriousadverseeffectsidentifiedafterFDAapprovalfoundthat22cancerdrugshadbeenlinkedwith25seriousadverseeffectsbetween2000and2002.233Theauthorsconcludethattheirfindings“haveimportantimplicationsforqualityoflifeandcould

affectdecisionsregarding[risksof]therapy.”A2004pioneeroverviewstudy,“TheContributionofCytotoxicChemotherapyto5-yearSurvivalin

AdultMalignancies,”byDrs.GraemeMorgan,RobynWard,andMichaelBartoninClinicalOncologyreportsthat“Theoverallcontributionofcurativeandadjuvantcytotoxicchemotherapyto5-yearsurvivalinadultswasestimatedtobe...2.1%intheUSA.”234Thatis,only2.1%ofpatientstreatedwithcytotoxicchemotherapyforvariousmalignanciessurvivefor5yearsasaresultofchemotherapy.Theynotethattheirestimateofbenefitisstatisticallygenerous,usingthe“upperlimitofeffectiveness,”and“thebenefitofcytotoxicchemotherapymayhavebeenoverestimatedforcancersofesophagus,stomach,rectum,andbrain.”Theauthorsreferto“theminimalimpactofcytotoxicchemotherapyon5-yearsurvival,andthelackofanymajorprogressoverthelast20years.”

5AnHonestLookattheFailuresofAmericanHealthcare

UnnecessarySurgicalProcedures

In1974,2.4millionunnecessarysurgerieswereperformed,resultingin11,900deathsatacostof$3.9billion.235,236In2001,7.5millionunnecessarysurgicalprocedureswereperformed,resultingin37,136deathsatacostof$122billion(using1974dollars).237,238

Itisverydifficulttoobtainaccuratestatisticswhenstudyingunnecessarysurgery.In1989,Leapewrotethatperhaps30%ofcontroversialsurgeries—whichincludecesareansection,tonsillectomy,appendectomy,hysterectomy,gastrectomyforobesity,breastimplants,andelectivebreastimplants239—areunnecessary.

In1974,theCongressionalCommitteeonInterstateandForeignCommerceheldhearingsonunnecessarysurgery.Itfoundthat17.6%ofrecommendationsforsurgerywerenotconfirmedbyasecondopinion.TheHouseSubcommitteeonOversightandInvestigationsextrapolatedthesefiguresandestimatedthat,onanationwidebasis,therewere2.4millionunnecessarysurgeriesperformedannually,resultingin11,900deathsatanannualcostof$3.9billion.240

AccordingtotheHealthcareCostandUtilizationProjectintheAgencyforHealthcareResearchandQuality,241in2001the50mostcommonmedicalandsurgicalprocedureswereperformedapproximately41.8milliontimesintheUS.Usingthe1974HouseSubcommitteeonOversightandInvestigations’figureof17.6%asthepercentageofunnecessarysurgicalprocedures,andextrapolatingfromthedeathratein1974,therewerenearly7.5million(7,489,718)unnecessaryproceduresandadeathrateof37,136,atacostof$122billion(using1974dollars).In1995,researchersconductedasimilaranalysisofbacksurgeryprocedures,usingthe1974“unnecessarysurgerypercentage”of17.6%.TestifyingbeforetheDepartmentofVeteransAffairs,theyestimatedthatofthe250,000backsurgeriesperformedannuallyintheUSatahospitalcostof$11,000perpatient,thetotalnumberofunnecessarybacksurgeriesapproaches44,000,costingasmuchas$484million.242

Likeprescriptiondrugusedrivenbytelevisionadvertising,unnecessarysurgeriesareescalating.Media-drivensurgerysuchasgastricbypassforobesity“modeled”byHollywoodcelebritiesseducesobesepeopleintothinkingthisrouteissafeandsexy.

UnnecessarysurgerieshaveevenbeenmarketedontheInternet.243AstudyinSpaindeclaresthat20–25%oftotalsurgicalpracticerepresentsunnecessaryoperations.244AccordingtodatafromtheNationalCenterforHealthStatisticsfor1979to1984,thetotalnumberofsurgicalproceduresincreased9%whilethenumberofsurgeonsgrew20%.Thestudynotesthatthelargeincreaseinthenumberofsurgeonswasnotaccompaniedbyaparallelincreaseinthenumberofsurgeriesperformed,andexpressedconcernaboutanexcessofsurgeonstohandlethesurgicalcaseload.245

From1983to1994,however,theincidenceofthetenmostcommonlyperformedsurgicalproceduresjumped38%,to7,929,000from5,731,000cases.By1994,cataractsurgerywasthemostcommonprocedure,withmorethantwomillionoperations,followedbycesareansection(858,000procedures)andinguinalherniaoperations(689,000procedures).Kneearthroscopyproceduresincreased153%whileprostatesurgerydeclined29%.246

Thelistofiatrogeniccomplicationsfromsurgeryisaslongasthelistofproceduresthemselves.Onestudyexaminedcathetersthatwereinsertedtodeliveranestheticintotheepiduralspacearoundthespinal

nervesforlowercesareansection,abdominalsurgery,orprostatesurgery.Insomecases,non-steriletechniqueduringcatheterinsertionresultedinseriousinfections,evenleadingtolimbparalysis.247

Inonereviewoftheliterature,theauthorsfound“asignificantrateofoverutilizationofcoronaryangiography,coronaryarterysurgery,cardiacpacemakerinsertion,uppergastrointestinalendoscopies,carotidendarterectomies,backsurgery,andpain-relievingprocedures.”248

A1987JAMAstudyfoundthefollowingsignificantlevelsofinappropriatesurgery:17%ofcoronaryangiographyprocedures,32%ofcarotidendarterectomyprocedures,and17%ofuppergastrointestinaltractendoscopyprocedures.249

BasedontheHealthcareCostandUtilizationProject(HCUP)statisticsprovidedbythegovernmentfor2001,697,675uppergastrointestinalendoscopies(usuallyentailingbiopsy)wereperformed,aswere142,401endarterectomiesand719,949coronaryangiographies.250

ExtrapolatingtheJAMAstudy’sinappropriatesurgeryratesto2001produces118,604unnecessaryendoscopyprocedures,45,568unnecessaryendarterectomies,and122,391unnecessarycoronaryangiographies.Theseareallformsofmedicaliatrogenesis.

Whilesome12,000deathsoccureachyearfromunnecessarysurgeries,resultsfromthefewstudiesthathavemeasuredunnecessarysurgerydirectlyindicatethatforsomehighlycontroversialoperations,theproportionofunwarrantedsurgeriescouldbeashighas30%.251

HighMortalityRatesItisinstructivetoknowthemortalityratesassociatedwithvariousmedicalandsurgicalprocedures.

Althoughwemustsignreleaseformswhenweundergoanyprocedure,manyofusareindenialaboutthetruerisksinvolved;becausemedicalandsurgicalproceduresaresocommonplace,theyoftenareseenasbothnecessaryandsafe.Unfortunately,allopathicmedicineitselfisaleadingcauseofdeath,aswellasthemostexpensivewaytodie.

Perhapsthewords“healthcare”confertheillusionthatmedicineisabouthealth.Allopathicmedicineisnotapurveyorofhealthcarebutofdiseasecare.TheHCUPfiguresareinstructive,252butthecomputerprogramthatcalculatesannualmortalitystatisticsforallUShospitaldischargesisonlyasgoodasthecodesenteredintothesystem.Inemailcorrespondence,HCUPindicatedthatthemortalityratesforeachprocedureindicatedonlythatsomeoneundergoingthatprocedurediedeitherfromtheprocedureorfromsomeothercause.

Thus,thereisnowayofknowingexactlyhowmanypeoplediefromaparticularprocedure.Whilecodesfor“poisoningandtoxiceffectsofdrugs”and“complicationsoftreatment”doexist,themortalityfiguresregisteredinthesecategoriesareverylowanddonotcorrelatewithwhatisknownfromresearchsuchasthe1998JAMAstudy253thatestimatedanaverageof106,000prescriptionmedicationdeathsperyear.Nocodesexistforadversedrugsideeffects,surgicalmishaps,orothertypesofmedicalerror.Untilsuchcodesexist,thetruemortalityratestiedtomedicalerrorwillremainburiedinthegeneralstatistics.

AstudysupportedbytheAgencyforHealthcareResearchandQualitythatanalyzeddatafromnearly3millionoperationsbetween1985and2004foundthat1in112,994surgeriesoccurredatthewrongsurgicalsite.Otherstudieshavereportedincidenceratesuptofivetimeshigher,andbecausenotallsentineleventsarereported,thesefiguresarelikelyunderestimated....

Wrong-sitesurgeryresultsindevastatingconsequencesforthepatientintermsofmorbidityandmortality,aswellasnegativefinancialconsequencesforsurgeonsandhospitals.Forexample,studieshaveshownthat79percentofwrong-siteeyesurgeriesand84percentofwrong-siteorthopedicsurgeriesresultinmalpracticeclaims.254Since2004,surgeonshavebeenrequiredbytheJointCommission[UniversalProtocolfor

PreventingWrongSite,WrongProcedure,WrongPersonSurgery]*tomarkthesurgicalsitewhile

consultingwiththepatientbeforesurgery.Nevertheless,wrong-sitesurgeriespersistatlowbutunacceptablerates,leadingtodevastatingconsequencesforthoseaffected.Wrong-sitesurgeriesoccurduetoalackofformalsystemsthatensurecompliancewithsurgicalsitemarkingrequirements.255

WrongSite,WrongProcedure,WrongPersonSurgeryisnottheonlyiatrogenicsurgerythatcaninducedeath.TheOfficeoftheChiefMedicalExaminerofNewYorkCityhadamortuarymuseumstarted,inpart,forthepurposeofmedicaleducationandiatrogenicreformbyinnovativeNYCChiefMedicalExaminerMiltonHelpern,MD(CME1954–1973),basedonautopsiesperformedthere.(ThismuseumwaslatertransferredtotheArmedForcesInstituteofPathologyinWashington,DC).

Thereisaparticularlychillingexhibitinthiscollection.Itissimplyasurgicalclampandalargesurgicalgauzepad,withadescriptivecasecard.Thisisatruemedicalhistory.Athirty-five-year-oldwomanenteredahospitalinNewYorkforanappendectomy.Postoperativerecoverywasuneventful,andshewasdischargedtogohomeontheeighthdayafterheroperation.Thenextmorningshephonedhersurgeontocomplainaboutabdominalcramps.Heprescribedroutinemildmedication,reassuringherthattherewasnothingtoworryabout.Whenthepainpersisted,sheconsultedaseconddoctor,whodiagnosedan“acuteintestinalobstruction,”andadmittedhertoanotherhospitalasanemergencycase.Thesecondhospitalwasfarawayfromthefirst,andadifferentsurgeonperformingthesecondoperationdiscoveredthatthefirstsurgeonhadfailedtoremoveasurgicalclampfromthepatient’sabdomen.Somecoilsofthesmallintestinehadbecomeentwinedwiththeclamp,resultingingangrene.Thesecondsurgeonremovedthegangrenoussectionofintestine,sewedtogetherthetwohealthyends,andclosedthatincision.256

Thepatient’spostoperativecourseafterthesecondsurgerywasmarkedbyfailureoftheincisionwoundtoheal,withaccompanyingfever.Adiagnosisofperitonitiswasmade.The“wonder”drugswerenotyetinuse;intwodaysthepatientwasdead.Thecauseofdeathregisteredbythemedicalexaminer’sofficewas“septicperitonitisduetothepresenceofaforeignbody.”Theautopsyhadrevealedthatthesecondsurgeoninthesecondhospitalhadleftalargesurgicalgauzepadintheabdominalcavityduringtheoperationthathewasperformingtoremovethemetalclampthathadbeenleftbythefirstnegligentsurgeon.Surgicalmalpracticehasbeendocumentedformanyyears,butithasnotbeeneliminated.

Ifyouthinkthatmightjustbeasurgicalhorrorstorythatcannotoccurtoday,thenyoumaybeunfamiliarwithcurrentmedicalmalpracticecaselaw.TheJanuary2009articleonInjuryBoard.com,“VirginiaHasSpecialMedicalMalpracticeLawonRetainedSurgicalTowels,”states,“Obviouslythehospitalanddoctorarenotsupposedtoleavethingsinyou,butitisnotuncommonfortheseretainedsurgicaldevicecasestoarise.”257

Oftenthepatientwillgomonthsifnotlongerbeforecomingtorealizethattheyhavesomemedicalequipmentlikeasurgicaltowelorlapspongestillinsidetheirabdomenafteranoperation.Whattypicallyhappensisthattheobjectbecomesinfectedorblocksupsomebodilyfunctioncausingpain.EventuallythepatientwillgetanX-rayorotherdiagnostictestwhichwillshowthatsomethingforeignisinsidetheirbodycavity.Realizingthattherewasnotaproperaccountingofmedicalsuppliesdoneintheoperatingroommaytakesometime.

Thesurgeonwilltypicallyblamethehospitalstafffortheirfailuretodothetowelandspongecountandtheywillinturnpointthefingerbackathimforbeingthecaptainoftheshipwholetsomethingbadhappenonhiswatchandunderhiscommand.Bothhealthcareproviderswilltrytosaythatmaybethepatientherselfdidsomethingwrongorisn’tashurtassheclaimsdespitewhatistypicallyaverybadperiodofpainandtheneedforatleastonemoreoperationtogoinandremovethesurgicaltowelorspongefromthepatient’sbody.258AndthePhiladelphiaEnquirerrecentlyreported:

AmedicalteamleftbehindanunwantedmementoinDonaldGable’schest...:atwo-foot-longguidewire.“Iwasflabbergasted,”saidGable,whodevelopedabloodclotandhadtobe

hospitalizedagainafterthewirewasremoved.“Thatthingcouldhavepenetratedmyvein,andIcouldhavebledtodeath.”

DoctorsreviewedtheX-raysatleastsixtimesbeforehisdischargeanddidnotspotthewire,accordingtoGable’ssuit.AdoctordiscoveredthewirewhenGablereturnedforaroutinefollow-up.

About80timesayearinthePhiladelphiaregion[alone],thetoolsofsurgery—gauze,scalpels,needles,retractorsandthelike—arefoundleftbehindinpatients.

Awomansetoffanairportmetaldetectorin2002becauseofa...ruler-lengthinstrumentleftinsideherabdomen.“Thereisabsolutelynoreasonforthesetooccur,”saidPhiladelphialawyerPaulLauricella,whowona$2.5millionverdictinaforeign-bodycaseagainstFrankfordHospital....A15-inch-squaretowelhadbeenleftinhisclient’sabdomenforthreeweeks.“Allyouhavetodo[topreventthem]isbeabletocount.”

Gauzepadsthatsopupblood—themostcommonitemsleftbehind—havebeentaggedwithaspecialstripsincethemid-1950s,makingthemstandoutonX-rays.SeveralareasurgeonssaidtheycallforsuchX-rayswhencountsdonotaddup.

Butthesystemisfarfromfoolproof.ChunliuZhan,aphysicianandresearcherforthefederalAgencyforHealthcareResearchandQuality,foundthatthismistakeoccurs2,700timesayearintheUnitedStates....Whilemedicalexpertshavebeentryingtodoawaywiththiserrorfordecades,regulatorshavebeenslowtocollectcasesandstudythem.

Gauzepads—“sponges”inmedicallingo—wereleftbehindtwiceasoftenassurgicalinstruments.Gauzecantrapfluidandleadto[potentiallyfatal]infections,whileinstrumentscanpunctureanorgan.Nearlyallrequireasecondoperationtoberemoved[unlessthepatientexpiresbeforetheproblemisdiscovered].259Thedifficultyintracingdeathsresultingfromfailuretoremovespongesandinstrumentsfrombody

cavitiesisthatifapatientwhohashadsurgeryduetoillnessdies,particularlyathome,anautopsyisoftennotrequiredbecausethedeathisattributedtothedisease,nottoanunsuspectedforeignobject.

Thesearethekindsoferrorsthatareapparentlynotbeingreportedbyhospitals,lamentsJoshGoldsteinofThePhiladelphiaInquirer:“‘Anybodythatissupposedtoreportclosecallsandhaszeroreportsisclueless,’saidJamesBagian,headoftheDepartmentofVeteransAffairs’NationalCenterforPatientSafety.‘Managementisasleepattheswitchandjustwaitinguntiltheykillsomeone.’”260

Thereisatwo-prongedSurgicalSafetyChecklist:pre-surgical,aswellaspost-operativechecklistproceduresnowhelptopreventsurgicalmisadventure/death.Whileitisnotanabsoluteguaranteeofsafety,itappearstohelp.

AlexB.Haynes,MD,MPH,oftheHarvardSchoolofPublicHealthandMassachusettsGeneralHospital,andhiscolleaguesstateintheirarticle,“ASurgicalSafetyChecklisttoReduceMorbidityandMortalityinaGlobalPopulation,”publishedintheJanuary29,2009,issueoftheNewEnglandJournalofMedicine:

Surgicalcomplicationsarecommonandoftenpreventable.Wehypothesizedthataprogramtoimplementa19-itemsurgicalsafetychecklistdesignedtoimproveteamcommunicationandconsistencyofcarewouldreducecomplicationsanddeathsassociatedwithsurgery.

Surgicalcareanditsattendantcomplicationsrepresentasubstantialburdenofdiseaseworthyofattentionfromthepublichealthcommunityworldwide.Datasuggestthatatleasthalfofallsurgicalcomplicationsareavoidable.

In2008,theWorldHealthOrganization(WHO)publishedguidelinesidentifyingmultiplerecommendedpracticestoensurethesafetyofsurgicalpatientsworldwide.Onthebasisoftheseguidelines,wedesigneda19-itemchecklistintendedtobegloballyapplicableandtoreducetherateofmajorsurgicalcomplications.261

TheNewYorkTimesreportsintheirJanuary14,2009,article,“ChecklistReducesDeathsinSurgery”byEricNagourney,that“ayearaftersurgicalteamsateighthospitalsadopteda19-itemchecklist,theaveragepatientdeathratefellmorethan40percentandtherateofcomplicationsfellbyaboutathird.”262

[Thechecklistincludes]arequirementthatthenursingstaffconfirmthateverythinghasbeensterilizedandthatallequipmentneededispresent.Teammembersmustalsoconfirmthatthepatienthasbeengivenantibioticsaheadofthesurgery,ifcalledfor,toreducethechanceofinfection.Thechecklistalsorequiresteammemberstoverifythatthereisenoughbloodonhandifthereisariskofbloodloss,thatapieceofequipmentthatmeasuresbloodoxygenationisworkingandthatallthemedicalimagesneededarepresent.

Beforetheoperationbegins,thechecklistcallsfortheteamtoconfirmtheidentityofthepatientandthenatureoftheprocedure.Afterward,thedoctorsandnursesaresupposedtoreviewwhathasbeendone,includingdiscussinganyspecialstepsthatneedtobetakentoaidrecoveryandconfirmingnoequipmenthasbeenleftinthepatient....

Theresearchersreviewedtheoutcomeof7,688patientswhowereundergoingnoncardiacsurgeryatthehospitals.Abouthalfthepatientshadsurgerybeforethechecklistswereadopted,andhalfafter.Attheendofthestudy,theaveragedeathratedroppedto0.8percentfrom1.5percent,andtheaveragecomplicationratefellto7percentfrom11percent.263

FewMedicalProceduresSubjecttoClinicalTrialIn1978,theUSOfficeofTechnologyAssessment(OTA)reported,“Only10–20%ofallprocedures

currentlyusedinmedicalpracticehavebeenshowntobeefficaciousbycontrolledtrial.”264In1995,theOTAcomparedmedicaltechnologyineightcountries(Australia,Canada,France,Germany,theNetherlands,Sweden,theUK,andtheUS)andagainnotedthatfewmedicalproceduresintheUShavebeensubjectedtoclinicaltrial.ItalsoreportedthatUSinfantmortalitywashighandlifeexpectancylowcomparedtootherdevelopedcountries.265Legally,theOTAcouldnotbecensored,butitcouldbeshutdown.

ThecongressionalOfficeofTechnologyAssessment(OTA)closeditsdoorsSeptember29,1995.For23years,thenonpartisananalyticalagencyassistedCongresswiththecomplexandhighlytechnicalissuesthatincreasinglyaffectoursociety.[UnderPresidentBillClinton,]the104thCongressvotedtowithdrawfundingforOTAanditsfull-timestaffof143persons,andcoveronlyaskeletonstaffandtheamountneededfortheagency’sfinalcloseout.266AJanuary30,2009,headlinereads,“HospitalsareStillNeglectingtoReportSeriousMistakes”:

DespitelawsinNewJerseyandPennsylvaniarequiringhospitalstoreportmajormedicalerrors,unanticipatedcomplications,andnearmissestostateagenciesforthepurposeofreducingmedicalmistakes,expertssaythathospitalsinbothstatesareneglectingtoreportthesekindsofincidents....

In2007,majormedicalerrorsinPennsylvaniaincludedaccidentallyleavingsurgicalequipmentinsidetwoseparatepatientsatFoxChaseCancerCenter.AtAbingtonMemorialHospitalin2005,awomanrecoveringfromhipsurgerydevelopedopenbedsoresafterbeingleftlyingonabedpanforseveralhours.Inatotalviolationofstatelaw,noneoftheseincidentswasreportedbythehospitalsresponsible.

TheseindividualreportingfailuresareindicativeofalargertrendacrossPennsylvaniaandNewJersey.In2007,fiveoutofthe80hospitalsinNewJerseyneglectedtoreportasinglepreventablemedicalerrortostateagencies.Similarly,ahandfulofPennsylvaniahospitalsreportednoseriouseventsandnonearmissesthatcouldhavehurtpatients.267

Thenortheastisnottheonlyplaceinthenationfailingtocomply:Toputthisinperspective,JamesConway,aqualityexpertattheInstituteforHealthcare

ImprovementinCambridge,Mass.,saysthatonaverage,100patientmedicalchartsdocumentabout40instancesofpatientharm.Whenwecomparethesestatisticstotheonescominginfromhospitals,itbecomesapparentthatunderreportingisbothpervasiveandprofound.268Thereisa“currentclimateofsloppyenforcement.”Itisimperative“tomakecertainthathospitals

anddoctorsareheldresponsibleforseriouspatientharm,”269ormorecomplicationsanddeathswilloccur.

SurgicalErrorsCost$9BillionAnOctober2003JAMAstudyfromtheUSgovernment’sAgencyforHealthcareResearchand

Quality(AHRQ)documented32,000mostlysurgery-relateddeathscosting$9billionandaccountingfor2.4millionextrahospitaldaysin2000.270Datafrom20%ofthenation’shospitalswereanalyzedfor18differentsurgicalcomplications,includingpost-operativeinfections,foreignobjectsleftinwounds,surgicalwoundsreopening,andpost-operativebleeding.

Inapressreleaseaccompanyingthestudy,AHRQdirectorCarolynM.Clancy,MD,noted,“ThisstudygivesusthefirstdirectevidencethatmedicalinjuriesposearealthreattotheAmericanpublicandincreasethecostsofhealthcare.”271Accordingtothestudy’sauthors,“Thefindingsgreatlyunderestimatetheproblem,sincemanyothercomplicationshappenthatarenotlistedinhospitaladministrativedata.”Theyadded,“Themessagehereisthatmedicalinjuriescanhaveadevastatingimpactonthehealthcaresystem.Weneedmoreresearchtoidentifywhytheseinjuriesoccurandfindwaystopreventthemfromhappening.”

Thestudyauthorssaidthatimprovedmedicalpractices,includinganemphasisonbetterhandwashing,mighthelpreducemorbidityandmortalityrates.InanaccompanyingJAMAeditorial,health-riskresearcherDr.SaulWeingartofHarvard’sBethIsraelDeaconessMedicalCenterwrote,“Giventheirstaggeringmagnitude,theseestimatesareclearlysobering.”272

Therearetwoinitiativesunderwaynowtoaddresssurgicalerrorsdirectly.Theyarepre-operativeandpost-operative.

UnnecessaryX-raysWhenX-rayswerediscovered,nooneknewthelong-termeffectsofionizingradiation.Inthe1950s,

monthlyfluoroscopicexamsatthedoctor’sofficewereroutine,andyoucouldevenwalkintomostshoestoresandseeX-raysofyourfootbones.WestilldonotknowtheultimateoutcomeofourinitialfascinationwithX-rays.

Inthosedays,itwascommonpracticetoX-raypregnantwomentomeasuretheirpelvisesandmakeadiagnosisoftwins.Finally,astudyof700,000childrenbornbetween1947and1964in37majormaternityhospitalscomparedthechildrenofmotherswhohadreceivedpelvicX-raysduringpregnancytothoseofmotherswhodidnot.Itfoundthatcancermortalitywas40%higheramongchildrenwhosemothershadbeenX-rayed.273

Inpresent-daymedicine,coronaryangiographyisaninvasivesurgicalprocedurethatinvolvessnakingatubethroughabloodvesselinthegroinuptotheheart.Toobtainusefulinformation,X-raysaretakenalmostcontinuously,withminimumdosagesrangingfrom460to1,580mrem.TheminimumradiationfromaroutinechestX-rayis2mrem.X-rayradiationaccumulatesinthebody,andionizingradiationusedinX-rayprocedureshasbeenshowntocausegenemutation.Thehealthimpactofthishighlevelofradiationisunknown,andoftenobscuredinstatisticaljargonsuchas,“Theriskforlifetimefatalcancerduetoradiationexposureisestimatedtobe4in1millionper1,000mrem.”274

Dr.JohnGofmanhasstudiedtheeffectsofradiationonhumanhealthfor45years.AmedicaldoctorwithaPhDinnuclearandphysicalchemistry,Dr.GofmanworkedontheManhattanProject,discovereduranium–233,andwasthefirstpersontoisolateplutonium.

Infivescientificallydocumentedbooks,Dr.Gofmanprovidesstrongevidencethatmedicaltechnology—specificallyX-rays,CTscans,andmammographyandfluoroscopydevices—areacontributingfactorto75%ofnewcancers.Inanearly700-pagereportupdatedin2000,“RadiationfromMedicalProceduresinthePathogenesisofCancerandIschemicHeartDisease:Dose-ResponseStudieswithPhysiciansper100,000Population,”275GofmanshowsthatasthenumberofphysiciansincreasesinageographicalareaalongwithanincreaseinthenumberofX-raydiagnostictestsperformed,therateofcancerandischemicheartdiseasealsoincreases.

GofmanelaboratesthatitisnotX-raysalonethatcausethedamagebutacombinationofhealthriskfactorsthatincludepoordiet,smoking,abortions,andtheuseofbirthcontrolpills.Dr.Gofmanpredictsthationizingradiationwillberesponsiblefor100millionprematuredeathsoverthenextdecade.

InhisbookPreventingBreastCancer,Dr.GofmannotesthatbreastcanceristheleadingcauseofdeathamongAmericanwomenbetweentheagesof44and55.Becausebreasttissueishighlysensitivetoradiation,mammogramscancausecancer.

Thedangercanbeheightenedbyotherfactors,includingawoman’sgeneticmakeup,preexistingbenignbreastdisease,artificialmenopause,obesity,andhormoneimbalance.276

TheJournaloftheNationalCancerInstitutepublishedthefollowingstatementsintheir2004paper,“Full-BodyCTScreening:PreventingorProducingCancer?”byR.Twombly.“Full-bodycomputedtomography(CT)screeningmayconstitutemoreofacancerriskthanacancerfoil,sayresearcherswho...likentheradiationexposureduringasinglescantothatexperiencedwithinmilesofaWorldWarIIatombombexplosion.”277

TheSeptember2004issueofRadiologyincludesanarticlebyDavidBrenner,Ph.D.,ProfessorofRadiationOncologyandPublicHealthatColumbiaUniversityinNewYork.

[Brenner]estimatedthedoseofradiationtothelungorstomachfromasinglefull-bodyCTscantobe14–21milligrays(mGy,aunitofabsorbedradiation).Thatcorrespondstoadoseregion—about1.5milesfromtheblastofanatomicbomb—forwhichthereisdirectevidenceofincreasedmortalityamongatomicbombsurvivors,Brennersaid.Theexposureis“equalto100chestX-raysor100mammograms,”hesaid.278Inthelastfewyears,independentcompaniesofferingfull-bodyCTscanshasdoubled.TheCTscan

ispopularwiththewell-to-domiddle-agedandseniors“whoarewillingtopayanaverageof$1,000toensurethattheiragingbodiesarenotharboringtumorsorotherincipientdiseases.”279TheydonotknowthattheymaywelldevelopmalignantneoplasticdiseaseasaresultoftheCTscanitself.

EvenX-raysforbackpaincanleadsomeoneintocripplingsurgery.Dr.JohnE.Sarno,awell-knownNewYorkorthopedicsurgeon,foundthatthereisnotnecessarilyanyassociationbetweenbackpainandspinalX-rayabnormality.HecitesstudiesofnormalpeoplewithoutatraceofbackpainwhoseX-raysindicatespinalabnormalitiesandofpeoplewithbackpainwhosespinesappeartobenormalonX-ray.280PeoplewhohappentohavebackpainandshowanabnormalityonX-raymaybetreatedsurgically,sometimeswithnochangeinbackpain,worseningofbackpain,orevenpermanentdisability.

Moreover,doctorsoftenorderX-raysasprotectionagainstmalpracticeclaims,togivetheimpressionofleavingnostoneunturned.Itappearsthatdoctorsareputtingtheirownfearsbeforetheinterestsoftheirpatients.

UnnecessaryHospitalizationNearly9million(8,925,033)peoplewerehospitalizedunnecessarilyin2001.281–284Inastudyof

inappropriatehospitalization,twodoctorsreviewed1,132medicalrecords.Theyconcludedthat23%ofalladmissionswereinappropriateandanadditional17%couldhavebeenhandledinoutpatientclinics.Thirty-fourpercentofallhospitaldaysweredeemedinappropriateandcouldhavebeenavoided.285

Therateofinappropriatehospitaladmissionsin1990was23.5%.286In1999,anotherstudyalsofoundaninappropriateadmissionsrateof24%,indicatingaconsistentpatternfrom1986to1999.287TheHCUPdatabaseindicatesthatthetotalnumberofpatientdischargesfromUShospitalsin2001was37,187,641,288meaningthatalmost9millionpeoplewereexposedtounnecessarymedicalinterventioninhospitalsandthereforerepresentalmost9millionpotentialiatrogenicepisodes.289–292

NosocomialInfectionsTherateofnosocomial(in-hospital)infectionsper1,000patientdaysrosefrom7.2in1975to9.8in

1995,a36%jumpin20years.Reportsfrommorethan270UShospitalsshowedthatthenosocomialinfectionrateitselfhadremainedstableovertheprevious20years,withapproximately5–6hospital-acquiredinfectionsoccurringper100admissions.Duetoprogressivelyshorterinpatientstaysandtheincreasingnumberofadmissions,however,thenumberofinfectionshasincreased.

Itisestimatedthatin1995,nosocomialinfectionscost$4.5billionandcontributedtomorethan88,000deaths,oronedeatheverysixminutes.293The2003incidenceofnosocomialmortalityisprobablyhigherthanin1995becauseofthetremendousincreaseinantibiotic-resistantorganisms.MorbidityandMortalityReportfoundthatnosocomialinfectionscost$5billionannuallyin1999,294representinga$0.5billionincreaseinjustfouryears.Atthisrateofincrease,thecurrentcostofnosocomialinfectionswouldbecloseto$6billion,ormore.

AsmentionedearlierinTable1(page27),theCDCreportsthatthenumberofdeathsfromhealthcare-associatedinfectionsinhospitalsalonehasrisento99,000peryear.Someofthesedeathsmaybeduetopoorhygieneonthepartofphysicians.295,296

AccordingtoHealthGrades’sSecondAnnualPatientSafetyinAmericanHospitalsReport,May2005:

IfAmericanhospitalsweretoimplementwhatweknowworks,manycostlycomplicationscouldbeavoidedandliveswouldbesaved.Forexample,weknowthatwashinghandsbeforepatientcontactisasimpleandeffectiveprocessthatisproventoreducehospital-acquiredinfectionrates.297

OutpatientIatrogenesisIna2000JAMAarticle,Dr.BarbaraStarfieldpresentswell-documentedfactsthatarebothshocking

andunassailable.298,299TheUSranks12thof13industrializedcountrieswhenjudgedby16healthstatusindicators.Japan,Sweden,andCanadawerefirst,second,andthird,respectively.Morethan40millionpeopleintheUShavenohealthinsurance,and20–30%ofpatientsreceivecontraindicatedcare.

Starfieldwarnedthatonecauseofmedicalmistakesisoveruseoftechnology,whichmaycreatea“cascadeeffect”leadingtostillmoretreatment.SheurgestheuseofICD(InternationalClassificationofDiseases)codesthathavedesignationssuchas“Drugs,Medicinal,andBiologicalSubstancesCausingAdverseEffectsinTherapeuticUse”and“ComplicationsofSurgicalandMedicalCare”tohelpdoctorsquantifyandrecognizethemagnitudeofthemedicalerrorproblem.

Starfieldnotesthatmanydeathsattributabletomedicalerrortodayarelikelytobecodedtoindicatesomeothercauseofdeath.SheconcludesthatagainstthebackdropofourpoorhealthreportcardcomparedtootherWesterncountries,weshouldrecognizethattheharmfuleffectsofhealthcareinterventionsaccountforasubstantialproportionofourexcessdeaths.

StarfieldcitesWeingart’s2000article,“EpidemiologyofMedicalError,”aswellasotherauthorsto

suggestthatbetween4%and18%ofconsecutivepatientsinoutpatientsettingssufferaniatrogeniceventleadingto:

116millionextraphysicianvisits77millionextraprescriptionsfilled17millionemergencydepartmentvisits8millionhospitalizations3millionlong-termadmissions199,000additionaldeaths$77billioninextracosts300

6Women’sExperienceinMedicine

Hysteria

Dr.MartinCharcot(1825–1893)wasworld-renowned,themostcelebrateddoctorofhistime.HepracticedintheParishospitalLaSalpetriere.Hebecameanexpertinhysteria,diagnosinganaverageof10hystericalwomeneachday,transformingtheminto“iatrogenicmonsters”andturningsimple“neurosis”intohysteria.301Thenumberofwomendiagnosedwithhysteriaandhospitalizedrosefrom1%in1841to17%in1883.

“Hysteria”isderivedfromtheLatinhystera,meaninguterus.AccordingtoDr.AdrianeFugh-Berman,USmedicinehasatraditionofexcessivemedicalandsurgicalinterventionsonwomen.Only100yearsago,maledoctorsbelievedthatfemalepsychologicalimbalanceoriginatedintheuterus.Whensurgerytoremovetheuteruswasperfected,itbecamethe“cure”formentalinstability,effectingaphysicalandpsychologicalcastration.

Fugh-BermannotesthatUSdoctorseventuallydisabusedthemselvesofthatnotionbuthavecontinuedtotreatwomenverydifferentlythantheytreatmen.302Shecitesthefollowingstatistics:

Thousandsofprophylacticmastectomiesareperformedannually.OnethirdofUSwomenhavehadahysterectomybeforemenopause.Womenareprescribeddrugsmorefrequentlythanaremen.Womenaregivenpotentdrugsfordiseaseprevention,whichresultsindiseasesubstitutiondue

tosideeffects.FetalmonitoringisunsupportedbystudiesandnotrecommendedbytheCDC.303Itconfines

womentoahospitalbedandmayresultinahigherincidenceofcesareansection.304(Fetalmonitorisalsoaninstrumentinadvertentlyleftinbodycavityofthemother.)

Normalprocessessuchasmenopauseandchildbirthhavebeenheavily“medicalized.”Synthetichormonereplacementtherapy(HRT)doesnotpreventheartdiseaseordementia,but

doesincreasetheriskofbreastcancer,heartdisease,stroke,andgallbladderattack.305Asmanyasathirdofpostmenopausalwomenusenon-natural(synthetic)HRT.306,307This

numberisimportantinlightofthemuch-publicizedWomen’sHealthInitiativestudy,whichwashaltedbeforeitscompletionbecauseofahigherdeathrateinthesyntheticestrogen–progestin(HRT)group.308

HysterectomyPerhapsthemostinfamousandoftenunnecessarysurgicalprocedureisthehysterectomy,especially

whenperformedonwomenclosetomenopause,afterwhichmanyadversesymptoms,suchasuterinebleeding,disappearwiththenaturalreductionofestrogenlevels.

“Sincethe1960s,hysterectomyhasbeenoneofthemostfrequentlyperformedinpatientsurgicalproceduresintheUnitedStates,withanestimated33%ofwomenundergoingahysterectomyby60yearsofage,”accordingtotheCDC.309Itisclearfromthesestatisticsthatuntilthelate1980s(orlater),one-thirdofallwomenintheUShadhysterectomies.Itisprobablethatmanymoreweretoldtohaveahysterectomy(itwas“infashion”),butiftheywentforasecondopiniontoamoreconservativedoctor,

skilledatconsideringtheircasecarefullyonanindividualbasis,theymightbetoldtojustgohome.Itiswellknownthatmanyofthesewomenlivedwellintotheireightieswithouttherecommendedsurgery,accordingtoempiricalevidence.

Thehysterectomyiscontroversialtothisday,butmanydoctorsaremorecautiousnowbeforetheyperformtheseoperationsthatprojectwomenintoprematuremenopause,andtheywillreservethissurgeryforlife-savingpurposesonly,notfor“comfort”frompainorbleeding.Thissurgerymayplacewomenatgreaterriskfordisease,asitshiftshormonalbalancedrastically.

CesareanSectionIn1983,809,000cesareansections(21%oflivebirths)wereperformedintheUS,makingitthe

nation’smostcommonobstetric-gynecologic(ob-gyn)surgicalprocedure.Thesecondmostcommonob-gynoperationwashysterectomy(673,000),followedbydiagnosticdilationandcurettageoftheuterus(632,000).In1983,ob-gynproceduresrepresented23%ofallsurgeriescompletedintheUS.310

In2001,cesareansectionwasstillthemostcommonob-gynsurgicalprocedure.Approximately4millionbirthsoccurannually,with24%(960,000)deliveredbycesareansection.IntheNetherlands,only8%ofbirthsaredeliveredbycesareansection.Thissuggests640,000unnecessarycesareansections—entailingthreetofourtimeshighermortalityandtwentytimesgreatermorbiditythanvaginaldelivery311—areperformedannuallyintheUS.

TheUScesareanraterosefromjust4.5%in1965to24.1%in1986.Sakalacontendsthatan“uncontrolledpandemicofmedicallyunnecessarycesareanbirthsisoccurring.”312VanHamreportedacesareansectionpostpartumhemorrhagerateof7%,ahematomaformationrateof3.5%,aurinarytractinfectionrateof3%,andacombinedpostoperativemorbidityrateof35.7%inahigh-riskpopulationundergoingcesareansection.313

7PoorCareoftheElderly

Bedsores

Over1millionpeopledevelopbedsoresinUShospitalseveryyear.Itisatremendousburdentopatientsandfamily,anda$55billionhealthcareburden.314Bedsoresarepreventablewithpropernursingcare.Itistruethat50%ofthoseaffectedareinavulnerableagegroupofover70.

Intheelderly,bedsorescarryafourfoldincreaseintherateofdeath.Themortalityrateinhospitalsforpatientswithbedsoresisbetween23%and37%.315Evenifwe

justtakethe50%ofpeopleover70withbedsoresandthelowestmortalityat23%,thatgivesusadeathrateduetobedsoresof115,000.Criticswillsaythatitwasthediseaseoradvancedagethatkilledthepatient,notthebedsores,butourargumentisthatanearlydeath,bydenyingpropercare,deservestobecounted.Itisonlyaftercountingtheseunnecessarydeathsthatwecanthenturnourattentiontofixingtheproblem.

MalnutritioninNursingHomesTheGeneralAccountabilityOffice(GAO),aspecialinvestigativebranchofCongress,cited20%of

thenation’s17,000nursinghomesforviolationsbetweenJuly2000andJanuary2002.Manyviolationsinvolvedseriousphysicalinjuryanddeath.316

AreportfromtheCoalitionforNursingHomeReformstatesthatatleastonethirdofthenation’s1.6millionnursinghomeresidentsmaysufferfrommalnutritionanddehydration,whichhastenstheirdeath.Thereportcallsforadequatenursingstafftohelpfeedpatientswhoarenotabletomanageafoodtraybythemselves.317Itisdifficulttoplaceamortalityrateonmalnutritionanddehydration.

Thecoalitionreportstatesthatcomparedwithwell-nourishedhospitalizednursinghomeresidents,malnourishedresidentshaveafivefoldincreaseinmortalitywhentheyareadmittedtoahospital.Multiplyingtheonethirdof1.6millionnursinghomeresidentswhoaremalnourishedbyamortalityrateof20%318,319resultsin108,800prematuredeathsduetomalnutritioninnursinghomes.

WarehousingOurEldersOnewaytomeasurethemoralandethicalfiberofasocietyisbyhowittreatsitsweakestandmost

vulnerablemembers.Insomecultures,elderlypeopleliveouttheirlivesinextendedfamilysettingsthatenablethemtocontinueparticipatinginfamilyandcommunityaffairs.Americannursinghomes,wheremillionsofoureldersgotoliveouttheirfinaldays,representthepinnacleofsocialisolationandmedicalabuse:

InAmerica,approximately1.6millionelderlyareconfinedtonursinghomes.By2050,thatnumbercouldbe6.6million.320,321

Twentypercentofalldeathsfromallcausesoccurinnursinghomes.322Hipfracturesarethesinglegreatestreasonfornursinghomeadmissions.323Nursinghomesrepresentareservoirfordrug-resistantorganismsduetooveruseof

antibiotics.324

Presentingareporthesponsoredentitled“AbuseofResidentsIsaMajorProbleminUSNursing

Homes”onJuly30,2001,Rep.HenryWaxman(D–CA)notedthat“asasocietywewillbejudgedbyhowwetreattheelderly.”Thereportfoundonethirdofthenation’sapproximately17,000nursinghomeswerecitedforanabuseviolationinatwo-yearperiodfromJanuary1999toJanuary2001.325AccordingtoWaxman,“thepeoplewhocaredforusdeservebetter.”Thereportsuggeststhatthisknownabuserepresentsonlythe“tipoftheiceberg”andthatmuchmoreabuseoccursthatwearenotawareoforignore.326Thereportfound:

Over30%ofUSnursinghomeswerecitedforabuses,totalingmorethan9,000violations.Tenpercentofnursinghomeshadviolationsthatcausedactualphysicalharmtoresidentsor

worse.Over40%(3,800)oftheabuseviolationsfollowedthefilingofaformalcomplaint,usuallyby

concernedfamilymembers.Manyverbalabuseviolationswerefound,aswereoccasionsofsexualabuse.Incidentsofphysicalabusecausingnumerousinjuries,suchasfracturedfemurs,hips,elbows,

andwrists,alsowerefound.

Dangerouslyunderstaffednursinghomesleadtoneglect,abuse,overuseofmedications,andphysicalrestraints.In1990,Congressmandatedanexhaustivestudyofnurse-to-patientratiosinnursinghomes.Thestudywasfinallybegunin1998andtookfouryearstocomplete.327AspokespersonfortheNationalCitizens’CoalitionforNursingHomeReformcommentedonthestudy:

Theycompiledtworeportsofthreevolumes,eachthoroughlydocumentingthenumberofhoursofcareresidentsmustreceivefromnursesandnursingassistantstoavoidpainful,evendangerous,conditionssuchasbedsoresandinfections.YetittooktheDepartmentofHealthandHumanServicesandSecretaryTommyThompsononlyfourmonthstodismissthereportas“insufficient.”328Althoughpreventablewithpropernursingcare,bedsoresoccurthreetimesmorecommonlyin

nursinghomesthaninacutecareorveteranshospitals.329Becausemanynursinghomepatientssufferfromchronicdebilitatingconditions,theirassumedcause

ofdeathoftenisunquestionedbyphysicians.Somestudiesshowthatasmanyas50%ofdeathsduetorestraints,falls,suicide,homicide,andchokinginnursinghomesmaybecoveredup.330,331Itispossiblethatmanynursinghomedeathsareinsteadattributedtoheartdisease.Infact,researchershavefoundthatheartdiseasemaybeover-representedinthegeneralpopulationasacauseofdeathondeathcertificatesby8–24%.Intheelderly,theover-reportingofheartdiseaseasacauseofdeathisasmuchastwofold.332

Whenelucidatingiatrogenesisinnursinghomes,somecriticshaveasked,“Towhatextentdidtheseelderlypeoplealreadyhavelife-threateningdiseasesthatledtotheirprematuredeathsanyway?”Ourresponseisthatifalovedonediesoneday,oneweek,oneyear,adecade,ortwodecadesprematurelyasaresultofsomemedicalmisadventure,thatisstillanuntimelyiatrogenicdeath.Inalegalisticsenseperhapsmoreweightisplacedonthelossofmanypotentialyearscomparedtoanadditionalfewweeks,butthisattitudeisnotjustifiedinanethicalormoralsense.

Thatveryfewstatisticsexistconcerningmalnutritioninacutecarehospitalsandnursinghomesdemonstratesthelackofconcerninthisarea.WhileasurveyoftheliteratureturnsupfewUSstudies,onerevealingUSstudyevaluatedthenutritionalstatusof837patientsina100-bedsubacutecarehospitalovera14-monthperiod.Thestudyfoundonly8%ofthepatientswerewellnourished,while29%weremalnourishedand63%wereatriskofmalnutrition.Asaresult,25%ofthemalnourishedpatientsrequiredreadmissiontoanacutecarehospital,comparedto11%ofthewellnourishedpatients.Theauthorsconcludedthatmalnutritionreachedepidemicproportionsinpatientsadmittedtothissubacute

carefacility.333Manystudiesconcludethatphysicalrestraintsareanunderreportedandpreventablecauseofdeath.

Studiesshowthatcomparedtonorestraints,theuseofrestraintscarriesahighermortalityrateandeconomicburden.334–336Studieshavefoundthatphysicalrestraints,includingbedrails,arethecauseofatleast1inevery1,000nursing-homedeaths.337–339

Deathscausedbymalnutrition,dehydration,andphysicalrestraints,however,arerarelyrecordedondeathcertificates.Severalstudiesrevealthatnearlyhalfofthelistedcausesofdeathondeathcertificatesforelderlypeoplewithchronicormulti-systemdiseaseareinaccurate.340Althoughoneinfivepeoplediesinnursinghomes,anautopsyisperformedinlessthan1%ofthesedeaths.341

OvermedicatingSeniorsTheCDCseemstobefocusingonreducingthenumberofprescriptionstochildren,buta2003study

findsover-medicationofUSelderly.Dr.RobertEpstein,chiefmedicalofficerofMedcoHealthSolutionsInc.(aunitofMerck&Co.),conductedastudyin2003ofdrugtrendsamongtheelderly.342Hefoundthatseniorsaregoingtomultiplephysicians,gettingmultipleprescriptions,andusingmultiplepharmacies.Medcooverseesdrug-benefitplansformorethan60millionAmericans,including6.3millionseniorswhoreceivedmorethan160millionprescriptions.

Accordingtothestudy,theaverageseniorreceives25prescriptionseachyear.Amongthose6.3millionseniors,atotalof7.9millionmedicationalertsweretriggered:lessthanhalfthatnumber,3.4million,weredetectedin1999.About2.2millionofthosealertsindicatedexcessivedosagesunsuitableforseniors,andabout2.4millionalertsindicatedclinicallyinappropriatedrugsfortheelderly.

ReutersinterviewedKaseyThompson,directoroftheCenteronPatientSafetyattheAmericanSocietyofHealthSystemPharmacists,whonoted:“ThereareseriousandsystemicproblemswithpoorcontinuityofcareintheUnitedStates.”Hesaysthisstudyrepresents“thetipoftheiceberg”ofanationalproblem.343

AccordingtoDrugBenefitTrends,theaveragenumberofprescriptionsdispensedpernon-MedicareHMOmemberperyearrose5.6%from1999to2000,from7.1to7.5prescriptions.TheaveragenumberdispensedforMedicaremembersincreased5.5%,from18.1to19.1prescriptions.344ThetotalnumberofprescriptionswrittenintheUSin2000was2.98billion,or10.4prescriptionsforeveryman,woman,andchild.345

Inastudyof818residentsofresidentialcarefacilitiesfortheelderly,94%werereceivingatleastonemedicationatthetimeoftheinterview.Theaverageintakeofmedicationswasfiveperresident;theauthorsnotedthatmanyofthesedrugsweregivenwithoutadocumenteddiagnosisjustifyingtheiruse.346

SeniorsandgroupsliketheAmericanAssociationofRetiredPersons(AARP)haveacceptedallopathicmedicine’soverridingassumptionthataginganddyinginAmericamustbeaccompaniedbydrugsinnursinghomesandeventualhospitalization.347Seniorsaregiventhechoiceofeitherhigh-costpatenteddrugsorlow-costgenericdrugs.Drugcompaniesattempttokeepthemostexpensivedrugsontheshelvesandsuppressaccesstogenericdrugs,despitefacingstifffinesofhundredsofmillionsofdollarsleviedbythefederalgovernment.348,349In2001,someoftheworld’slargestdrugcompanieswerefinedarecord$871millionforconspiringtoincreasethepriceofvitamins.350

Whatifsomeofthesechronicdiseasesarereallylifestylediseasescausedbydeficiencyofessentialnutrients,lackofcare,inappropriatemedication,overmedication,andisolation?Thisquestionisextremelyimportanttoconsider,yetcurrentAARPrecommendationsfordietandnutritionassumethatseniorsaregettingallthenutritiontheyneedinanaveragediet.Atmost,AARPsuggestsaddingextracalciumandamultivitaminandmineralsupplement.351WewouldurgeAARPtobecomemoreinvolvedinpreventionofdisease,andnottorelysoheavilyondrugs.Wewouldliketosendthesamemessageto

theHemlockSociety,whichofferseuthanasiaoptionstochronicallyillpeople,especiallythoseinseverepain,whomayhavebecomedepressed.Wemustlooktohealing,liftingpain,releasingdepression,insteadofcashingingranny’schips.Let’salsolookattheironyofunderuseofproperpainmedicationforpatientswhoreallyneedit.

Ironically,studiesdoindicateunderuseofappropriatepainmedicationforpatientswhoneedit.Onestudyevaluatedpainmanagementinagroupof13,625cancerpatients,aged65andover,livinginnursinghomes.Whilealmost30%ofthepatientsreportedpain,morethan25%receivednopain-reliefmedication,16%receivedamildanalgesicdrug,32%receivedamoderateanalgesicdrug,and26%receivedadequatepain-relievingmorphine.Theauthorsconcludedthatolderpatientsandminoritypatientsweremorelikelytohavetheirpainuntreated.352

Thetimehascometosetastandardforcaringforthevulnerableamongus—astandardthatgoesbeyondmakingsuretheyarehousedandfed,andnotopenlyabused.Wemuststoplookingtheotherwayandwe,asasociety,musttakeresponsibilityforthewayinwhichwedealwiththosewhoareunabletocareforthemselves.

8MedicalEthicsandConflictsofInterestinScientific

Medicine

JonathanQuick,directorofessentialdrugsandmedicinespolicyfortheWorldHealthOrganization(WHO),wroteinaWHObulletin:

Ifclinicaltrialsbecomeacommercialventureinwhichself-interestoverrulespublicinterestanddesireoverrulesscience,thenthesocialcontractwhichallowsresearchonhumansubjectsinreturnformedicaladvancesisbroken.353AsformereditoroftheNewEnglandJournalofMedicine,Dr.MarciaAngellstruggledtobring

greaterattentiontotheproblemofcommercializingscientificresearch.Inheroutgoingeditorialentitled“IsAcademicMedicineforSale?”Angellwrotethatgrowingconflictsofinterestaretaintingscience,andcalledforstrongerrestrictionsonpharmaceuticalstockownershipandotherfinancialincentivesforresearchers:“Whentheboundariesbetweenindustryandacademicmedicinebecomeasblurredastheyarenow,”Angellwrote,“thebusinessgoalsofindustryinfluencethemissionofmedicalschoolsinmultipleways.”ShedidnotdiscountthebenefitsofresearchbutsaidaFaustianbargainnowexistedbetweenmedicalschoolsandthepharmaceuticalindustry.354

AngelllefttheNewEnglandJournalinJune2000.InJune2002,TheNewEnglandJournalofMedicineannouncedthatitwouldacceptjournalistswhoacceptmoneyfromdrugcompaniesbecauseitwastoodifficulttofindoneswhohavenoties.Anotherformereditorofthejournal,Dr.JeromeKassirer,saidthatwasnotthecaseandthatplentyofresearchersareavailablewhodonotworkfordrugcompanies.355AccordingtoanABCNewsreport,pharmaceuticalcompaniesspendover$2billionayearonover314,000eventsattendedbydoctors.

TheABCNewsreportalsonotedthatasurveyofclinicaltrialsrevealedthatwhenadrugcompanyfundsastudy,thereisa90%chancethatthedrugwillbeperceivedaseffective,whereasanon-drug-company-fundedstudywillshowfavorableresultsonly50%ofthetime.Itappearsthatmoneycan’tbuyyoulove,butitcanbuyany“scientific”resultdesired.

CynthiaCrossen,astafferfortheWallStreetJournal,in1996publishedTaintedTruth:TheManipulationofFactinAmerica,abookaboutthewidespreadpracticeoflyingwithstatistics.356Commentingonthestateofscientificresearch,shewrote:“Theroadtohellwaspavedwiththefloodofcorporateresearchdollarsthateagerlyfilledgapsleftbyslashedgovernmentresearchfunding.”Herdataonfinancialinvolvementshowedthatin1981,thedrugindustry“gave”$292milliontocollegesanduniversitiesforresearch.By1991,thisfigurehadrisento$2.1billion.

Universitieshavebeentreadingondangerousgroundwiththeirincreasinglycomplexfinancialtiestoindustry....Theyareworriedthatthesethingscouldultimatelyaffecttheirtax-freestatus,”Dr.KassirersaidinSeptember2008.357InSeptember2008,

TheWallStreetJournalreportedthatChairoftheSenateFinanceCommitteeSen.ChuckGrassley...confrontedabout20universitiesacrossthenation,includingBrown,HarvardandStanfordforfailingtopublicizeadditionalgrantsobtainedfromdrugmakers.358Theuniversityisnottheonlyvenueforpharmaco-gifts.“Rightnowthepublichasnowaytoknow

whetheradoctor’sbeengivenmoneythatmightaffectprescribinghabits,”Grassleysaidasheintroduced

thePhysicianPaymentsSunshineActforpublicdisclosureofpaymentstophysicians.Sen.Grassleycontinues:

Paymentstoadoctorcanbebigorsmall.Theycanbeasimpledinnerafterworkortheycanadduptotensofthousandsandevenhundredsofthousandsofdollarseachyear.That’sright—hundredsofthousandsofdollarsforonedoctor.It’sreallyprettyshocking.Companieswouldn’tbepayingthismoneyunlessithadadirecteffectontheprescriptionsdoctorswrite,andthemedicaldevicestheyuse.Patients,ofcourse,areinthedarkaboutwhethertheirdoctorisreceivingthismoney.

Thispractice,andthelackoftransparencyaroundit,canobscurethemostimportantquestionthatexistsbetweendoctorandpatient:whatisbestforthepatient?359

”MoreStudies!”ScientistsclaimedtherewereneverenoughstudiesrevealingthedangersofDDTandother

dangerouspesticidestobanthem.Theyalsousedthisargumentfortobacco,claimingthatmorestudieswereneededbeforetheycouldbecertainthattobaccoreallycausedlungcancer.EventheAmericanMedicalAssociation(AMA)wascomplicitinsuppressingtheresultsoftobaccoresearch.In1964,whentheSurgeonGeneral’sreportcondemnedsmoking,theAMArefusedtoendorseit,claiminganeedformoreresearch.Whattheyreallywantedwasmoremoney,whichtheyreceivedfromaconsortiumoftobaccocompaniesthatpaidtheAMA$18millionoverthenextnineyears,duringwhichtheAMAsaidnothingaboutthedangersofsmoking.360

TheJournaloftheAmericanMedicalAssociation(JAMA),“aftercarefulconsiderationoftheextenttowhichcigaretteswereusedbyphysiciansinpractice,”beganacceptingtobaccoadvertisementsandmoneyin1933.StatejournalssuchastheNewYorkStateJournalofMedicinealsobegantorunadvertisementsforChesterfieldcigarettesthatclaimedcigarettesare“Justaspureasthewateryoudrink...andpracticallyuntouchedbyhumanhands.”In1948,JAMAargued,“Morecanbesaidinbehalfofsmokingasaformofescapefromtensionthanagainstit...theredoesnotseemtobeanypreponderanceofevidencethatwouldindicatetheabolitionoftheuseoftobaccoasasubstancecontrarytothepublichealth.”361Today,scientistscontinuetousetheexcusethatmorestudiesareneededbeforetheywillsupportrestrictingtheinordinateuseofdrugs.

9Conclusion

WhatRemainstoBeUncovered

Ourongoingresearchwillcontinuetoquantifythemorbidity,mortality,andfinanciallossdueto:

X-rayexposure(mammography,fluoroscopy,CTscans)OveruseofantibioticsforallconditionsCarcinogenicdrugs(hormonereplacementtherapy,†immunosuppressiveandprescription

drugs)CancerchemotherapySurgeryandunnecessarysurgery(cesareansection,radicalmastectomy,preventivemastectomy,

radicalhysterectomy,prostatectomy,cholecystectomies,cosmeticsurgery,arthroscopy,etc.)DiscreditedmedicalproceduresandtherapiesUnprovenmedicaltherapiesOutpatientsurgeryDoctorsthemselves

InDecember2000,agovernmentscientificadvisorypanelrecommendedthatsyntheticestrogenbeaddedtothenation’slistofcancer-causingagents.HRT,eithersyntheticestrogenaloneorcombinedwithsyntheticprogesterone,isusedbyanestimated13.5to16millionwomenintheUS.362TheabortedWomen’sHealthInitiativeStudy(WHI)of2002showedthatwomentakingsyntheticestrogencombinedwithsyntheticprogesteronehaveahigherincidenceofbloodclots,breastcancer,stroke,andheartdisease,withlittleevidenceofosteoporosisreductionordementiaprevention.WHIresearchers,whousuallynevermakerecommendationsexcepttosuggestmorestudies,adviseddoctorstobeverycautiousaboutprescribingHRTtotheirpatients.363–368

Resultsofthe“MillionWomenStudy”onHRTandbreastcancerintheUKwerepublishedinmedicaljournalTheLancetinAugust2003.AccordingtoleadauthorProf.ValerieBeral,directoroftheCancerResearchUKEpidemiologyUnit,“Weestimatethatoverthepastdecade,useofHRTbyUKwomenaged50–64hasresultedinanextra20,000breastcancers,estrogen-progestagen(combination)therapyaccountingfor15,000ofthese.”369

Wewereunabletofindstatisticsonbreastcancer,stroke,uterinecancer,orheartdiseasecausedbyHRTusedbyAmericanwomen.BecausetheUSpopulationisroughlysixtimesthatoftheUK,itispossiblethat120,000casesofbreastcancerhavebeencausedbyHRTinthepastdecade.

Accordingtothearticle“BreastCancerRiskRemainsAfterStoppingHRT,”publishedonMarch5,2008,

WomenwhotookestrogenplusprogestinintheWomen’sHealthInitiative(WHI)trialofhormonereplacementtherapy(HRT)remainathigherriskofbreastcancerthreeyearsafterthetrialwasstopped,comparedwiththosewhotookplacebo....

Dr.GerardoHeiss(UniversityofNorthCarolina,ChapelHill)andcolleaguesreporttheirfindingsintheMarch5,2008issueoftheJournaloftheAmericanMedicalAssociation....“Whatwasnotanticipatedwasthegreaterriskofmalignanciesoverall....”saidDr.Heiss.

TheWHItrialofestrogenplusprogestinincluded16,608postmenopausalwomenandsetoutto

examinewhetherconjugatedequineestrogens(CEE)plusmedroxyprogesteroneacetate(MPA)preventedcardiovasculardiseaseandfracturesandtoexamineanyassociatedchangeintheriskofbreastcancer.Thetrialwasstoppedprematurelyin2002whendataindicatedanincreasedriskofbreastcancerandunexpected,higherrisksofstroke,MI,andvenousthromboembolism.

Inthenewanalysis,Heissandcolleaguesexaminedtherisk/benefitbalanceof15,730oftheparticipantsafterthetrialwasstoppedinJuly2002outtoMarch2005....Theannualizedeventratesfortheoutcome“allcancers”washigherduringthepostinterventionfollow-upfortheHRTgroup(1.56%peryear)comparedwiththeplacebogroup(1.26%peryear).Thiswasprimarilyduetoagreaterriskofinvasivebreastcancer:79womenwhotookHRTdevelopedbreastcancerinthepostinterventionphasecomparedwith60whogotplacebo....“Thehormones’effectsonbreastcancerappeartolinger,”saysDr.LeslieFord(NationalCancerInstitute,Bethesda,MD)....

ThereissomeevidencethatHRTisassociatedwithdecreasedsurvivalinwomenwithlungcancer.

DrElizabethG.Nabel(director,NationalHeart,Lung,andBloodInstitute,Bethesda,MD)alsowarns,“Thesefindingsalsoindicatethatwomenwhotakeestrogenplusprogestincontinuetobeatincreasedriskofbreastcancer,evenyearsafterstoppingtherapy.Today’sreportconfirmsthestudy’sprimaryconclusionthatcombinationhormonetherapyshouldnotbeusedtopreventdiseaseinhealthy,postmenopausalwomen.”Heissagrees:“Thebalanceofthebenefitsandrisksofestrogenplusprogestintherapycontinuestobeunfavorableafterstoppingtherapy,”heexplainedtoHeartWire.“Assuch,thesefindingsconfirmtheresultsoftheWHIstudyasoriginallypublished—thisisnotapreparationthatoughttobeusedoverlongperiodstopreventchronicdisease.That’sitinanutshell.

“Overall,thesummaryofbenefitsandrisksappearstobeunfavorable,”Heissreiterates,“andthissuggeststhatvigilanceisrequiredaftertheuseofthesepreparations.Womenshouldtakecareoftheirhealthandlifestyle....”

TheresultsoftheWHItrial[include]increasedrisksformyocardialinfarction,stroke,deepvenousthrombosis,andbreastcancerassociatedwithactivetreatment.Aglobalindexsuggestedthattheoverallrisksforhormonetherapyoutweighedanybenefits.370WhathasyettobeuncoveredaboutthisHRTiswhythetrialscontinuedaslongastheydidwiththe

women’slivesatstake.Wedonotrecommendsynthetichormonereplacementtherapy.

SummaryTheOfficeofTechnologyAssessment(OTA)wasperhapstheUSgovernment’slasthonestagency

thatcriticallyreviewedthestateofthenation’shealthcaresystem.ThepurposeoftheOTAwastoprovideCongresswithobjectiveandauthoritativeanalysisofcomplexscientificandtechnicalissues.Initsfinalcriticalreport,theOTAconcluded:“Therearenomechanismsinplacetolimitdisseminationoftechnologies,regardlessoftheirclinicalvalue.”

ShortlyaftertheOTAreleasedareportthatexposedhowentrenchedfinancialinterestsmanipulatehealthcarepracticeintheUnitedStates,CongressdisbandedtheOTA.

Someonehassaidthathealthcareistheonlybusinesswhereyoukeeppayingwhetheryougetgoodresultsornot.Wedonottoleratepoorserviceinthenon-medicalmarketplace,yetwehaveaccepteditforyearsinhealthcare.Foryears,ournationhasavoidedresponsibilityforexaminingthismajorhealthcrisis,toourownmountingperil.Now,wehaveaniatrogenicepidemic.MoreAmericansaredyingeachyearatthehandsofmedicinethanallofourAmericancasualtiesintheFirstWorldWarandtheCivilWarcombined.

Whywouldhighlytrainedmedicaldoctorscontinuetofollowfailingprotocolsyearafteryear,producingnegativeresults?Thechemotherapystudiescitedinthispapershowthatthecytotoxicityis

damagingthequalityoflifeandoftencausingdeath.Thereasonthemedicalestablishmentcancontinuetobetraythepublictrustisbecausethereareno

sufficientconsequencesforkillingormaimingpatients.Thephysicianisrewardedforhisefforts,notforhisresults.Itistakenforgrantedthatifyouhavechemotherapy,youwillbemaimed,andpossiblykilled.Thepatientevensignsawayhisorherrightsbeforesurgery,sothatthesurgeonandhospitalareprotectedeveniftheyarenegligent.

Theproprietaryinterestsconnectedwiththeseapprovedprotocolsmakethemattractiveforphysiciansandhospitalstofollow.Thepharmaceuticalcompaniesrewardphysicianswhobuyandusetheirdrugs.Grantsareofferedtohospitalsforresearch.Manyfinancialincentivespavethewayforacceptanceofprotocolsthatprovedeadlyandcostly.Medicalstudentsareevenofferedincentivesthroughsponsorshipbydrugcompaniestoprescribecertaindrugsassoonastheyareabletodoso.

ThepublichasacceptedtheFaustianbargainthathisphysicianhasmadewiththedrugcompaniesbecausethepatientbelievesthereisnootherchoice.Hemusttaketendifferentprescriptiondrugsifheisover60.Hemusthaveinvasivetests.HemusthaveaCTscanwiththepowerof100chestX-rays.Hemustrespondtothedirect-to-consumerpharmaceuticaladvertisingandaskhisdoctortoprescribeTVmeds,despitethehorrificside-effectswarnings.Thepublicnowreceivestelevisionmessagesthatappeartobecomingfromavunculardoctors,buttheyarereallycomingfromBigPharmatogetyourmoney.

Whenitcomestochoosingbetweenpreventionofdisease,atleastwhereaconditioncouldbeprevented,ortreatmentofdisease,itisadvantageoustotheallopathicdoctortochoosetreatment.Thereisrewardinchoosingtreatmentbecausethedrugcompaniesofferincentivestodoctorswhobuytheirproducts.Preventionismoreaboutvitaminsandsupplementsandtheyarefarlesslucrativeforpharmaceuticalcompanies.Thereisnowacampaigntoraisethepricesofthesenaturalproductsthathavefew,ifany,sideeffects.Aprescriptionmaybenecessarysoontoobtainthevitaminsthatarenowsoreadilyavailableatreasonableprices.Wehavethedrugcompaniestothankforthis.

Forexample,ifanhonestjournalistwishestodoanarticleonthebenefitsofSt.John’sWortforminordepression,hemaycallseveralgovernmentagenciesforastory.IfthejournalistpresentsevidencethatSt.John’sWortishelpful,theFDAandtheCDCmayencouragethejournalisttopromotemoreproventherapies,suchasexpensiveprescriptionanti-depressants.TheymayencourageorevenpaythejournalisttodownplayanymeritsofSt.John’sWort.Thisiswherethedrugcompaniesinterferewiththepublic’seducationaboutnaturalremedies.Thefar-reachingarmofthepharmaceuticalcompany’sinfluenceevenextendstothefalsificationofnutrientstudies,inordertopromoteprescriptiondrugsinstead.Thereiscurrentlyasystematicprogramtodefameeverynaturalvitamin,supplement,andhealthfoodthroughouttheworld.

Corruptionisrampantwhenlegislatorspayjournaliststodoahatchetjobonnaturalpreventiveremedies,sothatthepublicwillbuyprescriptiondrugs.Wherehonestscientistsdoexist,theyhavenopowertooverridethecorruption.Thepricetheywouldpayforwritingorspeakingthetruthaboutthedrugcompanyinvasionintomodernmedicine,orforcensuringacolleagueforcause,isthatthedoctororresearcherwouldbealienated,unabletogetgrants,unabletopublish,possiblyevenunabletowork.Thatrarecourageousdoctorwouldhavehiscareerdestroyed,thoughhisgoodcharacterwouldbeintact.

Themedicalenvironmenthasbecomealabyrinthofinterlockingcorporate,hospital,andgovernmentalboardsofdirectorsandadvisors,infiltratedbythedrugcompanies.Thereareevenghostwriterswhoaredrugcompanyrepresentativeswhowriteglowingarticlesaboutpharmaceuticals,thentheyaresignedbywell-knownphysicianswhoarepaidhandsomelyfortheircooperation,thoughtheymaynotknowalloftheadverseside-effectsofthedrugstheypromote.Thephysiciansarepaidtogivepositivereviewsofdrugcompanystudies;theyarepaidtoendorsechemicalsthatmayharmpatientsbecausethereisarushtogetthedrugsonthemarket.Themosttoxicsubstancesareoftenapprovedfirst.Milderalternativesmaybeignoredforfinancialreasons.

Drugcompaniesnowcontrolthedisseminationofcontinuingeducationcoursestodoctors,andtheremaybesomebrainwashinggoingon;adsinmedicalpublicationsarecontrolledbydrugcompanies;informationgiventotheFDAtopromoteisinfluencedbydrugcompanies;drugcompaniesmaypaytheFDAtoreviewtheirstudiesfavorably.Influenceisforsale.

Thereareastronomicalprofitsincooperatingwiththedrugcompanies.DrugcompaniesarebehindMedicare,sothatpeopleremainovermedicated;ortheyreceivethepropermedicationsathigherdosestosellmore,withinjuryordeathasaconsequence.

Drugcompaniespayourlegislators,ourscientists,theNAS.DrugcompanieshavepropagandacampaignslaunchedthroughtheCDC,suchasarushtovaccinatethemomenta“birdflu”appearsonthehorizon.Vaccinateinfants,children,teens,adults,elders,eachoneapotentiallylucrativemarketingniche,evenanopportunitytoselldrugstootherwisehealthypeople.Whynotmakethesevaccinationsmandatory?Forceustopayforpossiblesideeffects,“forourowngood.”Frighttacticsareusedtopetrifythepublicintorushingtopayforvaccinesthatmayprovedebilitatingorworse.

Allofthisisdonewithawinkandanod.Notacentisspentonprevention(exceptpseudo-preventionthroughtoxicinoculationsthatdonotreallypreventdisease,andmaycauseharm);instead,everydollargoesfortreatment.

Themedia,scientists,professors,universities,hospitals,governmentalagencies,suchastheFDA,theEPA,andtheCDC,areallhavingabanquetatthepharmaceuticaltable.Thisisnotthewaytopracticemedicine.Everysooften,bravephysicianslikeDrs.GraemeMorgan,RobynWard,andMichaelBartonstandupandtellthetruth,aboutcytotoxicchemotherapy,inthiscase,asintheirarticleinClinicalOncology,“TheContributionofCytotoxicChemotherapyto5-yearSurvivalinAdultMalignancies.”Curativeandadjuvantchemotherapyisonly2.1%effectiveinAmericainthisstudy;withnoprogressinthefieldoverthepast20years.

Therearealsoafewthousandcomplementaryphysicianswhoarehelpingpatients.Manycomplementaryhealthcareprovidersaredeniedpublicationthroughtheinterventionofpharmaceuticalcompanies.Ifthey,ortheirallopathiccolleagues,domanagetospeakoutagainstcorruptionintheestablishment,theyareconsideredtraitorstothemedicalbrotherhood.Thisisnotascientificcommunity;insteadofobjectivityandcompassion,ourmedicalsystemispoweredbyweakness,greed,envy,andfear.Thereareexceptions,suchasDr.DavidGrahamoftheFDA.

Medicinealsohasmanyspectacularbreakthroughsandmodalitiesforhelpingpeopletohealandsurvive—butletuscontinuetodeterminewhatdoesnotworkandrequestthatimprovementsbemade.Letusbehonestaboutthecausesofourillnesses.Youraveragedoctorisnottellingyouthatyourlifestylemaybemakingyouill,andthatyoucandosomethingeconomicaltoimproveyourhealth,andpossiblyreducetheneedforcostlymedicationheprescribes(neverchangeyourmedicationdosagewithoutyourdoctor’sapproval).Youareyourdoctor’s“client.”

Thecumulativedailyeffectsofsteaks,colas,pizzas,pollution,computers,cellphones,andpesticidesplaceusinatoxicsoupenvironment.Insteadofcleaningthisup,manyturntomedicationforhelp.Drugcompaniesarepayingourlegislators,televisionandradiostations,schools,andnewsoutletstokeepthisinformationfromyou.YouareBigPharma’s“client.”BPwantsyour“account.”Andtheypaythequackbusterstoattackanyonewhotellsyouthetruthaboutwhatisreallymakingyousickenoughtoseekexpensive“care”fromthenumberonesourceoffatalitiesinAmerica,carethatmightreadilykillyouandyourlovedones:deathbymedicine.

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Notes

*TheJointCommission’sUniversalProtocolforPreventingWrongSite,WrongProcedure,WrongPersonSurgery[updatedversion,effectiveJanuary1,2009]isavailableathttp://www.jointcommission.org/PatientSafety/UniversalProtocol/;accessedFebruary1,2009.

†Partofourongoingresearchwillbetoquantifythemortalityandmorbiditycausedbyhormonereplacementtherapy(HRT)sincethe1940s.

Index

AAARP(AmericanAssociationofRetiredPersons)AbbottLaboratoriesABCNewsAbel,UlrichABHM.SeeAmericanBoardofHospitalMedicineAccutaneacid.Seestomachacidacnedrug.SeeAccutaneacquiredimmunodeficiencysyndrome.SeeAIDSacuteliverfailureADRs.Seeadversedrugreactionsadvancedcarcinomaadversedrugreactions(ADRs)causesofmortalityassociatedwithstatisticsrelatingtounderreportingofAdvilAgencyforHealthcareResearchandQuality(AHRQ)AHRQ.SeeAgencyforHealthcareResearchandQualityAIDS(acquiredimmunodeficiencysyndrome)albuterolasthmainhalersallopathicmedicineAlonso-Zaldivar,RicardoAltman,DrewE.AMA(AmericanMedicalAssociation)tobaccofundingofAmericanAssociationofRetiredPersons.SeeAARPAmericanBoardofHospitalMedicine(ABHM)AmericanCollegeofSurgeonsAmericanMedicalAssociation.SeeAMAAmericanPsychiatricAssociationAmericanSocietyofHealth-SystemPharmacistsanalgesicsanaphylaxisanemiaanesthesiaAngell,Marciaantibioticresistanceantibioticsmisuseofresistancetoantidepressantsantihistaminesanti-inflammatoryagentsappendectomyAravaArchivesofInternalMedicineArmedForcesInstituteofPathologyarthroscopyartificialmenopauseasthma“ASurgicalSafetyChecklisttoReduceMorbidityandMortalityinaGlobalPopulation”

BBagian,JamesBailey,Blake

Barton,MichaelBaycolBayerBedellbedsoresbenignbreastdiseaseBeral,ValerieBesser,RichardBethIsraelDeaconessMedicalCenterBigPharmaBingaman,Jeffbioidenticalhormonesbiostatisticsbirthcontrolpillsbirthdefectsblindnessbloodclotsdisordersinfectionsbreastcancer“BreastCancerRiskRemainsAfterStoppingHRT”breastimplantsBrenner,DavidBritishMedicalJournalBrodie,Mollyannbronchitis

Ccalcium-channelblockersCampbell,ErikCampylobacterjejunicancerbreastcervicaluterinex-raysandcardiacpacemakerinsertioncarotidendarterectomiescascadeeffectcatheterinsertionsCDC(CenterforDiseaseControlandPrevention)Cedars-SinaiMedicalCenterCEEs.SeeconjugatedequineestrogensCenterforDiseaseControlandPrevention.SeeCDCCenterforDrugEvaluationandResearchCenteronPatientSafetycesareansectionCharcot,Martin“ChecklistReducesDeathsinSurgery”chemotherapyadverseeffectsof“ChemotherapyofAdvancedEpithelialCancer”cholecystectomiescholesterol-loweringdrugClancy,CarolynM.ClinicalOncologyclinicaltrialsinadequacyofCoalitionforNursingHomeReformCohen,JayColumbiaUniversitycomorbidconditionsconflictsofinterest

CongressionalBudgetOfficeCongressionalCommitteeonInterstateandForeignCommerceconjugatedequineestrogens(CEEs)“ContributionofCytotoxicChemotherapyto-yearSurvivalinAdultMalignancies,The”Conway,JamescoronaryangiographycoronaryarterysurgeryCrossen,CynthiaCTscanscytotoxicchemotherapy

DdandelionrootDateline(NBC)DDTdecongestantdeep-veinthrombosisdehydrationdementiadepressionDGL.SeedeglycyrrhizinatedlicoriceDHEAdiabetesdrug.SeeRezulindiarrheadilationandcurettageoftheuterusdirect-to-consumeradvertising(DTCA)disease-causingfactorsdislocationsdizziness“DoctorsDon’tReportMedicalErrors”DrugBenefitTrendsdrugcompanies.Seealsospecificdrugcompaniesbynamedrugs,pharmaceutical.Seealsospecificdrugsbynameadvertisingofcarcinogeniccardiovascularoveruseofsideeffectsofweightloss“drugswitch”drugtestingDTCA.Seedirect-to-consumeradvertisingDVA(DepartmentofVeteransAffairs).SeeVeteransAffairs,USDepartmentof

EearinfectionsEarle,CraigC.elderberryelectrolytedisordersemesisemphysemaendoscopy,gastrointestinaltractEnterococcienvironmentaltoxins“EpidemiologyofMedicalError”epithelialcancerEpstein,Roberterrorreportingerythromycinestrogen,synthetic

Ffatigue“FDAandDrugSafety:AProposalforSweepingChanges,The”

FDA(USFoodandDrugAdministration)andADRsanddrugcompaniesanddrugsafetyandnaturalmedicinecultureoffinesFen-PhenfetalmonitoringfetaltoxicityfeverflufluoroscopyFoodandDrugAdministration,US.SeeFDAFord,LeslieFoxChaseCancerCenter(PA)fracturesFrankfordHospital“FrequencyandCostofChemotherapy-RelatedSeriousAdverseEffectsinaPopulationSampleofFugh-Berman,AdrianeFurberg,CurtD.

GGable,DonaldgallbladderattackgangreneGAO(GeneralAccountabilityOffice,US)garlicgastrectomyforobesitygastricbypassgastro-esophagealrefluxdisease.SeeGERDGeneralAccountabilityOffice,US.SeeGAOGetSmartAboutAntibioticsWeekGofman,JohnGoldstein,Josh“government-approved”medicineGraham,DavidGrassley,CharlesEGroupAbeta-hemolyticstreptococciGundersenLutheranMedicalCenter

HHAIs.Seehealthcare-associatedinfectionsHarvardMedicalPracticeStudyHarvardMedicalSchoolHarvardSchoolofPublicHealthHassett,MichaelJ.Haynes,AlexB.HCUP(HealthcareCostandUtilizationProject)headachesHealthandHumanServices,USDepartmentof(HHS)healthcarecostsandspendingsafetyunnecessaryhealthcare-associatedinfections(HAIs)HealthcareCostandUtilizationProject.SeeHCUPHealthcareEconomist(website)healthcaretechnologiesHealthGrades’sSecondAnnualPatientSafetyinAmericanHospitalsReporthealthinsuranceheartarrhythmiadisease

failurevalveinjuryheartburn.Seealsoacidreflux;antacids;GERDHeartWireHeinrich,JanetHeiss,GerardoHelicobacterpylori.SeeH.pyloriHelpern,MiltonhematomaHemlockSocietyhemolyticanemiahemorrhagicstrokeheparinHHS(DepartmentofHealthandHumanServices).SeeHealthandHumanServices,USDepartmentofHicks,Laurihigh-dosechemotherapy.Seechemotherapy,adverseaffectsofhipfracturesHochman,J.S.Hodgkin’sdiseasehormoneimbalancehormonereplacementtherapy(HRT)risksassociatedwith“hospitalists”hospitalizationHospitalMedicineHouseSubcommitteeonOversightandInvestigationsHRT.Seehormonereplacementtherapyhydrochloricacid.SeeHCL(HCL-pepsin)hyperthyroidism.SeeGraves’diseasehysterectomyhysteria

Iiatrogenesisandadversedrugreactionsandimpropertransfusionsandinjuriesandoutpatientcareandwrong-sitesurgeriesdeathfrominnursinghomes.SeenursinghomesICD((InternationalClassificationofDiseases)immunesystemIndianaUniversitySchoolofMedicine“infallibilitymodel”ofmedicineinfantmortalityinfectionsinguinalherniaoperationsInjuryBoard.comInstituteforHealthcareImprovementInstituteofMedicineinstitutionalreviewboards(IRBs)insurancefraudintensivecareunit(ICU)errorrateInternationalClassificationofDiseases.SeeICDionizingradiationIRBs(institutionalreviewboards)irritablebowelsyndrome“IsAcademicMedicineforSale?”ischemiaischemiccolitis

J

JAMA(JournaloftheAmericanMedicalAssociation)tobaccofundingofJohnsHopkinsUniversitySchoolofMedicineJointCommissionUniversalProtocolforPreventingWrongSite,WrongProcedure,WrongPersonSurgeryJournalofHealthAffairsJournaloftheAmericanMedicalAssociation.SeeJAMAJournaloftheNationalCancerInstitute

KKaiserFamilyFoundationKaldjian,LaurisKassirer,JeromekidneyfailurekidneyinfectionKneearthroscopy

LlactoferrinLancet,TheLaSalpetriereLauricella,PaulLazarou,JasonLeape,LucianL.lethargyLIBRAliverfailureLosAngelesTimesLotronexLutter

MMadisonAvenuemalignantneoplasticdiseasemammographyManhattanProjectMarkey,EdwardJ.MassachusettsGeneralHospitalmastectomies,prophylacticMcIntyreMedcoHealthSolutionsInc.medicalerrorsmedicalinjuriesMedicaremedicationerrorsmedroxyprogesteroneacetate(MPA)MedscapeMedicalNewsMemorialSloan–KetteringCancerCentermeningitisMerck&Co.methicillin-resistantStaphylococcusaureus(MRSA)migraines“MillionWomenStudy”MorbidityandMortalityReportMorgan,GraememortuarymuseumMotrinMRSAmultiplemyelomamyocardialinfarction(MI)

NNabel,ElizabethG.Nagourney,EricNaprosyn

NAS.SeeNationalAcademyofScience,USNationalAcademyofSciences,US(NAS)NationalCenterforHealthStatisticsNationalCenterforPatientSafetyNationalCitizens’CoalitionforNursingHomeReformNationalCoalitiononHealthcareNationalFoundationfortheTreatmentofPainNationalPatientSafetyFoundation(NPSF)naturalmedicinenauseanervedamageNewEnglandJournalofMedicineNewhouse,JosephP.NewYorkStateJournalofMedicineNewYorkTimesNewYorkUniversityMedicalCenternonsteroidalanti-inflammatorydrugs.SeeNSAIDsnosocomialinfectionsNPSF.SeeNationalPatientSafetyFoundationNSAIDs(nonsteroidalanti-inflammatorydrugs)nursinghomesabuseinbedsoresmalnutritionanddehydrationinnutraceuticalsnutritionalsupplements.SeesupplementsNYCChiefMedicalExaminer

OobesityOfficeofPostMarketingDrugRiskAssessmentOfficeofTechnologyAssessment(OTA)O’Malley,A.JamesOmnifloxoncologists“OperationCleanHands”Orszag,PeterosteoarthritisosteoporosisOTA.SeeOfficeofTechnologyAssessment

PpainmedicationPakes,JulianaR.patentmedicinecompanies.SeedrugcompaniesPatientSafetyandQualityImprovementActofPediatricspenicillinperitonitisPersell,Stephenpharmaceuticalcompanies.Seedrugcompaniespharmaco-epidemiologypharmacologytextsphenylpropanolamine.SeePPAPhiladelphiaEnquirerPhillips,JerryphysicalrestraintsPhysicianPaymentsSunshineActpneumoniaPopperPostalService,USpost-operativebleedingpost-operativeinfectionsPPA(phenylpropanolamine)

PreventingBreastCancerProgressivePolicyInstitute(PPI)prostate.Seesurgery,prostateprostatectomyPsychiatricTimespsychoactivepharmaceuticalpropagandaPublicCitizenHealthResearchGrouppulmonaryembolism

QQuaidTwinsQuick,Jonathan

RradiationexposuretoRadiologyRandCorporationReduxrenalfailureReutersRezulinrheumatoidarthritisRitalinRofecoxib.SeealsoVioxxrouteswitch

SSakalasalmonellaSarno,JohnE.Schering-Plough(Corp.)SchimmelSCT.Seestem-celltransplantseizuresSeldanesepticperitonitisserotoninreuptakeinhibitors.SeeSSRIsseveremuscleinjuryshockShojaniasmokingsocialanxietysorethroatSSRIs(serotoninreuptakeinhibitors)StaphylococcusaureusStarfieldSteelstem-celltransplant(SCT)St.John’sWortStreptococcuspneumoniaestressstrokeSubcommitteeonHealthcaresuicidessupplementsdietaryeffortstocurtailsurgerybackcataractchecklistcomplicationsfromdeathsfrom

implementsunremovedfromob-gynoveruseofprostatesiteinfectionsunnecessary

TTaintedTruth:TheManipulationofFactinAmericatertiarycarehospitalThompson,KaseyThompson,TommythyroiddisordersTierney,WilliamTierno,PhiliptonsillectomyTrovanTwombly,R.

U“UnderreportingofMedicalErrorsAffectingChildrenIsaSignificantProblem,ParticularlyamongPhysicians”uninsuredUnionofConcernedScientistsUniversityofPennsylvaniaunnecessarymedicaleventsunneededmedicaltreatmentuppergastrointestinaltractendoscopyupperrespiratorytractinfectionsurinarytractinfectionsUSSpends$BilliononUnnecessaryMedicalTestsuterinebleeding

Vvaccinesvalve.SeeLESvalveVanHamvenousthromboembolismVeteransAffairs,USDepartmentof(DVA)VietnamWarVioxx.SeealsoRofecoxib“VirginiaHasSpecialMedicalMalpracticeLawonRetainedSurgicalTowels”vitaminseffortstocurtailuseof

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AbouttheAuthors

Foroverthreedecades,GaryM.Null,PhD,hasbeenoneoftheforemostadvocatesofalternativemedicineandnaturalhealing.Anaward-winningjournalistandNewYorkTimesbest-sellingauthor,Dr.Nullhaswrittenover70booksonnutrition,self-empowerment,andpublichealthissues.Hissyndicatedpublicradioshow,“NaturalLivingwithGaryNull,”isthelongest-running,continuouslyairedhealthprograminAmerica.

AresearchscientistattheMt.SinaiSchoolofMedicineinNewYork,MartinFeldman,MD,hasauthoredseventy-fivepeer-reviewedresearcharticlesonneurophysiology,clinicalneurology,andneurochemistry.DeboraRasio,MD,isaresearcher,contributingauthor,andeditorofnumeroushealth-relatedbooksandinvestigativereports,including“IatrogenicDisease:TheDownsideofModernMedicine.”AndCarolynDean,MD,ND,isthemedicaldirectoroftheNutritionalMagnesiumAssociationandtheauthororcoauthorofeighteenbooks,includingTheMagnesiumMiracleandDeathbyModernMedicine.

SOMETHINGISWRONGwhenregulatoryagenciespretendthatnaturalhormonesandnutritionalsupplementsaredangerous,yetignorepublishedstatisticsshowingthatgovernment-sanctionedmedicineistherealhazard.

UNTILRECENTLY,thosewhochallengedthemedicalestablishmentcouldciteonlyisolatedstatisticstomakeacaseaboutthedangersofconventionalmedicine.Noonehadanalyzedandcompiledallofthepublishedliteraturedealingwithinjuriesanddeathscausedbytoday’smedicalsystem.

AGROUPOFRESEARCHERShasmeticulouslyreviewedthestatisticalevidence,andtheirfindingsareabsolutelyshocking.Theseresearcherspresentcompellingevidencethattoday’shealthcaresystemmightevencausemoreharmthangood.

THISFULLYREFERENCEDBOOKrevealshighnumbersofpeoplewhosufferin-hospitaladversereactionstoprescribeddrugs;areprescribedunnecessaryand/orinappropriateantibiotics;receiveunnecessarymedicalandsurgicalprocedures;andareexposedtounnecessaryhospitalization.

THEMOSTSTUNNINGSTATISTIC,however,isthatthetotalnumberofdeathscausedbyconventionalmedicineisnearly581,926peryear.ThisdatamakesitevidentthattheAmericanmedicalsystemisoneoftheleadingcausesofdeathandinjuryintheUS.

—WILLIAMFALOON,co-founder,LifeExtensionFoundation(www.lef.org)

TableofContentsPraiseforDeathbyMedicineTheAward-WinningFilmDocumentaryDeathbyMedicine

FilmFestivalAwardsDeathbyMedicineDeathbyMedicine

1IntroductionTable1:EstimatedAnnualMortalityandCostofMedicalInterventionTable2:EstimatedAnnualMortalityandCostofMedicalInterventionTable3:Estimated10-YearDeathRatesfromMedicalInterventionTable4:EstimatedTen-YearUnnecessaryMedicalEvents

2MedicallyInducedDeath:TheEquivalentofSixJumboJetsFallingOutoftheSkyEachDayIsAmericanMedicineWorking?HealthInsuranceUnderreportingofIatrogenicEventsTheFirstStudyofIatrogenesisOnlyaFractionofMedicalErrorsAreReportedNoImprovementinErrorReportingMedicalErrorsaGlobalIssuePublicSuggestionsonIatrogenesis

3ProblemswithDrugsMedicationErrorsAdverseDrugReactionsUnderreportingofSideEffectsMedicatingOurFeelingsTelevisionDiagnosisHowDoWeKnowDrugsAreSafe?DrugsPolluteOurWaterSupplyDrugCompaniesFined

4ProblemswithSpecificClassesofDrugsAntibioticsNSAIDSCancerChemotherapy

5AnHonestLookattheFailuresofAmericanHealthcareUnnecessarySurgicalProceduresHighMortalityRatesFewMedicalProceduresSubjecttoClinicalTrialSurgicalErrorsCost$9BillionUnnecessaryX-raysUnnecessaryHospitalizationNosocomialInfectionsOutpatientIatrogenesis

6Women’sExperienceinMedicineHysteriaHysterectomy

CesareanSection7PoorCareoftheElderly

BedsoresMalnutritioninNursingHomesWarehousingOurEldersOvermedicatingSeniors

8MedicalEthicsandConflictsofInterestinScientificMedicine”MoreStudies!”

9ConclusionWhatRemainstoBeUncoveredSummary

ReferencesNotesIndexAbouttheAuthors